WELLESLEY, Mass.—How big a problem is bleeding during surgery? According to Arch Therapeutics Inc. CEO and Founder Dr. Terrence Norchi, it can lead to morbidity, suffering and death, of course, but putting things in even more context, he added that 30 to 50 percent of the time a surgeon spends on a patient can involve the controlling of bleeding.
“Bleeding during surgery stresses organs, compromises the surgeon’s visual field, slows down operating room time and requires the use of other materials or transfusions that can lead to infections, sepsis and less-than-optimal immune responses,” Norchi tells DDNews. “Current products on the market have not kept up with the need.”
The AC5 Surgical Hemostat Device, developed by Arch Therapeutics, “stops bleeding promptly, conforms to irregular wound geometry, allows for normal healing and helps maintain a clear field of vision,” according to the company website. An independent third-party research group garnered positive data from a preclinical study assessing the use of AC5 in animals treated with therapeutic doses of the antiplatelet medications Plavix (clopidogrel) and aspirin alone and in combination.
The results of the study, which was sponsored by Arch, support the ability of AC5 to achieve rapid hemostasis in living animals treated with commonly used and prescribed antiplatelet medications. The research was led by Dr. Rudolf Urbanics and Dr. Domokos Csukas at Semmelweis University Faculty of Medicine in Budapest, Hungary, within the Department of Surgical Research and Techniques. The research team also included Dr. Ellis-Behnke, director of the Nanomedicine Translational Think Tank in the Department of Ophthalmology at the Medical Faculty Mannheim of the University of Heidelberg. Ellis-Behnke is also affiliated with three U.S. academic institutions, and he is an advisor to and co-founder of Arch.
The results are consistent with data from two previous preclinical studies, in which AC5 quickly stopped bleeding from surgical wounds in rats following treatment with clinically relevant doses of the anticoagulant medication heparin. Antiplatelet and anticoagulant medications are commonly referred to as blood thinners. Even if the patient is not on one of the drugs, the bleeding stops promptly, according to Norchi.
Physicians, industry and patients need a universal sealant for the challenges presented when an opening is created in the body, whether via surgery, trauma, colonoscopy biopsy, device implantation or in consumer settings, according to Norchi. The surgeon must manage and preferably prevent bleeding and leakage, as well as other challenges. Currently available tools to resolving these problems are often inadequate, Norchi noted. Arch intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue.
The company’s solution controls the movement of bodily substances. The AC5 Surgical Hemostatic Device is designed to achieve hemostasis in minimally invasive (laparoscopic) and open surgical procedures. Because it is not sticky or glue-like, it is ideal for use in the laparoscopic setting—a challenge for much of the competition, according to Norchi. Furthermore, it is transparent, enabling a surgeon to operate through it in order to prophylactically stop bleeding as it starts.
As Norchi explained in an interview in Megagadgets, “AC5 is a synthetic peptide comprising amino acids that exist in nature, but which are not sourced from animals. When squirted or sprayed onto a wound, the clear, transparent liquid promptly intercalates into the nooks and crannies of the connective tissue where it self-assembles itself into a lattice-like gel—a physical structure that provides a barrier to leaking substances. The time to hemostasis with AC5 based on animal testing to date is measured in a matter of seconds—typically in less than 15 or 30 seconds—rather than several minutes, as provided by much of the competition.”
There is huge commercial potential for AC5, according to Norchi. Revenues in the hemostasis market in 2013 were $4.6 billion, meaning that they are probably upwards of $5 billion for 2014. “The market is growing at a 10-percent clip, so it could take off even faster with better products,” he added.
Arch anticipates taking the product to the European market first, hoping for a 2015 launch date. Hopefully, it will then be approved in the U.S. market and regulated as a medical device, he said.