Matt here is my pick im long on this nasd. pick! [TMED] ez. Trimedyne Subsidiary Receives ISO Certification, CE Mark
IRVINE, Calif.--(BUSINESS WIRE)--May 17, 1999--Trimedyne Inc. (Nasdaq/NMS:TMED) Monday announced its 90%-owned subsidiary, Cardiodyne Inc., received ISO 9001 and EN 46001 certification and was granted CE Mark authority covering the SuperPulse(TM) 80 watt Holmium Laser used in its Angiogenic Injection and Laser System for the treatment of coronary artery disease.
Cardiodyne's System uses the laser to make channels through the heart wall during diastole, when the heart wall is momentarily at rest between heartbeats. The channels enable blood from the heart chamber to perfuse the heart muscle. The laser energy also stimulates the release of naturally occurring angiogenic growth factors, causing new blood vessels to form in the tissue around the channels, a process called angiogenesis.
The body's supply of angiogenic growth factors is limited. However, copies of human growth factors, or the genes that give cells the ability to manufacture growth factors, can be made with today's genetic engineering techniques. Cardiodyne's System is designed to inject genetically engineered growth factors or genes during the last 100 milliseconds of the channel making procedure, to stimulate additional angiogenesis.
Cardiodyne holds an exclusive license to the basic U.S. Patent covering the use of a laser or any other therapeutic device, such as a drug injector, in the heart which is synchronized with the patient's ECG.
Clinical trials of Cardiodyne's channel making laser system are expected to begin in the Fall at medical centers in the United States and overseas.
Trimedyne is a leading manufacturer of surgical lasers for use in urology, orthopedics, ENT surgery, gynecology and general surgery to treat a variety of diseases and medical conditions.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act: With the exception of any historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may, individually or mutually, impact the matters herein described. Such risks may be outside the control of the company, and may be detailed from time to time in the company's periodic SEC reports.
CONTACT:
Trimedyne Inc., Irvine
Shane H. Traveller, 949/559-5300 (ext. 203)
KEYWORD: CALIFORNIA
BW1232 MAY 17,1999
6:30 PACIFIC
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Trimedyne Subsidiary Enters Gene Therapy Collaboration With Endovasc Ltd. Inc.
IRVINE, Calif.--(BW HealthWire)--May 20, 1999--Trimedyne Inc. (Nasdaq/NMS:TMED) Thursday announced its 90 percent owned subsidiary, Cardiodyne Inc., has entered into a Collaboration Agreement with Endovasc Ltd. Inc. (Nasdaq:ENDV) under which the parties will collaborate on the development of liposome encapsulated agents to promote angiogenesis, such as fibroblast growth factors and vascular endothelial growth factors, the genes that cause cells to produce such growth factors, and agents to treat congestive heart failure.
The liposome coated agents will be injected into channels in the heart wall created by Cardiodyne's proprietary Laser Transmyocardial Revascularization ("TMR") System, which is designed to treat severe angina resulting from blockages in coronary arteries and other cardiac conditions. Cardiodyne expects to begin human clinical trials of its Laser TMR System in late 1999 in the United States and overseas.
The laser created channels enable blood from the heart's chamber to perfuse the heart muscle and stimulate the release of naturally occurring growth factors, which cause new blood vessels to form (angiogenesis). While the body's supply of naturally occurring angiogenic agents is limited, these substances can be manufactured with today's genetic engineering techniques. Injecting genetically engineered angiogenic agents with Cardiodyne's TMR System could increase the angiogenesis effect. Encapsulating the growth factors or genes will enable them to more easily penetrate the heart's muscle cells. If various liposomal capsule compositions are employed, the contents can be released at different times, providing a longer term effect.
