LAKE FOREST, CA--(Marketwire - Nov 28, 2012) - TRIMEDYNE, INC. (
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 |
In the U.S. Affected
|Present Estimated |
Cost of Treatment
Asthma Which is Not Controllable by Drugs
|Cardiodyne, Inc.||Heart Attack LTMR Therapy* |
Heart Valve Leakage
Arrythmia (irregular heartbeat)
|$15 billion |
|Gastrodyne, Inc.||GERD (Heartburn)* |
|$20 billion |
|Hyperdyne, Inc.||Hypertension (high blood pressure) Which is Not |
Controllable by Drugs
|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)*||1,000,0001||$5 billion1|
|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.
This is an extremely ambitious program for a small company, and there is no assurance Trimedyne will be able to obtain $12 to $18 million of financing for any of these subsidiaries in Private Placements, that the results of any of the clinical trials will be successful or that Trimedyne will be able to conclude arrangements with any large, established companies in the healthcare field to market any of the new Devices or acquire any of the subsidiaries.
If and when the clinical trials are concluded and if the results of any subsidiary's clinical trials are successful, which cannot be assured, Trimedyne intends to register a spin-off of all or part of its shares of such subsidiaries as a dividend to its shareholders.
Since Trimedyne is commencing the distribution of Business Plans of the above subsidiaries to venture capital firms, private equity groups and institutional investors on a confidential basis in Private Offerings, Trimedyne is making this announcement to assure that its plans are properly disclosed to the public and to avoid prospective investors trading in Trimedyne's shares based on non-public information.
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.