Fogarty Innovation

10/09/2025

Welcome! We are thrilled to announce that Matt Hillebrenner has joined Fogarty Innovation as Director of Government Affairs. His move follows 22 years at the FDA, where he most recently served as Deputy Director, Office of Product Evaluation and Quality in the Center for Devices and Radiological Health.

At Fogarty, Matt will be part of our senior coaching team, helping medtech startups and entrepreneurs better navigate the regulatory environment and engage more effectively with other government agencies including the USPTO, Centers for Medicare & Medicaid Services, and The National Institutes of Health. He will also collaborate with Marga Ortigas-Wedekind and her team to deliver educational programming that leverages his significant experience and provides an insider’s perspective.

Reflecting on the move, Matt shared, “At FDA, I worked with a remarkable team dedicated to improving patient care by helping deliver safe and effective new devices. I can’t imagine a better place to explore new ways to make a difference for patients than Fogarty Innovation, where people and mission—and how they combine to form culture—are paramount. I look forward to learning from such a talented group and using my experience to support the early stage medtech innovation ecosystem.”

Fogarty Innovation CEO Andrew Cleeland added, “Matt’s arrival further strengthens our deeply experienced coaching team. His unique perspective and decades of regulatory leadership will be invaluable to our community and to advancing our mission of improving patient care through medtech innovation.”

Welcome to the Fogarty Innovation family!

10/09/2025

10/06/2025

Last week, Fogarty COO Denise Demarais led an IP roundtable on navigating patent office actions from an inventor’s perspective.

While receiving feedback from the PTO can feel intimidating, Denise walked participants through six types of rejections, real-world case studies, and practical strategies for working with attorneys to turn obstacles into allowable claims that support business goals.

Fogarty roundtables are exclusive events for our current and alumni companies, offering deep dives into IP, clinical trials, and regulatory issues—and giving company leaders the chance to both share experiences and get guidance on their unique challenges.

09/30/2025

Medtech startup leaders need to master far more than their core area of expertise—and one of the most critical topics is understanding startup funding, exits, and all the terminology that comes with them.

Last week, Brian Appel, partner in the medtech practice at Wilson Sonsini Goodrich & Rosati joined us for a Lunch & Learn to break it all down. Drawing on his extensive experience representing startups and guiding venture financings, he explained:

▪️ The three types of instruments for raising venture capital: convertible notes, SAFEs, and equity financing
▪️ The key terms in an equity financing term sheet
▪️ An overview of the M&A process and critical deal terms for startups being acquired
▪️ Current trends in the medtech financing market
…and much more!
A huge thank-you to Brian for sharing his insights.

✨ What do you want to learn? Our Q4 educational calendar just published and includes a Washington update from Mark Leahey, president of Medical Device Manufacturers Association (M**A) on Oct. 7, a talk on structuring partnerships from Brian’s colleague, Alex Key on Nov. 4, and more! Don’t miss out—sign up to be notified about future events here: https://www.fogartyinnovation.org/get-involved/

09/23/2025

Meet the final 2025 Thomas J. Fogarty Innovation Prize finalist:
⭐Fetal Surgery: Michael R. Harrison. M.D.⭐
Families facing life-threatening birth defects now have hope thanks to the pioneering field of fetal surgery. Conditions such as spina bifida, congenital diaphragmatic hernia, and twin-to-twin transfusion syndrome—which once meant stillbirth, disability, or early death—can now be treated before a child is even born, dramatically improving survival and long-term outcomes.

This groundbreaking field was launched in the 1980s by Dr. Michael Harrison and his colleagues at UCSF, who developed delicate techniques ranging from minimally invasive fetoscopy guided by ultrasound to complex open surgeries. To enable these procedures, they also created specialized tools such as amniotic staplers and fetal monitors adapted from NASA technology. Today, more than 50 advanced fetal therapy centers across the U.S. perform thousands of procedures each year, and Dr. Harrison’s trainees and research continue to define the standard of care worldwide.

The Fogarty Prize honors an innovator or team who has developed and successfully commercialized a life-changing medical technology. The finalists will be celebrated, and the winner announced, at a black-tie gala in San Francisco on October 24. The winning individual or team will receive an unrestricted $100,000 cash prize and a custom-cast bronze medal.

Learn more and join us on October 24: bit.ly/Fogarty_Prize_2025

09/19/2025

Meet the second 2025 Thomas J. Fogarty Innovation Prize finalist:
⭐ FARAPULSE Pulsed Field Ablation (PFA) System: Allan Zingeler; Raju Viswanathan, PhD; Mike Mahoney ⭐
Atrial fibrillation (AFib), the most common sustained cardiac arrhythmia, affects more than 10 million Americans and dramatically increases the risk of stroke, heart failure, and dementia. FARAPULSE is an advanced treatment for AFib that delivers precisely timed electrical pulses that selectively inactivate the problematic heart cells while leaving nearby critical structures like the esophagus, nerves, and blood vessels unharmed.

