MiCardia Announces New Funding and Spin-off Company

Irvine, Calif.-based MiCardia Corp. has completed an internal round of funding, which will funnel $4.4 million into the cardiac device company during 2012 and 2013. MiCardia intends to use the funding for the expanded commercialization of its enCorSQ mitral valve repair system in Europe and select countries worldwide.

This news broke in tandem with an announcement that MiCardia will be spinning off its transcatheter technology business into a new company called ValCar Inc., backed by Israel-based investment firm Accelmed Medical Partners LP. Accelmed will invest $8 million to further advance the technology.

EnCorSQ is an annuloplasty device indicated for the treatment of mitral regurgitation (MR) with features that enable the physician to adjust the device after initial implantation without further surgery. This late adjustment capability allegedly corrects recurrent mitral valve regurgitation that results from the progressive nature of the underlying cardiovascular disease. MR occurs when the heart’s mitral valve does not close properly resulting in an inadequate blood flow to the body. It is the abnormal leaking of blood from the left ventricle, through the mitral valve, and back into the left atrium when the left ventricle contracts. Both the American Heart Association and the American College of Cardiology recommend open-heart surgery to repair or replace the mitral valve for patients who suffer from moderate to severe MR.

“Late adjustment, which can be achieved weeks to months post implantation without the need for a repeat high risk surgical procedure, has the capability to expand the market for mitral valve repair,” said MiCardia CEO Don Rohrbaugh. In the European Union, approximately 20,000 mitral valve repair procedures are performed annually. Up to 30 percent of those patients may experience recurrence of mitral valve regurgitation depending upon the etiology of the disease. The enCorSQ mitral valve repair system is the only device available that can correct recurrent regurgitation without further surgical procedures, MiCardia claims.

Meanwhile, ValCare is readying itself for takeoff. ValCare’s transcatheter mitral valve repair system uses interventional cardiology methods to implant a mitral annuloplasty device. Mitral annuloplasty devices are used in the treatment of moderate to severe mitral valve regurgitation. Nearly 4 million people in the United States suffer with moderate to severe mitral regurgitation and the total U.S. market for treatment of MR is estimated to be $3.5 billion. This non-surgical catheter delivered system preserves the “gold standard” of mitral repair and is hoped by the company to be a new effective means for treatment of a substantial number of these patients while lowering the risks of the traditional open-heart treatment.

“To date, laboratory and pre-clinical tests have demonstrated feasibility of the designs and initial patent applications,” said Valcare CEO Sam Shaolian. “The next phase is to complete the development and validate the device in a pre-clinical studies in the near term.”

ValCare will remain based in Irvine alongside its parent company.