Kidney stones, hard deposits of minerals and salts that form inside the kidneys, are among the most painful conditions, sending more than half a million people to the emergency room each year. An estimated one in 10 people will suffer from kidney stones at some point in their lives, and studies show the frequency in the U.S. is on the rise.
Current treatments include waiting for the kidney stones to pass naturally, performing shockwave therapy to break up the stones, or surgically removing larger ones; however, each comes with its own complications.
Anodyne, one of the two Stanford Biodesign Summer Extension projects hosted by Fogarty Innovation, aims to provide a better, less invasive solution through a catheter-based ultrasound device that can break up kidney stones with minimal trauma in an office setting.
A collaboration by accomplished professionals
The project was formed by Alex Sackeim, MD, and Nishant Doctor, who were teammates during the Innovation Fellowship at Stanford Biodesign.
Alex is an emergency medicine physician, who was practicing before joining the Stanford Biodesign program and had already worked with two digital health companies. He became interested in creative answers to healthcare problems early on through watching his dad, a clinical researcher in electro-convulsive therapy (ECT), improve the safety and efficacy of that therapy while doing foundational work on deep brain and transcranial magnetic stimulation.
Although Alex was fascinated by the complexities and intricacies of the human brain, he was also interested in urban planning. He earned a BA in Urban Studies and Pre-Medicine from Columbia University, then later decided to also pursue his MD from Columbia University College of Physicians and Surgeons. “I always wanted to do things on a system level, so I wasn’t an exact fit with the medical school model,” he says. This led him to pursue other projects outside of being a physician, including launching a course for medical students to learn healthcare process improvement and working for a small startup developing a secure messaging for health systems. To further his opportunities in healthcare entrepreneurship, he joined the Stanford Biodesign Fellowship.
Nishant is an experienced medical device professional who recently joined Santé, a venture capital and private equity firm, as principal of Medical Device & Healthcare Consulting. Nishant received his BS in Biomedical Engineering from the University of Texas at Austin, an MS in Electrical and Computer Engineering from Rice University and a nanodegree in computer science and artificial intelligence from Udacity.
His passion for the industry began when he was working with Cyberonics (now LivaNova), where he experienced firsthand the vital impact medical devices have on patients. “I was working with a neuromodulation device designed to treat epilepsy, and the positive feedback we received from these patients and their families on how our device helped change their lives made me realize that I wanted to be part of this field,” he says. That spurred his interest in continuing to pursue healthcare innovation, which led him to the Biodesign fellowship.
Finding an unmet need
Nishant and Alex explored more than 300 unmet needs during the clinical observation immersion portion of the program as they shadowed urologists and nephrologists. “By observing many cases and interacting with physicians and patients, we discovered numerous opportunities and narrowed them through a series of progressive filtering criteria that included market size, clinical impact, reimbursement and regulatory strategy,” said Nishant. “Both of our team’s final choices entailed kidney treatments, and Alex and I ultimately selected kidney stones due to their prevalence and our desire to help patients experiencing this incredible pain. Something needed to be done.”
“As a physician, I see a lot of kidney stone patients, and this condition really resonated with me,” added Alex. “Existing treatment options aren’t optimal, and we saw a real opportunity to come up with a better approach.”
Working with Fogarty Innovation
Alex and Nishant received a $60,000 grant in extension funding and worked over the summer with Stanford Biodesign and Fogarty Innovation to advance their project. Fogarty team members were part of the selection process.
“We are thrilled to work with the Fogarty Innovation team as they have deep experience in launching successful companies and developing technologies that are both novel and transformative,” said Nishant. “We realize we will face roadblocks and challenges, especially as this is a new procedure that requires a unique regulatory and reimbursement strategy, and we look forward to their guidance.”
“We appreciate that Fogarty executives lent their expertise and play a critical role in filling our knowledge gaps and connecting us with the right people in the industry,” added Alex.
About the Stanford Biodesign Innovation and Summer Extension Programs
The Biodesign Innovation Fellowship is a 10-month, full time, hands-on program for experienced professionals with backgrounds in engineering, medicine, and business. During the fellowship, trainees learn and apply the Biodesign innovation process to uncover and validate clinical needs, invent novel digital and device-based health technologies to address them, and prepare to bring those products to the market to improve patient care.
The Biodesign Summer Extension program provides qualifying teams from the Stanford Biodesign Innovation Fellowship and the graduate-level Biodesign Innovation course with additional funding and mentoring to pursue their projects through the summer. Recipients use this time to further de-risk their technologies, develop business plans, and line up additional funding to take their projects to the next level.
Fogarty Innovation partners with these young companies to offer its signature hands-on mentoring from each member of the executive team, in addition to a dedicated mentor, along with a comprehensive development plan and opportunity to participate in educational workshops tailored to their specific needs.
From undergoing a full company review, to connecting the companies with the right people and physicians in the industry, program attendees have a unique opportunity to quickly propel projects forward and get closer to becoming a potentially viable company.