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If cleared, dermatologists might find the technology useful when excising lesions in patients on blood thinners and more.
Dr. NorchiArch Therapeutics has announced that the company plans a 510(k) filing approximately mid-2017 with the FDA focused on external skin applications for its AC5 Topical Hemostatic Device.
In the technology’s first study in humans, researchers at a single center compared AC5 to placebo applied to skin wounds of 46 patients undergoing excisions of lesions on their trunks and upper limbs. AC5 met safety outcomes. But researchers also noted the median time to hemostasis of wounds in the AC5 treatment group was 41% faster than among controls, and wounds healed satisfactorily in both groups.
“Ten of the 46 patients in the trial were on an antiplatelet drug, and those patients tend to bleed a lot. In this case, not only did they heal equally well, but the bleeding stopped equally quickly for AC5-treated wounds in the patients on antiplatelet therapy,” says Terrence W. Norchi, M.D., president and CEO of Arch Therapeutics and once a practicing internist.
While Dr. Norchi says the results are not yet published and he can’t share specifics from the trial, he did share that the time to hemostasis for the AC5-treated wounds was less than 30 seconds.
“… and that was the case for the group of patients overall and also for the separate group of patients who were on the blood thinners. Whereas, for the patients who were on the blood thinner, the time to stop bleeding for the control wounds was well over two times longer,” he says.
Dr. Norchi describes the technology as a self-assembling peptide platform. The liquid is a little thicker than water, is clear and not sticky.
“If you would get down to the microscopic level … you’d see these peptides floating around in water, occasionally entangling and disentangling. But if you take that and squirt it onto a wound-a bleeding wound or really any wound-what happens is they go from these fibers that are moving around minding their own business to being entangled into this dense nanofiber network that would have the appearance of almost steel wool at the microscopic level. The liquid becomes more like a gel and gets itself into the nooks and crannies of the connective tissue and mitigates a lot of the bad things we try to stop-the bleeding and leaking,” Dr. Norchi says.
That’s because the wound is a highly charged environment and charges cause the assembly, he says.
Arch Therapeutics, according to Dr. Norchi, first targeted the area of bleeding for its research and development focus because bleeding is a well-walked regulatory path. The company is working on commercializing the product in Europe and plans to file a 510(k) in the US in mid 2017, addressing external applications first in both jurisdictions.
“It’s going to be up to the FDA to decide on a label. What we would hope for is for a very broad label that on the mild end of the spectrum covers minor cuts and abrasions and on a more complicated end of the spectrum can cover surgical lesions …, chronic cutaneous ulcers (including hard-to-heal ulcers like pressure ulcers), and everything in between,” he says. “We’re also doing preclinical work on some other applications, with specific work in burns and specific work in diabetic foot ulcers.”
The hope, according to Dr. Norchi, is that AC5 will be available to dermatologists and others next year.
Disclosure: Dr. Norchi is president and CEO of Arch Therapeutics.