MMCV News MicroMed Announces Hiring of Alan Totah as Senior Vice President of Regulatory Affairs and Quality Systems
HOUSTON--(BUSINESS WIRE)--July 13, 2006--MicroMed Cardiovascular, Inc. (OTCBB:MMCV) is pleased to announce that Alan Totah has joined the company as Senior Vice President, Regulatory Affairs and Quality Systems. Mr. Totah previously served as Vice President of Regulatory Affairs and Quality Systems for Cyberonics, Inc. (Nasdaq:CYBX), the company that created the Vagus Nerve Stimulation (VNS Therapy(TM)) System for the treatment of epilepsy and other debilitating neurological disorders. Prior to his association with Cyberonics, Mr. Totah served in Regulatory Affairs management capacities with Medtronic, Inc. in the Heart Failure Tachycardia and Bradycardia Systems division and with Sultzer Intermedics, a pacemaker and defibrillator company.
"We are very pleased to have Alan join our management team," said Travis E. Baugh, President and CEO of the company. "He brings a wealth of knowledge and over 30 years of professional experience in US and international regulatory matters and quality systems management to MicroMed."
About our Technology
MicroMed's initial platform in heart failure products is the DeBakey VAD(R) (Ventricular Assist Device) for the treatment of advanced heart failure. There are currently 15 million victims of heart failure worldwide. With approximately 2,000 donor hearts suitable for transplantation becoming available each year in the United States or 4,000 worldwide, MicroMed believes that the DeBakey VAD represents an important therapeutic option for this population. The DeBakey VAD represents a new generation of miniaturized implantable mechanical circulatory support devices. Designed in collaboration with NASA, the Baylor College of Medicine and Drs. Michael DeBakey and George Noon, the DeBakey VAD is intended for adult and pediatric advanced heart failure patients who can no longer provide necessary blood flow with their native heart. The proprietary technology is designed to take over virtually all left ventricular function and concurrently monitor real-time flow parameters.
About MicroMed Cardiovascular, Inc.
MicroMed currently has two ongoing clinical investigations in leading US heart transplant centers to evaluate the safety and effectiveness of the DeBakey VAD for use as a Bridge to Heart Transplantation and for Destination Therapy for patients ineligible for heart transplant. The DeBakey VAD system has been awarded the CE mark for Bridge to Transplant and Destination Therapy for commercial distribution in Europe. The DeBakey VAD Child, the only approved miniaturized implantable VAD in the US, is available for use in children. It has also been awarded the CE mark for commercial distribution in Europe. Over 380 adult and pediatric devices have been implanted worldwide for almost 100 patient years of experience. MicroMed's manufacturing facility, located in Houston, Texas, is ISO 9001/13485 certified.
This news release contains certain forward-looking statements pertaining to future anticipated projected plans, performance and developments, as well as other statements relating to future operations and results. Any statements in this news release that are not statements of historical fact may be considered to be forward-looking statements. Written words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements. These statements by their nature are estimates of future results only and involve substantial risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors including, but not limited to, risks related to: our ability to obtain additional funding to support our business activities; the early-stage market for ventricular assist products and services; an expected dramatic rise in expenses; rapid growth and change in our business; as well as those risks more fully discussed in the Company's reports filed from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing its views as of any subsequent date. We do not undertake any obligation to update any forward-looking statements to reflect events or circumstances after the date of this release.
The MicroMed DeBakey VAD(R) is an investigational device and is limited by federal law for investigational use in the United States.
