MEDICAL INNOVATION NEWS

From the CEO's Desk

"Boldness has genius, power, and magic in it. Begin it now." – Johann Wolfgang Von Goethe

In just the few short months since I joined the Institute, thanks to the support and insight of our team, entrepreneurs, Dr. Fogarty and our board, we have been making great progress in continuing to build the infrastructure to best support our companies-in-residence. It is by creating a strong team that we will be best positioned to provide the foundation our innovators need to take their product from inception to commercialization.

In this edition, we explore more of this continuing evolution. First, we are pleased to announce the addition of industry veteran Denise Zarins who will lend her experience to our education and mentoring programs, which form the bedrock of our offerings to our companies-in-residence.

We are also proud to share that after a very competitive application process, our team selected four very diverse new startups that are joining us this month, following on the footsteps of two graduates.

In addition, we share a Q&A with Dr. Fred St Goar on the challenges and triumphs inherent in developing innovative technologies and the critical role that organizations like El Camino Hospital play in helping new devices reach patients; and how Julia Fox, a Ferolyn fellow, has already benefited from her mentors in helping shape the direction of her career.

Lastly, save the date for our much-anticipated Wine with Heart event on September 8, which will commemorate our 10-year anniversary. And we hope you will join us in attending Stanford Biodesign's From the Innovator's Workbench for an informal interview with Boston Scientific's chairman and CEO, Michael Mahoney, on Tuesday, April 25.

As always, we appreciate your support and welcome your feedback and thoughts.

Andrew Cleeland, CEO of the Fogarty Institute

"Thanks to the support and appreciation for innovation that El Camino Hospital and its community provide, we will be seeing a parade of 'MitraClip like' projects generated by the Fogarty Institute." – Fred St Goar, MD

Fogarty Institute Updates

Denise Zarins Joins Fogarty Institute for Innovation as Chief Technology Officer

As the Fogarty Institute continues to shape its future direction, the team is growing, with a focus on unparalleled support for its startups. To this end, the Institute recently hired medtech industry veteran Denise Zarins as chief technology officer.

In her new role, Denise is responsible for mentoring the Institute's companies-in-residence and entrepreneurs and working with the leadership team to develop a high-quality educational curriculum, designed to prepare the innovators to successfully launch a startup.

Beginning in April, the entrepreneurs will attend monthly half-day courses, which will be led by high-caliber internal and external subject matter experts. Sessions will include information on intellectual property, product development, fundraising, engineering, operations, sales and marketing, business operations and quality systems, among others.

"This is a very exciting time at the Fogarty Institute, and I am thrilled to be part of the team tasked with developing and driving our education and mentorship program," said Denise. "We have met with each of our entrepreneurs to discuss their individual needs and how we can best help them move their companies forward. Based on their feedback and our own experience in launching successful companies, we are building a customized faculty roster that addresses each skill set."

Denise's passion and knowledge in the medtech industry runs deep. She first knew she wanted to seek a career in this field as a sophomore in high school when she recognized it perfectly blended her two chief interests of medicine and technology. To make the dream a reality, she moved from her native Wisconsin to California despite only knowing two people there.

She landed her first job working as a research and development engineer and manager at AneuRx, a startup that was founded by Dr. Fogarty and later acquired by Medtronic. She subsequently joined another Fogarty-backed startup, Bacchus Vascular, which was later acquired by Covidien. After joining the Foundry, she co-founded Ardian, Inc. and became the Vice President of R&D. In this role, she was involved in every aspect of product development from concept through early commercialization, and ultimately, an acquisition by Medtronic. She also had the opportunity to work with Andrew Cleeland, who invited her to consider coming to the Fogarty Institute.

"One of the most rewarding aspects of my career is being involved with startups whose products have gone to market and are still being used to help patients today," said Denise. "I am really looking forward to using my experience to help Fogarty Institute entrepreneurs achieve that success."

Our Companies

The Raydiant team (from left to right): Terry Han, chief scientific officer; Neil Ray, MD, chief medical officer; and Nicole Hlava, MD, chief executive officer

Fogarty Institute adds four new startups; two companies graduate

Following a very competitive application process, the Fogarty Institute is excited to welcome four new startups to its incubator program: Healyx, palmm, Radial Medical and Raydiant Oximetry. The companies were selected based on their proven experience in the space, potential to develop innovative methods to serve unmet healthcare needs and interest in advancing our mission of transforming the industry.

