FDA Provides Written Guidance Following INTERACT Meeting, Supporting the Company’s Regulatory Strategy for IND Submission KONTICH, Belgium--(BUSINESS WIRE)--Flen Health Pharma NV, a Belgium-based biopharmaceutical company with more than 25 years of experience in wound and skin healing solutions, today announced that the U.S. Food and Drug Administration (FDA) has provided positive written feedback following an INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting regarding VES gel, a novel biologic designed to accelerate healing in chronic diabetic foot ulcers (DFUs). The FDA’s response provides guidance on Chemistry, Manufacturing and Controls (CMC) and nonclinical development, marking a key regulatory milestone as the company advances toward Investigational New Drug (IND) submission. “The FDA’s feedback gives us a clear regulatory roadmap to advance VES gel toward clinical trials in the United States,” said Julie Kerckhof, U.S. Business Strategy Director for Flen Health Pharma NV. The FDA provided written responses addressing key aspects of the company’s development program, including its CMC strategy and proposed nonclinical study design. The Agency’s recommendations provide a clear framework for the documentation and testing requirements needed to support IND submission. “The FDA’s feedback gives us a clear regulatory roadmap to advance VES gel toward clinical trials in the United States,” said Julie Kerckhof, U.S. Business Strategy Director for Flen Health Pharma NV. “Diabetic foot ulcers remain one of the most undertreated complications in chronic wound care, and we believe VES gel has the potential to meaningfully change outcomes for millions of patients.” Flen Health is now advancing VES gel toward clinical trials in the United States, which the company expects to begin in 2026. The company is seeking a strategic partner to support clinical development and U.S. commercialization. About VES GelVES gel is a first-in-class, patented topical biologic for the treatment of diabetic foot ulcers. It leverages a proprietary recombinant enzyme complex in an alginate ointment to modulate inflammation and promote wound healing while eliminating bacteria and yeast without the development of resistance. VES gel is currently undergoing preclinical evaluation and regulatory review as a combination product integrating biologic and medical device classifications. About Diabetic Foot UlcersDiabetic foot ulcers (DFUs) are a serious complication of diabetes mellitus, affecting up to 25% of diabetic patients in their lifetime with an annual cost of $13B to the US healthcare system. DFUs are the leading cause of lower extremity amputations among people with diabetes, accounting for about 85% of such procedures. Globally, 10.2% of the population are living with diabetes and the prevalence of diabetes continues to rise, increasing the risk of non-healing foot ulcers and further straining healthcare systems. Effective wound repair in DFUs is challenged by disrupted cell communication, impaired inflammatory responses, and a hostile healing environment. About Flen Health Pharma NVFlen Health Pharma NV is a biopharmaceutical company dedicated to developing innovative therapies for unmet needs in wound care. Founded in 2000 and headquartered in Kontich, Belgium, the company has more than 25 years of experience delivering trusted wound and skin healing solutions across Europe and in more than 40 countries worldwide. Flen Health is now leveraging this expertise to bring its novel therapeutics to the U.S. market. For more information, visit www.flenhealth.com. Forward-Looking StatementsThis press release contains forward-looking statements relating to the development, regulatory approval, and commercialization of VES gel. Actual results may differ due to various factors. Flen Health Pharma NV assumes no obligation to update these statements to reflect future events or circumstances.
