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Arch Therapeutics Seals The Deal On Strong Trial Data For Its AC5 Hemostatic Device
Summary
AC5 provides statistically significant data for safety and efficacy.
The AC5 sealant can be a revolutionary treatment for wound and incision sealing.
The company will quickly progress on its AC5 CE mark application.
With safety and efficacy proven, bolstered by statistical significance, the company can seek partnership and/or license deals.
Arch Therapeutics ( OTCQB:ARTH ) reported on August 15, 2016 the results from its first "in human" trial of its AC5 Topical Hemostatic Device. The company reported that the study met both its primary and secondary endpoints, with a statistically significant p<.001 value using the Wilcoxin signed rank test. The p-value represents a strong indication for future positive results, based on the Wilcoxin model, which suggests that a p-value of less than .05 is representative that the likelihood of known results happening by chance is less than five percent. The p<.001, ranked to the AC5 trial, indicates that the results demonstrated by the AC5 had less than a one-tenth of one percent chance of happening as a random occurrence.
The company successfully completed its first primary endpoint, which was the overall safety of the device throughout the surgical procedure, and also included a 30-day patient follow up period once the procedure was completed. The first primary endpoint was successful with regard to overall safety, with no patients reporting any adverse side effects or responses. The AC5 was compared against an untreated and placebo based control group and showed no discernible difference in safety or adverse events.
The secondary endpoint assessed the performance of the AC5 device by time to hemostasis, which is the stopping of the flow of blood. The company reported that the median time to hemostasis of wounds treated with the AC5 performed 41% faster than patients that were in a control group and not treated with the AC5 device. The p-value assigned by the Wilcoxin signed rank test was p<.001, a robust and statistically significant score.