The new startups join the Institute as two other companies, nVision Medical and InPress Technologies, graduate. Both companies have received funding and shown that their technologies have evolved sufficiently to allow the startups to move to their own facilities and operate independently. Seven companies have now successfully graduated since the Institute's inception nearly 10 years ago.

"The application process was rigorous, and we are delighted to welcome these qualified companies, whose unique focuses support our goal to address a broad spectrum of patient needs," said Andrew Cleeland, CEO of the Fogarty Institute. "We look forward to mentoring and educating them to help them thrive and make an impact – not only to solve specific healthcare needs, but to become financially successful entities that will offer a sustained impact. We believe they will be a strong addition to our growing roster of successful graduate companies."

The Radial Medical team in front of the R&D garage workshop where they started. From left to right: James Wall, MD; Gil Laroya; Eric Johnson; and Conrad Salinas.

About the New Startups

  • Healyx is developing an innovative, cost-effective solution aimed at helping doctors in low-income countries successfully treat patients with severe wounds, with a device that improves on the highly regarded method of Negative Pressure Wound Therapy (NPWT).

    In resource-constrained countries, non-healing wounds such as burns, trauma wounds, diabetic ulcers and pressure sores compound overcrowding in hospitals and place a significant expense on patients, driven by daily gauze dressing changes and hospital charges. The problem is immense: The incidence of open wounds exceeds 110 million patients worldwide and is growing due to an aging global population and increasing rates of diseases that cause chronic wounds.

    Healyx was launched in 2015 as part of one of Stanford's social innovation programs, Design for Extreme Affordability. The leadership team consists of co-founders Cam Hutton, CEO, and Madeline Sides, product lead.

Justin Huelman and Véronique Peiffer, co-founders of palmm

  • palmm is developing a simple, at-home treatment for hyperhidrosis, also known as excessive sweating. Fifteen million Americans suffer from this condition, which can dramatically affect quality of life in both social and professional situations.

    While hyperhidrosis can affect several locations on the body, patients find the condition the most bothersome on the hands, which is palmm's initial focus. Current treatment options (including antiperspirants, iontophoresis, botox injections and cardiothoracic surgery) are all either ineffective, inconvenient, costly or invasive, leaving an important clinical need unmet.

    palmm was founded by Justin Huelman and Véronique Peiffer, both former Innovation Fellows at Stanford University's Byers Center for Biodesign.

  • Radial Medical is an early-stage company developing innovative therapies in the consumer and medical fields.

    Founded in 2016 by Eric Johnson and Dr. James Wall, the team has over 75 years of combined experience in developing and commercializing medical devices. Most recently, Eric founded Crux Biomedical, a company which developed an inferior vena cava filter to treat pulmonary embolisms that was acquired by Volcano Corporation. Dr. Wall founded Insite Medical Technologies, a company that commercialized a proprietary medical device to provide safe and accurate delivery of epidural anesthesia.

  • Raydiant Oximetry is developing a novel, non-invasive, medical device to determine fetal oxygen levels during the third trimester of pregnancy and labor. Inaccuracies in the current system of monitoring fetal health during labor have led to almost one in 10 pregnancies requiring an unanticipated Cesarean section.

    Although sometimes necessary, C-sections can have multiple negative effects to the health of both mothers and babies and increase healthcare and insurance costs. With knowledge of the baby's oxygen level, Raydiant's device can keep women and babies safer and healthier after childbirth.

    The team consists of Nicole Hlava, MD, chief executive officer; Neil Ray, MD, chief medical officer; Terry Han, Ph.D., chief scientific officer; and Heidi Bell, MD, medical director.

