ChitogenX Inc (CSE:CHGX), which was formally known as Ortho Regenerative Technologies, announced its decision to pursue sales of medical grade chitosan as a new near-term commercial revenue initiative following the completion of an internal commercial and regulatory readiness process.
The Montreal-based regenerative medicine company focused on the development of novel soft tissue repair regenerative technologies, noted that the global market for medical grade chitosan is currently pegged at around $250 million a year, and forecasted to double over the next seven years.
"ChitogenX has spent years and significant financial resources developing a unique and proprietary chitosan/platelet-rich plasma (PRP) formulation to increase the healing rates of soft tissues,” ChitogenX CEO Philippe Deschamps said in a statement.
“Now that we have at our disposal a low cost optimized GMP manufacturing process for the chitosan portion of our ORTHO-R product, industry leading 3-year shelf life as well as recently filed patent applications, we are ready to pursue additional commercial initiatives such as the sale of medical grade chitosan," he added.
Chitosan nanoparticles on their own can be used as antibacterial and antimicrobial agents and gene delivery agents. The company added that chitosan nanoparticles can also be used for skin regeneration.
Moreover, these types of nanoparticles can also be used in drug delivery systems to treat cancer cells. Since chitosan is positively charged, it can attract negatively charged mucus and serve as an excellent carrier for mucosal adhesive drugs, explained the company.
As a generally-recognized-as-safe (GRAS) biomaterial in the US and Europe, the sale of medical grade chitosan is not subjected to the same stringent regulatory approval pathway applicable to drugs and or biologics, noted the company.
Furthermore, ChitogenX recently completed a stability study confirming three years of shelf life for its proprietary chitosan formulation, which is a characteristic that would be well received by the biomedical industry.
"This new revenue generation initiative is just one of the additional pathways the company is currently investigating to leverage its expanded clinical and commercial opportunities".
The company is working on the clinical development of its RESTORE technology platform, a muco-adhesive chitosan-based biopolymer matrix, designed to deliver biologics such as platelet-rich plasma or bone marrow aspirate concentrate (BMAC), to help healing in musculoskeletal conditions.
ORTHO-R, the firm’s lead chitosan-PRP hybrid biologic implant combo product, is aimed at increasing the healing rates of sports-related injuries to tendons, ligaments, and cartilage such as the meniscus. ORTHO-R is currently part of an ongoing US Phase I/II clinical trial for rotator cuff tear repair in 10 US clinical centers.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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