[Photo courtesy of Edwards Lifesciences Foundation]

From the CEO's Desk

"The only thing that is constant is change." Heraclitus

Helping launch the Fogarty Institute for Innovation almost 10 years ago and leading this innovative organization for the past five years has been extraordinarily rewarding and a true privilege. What started as a concept and a single company-in-residence has evolved into hosting as many as 16 startups that are shaping the future of healthcare, a strong women and infant program, a successful internship program, among many other accomplishments.

I could not be more proud of where the Institute is today. That's why it is with a bittersweet feeling that I am announcing I will be ending my tenure at the Institute at the end of April. So much has been accomplished in the past 10 years, but it is now time to recast our vision to the future and hand the reins to a new leader who can build on our vision and continue to grow our organization.

Change and advancement in innovation have always gone hand in hand, and this is truly an exciting time for the Institute as we continue to grow our mission to promote medical innovation, and raise the next generation of medical entrepreneurs who strive to improve patient care and lower healthcare costs.

I am truly thankful to our donors, industry partners and colleagues for helping shape what the Institute has become today, and looking forward to following the progress of this wonderful and effective organization.

In this edition, our Chairman Dr. Krummel discusses the vision for the future of the Institute, and we celebrate our long-time partnership with Edwards Lifesciences, the progress of our company-in-residence CyberHeart and our educational programs.

We hope you enjoy our latest newsletter and we thank you for your continued support of the Institute.

Ann Fyfe, President and Chief Executive Officer

Ann Fyfe

"Great leaders don't set out to be a leader....they set out to make a difference. It's never about the role – always about the goal." – author unknown

Thoughts from the Board

by Thomas Krummel, MD, Chairman

As we begin to celebrate the 10-year anniversary of the Fogarty Institute, we feel proud of the numerous accomplishments that we have achieved since our inception, thanks to incredible financial support from many donors:

  • We started with one company-in-residence in 2007, and we reached a high of 16 in 2015;
  • We have given direct, sustained support to 20 hand-picked companies, and six have already successfully graduated;
  • Combined, our startups are projected to improve and/or save the lives of millions of people worldwide;
  • We have created a strong internship program that is educating and inspiring tomorrow's generation of medical innovators;
  • We are viewed by our peers as an epicenter of global innovation thanks to our strong relationships with investors, corporations, physicians, hospitals, government officials and innovators;
  • We have launched an international educational and mentorship program that is helping global companies embrace our innovative approach to advancing medical technology;
  • We established the Lefteroff and Ferolyn funds to support the next generation of medical entrepreneurs.

These accomplishments could not have happened without the dedication, vision, direction and hard work of our President and CEO, Ann Fyfe, who helped launch the Institute and was instrumental in shaping who we are today. We could not have asked for a better leader and are grateful for her wisdom and strength.

With Ann's departure, the time has come for us to plan and look to the future: our direction and new leadership, how we build on our accomplishments, advance our mission, and strengthen our presence and impact in the industry.

While we have big shoes to fill, we are excited at the prospect of a broad search for a high-caliber, nationally recognized leader who understands and embraces our culture, and can build on our legacy. Already, we have a strong list of potential candidates and we are exploring an engagement with a leading search firm to ensure we find the best fit for the Institute.

We are also excited to share several of our goals and vision for the next 10 years:

  • Considerably expand our footprint and find a new building to host our companies-in-residence;
  • Selectively increase the number of companies-in-residence;
  • Strengthen and broaden our partnerships and presence in the industry;
  • Continue to explore areas where we can make the biggest impact to advance healthcare;
  • Bolster our board of directors and strengthen our advisory boards to further our mission to improve patients' lives and lower healthcare costs.

This is a time of transition for the Institute, but we are energized by the opportunity to shape our future, grow our organization and galvanize our industry. The board and the executive team are fully committed to strengthening our organization and look forward to a bright and healthy future.

We will continue to keep you apprised on our search and thank you for your continued support and future involvement as we prepare for this new chapter.

FII Updates

Edwards Lifesciences has been a long-time supporter and partner of the Fogarty Institute. Their CEO Michael Mussallem met with the Lefteroff Fund interns last summer.

Fogarty Institute Receives Grant from Edwards Lifesciences Foundation

The Edwards Lifesciences Foundation has been a long-time supporter of the Fogarty Institute, investing a total of nearly half a million dollars since our inception. The organization recently awarded the Institute another grant that will go towards funding medical technology innovation and the Lefteroff internship programs, which support individuals and early-stage ideas designed to create the next generation of life sciences companies.

Edwards Lifesciences has also been the manufacturer of the Fogarty family of vascular products, which were innovated with Dr. Thomas Fogarty. These products are used in more than 300,000 procedures worldwide per year and are estimated to have saved the lives and limbs of 20 million patients.

"We are grateful to Edwards Lifesciences Foundation for its continued support and for sharing our passion to improve patient care," said Ann Fyfe. "These funds will help our medical startups continue to develop their innovative technologies, projected to improve and/or save the lives of nearly 10 million people worldwide. They will also help us expand our thriving internship program, which provides invaluable real-world, on-the-job experience for young people who are just starting to explore the world of cardiac surgery and medical technology."