Q&A with Fred St Goar, MD, Interventional Cardiologist and Fogarty Institute Vice Chairman

Celebrating the 100th MitraClip procedure at El Camino Hospital. From left to right: Chad Rammohan, MD, F.A.C.C., Interventional Cardiologist, PAMF/ ECH Medical Director, Cardiac Cath Lab, Chest Pain Center, and TAVR; Deepu Nair, MD, Cardiologist, PAMF/ ECH Medical Director, Echocardiography; MitraClip inventor Fred St Goar, MD; Vincent Gaudiani, MD, Cardiothoracic Surgeon, PAMF/ Medical Director, Norma Melchor & Vascular Institute at El Camino Hospital (Photo courtesy of El Camino Hospital)

Fred St Goar, MD, F.A.C.C., is a practicing interventional cardiologist with Advanced Cardiovascular Specialists, a leading cardiovascular care group based at El Camino Hospital in Mountain View. He is also Vice Chairman of the Board at the Fogarty Institute for Innovation, and mentor and advisor for the majority of the organization's startups.

He attended Harvard Medical School and completed his medical and cardiology training at Stanford. While he was a fellow at Stanford in the early '90s, Dr. St Goar helped launch several companies, including HeartPort and Cardiovascular Imaging Systems (CVIS).

In 1999, he co-founded Evalve, one of the leading companies in the area of structural heart and valvular intervention, and was the physician inventor of the company's minimally invasive catheter-based MitraClip system. Evalve was later acquired by Abbott Vascular.

As El Camino Hospital celebrated the 100th MitraClip procedure, we had the privilege of catching up with Dr. St Goar to discuss why he invented the device, its impact on patients and the value of partnering with El Camino Hospital.

Q. How did you come up with the premise for the MitraClip?
A. Up to 10 percent of patients in their mid-seventies suffer from moderate to severe degrees of mitral regurgitation, which is caused by a leaky heart valve. Open-heart surgery used to be the only way to fix this debilitating heart condition, but patients are often too old or sick to survive such an invasive intervention and thus have no therapeutic options.

During my training at Stanford, I was introduced to the medtech entrepreneurial environment and the opportunities it offered for making a big impact. Pioneers like John Simpson, Tom Fogarty, Simon Stertzer and Paul Yock were establishing a tradition of successful cardiovascular innovation, and the significant effect on patient wellness that their contributions were having wasn't lost on my fellow cardiology trainees and me.

I had a special interest in valvular disease in part due to the technical challenges it posed. In the fall of 1998, I heard of a unique and intriguing surgical approach to repair the mitral valve, the "edge-to-edge repair" where a single stitch was used to fix the leaking valve. I was impressed by the simplicity and elegance of this approach. It struck me that such a simple repair technique should be able to be performed with a catheter, thus using a significantly less invasive approach than open-heart surgery.

I put some ideas on paper and recruited a team of very talented engineers and dedicated professionals, headed by the late, very creative and dynamic Ferolyn Powell. It took us a couple of years of testing to learn that the suture-based approach was not optimal and in fact, was dangerous. On the other hand, a clip system that could be placed on the two leaflets at the location of the regurgitation was not only safer, but significantly more effective and offered a variety of other advantages.

With the newly designed clip device, in June 2003 we traveled to Venezuela where we successfully treated the first patient, a woman in her late 40s. We were fortunate that the procedure was successful, and now 13 years later, this patient is still doing well. This was undoubtedly one of the most memorable days of my professional life, and I am thrilled that the result has been durable.

Q. What were some of the challenges you had to overcome to get the device to market?
A. Getting the MitraClip to market was a marathon process. We had to undergo three sequential, highly complex trials to prove the safety and efficacy of the device. We finally received FDA approval 10 years after treating our first patient. Had we not had the strong commitment, determination and dogged dedication of our team who knew that this device would be of great benefit to patients, the MitraClip would likely have failed to get to market.

Another challenge we faced was convincing physicians and especially the surgical community of the value and benefit of this novel approach. We would often find that "hospital systems" were reluctant to give it a try. This was not true at El Camino Hospital: Thanks to the organization's open mind and willingness to try new technologies and the patients' confidence in their physicians, they did a great job of integrating the technology into the hospital's healthcare portfolio.

On a global perspective, we are also very proud that today the device has been used to successfully treat more than 40,000 patients in 570 hospitals worldwide - that is a lot of patients, patients' families and patients' communities who have benefited from this therapy.

Q. What is the significance of the 100th procedure celebration at El Camino Hospital?
A. Back when we were starting companies in the '90s, there were challenges, but we had many more resources available to support and fund the development of new technologies. There were significantly fewer barriers in terms of both regulatory and reimbursement hurdles. These days, there is less appetite to support these kind of complex, game-changing therapeutic projects as the risks are viewed as high and the returns are unpredictable.

