Market for Hemostatic Agents Drives Quest for Innovation

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By Terrence W. Norchi, MD

Surgical and trauma patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluids. Approximately 114 million surgical and procedure-based wounds are now made annually worldwide, including 36 million from surgery in the U.S. alone, according to a 2012 report from MedMarket Diligence, LLC. With these numbers rising, so is the need for better sealants and hemostatic agents to stop bleeding as quickly as possible. Such products are forecast to produce global combined sales surpassing $6.5 billion in 2017.

Unfortunately, the best currently available hemostatic products possess various limitations, ranging from high cost—upwards of $500 per application for some products—to slow onset of action, unreliability and risk for adverse effects, including healing problems, adhesion formation and infection. Although surgical techniques, instrumentation and technology have made tremendous strides over the last couple of decades, the majority of hemostatic agents and sealants haven’t kept up. Surveys of surgeons have affirmed the need for products that will work within one minute (preferably 15 to 30 seconds) and remain effective while the underlying wound is healing. This reality is opening the door to the search for new and better-performing hemostatic products.

This search is being driven by the quest for new hemostatic agents that are laparoscopic-friendly, simple to prepare and simple to store. In addition, surgeons need new hemostatic agents that are easily handled, transparent, flowable, nontoxic and that enable normal healing. 

There are several categories in which the development of new hemostatic agents could be pursued. These include fibrin/thrombin; cellulose/collagen/gelatin; certain polymer hydrogels; and dessicants/concentrators. Of peripheral interest are products based on cyanoacrylates and polyethylene glycol. Each of these categories is represented by several products currently on the market, but each also presents its own set of drawbacks. For example, many products involving fibrin/thrombin (including Tisseel, Evicel, Thrombin-JMI, and Floseal, as well as products that may be combined with thrombin such as SurgiFoam and Avitene) can present unreliable or slow onset of action, may be difficult to use and prepare, and might require an intact clotting cascade. Meanwhile, products involving cellulose (such as Surgicel and others) and certain polymer hydrogels may involve poor adhesion and clotting. And products in the dessicant/concentrator category, such as Perclot and QuikClot, must be kept dry and require removal.

My company, Arch Therapeutics, Inc., is taking an alternative approach. Focusing on the rapid cessation of bleeding and control of fluid leakage during surgery and trauma care, the company is creating its first product, AC5 Surgical Hemostatic Device™. Currently in preclinical development, AC5™ is being designed to achieve hemostasis in laparoscopic and open surgical procedures.

The time to hemostasis with AC5 is measured so far in a matter of seconds—typically in under 15 or 30 seconds—rather than several minutes as provided by much of the competition. AC5 is also being designed to conform to irregular wound geometry, to allow for normal healing and to help maintain a clear field of vision in the wound area during the surgical procedure. Because it is transparent and neither sticky nor glue-like, evidence supports that it can be ideal for use in the laparoscopic or minimally invasive surgical setting.  

AC5 is a synthetic peptide comprising naturally occurring amino acids that 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. 

AC5 is designed to quickly stop bleeding with rapid onset of hemostasis, and it may also allow surgeons to safely operate through the resulting protective barrier. During the healing process, AC5 is absorbed. Physicians, patients and the industry could one day benefit greatly from such a product when wounds are created in the body, whether via surgery, trauma, colonoscopy biopsy, device implantation or in a variety of consumer settings. 

The development and commercialization of AC5 was initially proposed by Rutledge Ellis-Behnke, PhD, who discovered the hemostatic and other barrier properties of self-assembling peptides that could make future surgery and interventional care faster and safer.  

As an entrant in the field of “stasis and barrier applications,” AC5 could be a strong contender.

Terrence W. Norchi, MD is the President and CEO of Arch Therapeutics, a life sciences company and developer of the AC5 Surgical Hemostatic Device™, a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care.