MEDICAL INNOVATION NEWS

From the CEO's Desk

"It is my aspiration that health finally will be seen not as a blessing to be wished for, but as a human right to be fought for." – United Nations Secretary-General Kofi Annan

In this edition, we are excited to share news about our companies-in-residence who are "fighting" every day to bring better healthcare to patients globally.

Among these companies are three new startups targeting women's healthcare that were just accepted into the Institute: Igantia Therapeutics, Marz Medical and Madorra. These early-stage companies are following in the footsteps of two graduating companies, InterVene and Prescient Surgical, which successfully graduated from the Institute with a strong round of funding.

We are also proud to announce the launch of the Ferolyn Fund as a tribute to Ferolyn Powell's invaluable contributions to the medtech industry. Ferolyn embodied the spirit of raising the bar for better patient care, both as a CEO at Evalve and as a mentor to young medtech entrepreneurs.

We hope you enjoy this edition and would love to hear from you about what you would like to read more of! You can also follow us on Twitter, Facebook and LinkedIn.

Ann Fyfe
President and Chief Executive Officer

Ann Fyfe

"More entrepreneurs and investors are realizing that women make most healthcare-related decisions and recognize that as an unmet opportunity." – Surbhi Sarna, founder and CEO of nVision

Fogarty Institute for Innovation Updates

Lindsay Axelrod, a senior at UC Davis; and Natasha Kafai, a recent graduate of UC Berkeley.

Our Lefteroff interns formed a strong bond this summer. Pictured: Lindsay Axelrod, a senior at UC Davis; and Natasha Kafai, a recent graduate of UC Berkeley.

Internship Program Gives Life-Long Lessons on the Innovative World of Medical Technology

Silicon Valley is revered as a hot bed of innovation and the Fogarty Institute is at its epicenter – providing entrepreneurs, interns and fellows from all over the world with exposure to leading investors, corporations, physicians, hospitals, government officials and innovators in the medtech field.

As part of our education program, we offer interns and fellows from partner companies valuable exposure to these diverse experts, in addition to on-the-job experience, to offer the best potential for young students and professionals to hone in on their career skills and options.

This year we had the privilege of hosting 10 interns from throughout the U.S., and from several European and Asian countries. The internships are funded by our Lefteroff Fund and the students are selected by its advisory board.

The interns' experience at the Institute was eye opening. "Never be comfortable. Always keep doing new things that make you wake up in the morning, but also sleep at night," said Renee Ryan, VP of Investments at Johnson & Johnson Innovation, one of their mentors. The interns took her advice to heart.

The Lefteroff summer interns had an action packed and fruitful summer, thanks to the hard work of our office manager Gretchen Berstler.

The Lefteroff summer interns had an action packed and fruitful summer, thanks to the hard work of our office manager Gretchen Berstler.

When the interns entered the Fogarty Institute program, they expected to learn about the field of medicine, gain insight into the different responsibilities within a startup, receive mentoring from industry leaders and understand the unique Silicon Valley innovation ecosystem.

They accomplished all that, and much more, thanks to our intensive, hands-on program. The interns learned the importance of finding a need in the medical field, then developing a solution; the benefits of working as a team to create a product; the value of drawing on passion as a daily motivator to overcome obstacles and stay on track; the payback inherent in challenging themselves every day; and the fact that while money is a perk, in the end, you work to improve patients' lives.

During their eight-week stay at the Institute, the interns were each assigned to work with our startups and partner companies, and their experiences were broad and varied. They learned about the intraoperative approach to cleaning a surgical site in abdominal surgery; helped name a pelvic device and designed its case; created birthing device straps; designed and built a knee extension torque measurement device; worked on vein demonstration models; had hands-on experience with Samsung's new health tracker technology; and generated mechanisms of muscle contraction in the gut; among many other opportunities.

They also learned from and were inspired by the best in field: 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.

Intern Eli Fulton was treated to a fishing trip at the Fogarty Ranch. Eli attended the same high school as Dr. Fogarty in Cincinnati, Ohio.

Intern Eli Fulton was treated to a fishing trip at the Fogarty Ranch. Eli attended the same high school as Dr. Fogarty in Cincinnati, Ohio.

Most importantly, they learned life-long lessons that will help them create their own life-changing medical device technologies. And now they know how to get started: as Jessie Becker, founder of InPress Technologies, told them, "Always start with a real need that captures your imagination. Start with something that truly matters to you."

