Brad McCarty • April 30, 2018

One factor that makes the heart such an amazing muscle is how precisely every part of it must work together to perform its job. A simple leaky valve — known as aortic insufficiency (AI) — can lead to a complicated and difficult valve replacement that often requires repeat treatment and special medication for the life of the patient. BioStable Science & Engineering, an Austin-based company, has developed an alternative treatment device that reinforces the natural ring around the heart valve. This annuloplasty device simplifies and standardizes the procedure and solves the complex anatomy problems of the aortic valve.

Aortic Insufficiency in the World

Over 2.5 million people suffer from AI. A quarter of those undergo surgery each year to treat the problem. The current options are either replacement or repair. The outcomes of these surgeries are largely positive, but they have lifelong negative impact. For instance, biologic valves require a subsequent operation in as little as 10 years, while mechanical valves require a lifetime of anticoagulation medication.

The underlying issue with valve surgery goes back to an earlier point related to the precision and complexity of the heart muscle. The ring of the valve, known as the annulus, needs to be an exact shape. If it’s distorted in any way, it can allow for aortic insufficiency. While annuloplasty (the surgery required to repair the annulus) is not an entirely new technology, it’s complicated by the exacting needs of the heart.

The BioStable Science Solution

BioStable Science & Engineering has two products in its portfolio that directly answer the problems related to aortic annuloplasty. The HAART 300 device is designed for patients with normal (trileaflet) aortic valves, while the HAART 200 device treats the congenital heart defect of bicuspid valves. Both devices are implanted with sutures, using proven and familiar principles of previously-successful valve repair procedures.

The end result is a faster, simpler, and more standardized technique that is applicable to every type of aortic insufficiency. Compared to valve replacement surery, patients see more positive outcomes and improved quality of life.

The Journey Thus Far

BioStable Science & Engineering is in the commercial stage, with the HAART 300 device being implemented into 16 centers across seven European countries. The FDA has cleared the HAART 200 and 300 devices for use in the United States, with the products seeing use in seventeen heart centers across the country.

The company is presently seeking an additional $2 million to its Series B round, with the intent to seek a strategic exit from existing interested parties. Alternately, as the company is already producing significant revenue ($735,000 to date), the additional money could be used to provide the resources needed for a near-term cash positive position.

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