AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction
“FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our RECELL System technology platform. We are pleased with the strong interest expressed by the clinical community in participating in this study and we look forward to working with physicians and their patients upon study commencement,” said Dr. Michael Perry, Chief Executive Officer of AVITA Medical.
Silverlon Antimicrobial Dressings Demonstrate Kill Rate of Candida Auris Superbug at 99.999% Reduction in 3 Hours
“Results from our testing indicate our silver-plated nylon dressings can quickly kill C. Auris,” said Amanda Budak, PhD, RN clinical director of Argentum Medical. “We are pleased that lab results show Silverlon to be an effective tool against this dangerous pathogen.”
The financing will further support MolecuLight's commercial expansion for the growing global demand for its MolecuLight i:X device.
The 26-week, single-arm, observational study included 16 patients treated at three hospitals in the United Kingdom, including Manchester Royal Infirmary, Kings College Hospital and Northwick Park Hospital.
The results of the study included the healing of all harvest sites and complete SkinTE graft take one week after SkinTE™ application
3/12/19: Namal Nawana, Chief Executive Officer, Smith & Nephew, said: “Greater presence in the fast growing regenerative medicine market enhances our portfolio and will help immediately accelerate our wound management business as well as provide longer term innovations in additional channels and indications. We sought out a fast growing portfolio with strong clinical evidence addressing critical needs in the marketplace.”
First Patient Successfully Treated in Pain Prevention Study Prior and Post-Surgical Debridement of Venous Leg Ulcers
2/19/19: Professor Keith Harding, Principal Investigator, Welsh Wound Innovation Centre, commented: “We are pleased to initiate this important study looking at mitigating pain for patients with venous leg ulcers. The first patient was successfully treated, allowing the wound to be fully debrided without any reported sensation or pain. Pain associated with venous leg ulcers is a significant unmet need and I am excited by the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in such wounds. I look forward to delivering the full data following completion of the clinical trial.”
Argentum Medical Leads the Way: Company Awarded $8.4M BARDA Contract for Silverlon Wound Technology to Prepare U.S. for Nuclear and Radiation Emergencies
1/24/19: Raul Brizuela is the president and CEO of Argentum Medical, a privately held company that has pioneered the company’s Silverlon antimicrobial wound-care technology. Dr. David Barillo, the principal investigator for the BARDA contract, is a burn and trauma surgeon and former chief of the U.S. Army Burn Flight Team, U.S. Army Institute of Surgical Research and U.S. Army Burn Center. He currently serves as Argentum’s medical director.