Compared to traditional thermal ablation methods, pulsed field ablation increases procedural safety, speed, and ease of use, leading it to become one of the fastest adopted treatments in medical device history. FARAPULSE achieved CE Mark in 2021 and FDA approval in 2024. To date, nearly half a million patients worldwide have been treated.

The Fogarty Prize honors an innovator or team who has developed and successfully commercialized a life-changing medical technology. The finalists will be celebrated, and the winner announced, at a black-tie gala in San Francisco on October 24. The winning individual or team will receive an unrestricted $100,000 cash prize and a custom-cast bronze medal.

Learn more and join us on October 24: bit.ly/Fogarty_Prize_2025

09/16/2025

With a broad skill set that includes mechanical engineering, product and industrial design, biology, physiology, project management, and communications, John Morriss is perfectly suited for his role as director of Fogarty’s Invention Acceleration Program (IAP), where he helps first-time innovators translate research projects and clinical insights into viable, fundable medical devices.

John likens the IAP process to puzzle solving, but with a twist. “When you work on a puzzle, you typically do the easiest part first – like building the border,” he explained. In the IAP, where the goal is to develop, refine, and pressure-test projects across multiple key areas, Morriss likes to start with whatever is hardest.

You can find out why, and learn more here:

John Morriss is good at a lot of things. His broad skill set includes mechanical engineering, product and industrial design, biology, physiology, project management, and communications, among others. He has the rare ability to dive deep into individual elements of a project while keeping an eye on t...

09/16/2025

📩 You've got mail! Check your inbox for a sneak peek at what's coming up this fall with DxD, including and can't miss events from our partners.

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09/12/2025

Meet the 2025 Thomas J. Fogarty Innovation Prize finalists:
⭐ Frameless Stereotactic Radiosurgery: John Adler, MD ⭐
Cancer patients worldwide have benefited from CyberKnife, the first frameless stereotactic radiosurgery system. The technology combines a lightweight linear accelerator with a robotic arm, enabling radiation to be delivered from hundreds of unique angles—even to tumors that move with breathing or are located in areas once considered untreatable. The system uses real-time imaging to dynamically track and adjust during treatment, maintaining precision and protecting surrounding healthy tissue. Unlike earlier radiosurgery approaches, CyberKnife is non-invasive, eliminating the need for head frames, sedation, or hospitalization.

Approved by the FDA in 1999, CyberKnife redefined radiation therapy, helping millions of patients and influencing every modern system that has followed. Dr. Adler later advanced the technology further with ZAP Surgical Systems, Inc. which eliminated the need for expensive shielded vaults, expanding access for hospitals and clinics worldwide.

The Fogarty Prize honors an innovator or team who has developed and successfully commercialized a life-changing medical technology. The finalists will be celebrated, and the winner announced, at a black-tie gala in San Francisco on October 24. The winning individual or team will receive an unrestricted $100,000 cash prize and a custom-cast bronze medal.

Learn more and join us on October 24: bit.ly/Fogarty_Prize_2025

📸Annie Leibovitz

09/11/2025

We are thrilled to announce that therapies that have transformed the treatment of cancer, atrial fibrillation, and life-threatening birth defects have been named finalists for the inaugural Thomas J. Fogarty Innovation Prize!

This prestigious new recognition honors an innovator or team who has developed and successfully commercialized a life-changing medical technology. The finalists will be celebrated, and the winner announced, at a black-tie gala in San Francisco on October 24. The winning individual or team will receive an unrestricted $100,000 cash prize and a custom-cast bronze medal.

The three finalists are:
🌟 Frameless Stereotactic Radiosurgery: John Adler, MD
🌟FARAPULSE Pulsed Field Ablation (PFA) System: Allan Zingeler; Raju Viswanathan, PhD; Michael Mahoney
🌟Fetal Surgery: Michael R. Harrison. M.D.

Named in honor of Thomas J. Fogarty, MD, a pioneering cardiovascular surgeon and icon in medical device innovation, and made possible through a foundational grant from the Linda and Mike Mussallem Foundation, the Fogarty Prize celebrates individuals who have made a significant contribution to improving patient care through innovative technology.

“The Fogarty Prize celebrates the spirit of innovation and the drive to make a lasting difference in patients’ lives through bold medical technology breakthroughs,” said Mike Mussallem, co-founder of the Linda and Mike Mussallem Foundation. “The selection process went far beyond technical achievement to identify leaders whose integrity, vision, and relentless dedication to improving patient outcomes set them apart. We are proud to play a part in recognizing the next generation of innovators who are redefining what’s possible in medicine.”

Learn more: https://www.businesswire.com/news/home/20250910801926/en/Three-Life-Saving-Medical-Technologies-Named-Finalists-for-the-Inaugural-Thomas-J.-Fogarty-Innovation-Prize

UCSF

09/11/2025