Who We Are
“A small body of determined spirits fired by an unquenchable faith in their mission can alter the course of history.”
We are a dedicated team of proven medtech innovators, passionate about using our know-how and experience to make medical advancement happen.
Fogarty Innovation is led by seasoned executives who bring 250+ years of cumulative leadership experience from over 60 companies. In total, these companies have returned over $5 billion to investors through both public markets and private transactions. We have chosen to invest our time in Fogarty Innovation to give back to the community we love, and which has improved the lives of so many. Our team is complemented by our board of directors and our network of industry veterans, all of whom contribute meaningfully to our entrepreneur and student programs.
As mentors, we help early-stage technology companies cross the chasm from novel idea to notable solution. Our primary focus is to help our entrepreneurs become leaders, because we understand that early-stage investors are betting on the team, not just the technology. Investors seek leadership teams who have demonstrated the maturity and wherewithal to navigate problems and think creatively through business setbacks. Because, inevitably, the technology will change.
“Investors want more and more rigor around how you can build a business that can thrive and not just a widget that can be acquired.”
– Venture capitalist
Our real-world experience is broad and deep, yet we pride ourselves on being perpetual students, eager to broaden our own perspectives.
Clinical domain knowledge
Early and late venture capital
Small-to-large medtech strategic corporate partners
We operate out of a state-of-the-art Innovation Center located in the heart of the Silicon Valley on the campus of El Camino Health’s main hospital. Here, we co-locate and immerse ourselves with the companies we support and offer them access to needed resources in their quest to change the world.
Chief Executive Officer
As recounted by Greg Bakan
Andrew is a seasoned executive with over 30 years experience in the medical device industry. During this time, he has held key leadership positions in organizations ranging from early-stage startups to large multinationals. In joining Fogarty Innovation he further broadens this range of experience to include managing a nonprofit. The versatility required to be effective across such diverse groups is rare and is a testament to Andrew’s strong leadership skills.
A native Australian who grew up in a suburb of Melbourne, Andrew’s leadership capabilities became evident at an early age. Raised by a single parent, Andrew was forced to grow up quickly and play a supportive role for his mother and brother. These early experiences were formative in shaping the person Andrew would become and the things he would inevitably accomplish.
Andrew’s values and life philosophy were also greatly influenced by sport. His natural athleticism and leadership propelled him into many team captain roles and ultimately competing in Australian Rules Football at a semi-professional level. If you’ve never seen this sport played, do so. It won’t take long to recognize the toughness, teamwork and grit the sport demands, all traits which Andrew continues to bring to every position he holds.
After completing his undergraduate degree, Andrew began his medtech career working for the Australian Therapeutic Goods Administration. This provided an invaluable introduction to the industry along with an appreciation for the challenges regulators face when balancing innovation with protecting public health. Several years into this role, serendipity presented him with a unique opportunity to work for a company based in the United States. Although he had never lived outside Australia, he saw it as a great opportunity and moved alone to Denver, Colorado, to work for Telectronics. He probably didn’t realize it at the time, but this move exemplifies a classic element of Andrew’s personal and professional mindset: think big, set audacious goals and act boldly. At the time, Andrew expected this to be a two-year position. Thirty years later, he’s still in the U.S., setting and achieving big goals.
Andrew’s rapid career advancement during this timeframe has been impressive. After Telectronics, he accepted a management role at Baxter Healthcare’s Novacor division, and later as vice president of Clinical and Regulatory Affairs at Bay Area startup company Radiant Medical. Following this, he was CEO of Ardian, which pioneered the use of renal denervation to treat hypertension. Ardian was acquired by Medtronic in 2011 in a transaction valued at over $1.3B which, at the time, was the largest medical device acquisition ever for a pre-revenue medical device company.
Whenever a first time CEO has such a wildly successful exit, the market often wonders: Is the person really that good or were they just lucky? Andrew quickly answered that question by taking the role of CEO at Twelve, a startup in the transcatheter mitral valve space. Several years after his joining, this company was also acquired by Medtronic in a transaction valued at $458M. Back to back successes at such large valuations answered the question – it wasn’t just luck.
Propelled by these successes, Andrew has become a key figure in the medical device community. His leadership, experience and insights have led many organizations to seek his involvement. He currently serves on the board of three venture-funded companies — Saluda Medical, Zenflow, Inc. (chairman) and MMI S.p.A. (chairman). He also holds advisory positions at two top-tier venture capital firms: Longitude Capital and Arboretum Ventures. At a global industry level, he has been invited to serve on multiple initiatives including the UCSF-Stanford Pediatric Device Consortium; the Medical Device Innovation Consortium; and the Singapore government’s Biomedical Research Council (BMRC).
Passionate about healthcare, Andrew is a champion of innovators and innovation in the medtech field. His commitment to mentoring and education is rooted in his passion for helping patients and being a catalyst for positive change. This purpose and drive is captured in one of his favorite quotes, by Mahatma Gandhi: “A small body of determined spirits fired by an unquenchable faith in their mission can alter the course of history.”
“Working at Fogarty Innovation gives me the ability to positively influence the medtech ecosystem and give back in a meaningful and effective way,” summarizes Andrew. “To have worked with such amazing teammates on such impactful programs has allowed me to do something BOTH meaningful and enjoyable…I love the challenge.”
Andrew has received numerous awards and honors and is a frequent invited lecturer at major industry conferences and leading academic institutions. Andrew holds a BS in biophysics from the Swinburne Institute of Technology.
Engineer in Residence
As recounted by Laura Hamilton
With his love of repairing cars, building medical devices, or running a company, Bernie has been a hands-on, key contributor in the medical device industry for more than 30 years.
Bernie attributes his strong personal values and “will do” mindset to his parents, who immigrated from Germany to California a few years before he was born. Growing up, Bernie witnessed firsthand that almost anything was possible with a goal, a plan and a solid work ethic. A key formative example illustrates how he lived out his belief: his goal was to attend college; his plan was to use his talents as a mechanic; and his solid work ethic enabled him to earn and save enough money to cover his University of California, Davis, tuition.
After graduating from UC Davis with bachelor’s degrees in both mechanical engineering and materials science, Bernie applied for what he believed was an ideal engineering opportunity with a medtech company, a position he learned during the interview had already been filled. At that point, his career could have taken a drastic turn when he was offered more senior engineering positions at companies in other fields.
However, undeterred in his desire to follow his passion and armed with that “will do” mindset, Bernie got his first taste of the medtech world by joining DVI, a company that later became part of Guidant, in an entry-level position. He was quickly promoted to a role as an R&D engineer, designing and developing medical devices. That began an illustrious career in the medtech industry, where he has helped create therapies that have improved the quality of life of tens of thousands of individuals.
Over his career, Bernie has held senior management roles with both industry pillars and startups, including Chrono Therapeutics, Johnson & Johnson, Acclarent, The Foundry and Perclose. His decades of R&D engineering experiences provided him a solid foundation in innovation that led to him earn more than 100 medical device patents and co-found two companies, Xtent and ReSept Medical Inc.
Bernie appreciates the opportunity he has at Fogarty Innovation to work alongside a group of professionals who have already achieved excellence in their careers and now share their years of industry experience to mentor, support, educate and elevate the next generation of medtech innovators.
In his spare time, you can find Bernie serenading his fantastic family, or playing golf, or hiking. And if you know Bernie and his giving spirit, you wouldn’t be surprised to find him helping out his neighbors.
Director of Strategic Initiatives
As recounted by Andrew Cleeland
Greg has a deep passion for medtech. “A major driver for my interest in this field is the purpose-driven nature of the work. We’re developing products and services that directly improve patients’ lives.” Another attraction is that successful medtech innovation truly requires the integration of science and business know-how, both of which are areas of keen interest for Greg as reflected in his educational background.
That’s why he has devoted over 30 years to the medical device industry, holding senior management positions at several successful startup companies, including Ardian, Emphasys Medical, Nevro and Fox Hollow Technologies. In aggregate, these startups have generated more than $2.5 billion in returns to their investors, reflecting the impact on the thousands of patients who benefitted from their therapies.
Earlier in his career, he built a strong foundation working at larger, well-established companies, holding positions in marketing, sales, strategic planning and business development at Medtronic, Johnson & Johnson, Guidant and Eli Lilly and Company. Greg feels this early experience was invaluable and laid the foundation for his success in start-ups. “My time at the larger companies afforded me incredible training, the chance to work on a wide range of projects across many sectors, and most importantly, the opportunity to work with and learn from some of the best and brightest leaders in our industry,” notes Greg. Another advantage Greg sees in this early career experience is that it allows him to understand and work more effectively with larger companies which is critical since they form an important funding and exit pathway for medtech start-ups.
Greg sees his work with Fogarty Innovation as not only allowing him to pursue his passion for the medtech space, but also as a way to give back to an industry which has afforded him so many unique opportunities. He fondly recalls the many people throughout his career who were willing to take the time to share their insights, experience, and advice. This mentoring has had a life-changing impact on him both professionally and personally. The hope of “paying forward” this gift is a large part of what attracted Greg to Fogarty Innovation.
Fogarty’s Companies in Residence CEOs in turn have a great amount of respect for Greg’s keen strategic mind and seek him out to help them think through the chess moves they must consider as they steer their companies forward. As one of them said, “One of the things that attracted me most to Fogarty Innovation was my interaction with Greg and, now that I’ve joined, I am fully convinced that my collaboration with him and the rest of the management team has been incredible. He is a trusted resource.”
In his free time, Greg enjoys working with his hands, whether it’s woodworking or restoring old cars, and riding motorcycles. He also has a passion for teaching and occasionally gives guest lectures at Fogarty Innovation and Stanford University.
Greg holds a Bachelor of Arts in biology from the University of California, San Diego, and an MBA from the University of Michigan.
Director of Finance
As recounted by Julie Regan
Mariela began working with medtech startups because she loved the process of bringing ideas into fruition. Thirty years later, she is still in the field, enjoying the family environment and satisfaction of hearing stories from gratified patients whose lives have been improved by the devices she has helped support.
Mariela was inspired to launch her career in finance after an early job as an accounts payable clerk. She took her first position in medtech as an accountant with ADAC Laboratories, then went on to serve as an accounting manager for CardioThoracic Systems before moving on to positions of increasing responsibility at Boston Scientific, Spiracur, and Vascular Dynamics, among others. Most recently, she worked at PQ Bypass, which is an alumni company of Fogarty Innovation although she didn’t know it when she joined.
The unique needs of each company have kept Mariela happily challenged over the years, and she not only went to night school to add a bachelor’s degree in accounting to her associate’s degree, but has acquired expertise in HR and general finance in addition to corporate accounting. The variety not only keeps the work fresh, it also makes her an extremely valuable asset in startup companies where wearing multiple hats and shouldering a range of responsibilities is part of the landscape.
