The world of medicine is a bloody place, with surgical and trauma patients 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. 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 approaching $7 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. This reality is opening the door to the search for new and better-performing hemostatic products.
Among the contenders in this area is Arch Therapeutics, Inc., a Wellesley, MA-based medical device company. 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 designed to achieve hemostasis in minimally invasive and open surgical procedures.
The time to hemostasis with AC5 is measured so far in a matter of seconds—rather than several minutes as provided by much of the competition. AC5 has also been 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, it can be ideal for use in the 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,” says Terrence W. Norchi, M.D., the President and CEO of Arch Therapeutics. “During the healing process, AC5 is absorbed. We believe 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. As an entrant in the field of ‘stasis and barrier applications,’ we believe it will be a strong contender.”