AC5 Topical Hemostatic Device achieves study endpoints
The first clinical study of the AC5 Topical Hemostatic Device from Arch Therapeutics Inc. (Framingham, Mass.) for skin lesions with bleeding wounds was found safe throughout the surgical procedure and up to 30-days postoperatively. Performance as assessed by time to hemostasis was also 41% faster than standard care.
“This hemostatic device is one of a set of products we are developing based on our self-assembling peptide technology,” says company president and CEO Terrence W. Norchi, M.D., in an interview with Cosmetic Surgery Times. “We believe these products have the potential to make a difference in patient care, leading to better outcomes while being a valuable tool in the surgeon’s or healthcare provider’s toolbox.”
Dr. Norchi explains that when the hemostatic device’s self-assembling peptide is exposed to a highly charged environment, such as a wound or salt water, “the interactions among and between the peptide’s amino acid side chains and that environment lead the peptide to assemble into a physical mechanical barrier. You typically can see the liquid become more gel-like at that time. This is a very different mechanism of action compared to other successfully commercialized products and we believe it will help make a difference for patients.”
The European 46-patient study included 10 patients who were on antiplatelet monotherapy. All patients had bleeding wounds from excision of at least two skin lesions under local anesthetic in the same setting.
“The trial was designed to focus primarily on safety because this is very important both for us and for the regulatory authorities,” Dr. Norchi says. “In fact, especially in the European Union (EU), one can argue that showing safety matters even more than efficacy in order to be allowed to sell a product.”
Arch Therapeutics expects to launch the AC5 Topical Hemostatic Device in Europe next year.
“In the near future, we hope to see data that show hematoma and seroma formation is lessened,” Dr. Norchi says. “We further anticipate that tissues will heal normally, even in patients who have underlying diseases such as diabetes. Thus, if all goes well, the patient’s outcome will be improved with less bruising — which are both cosmetically and medically troubling — along with less scar formation and normal healing. That would be a wonderful outcome.”
Apart from hemostasis, potential applications for the technology include sealants and prevention of surgical adhesions, gastrointestinal bleeding (peptic ulcers) and bleeding from antithrombotic medications (blood thinners). Wound care applications are also promising, such as hard-to-heal ulcers (pressure ulcers and diabetic foot ulcers), plus specialty applications like central nervous system surgery, burn care and plastic surgery.
“Patients who are having biopsies or skin procedures that leave them prone to bruising, hematomas and seromas, could potentially benefit as well,” Dr. Norchi says.