Mariela is still multi-tasking today. In addition to her current role at Fogarty Innovation, she serves as the director of finance for two of Fogarty’s current companies-in-residence, Boomerang Medical and Ryme, and is also helping with their HR needs. Although the medtech startup field is clearly Mariela’s wheelhouse, it is also a field that has her heart because she has seen the positive impact it can have on people.
When Mariela isn’t helping medical device companies bring new technologies into patient care, you find her attending concerts and art/wine festivals, unwinding at the beach, or just out walking her two pups, a German Shepherd and a Corgi. She likes to visit her eldest daughter, who recently enlisted in the Marines, and is looking forward to watching her youngest daughter graduate from high school.
As recounted by Birgit Johnston
With 17 years of experience working in the healthcare industry, Gretchen is always ready to extend a hand and tackle new programs and projects.
Prior to joining Fogarty Innovation, Gretchen oversaw a number of key communications initiatives at El Camino Health, including supporting internal services programs, managing events, directing patient and physician outreach and developing marketing campaigns. “Working with such a close-knit team of like-minded individuals was a real privilege,” she said. “While we weren’t in direct contact with the patients, we felt that the programs we launched went a long way towards supporting the hospital’s mission to heal, relieve suffering and advance wellness.”
Striving to continue making a deep impact on patients’ lives, she joined Fogarty Innovation as one of its first employees. As program manager, she plays an important role in supporting both the education and incubation programs by developing, managing and executing educational programs and events for the organization, its companies-in-residence, the FDA and the Ferolyn and Lefteroff fellowships. “I am honored to have been part of the organization since its inception and while we have grown, our mission to advance human health and personalized approach is still what we live by.”
Education is where she thrives—closely interacting with the students as she helps them learn the ins and outs of developing a medical device and explore different career paths, whether with a startup or larger company. She especially loves to hear from them later in life to learn how well they are doing and see how they are already giving back to the community, appreciating how their internship influenced their future success.
Gretchen also welcomes the chance to help support the entrepreneurs, watching them as they conquer their daily challenges and seize opportunities to develop and advance therapies, with the promise that one day they may help improve or save the lives of a significant number of patients.
An Ohio native, Gretchen likes to cook, particularly Italian favorites. She loves spending time at the coast for its beauty and fresh air and has recently found a new passion in meditating, which helps her tackle new challenges and opportunities that come her way.
Engineer in Residence
As recounted by Birgit Johnston
Whether he’s fabricating car parts in his backyard workshop or medtech devices at Fogarty Innovation, Peter is in his element building things and working with his hands. Like many Fogarty staff who found their inspiration in different fields, Peter’s initially came from the automotive sector; he’s been tinkering with cars since high school, where he discovered an affinity for identifying and solving various issues his classmates had with their vehicles.
After high school he joined De Anza College Auto Technology program, where he excelled at troubleshooting and helped lead the school’s participation in state and national competitions.
That led him to mechanic roles with BMW and Nissan and an initial plan to own his own shop. But then he got into car racing, and the experience offered the ideal background to pivot to fabricating and maintaining the cars.
Peter got his first taste of medical technology through a college friend who was working for one of Dr. Fogarty’s startups, Microline Surgical, a company dedicated to delivering precision instruments for minimally invasive surgery. It turned out that the initial troubleshooting they were doing with the wiring was very similar to the type of engineering work Peter was doing as a lead car mechanic, and he joined the company full time. It suited him fine as he was a hands-on kind of guy, who enjoyed going from the “napkin” design to market, improving through all the iterations to develop a product and get it to the end users.
He stayed there for 12 years until the company was eventually sold, when he began working as a consultant. One day he stumbled upon an article on Fogarty Innovation which caught his eye since he had met Dr. Fogarty while at Microline.
His interest piqued, he toured the facility and met the Terumo Medical Innovation team, which resides at the organization, and joined their team as an R&D engineering consultant. While there he parlayed his expertise in maintaining equipment into a position with Fogarty Innovation’s machine shop, which turned into a full-time job in 2021. It’s the perfect match for his skills and desire to constantly improve each prototype or part he builds.
He loves the opportunity to work with so many different technologies and is able to indulge his interest in passing on his skills by training the Lefteroff interns on how to program and run select machines.
No big surprise, but Peter spends much of his free time racing cars – he has three of his own. And, he also loves to camp and boat camp, with a race car or dirt bike along for the trip behind his motor home.
Zach Edmonds, MD
As recounted by John Morriss
As a hospitalist practicing at El Camino Health’s Mountain View hospital and a site director for the Palo Alto Medical Foundation (PAMF) Department of Hospital Medicine, Zach is, first and foremost, a clinician. He describes his hospitalist role as being the patient’s primary care physician while they are in the hospital. This involves building a rapport with the patient, identifying their needs, bringing the necessary resources together, and finding solutions. He says he is proudest of his professional success when he receives a note from a patient thanking him for the positive role he played in their care and the difference he made in their life during a time of great vulnerability and need.
He brings that passion to the companies and his projects within Fogarty Innovation as well. Zach provides what he describes as a clinical lens, a practitioner’s point of view, as he assesses potential innovations to anticipate whether they would be adopted by physicians and hospitals. Because he shares patients in common with physicians across various specialties, Zach understands his colleagues’ perspectives and the possible inertia that must be overcome to change clinical practice and adopt a novel system. Yet Zach remains an avid believer in innovation as he sees countless examples of unaddressed clinical needs in his daily life — conditions and diseases that lead to pain, suffering, and loss of life. “I am passionate about medtech for its potential to help address these unmet needs,” says Zach.
Fogarty Innovation is an opportunity he appreciates for the chance to support the efforts of young innovators. Zach plays a key role in clinical diligence, facilitating clinical research, and building collaborations with community physicians. He blends his clinical perspective with a business background, stressing that even early stage projects should establish how they will be cost-effective solutions.
He believes his work with Fogarty has enhanced the rest of his career, allowing him to be part of an incredibly rich, stimulating and rewarding “professional village.” That’s largely because of the resonance he finds between his own values and that of the Institute: mission-driven purpose, passion, hard work, accountability and excellence.
When he’s not in the hospital, you’ll find Zach with his wife and two daughters. Family dinners each evening, Friday movie night and discussion, and a Sunday ritual that starts off with the kids ceremoniously putting the family’s phones and iPads in a drawer and closing it are only a few examples of how they spend time together, being silly, having adventures, and learning new things.
Zach holds an MD from the UCLA School of Medicine and an MBA from the UCLA Anderson School of Management. He completed his internal medicine residency training and the Biodesign Fellowship at Stanford University.
Executive Director, Diversity by Doing HealthTech
Engineer in Residence
As recounted by John Morriss
In many ways Eric’s enthusiasm for solving problems, motivation to help patients, and expertise across clinical areas has found an ideal fit at Fogarty Innovation. As he describes, “I’ve known about Fogarty Innovation for a long time and have great respect for the team. I was very attracted by the diversity of initiatives at the organization – from innovation to education to outreach – and the variety of therapies and technologies the companies-in-development are pursuing.”
The son of a surgeon-innovator, Eric grew up planning to follow in his father’s footsteps. Seeing his interest, his dad encouraged him, and Eric began helping his dad prototype devices when he was only 12 years old. He went on to earn BA in biology at Dartmouth College, but before taking his MCATs, spent time working in environmental management and clinical trial consulting. The interlude helped him realize that his interest in medicine lay more in being able to create and build products that could help patients rather than practicing as a physician.
Eric was accepted into the mechanical engineering master’s program at Stanford. His coursework was complemented by his hands-on role as a teaching assistant in the Product Realization Lab. “That was amazing, a true melting pot of different people and innovative ideas, which really confirmed my passion for engineering,” Eric says.
He also helped develop and teach the university’s first class in medical device design, which eventually merged into the program now known as the Stanford Byers Center for Biodesign. As a teaching assistant for that class, he escorted the students on a visit to The Foundry, which proved to play a pivotal role in his career.
After graduation, Eric reached out to The Foundry and connected with Ferolyn Powell, who was spearheading Evalve, one of the newly incubated companies. He took a position leading the R&D team that was responsible for developing the MitraClip, a breakthrough technology that repairs leaky heart valves in patients with mitral regurgitation without open-heart surgery. At Evalve, Eric had the opportunity to attend the company’s first in-human case. “To this day it is incredibly rewarding to have been at that first case and to know how well the patient did with the procedure – it is a testament to why we work in this industry,” he says.
After Evalve, Eric sought the experience of developing a device with a broad commercial customer base. He joined Acclarent as director of R&D and was responsible for the evolution of balloon sinuplasty technology, which was a disruption of the standard of care for sinus surgery. Eric next joined ExploraMed as project architect, where he gained an even broader perspective on need finding and product development by helping to co-found a women’s health company, Nuelle.
Following the Nuelle product launch, Eric returned to the otolaryngology space. He co-founded Tusker Medical and led R&D and operations with the goal of commercializing Tula, a technology that originated at Acclarent. Tula enabled pediatric ear tubes to be inserted in awake, unsedated children in the physician’s office rather than in the OR under a general anesthetic. After Tusker was sold to Smith+Nephew, Eric stayed on as vice president of R&D and operations and was the site leader in Menlo Park.
Realizing his passion remains with early-stage startups, Eric joined Fogarty Innovation in August 2022. “I’m thrilled to be a resource for the community and to continue to develop technologies that improve patient care and outcomes.”
In his spare time, Eric enjoys spending time outdoors skiing, mountain biking, windsurfing, running, hiking, camping and chasing his dog around; and joining his family in all their pursuits.
Executive Services Administrator
As recounted by Marga Ortigas-Wedekind
Mary wants to see people happy. “If there are 100 people in a room with different philosophies, backgrounds, and levels, I’ve found that I can bring them together, break down social and status barriers, and relate to them myself, especially when entertaining with food.”
She seeks that happiness for people in many other ways as well, which is why she thinks the executive administrator role has been a great fit for her. Starting as an executive assistant at the age of 18, she put herself through school at night and did other weekend work. She found she had strong listening and organizational skills as well as a streak of creativity, always seeking to “wow” with any project she took on; “I was a natural at it, I got better, adapted, learned and developed.” As she gained more responsibility and progressed through her career, now at Fogarty and in previous roles at Vertex Ventures HC and Stanford Biodesign, Mary found that working in the medtech innovation space fit right in with her personal goals as well. She has a particular interest in healthcare solutions for the elderly because she is drawn to “helping people who don’t have a voice,” having experienced it firsthand in the last 11 years as primary caregiver for her mother who suffered from Alzheimer’s disease.
