The Framingham, Mass.-based company’s AC5 surgical and topical hemostatic devices are being designed using a self-assembling materials technology platform, seeking to improve hemostasis during surgical, wound and interventional care.
“Our anticipated 510(k) filing focusing on external skin applications should present a nearer-term opportunity for AC5, compared to the company’s prior plan of filing a Premarket Approval Application for all uses in the United States. We anticipate that the potential benefit from an earlier 510(k) filing is significant in terms of business opportunity and technology validation, and consequently, we have concentrated some internal resources to focus on this objective. Our intent to file a PMA for internal use after completing related human clinical work remains intact,” CEO Dr. Terrence Norchi said in a press release.
Arch Therapeutics said it is maintaining guidance on its CE Mark submission, hoping to file it for the topical version of the device “as soon as possible,” according to the press release. The regulatory submissions this year will be the company’s 1st.
The company completed the 1st-in human study of its novel AC5 topical hemostatic device last August, touting that study primary objectives were met with no serious adverse events and safety outcomes similar between the AC5 and control groups.
The study aimed to evaluate the safety and performance of the AC5 in patients undergoing excision of skin lesions on the trunk or upper limbs, with a primary endpoint of safety throughout the surgical procedure through 30-days.