Trimedyne Announces the Development of New Breakthrough Laser Devices

Wednesday, November 28th 2012

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
                  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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