Research Project
8396428
DESCRIPTION (provided by applicant): The goal of this STTR project is to develop a pre-formed, naturally-based hydrogel postoperative adhesion barrier with improved handling characteristics, laparoscopic deliverability, and consistent efficacy. Our technology is based on a novel, patented process that imparts exceptional elasticity and toughness on normally brittle, weak materials. Postoperative adhesions carry a profound public health burden. An annual $3.45 billion (US) is spent in hospitalization costs associated with adhesion-related complications. Despite tremendous efforts to resolve this unwanted scar formation there exists no consistently efficacious and safe solution. To meet the criteria of an ideal adhesion barrier and to overcome current anti-adhesion technology limitations, we propose a pre-formed barrier that exhibits exceptional handling properties and improved anti- adhesive effectiveness. Our membrane consists of hyaluronic acid (HA) and alginate, natural polysaccharides well established for wound healing and anti-adhesion. HA-based anti-adhesion barriers have been FDA-regulated for over 14 years. HA is metabolized following enzymatic degradation, and with non-toxic modification, degradation rate can be tuned. Alginate-based wound dressings have been FDA- regulated for over 20 years. Alginate is quickly hydrolyzed with subsequent renal clearance. Our films utilize a novel, patented processing technology developed in our lab that enables mechanical properties such as elasticity and improved toughness in otherwise weak materials. This simple processing method does not require specialized or expensive equipment, toxic components, and is easily scaled up. In Phase I, we will optimize our anti-adhesive membrane for handling properties and degradation tunability, and perform a pilot safety and efficacy study. The goal of these tests will be to a) understand the basic science supporting the mechanical behavior from pre-implanted membrane to fully-bioabsorbed, and b) ensure feasibility of safe and effective adhesion prevention. In Phase II, we will to prepare our technology for commercialization by addressing product development, regulatory, and other clinically relevant issues. These issues include shelf-life stability, in vivo degradation rate, tisue adherence timing, healing mechanism for prevention, localized anti-adhesive efficacy, and secondary indication of use. Finally, we will outsource specific biocompatibility assessment per FDA guidance and International Organization for Standardization (ISO) 10993 standards. At the end of the Phase II program we will have developed and manufactured a final product and will have accomplished all prerequisites to initiate first in human trials. PUBLIC HEALTH RELEVANCE: The goal of this program is to develop a postoperative adhesion barrier with improved handling characteristics, laparoscopic deliverability, and consistent efficacy. The problem we address is that of post-surgical adhesions. Patients undergoing surgery have an 80% risk of developing post-surgical adhesions. Adhesions are a result of the body's natural healing process causing one or more tissues to tether to other tissues that should remain separate and freely glide past one another. $3.4 Billion dollars were spent in 2008 on hospitalizations for adhesion related illnesses annually in the US alone. The current clinical barrier options, including Genzyme's Seprafilm(R) (the leading product on the market), do not adequately address the profound public health burden that results from postoperative adhesions. Our proposed material is composed of alginate and hyaluronic acid, which are already used clinically, thus making them excellent candidate biomaterials for ultimate clinical utility. Our unique patented in situ crystallization process results in a robust, elastic, conformable and bioresorbable membrane. Ultimately, our solution will result in a significant decline in readmission for adhesion related illness, pain, suffering, reoperations, and the potential multimillion or billion dollar savings.
