Trimedyne Announces the Development of New Breakthrough Laser Devices
LAKE FOREST, CA -- (Marketwire) -- 11/28/12 -- TRIMEDYNE, INC. (OTCBB: TMED) today announced it has patented and filed patent applications covering several new laser devices ("Devices") designed to treat medical conditions that affect millions of people in the United States and many more millions of people throughout the world.
To establish the safety and efficacy of a new medical device in the treatment of a medical condition requires a large, expensive, randomized, controlled clinical trial, usually involving 300 or more patients. Each of such clinical trials can cost $5 million or more and each can take two years or longer to complete. Once completed, the publication of a paper in a peer-reviewed medical journal can take an additional six months or longer, and obtaining Medicare reimbursement for the therapy can take another nine months or longer. Medical devices usually are not launched into the market until Medicare, other third party and foreign government reimbursement are available.
Since Trimedyne cannot afford to fund a number of large, randomized, controlled clinical trials to prove the safety and efficacy of its new Devices in the treatment of multiple medical conditions, Trimedyne plans to organize seven (7) subsidiaries, each of which will attempt to secure $12 to $18 million of funding in Private Offerings (pursuant to Rule 506 of Regulation D of the SEC) to conduct large, randomized, controlled clinical trials of the new Devices in the treatment of one to three of these medical conditions. If the proposed financing of any of the subsidiaries is consummated, which cannot be assured, we expect Trimedyne will hold a 50% interest in each of such subsidiaries.
Trimedyne's Holmium Lasers and new patented and patent pending Devices, which will be used in the clinical trials to treat these new medical conditions if their funding is consummated, have already been cleared for sale in the United States by the FDA. Several of these Devices are already CE Marked and we expect to have the others CE Marked for sale in the European Union. Several of these Devices are and we expect the others will be registered for sale in countries which require their own registration of medical devices, including Australia, Brazil, Canada, China, India, Indonesia, Korea, Mexico, Russia, Taiwan, Turkey and elsewhere. However, Japan requires a local clinical trial for registration of medical devices with its Ministry of Health, which is an expensive and lengthy process.
The names of the subsidiaries, the conditions Trimedyne believes its Lasers and new Devices will be able to treat more safely and effectively than currently available drugs or medical devices, the number of people estimated to suffer from these conditions in the United States and our estimate of the cost of their current treatment in the United States, to the best of our knowledge, are as follows (comparable Medicare reimbursed therapies are indicated with an asterisk):
Estimated Number of People Subsidiary Medical Conditions In the U.S. Present Estimated Affected Cost of Treatment ---------------------------------------------------------------------------- Asthmadyne, Inc. Asthma Which is Not Controllable by Drugs 4,000,000 $18 billion Cardiodyne, Inc. Heart Attack LTMR Therapy* Heart Valve Leakage 750,000 $15 billion Arrythmia (irregular 125,000 $7 billion heartbeat) 20,000,000 $10 billion Gastrodyne, Inc. GERD (Heartburn)* 30,000,000 $20 billion Obesity 70,000,000 $60 billion Hyperdyne, Inc. Hypertension (high blood pressure) Which is Not Controllable by Drugs 27,000,000 $50 billion Orthodyne, Inc. Herniated, Ruptured & Degenerated Discs 15,000,000 $42 billion Surgidyne, Inc. Laser for Sealing Incisions after Surgery in lieu of Stitching, Staples or Clips 50,000,000 $25 billion Urodyne, Inc Enlarged Prostates (BPH)* 1,000,000(1) $5 billion(1) Urinary Stones* 1,500,000 $22 billion Urinary Incontinence 25,000,000 $26 billion Fecal Incontinence 16,000,000 $25 billion
(1) Estimated U.S. and foreign number of patients and cost.
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