Born and raised in California to working class parents, she was taught to “work hard, be respectful, and learn how to get along in the world,” and that comes to life as she relates her proudest professional moments planning and executing the Stanford Biodesign fellowship graduations over the past 10 years.
It’s not surprising that Mary’s own family today is “rich in science.” Her husband works in the pharmaceutical industry, one of her sons works at a startup out of Stanford Biodesign, and the other works in fishery sciences and is involved in ecological pursuits. A common thread that has run through generations in this family is a fondness for fishing and crabbing which plays right into Mary’s love of entertaining, cooking, and organizing gourmet meals for family, friends, and neighbors!
Chief Alliance Officer
As recounted by Stacey McCutcheon
Eighteen years ago, Allie Gregorian had a career epiphany. She was working for Morgan Stanley Smith Barney, cultivating corporate and individual relationships and helping wealthy clients make charitable gifts. “When I started, I didn’t realize how transformative these gifts could be to the organizations that received them,” she said. “But once I saw the impact of giving, I knew that I wanted to be on the other side. I wanted to work with mission-driven organizations and help them secure the financial resources they need to support their work.”
Since then, she has been a leader and an advocate in the nonprofit sector and has never looked back. “I made a decision to dedicate my skills and service to supporting these kinds of organizations and I have not wavered,” she said. “I have raised almost $100 million in philanthropic resources and am very proud of what those funds have accomplished.”
The decision to devote herself to supporting high-impact charitable work is a perfect fit for Allie’s broad and varied skill set. She is a gifted communicator with a journalism background, an experienced relationship manager, and a strategic visionary who excels at aligning philanthropic interests with programs that provide critical support for vulnerable populations. It’s also a career that makes her feel at home.
“I was raised in a family that always gave back,” she explained. “We did community service on the weekends, and my mom dedicated her life to supporting and fighting for at-risk youth. I always wanted to be involved in work like hers.”
After leaving Morgan Stanley, Allie joined her first nonprofit, Children’s Hospital Los Angeles, as the director of major and planned gifts. There she solicited high-profile benefactors and secured transformational funding to establish the Children’s Orthopaedic Center, which currently ranks fourth in the nation for pediatric orthopaedic programs.
Her success caught the attention of LA Family Housing, which recruited her to create a giving program, re-develop the board of directors, and partner with the LA Housing Commission to provide permanent supportive housing to formerly homeless families. She was part of a team that developed the first-ever housing development for homeless seniors in Los Angeles.
Around that time, a chance encounter at a coffee shop led to marriage, a subsequent move to Northern California, and two small energetic boys who love the beach, building forts, hiking, and anything else outdoors. The family is also devoted to baseball, in part because of the boys’ burgeoning t-ball careers, and in part because Allie’s dad is the long-time pitching coach for the 2021 World Series-winning Atlanta Braves.
Not surprisingly, athleticism runs in the family. Allie’s mom was a swimmer, and by the age of six, Allie was swimming competitively and practicing two hours a day. As she got older, the practices stretched to four hours a day and trophies and medals on the shelf multiplied, reflecting her status as an aspiring Olympic athlete in 200M breaststroke. Allie trained alongside other swimming luminaries including Misty Hyman, Gary Hall Jr., and Amanda Beard, and continued to compete as a D1 athlete throughout her first two years of college at University of Arizona.
After relocating to the Bay Area, Allie joined Stanford University as a senior director of development for the Medical Center. In that capacity, she managed complex fundraising programs for Department of Neurosurgery and the Stanford Byers Center for Biodesign, where she first learned about, and became fascinated with, health technology innovation. That passion, for helping innovators address important unmet medical needs and bring their solutions all the way to patient care, is what led her to Fogarty Innovation. As Fogarty’s Chief Alliance officer, Allie is focused on building strategic partnerships and a robust fundraising program for the organization and its companies-in-development.
When Allie isn’t working or parenting, you can find her open water swimming and training for triathlons.
Performance Optimization Leader
As recounted by Bernie Andreas
Laura works to draw out and optimize the best in people. She brings to Fogarty Innovation more than two decades of experience working in mental health, executive coaching and human resources. Laura is passionate about helping clients identify root issues and design a path that applies their intrinsic strengths to maximize potential and elevate their performance.
Laura grew up in Pittsburgh, Pennsylvania, (yes, an ardent Steelers fan) and, through the course of her childhood, developed a strong work ethic that she learned from her parents, both hard-working professionals. From an early age, Laura was given many daily responsibilities, which created the diligent, independent, and goal- oriented professional she ultimately became.
At the University of Pittsburgh, Laura originally majored in criminal justice with a minor in psychology. However, while working for an attorney as a private investigator, she quickly discovered that she more naturally gravitated toward understanding, supporting and elevating individuals, hence changed her major to psychology.
With her bachelor’s degree in hand, Laura moved to Southern California where she began a career with a well-known law firm, Fragomen. Initially she served as a paralegal, where her work with some of the world’s largest companies led to being appointed to leadership roles.
Her desire for knowledge deepened, and with the encouragement of the firm’s leadership team, she continued to manage her full-time job while simultaneously attending graduate school at California State University, Long Beach, where she received her master’s degree in social work.
During this time, Laura started devoting more of her energy to the internal needs of the firm, aligning with her academic aspirations to help individuals reach their potential and solve challenges. That led to an executive role in human resources and, not long after, a transfer to the firm’s San Francisco Bay Area office.
After nearly a decade focused on helping Frangomen adapt its organizational model and elevating individual performance, Laura became increasingly fascinated with the dynamic nature of people. She pivoted her career path to become a psychiatric social worker at Napa State Hospital, working with individuals suffering from mental illness.
Subsequently, she became a licensed clinical social worker and moved to the VA Palo Alto Healthcare System.
In 2007, Laura opened her own practice, True Insight, as a psychotherapist and executive coach, assisting clients in their quest to become self-aware, authentic and empowered to meet their true potential.
Laura finds energy and peace while hiking and cycling, but her best moments come from spending time with her family and her three dogs… never a dull moment.
As recounted by Gretchen Berstler
With a passion for working with nonprofits and companies that inspire others and make an impact, Birgit founded Johnston Communication over 16 years ago. Her proudest achievements revolve around promoting groundbreaking ideas and ideologies— telling her clients’ stories as a way to inspire others to push their own boundaries.
Joining the Institute in 2015, her work at the Fogarty Institute combines all these core competencies, while allowing her to be part of a close-knit community that thinks outside the box in the endless pursuit of finding a better way to care for patients. It fits well with her ethos of continuously striving to learn something new and conquer a new challenge.
Prior to consulting, Birgit led the communications function at Solectron Corporation (Flextronics), where she gained valuable global experience in the broad range of industries served by the company. That well-rounded view influences her ability to bring a well-balanced perspective and fresh ideas to clients.
Birgit’s interest in advancing nonprofits stems from forming and spearheading the communications department at Silicon Valley Community Foundation, a nonprofit that donated over $500 million in grants to worthy projects locally, nationally and internationally. She expanded her experience in advocacy and policy by heading the communications function at the Silicon Valley Manufacturing Group (Silicon Valley Leadership Group), a leading nonprofit that represents over 300 companies forming the innovation economy of Silicon Valley. For her work at this organization she was honored with the YWCA Tribute to Women in Industry Award.
A competitive athlete throughout her life, she believes in the power of teamwork and abides by the goal of “doing something that challenges you” every day.
Born in Denmark and raised in Italy, Birgit holds a Bachelor of Arts in International Affairs from the University of Colorado, Boulder, and a master’s degree from the University of San Francisco. An outdoor enthusiast, she is an off-road triathlon age group World Champion and winner of the Silicon Valley Marathon—and also uses those athletic skills keeping up with three active kids and two equally active dogs. Birgit loves to travel. She also enjoys cooking for her family, and aspires to grow her own garden full of fresh ingredients to cook with.
Chief Financial Officer
As recounted by Craig Straley
With a long history of working with medical startups, Gayle has more than 30 years of diverse experience in a variety of senior management roles that include finance, accounting, human resources, manufacturing and operations. After stints at other technology companies, she found that medtech’s mission to help patients mirrored her own philosophy and was more personally rewarding. Perhaps an enigma for an expert in finance, Gayle’s regard for financial return, while understanding its importance, is far outweighed by her devotion to advancing human health and making the world a better place.
She has had the opportunity to work across several sectors in medtech (e.g, medical devices, drug discovery, diagnostics, instrumentation), including serving as chief financial officer for Biodesy (now Blue Light Therapeutics) which commercialized a tool for drug discovery. She also was the vice president of finance at Isostent, a radioisotope stent which was acquired by Cordis, a Johnson & Johnson company, and the chief financial officer at Radiant Medical, which induced local hypothermia in heart attack patients to preserve heart tissue.
She later started her own company offering chief financial officer consulting to more than 15 life science startup companies. In total, she has been responsible for helping raise more than $200 million in venture funding.
Gayle is always happy to help Fogarty CIRs with all types of finance matters, but what really excites her is when she can help with broader strategy – to assess markets, plan how to navigate the path to market and treat patients, and how to position a business to be financially appealing to potential investors.
Gayle also offers unique perspectives based on her experience on both sides of clinical trials, as a patient and a technology provider, which further inspires her passion for the field. “Medical technology literally saved my life, and I would like to return the favor to others,” acknowledges Gayle
She received her MBA from the Tepper School at Carnegie Mellon University in Pittsburgh, Pennsylvania, and her BA in economics, magna cum laude, from the University of Washington in Seattle.
Gayle was the fifth of seven children, with a father who was an engineer and a mother who was a nurse – clear influences that impacted her career choices. Before moving back to her birthplace of Seattle after high school, she grew up in a rural college town in eastern Washington which gave her a lasting appreciation for the value of education, a strong work ethic, a belief in social justice and the desire to impact the lives of others less fortunate. A health devotee and mother of two grown children, Gayle loves running, traveling, and gardening. Between tackling her own remodeling projects, she was also responsible for the buildout of Fogarty Innovation’s brand new home in the Sobrato building on the El Camino Campus.
As recounted by Denise Zarins
Corinne Landphere helps propel individuals and teams into high-performing, emotionally intelligent excellence with her unique ‘people-first’ approach and nearly 30 years of experience in the life sciences industry.
After 20 years of coaching with Corinne Landphere Consulting, Corinne has become a ‘go to’ resource for guiding individuals and teams through a wide variety of challenges and growth, including team building, conflict resolution, leadership transitions, rapid growth/downsizing, and executive development.
Corinne’s vision for empathy-based leadership drew her to Fogarty Innovation, where she could work with like-minded individuals dedicated to building something bigger and better every day. She was particularly drawn to our commitment to developing the next generation of life sciences industry executives and our unwavering promise to always put patients first. In addition to her performance-based coaching, Corinne also leads our wellness efforts including introducing the ongoing Mindfulness Based Stress Reduction program, curating best-in-class wellness resources, and encouraging team creativity as a stress-releasing outlet by initiating the Creative Spotlight series for amateur talent.
