Aroa Biosurgery reports their wound care products, the 8.5 by 6-inch device has been launched in the US and Canadian markets, following its recent approval for reimbursement within the U.S. healthcare system.
The flexible and transparent graphene-based biosensor enables doctors and nurses to provide hyper-responsive treatment of chronic wounds.
The solution is an extension of Healthy.io's clinical-grade color recognition products in use by tens of thousands of people worldwide and helps healthcare professionals objectively assess chronic wounds and track their progress over time through a repeatable process. The solution was successfully registered with the U.S. Food and Drug Administration (FDA) in December 2019.
The successful first case was performed by Mark Archie, MD, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, and Nina Bowens, MD, sub-investigator for the PROMISE II trial at Harbor-UCLA Medical Center.
The Institutional Placement was managed by Bell Potter as sole lead manager.
Results of its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial, successfully achieving all primary (P < 0.0001) and secondary endpoints with very low rates of major amputation and all-cause death.
Dr Olufemi Oshin, Consultant Vascular Surgeon, Clinical Director, Clinical Operations Royal Perth Bentley Hospital Group says, "The foot and leg ulcers that can develop with diabetes are hard to treat without regular assessments and tracking the patient's care. Silhouette enables us to much more accurately track wound healing progress and deliver community based care; something that is extremely important to the Aboriginal population. With Silhouette we are aiming to reduce the serious implications of diabetes, such as amputations, and really improve the quality of life for people with diabetes across Western Australia."
PROMISE II is a multi-center, prospective, single-arm study to be conducted in the U.S. and Japan. Using an adaptive statistical design, the study plans to enroll 60 to 120 “no option” CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, and subjects will be followed out to three years. The “no option” patients who are candidates for the PROMISE II study are no longer eligible for conventional endovascular or surgical therapy for CLTI, as determined by an independent physician committee.