Framingham, Mass.-based Arch, which won approval for the randomized, controlled, single-blind study last December, said the 46-patient trial will include a 10-subject arm who are taking blood thinners. Each patient will have at least 2 lesions removed, with 1 wound treated using the AC5 hemostat and the 2nd with a control treatment. Arch bills AC5 as designed to stop bleeding in seconds, rather than minutes, and conform to wound geometries while staying transparent, without the stickiness of other hemostats that makes them a challenge to use in laparoscopic procedures.
Endpoints in the trial include time to hemostasis and product-related adverse effects at 30 days, with follow-up at 7 days and 30 days post-procedure. Data from the trial are slated to drop within 2 quarters, Arch said.
The endpoints include product related adverse effects and time to hemostasis. Follow-up assessments of patients are planned for seven and 30 days following the procedure. As previously stated, data are projected to be available within two quarters of the start of the trial.
“The start of this trial marks a major milestone for the company. It is firmly underway with patients being actively screened, enrolled, and treated or scheduled for treatment. Our team has put in tremendous effort to get us to this point and we are pleased with this progress,” president & CEO Dr. Terrence Norchi said in prepared remarks. “This clinical trial is a key component of our commercialization plan, representing the first time that AC5 has been used on humans in a surgical setting. Further, it highlights that Arch has completed a number of important achievements that are required before a patient could be treated with AC5. As we are getting closer to bringing AC5 to market, we continue to advance our pre-clinical work and clinical-regulatory planning for additional indications for AC5 and other products, in each case with the ultimate goal of making a difference in patients’ lives.”