Prior to consulting, Corinne excelled in a variety of high-profile sales and marketing positions at Genentech, Guidant and Perclose (Abbott), after beginning her professional career as an E.R. nurse at Methodist Hospital’s Trauma I Center in Indianapolis. This diverse background has provided her with a 360-degree view of the industry, having first worked closely with patients, physicians and healthcare practitioners, and now working with industry professionals.
Born to Polish immigrant parents and a proud Hoosier, she holds a Bachelor of Science in Nursing from Indiana University, along with a Master of Arts in Counseling Psychology from Notre Dame de Namur University. She serves as a mentor and guest lecturer at both schools and others, including Stanford University.
Corinne is a big believer in incorporating compassion and mindfulness into life and business, something that she lives every day. As an entrepreneur, mentor, artist, philanthropist and mother of two, Corinne leads a full and varied life and prioritizes volunteer work with nonprofit organizations. She is an avid runner, a former volunteer coach for Girls on The Run and a strong advocate for diversity. A talented painter who was part of Papyrus’ Artists in Residence program, she donates all proceeds from her sales towards the causes she supports.
R&D Engineer in Residence
As recounted by Birgit Johnston
Jesus’ humble beginnings led to a life-long passion for tinkering. He grew up in a family of six kids in rural Mexico, where they lacked even the most basic of amenities, like electricity and running water. But that didn’t dim his spirit, and early on, he began repurposing things in creative ways. When he was just five years old, he remodeled the rim of a bicycle wheel without spokes that he had found, using a few wood sticks to fashion an easier way to carry the wood needed for the kitchen fire, rather than carrying it on his shoulders.
He took the perspective of viewing everything as an adventure, whether fashioning their own shelter or planting corn to make nixtamal and tamales from scratch.
At age 18 he borrowed money to move to the U.S. and found full-time employment in a produce store, followed by a stint in construction in Redwood City. He started his career in medtech at Heartport, a company that helped pioneer minimally invasive cardiac surgery, after learning about them through family friends. He started as an assembler doing final inspections and, despite little knowledge in the field, was quickly promoted to R&D technician by management who recognized his interest and impressive work ethic.
Jesus’ second industry job was at Ventrica, which develops surgical devices for heart bypass, followed by several other device companies, thanks in large part to mentors, such as Adam Sharkawy, who helped guide him and find opportunities. He later joined Abbott’s cardiovascular division as senior R&D/mechanical technician.
Constantly in search of his next challenge, he learned of nVision, a Fogarty company that offers a platform for potentially earlier detection of ovarian cancer and in 2014 became its second employee, an engineering specialist.
He stayed with the company and transferred to Boston Scientific when the company acquired the startup in 2018. While there, he had the opportunity to continue developing the product in Costa Rica. Thanks to his hard work and creativity, Jesus has acquired 20 patents to date.
Having been part of Fogarty Innovation as a Company-in-Residence (CIR), Jesus was intrigued by the concept of helping a group of startups evolve so they could grow and benefit patients. He initially did some consulting for a few of the CIRs and is now leverages his expertise in working with early-stage companies and building prototypes.
In his spare time, you’ll find Jesus playing soccer and volleyball or enjoying much-earned downtime with his kids, wife and family. An avid barbequer, his is especially known for his awesome ribs.
Stacey Paris McCutcheon
Director, Communications & Education
As recounted by Allie Gregorian
As the Director of Communications & Education, Stacey is here to make some noise! By creating relevant, timely content for FI’s digital platforms, as well as developing a robust series of educational offerings for FI’s varied constituent base, Stacey seeks to sharpen the focus on things that differentiate and elevate Fogarty from other incubators. “We need to be louder sooner, because it helps drive the interest that will help our organization and its companies succeed,” she said.
A professional writer for more than 20 years, Stacey began her career in public relations, leading communication campaigns for companies in diverse industries, including law, commercial real estate, technology, architecture, and non-profit, before starting her own public relations firm and discovering her passion for healthcare. “When I found healthcare, I was communicating in a space that matters to everyone,” she said. Her ability to transform complicated material into clear content is a powerful tool that brings immeasurable value to the organization.
Prior to joining Fogarty, Stacey was the communications manager for Stanford Byers Center for Biodesign, a training and education program for healthtech innovators and long-standing partner of Fogarty Innovation. “I love that there is a strong partnership between Fogarty and Biodesign because it enables me to stay in touch with my Biodesign family,” she said. Now, Stacey is looking forward to supporting her Fogarty work family by taking on the exciting challenge of leading education programs, which is a new endeavor for her.
A resolute optimist, Stacey loves spending time with her three adult children, playing tennis, scuba diving, and listening to audiobooks. She admits to having a childlike sense of humor and believes that “if you look for the humor in most situations, it’s much easier to thrive.” This open, welcoming view of the world enables her to be a constant problem solver. Stacey does not just have big ideas- she comes with the plan to see them through.
Strategic Clinical and Regulatory Advisor
As recounted by Birgit Johnston
Peggy loved STEM before STEM was a thing. By third grade she already knew she wanted to focus on science and went to UCLA as a biology major with the intention of attending medical school after graduation. But anxious to “get to work” and cognizant of the many years that medical school would require, she decided to jump into the industry, making her mark in a host of ways that didn’t involve a medical degree.
That was 30 years ago and along the way she has amassed an impressive list of experiences and successes. Her first job out of college was in sales with a startup in the medtech space doing chemosensitivity testing for cancer patients, where she had first-hand access to clinicians and cutting-edge science. She soon joined Target Therapeutics, a joint venture between Advanced Cardiovascular Systems and Eli Lilly, where she handled projects ranging from pre-clinical trials to the lab and eventually hired the company’s first salespeople, customer service and marketing team and selected and managed its international distributors.
She spent over 10 years there as both an employee and later a consultant and helped to guide the evolution of the business from a focus on oncology to becoming a leader in the nascent interventional neuroradiology field.
After the birth of her second child, Peggy began a consulting career, which allowed her flexibility while her children were young. When she felt like her third child was settled in elementary school, she took a full-time role with Abbott Vascular Devices, where she led its drug-eluting stent project.
One of her former colleagues asked her to join a startup housed within The Foundry, which was the perfect match for her skillsets and interests. She later joined the Kleiner Perkins-backed start-up, Autonomic Technologies, which was developing a neuromodulation technology for the treatment of migraines. While neither of these companies reached commercial success, the experiences and lessons learned added to Peggy’s acumen.
Today she is delighted to bring that expertise to Fogarty Innovation where she is a strategic clinical and regulatory advisor, indulging her passion for early-stage companies.
With particularly deep experience in First In Human clinical studies and de novo petition submissions for novel medical products her skills are uniquely suited to support both clinical and regulatory needs at Fogarty.
In her spare time, Peggy likes to garden, hike or run, do yoga and spend time with her family and new puppy. She also enjoys indulging her passion for books and reading while helping the local community by serving on the board of her local library foundation. And she continues to mentor and teach at the Stanford Biodesign program, which she has done for over 11 years. Peggy is also an avid traveler, which she found to be a fantastic byproduct of working on clinical trials.
Director of Invention Acceleration
As recounted by Zach Edmonds, MD
A seasoned R&D professional, John has 18 years of experience in the medical devices industry, with a focus on supporting early-stage companies through the entire process, from device inception and iteration to technological and clinical validation and finally, physician training.
John’s passion for the medical field developed organically. Growing up, family dinner conversations were often about medicine, given that both his parents are physicians. He saw how they valued hard work, attention to detail and putting the patient first, and aims to live by those same values. He firmly believes that poor health is an overwhelming stressor and is passionate about medtech innovation because of its potential to reduce suffering. Working on challenging, complex problems motivates and inspires John to get up each day and come to work with enthusiasm and passion.
As an endurance athlete, John has learned the importance of focus, persistence, and tenacity. He finds running and cycling great distances to be meditative and restorative. These activities continue to deepen John’s ability to keenly observe himself and the world around him. He brings this attitude of commitment, consistency, resilience, and full attention / presence to his work and passions outside the lab / office.
Most recently, John served as partner of the Foundry for six years, where he also co-founded Twelve and led the development of its transcatheter replacement mitral valve. Prior to that, he gained his vast experience working in a variety of R&D engineering positions within several startups, including Acclarent, now a subsidiary of Johnson & Johnson. He is named on over 80 patents.
John finds Fogarty Innovation to be a rare combination of extremely bright people, a diverse set of projects, the energy of a startup environment and a collective sense that together they can advance the ecosystem. Through the Invention Accelerator Program (IAP), he has had the privilege of working with physicians who are developing their own novel solutions for unmet clinical needs.
His background is rooted in broad experiences and his R&D training has influenced how he approaches building anything new. He tackles each product with an open and fresh approach. In his own words, “In part, it’s the set of activities: rapid iterations of defining the problem, developing a strategy for addressing it, implementing the prototype, testing it, and analyzing the results. In part, it’s the mindset—ideally a combination of optimism, criticism, and flexibility. And in part, it’s the motivation that the outcome will improve the quality of life for many others.”
John holds a BA from Duke University, a BS in Mechanical Engineering from North Carolina State University and a MS in Mechanical Engineering from Stanford University. As an avid outdoorsman, nothing prepares him better for a busy morning or smoothens a rough day than a long run, bike ride, swim, or hike.
Chief Commercial Strategy Officer
As recounted by Mike Regan
When Marga boarded the plane at age seventeen to travel from her home in Manila to start her undergraduate studies at Williams College and eventually, Wellesley, little did she know that it would be just the starting point of what has turned out to be a continuous wonderful adventure. She says the benefit of starting so young was that “I didn’t know, what I didn’t know,” and so she felt compelled to “just figure it out.” This thinking has formed the foundation for Marga’s approach to life and her comfort with chaos, uncertainty, and change!
Upon graduating, Marga returned to the Philippines and entered the traditionally male-dominated field of agri-business which took her on travels to farms in the deepest reaches of the islands and exposed her to lifestyles and politics very different from her prior experience. This, plus the social unrest in the country at that time, led Marga to realize that she wanted to get involved in just causes to help better people’s situations.
Marga’s next stop was at Stanford University’s Graduate School of Business where she focused on International Business and Marketing and honed the strategic mind for which she is known. While at Stanford, Marga experienced an epiphany while enrolled in an Ethics class. As an assignment, she interviewed Ron Dollens, the CEO of Advanced Cardiovascular Systems (later Guidant Corporation), and was completely engrossed with how he characterized the responsibility he and his team faced when making decisions for a business in which they held patients’ lives in their hands. From this discussion, she saw that there is always a patient, a family, and a provider who benefit from a well-developed solution and appreciated the earnestness required to realize this opportunity. She eventually joined ACS/Guidant Vascular Intervention as Director of International Marketing and never looked back.
