Arch Therapeutics Inc (OTCBB:ARTH) has transformed into one of the biggest volume movers on the entire OTC since rocketing up off its base at $0.40 making recent highs of $0.945. Since then ARTH saw a massive shakedown to mid $0.40s before taking off north again!
ARTH has been running since they announced they completed patient enrollment in the clinical study of AC5. Arch anticipates announcing the results from the study during summer 2016 after completion of a 30-day follow-up and subsequent statistical analysis. They also anticipate filing a CE mark application for AC5 during summer 2016 and is currently planning its next clinical-regulatory steps for both the EU and the US.
Arch Therapeutics Inc (OTCBB:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch’s flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device (TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures.
According to Arch, the Company intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue. Arch’s solution elegantly controls the movement of these fluids and substances.
Arch’s products are currently progressing in preclinical development. The first product, AC5 Surgical Hemostatic Device,™ is designed to achieve hemostasis in minimally invasive (laparoscopic**) and open surgical procedures.
AC5™ stops bleeding promptly. Unlike many competitive products, it conforms to irregular wound geometry, allows for normal healing, and helps maintain a clear field of vision directly into the wound area.
On June 6 ARTH announced it had completed patient enrollment in its first clinical study to assess the safety and performance of AC5 in humans. The study is being carried out in collaboration with CÚRAM, Science Foundation Ireland Centre for Research in Medical Devices and the Clinical Research Facility based at National University of Ireland Galway.
A total of 46 patients have been enrolled in this randomized controlled single-blind study, which is taking place in Ireland. The Company anticipates announcing the results from the study during summer 2016 after completion of the patient follow-up assessments (30-day) and subsequent statistical analysis. The endpoints include product-related adverse events and time to hemostasis. To date, no serious adverse events have been reported.
The current study design is intended to assess safety and performance of AC5 during the course of a dermatological procedure performed on the 46 patients, of whom 10 were taking an antiplatelet medication, such as aspirin, during the study period, and was designed so that neither the patients nor the clinical personnel performing the 30-day follow-up assessments would be aware of whether a particular lesion had been treated with AC5 or a control. Patients participating in the study had at least two dermatological lesions removed surgically, of which one was randomly assigned to be treated with AC5 and the other lesion assigned to be treated with a control treatment.
CEO of ARTH Terrence W. Norchi, MD stated “This is yet another milestone for Arch Therapeutics on the path toward regulatory approval of AC5. Now that the planned number of patients have been treated, we are awaiting completion of the remaining 30-day follow-up assessments. We are eager to obtain the data when the statistical analysis is available, and we look forward to reporting the results later this summer.”
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Currently trading at a $77 million market valuation ARTH has transformed into an explosive runner in recent weeks. Arch is an exciting story in small caps; they are the developer of the AC5 Surgical Hemostatic Device(TM) (“AC5(TM)”), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care and they have just completed patient enrollment in the clinical study of AC5 with results expected in summer 2016 which could be any day now. We will be updating on ARTH when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ARTH.
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Disclosure: we hold no position in ARTH either long or short and we have not been compensated for this article.