BioStable Science & Engineering Surpasses 500 Patients Treated Worldwide with the HAART Devices

HAART Aortic Annuloplasty Devices Simplify and Standardize Aortic Valve
Repair

AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, a medical technology company focused on
products for aortic valve repair for the treatment of aortic
insufficiency, today announced that over 500 patients worldwide have now
been treated using the HAART Aortic Annuloplasty Device.

“Many cardiothoracic surgeons recognize that the young aortic
insufficiency patient population cannot be treated with percutaneous
aortic valve replacement devices and should be treated surgically with
aortic valve repair whenever possible.¹ The HAART Aortic
Annuloplasty Devices are enabling surgeons to perform successful aortic
valve repair across a broad spectrum of this underserved patient
population,” says John Wheeler, President and CEO of BioStable Science &
Engineering.

While patients have benefited from advances in mitral valve repair
procedures for decades, reproducing the same positive results ─
long-term durability, freedom from re-operation and normal life
expectancy ─ using aortic valve repair techniques has been challenging.
The HAART family of products received clearance from the U.S. Food &
Drug Administration in 2017 and provides an attractive surgical solution
for patients suffering from aortic valve regurgitation. To date, over 50
heart centers have adopted the HAART technology including five new
hospitals in April alone performing their first HAART implant.

“Aortic valve repair has only been provided to a fraction of aortic
insufficiency patients. The HAART technologies offer surgeons the means
to standardize and simplify the approach to aortic valve repair for
consistent, effective outcomes and the opportunity to avoid valve
replacement for many more patients,” said Chief of Cardiovascular and
Thoracic Surgery at Franciscan St. Francis Heart Center, Marc W.
Gerdisch, MD. “We have used the HAART devices in more than two dozen
patients, and they have performed exceptionally.”

“As surgeons experience the versatility of our approach, they are
becoming increasingly confident using our devices in lieu of alternative
aortic repair or replacement methods. We believe increasing awareness of
the potential benefits of early surgical intervention in patients with
severe aortic insufficiency² combined with the growing
positive experience with our HAART Technologies will drive a shift
towards wider adoption of aortic valve repair,” said Wheeler. “We are
excited about our prospects for accelerating adoption of our
technologies.”

About BioStable Science & Engineering

BioStable Science & Engineering is a cardiovascular device company
focused on developing and commercializing proprietary valve repair
technologies that provide an alternative to valve replacement for
patients with aortic valve disease. The company’s HAART Aortic Repair
Technologies are designed to simplify and standardize aortic valve
repair, enabling surgeons to offer the recognized clinical benefits of
valve repair to patients undergoing surgical correction of aortic
insufficiency or aortic aneurysm. To learn more visit www.biostable-s-e.com.

1. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for
   the management of valvular heart disease. Eur Heart J. 2017 Sep
   21;38(36):2739-2791.
2. Yang LT, Michelena HI, Scott CG. et al. Outcomes in Chronic
   Hemodynamically Significant Aortic Regurgitation and Limitations of
   Current Guidelines. J Am Coll Cardiol. 2019 Apr 16;73(14):1741-1752.

Contacts

Tom Williamson
Chief Commercial Officer
tom.williamson@biostable-s-e.com
512-386-1996
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