The theme of helping patients get a shot at a better life has reverberated throughout her career. Most recently she served as EVP of marketing and payor relations at iRhythm Technologies, a digital healthcare provider of cardiac monitoring services that she helped take from startup to successful IPO. One of the defining moments of her career was seeing the team’s image light up on Times Square when the company went public, knowing they had brought an important technology to market.
Prior to iRhythm, she was the EVP of global marketing and product development at Omnicell, Inc. a creator of pharmacy automation technology and analytics, and SVP of marketing, development and clinical affairs at Xoft, Inc. (acquired by ICAD), a startup that pioneered disruptive technology for cancer radiation therapy. She began her startup experience as VP sales and marketing for ProDuct Health (now part of Hologic) which developed an early breast cancer risk stratification and detection device.
With over 30 years of leadership experience, Marga has enjoyed many successes with companies at various stages of development. Ironically, it is the failures she has experienced that have reinforced some of her most essential learning. A few of her valuable lessons include: “You’ve got to anticipate the unexpected,” “Seek advice all along the way”, “You need to bring people along with you to achieve a goal,” “A dysfunctional team can drive a company into the ground”, and finally her favorite, “None of us is smart as all of us.”
At this point in her career, Marga believes you can’t surpass the meaningful satisfaction and honor of bringing life-altering solutions to patients and their families, which she defines as leaving the world a little bit better as you pass through. With this belief, Marga is a perfect fit for the mission undertaken daily at Fogarty Innovation!
When Marga is not busy at Fogarty, she is an energetic sports fanatic supporting local teams, The Warriors, The Earthquakes, and the 49ers. She spends active time with her husband in the mountains of Lake Tahoe, dabbles as an early stage investor, but most importantly, is a proud Mom to two adult children who are starting their own adventures!
Chief Innovation Officer
As recounted by Marga Ortigas-Wedekind
Mike Regan feels a strong sense of duty given his experience in medtech. He believes there is a need to let the upcoming generation of entrepreneurs know just want an honor it is when a product they’ve worked on potentially helps improve people’s lives. “Unlike any other business, the profit motive is subservient when people rely on you to make their family member better. People count on us every day to do our job and make the right decisions to provide safe and reliable solutions.”
For all the seriousness with which he takes his business responsibilities, Mike is one of the sunniest and most likeable people you will meet. Both Fogarty Innovation entrepreneurs and his colleagues seek his counsel, which is often delivered with self-effacing humor. “As cliché as it sounds, it IS all about the people, and the medtech industry attracts the ones who are passionate, ethical and determined.” Mike is observant and loves learning people’s stories, “gaining magical insight” about them. He thrives when surrounded by those who share his core values yet are willing to challenge his point of view, creating a healthy tension that leads to better outcomes.
After a first job with American Medical Optics (now Johnson & Johnson) that had him moving quickly up the management track, he decided to give it all up and became a “ski bum,” for 18 months. “That was a foundational experience because I discovered that I could be just as happy as an engineer or a short order cook. It was up to me to look for things that made me happy as a human being.”
After that, Mike put his mind to a 35+ year career which spanned several leadership roles, not to mention clinical foci. Before moving to the medtech field, Mike worked with Coopers & Lybrand consulting, Clorox, and Walt Disney Engineering. Immediately prior to joining Fogarty Innovation, he served as chief operating officer at Minerva Surgical, a medical technology company focused on women’s healthcare. Before that, he was vice president of operations at Emphasys Medical (now Pulmonx), a developer of therapeutic solutions for emphysema patients. He was also chief operating officer of Cardeon Inc., working on innovative approaches for coronary artery bypass grafting surgery. His first major medtech company was Guidant Corporation, which absorbed the start-up company where he was working, Advanced Cardiovascular Systems. Mike had roles as varied as Pilot Plant Manager, Director of International Sales and Division General Manager of the Peripheral Systems Group. Guidant has a special place in his heart be use it was there he met his wife, Theresa, whose outgoing personality he attributes with helping to draw him out of his own shyness. It also gave him his first opportunity to work and live outside the US, which he has done and enjoyed in many subsequent roles.
Mike still gets a catch in his voice when relating his proudest professional achievement. In a pediatric procedure where the patient was crashing and the doctor could not get a central line into the baby, someone in the ER suggested trying the Ultrasound needle product. He clearly recalls that faint little sound that guided the doctor to locate the baby’s vein and enabled him to revive the infant; even the most callous and experienced ER nurses had tears in their eyes. “If my whole career was just that one day and that one kid, we’d have done okay.”
At Fogarty, Mike loves to visit with each entrepreneur daily to see what he can do to help. He epitomizes our “full contact mentoring” approach, winning our innovators’ appreciation. Mike has been a great ambassador for Fogarty, representing us in the broader medtech ecosystem. He is one of the founders of the Diversity by Doing initiative with colleagues from Stanford School of Biodesign. Mike is also a frequent speaker and panelist in different industry forums.
When not working, Mike likes to keep moving — hitting the ski slopes, open water swimming in San Francisco Bay, hiking, playing tennis or learning Italian with his wife, who is a nurse at Stanford and with whom he shares the love of their two adult children. Mike holds a BS in industrial engineering from Cal Poly, San Luis Obispo, and an MBA from Santa Clara University.
Operations and Quality Associate
As recounted by Mariela Baughman
As a business associate at Fogarty Innovation, Julie spends her time working on projects related to people, safety, and operations. She is particularly focused on creating a safe and efficient lab area for the engineers at Chronus, one of Fogarty’s current companies in residence. “Chronus works with blood, so their lab space has to meet higher safety standards,” she explains. Julie purchases chemicals and consumables for the team, creates safety binders and training presentations, and provides personal trainings.
While she loves the intense operations focus, she notes that the variety of work she encounters on a daily basis that keeps her engaged. “Working here has taught me to switch gears in a second,” she says. “One minute I am working in the lab learning about a new chemical, and the next minute I have a completely different project. I am learning how a facility operates, the legalities of owning a business, and how medical device companies operate,” she says.
A Bay Area native, Julie went to school at St. Johns in Queens, New York, where she earned a degree in marketing and discovered that she likes the East Coast, cold weather and all. After graduating she completed an internship in the employer division at Stanford University to learn more about the field of human resources. Still uncertain about a career path, she stepped into a role in lab operations at Fogarty Innovation and discovered a passion for designing and implementing procedures that help companies operate safely and efficiently. “Creating streamlined processes for startups makes me feel like I helped them keep their minds on the bigger picture for their companies – solving important medical problems,” she said. “I want to see these companies succeed and really enjoy doing whatever I can to help.”
Going forward, Julie hopes to be able to take on more responsibilities in the lab area for the companies incubating at Fogarty. Her goal is to eventually move into a facilities manager role. She’s also interested in continuing her East Coast adventures and is considering an eventual move to North Carolina. A club swimmer for ten years, she has also worked as a swim instructor and is particularly fond of teaching children. She also likes to spend time listening to live music, walking her dog, hiking, and going to the beach.
Clinical and Regulatory Director
As recounted by Gayle Kuokka
Craig sums up his love for the medtech industry:”at the end of the day, your work ends up helping patients with life-improving or life-saving therapies, that is easy to get passionate about.”
With more than 25 years of experience conducting clinical research, Craig has forged strong relationships with co-workers, health-care providers, patients, and regulators. It has been a rewarding way to combine his engineering education—he holds a BSE and ME in Biomedical Engineering from Duke University—with his strong interest in medicine to help drive medical device innovation.
Craig has worked at both large companies and early-stage startups, most recently at Medtronic, following its acquisition of Twelve, Inc. As vice president of clinical affairs at Twelve, Craig developed and executed the early clinical studies for the Transcatheter Mitral Valve Replacement program. Earlier, as VP of clinical affairs at Ardian, Craig led the early stage clinical studies for a first-of-its-kind therapy of renal denervation, culminating in Ardian’s acquisition by Medtronic.
One of Craig’s proudest professional achievements is Ardian’s groundbreaking European randomized study of renal denervation to treat hypertension. He is delighted not only with beating enrollment projections and the trial’s ultimate success, but also with the team he worked with, including the physicians, research nurses, as well as the patients who courageously agreed to participate.
At Fogarty Innovation, Craig continues to embrace Dr. Fogarty’s philosophy of a “patient-first” focus, emphasizing to the companies-in-residence that developing robust clinical evidence will drive the ability to benefit the most patients.
Craig feels fortunate to work with a stellar group of experts, who also happen to be good friends. The opportunity to impact the next generation of medtech entrepreneurs across a fascinating variety of devices and technologies is more than exciting to him.
While he loves traveling with his family, he’s also always ready for a round of golf locally. Craig has a unique talent for practical jokes – just ask him to share a story or two when you meet him.
Chief Operations Officer
As recounted by Corinne Landphere
Always committed to seeking innovative solutions and creating meaningful and effective programs, makes Denise an invaluable team player on the Fogarty Innovation team. Her 25 years of experience in the medical device industry include devising and developing products in multiple spaces, including cardiovascular, obesity, pulmonary and women’s health. She is proud of the 100-plus patents in her portfolio accumulated in these many clinical disciplines.
While she had always known she wanted to be involved in medicine, she also knew she didn’t want to become a doctor. Thanks to her mom who gave her a flier on a biomedical engineering open house at Marquette University, she found an immediate fit that dovetailed with her love of math and science. Medtech has proven to be a satisfying career path where she can help countless patients rather than just one at a time.
Denise began her career as a research and development engineer and manager at AneuRx, a startup that was founded by Dr. Fogarty and later acquired by Medtronic; then she subsequently joined another Fogarty-backed startup, Bacchus Vascular, which was later acquired by Covidien. With roots in engineering, Denise found her stride in project management and intellectual property development.
One of the most rewarding aspects of her career has been involvement with startups whose products have gone to market and are still being used to help patients today. That was the case with her time at The Foundry, where she co-founded Ardian, Inc., the pioneer of renal denervation for hypertension, heart failure and other associated disorders, which was acquired by Medtronic in 2011.
Denise then co-founded Ziva Medical (now Ablacare), an early-stage medical device company treating infertility caused by polycystic ovary syndrome. While launching this company, she also consulted in project management, due diligence, and intellectual property development.
Her work at Fogarty Innovation allows her to be involved in multiple projects simultaneously, while also helping young entrepreneurs avoid missteps as they launch their companies. She finds it a place she can live her values every day, as integrity and the concept of “team before self” drive everything she does. Denise has received several awards and is a frequent guest lecturer at Stanford University.
