Arch Therapeutics' AC5(TM) Compared Favorably vs. Commercially Available Combination Hemostat in Animal Study
Data Shows Time to Hemostasis With AC5 Significantly Less Than Compared Product
FRAMINGHAM, MA--(Marketwired - Apr 16, 2015) - Arch Therapeutics, Inc. (
In this study, full thickness penetrating wounds were surgically created in rat livers, which are highly vascularized parenchymal organs, and then either AC5™ or gelatin-thrombin hemostat was applied in order to stop the bleeding. The time to hemostasis (TTH), which is the time required to stop bleeding, was measured.
The average TTH after application of AC5 was significantly less than 30 seconds, whereas the average TTH after application of the gelatin-thrombin hemostat was over 200% longer.
AC5 was maintained at room temperature without requiring cold storage, whereas the thrombin component of the gelatin-thrombin hemostat was maintained frozen during storage, in accordance with its prescribing directions. This is a common constraint of many commercial hemostatic agents that are derived from blood-products. Such products also require a multi-step preparation procedure prior to use.
The thrombin component of the gelatin-thrombin hemostat is made from pooled human plasma and, therefore, carries a risk of transmitting infectious agents. In general, products of human origin present increased risk due to the potential to transfer infections. The gelatin component of the gelatin-thrombin hemostat is derived from pigskins. Gelatin can carry an increased specific risk for causing allergic reactions in some patients because it is animal sourced. AC5 contains a self-assembling peptide comprising naturally occurring amino acids that are not sourced from humans or animals.
The study group intends to submit the data for publication, at which time additional details would be made publicly available. This study is one of series of animal trials comparing AC5 with currently marketed hemostatic products that are used in surgical procedures.
Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, "We believe that the Arch technology holds great potential in addressing a range of unmet clinical needs, the first of which is surgical hemostasis. Data from the studies conducted to date indicate that AC5 continues to perform favorably versus well-established hemostatic products, including those based on cellulose, gelatin, gelatin-thrombin, and fibrin. Other noteworthy features of AC5 include ease of use, simple preparation, room temperature storage and lack of human or other animal sourcing."
The research was led by Rudolf Urbanics, MD, PhD, and Domokos Csukas, DVM at Semmelweis University Faculty of Medicine in Budapest, Hungary within the Department of Surgical Research and Techniques. The research was sponsored by Arch. Also part of the research team was Dr. Rutledge Ellis-Behnke, Director of the Nanomedicine Translational Think Tank in the Department of Ophthalmology at the Medical Faculty Mannheim of the University of Heidelberg in Germany. Dr. Ellis-Behnke is also affiliated with three U.S. academic institutions, and he is an advisor to and co-founder of Arch.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. 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 ™, is being designed to achieve hemostasis in minimally invasive and open surgical procedures.
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On Behalf of the Board,
Terrence W. Norchi, MD
Arch Therapeutics, Inc.
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Arch Therapeutics, Inc.