BioStable

About BioStable

BioStable Science & Engineering, Inc. operated as a cardiovascular medical device company with a sharp focus on creating and marketing proprietary technologies for aortic valve repair. The firm was established in 2008 by a seasoned team from CarboMedics' senior management, including former President Charles Griffin, Rusty Phillips, Al Beavan, Doug Frank, and Don James, who collectively brought over 100 years of experience in the implantable medical device sector. Their extensive background in developing products for valvular heart disease directly shaped the company's trajectory. The company's primary mission was to provide a viable alternative to valve replacement for patients suffering from aortic valve disease, specifically aortic insufficiency and aortic root aneurysm.

The core of BioStable's business was the development and sale of surgical devices to hospitals and cardiac surgeons. Its flagship product line, the HAART (Hemispherical Aortic Annuloplasty Repair Technology) Aortic Repair Technologies, was engineered to simplify and standardize the complex procedures of aortic valve repair. This product portfolio included the HAART 300 Aortic Annuloplasty Device, the first internal aortic annuloplasty ring designed to replicate the aortic valve's natural anatomy, and the HAART 200, which was tailored for bicuspid aortic valve repair. These devices aimed to resize, reshape, and stabilize the aortic annulus, thereby restoring proper valve function and preventing recurrent aortic regurgitation. The business model centered on direct sales and providing educational training to surgeons on the use of its technology.

The company achieved several key milestones, including securing a $5.5 million Series A financing round in 2008 to launch its product development. It later gained CE Mark approval in Europe for the HAART 300 in 2016 and the HAART 200, allowing for a commercial launch in select European heart centers. In 2017, the HAART 300 became the first device of its kind to receive clearance from the U.S. Food and Drug Administration (FDA), followed by the HAART 200. This regulatory success enabled the company to initiate a pilot launch in the U.S. After years of venture capital backing and achieving commercial use in over 1,000 patients, BioStable Science & Engineering's assets were acquired by Corcym, a global medical device company, in April 2023.