For many people, a diagnosis of heart failure brings with it a feeling of hopelessness. Heart failure is the condition in which the heart muscle doesn't pump blood nearly as well as it needs to. Until recently, there have been limited treatment options, with all having a poor, long-term outlook.

How big is this problem? Nearly 6 million Americans are afflicted with heart failure.

Avery Therapeutics, a biotech startup in Tucson, wants to change all that with "a beating heart graft" which when attached to the surface of the heart begins the process of regenerating damaged tissue.

Avery's ground-breaking product, called MyCardia™, won first place at Get Started Tucson, one of a series of high-paced pitch competitions held around the country in which local entrepreneurs present their ideas to a panel of experts. Cox Business created these events to help put a spotlight on local entrepreneurs and provide them with cash and resources to get them to the next level.

"The realm of health-care technology is a unique business, which requires a lot of steps and a lot of governmental approvals," explains Ken Kraft, one of the judges and Vice President of Marketing for Cox Business. "The judges were impressed with the long-term potential of the technology, because these regenerative tissues have a lot of different applications, such as improving musculoskeletal conditions."


Stimulating the Hippocampus

"Long term" is a phrase at the core of all messaging surrounding Avery Therapeutics. It speaks to both the vast potential the company's therapy has to improve people's lives, as well as the unique business challenges the company's founders face in bringing their therapies from the lab to the marketplace.

"There is a major difference in your approach to working on a problem in the laboratory and starting a business," says Dr. Steve Goldman, co-founder and chief medical officer whose research provided the foundation for MyCardia™. "It's the classic story that when you try something new, you keep your hippocampus, the emotional and intuitive center of the brain, stimulated."

And the founders' brains have been positively lit up navigating the many challenges that come with bringing a new therapy to life. Can they get people to grasp the importance of the breakthrough, which uses cells whose creator was honored with a Nobel Prize? Can they validate that the approach works outside the lab? Can they prove it's more cost-effective than current treatments?

"With any new therapy, there is a challenge involved in simply explaining how it works and what it does, especially to laypeople," says Dr. Jen Koevary, Avery's chief operating officer. "This is especially true when dealing with ground-breaking areas like regenerative medicine."

Planting In the Desert

Some other new therapies try to address heart failure by injecting cells into the damaged heart. In Koevary's view that provides limited benefits because it's like trying to grow plants in a dried-up field were the soil has no nutrients.

MyCardia™ takes a different approach. The graft actually attracts nutrients to the damaged heart muscle and stimulates growth of new blood vessels and heart muscle in the previously damaged region.

The results have been dramatic with 30 percent improvements in both the contraction and relaxation of heart function.

These figures are appealing to both medical practitioners and the venture capitalists that Avery's founders are now approaching. Not only does MyCardia™ have vast potential to improve the quality of life of patients, it also provides the business benefits that are demanded in the new era of outcomes-based medicine. Heart failure is the number one cause of hospital admission for patients over 65 in the United States, so a therapy that reduces the need for additional treatment could provide significant cost savings.

"That isn't the kind of thing you focus on when you are in the research phase," says Dr. Jordan Lancaster, co-founder and chief scientific officer. "During the research, you're testing and throwing rocks at ideas just to see if they hold up. But when you move from research to developing a clinical product, your goals change, and you need to focus on demonstrating value."

MyCardia™'s value was recently recognized by the National Institutes of Health, which awarded Avery with a Small Business Innovation Research (SBIR) grant of almost $500,000. Avery is using this funding to begin manufacture of the beating heart graft technology.

The startup has been self-funded so far, and the prize from the GetStarted competition will allow the founders to hire consultants in areas like FDA compliance, which will help them bring the therapy to market more quickly.

"The biggest surprise is how fast this is all happening," Lancaster says. "In the research phase everything goes slow; in the startup phase, things go fast, and you're always fighting to keep the ball rolling to the next step."

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Published on: Dec 6, 2016