"We are excited to partner with the Fogarty Institute to inspire new innovation in medical technology that will help underserved patients," said Amanda C. Fowler, Executive Director, Global Corporate Giving of Edwards and Edwards Foundation. "As a convening point for global innovation, the Fogarty Institute is a strong partner for programs that inspire and guide students and startups that will create the next generation of devices seeking to lower healthcare costs and improve patients' quality of life."

Our Companies

Sarah Avery Long, a Lefteroff intern, presented proof of CyberHeart's treatment to the American College of Surgeons Clinical Congress.

CyberHeart Offers Only Non-Invasive Cardiovascular Solution to Treat Heart Arrhythmias

Cardiac arrhythmia is much too common, affecting 2.5 million Americans and costing $6.5 billion in healthcare costs annually. Current therapies, including medicines and catheter ablation, are effective for only a small percentage of patients. If left untreated, cardiac arrhythmia can lead to stroke and heart failure.

Fortunately, CyberHeart, a Fogarty Institute company, has found an effective solution to this problem by developing the first non-invasive robotic ablation treatment for cardiac arrhythmias such as atrial fibrillation and/or ventricular tachycardia.

The startup has made strong strides in the past months:

  • CyberHeart's abstract reporting "First-in-Man Cardiac Radiosurgery for Atrial Fibrillation" has been accepted for the prestigious Heart Rhythm Society meeting that will be held this May in San Francisco. The event is the world's largest annual meeting of electrophysiologists, cardiologist and medical companies devoted to the diagnosis and treatment of arrhythmias.
  • CyberHeart will enter into an agreement with a major national clinical center in Tokyo for clinical development. The site will also serve as a regional training center;
  • The company received a seminal patent, underscoring the importance of its technology and value in creating a new technology and therapeutic application ("Heart Tissue Surface Contour based treatment planning" US 9,205,279);
  • It received FDA approval to conduct clinical trials for cardiac arrhythmias, which will begin in March at MedStar Washington Hospital Center, Washington D.C.;
  • The startup is also raising its second round of funding and is working on a joint-venture partnership in China.

CyberHeart's software can treat a variety of arrhythmias and cardiovascular conditions, including hypertension, a fast-growing condition and unmet clinical need that carries serious risks for renal and cardiovascular complications and mortality worldwide.

The startup's technology utilizes its proprietary software, the most accurate robotic radiosurgical system commercially available worldwide, the CyberKnife® Robotic Radiosurgery System, and the latest in medical imaging. Currently it is developed for use by radiation oncologists, medical physicists, electrophysiologists and cardiac surgeons to non-invasively treat cardiac arrhythmias. The technology is successfully used in an outpatient setting and without anesthesia.

Proof of its successful treatment was recently compiled and presented to the American College of Surgeons Clinical Congress by Sarah Avery Long, a Fogarty summer intern who worked closely with CyberHeart. Sarah discussed how CyberHeart's technology treated refractory hypertension without adverse effects, with a minimally invasive and painless approach. Sarah, a second-year med student at Tulane University, has a passion for cardiac surgery and advancing the field.

CyberHeart was founded by world-renowned cardiovascular surgeon, inventor and entrepreneur Dr. Thomas Fogarty, and venture partner Rod Young; and is led by Dr. Patrick Maguire, a successful medical device and pharmaceutical executive, and former cardiovascular and thoracic surgeon.

Guest Q&A

Amanda Fowler, Executive Director, Global Corporate Giving, Edwards Lifesciences, and Dirksen Lehman, Corporate VP, Public Affairs, Edwards Lifesciences, at a recent medical mission to Peru.

For this newsletter edition, we had the privilege of talking to Amanda Fowler, Executive Director, Global Corporate Giving, Edwards Lifesciences, regarding the incredible work the Foundation is doing to help patients live better lives. Ms. Fowler was appointed to the newly created role of executive director in 2011 and is responsible for the company's global philanthropic efforts including oversight of more than $6 million in annual philanthropic giving, activation of more than 8,500 global employees in community volunteerism, and donation of thousands of medical devices for indigent care around the world.

Q. Why did you start the foundation?

A. Edwards Lifesciences is dedicated to helping patients, so giving comes natural and is something that we have always taken very personally. More than five decades ago, the company was founded based on a vision of giving patients hope for longer and better lives. This same passion continues to thrive today and has led to many medical innovations that now fuel our philanthropy and our ability to improve the lives of some of the world's most underserved people.

Q. What do you hope to accomplish with your efforts?

A. Our philanthropy is focused on what we know best – underserved heart valve and critically ill patients, as well as strengthening the communities where our employees live and work. By supporting patient- and community-centric non-profit organizations through grants from our foundation, donations of employees' time and talent and our products, we aspire to make a meaningful impact in people's lives. We hope to bring an opportunity for life, smiles and happiness to those who are struggling the most.

