SoftWave TRT Affiliate Study Featured in Prominent Medical Journal

2024-06-27

ALPHARETTA, Ga., June 27, 2024 /PRNewswire/ -- Cardiac shockwave therapy leads to the regeneration of heart tissue after coronary bypass surgery, a study published in the prominent European Heart Journal showed. The study is co-authored by SoftWave TRT Medical Director Dr. Wolfgang Schaden, one of the original founders of the shockwave industry and pioneer of the regenerative applications of shockwaves.

"I would not have expected that I could get old enough to really see this happen, because there were so many obstacles over the years," Dr. Schaden told BBC News in a medical report about the study. "Johannes (Holfeld), in my eyes, he's a hero."

The study led by Dr. Johannes Holfeld from the Medical University of Innsbruck in Austria performed an interim analysis after enrolling 63 patients suffering from ischemic heart failure. All of the patients required surgical intervention and were given shockwave treatment during surgery after the bypass was established. Half of the patients in the study were put in a control group and given a sham treatment while the other half were given cardiac shockwave therapy. The patients given the shockwave treatment showed significant improvement in left ventricular ejection fraction (LVEF) as early as six months after the procedure. After a year, the LVEF improvement measured 11.3% in the shockwave patients, compared to an LVEF improvement of 6.3% for the sham group of patients. Such changes in LVEF are known to cause significant improvements in survival and reductions in heart failure hospitalizations. In addition, the shockwave patients were also able to walk significantly farther and reported a higher quality of life. Some patients who required assistance with everyday activities were able to again take care of themselves.

Due to the results of the research, the study was terminated in agreement with the ethics committee as it was determined to be unethical to withhold the cardiac shockwave treatment from the sham group of patients.

"To be able to improve a patient's ejection fraction 36% with a single shockwave treatment not only revolutionizes the treatment for ischemic heart disease but lays the foundation for the repair or regeneration of other organs as well," said SoftWave TRT founder John Warlick. "We applaud Heart Regeneration Technologies, Dr. Holfeld, and his team of authors and researchers for completing this herculean task and finishing the work we started over a decade ago to prove our patented technology can reanimate hibernating myocardium. We were excited to see the results of this extensive study and look forward to continuing our support for these pioneering researchers."

More than a decade ago, SoftWave TRT's cardiology subsidiary CRT performed large and small animal trials and treated 10 cardiac patients with shockwave therapy using its patented cardio applicator and device interface. These early results provided the foundation for the clinical trial published in the European Heart Journal that was based on SoftWave TRT's patented technology.

"This publication by Dr. Holfeld and his team is the culmination of over a decade of painstaking scientific research that has been subjected to the rigorous rules of medical research," stated reconstructive surgeon and former Chief of Surgery at Piedmont Atlanta Hospital, Dr. John David Mullins. "As the effects of shockwaves on soft tissue are scientifically explained, the possibilities are far reaching."

Dr. Mullins, the U.S.-based Medical Director for SoftWave TRT, is a leader in the use of SoftWave Therapy for surgical and wound care applications in the U.S. He added, "Clinical observations have been made since the mid-1980s, but this well-designed and executed study is now in publication for critical analysis."

"It's the most earth-shaking science I've ever seen in cardiac reanimation. The results are incredible and Dr. Holfeld is a remarkable scientist," said Dr. David Dean, former Director of the Samsky Advanced Heart Failure Center at Piedmont Heart Institute. "This is one of the greatest results of the 21st century for people living with heart disease."

"Heart disease is the number one cause of death worldwide and this trial offers hope to these long-suffering patients limited in their day-to-day lives. Up until now, no technology has been proven to improve a patient's ejection fraction enough to make a difference in their daily lives," stated Warlick. "Other therapies are utilized primarily to prevent a patient's further deterioration. This publication is a real difference maker, and our investors who have already committed over $10 million to this project should be proud that their efforts have finally been published in a high-level journal. These are the BEST results ever published for the ischemic heart including all stem cell studies."

Reference list

European Heart Journal (2024, June 20). Cardiac shockwave therapy in addition to coronary bypass surgery improves myocardial function in ischaemic heart failure: the CAST-HF trial | European Heart Journal | Oxford Academic (oup.com)

BBC News (2024, June 20). 'Space hairdryer' regenerates heart tissue in study (bbc.com)

About SoftWave Tissue Regeneration Technologies

SoftWave TRT, a Alpharetta, GA-based company, has been at the forefront of extracorporeal shockwave therapy (ESWT) since its inception in 2004. With a reputation for German engineering excellence, SoftWave is trusted by leading medical research centers in the United States and around the globe. The efficacy of the company's technology is backed by hundreds of published studies. SoftWave's devices have received FDA 510(k) clearance for connective tissue activation, chronic diabetic foot ulcer treatment, acute second-degree burn management, pain reduction, and improved blood supply.

SOURCE SoftWave TRT