Cardiodyne, Inc.

    Cardiodyne, Inc. holds an exclusive license to the basic U.S. Patent on firing a laser or the use of any other therapeutic device in the heart which is synchronized with the patient's ECG. Cardiodyne, Inc. also holds a U.S. Patent covering its AutoFire™ Automated Interface and ChannelMaker™ Catheters. Most importantly, in 1999, Cardiodyne, Inc. filed a U.S. patent application covering a unique, new angiogenic composition, a "cocktail" of angiogenic agents, enhancers, promoters and stabilizers. While one angiogenic agent can produce capillaries, the body requires a variety of angiogenic agents to produce arterioles, and enhancers, promoters and stabilizers are necessary for them to grow and survive as arteries. A study of Cardiodyne's angiogenic composition in the hearts of animals (pigs), in which one of their major coronary arteries has been intentionally constricted, is underway at the Texas Heart Institute of the University of Texas in Houston. While we will not be able to ascertain the value of Cardiodyne's angiogenic "cocktail" until the animal study is completed; our composition, if successful, has the potential to produce greater blood vessel formation than the single angiogenic agents or genes being tested by others to treat angina.

Cardiodyne's Heart Revascularization System may also be beneficial in treating areas of the legs that are not receiving adequate blood flow due to blockages in the arteries in the limbs,  a condition called Peripheral Artery Disease or "PAD." Approximately 100,000 limbs are amputated annually in the United States due to this condition, at considerable hospitalization and rehabilitation costs. Cardiodyne, Inc. plans to test its angiogenic composition in the legs of animals in which a major vessel has been surgically closed to create the blood deprived condition seen in PAD.

Cardiodyne, Inc. has filed an Investigational Device Exemption ("IDE") Application with the FDA to commence a clinical trial of its Intraoperative Laser TMR System in the treatment of "no option" angina patients who have exhausted all available therapies (drugs, balloon angioplasty and bypass surgery) and still have significant chest pain. Subject to FDA approval, this clinical study is expected to begin in 2001.  Later in 2001, Cardiodyne, Inc. plans to file IDE applications with the FDA to begin clinical trials of its Angiogenic Injection and Laser TMR System as an adjunct to coronary artery bypass surgery and coronary balloon angioplasty.

Cardiodyne, Inc. expects to complete the development of its Heart Revascularization System, receive the CE marking and commence marketing its Injection and Laser TMR System in Europe in early 2001. Extensive clinical trials of Cardiodyne's Angiogenic Injection and Laser TMR System versus conventional therapies must be completed before Cardiodyne, Inc. can submit a Premarket Approval ("PMA") application to the FDA to market its Revascularization System in the United States. This process could take three years or longer and will require that Cardiodyne, Inc. raise additional funds.

For more information on Cardiodyne, Inc., email us at: info@trimedyne.com

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