Commenting on the Agreement, Endovasc spokesman, Dr. David Summers, said, "Cardiodyne's ECG Synchronized Injection and Laser TMR System is vastly superior to any other laser TMR system we've seen. Injecting our liposome encapsulated agents into the newly created laser channels, if successful, may revolutionize the treatment of coronary artery disease and congestive heart failure. The treatment of these conditions costs in excess of $100 billion each year in the United States."
Endovasc, which is based in Montgomery, Texas and also has research facilities in San Francisco, is a leader in liposomal encapsulation technology and holds important patents and technological skills in this promising new area. Endovasc has already completed design formulation of a liposome encapsulated vascular endothelial growth factor (VEGF) and plans to encapsulate a fibroblast growth factor (FGF), as well as the genes which enable cells to manufacture VEGF and FGF and other agents.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act: With the exception of any historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may, individually or mutually, impact the matters herein described. Such risks may be outside the control of the company, and may be detailed from time to time in the company's periodic SEC reports.
CONTACT:
Trimedyne Inc., Irvine
Shane H. Traveller, 949/559-5300 ext. 203
KEYWORD: CALIFORNIA TEXAS
BW1125 MAY 20,1999
6:17 PACIFIC
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Endovasc Ltd. Inc. Announces Collaboration With Trimedyne/Cardiodyne for New Laser Heart Treatment
MONTGOMERY, Texas--(BWHealth Wire)--May 18, 1999--Endovasc Ltd. Inc. (OTC BB:ENDV) today announced that the Company had entered into a collaboration with Trimedyne Inc.'s (Nasdaq:TMED) 90% owned subsidiary, Cardiodyne Inc. The parties will co-develop liposomal therapeutics aimed at enhancing Cardiodyne's revolutionary ECG synchronized Gene Injection and Laser Transmyocardial Revascularization ("TMR") System, which is designed to be used for treating angina, congestive heart failure, and other indications.
According to a recent Gore Horvath(a) report on Trimedyne/Cardiodyne, which estimates a multibillion dollar market, Cardiodyne's revascularization procedure could "potentially revolutionize the treatment of heart disease," especially for the elderly, many of whom suffer from angina due to blockages in the coronary arteries and congestive heart failure. The treatment of these conditions costs in excess of $100 billion annually in the U.S.
Dr. David P. Summers, Endovasc's chairman, said, "Literally millions of patients with declining heart function -- most accompanied by angina and shortness of breath, who become progressively immobilized due to the heart's inability to push enough blood through their coronary arteries -- could be candidates for Cardiodyne's new 'cold' laser treatment which will be combined with our liposomes containing new blood vessel growth factors. Our goal is to provide the heart with a new blood supply network which will enable the heart to regain some of its former capabilities."
Endovasc will collaborate with Cardiodyne on the design, development and testing of the drugs used to create new blood vessels to and from the newly created laser channels in the heart muscle. Endovasc has liposomal products containing Prostaglandin E-1 (Liprostin(TM)) already completed and awaiting FDA approval to commence Phase I/II clinical trials. Endovasc recently completed design formulation for a liposome encapsulated growth factor ("VEGF"), and will develop these and other gene encapsulation formulations during the collaboration. The Agreement gives Cardiodyne certain rights to any products which the parties develop through the Collaboration.
About the Company:
Endovasc Ltd. Inc. is a biopharmaceutical company located in Montgomery, Texas. Endovasc uses liposomal and nanosphere drug delivery for products that have already shown safety and efficacy in generic form. The company's products and processes are covered by patents and trade secrets for competing in a $2 billion market.
The foregoing statements are made under the "Safe Harbor" Private Securities Litigation Reform Act of 1995 and may contain forward-looking statements that involve risks and uncertainties that may not be evident at the time of this release.
(a) Available through Gore Horvath at 800/965-8284
CONTACT:
PMR & Associates
Phone: 760/942-0015 or 409/448-2222
E-mail: pmrandco@aol.com
or
Endovasc Ltd. Inc.
Phone: 409/448-2222
KEYWORD: TEXAS
BW0114 MAY 20,1999
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