MEDICAL INNOVATION NEWS

Message from the Chairman

"If you want to make life better for a community, you should start by investing in its women and girls." – Melinda Gates

We hope everyone is enjoying a relaxing and/or productive summer. Mine has been both, but a highlight has been in the "productive" category. I personally had the honor to once again visit and speak at the prestigious IRCAD Laparoscopic Training Center, a nonprofit educational institute based on the campus of Strasbourg's University Hospital. It's always a treat to learn about new approaches to medical device innovation.

In this edition, we showcase our own display of Melinda Gates' quote – our ongoing emphasis on women's healthcare, which is one of our core areas of focus at the Institute. Thanks to the leadership of Liz McDermott, sister of the late Ferolyn Powell; Ann Fyfe, former CEO of the Institute; and the newly formed advisory board, we are excited to announce the launch of the Ferolyn Fellowship and the selection of its first-year awardees.

We are also particularly proud to share that two of our startups targeting women's healthcare have secured funding – a compelling validation that these companies are making impressive progress and that their technologies show significant promise to make an impactful difference in healthcare.

And lastly, we feature a Q&A with Nurse Barb Dehn, who has been an invaluable resource to women worldwide as they seek to better understand health issues that impact them, as well as an ongoing champion of medical innovation.

As always, we welcome your feedback and thoughts.

Thomas Krummel, MD, Chairman

"Most of us in developed countries take healthy mothers and healthy babies for granted, but the truth is that we can do a better job everywhere helping ensure safer childbirth and more effective neonatal resuscitation." – Nurse Barb Dehn, RN, MS, NP

Fogarty Institute Updates

Ferolyn Fund Advisory Board formed; announces first-year fellows

The Ferolyn Fund Advisory Board, which was formed this spring, has been hard at work to shape the direction of the Ferolyn Fellowship and select its first-year awardees.

The 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.

After a thorough review process, the Advisory Board selected three fellows: Kate Garrett, a Biodesign Innovation graduate and co-founder and CEO of Ciel Medical; Matthew McClean, senior R&D manager at Medtronic; and Julia Fox, senior group manager, Upstream Innovation, at Abbott Vascular.

The three fellows will undergo a nine-month program that will help accelerate and advance their careers by providing them with individualized leadership development opportunities to succeed in the healthcare industry. They'll receive goal-setting assistance, personalized mentorship, exposure to diverse industry experts and leaders, and the opportunity to attend select industry events. The fellowship will culminate with a presentation to the Board on lessons learned, accomplishments and suggestions for program enhancements. All associated costs are covered by the fund.

"We had a very impressive pool of applicants to choose from, and we selected the three we thought were at a stage of their career where they would most benefit from our program," said Liz McDermott, former vice president of Evalve, Inc., Advisory Board co-founder, and Ferolyn's sister. "Kate, Matt and Julia, with their distinct backgrounds, each bring a different perspective to medical technology, yet they all exhibit strong leadership styles and share the same passion for advancing the field. We could not have asked for better first-year ambassadors for the program."

In addition to Liz McDermott, the Advisory Board members include: Allan Will, founder of The Foundry and chairman, president and CEO of EBR Systems; Andrew Cleeland, vice chairman of The Foundry and vice president and general manager TMVR, Medtronic; Angela Macfarlane, president and CEO of ForSight Labs; Ann Fyfe, former CEO of the Fogarty Institute; Fred St. Goar, vice chairman of the Fogarty Institute; Jamey Jacobs, divisional vice president, Global Product Development at Abbott; Jonathan Coe, co-founder, president and CEO of Prescient Surgical; Maria Sainz, president and CEO of CardioKinetix; Mike Buck, president of the Medical Products division at Cardinal Health; Paul Yock, Weiland Professor of Medicine at Stanford and founding co-chair of the Department of Bioengineering; and Marian Powell, partner and co-founder of Bamboo Partners.

