The financing was led by BioStar Ventures and the MedFocus Fund who assembled a strong syndicate of investors, including new investments by Edwards Lifesciences Corporation and Hatteras Venture Partners. In conjunction with this closing, Douglas Reed, M.D., General Partner of Hatteras Venture Partners, will join the board of directors of Embrella.
Proceeds of the Series B financing will fund Embrella to key inflection points. “This capital will allow the company to complete the European Clinical trials and submit our results to European Regulatory Authorities with the intent of achieving CE Mark approval,” said Mr. Jeffrey O’Donnell, Embrella’s CEO. “Once this is achieved, we would then be approved to commercialize our device in the EU.”
Embrella Cardiovascular, Inc., is developing an embolic protection device called the Embrella Embolic Deflector. The device is designed to prevent dangerous debris or emboli from entering the brain by deflecting the emboli away from the carotid arteries. These dangerous emboli can cause neurological complications during cardiovascular procedures.
The Embrella Embolic Deflector will serve as an adjunctive device to be used in procedures such as the less invasive Transcatheter Aortic Valve Implantation (TAVI) procedure. This technology is currently approved in Europe for high risk patients with severe aortic stenosis. Frequently the aorta contains atheromatous plaque and the valve can be densely calcified. During TAVI, wires, catheters and balloons pass over the aortic arch where they may dislodge debris and calcific particles. Unless deflected from the arteries leading to the head, such debris may embolize to the brain and cause stroke. “The Embrella Deflector is an elegant device that we believe will significantly improve the safety of transcatheter valve replacement procedures,” Dr. Reed commented.