Our Companies

Holly Rockweiler, founder and CEO of Madorra; and Sohila Zadran, founder and CEO of Igantia – two of the Institute's new startups targeting women's healthcare.

Congratulations Graduates, Welcome New Companies-in-Residence

The Fogarty Institute for Innovation is proud to continue to strengthen its presence in women"s healthcare innovation, with the addition of three new startups, which have joined the organization as new companies-in-residence: Igantia Therapeutics, Marz Medical and Madorra.

Each of the companies are working on technologies that will address unmet healthcare needs that afflict aging women and millions of female cancer patients. The Institute now has seven in-residence startups focused on women and infant healthcare issues.

"Women's health has historically been underdeveloped and underfunded in terms of medical innovation, yet it offers an opportunity to revolutionize patient care globally," said Ann Fyfe, President and CEO of the Fogarty Institute for Innovation. "We are excited to not only increase the number of medical technologies aimed at helping women, but also delighted to support more women leaders in this industry."

About the New Startups

Josh Korman

Josh Korman, Founder and CEO of Marz Medical

Igantia Therapeutics, a health and research company, is developing a first-of-its-kind medical device/digital health technology for the treatment and study of an age-related ailment that affects most women – hot flashes.

Madorra is developing the first, non-hormonal, medical device treatment for vaginal dryness and atrophy, which will improve the quality of life for breast cancer survivors and post-menopausal women. There are 1.4 million breast cancer survivors in the United States who suffer from vaginal atrophy.

Marz Medical is developing a technology aimed at reducing pain and recovery time for patients undergoing breast or burn reconstruction surgery. The technology will help mastectomy patients, and also individuals who suffered from burns anywhere on their body. Significantly, the technology has already received FDA approval to assist with tissue expansion needed during reconstructive surgery. One in eight women are diagnosed with cancer each year and about 100,000 women undergo mastectomy in the U.S.

Success Leads to Two "Graduations"

These newly admitted startups follow in the footsteps of two graduating companies, which recently raised Series A funding and will move to their own facilities in the Bay Area.

InterVene is creating a novel, minimally invasive device for the treatment of venous disease in the legs, and Prescient Surgical is creating technology that holds the promise of reducing the incidence of surgical infections.

"We are proud of our success rate in launching medical device companies and our ability to help them obtain Series A funding – a critical milestone startups must achieve to commercialize their technologies. Six Fogarty Institute companies have now achieved this turning point, making their vital technologies one step closer to benefitting patients," Fyfe said.

Guest Q&A — Hank Plain, General Partner of Lightstone Ventures and Morgenthaler Ventures

Our interns had the opportunity to chat with Hank Plain, one of the most prominent and successful VCs in medtech.

Recently we had the privilege of catching up with Hank Plain, an experienced medtech venture capitalist. As General Partner of Lightstone Ventures, General Partner at Morgenthaler Ventures, former Vice Chairman of the Foundry, co-founder of eight medical device companies and director of multiple companies that were acquired with a combined value in excess of $3 billion, Hank knows the medtech space very well.

Hank has been a long-time friend and supporter of the Fogarty Institute and a mentor to many of our startups. During a recent Lunch-n-Learn at the Institute, our interns and entrepreneurs were treated to a candid discussion with Hank, on topics ranging from the state of medtech; to overcoming "the valley of death," or lack of venture funding; to best tips on pitching VCs, among other items discussed.

Q. You have been involved in the medical device industry for many years, both as a company founder and a venture capitalist. What drives you to pursue this industry?

A. It's where I have focused my 35-year career and frankly all I know. As a Partner in a VC firm, I sat in pitches from companies in the IT space and other industries. I have had the opportunity to listen to very interesting pitches from startups that have made for a great investments - for example, Siri. The reality is that I don't know how to help these companies or how I can add value. I grew up in the healthcare space, going from pharmaceuticals, to getting involved in startups, to founding eight companies. Medtech is where I hopefully add value; it's the field I am passionate about.

Q. What are the challenges and opportunities facing medical device companies seeking venture funding today?

A. The medtech space has become more difficult over time.

I have been doing this for a long time, and have been on both sides of the fence – I have raised hundreds of millions when I was an entrepreneur and invested $150 million as a VC – in good and bad times. Right now is probably the toughest time to raise money. I don't know if this is just a phase or the new reality. Medtech funding is down 60-70 percent and healthcare VCs are investing about 20 percent in medtech and 80 percent in biotech.