Our Companies

InPress and nVision raise funding as they show promise to dramatically improve women's healthcare

InPress Technologies and nVision, two Fogarty Institute companies aiming to improve women's health, recently received Series A and Series B rounds of funding respectively, further validating the legitimacy and significance of the medical devices they are developing.

nVision

Headed by founder, CEO and president Surbhi Sarna, nVision announced its Series B round of $12 million led by Arboretum Ventures. All Series A investors, including Catalyst Health Ventures, also participated in the second round of funding. The new infusion will be used to further advance the startup's technology and support additional regulatory clearance submissions and clinical studies.

nVision has long captured the interest of investors and healthcare professionals with its patented micro-catheter technology that allows unprecedented access to the fallopian tubes. The technology greatly expands diagnostic procedures that can be conducted in the gynecologist's office, without painful incisions or general anesthesia, and allows detection of a host of clinical indications previously thought impossible.

The startup has developed two diagnostic devices: the first allows physicians to safely and non-invasively collect cells from the fallopian tubes for further evaluation, and the second provides direct visualization of the fallopian tube lumen, which, when blocked, is one of the leading causes of infertility.

nVision has obtained FDA clearance for its first device, supported by a recent clinical study which demonstrated that 99 percent of the cell samples collected from the fallopian tube were adequate for further diagnostic evaluation.

First-in-women studies were successfully conducted for the second device and more will be underway in the coming months along with FDA submissions.

Anne Morrissey was recently named CEO of InPress Technologies.

InPress Technologies

A mother dies of postpartum hemorrhage (PPH) every four minutes. This staggering statistic and InPress' simple, yet effective solution, has helped the startup secure a Series A round of $1.2 million, led by seasoned life science investors and executives who embrace InPress' vision to eradicate PPH globally.

Nearly 80 percent of PPH cases are caused by uterine atony, or the failure of the uterus to contract to its correct postpartum size, which leaves intra-uterine blood vessels fully dilated. Women suffering from this condition are at risk of severe and dangerous blood loss that can lead to death.

The startup has developed and patented the only device that treats uterine atony. Unlike other treatments available, its technology encourages the body's natural response after childbirth by collapsing the uterus to its correct postpartum size to stop PPH.

InPress' first-in-women clinical studies stopped postpartum hemorrhage within two minutes in all of its cases, without recurrence. The single-use device has the potential to dramatically reduce the cost of intervention during childbirth and substantially reduce the risk of loss of life, particularly in the developing world where the greatest incidence of maternal morbidity and mortality exist.

The company recently hired Anne Morrissey, a seasoned healthcare veteran and social entrepreneur, as its CEO. Jessie Becker is the founder and COO of the startup.

Q&A with Nurse Barb Dehn, Practicing Nurse Practitioner, Award-Winning Author, Nationally Recognized Health Expert

Barbara Dehn, RN, MS, NP, best known as Nurse Barb, has a wealth of knowledge on a broad range of health issues, which she has shared with girls and women of all ages. Her goal is to help them tackle medical conditions that impact them with the most up-to-date treatment options.

Dehn started her career as a nurse in pediatric intensive care at Stanford, where she was on the team that cared for the first children to have heart transplants. That experience fueled her passion for advancing patient care, particularly for women.

Since then, she has become one of the most sought-after speakers on women's health and has appeared on CBS, ABC, CNN, Good Morning America Now and NBC's iVillageLive. She is also a lecturer at Stanford University, contributor for the Huffington Post and has launched her own health publishing company, Blue Orchid Press, which has issued a series of innovative and award-winning health guides that are used by millions of women across the country.

Nurse Barb has been a strong advocate of medical innovation and the Fogarty Institute for Innovation. Recently, we had the privilege of catching up with her to discuss her career, passion for helping women and her work supporting several Fogarty Institute startups.

