Lynch Regenerative Medicine Completes Phase II Wound Trial

FRANKLIN, Tenn., August 18, 2026

Phase II Trial Evaluates PDGF-BB for Complex Wounds

The Phase II study is evaluating whether an rhPDGF-BB-enhanced collagen wound matrix can accelerate the formation of healthy granulation tissue and help complex wounds progress toward closure. Such defects may require prolonged healing before definitive reconstruction can be performed, particularly in older adults and medically vulnerable patients. Participants were randomized to receive either the rhPDGF-BB-enhanced collagen matrix or a saline-treated collagen wound matrix representing standard of care. The double-blind design is intended to provide an objective assessment of treatment effects while minimizing potential bias in evaluating healing outcomes. The study includes patients with wounds that could not be closed primarily using sutures, staples or glue after skin cancer excision. According to LRM, the clinical program is focused on determining whether pure PDGF-BB can help improve the healing process and potentially shorten the period before wound closure or reconstruction.

Clinical Endpoints Focus on Healing and Patient Outcomes

The trial is evaluating multiple safety and effectiveness endpoints during an eight-week assessment period. Investigators will assess the time and rate of granulation tissue formation, time and rate of wound closure, overall healing, scar appearance and aesthetic outcomes. The study also incorporates patient-reported measures examining pain and quality of life. Blinded expert assessments, standardized wound imaging and quantitative digital analysis are being used to evaluate wound progression. The enrolled population includes nine participants with full-thickness scalp wounds and 25 with facial or neck wounds, providing clinical experience across several challenging anatomical locations. Enrollment completion represents an important milestone, but the company emphasized that the study remains ongoing. The collected clinical data will be analyzed after the assessment period, and no conclusions regarding the safety or effectiveness of investigational rhPDGF-BB for this indication can yet be drawn. The study is registered on ClinicalTrials.gov as NCT06634030 and reflects LRM’s broader efforts to investigate potential applications for recombinant human PDGF-BB beyond its currently approved uses.

Regenerative Medicine Approach Targets Tissue Repair

PDGF-BB is a growth factor involved in tissue repair and regeneration, and LRM is investigating whether delivering pure recombinant PDGF-BB through a wound matrix can support healing in complex surgical defects. The approach combines the growth factor with an engineered collagen tissue substitute designed to provide a local environment for wound repair. The company believes the strategy could potentially reduce the need for additional reconstructive procedures in some patients, although this possibility remains investigational and must be evaluated through clinical evidence. The current trial is particularly relevant to patients undergoing treatment for skin cancer, where surgical removal can sometimes leave substantial defects requiring staged reconstruction. LRM is a commercial-stage biotechnology company focused on regenerative medicine, recombinant growth factors and aesthetic solutions. Its portfolio includes Regranex Gel, an FDA-approved biologic for certain chronic wounds, and GEM 21S, an FDA-approved combination product for specified periodontal defects. The company also markets a cosmetic pure PDGF product. The completion of Phase II enrollment provides an opportunity to advance the clinical evaluation of rhPDGF-BB in complex head and neck wound healing. Results from the ongoing study will be important in determining whether the investigational treatment can demonstrate meaningful improvements in healing, wound closure and patient outcomes.

Source: Lynch Regenerative Medicine press relese