Raised in a small town in suburban Milwaukee, Denise grew up watching NFL football, a favorite pastime to this day as she regularly cheers on the Packers and the Patriots. She is a lover of all animals and in some circles is known as “The Zookeeper,” referencing her eclectic home menagerie of pets. Equally important to Denise is her passion for music, especially sappy love songs. You can often find her in the first few rows of the local live concert venue, cold beer in hand, one of her favorite ways to relax before diving into her next project.
At our core…
We behave with integrity first and foremost, knowing we affect the lives of patients and their loved ones.
We put team before self, valuing mutual trust and respect for each other, and sharing a foundational belief that strong teams enhance performance.
We believe in equality and seek diversity to keep growing as a team — not only in race and gender, but also in expression.
We value continuous learning, both as teachers and perpetual students.
We believe the process of innovation is a discipline that can be taught and honed.
We trust in the power of an audacious vision because it taps into a basic human desire: belonging to and believing in something bigger than ourselves.
We have a sense of wonder and a spirit of adventure as we push boundaries to create positive impact on the global medical ecosystem.
We stay humble for all that remains to be done in shaping the future of human health.
Board of Directors
Tom M. Krummel, MD
Chairman of the Board
Tom is one of those unique individuals who has seen and experienced medical innovation from every front, including stints as an academic, surgeon, writer, mentor and administrator. A long-time friend of Dr. Fogarty’s, he joined the board of directors of Fogarty Innovation in 2014 and soon was appointed chairman.
In addition to Fogarty, his service is vast: He has been co-director of the Stanford Byers Center for Biodesign since 2002, holds the Emile Holman Professorship and serves as chair emeritus of the department of surgery at Stanford University School of Medicine, and is the Susan B. Ford Surgeon-in-Chief Emeritus at Lucile Packard Children’s Hospital.
Through this distinguished career, he is proudest of the patients he was privileged to care for, whom he believes embody the pediatric surgeon’s credo of “saving lifetimes.” He is also grateful for his 300 + trainees and mentees, whom he considers a “force multiplier” for future generations of progress.
In fact, that’s what he finds to be most rewarding about his work with the Fogarty Institute—the next generation which will yield additional “Tom Fogartys,” who will continue to invent the future of better care.
His philosophy is embodied in the painting “The Doctor,” which reminds him that if you always keep the patient front and center, the rest will take care of itself.
As a pediatric surgeon, Tom has been a pioneer in innovation and advancing healthcare. Among his career highlights were his role as an early adopter of extracorporeal membrane oxygenation (ECMO) in the treatment of neonatal cardiopulmonary collapse, as well as driving the application of information technology in simulation-based surgical training and surgical robotics.
An involved and influential consultant to the medical device industry, Tom serves on multiple scientific advisory boards and boards of directors, and has received two Smithsonian Information Technology Innovators awards for his work.
An avid outdoorsman, Tom has ridden his bike across the Alps, Dolomites and the Pyrenees, and across the U.S. He loves to cook and travel and spend time with his wife, kids and grandkids.
Frederick St Goar, MD
Vice Chairman of the Board
A surgeon, entrepreneur, mentor and global health advocate, Fred is a champion of advancing access to medical therapies. He is currently an interventional cardiologist, practicing at El Camino Health’s Mountain View hospital, and the Medical Director of the Norma Melchor Heart and Vascular Institute based at El Camino.
In parallel with his clinical work, Fred has been an active participant in the medtech industry, including helping to found HeartPort and Evalve, where he was also the physician inventor of the company’s revolutionary minimally invasive catheter-based MitraClip system (Abbott), which recently won the prestigious Prix Galien USA award.
That combination is one of the facets of his work of which he is most proud—the rare opportunity to both care for patients on a one-on-one, high-touch level, coupled with the widespread impact of engaging in therapeutic advancements that improve the lives of patients, families and the larger community.
Because he thrives on interacting with creative entrepreneurs he finds it a privilege to help them in their endeavors. He consequently has a special interest in Fogarty Innovation’s Lefteroff and Ferolyn fellowships and regularly mentors fellows in the Biodesign program at Stanford School of Medicine and several Fogarty graduates, including HeartFlow and Alydia Health, where he has played a critical role in helping bring its life-saving device, Jada, to market.
Widely published, Fred serves as a consultant for established medical device companies and startups and is listed on multiple medical device patents. He also has a growing passion for global health and strives to make enhanced, easy-to-use medical therapies accessible to all. He is currently working in Rwanda with a new rural-based medical school, the University of Global Health Equity, under the umbrella of Partners in Health, where he serves on the advisory board.
In parallel, he is on the board of a women’s obstetrical and surgical training hospital under construction by Village Health Works in Burundi. “There are so many ways that we can constructively engage with developing countries. It’s very encouraging to see prominent organizations like Fogarty Innovation and Stanford embrace the concept of global medicine,” he says.
Fred attended Harvard Medical School and completed his medical and cardiology training at Stanford University. An avid outdoorsman, he is known for his joy on a big powder day on the ski slopes and also revels in sharing his passion for cycling and kayaking with his wife and kids.
Thomas J. Fogarty, MD
Founder and Director
Sometimes referred to as the “Edison of medicine,” Dr. Fogarty is one of the most prolific inventors and credited as one of the early pioneers in the launch of the medical device industry.
As an internationally recognized cardiovascular surgeon, inventor, entrepreneur and vintner, he has dedicated his entire career to improving patient care and is named on over 200 medical device patents, including the “industry standard” Fogarty balloon catheter, which 50 years later is still being used, saving the lives and limbs of more than 16 million patients.
His knack for building things started at an early age—when he was just 15, he invented the centrifugal clutch, which sparked a lifetime of innovation in medical technology.
The motto, “There has to be a better way,” inspired Dr. Fogarty to found more than 45 medical device companies and create numerous devices, including the widely used Aneurx Stent Graft that replaced the traditional surgical repair. This less invasive approach has resulted in a significant reduction in mortality and morbidity in the management of the aneurysmal disease. But perhaps even more importantly than his contributions to surgery today, he has inspired and aided countless other entrepreneurs to continually push the envelope of innovation, which has led to a legacy of new inventions and lives saved.
A strong believer in the power of mentoring, he founded Fogarty Institute for Innovation (now Fogarty Innovation) on the campus of El Camino Hospital in 2007 to spur medical device innovation, improve patient care and lower healthcare costs. While he loved helping people as a surgeon, he believes in the multiplier effect that is created through widely adopted technology.
Dr. Fogarty believes that whether you are a physician, an engineer or entrepreneur, we are all here to benefit humankind, and that takes a team effort. In fact that approach is what makes him proudest about Fogarty Innovation—a dedicated team who coalesces around a common goal to advance human health.
Dr. Fogarty has been recognized by countless organizations for his contributions to medical science, including receiving the prestigious Presidential Medal of Technology and Innovation. In his “free” time, Dr. Fogarty pursues a number of activities as an avid fisherman, reader and tinkerer.
Stacy Enxing Seng
Stacy Enxing Seng currently serves as a venture partner with Lightstone Ventures; member of the board of directors for Hillrom Holdings, Sonova AG, LivaNova PLC and preCARDIA, as well as chairwoman of the board for CALA Health and Contego Inc.
But her business philosophy wasn’t honed in the boardroom; instead she turns to “the dinner test.” In other words, she believes you should only work with people with whom you would enjoy dining—an outlook gleaned from her time with several impressive organizations. “At the end of the day it’s all about the people.”
With 30 years of experience in medtech, Stacy has a proven track record for leading technologies and companies from early concept and development through global market leadership. Her passion for the field comes from the people it attracts: From the physicians to the engineers to the sales people to the boardroom, she’s inspired by their focus on making a difference in the world through helping people live life more fully.
And over the years, she has made her own mark in that regard. Most recently Stacy was president of Covidien’s Vascular business, which she joined through the $2.6B acquisition of ev3, where she was a founding member and executive officer responsible for leading ev3’s peripheral vascular division from inception.
Prior to ev3, Stacy held various positions at other high-profile medtech organizations, including Boston Scientific, SCIMED Life Systems, Baxter Healthcare and American Hospital Supply. She received an MBA from Harvard University and holds a Bachelor of Arts in public policy from Michigan State University.
A frequent speaker and panelist at healthcare industry events, Stacy favors those focused on authentic leadership, where she provides insight on building vibrant and winning cultures, innovation and owning your career. Named as both one of the “Top 100 Women in Business” and “Favorite Role Model for Women in Business” in Minnesota, she especially enjoys addressing these topics in the context of women’s leadership, communication and empowerment.
Today, she brings that inspiring spirit to her work as a board member for Fogarty Innovation.
As president and CEO of the Medical Device Manufacturers Association (MDMA), a leading national trade association representing hundreds of innovative and entrepreneurial medical technology companies in Washington, D.C., Mark acts as their voice and advocate on Capitol Hill.
Although Mark earned his JD from Georgetown University Law Center and his MBA from Georgetown University McDonough School of Business, he decided not to pursue a traditional law office job. Instead he began his career as a clerk in the DA and Attorney General’s office in Massachusetts and then worked on the Hill for a member of Congress in his home district.
A chance meeting with the chief of staff for a member of Congress revealed MDMA’s need for someone who could help on policy. Realizing it would be a great fit for his expertise and interests, he joined the organization and since then has helped it grow from 80 to nearly 300 member companies. Throughout his career, he has forged numerous collaborative relationships and notched a number of significant wins for favorable legislation that helps support the growth of the medtech industry as a whole, including leading a 10-year effort to repeal the medical device tax.
Inspired by Dr. Fogarty’s life-long dedication to improve patient care and the Fogarty’s team commitment to the industry and raising the next generation of innovators, he joined the board in 2019 to lend his expertise and insight. Like his fellow board members and others associated with Fogarty Innovation, he believes that challenges in policy are more easily addressed when diverse industry members partner and focus their efforts. He believes that smoothing the path, allowing creative companies to excel and enabling increased investment will lead to more options for patients and clinicians.
A proud native of Lowell, Massachusetts, when not focused on his work with the MDMA, Mark likes to spend time with his wife and two daughters, golfing or skiing, two of the favorite activities they share.
A dynamic leader and inspiring role model, Angela currently serves as CEO of ForSight Labs, CEO of Voyant Biotherapeutics and is an active manager and mentor in the Ferolyn Fellowship program.
Despite her tremendous success in the medical technology arena, her path in the field hasn’t been a traditional one, as she kicked off her career as a judicial extern for the United States District Court. However, her interest in early-stage startups soon led her to the realization that medtech companies were the ones in the greatest need of a strong IP strategy, which led to her first job with VidaMed (Medtronic).
Angela later joined AneuRx, where she first met Dr. Fogarty who imparted his successful approach to innovation and minimally invasive surgery. This forged the notion and motto that “patients are waiting,” which sparked her interest in broadening her experience in medtech.