Q. How did you first become interested in healthcare and how did you become one of the leading experts in the field?

A. I read a lot as a kid, especially when I lived in Kodiak, Alaska. One book that had a profound impact described the early days of heart transplantation by industry pioneers Dr. Christiaan Barnard and Dr. Michael DeBakey. That was it! I was hooked into the idea of working in healthcare. As luck would have it, my first job as a nurse was at Stanford, where I was privileged to work in Pediatric Intensive Care caring for some of the first children to have heart transplants from Dr. Norman Shumway's team.

It's amazing to think back now and realize that Dr. Fogarty was part of that team too, though our paths never crossed. And now, it's such a privilege to be invited to work with some of the innovators that Dr. Fogarty has inspired and mentored.

How did I become a leading Nurse Practitioner?

This is a difficult question to answer, because I'm one of many nurse practitioners working with millions of people every day and my contributions pale in comparison to some of my colleagues.

My goal is to empower people with health information in a way that is easily understandable, while also validating their concerns and anticipating the underlying issues and understandable fears that swirl around any health issue. I want to help people make the best choices for their lives and their family's lives.

I started a health publishing company (Blue Orchid Press) in 2004 to do just that, and I'm proud that over five million health guides have been distributed in English, Spanish and Mandarin. I also have been providing health education on television, through on-line videos and via my blog, Nurse Barb's Daily Dose, as well as on social media (@NurseBarbDehn, facebook.com/Nurse-Barb-Dehn).

Q. What are the most rewarding aspects of your job/s?

A. I love caring for patients. It's an honor and a privilege when people trust you with their health. I always say: we have two ears and one mouth so that we can listen twice as much as we talk. I've found that by listening carefully to my patients, I can better guide them to the information and menu of options they have for treatments. Sometimes, just listening is enough! I think all of us want a real connection with our health care providers, and I hope that I'm providing that.

Q. What are the most critical health issues you are seeing, and how do we go about addressing them?

A. We have a range of critical health issues that impact people across the globe. I think most of us in developed countries take healthy mothers and healthy babies for granted, but the truth is that we can do a better job everywhere helping ensure safer childbirth and more effective neonatal resuscitation.

What happens in labor and delivery and the immediate postpartum time period continues to be one of the most impactful events with long-term and potentially multiple consequences for women, children and the entire family. That's why I've been so impressed by the Fogarty Institute's commitment to women's and newborn health, through such companies as MedicalCue, Materna and InPress.

Q. What role is medical technology playing to support your field and what innovations/trends are you most excited about?

A. Medical technology is changing women's health care in so many unexpected ways, and the innovators are looking at the concerns from different angles. I've been really impressed with Materna's devices, which have the potential to reduce complications after childbirth, and Madorra's ultrasound technology that can help sensitive tissue recover without hormones.

When I first saw a demonstration of how NeoCue (MedicalCue's innovative technology) works to help providers resuscitate newborns, I was overwhelmed by the potential to not only save babies, but to also help the health care workers do what is needed, in the right sequence and in the right way when they themselves might be anxious in what is literally a life-and-death situation.

Q. How did you become involved with the Fogarty Institute and what role are you playing in supporting some of its startups?

A. I became involved at the Fogarty Institute after Dr. St. Goar saw an article I wrote for the Huffington Post on a TAVR/CORE valve heart surgery. I think he saw how excited I was about innovation and very graciously asked me to come and meet some of the companies-in-residence at the Fogarty Institute, where he is on the board.

I was blown away, inspired and in awe of the creativity and innovation happening right here on the El Camino Hospital campus. The new and novel ways to solve a variety of vexing medical conditions and problems gave me goose bumps. It was, and still is, so exciting that I offered my help.

My role is first to be an enthusiastic cheerleader, which is easy because the innovations are going to impact so many millions of lives. Some of the companies have tapped me as a consultant; and others to help them connect with more patients, key opinion leaders and other experts for feedback and perspective. It's a true privilege to be a very small part of this incredible place.

Celebrating 20 Years: Wine with Heart

One of our most popular fundraisers, Wine with Heart, is set for Friday, September 9 from 6-10 p.m. at the beautiful Thomas Fogarty Winery. For more information, please email us at infofogarty@fogartyinstitute.org