The reason many funds have moved out of medical devices is because of overall poor returns on investment. Venture firms have to look at the biggest returns for their Limited Partners – and in many cases medtech companies have generally not offered as high of returns as other areas. But firms like ours have been very successful medtech investors. We have been fortunate to be a part of some of the biggest exits in the medtech space.

Launching a medtech company is expensive and takes time. Startups have to conduct clinical trials to prove their technology is safe and effective; obtain FDA approval, which is a very challenging and unpredictable process; prove to doctors their product works; and get reimbursement. It's a cold, hard fact that raising sufficient capital to get an innovative idea all the way through FDA approval and reimbursement is a difficult challenge in this environment.

I've been described as a "unicorn," in this space, as so many other VCs have departed the medtech space – especially early stage medtech investing. Yet the need for innovation remains strong and the big medtech companies are starved for growth. It's hard to find funding. But the really good concepts are still finding a way to succeed and the large acquirers still need innovative new products.

Q. What's makes a strong pitch?

A. While the team is key to the success of the company, start with the clinical need, why it's a big market and how your technology is differentiated. Show a reasonable, predictable clinical trial and regulatory path. And make sure you explain how it's going to be reimbursed or paid for by the patient. It's also important to be forthright on the technical, clinical, regulatory and fundraising challenges; what has been accomplished thus far, and reasonable plans for getting the product to market. Credibility is the key to the pitch.

We need to be convinced that there is a big opportunity, which can be patent protected, with straightforward technology that can be proven in clinical trials, approved and reimbursed.

We also look at risk. Managing risk is the difference between success and failure. If I can't convince myself that a startup team can find their way through challenges, I don't invest. We don't expect early-stage companies to have everything sorted out – they just need to be aware of the challenges, how to overcome them and be open to input from experts to help them through the process.

One of the values of having experienced investors is to help startups get the right team in place so they can succeed and ultimately improve the lives of millions of patients. And founders need to be open to the concept that if the time comes for the founder to hand over the reins to a new CEO or management team, he or she needs to be willing to do so.

Q. What do you look for when investing in a company?

A. The key ingredients to the question of "can the startup be funded" are: is there a big market, can the technology be proven in a clinical trial, is there a predictable regulatory path, will the technology be reimbursed, what are the commercialization opportunities and what is the likelihood of a sale of the company to a large acquirer.

In the end, we access the probability of success: Where will the funding come from? How big is the market – does the technology address a significant clinical need? Does it really work? What are the risk factors? How good is the invention? Is the technology innovative and how much competition will it have?

We also consider what the clinical trials will look like – the size, cost and length of follow up. And the regulatory and reimbursement process – is the technology in a market that is reimbursed or who will pay for the product?

When investing, we weigh all these factors. We bring in a team of experts including regulatory and reimbursement consultants. One of our favorite areas to invest in are medtech projects with technologies that are focused in the space that has historically been served by drugs.

Q. What is the key to success for a startup?

A. Launching a medtech startup is not an easy process, so it's not just the invention... it's the ability to put together the right team to solve whatever issue comes up, whether it is during development/clinical stage, regulatory process or the commercial launch.

In today's environment, having committed investors to eliminate fundraising risk is also an important component. Startups need a minimum of $5 million in funding for small projects, and $100 million for more complex PMA projects. VCs tend to invest in the larger projects that require more financing. We can also contribute by bringing in the right team of experts to help the company be successful and sit on the board to offer input and advice. This can be an invaluable tool for startups to succeed.

Q. At what stage of the startup do you look to invest?

A. As early as possible. Even if it is still a drawing on a napkin. We are not afraid to seed companies, provide Series A funding and support future financings.

Q. What makes a good team?

A. It's largely about experience. We love to invest in serial entrepreneurs. We look for experienced people who are still very hungry and driven to succeed.

It's also about diversity within a team. It's important to have different backgrounds and experiences, with a team that is willing to collaborate with a focus on success.

Peter's Corner

Ferolyn Fund To Support Women Medtech Entrepreneurs

"You need to create a record of success. Know what you are worth, and don't doubt it." – Ferolyn T. Powell, 1962-2015

The passing of Ferolyn Powell, a medical device pioneer, was a huge loss that deeply affected the medtech community and all of us here at the Fogarty Institute.

Ferolyn was not only an innovator at heart, but a phenomenal leader and mentor who inspired and touched all those who surrounded her. As a tribute to Ferolyn's invaluable contributions to the medical industry and to the lives of all she knew, we are honored to host the Ferolyn Fund, which was established by her friends and family to benefit innovators who exemplify her spirit, with an emphasis on female entrepreneurs with strong leadership skills who embody her core values.

