From the CEO's Desk

"The method of the enterprising is to plan with audacity and execute with vigor; to sketch out a map of possibilities, and then to treat them as probabilities." – Christian Nestell Bovee

The new year ignites the desire to launch bold new projects, and the Fogarty Institute is going full speed ahead.

2017 was a year of growth as we refined our mission, strengthened our team, welcomed new companies and partners, and perhaps most importantly, established our vision for the future.

2018 promises to bring even more progress through audacious plans to expand our services and strategic partnerships, as we seek to strengthen the global medtech ecosystem.

First, there are a few announcements we want to share:

Our heartfelt congratulations to Paul Yock for winning the prestigious National Academy of Engineering's 2018 Gordon Prize for Innovation in Engineering and Technology Education. Paul is an inspirational educator and leader who continues to have tremendous impact on our industry today and well into the future, and I cannot think of a more deserving recipient.

I'd like to express the immense gratitude we offer to Gordon Moore; Pamela and Edward Taft; Tom Fogarty and the William K. Bowes, Jr. Foundation for their sustained, generous support of the Fogarty Institute.

I'd also like to thank Kerry Pope for his invaluable guidance during his time here as executive director of mentoring. We wish him success in his new endeavor as president and CEO of Core Mobility.

We are accepting applications for our Lefteroff summer internship program through February 11.

Please join us at next month's Stanford Biodesign's speaker series of which we are a co-sponsor. You won't want to miss this program where Biodesign will be honoring Tracy Lefteroff and featuring Josh Makower.

And now on to our newsletter! In this edition, we provide an update on CyberHeart, which has enjoyed important clinical successes; profile Ferolyn Fellow and CTO of Zenflow, Shreya Mehta; and share insight on one of our latest educational seminars on the value of clinical and health economics in bringing startups to market. I also had the privilege of being invited to The MedTech Strategist Innovation Summit in San Francisco and share a brief summary of my presentation.

Our future is indeed bright, and we look forward to keeping you apprised of the bold plans that we have in store for 2018/2019.

Andrew Cleeland
Chief Executive Officer

Fogarty Institute for Innovation Updates

Andrew Cleeland was the closing speaker at the recent MedTech Strategist Innovation Summit; with David Cassak moderating the discussion. (Photo courtesy of The MedTech Strategist)

Fogarty Institute Closes Prestigious MedTech Strategist Innovation Summit 2017

Industry conferences seem to bring out the best in participants as different entities come together to support and learn from one another. The close-knit medtech ecosystem is no exception, as entrepreneurs and industry leaders attended the recent MedTech Strategist Innovation Summit in San Francisco, united in their mission to advance patient care.

The annual conference gives emerging medical device companies a forum to share their innovative technologies with a "who's who" of potential investors and collaborators, as more than 400 of the top venture capitalists, investment bankers and senior business development executives from large medical device companies gathered from around the world.

More than 40 companies developing minimally invasive technologies targeting conditions such as scoliosis, structural heart disease, osteoporosis and chronic kidney disease presented their ideas. The two-day seminar also featured thought leaders who provided insight on some of the industry's most relevant and impactful topics, which included attracting and securing funding, big company investment strategies and a look into the venture funding landscape in 2018.

The seminar concluded with a fireside chat with Fogarty Institute CEO Andrew Cleeland, who shared the organization's vision to elevate the global medtech ecosystem.

The chat was moderated by long-time Fogarty Institute friend and industry supporter David Cassak, who is also editor-in-chief of The MedTech Strategist, and managing partner, Innovation in Medtech LLC.

Andrew shared the history of the Institute, started by Dr. Thomas Fogarty, arguably the industry's biggest disruptor; and its genesis of the Institute, which is reflected in one of Dr. Fogarty's quotes: "I certainly wouldn't be where I am today if it wasn't for my mentors."

He also reiterated the Institutes strong focus on education, and interest in strengthening its partnerships with U.S. and global partners and government agencies to build a stronger ecosystem.

The next MedTech Strategist Innovation Summit will be held in Dublin, Ireland, from April 17 to 19, 2018.

Our Companies

A 38-year-old patient immediately after being treated with CyberHeart's technology. He had failed traditional invasive ablation treatment five times.

CyberHeart, a startup that is developing the world's first non-invasive treatment for cardiac arrhythmias, has experienced tremendous clinical successes in the past few months.

"This is a game changer," (for patients with irregular heart rhythm), said Dr. Melvin Scheinman, a professor of medicine at the University of California, San Francisco, and past president of the Heart Rhythm Society, during a recent interview with the New York Times. "There is no question that this will catch on," he added.

Trials show early signals of efficacy

The New York Times story was prompted by a report published in the New England Journal of Medicine highlighting extremely positive outcomes for patients who were treated using CyberHeart's technology.

Researchers at the Washington University in St. Louis treated five patients using the CyberKnife® Robotic Radiosurgery System, which allows physicians to treat cardiac arrhythmias painlessly and accurately, in an outpatient setting without anesthesia, by utilizing the latest in medical imaging and the most accurate robotic radiosurgical system commercially available.

