Lynch Biologics, LLC (“LBIO” or “the Company”) is a biotechnology company whose mission is to develop safe and effective therapies to promote wound healing. Its primary focus is treatment of DFUs. Other indications of interest include post amputation wounds (possible Orphan Drug), venous stasis ulcers, pressure ulcers (bed sores), surgical wounds, including plastic surgery wounds and other complex or poorly healing wounds, e.g. major trauma and burns. The CEO and Chairman of LBIO, Dr. Sam Lynch, has 25 years of experience in research and development centered on recombinant human platelet-derived growth factor (rhPDGF) in regenerative medicine. He founded and led his previous company, BioMimetic Therapeutics, Inc. (BMTI) successfully over a 12 year period from product concept, to pre-clinical development to large randomized controlled clinical trials to two FDA approved (both full PMAs) combination products based on rhPDGF-BB for healing of musculoskeletal tissues.
We propose to leverage the extensive therapeutic human use of rhPDGF-BB, including established recombinant expression systems, purification and analytical test methods, commercial lot release criteria, known stability profiles, non-clinical toxicology information, human dosing information and human case reports supporting our hypothesis for an improved treatment regimen to develop a less expensive, more user friendly, more patient compliant and more efficacious treatment to improve the healing of DFUs.
ABSOLVE is the first and only innovative wound dressing that combines the benefits of both collagen “advanced wound dressings” and “wound biologics”. Specifically, ABSOLVE has the benefits of a collagen wound dressing and also delivers a new, highly purified, more potent version of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) to the DFU. The feasibility data presented here demonstrate that this product is a significant innovation compared to the advanced wound dressings and biologics currently available to treat DFUs.