Mitral regurgitation (MR), when the mitral valve allows blood to leak backwards into the left atrium, is a common valve disease that affects 6% of people over the age of 65 and 10% of people over 75. MR forces the heart to work harder, causing shortness of breath and fatigue, and potentially leading to heart failure. If not treated, mortality within five years of symptom onset can be as high as 50%.
In recent years, transcatheter mitral valve replacement (TMVR) has emerged as a minimally invasive alternative to an open surgical replacement or repair of the valve. However, not all patients with MR are eligible. Nearly half of patients are rejected because of a risk that the procedure could displace part of their valve and cause a life-threatening blockage. Mitracept, a new member of Fogarty’s company accelerator program, plans to mitigate that risk and open treatment options for those patients.
The company is led by CEO and co-founder Tejas Mazmudar, and CMO/inventor Dr. Mayra Guerrero, an interventional cardiologist at the Mayo Clinic and a key opinion leader in the TMVR space. The company is funded by NLC Health Ventures, a global healthtech venture builder and early-stage investor. During the company’s time at Fogarty, Mazmudar plans to advance the company’s regulatory and reimbursement strategies and explore market access pathways.
Mazmudar is a familiar face at Fogarty. His career includes nearly 12 years in R&D at women’s health company Minerva Surgical, which he joined as an early employee. For nine of those years, he worked with Mike Regan, Fogarty’s Chief Innovation Officer who was the COO of Minerva at the time.
“Mike is one of the best mentors I’ve had,” said Mazmudar. “He was instrumental in helping me succeed as I worked across the entire product lifecycle, from concept through post-commercialization,” he said.
Doing it all
When Mazmudar joined Minerva as an R&D engineer, he “hit the ground running.” The company’s first product, which addresses abnormal uterine bleeding, included both disposable and capital equipment components. “Initially, my responsibilities were on the mechanical side for the disposable,” recalled Mazmudar. “But we were a small team, which meant that I was also working on the capital equipment, doing everything from designing and testing to managing vendors and suppliers,” he recalled.
As the product advanced, Mazmudar’s responsibilities evolved in parallel. “I supported clinical trials in Hungary, Mexico, Canada and the US, and then I helped with regulatory audits,” he said. “Once the device was approved, I went into the field, working with salespeople, training physicians, and educating decision-makers on the clinical benefits of our solution. Post commercialization, I focused on sales support, KOL engagement, and then addressing the many small issues that arise once a product is on the market.”
The breadth of his experience at Minerva gave Mazmudar the confidence to lead a company in his own right. It also helped him internalize a key lesson – that “there will always be things that go wrong but there are also always ways of figuring out how to solve those problems.”
Shaping DxD
Mazmudar’s time at Minerva Surgical also fueled a second point of contact with Fogarty – his involvement with Diversity by Doing HealthTech (DxD). Mazmudar participated in the Stanford Biodesign/Fogarty Innovation gender summit, which was a precursor to the diversity initiative.
“At the time of the summit, I had been in medtech for 15 years,” he recalled. “And the first time I went into an endometrial ablation procedure, nearly everyone in the room – with the exception of the patient – was male. And it was the same at work on a daily basis.” He continued, “It just felt ridiculous – here we were developing products for women without any input from women. How could we presume to understand menstrual pain?”
After participating in the summit, Mazmudar stayed involved as part of the working group that shaped and launched DxD. His support for the initiative continues and he volunteers regularly across DxD programs.
Engineering Health
While engineering was always a passion, Mazmudar initially had his sights set on aeronautics and astronautics. The turning point was a cardiovascular biomechanics class at Stanford University taught by Charles Taylor, the co-founder of medtech companies Cardiovascular Simulation, Inc., and Fogarty alumni company HeartFlow.
“When I took his class, I realized that we were applying the same principles of engineering and fluid mechanics to the human body,” described Mazmudar. “And that opened a completely new door for me. I realized that, as an engineer, I could do work that would impact not only my own health, but also the health of many others.”
Intrigued, he looked for additional classes at the intersection of health and engineering, which led him to Stanford Biodesign. He went on to take the graduate level Innovation Course, which confirmed his desire to focus his career on health technology innovation. After completing his MS in mechanical engineering, Mazmudar worked for Conor Medsystems/Cordis, then Minerva Surgical, and then as a consultant and strategic advisor, which led to him taking the helm at Mitracept in partnership with the Mayo Clinic.
As a new CEO, Mazmudar’s decision to join Fogarty Innovation was simple. “This is my first experience building a company, not just a product,” he said. “So, I knew I needed experienced partners who have done this before and can share best practices and lessons learned. In addition to Mike, I knew the track records of most of the senior team. There was no question in my mind that Fogarty was the right partner for Mitracept.”