The five patients were in critical condition and were not responding to current available treatments, which include drugs and invasive surgery. Following the CyberHeart treatment, their episodes of tachycardia decline 99.9 percent from baseline events prior to the surgery.

The value of CyberHeart's technology was further validated during an additional clinical treatment conducted at Texas Heart Institute, Baylor University Hospital, which included a 38-year-old patient who failed traditional invasive ablation treatment five times.

The surgery, which was performed by Dr. David Burkland, MD, electrophysiologist at Baylor, was painless and took less than one-and-a-half hours.

"The patient was able to see immediate results and go home for Christmas," said Patrick Maguire, MD, CyberHeart's president and CMO. "We could not have been more proud of the results and our role in helping a patient be able to celebrate with his family after previously unsuccessful treatments."

What's next for the company

The company is currently exploring options to expand its presence in Asia by potentially partnering with Beijing's largest hospital, 301 Military Hospital, and has received Institutional Review Board approval from Xin Hua Hospital in Shanghai to treat tachycardia. This follows on the footsteps of signing an agreement with the National Cancer Center in Japan.

CyberHeart also has its eye on Europe as it awaits CE marking certification, and has engaged with the FDA to discuss pivotal trials. One of the trial sites will be El Camino Hospital, where the startup expects to treat its first patient in the second quarter.

Lastly, the company recently welcomed Ed Gardner, PhD, as principal engineer. Ed brings extensive expertise as a senior medical device engineer with experience in medical imaging and radiation therapy, including developing novel applications for radiation therapy and medical ultrasound from the proof-of-concept phase through to manufacturing. He returned to CyberHeart after serving as Director of Physics Development from 20017 to 2010, where he was an early contributor in determining the medical physics and techniques for the application of radiation therapy for the treatment of cardiac arrhythmia.

On May 9 to 12, the team will present in Boston at the Heart Rhythm Scientific Sessions, which hosts the brightest minds in cardiac pacing and electrophysiology.

Monthly Spotlight: Shreya Mehta, Ferolyn Fellow

Like many successful medtech entrepreneurs and Ferolyn Fellows, Shreya Mehta has a passion and knack for building and finding solutions to challenging and unsolved problems — skills which led her to co-found and launch Zenflow.

The startup, where she is currently CTO, is developing a better treatment for nearly 400 million men worldwide who suffer from urinary obstruction due to an enlarged prostate.

A passion for life sciences

Since she was a young child, Shreya was naturally drawn to taking things apart and seeing how they worked. While she felt like an "engineer," she found a particular interest in life sciences as she felt there was much to learn and many areas that were still largely misunderstood.

She thus pursued a master's in bioengineering from the University of Pittsburgh, and while there worked in the Medical Center's Artificial Heart Program as part of a team responsible for patients who were on mechanical cardiac support. She also participated in an independent study program that focused on artificial heart valves, part of which included designing an instrument to place artificial valve tissue into a bioreactor.

This expertise in cardiovascular biomechanics caught the attention of the FDA, and she was recruited as a scientific reviewer of medical heart valves and artificial hearts. The position leveraged her technical skills and provided excellent experience and a window into the regulatory processes as companies brought their life-improving devices to market.

Building her own company

Following her stint at the FDA, Shreya was ready for a shift in her career and a return to her "building" roots that would satisfy her desire to solve unmet clinical needs first-hand. She was selected into the Stanford Biodesign program, where she met her eventual company co-founder, Nick Damiano. As part of the fellowship, the group spent time finding and evaluating clinical needs in the areas of urology and nephrology, and it became immediately obvious that they had an unparalleled opportunity to dramatically improve the treatment of enlarged prostates.

As they age, the majority of men will develop a larger prostate, which can lead to benign prostatic hyperplasia (BPH), a condition that causes uncomfortable urinary problems, sleep disruption and potential kidney, urinary tract or bladder complications.

Despite its prevalence and significant impact on quality of life, current treatments are minimal – drugs, which have limited effectiveness, and surgery, which carries the potential risk of side effects and is not always successful in treating the condition.

Upon graduating from Stanford Biodesign, Nick and Shreya launched Zenflow to provide a minimally invasive, patient-friendly solution for men suffering from BPH. In true Silicon Valley fashion, they built their initial prototypes in a garage and quickly gained interest from several small investors. Their device, the Zenflow Spring System, is a permanent, flexible implant with minimal profile, which can be implanted in a simple, office-based procedure.

An early clinical trial has indicated that the Zenflow Spring System exceeds the outcomes of current therapies. The company is currently preparing for larger CE and FDA trials.

Joining the Ferolyn Fellowship brings her full circle

Not surprisingly, Shreya was nominated by several professionals for the Ferolyn Fellowship. Not only did she have the privilege of meeting Ferolyn while she was at Stanford, but coincidentally, she was on the review team for Evalve, the company Ferolyn formed.

