BIOSTEM TECHNOLOGIES

BioStem Technologies Initiates Pivotal Trial of Vendaje® for Diabetic Foot Ulcers

4 months ago

• BioStem Technologies has launched a clinical trial (BR-AM-DFU) to evaluate Vendaje® for treating non-healing diabetic foot ulcers (DFUs). • The multicenter, randomized, controlled study will enroll 60 patients across 12 U.S. sites to assess Vendaje®'s efficacy versus standard care. • The primary outcome is complete wound closure at 12 weeks, with a follow-up phase to measure wound durability. • This trial aims to demonstrate Vendaje®'s clinical effectiveness and support its market expansion in advanced wound care.

BioStem Technologies' BioREtain Shows Promise in Healing Diabetic Foot Ulcers

7 months ago

• A retrospective study published in the *International Wound Journal* highlights the clinical efficacy of BioREtain-processed placental membranes (RE-AC) in treating complex diabetic foot ulcers (DFUs). • Patients treated with RE-AC had an 8.53% higher probability of complete wound closure compared to the standard of care (SOC) group after 12 weeks. • The study included DFUs significantly larger and more complex than those typically seen in randomized controlled trials, demonstrating RE-AC's effectiveness in challenging cases. • BioStem Technologies plans to conduct further head-to-head studies to demonstrate the superiority of BioREtain, aiming to increase market awareness and adoption.

BioStem Technologies Initiates Clinical Trial of BR-AC for Diabetic Foot Ulcers

8 months ago

• BioStem Technologies has begun the BR-AC-DFU-101 clinical trial to assess BR-AC (BioREtain - Amnion Chorion) for treating non-healing diabetic foot ulcers (DFUs). • The study will enroll 60 patients across 10 U.S. sites, comparing BR-AC plus standard care to standard care alone, with completion expected by the end of 2025. • The primary goal is to determine if BR-AC enhances complete wound closure within 12 weeks, with secondary outcomes including closure time and wound area changes. • DFUs affect 15% of diabetic individuals, leading to significant hospitalization and amputation risks, with treatment costs in the U.S. ranging from $9 to $13 billion annually.