The Fogarty Institute for Innovation, which is housed on the El Camino Hospital campus and supported by the organization, was set up specifically to address these challenges and provide a supportive environment where new, cutting-edge technologies and therapies can be developed.

Thanks to the support and appreciation for innovation that El Camino Hospital and its community provide, we will be seeing a parade of "MitraClip like" projects generated by the Institute. These therapies will have a dramatic impact on the health and wellness of patients locally and globally - something that the hospital will be very proud of.

Monthly Spotlight: Julia Fox, Ferolyn Fund Fellow

Julia Fox at last year's Wine with Heart event with mentor Jon Coe, co-founder and CEO of Prescient

At the onset of her studies at Johns Hopkins University as a Biomedical Engineering student, Julia Fox knew she wanted her career path to be one that would make an impact on health and healthcare.

That devotion underscores a number of career moves she has made along the way, eventually bringing her to the Fogarty Institute as a Ferolyn Fellow, where she is receiving the support and guidance she needed to take her focus to the next level. While her end goal was always in sight, the Ferolyn Fellowship has given her the exposure and perspective she needed to define her voice and her role in driving healthcare innovation in a meaningful and sustainable way.

Throughout her career, Julia has undertaken a number of roles that have helped give her a holistic view of the healthcare industry.

Following her undergraduate studies, she was admitted to the prestigious Fulbright Scholar Program and spent a year in Denmark at the Aarhus University Hospital in the Orthopaedic Research Laboratory, studying the structure-function properties of bone as they relate to activity and aging. Julia continued this focus on orthopaedic biomechanics while earning her Ph.D. in Mechanical Engineering at the University of California at Berkeley.

While her work as an academic researcher was challenging and interesting, Julia learned that it can be a long path to making a direct impact on patients.

She went on to consulting, and then worked at Stanford University as the External Affairs manager of the pioneering interdisciplinary biosciences program, Bio-X. Most recently, Julia held several management positions in R&D and upstream marketing at Abbott Vascular, where she deepened her knowledge in medical device development and commercialization. Julia also discovered a real passion for understanding the needs of the multi-stakeholder healthcare ecosystem and delivering products and services that address not only the needs of physicians, but also improve patient outcomes and reduce overall healthcare costs.

The Ferolyn Fellowship has helped Julia identify her path to turning that passion into action.

Three months into her fellowship, Julia joined Siemens Healthineers as Director of New Ventures. In this position, she helps drive innovation in healthcare services, including digital health, education and enterprise services through internal and external incubation. In this capacity, she acts as the product development subject matter expert and is responsible for creating a startup environment within a larger company.

The conversations Julia had with her mentors as part of the fellowship greatly accelerated her growth as a leader in this rapidly changing healthcare environment. She has not only benefited from the mentorship but also the close interaction with the other two Ferolyn Fellows, Matt McLean and Kate Garrett.

"It's been a truly unique opportunity to engage with experts across the healthcare community," she said. "I look forward to giving back to this fellowship program and helping build a legacy that Ferolyn would have been proud to have her name on."

The Ferolyn Fellowship was created as a tribute to the late Ferolyn Powell, an invaluable contributor to the medical device industry, with the goal to improve patient care by supporting promising entrepreneurs with strong leadership skills, passion and aptitude to transform healthcare.

Save the Date!

The Fogarty Institute for Innovation is hosting its annual Wine with Heart fundraising event on Friday, September 8. We will be celebrating the Institute's 10-year anniversary. More details coming soon!

Stanford Byers Center for Biodesign
From The Innovator's Workbench

An informal, one-on-one interview with Michael Mahoney, Boston Scientific Chairman and CEO

Tuesday, April 25 from 5:30-7pm
Location: Paul Berg Hall, Li Ka Shing Center, 291 Campus Drive, Stanford

Register

In the News

HealthCareBusiness Magazine: : Medical technology must be at the heart of everything we do

HealthLeaders Magazine: New Market Realities (pg. 13-14)

HealthCareBusiness Daily News: EchoPixel reports progress in clinical adoption of interactive virtual reality for pediatric surgery

Kenneth Rainin Foundation Health Blog: A New Venture into the World of Tech