“The patent protects our substantial investment in cardiology and should reward our investors for this innovative approach to Ischemic Heart Disease” stated John Warlick, President and CEO of TRT. “This device represents the greatest hope for the millions of patients who have suffered a substantial heart attack and the associated loss of heart function. Shock waves recruit a patient’s own stem cells to the treated area to begin the process of perfusion and tissue regeneration”. Further, “in the history of the treatment of damaged heart tissue, with any therapy, including stem cells, there has never been a more successful series of preclinical and clinical studies and we are very excited about the future of this patented therapy."
"This device represents the greatest hope for the millions of patients who have suffered a substantial heart attack and the associated loss of heart function."
"in the history of the treatment of damaged heart tissue, with any therapy... there has never been a more successful series of preclinical and clinical studies"
Woodstock, GA, April 24, 2012 – Tissue Regeneration Technologies, LLC (TRT) today announced that the US patent and Trademark office (USPTO) has issued the company patent number US 8,162,859, titled “Shock Wave Treatment Device and Method of Use”. The patent relates to a side firing, sterile, disposable, hand held probe used in the direct application of shock waves to Ischemic Heart Tissue. TRT, with its cardiology affiliate Cardio Regeneration Technologies (CRT), is the first company worldwide to apply shock waves directly to the human heart. After exhaustive animal studies to establish safety, 10 patients with scarred heart tissue, post-heart attack, were treated with the patented device at the University of Vienna. After treatment, there was strong statistically significant evidence proving substantially improved heart function and quality of life measures. Phase II Trials are now scheduled to begin at the University of Innsbruck, Innsbruck, Austria.
SoftWaves™, defined as unfocused or defocused acoustic shock waves, deliver high energy acoustic shock waves to any pathologic tissue. After treatment, there is clear compelling evidence that Softwave’s™ stimulate a neovascular response, as well as stem cell recruitment and activation, growth factor production, anti-inflammatory properties, and the reduction of apoptosis. Together, these factors stimulate Tissue Regeneration, accelerating wound repair with healthy original tissue versus older technologies that result in scarring and avascular tissue. Contrary to competitors’ painful, high energy focused, shock wave technology; unfocused SoftWave™ therapy has better therapeutic results and does not require anesthesia. TRT’s SoftWave™ technology has a clear competitive advantage for patients, payers, and physicians over the current standard of care by producing better therapeutic outcomes faster, through a noninvasive intervention, at substantial cost savings.
About Tissue Regeneration Technologies
Tissue Regeneration Technologies is the leader in shock wave therapies for indications that benefit from the proven biologic response of shock waves. TRT’s clear advantage over competitors in the shock wave industry is TRT’s dominant patent portfolio for unfocused SoftWave™ technology.
Additional advantages for TRT include time to market, management team experience, internationally approved products and distributors, relationships within the shock wave community, and a multiple of modern device platforms for different indications.
TRT has FDA 510K approval for its premier kidney lithotripter, the LithoGold™ and successfully markets this device. Additionally, TRT has submitted a Premarket Approval Application (PMA) to the FDA for its orthopaedic device, the OrthoGold™, for the indication of non healing fractures. Also, TRT is engaged in a PMA study for its wound care device, the DermaGold™, at Walter Reed Army Medical Center, through a Congressional Appropriation.
TRT is actively seeking strategic partners and investors to propel this amazing technology forward and to establish SoftWave™ therapy as the new standard of care in wound care, cardiology, and orthopedics.