She continued working with Dr. Fogarty, serving as technology counsel where she participated in the formation and/or development of nine companies, and later rounded out her experience as chief technology counsel for The Foundry.
Having honed many of the skills needed to spearhead a company, she founded ForSight Labs, an ophthalmic incubator formed in 2005 in partnership with Dr. Eugene de Juan, Jr., MD, and The Foundry. The portfolio launched six companies and collectively raised over $200 million in capital, returning over $550 million to date with an additional $550 million in milestones.
Her ability to see opportunities and possibilities at every corner, passion for the success of others and motivation for creating a community of innovation is what led her to join the Fogarty Innovation board.
An inventor on over 25 U.S. patents, Angela received her Bachelor of Arts in business administration from San Francisco State University and her J.D. from Golden Gate University School of Law. Outside of work, she is deeply involved in animal rescue and enjoys being outdoors— hiking and mountain biking with her husband.
J. Casey McGlynn
Casey McGlynn is a partner at Wilson Sonsini where he focuses on the formation, funding and representation of medical device and life science companies. In 1988 Casey started the Life Science Group at the firm. Today there are several hundred attorneys focused on life sciences in the areas of corporate, securities, patents, FDA regulation and reimbursement.
The relationships Casey has built over the years originate from his early days in the medtech industry, where as a young lawyer he filed the Articles of Incorporation for a medical device company called Advanced Cardiovascular Systems, Inc. (“ACS”). In 1984 ACS was sold to Eli Lilly and eventually spun off as part of Guidant Corporation, which was eventually sold for over $27 billion. Out of that set of relationships Casey has built one of the largest medical device/life science legal practices in the country, focused on helping entrepreneurs start, fund, grow and sell their life science companies.
In fact, that is precisely why he is passionate about working with medtech entrepreneurs: They aren’t just creating new businesses that will make them wealthy, they are creating businesses that save lives and make the world a better place to live.
Casey joined the board of directors of Fogarty Innovation in 2013 after working closely with the organization over the years. He names Tom Fogarty as one of his heroes and appreciates how the Institute continues Tom’s passion for “finding a better way” to treat patients.
Every day, he looks forward to the chance to meet with entrepreneurs and hear their vision for a new life-saving product, and he also loves working with doctors, engineers and managers who are developing new products that can heal the sick, save lives and change the world.
Casey received his Bachelor of Science and Juris Doctor degrees from Santa Clara University, where he also met his wife. He proposed the day he got his job offer at Wilson Sonsini, and today they enjoy spending time with their three children and two grandchildren.
Lewis Wexler, MD
Lew has been a supporter of Fogarty Innovation since its inception and joined the board as an inaugural member, thus playing a significant role in the organization’s mission.
A staunch believer in the value of education, Lew spent more than 30 years in this field, with an illustrious tenure at Stanford, where he served as chief of cardiovascular radiology and co-director of the Stanford Catherization Angiography Laboratories. His bibliography includes an impressive collection of over 200 published articles, book chapters and abstracts on various aspects of cardiac and vascular imaging and interventions.
One of his most rewarding moments was to be among the pioneers in the evolution of angiography, finding new techniques to achieve the best images. He also got tremendous satisfaction from his years of teaching cardiology and radiology fellows, many of whom subsequently made a tremendous impact in healthcare.
Always looking for ways to get involved and support innovation and patients, Lew has held many public service positions, including as an original founder of the American Heart Association (AHA) Council on Cardiovascular Radiology and the president of the North American Society of Cardiac Imaging (NASCI). For his services, he received the first Gold Medal award from NASCI in 2002 and was also named Physician Volunteer of the Year by the California affiliate of the AHA, among other distinctions.
A Brooklyn, N.Y., native, Lew showed his educational acumen at a young age, entering undergraduate college when he was just 15. He completed his residency in diagnostic radiology at Stanford University School of Medicine right before joining the U.S. Air Force with the rank of captain. He followed his military service with a fellowship in cardiovascular physiology in London.
Today, in addition to serving on Fogarty’s board, he continues to be active at the Menlo Medical Clinic in the radiology department. A life-long learner, he still takes courses at Stanford and loves art of all kinds, including books, opera and museums, in addition to traveling with his wife.
Allan Will, Board Member
Allan Will is a seasoned executive with extensive experience at every stage of the medtech company life cycle. In his 30+ years in the industry, he has founded, led, built, sold, and funded numerous medical device companies, creating more than $2 billion in shareholder value. He currently serves as executive chairman of the board of EBR Systems and chairs the boards of Fractyl Labs and Setpoint Medical.
While his accomplishments and contributions to the healthcare field are vast, what gets him going each morning is people—he believes the ability to help patients and entrepreneurs be successful is a privilege and that few careers are more impactful on society and more rewarding to individuals than medtech.
With a remarkable record of building strong teams and leaders, Allan has spent the last 30+ years of his career as CEO of various Bay Area venture-backed startups. He also has founded or co-founded 11 companies including The Foundry, Evalve, Concentric Medical and Ardian. He added another element to his extensive experience in the field by joining St Paul Venture Capital and subsequently founding Split Rock Partners.
His entrepreneurial passion began as CEO of Devices for Vascular Intervention (DVI), a startup that he grew from 16 to more than 600 employees. This is where he first worked with Dr. Tom Fogarty, who sat on the DVI board; a partnership that continued as Allan spearheaded one of Dr Fogarty’s companies, AneurRx.
An inventor on more than 30 issued patents, Allan believes his work at Fogarty Innovation is critical as it allows him to seed the future of medtech with promising entrepreneurs, while honoring his friend and mentor, Dr. Fogarty. He subscribes to the philosophy of “Give a man a fish, and you feed them for a day. Teach them to fish, and you feed them for a lifetime,” which he feels aligns well with the organization’s philosophy.
A University of Maryland Distinguished Alumnus and recipient of the ASTIA/Deloitte Excellence in Mentoring Women Executives Award, he has served on the MIT Entrepreneurship Center Shareholders’ Board and the University of Maryland President’s Committee on Innovation and Entrepreneurship. He earned a bachelor’s degree in zoology from the University of Maryland and his master’s degree in management from MIT.
Fogarty Institute graduate Alydia Health developed and patented the Jada System, designed to stop postpartum hemorrhage (PPH). The leading cause of maternal death globally, it takes the life of one woman every four minutes; in the U.S., where PPH is less likely to result in death, it frequently manifests in blood transfusions or invasive surgery including hysterectomy.
Nearly 80% of PPH cases are caused by uterine atony, or the failure of the uterus to contract to its correct postpartum size, which leaves intra-uterine blood vessels fully dilated. Women suffering from this condition are at risk of severe and dangerous blood loss that can lead to injury or death.
Unlike other available treatments, Jada encourages the body’s natural response after childbirth by collapsing the uterus to its correct postpartum size, thus stopping PPH. The company recently announced the publication of its pivotal PEARLE Study in Obstetrics & Gynecology (the Green Journal), which demonstrated that Jada is safe and highly effective in using vacuum to control postpartum bleeding – within a median of three minutes.
In addition, following a Series C financing round of $13.9M, Alydia Health received market clearance from the U.S. Food and Drug Administration (FDA) in 2020 to commercialize the Jada system and was acquired by Merck on behalf of its planned spinoff of Organon in late March 2021.
CyberHeart pioneered the first non-invasive robotic ablation treatment for cardiac arrhythmias, which affect 2.5 million Americans, accounting for $6.5 billion in healthcare costs annually.
Current therapies, including medicines and catheter ablation, are effective for a limited group of patients. Despite improvements in catheter-based ablation modalities, success rates for atrial fibrillation (AF) have remained at approximately 60% even after multiple procedures, and ventricular tachycardia (VT) ablation success rates hover around 50%. If left untreated, cardiac arrhythmia can lead to stroke and heart failure.
CyberHeart’s CyberKnife Robotic Radiosurgery System has been shown to allow physicians to treat cardiac arrhythmias painlessly and accurately, in an outpatient setting without anesthesia, by utilizing advanced medical imaging and a novel robotic radiosurgical software and methods.
Using high-dose, focused radiation, radiosurgical systems are currently used to treat thousands of cancers each year, including those located in the lung, brain and other organs. The method and software pioneered by CyberHeart is designed to extend the use of these systems into the treatment of cardiac arrhythmias.
In 2019, CyberHeart was acquired by Varian Medical Systems.
There is a large clinical need for minimally invasive therapies and procedures that pose new and unique visualization demands. Procedure success is limited by 2D views of a 3D patient. In order to overcome this, hospitals and medical device companies, have become dependent on physician experience and on expensive “high-touch” support teams.
EchoPixel’s True 3D is the first software platform that empowers physicians with smart procedure guides (SPGs) that provide them with a digital twin of the patient that they experience as a hologram, AI tools that guide them through a procedure and a remote collaboration session environment to get live expert advice on the holographic digital twin.
True 3D is now the standard of care in several leading congenital heart defect programs across the U.S., growing in structural heart programs and is being developed of electrophysiology.
Learn more about EchoPixel: www.echopixeltech.com
Continuous and less-invasive patient monitoring is paramount for critically ill patients and the providers who treat them. Flosonics Medical has developed the FloPatch, a low cost, easy-to-use, wearable Doppler ultrasound sensor that is improving the management of critically ill patients at the point-of-care, such as in the ICU, emergency room and operating room. The device provides hands-free blood flow assessments by sending data wirelessly to mobile devices using low energy Bluetooth. The company is targeting a multi-billion dollar market opportunity and its technology has been cleared by both the FDA and Health Canada.
Learn more about Flosonics: www.flosonicsmedical.com
More than 110 million people worldwide suffer from non-healing, open wounds. High costs and overly complex technology severely limit, if not eliminate, access to advanced wound care technology. Healyx Labs is developing the lowest-cost and easiest-to-use wound vacuum technology for price-sensitive and underserved markets.
Learn more about Healyx Medical: www.healyxlabs.com
The Institute’s first company-in-residence and graduate, HeartFlow, Inc., developed the HeartFlow FFRct Analysis, the first and only non-invasive technology that provides insight into both the extent of coronary artery disease (CAD) and its impact on blood flow to the heart.
Tests commonly used to diagnose CAD, including stress tests and electrocardiograms, are inaccurate more than half the time or inconclusive, requiring the patient to undergo additional tests, such as coronary angiography, an invasive procedure shown to be unnecessary more than 60% of the time.
With HeartFlow’s approach, data from a patient’s non-invasive coronary CT angiogram is securely uploaded from the hospital’s system a private HeartFlow cloud. HeartFlow then leverages deep learning to create a personalized, color-coded, digital 3D model of the patient’s coronary arteries, and then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and assess the impact of blockages on coronary blood flow. Analysis and results are provided to the patient’s clinician via a secure web interface to offer actionable information on the optimal course of treatment.
