mixed second degree burns

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

ALPHARETTA, Ga., June 24, 2024 /PRNewswire/ -- Veteran football analyst and three-time Super Bowl Champion Randy Cross has endured his share of injuries and pain in his career. "That's what professional sports is all about. Everybody gets hurt," he said of his 13 years playing for the San Francisco 49ers. Long retired from football, Cross, a resident of Alpharetta, Ga., found himself dealing with a new level of pain brought on by hip replacement surgery, knee surgery, and carpal tunnel syndrome. "I tore my quad tendon off my patella last June and, at the time, a friend called me and said you need to try SoftWave Tissue Regeneration Therapy. At the time, I said, 'I'll be alright, don't worry about it," Cross recalled. "Then, I did a hip replacement in October, a revision to my knee in January, and started to notice how fast my hip was recovering, but the quad tendon was not healing like I expected it to." Cross said he called his friend back and said, this time, he was going to give SoftWave TRT a try. "I wanted something to help me start feeling normal again. After the initial treatment, I got really good reactions on my knee as well as my hand where the carpal tunnel was causing three of my fingers to start going numb," said Cross. "I know SoftWave has made a huge difference on the flexibility of my knee. I can bend it all the way up and extend it, and I couldn't do any of that stuff before. My doctors were even talking about more surgery. Now, that is no longer necessary." SoftWave TRT is a patented shockwave device that uses a broad-focused, low-intensity, extracorporeal shockwave (Li-ESWT) to promote both a physical and biological response to improve healing. It is currently cleared by the FDA for the activation of connective tissue, treatment of chronic diabetic foot ulcers, treatment of acute second-degree burns, improvement of blood supply, and temporary pain relief. Cross said his wife is now using SoftWave TRT for back issues that have not been relieved by epidurals. "She's playing golf again. She loves it." "I'm actually in contact with people at UCLA and with the 49ers. I think this can give them a gigantic advantage and I know a lot of professional teams already use it," Cross said. "This device is going to get your body to heal itself the way it was intended to do." About SoftWave Tissue Regeneration Technologies Headquartered in Alpharetta, GA, SoftWave TRT is German engineered with superior quality. It is worldwide in the healthcare fields of orthopedics, traumatology, urology, wound care, and aesthetics. SoftWave is committed to the scientific advancement of tissue healing and regeneration and the development of the most effective innovations to improve the quality of lives globally. It is trusted and researched by the top major medical research centers in the U.S. and worldwide and is internationally recognized by the International Society for Medical Shockwave Technology (ISMST). SOURCE SoftWave TRT

[08-January-2024] First patient treated with AGLE-102 demonstrated 99% epithelialization in a deep second-degree burn within 7 days of receiving a single dose No evidence of burn wound conversion nor ischemia reperfusion injury as evidenced clinically and by laser doppler studies WOBURN, Mass. and MIAMI, Jan. 8, 2024 /PRNewswire/ -- Aegle Therapeutics Corp., a leader in the development of novel extracellular vesicle ("EV") therapies to treat rare and severe dermatological, including immuno-dermatological, conditions, today announced positive 12-week data for the first patient enrolled in a Phase 1/2a clinical trial of AGLE-102™ for the treatment of severe second-degree burns. The first patient was treated with a single topical dose of AGLE-102 within 48 hours of burn injury. The patient achieved 99% epithelialization of the burn wound and had a significant reduction in edema within seven days of treatment. Subsequent doses of AGLE-102 were not required. The patient had no evidence of ischemia reperfusion injury, as measured by Laser Doppler, one week post treatment, and no evidence of burn conversion was noted. Patient and Observer Scar Assessment Scale (POSAS) measurements showed significant improvement seven days post treatment and continued to improve over 12 weeks of follow-up. By day 90, the patient's POSAS score (which measures pain, itch, thickness, stiffness, color and irregularity) improved from a score of 40 at baseline to a score of 10 (6 being normal). No safety issues were reported. "We are very pleased with the first patient's results in this first-in-human trial of AGLE-102," said Shelley Hartman, Aegle's Chief Executive Officer. "This milestone highlights our commitment to advancing EV therapy as an important, novel, multi-faceted approach to treating rare and severe dermatological conditions." About AGLE-102TM AGLE-102 is an investigational product comprised of extracellular vesicles isolated from allogeneic stem cells using Aegle's proprietary and patented methods. The product is a composite of native EVs and their associated complex assemblies of biologic molecules such as proteins, peptides, ligands and nucleic acids that have the potential to induce a wide variety of effects in recipient cells, including reducing inflammation, modulating the immune system and promoting regenerative healing. About the Phase 1/2a Clinical Trial The phase I/2a trial, "A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds," is a prospective, single arm multi-center study designed to evaluate the safety and efficacy of applying AGLE-102 to deep second-degree burns. The program is being advanced for the discovery and development of allogeneic stem cell derived extracellular vesicle therapy that has the potential to offer patients reduced inflammation, accelerated regenerative healing (with minimal/no scarring) and prevention of burn conversion. More information on the phase 1/2a study (NCT05078385) is available at clinicaltrials.gov. About Aegle Therapeutics Corp. Aegle Therapeutics is a clinical-stage regenerative medicine biotechnology company developing novel EV therapies to treat rare and serious dermatological, including immuno-dermatological, disorders with significant unmet medical need. Aegle's proprietary platform technology safely isolates a broad composite of native EVs from stem cells. In addition to its phase 1/2a study in severe second-degree burns, Aegle's pipeline includes an anticipated launch of a phase 1/2a study in Q1 2024 evaluating AGLE-102 for the treatment of the rare disease epidermolysis bullosa and a preclinical program for graft vs. host disease. Aegle's EV therapy has the potential to treat a broad range of indications in multiple therapeutic areas in dermatology including inflammatory disorders, immune-based conditions and others. The anti-inflammatory and immune modulatory effects of Aegle's EV therapy also hold significant promise in the treatment of numerous other disorders in therapeutic areas outside of dermatology. For more information about Aegle Therapeutics, please visit . For More Information Contact: info@aegletherapeutics.com