LAKE FOREST, CA -- (Marketwire) -- 12/20/12 -- TRIMEDYNE, INC. ("Trimedyne") (OTCBB: TMED) today announced that Robert S. Cowles, III, M.D. has agreed to serve as Co-Chairman with Dr. Marvin P. Loeb of the Boards of Directors and as Medical Director of Urodyne, Inc. ("Urodyne") and Hyperdyne, Inc. ("Hyperdyne"), two subsidiaries Trimedyne plans to organize. (See Trimedyne's Press Release of November 28, 2012).
Dr. Cowles will be the Chief Investigator of, and subject to their being funded, will direct the randomized, controlled clinical trials to be conducted by Urodyne and Hyperdyne throughout the world. He will also select the medical centers to participate in these clinical trials in North and South America and will train the Urologists of these medical centers on the use of the new lasers and new, disposable fiber-optic devices to be tested in these clinical trials.
Subject to the receipt of funding, Urodyne plans to conduct three (3), 300 patient, randomized, controlled clinical trials of its new lasers and new, disposable fiber-optic devices in the faster and safer treatment of Benign Prostatic Hyperplasia or "BPH," commonly referred to as an "Enlarged Prostate," as well as in the treatment of urinary incontinence and fecal incontinence. These three conditions affect more than 50 million Americans and cost Medicare, insurers and their families an estimated $60 billion dollars each year in the United States.
Likewise, Hyperdyne plans to conduct two (2), 300 patient, randomized, controlled clinical trials of its new lasers and new, disposable fiber-optic devices. One clinical trial will be in the Endoscopic or Laparoscopic treatment of Hypertension (high blood pressure) not controllable by drugs. The other clinical trial will be in the Percutaneous (intra-renal artery) treatment of uncontrolled Hypertension. Uncontrolled Hypertension affects an estimated 26 million Americans and costs Medicare, insurers and society an estimated $26 billion each year in the United States. Uncontrolled Hypertension affects an estimated $400 million people outside the U.S. and costs an estimated $186 billion each year in countries outside the U.S.
Trimedyne manufactures proprietary Holmium lasers and patented and patent pending fiber optic laser devices to treat a variety of medical conditions in minimally invasive, procedures, many of which are performed on an outpatient basis at substantially less cost than conventional surgery. For product, press release, financial, SEC Reports and other information, please visit Trimedyne's website, http://www.trimedyne.com.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act:
Statements in this news release may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, including words like "believe," "expect," "may," "could" and others. Such statements may involve various risks and uncertainties, some of which may be discussed in the Company's current Form 10-K Report and subsequently filed SEC Reports. There is no assurance such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in the statements in such Reports, which Trimedyne has no obligation to update.
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