Q. What is your goal for Every Heartbeat Matters and how will you go about achieving it?

A. In 2014, we launched a new charitable initiative called Every Heartbeat Matters, which is the center of our philanthropy. Through this, we invest in key philanthropic partners to help reach our goal: By 2020, our philanthropy will impact the global burden of heart valve disease by supporting the education, screening and treatment of one million underserved people. We think it's a bold goal...set for one very important reason...every heartbeat matters.

We plan to commit more than half of our charitable giving to this work, while also continuing our strong investments in community- and other health-focused non-profit programs. We are energized by strong interest in joining us in the fight for these patients and the promise of this effort.

Q. What are some of your favorite successes for the Foundation?

A. Without a doubt, our favorite philanthropic successes are seeing people's lives changed as a result of our partners' work – that's what it's all about!

Earlier this year, Dirksen Lehman, our corporate vice president, public affairs, and I were fortunate enough to travel to Peru with one of our key partners, Heart to Heart International Children's Medical Alliance, which brings together cardiac specialists to develop self-sustaining heart care in underserved regions. On this mission, we also brought our transcatheter heart valve technology to be used for the first time in Peru.

We had the beautiful opportunity of meeting a few of the patients after their successful transcatheter aortic valve replacement, which really drives home, in the most powerful way, why this work is important. It also reminds us that every success our partners have on these missions is a saved life. Nothing is more successful than that.

Q. You have been a supporter of the Fogarty Institute since its inception in 2007. What about the Fogarty mission dovetails with yours?

A. We value our partnership with the Fogarty Institute for Innovation and are proud to have supported its work for nearly a decade. From the beginning of the partnership, it was clear that Edwards Lifesciences Foundation and Fogarty Institute have a lot in common, and there is so much we can accomplish together – particularly bringing new innovation and talent to address unmet clinical needs. But the most important commonality we have is that singular focus on ultimately helping underserved patients. That's special.

Peter's Corner

The 2015 Lefteroff interns. The 2016 application process is now open; the deadline to apply is March 20.

Fogarty Institutes Prepares for 2016 Lefteroff Interns; Forms Ferolyn Fund Advisory Council

At the Fogarty Institute, we are committed to advancing our mission by teaching and raising the next generation of medtech innovators. That's why we established the Lefteroff Fund, in honor of Tracy Lefteroff, a remarkable leader and strong proponent for mentoring students who show the curiosity and desire to advance the field; and the Ferolyn Fund, a tribute to Ferolyn Powell's invaluable contributions to the medical device industry that will benefit innovators who exemplify her spirit.

We are excited to share that we are making strides with both of our programs and welcome your involvement.

Lefteroff Fund

Each year, we host 10 students from throughout the United States, Europe and Asia. We introduce them to the extraordinary world of medical technology innovation by offering them the opportunity to shadow and work on projects with our startups and medical technology partners. Through our mentorship program they learn from the best in the industry and receive guidance from industry experts on potential career paths and choices.

Last year alone, our interns gleaned knowledge from industry luminaries such as Hanson Gifford, Managing Partner, the Foundry; Hank Plain, General Partner, Lightstone Ventures; Congresswoman Anna Eshoo; Dr. Vincent Gaudiani, Medical Director of the Norma Melchor Heart & Vascular Institute; Dr. Ken Drazan, head of Johnson & Johnson Innovation; and Mike Mussallem, CEO of Edwards Lifesciences, to name a few.

The 2016 Lefteroff summer intern application process is now open and we need your help as the program depends entirely on charitable donations from generous donors. Please consider contributing today to honor Tracy Lefteroff and to help us mentor and educate the next generation of students, entrepreneurs and innovators who will shape the future of our healthcare.

To learn more about the program, or if you know someone who would be a good candidate, please visit our website. The application deadline is March 20.

Ferolyn Fund

The Fogarty Institute recently formed an Advisory Council comprised of a cross-section of community, business and medical leaders who will actively define, support and oversee the mission of the fund, which is to support entrepreneurs with strong leadership skills who embody Ferolyn's core values.

Ferolyn was best known as President and CEO of Evalve. During her 14-year tenure at Evalve, Ferolyn spearheaded the development and commercialization of MitraClip, a breakthrough technology that repairs leaky heart valves of patients with mitral regurgitation, a debilitating heart condition, without open-heart surgery. One of a handful of women CEOs in her field, she was generous with her time, mentoring young entrepreneurs via the Stanford Biodesign Program and at the Fogarty Institute for Innovation.

The Advisory Council meets twice a year and welcomes your participation. For more information on how to support the next generation of medical technology leaders, please visit our website.

In the News

The Wall Street Journal: Virtual Reality is Coming to Medical Imaging, featuring EchoPixel, a Fogarty Institute company

MassDevice: Edwards invests in Fogarty Institute

KSAT 12 (ABC): HeartFlow Test: Game Changing Diagnostic. HeartFlow is a Fogarty Institute graduate.

Becker's Health IT & CIO Review: 40 hospitals with innovation centers