Entrepreneur of the Year

Bartley GriffithBartley P. Griffith, MD
School of Medicine
Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery
Founder, Breethe, Inc.

After 1,250 heart transplants and 685 lung transplants, one would think Bartley P. Griffith could rest easy at night, knowing he had done everything possible for his patients.

But for the past 20-plus years, Griffith has felt a void. As he expressed when he was named UMB Researcher of the Year in 2010 “my own heart goes out to those suffering with breathlessness. I am eager to apply our artificial technology to those patients.”

Griffith, the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery at the School of Medicine, took a giant step toward helping the hundreds of thousands who die annually from lung failure in 2014 when he founded Breethe, Inc., which was formed to commercialize the world’s first wearable, artificial lung system that Griffith developed.

For decades, patients with lung disease have been tied to a breathing machine in a hospital bed. Griffith’s new device is fully portable.

The pump lung unit, which is a little larger than a Coke can and sits on the patient’s belt, draws blood out down through the cannula. It oxygenates and removes carbon dioxide from the blood, which then goes back in the body. The unit also is attached to a portable pack on wheels (which eventually could become a backpack), which contains batteries, the oxygen source, and the pump motor to control it.

Pumping the blood without clotting is a key element of the device built by Griffith, who earlier in his career was one of the first surgeons to implant a Jarvik heart and develop a pediatric heart pump. Breethe plans to file its 501(k) request for approval with the Food and Drug Administration in 2019.

Although they say he developed “the hard part” with the pump lung unit, Griffith says Breethe wouldn’t exist without his partners Carl Cohen and Marshal Linder.

“Carl counseled me early to believe in my own message,” Griffith says. “He gives me courage to persevere and the confidence to ask potential investors to ‘buy’ into the vision. Marshal [a medical device company executive who led the development and commercialization of the ZOLL LifeVest, the world’s first wearable defibrillator] is our quiet guide who knows how to build a medical device company from our laboratory models. These two pillars are the only reason we exist … how lucky I am.”

Griffith also is grateful to UM Ventures, UMB’s commercialization arm, and its director James L. Hughes, MBA, UMB’s chief enterprise and economic development officer and vice president. “Jim has been an early proponent of my dream and represents a gentility which I believe to be rare in this tough area,” Griffith says. “From advising my research protégé Jon Wu and me on the early next steps to endorsing UMB investment in Breethe, Jim has been there all along the way. He is a treasure.”

Cohen and Linder say Griffith is extraordinary, too.

“He’s amazing. This a visionary type person who is willing to step out of the mainstream and pursue an innovative idea and make it happen,” says Cohen, who practiced business law for 27 years.

Adds Linder, an expert in product development, “One thing that’s very clear is he really does have a passion for helping these patients, for making a difference, extending their lives. Unlike many other medical entrepreneurs, Bart continues to practice clinically. He’s in the operating room, he’s doing transplants, he’s seeing patients all the while he’s working on Breethe. That is unique.”

It’s also led the three of them to sometimes meet on Sunday nights for that is the only hole in their schedules. Still they have made it work.

Based at the BioPark, Breethe, Inc. is deep into product development, funded to date through three rounds of equity capital with Griffith playing an active role.

“When the three of us talk to investors, we open with him because he speaks with great authority about why current solutions for these patients have not been sufficient, and why we believe we can do better,” Linder says. “When he says that, people listen, and want to help.”

Previously chief of cardiac surgery at the School of Medicine, Griffith also has recently raised funding to endow a joint chair between the SOM Department of Surgery and the Department of Bioengineering in College Park. The chair helps to create new medical devices.

“I have received support for the commercialization of our device from the NIH and from the Abell Foundation here in Baltimore,” Griffith says. “Because I have seen the opportunities a surgeon can have to innovate past obstacles, Dr. [Stephen] Bartlett [chair, Department of Surgery] and I were able to achieve more than $1 million in funding for a full-time entrepreneur-based bioengineer in the Department of Surgery. We were fortunate to receive matching funds from the state to endow a Distinguished Professorship. This helped to recruit Jon Wu to UMB.”

Wu and Griffith are submitting a new NIH proposal as a follow-up on their earlier one that seeks to understand how to limit damage to the heart muscle after heart attacks.

Cohen for one isn’t surprised that Griffith is doing heart research in addition to his surgeries and Breethe duties. “He’s truly remarkable in his energy and his ability to work at this and all these other things.”

Delighted to be Entrepreneur of the Year (“so many others are more worthy”), Griffith says it’s a different feeling than being Researcher of the Year in 2010.

“Few think of heart surgeons as academically competitive at the highest NIH peer-review level,” he says. “I believe that this new award fits the appropriate pivot in our laboratory to focus on impactful devices that might change the practice of medicine.”