Biorubber (PGS) : evaluation of a novel biodegradable elastomer

Abstract

Poly(glycerol sebacate) (PGS), or biorubber, is a tough, biodegradable elastomer made from biocompatible monomers. The material was designed, synthesized and characterized in the Department of Chemical Engineering at MIT. Its main features are good mechanical properties, rubberlike elasticity and surface erosion biodegradation. PGS was proved to have similar in vitro and in vivo biocompatibility to PLGA, poly(L-lactic-co-glycolic acid), a widely used biodegradable polymer. PGS has been tested for use as nerve guide material and to fabricate artificial capillary networks for tissue engineering applications, both yielding promising results. Currently, the PGS research group continues to develop the material and to seek applications to maximize market potential and impact in the medical field, i.e. stenting (cardiovascular and non-vascular) and tissue engineering (cardiovascular and musculoskeletal). These markets were estimated at $5 billion dollars [1] and potentially over $10 billion dollars [2], respectively in the U.S. for 2004. Another promising field involves drug delivery, particularly in combination devices like drug-eluting stents. The potential non-medical applications are biodegradable rubbish bags, the absorbent material used in sanitary napkins or diapers, and even fishing lure or chewing gum.

(cont.) MIT submitted a patent application for PGS titled "Biodegradable Polymer": US2003/0118692 Al. The patent strongly presents the quality of the technology, protects methods for synthesizing the material and supports several products made from or with it; thus rendering large market potential for PGS. A patent search compares the PGS patent to intellectual property for other competing biodegradable elastomers; mainly to polymers developed by Ameer et al. in Northwestern University, using citric acid (PDC and POC) and similar to PGS in mechanical properties, elasticity and degradation mechanism. The recommended business model is to pursue development through NIH grants within MIT collaborating with Northwestern University. A joint venture for both materials can lead to founding a medical device start-up funded by SBIR grants or the Deshpande Center at MIT. After pre-clinical trials, the company may be offered for sale to larger players, i.e. Johnson & Johnson or Boston Scientific for stenting; and Genzyme, Advanced Tissue Science, or other upcoming companies focused on tissue engineering.