Biostable Science & Engineering scores FDA nod for aortic valve repair device

By Omar Ford, Staff Writer – Medical Device Daily

Biostable Science & Engineering Inc. received FDA clearance for its Haart 300 product, an annuloplasty device designed for aortic valve repair. The Austin, Texas-based company said it will launch the device in select heart centers this summer. The company has had CE mark for the Haart 300 since March 2016. Heart valve repair is a procedure to repair native valve function instead of replacing it with a mechanical or biological replacement device. Valve repair may be more durable than biological valve replacement and avoids the complications associated with anticoagulation medications required with mechanical valve replacement.

Haart 300 replicates the anatomy of the normal aortic valve. The device is designed to resize, reshape, and stabilize the aortic annulus to restore valve competence and help prevent recurrent aortic regurgitation.

“We know that if we could successfully repair the valve instead of replacing it, that it would be a better answer for patients,” John Wheeler, president and CEO of Biostable Science & Engineering, told Medical Device Daily. “We hope our technology helps make aortic valve repair an easy or reproducible procedure. We’re trying to offer a better patient solution through valve repair.”

Data from a study of the Haart 300 indicated that patients who underwent aortic valve repair using the company’s device showed significant improvements in aortic insufficiency grade and New York Heart Association scores, with a reported 89 percent freedom from valve reoperation and a 95 percent rate of freedom from all-cause mortality. Biostable is a private company and was formed in 2008.

Wheeler did not discuss specifics regarding Biostable’s funding. However, Wheeler was clear on the fact Haart 300 wasn’t targeting patients in the transcatheter aortic valve replacement (TAVR) market. “From our perspective TAVR really isn’t indicated in our patient population for the most part,” he said. “Our patients don’t have [calcification], which is really a key characteristic of TAVR. Our patients are typically much younger than an aortic stenosis patient.”

In addition to aortic valve repair, the company is also eyeing the mitral valve repair market, with its Haart 200 model. “Patients are extremely young when they develop problems in the mitral valve,” he said. “No one wants to put either a tissue valve or mechanical valve in a young patient with a long life expectancy. There is lots of time for problems to develop. A repair solution there would be a really great option.”

Biostable said it hopes to file for CE mark approval for the Haart 200 in the near future. Once that process is underway, the company would seek approval for Haart 200 in the U.S. Treatment of the mitral valve through either repair or replacement has become an attractive opportunity for many med-tech companies. The space has seen a great deal of mergers and acquisitions activity in the past few years.

Late last year, Edwards Lifesciences Corp. took a deeper dive into the transcatheter mitral valve replacement market when it revealed plans to acquire Or Yehuda, Israel-based Valtech Cardio Ltd. for $340 million, with the potential for $350 million in additional milestone payments.

With Valtech, Irvine, Calif.-based Edwards gains access to Cardioband, a transcatheter ring technology and sets the company firmly against Abbott Park, Ill.-based Abbott Laboratories’ Mitraclip device. In July 2015, Abbott Laboratories reported plans to pay $225 million for the equity of Roseville, Minn.-based Tendyne Holdings Inc. that it did not already own at the time, making the total deal worth $250 million plus potential regulatory-based milestone payments. The company closed on that deal in

September 2015. (See Medical Device Daily, July 31, 2015.) In a separate deal, Abbott said it had invested in mitral valve repair company Cephea Valve Technologies Inc., of Santa Cruz, Calif., with an option to buy.

Nearly two years ago, Dublin-based Medtronic plc jumped into the transcatheter mitral valve replacement pool and agreed to pay up to $458 million to acquire Redwood City, Calif.-based Twelve Inc.