Shreya is very excited about the Fellowship and eager to focus on the big picture of her career. "When working at a startup, everything moves so fast that you are constantly focusing on the company moving forward," she said. "I feel very fortunate to have Angela Macfarlane, CEO of ForSight Labs and experienced medtech entrepreneur, as my mentor, along with access to a whole cohort of experienced professionals who can provide invaluable insight into how I can expand my career."

Fogarty Lecture Series: Clinical Evidence and Health Economics

Seminar Reviews the Importance of Clinical Evidence and Health Economics in Getting to Market

Many medical device entrepreneurs believe that the single most important milestone to achieve in gaining market adoption of their technology is regulatory approval. While certainly an essential step, it is often not sufficient.

The current healthcare environment is becoming increasingly evidence-based. Payors and other stakeholders are demanding greater levels of clinical data in addition to clear and convincing health-economic data before embracing new therapies. Investors, recognizing this trend, are also looking for companies to have a well-thought-out plan for evidence development.

A recent Fogarty Institute seminar explored best practices and gave entrepreneurs timely advice about formulating such plans. The seminar featured a quartet of experienced industry insiders approaching the topic from various angles:

  • Greg Bakan, from the Fogarty Institute, provided a framework for developing an integrated evidence development plan and practical advice garnered from applying this approach across numerous technologies.
  • Jan Pietzsch, PhD, director of health economics and value at Stanford Biodesign and president and CEO of Wing Tech Inc., discussed key strategic and tactical considerations for health economics.
  • Jessica Holmes, director of reimbursement at Argenta Advisors, provided a payor and policy perspective.
  • Garrett Schwab, an independent consultant, offered case study examples.

Thorough planning drives data collection success

Presenters offered a deep dive into creating a plan to develop the data necessary to support regulatory approval, market adoption and hopefully, an eventual exit.

Since the process is costly both in terms of time and funds, entrepreneurs need to be particularly thoughtful about how to tackle it. Key considerations include:

  • Addressing the unique needs of multiple stakeholders, who may include investors, payors, providers, patients, hospitals and acquirers.
  • Considering the different level of evidence that most interests each stakeholder – such as clinical, safety and health economics – during each phase of development.
  • Planning for diverse business factors that include time, cost, risk and understanding how to finance.
  • Keeping health economics top of mind in an environment where medical care costs continue to grow more rapidly than other consumer costs and GDP.

Sharing best practices learned from personal experience

The workshop wrapped up with practical advice designed to help set entrepreneurs on the right path for developing a robust plan. Key factors include:

  1. Appreciate what motivates investor evidence requirements at various stages of development.

    Put yourself in a VC's shoes to consider what keeps them awake at night: Is it proving that you have a viable technology? A viable product? A viable business? Or maximizing the commercial potential of the opportunity once the development risks have been overcome?

    The clinical and economic data necessary to address each of these issues will vary. Understand what is required to overcome each concern and be sure to tailor your evidence development plans accordingly.
  2. Avoid the pitfalls of being either a minimalist or perfectionist.

    It's tempting to pursue the smallest, cheapest and fastest clinical studies necessary for regulatory approval. But with truly novel technology, such studies are likely to be insufficient to drive commercial adoption. Payors and other stakeholders may require health economics data and longer-term follow-up before agreeing to adopt a new technology.

    The opposite mindset can be equally problematic. A "perfectionist" approach in which a company waits to go to market until the ultimate embodiment of the technology has been achieved and studied in numerous large, long-term studies is likely not fundable. New technologies undergo continuous evolution and optimization through real-world experience. This evolutionary process needs to be embraced and actively managed.
  3. Pick a fight you can win.

    You typically only get one chance to show positive results with a pivotal clinical study. As such, design and conduct such clinical studies carefully. Design a study that identifies the patients most likely to benefit from your technology, even if it represents a potentially smaller market. Early success builds positive momentum and is essential to attracting investor interest. Future studies can always be conducted to expand indications and broaden adoption of the technology.
  4. Remember that every step sets the foundation for commercialization.

    Use your clinical work to "seed" the market with awareness and interest. Clinical sites can become your best early customers because of their direct, positive experience.

The bottom line is to never underestimate the power that positive data brings to investment buy-in and market adoption. If you don't have good data, the rest is moot.

From the Innovator's Workbench

Featuring Josh Makower, founder & chairman
ExploraMed Development LLC

Date and Time: Tuesday, February 13, from 5:30 to 7 p.m.
Location: Paul Berg Hall, Li Ka Shing Center, 291 Campus Drive, Stanford
Register today:

Co-sponsored by the Fogarty Institute for Innovation and honoring Tracy Lefteroff.

In the News

Scope: Verily executive outlines future health care goals at Fogarty Lecture

The New England Journal of Medicine: Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia (CyberHeart is a Fogarty Institute company)

The New York Times: A 'Game Changer' for Patients With Irregular Heart Rhythm (CyberHeart is a Fogarty Institute company)

UCSF Surgical Innovations: Measuring GI motor activity with a disposable wireless wearable (G-Tech is a Fogarty Institute company)

Chicago Tribune: Major Milestone" for New Noninvasive Heart Test (HeartFlow is a Fogarty Institute graduate)