Ferolyn was best known as President and CEO of Evalve, a medical device company that was founded in 1999. At Evalve, she 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.

Ferolyn Powell was a mentor and role model to many of our young entrepreneurs.

"I had the privilege of working with Ferolyn for many years. When we founded Evalve and where looking for a CEO, we did not think she was ready for the position. She proved us wrong. Within six months of working at the company, she climbed her way to the top," said Fred St. Goar, MD, founder of Evalve, and Vice Chairman of the Fogarty Institute. "Ferolyn was innovative, inspirational, a tenacious negotiator and always kept the end goal in mind – to benefit the patient. She is greatly missed."

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 here at Fogarty Institute for Innovation, where she played a crucial role in helping one of our companies-in-residence, Prescient Surgical, develop its technology. She also was instrumental in helping build the team and sharing her personal experiences as a CEO.

Currently we are in the process of creating an advisory board to oversee the direction of the Ferolyn Fund and select the inaugural women awardees who will receive support. Applicants will come from our incubators, the Stanford Biodesign Program and the biotech industry at large.

We invite you to donate to the Ferolyn Fund, to help ensure her legacy and spirit will live on and to ensure that more women have the opportunity and confidence to take on leadership roles, to "create a record of success" and make a lasting impact in the medtech field.

Thoughts from the Board

by Fred St. Goar, MD, Vice Chairman

The Lefteroff interns met with Mike Mussallem, Chairman and CEO of Edwards Lifesciences – one of the most respected leaders in this field.

Exposure to Great Thought Leaders and Teachers Offers Untold Value

You may not remember what you learned in a class, but you will always remember a great teacher.

Here at the Institute we take that observation to heart – our goal is to enable interns and entrepreneurs to be exposed to inspiring mentors and teachers who will make a lasting impact on their lives and careers. This fits with the Institute's vision of not only nurturing the current companies, but also creating a culture of innovation and strong leadership for the future.

This summer alone, our interns had the opportunity to meet with an amazing cohort of experts experienced in every facet of the medtech field – from regulators to business operations to engineers. They spent time hearing from and talking to notable professionals like Congresswoman Anna Eshoo, who co-chairs the House Medical Technology Caucus; Hank Plain, highly successful, seasoned VC; Mike Mussallem, of Edwards Lifesciences – one of the most respected CEOs in this field; Steve Levere, corporate lawyer from Jones Lang LaSalle; Dr. Thomas Krummel, renowned surgeon, medical pioneer and innovator; Josh Makower, leading medtech entrepreneur and CEO of ExploraMed; and Hanson Gifford, serial entrepreneur, inventor and founder of The Foundry.

As with most accomplished entrepreneurs and innovators, these luminaries have not just enjoyed immense success in their professional lives, but they have also experienced failure. Through those failures, they have learned lessons equally important as those learned from their achievements. They shared their stories and insights to the delight and appreciation of the interns: tales of the good, the bad and the ugly.

Learning from this field of experts will make a lasting impact on our interns and entrepreneurs, whether they are making a business decision or contemplating life choices. It's the type of exposure and experience that all of us who have grown up in the medtech space would have loved to have had, and certainly would have benefited from.

In several cases, these experts have even taken the next step and become mentors to our startups, guiding them through the challenges of building and leading a company. For example, Ferolyn Powell, former Evalve CEO, was instrumental in shaping one of our graduate companies, Prescient; and Annula Jayasuriya, VC and co-founder of the "Evolvence India Life Science Fund," helped Surbhi Sarna form nVision.

We are also replicating this successful mentoring model for our fellows who come to the Institute from around the world to learn from the best in the field. Whether it's business, innovation, medicine or telehealth, we provide the mentorship to inform and inspire a new crop of young creative minds.

The relationships developed and lessons learned in the mentoring of fellows are invaluable to their future success, and therefore to the future well-being of patients and the advancement of healthcare overall.

A quote that resonates with me is as follows: "The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires." Here at the Institute, we are fortunate to count among our supporters many inspiring teachers who are truly making an impact.

Events

  • Wine with Heart, September 11
    This annual fundraising dinner and auction at the Thomas Fogarty Winery is an event not to be missed. The event benefits the Fogarty Institute and its startups.
  • Investor & Donor Open House, September 23, 5 to 6:30 p.m.
    Monthly donor and investor event to learn more about the Institute and the important work of its companies.

    For more information email
    infofogarty@fogartyinstitute.org