HeartFlow has made major advances since graduating from the Institute in 2010. It has raised more than $500 million in funding, and in July 2021, it announced its intention to go public in a special purpose acquisition (SPAC) merger with Longview Acquisition Corp. II valued at $2.4B. The SPAC merger is expected to complete in Q4 2021.
One economic analysis performed as part of a larger study found the HeartFlow test reduced the healthcare system’s costs to care for patients with coronary heart disease by 26%, saving thousands of dollars per patient.
Fogarty Institute graduate InterVene developed a minimally invasive device for the treatment of venous disease in the legs.
Its BlueLeaf Endovenous Valve Formation System represents the first non-implantable, catheter-based therapy to address deep vein reflux, a major underlying cause of chronic venous insufficiency (CVI), which afflicts millions of patients in the U.S. and costs the U.S. healthcare system billions of dollars annually. CVI is characterized by insufficient blood flow back to the heart and elevated venous pressures, which leads to pain, swelling, skin changes and chronic ulcers.
Previous CVI treatments were limited to compression stockings and wound care, or in some instances, invasive surgery. However, these methods did not address the underlying problem of deep vein valve failure, and compression therapy yields low rates of patient compliance.
InterVene’s technology is intended to form new vein valves out of the layers of tissue that naturally make up a patient’s vein wall, avoiding the trauma of open surgery and allowing for multiple valves to be formed in a single procedure.
At the end of 2019, InterVene closed a $15M Series B round and won the highly competitive TCT “Shark Tank” competition. In 2020, the company received early feasibility IDE approval from the FDA and has since initiated clinical trials in the U.S.
Madorra has developed the first non-hormonal medical device treatment for feminine dryness and atrophy. It aims to improve the quality of life for 48 million post-menopausal women and the 1.4 million breast cancer survivors in the United States who suffer from the condition.
Following a Series A funding round led by Australia-based venture capital firm OneVentures, Madorra refined its medical device, and is currently working toward FDA approval. Madorra has received a series of grants from both the NIH and NSF. The company has expanded its base beyond Portland, Oregon, with an office in San Mateo, CA and a presence in Australia.
Madorra is continuing to run clinical studies in which patients have exhibited overwhelming interest.
Learn more about Madorra: www.madorra.com
More than 36 million patients in the U.S. suffer from chronic rhinosinusitis. In fact, the condition accounts for 1 to 2% of all physician visits and is associated with $7 to 12 billion in direct U.S. healthcare costs per year. Nasal steroid sprays are typically prescribed as standard of care, but are only partially effective as they cannot reach beyond the anterior portion of the nasal cavity. Nasus Medical is developing solutions for improved intra-nasal drug delivery through an innovative technology that is designed for patients to treat themselves at home, early in the pathway.
Learn more about Nasus Medical: www.nasusmedical.com
The company was acquired by Stryker in 2017.
Learn more about Niveus: www.linkedin.com/company/niveus-medical/
Fogarty Institute graduate nVision developed the Mako 7 device, the first and only device cleared by the FDA to collect cells from the fallopian tubes and aid in the earlier detection of ovarian cancer. In 2018 the company was acquired by Boston Scientific.
Often dubbed the “silent killer,” ovarian cancer is one of the deadliest types of cancer in women, ranking as the fifth leading cause of female cancer deaths in the U.S., according to the American Cancer Society. And while it has been estimated that a woman’s risk of getting ovarian cancer during her lifetime is about 1 in 78, only about 20% of these cases are detected at an early stage due to the initial asymptomatic nature of the disease.
Studies have shown that the most prevalent types of ovarian cancer may originate in the fallopian tubes; however, until the advent of the Mako 7, direct assessment of cells in the tubes had been an elusive goal.
The acquisition by Boston Scientific came on the heels of nVision’s clinical trials, where they examined pairs of fallopian tubes in 40 women, successfully demonstrating Mako 7’s ability to safely and effectively collect cell samples and detect signs of malignancy.
Learn more about nVision: www.nvisionmedical.com
PQ Bypass has developed the first fully-percutaneous femoral-popliteal bypass device intended to treat advanced peripheral arterial disease (PAD). In 2020, it received Breakthrough Device status from the FDA, which will allow patients suffering from long, complex blockages in the superficial femoral artery (SFA) to receive accelerated access to this treatment.
The Breakthrough Device label from the FDA is unique and broad for use in fem-pop lesions 200-460mm, chronic total occlusions (CTOs) 200-425mm with moderate to severe calcification and in-stent restenosis. The company’s innovations include the Detour procedure for percutaneous femoropopliteal bypass, the proprietary TORUS stent graft, the PQ Snare, and the PQ Crossing Device. Additionally, PQ is currently enrolling patients in its Torus2 Trial for the treatment of SFA disease in the range of 100mm-200mm. Enrollment will be completed in March of 2021 and, upon FDA approval, Torus will be the only other stent graft (apart from the Gore Viabian Graft) approved in the U.S. for placement in the SFA.
According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 18 million people in the U.S. suffer from PAD, a circulatory problem in which narrowed arteries reduce blood flow to the limbs. Estimates suggest that anywhere from 12 to 20 percent of individuals over the age of 60 are living with PAD.
After completing a $60M capital raise led by Deerfield Capital in 2019, PQ Bypass was acquired by Endologix in April 2021.
Learn more about PQ Bypass: www.pqbypass.com
Fogarty graduate Prescient Surgical is working to eliminate Surgical Site Infections (SSIs) with its CleanCision device, which has been shown to reduce SSI in certain high-risk surgeries from 61 to 100%. SSIs are particularly common in high-risk abdominal and colorectal surgeries, with three out of 20 patients undergoing these procedures developing an infection that results in an increased hospital stay or readmission, and potentially a higher risk of death.
CleanCision, the first in a new category of irrigating wound protection devices, received FDA 510(k) clearance in late 2017 and is now commercially available in the U.S. The device, which can be used on minimally invasive and open procedures, combines wound protection and irrigation into an intuitive and easy-to-use retraction system that deploys quickly, immediately beginning to clear harmful bacteria that may invade the incision during surgery.
Forward-thinking local hospitals like Stanford, Penn and The Cleveland Clinic are taking advantage of this innovative technology; surgeons are now confident closing their incisions with the topical therapy delivered by CleanCision, and patients are spending less time at the hospital.
The company recently closed $10M in financing to accelerate CleanCision’s early success and expand its customer base across the U.S. and eventually in Europe, where it already has CE mark in place. They are also focused on finding commercial partners to efficiently expand its market access, and is currently working with Baxter Healthcare in select markets.
Raydiant Oximetry has developed a non-invasive fetal pulse oximeter with the aim to more accurately identify fetal distress during labor, reduce the rate of medically unnecessary C-sections and improve outcomes for mothers and babies during childbirth. It has been estimated that nearly half of women give birth via a caesaren section in the U.S.
The company has earned a series of funding rounds and grants, including a $7.6 million Series A led by VCapital, the Global Health Impact Fund, RHIA Ventures, Avestria Ventures and Tri-Valley Ventures. It was among the first companies to achieve FDA Breakthrough Device status in late 2018 and completely a 25-patient feasibility study at Tufts University Medical Center, which provided first-in-human data.
Learn more about Raydiant Oximetry: www.raydiantoximetry.com
Ultrasound is a key tool for diagnosing potentially life-threatening problems, but patients too often die before they reach a facility. UltraSight facilitates point-of-care ultrasound in the cardiac imaging space by offering real-time on-screen guidance and quality assessment through a layer of intelligence that simplifies and standardizes ultrasound cardiac scanning. UltraSight’s software introduction is perfectly timed to coincide with the proliferation of cost-effective handheld devices designed for cardiac scans. However, despite the devices’ availability, it can take up to two years to master the skill of cardiac scans. UltraSight bridges the gap to allow any medical professional to become an expert in conducting cardiac scans, with AI technology that reduces the training to one day. The intuitive technology alerts the user when the image of the heart is aligned correctly; then it captures the image and saves it to be uploaded to a remote expert who can interpret it.
Learn more about UltraSight: www.ultrasight.com
Strokes are a leading cause of disability and the fifth leading cause of death in the United States. While physicians had largely been treating stroke with medication, treatment has been shifting to a procedure that removes the clot with a stent retriever. Xtract Medical is working on a device that’s simple to use and meets two significant needs: improving the ability to remove the clot on the first try, known as the “first pass” in thrombectomy; and preventing the clot from breaking up as it’s being removed.
Thomas J. Fogarty, MD
Innovator, Icon, Iconoclast
“If I have seen further,
it is by standing on the shoulders of giants.”
– Sir Isaac Newton
Dr. Thomas J. Fogarty founded Fogarty Innovation (previously known as the Fogarty Institute for Innovation) on the campus of El Camino Hospital in 2007. His vision: to spur medical device innovation, improve patient care and lower healthcare costs. An internationally recognized cardiovascular surgeon, inventor, entrepreneur and vintner, Dr. Fogarty has dedicated his career to improving medicine. During his acclaimed career, he has acquired 190 medical patents for his revolutionary work, including the “industry standard” Fogarty balloon embolectomy catheter, The Hancock Tissue Heart Valve, and the Aneurx Endovascular Aortic Stent Graft. He is the founder or co-founder of over 45 medical technology companies, and his inventions significantly and extensively influence the way surgery is performed today. Dr. Fogarty has been recognized by numerous organizations for his contributions to medical science, including:
- Presidential Medal of Technology and Innovation 2014
- Lemelsen-MIT Prize for Invention and Innovation 2000
- National Inventors Hall of Fame 2001
- Jacobson Innovation Award of the American College of Surgeons
- American College of Surgeons Icon in Surgery 2019
Dr. Fogarty’s first invention was far from the medical field, however. When he was just 12, he saw an unmet need and invented the centrifugal clutch still used today on motor scooters.
Today, Dr. Fogarty remains active on the board of Fogarty Innovation, and we maintain his “patient first” philosophy in all that we do.
“I certainly wouldn’t be where I am today if it wasn’t for my mentors.”
– Thomas J. Fogarty
We live out his belief everyday.
Facility: Where We Live
Embedded on the campus of El Camino Health in the heart of Silicon Valley, Fogarty Innovation is headquartered in a custom-designed facility with 30,000 square feet of dedicated office, laboratory, machine shop, conference, collaboration, and recreation space—all designed to support the entrepreneurs and companies in our incubation and acceleration programs, along with our staff, mentors, and partners. With a vista of the coastal ranges that give our city of Mountain View its name, these surroundings have a history of inspiring legendary innovations and will continue to spark new discoveries for years to come.