Clinical Trials
3
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
33.3%
Completed
1
33.3%
Not yet recruiting
1
33.3%
No approval data available
- BioStem Technologies completed the acquisition of BioTissue Holdings' surgical and wound care business for $15 million upfront, with potential additional payments up to $25 million based on regulatory and commercial milestones. - The acquisition includes the Neox® and Clarix® product lines, a nationwide sales force, and GPO contracts, expanding BioStem's reach into hospital-based acute wound care markets. - The acquired assets generated approximately $29 million in sales in 2025 and are expected to contribute positive EBITDA for BioStem in 2026. - BioTissue will focus exclusively on ocular innovation with products like Prokera®, while continuing to manufacture the divested products for BioStem under the agreement.
- The Centers for Medicare & Medicaid Services (CMS) has dramatically reduced Medicare coverage for skin substitutes from 340 products to just 18 evidence-based products for treating diabetic foot and venous leg ulcers, effective January 1, 2026. - All covered products will be reimbursed at a standardized rate of $127/cm², eliminating pricing-driven treatment decisions and allowing clinicians to focus on selecting the most appropriate therapy for each patient. - An additional 154 products have been placed in a discretionary category with 12-month status quo period, remaining eligible for case-by-case payment at Medicare Administrative Contractors' discretion. - The policy changes only apply to diabetic foot ulcers and venous leg ulcers, leaving coverage for other wound types like pressure ulcers unaffected.
- BioStem Technologies reported that its BioRetain-processed amnion chorion allograft achieved a 53% healing probability versus 31% for standard care in a randomized controlled trial of 71 diabetic foot ulcer patients. - The multicenter BR-AC-DFU-101 study enrolled only hard-to-heal wounds by excluding patients who showed greater than 30% wound size reduction during a 2-week standard care run-in period. - The trial followed FDA guidance for cutaneous ulcers and required wounds to remain closed for 4 weeks after initial closure to qualify as achieving lasting wound closure. - Results were published in the International Journal of Tissue Repair, with BioStem continuing enrollment in a separate venous leg ulcer study using the same technology.
- The Centers for Medicare & Medicaid Services (CMS) has proposed a new per-square-centimeter payment methodology for skin substitutes based on FDA classification under the CY 2026 Physician Fee Schedule. - Leading regenerative medicine companies Organogenesis and BioStem Technologies applaud the reform, believing it will curb abuse and reduce rapid escalation in Medicare spending while ensuring consistent payment across care sites. - The proposed changes recognize clinical differentiation of PMA products and aim to expand access to innovative wound healing technologies that have been proven to reduce life-threatening amputations. - Companies view the reform as promoting long-term stability in the wound care market while encouraging investment in innovation and improving patient outcomes.
- BioStem Technologies has completed enrollment of 71 patients in its BR-AC-DFU-101 clinical trial evaluating BioREtain Amnion Chorion allograft versus standard care for non-healing diabetic foot ulcers. - The multicenter, randomized controlled trial aims to demonstrate superior wound closure rates over 12 weeks, with topline results expected in Q4 2025. - Diabetic foot ulcers affect approximately 15% of diabetic patients and represent a $9-13 billion annual healthcare burden in the United States. - The company is simultaneously advancing three clinical trials to validate its proprietary BioREtain processing platform for advanced wound care applications.
- BioStem Technologies received Notice of Allowance from the USPTO for three new patents covering fenestrated human placental allograft designs manufactured using their proprietary BioREtain process. - The patented fenestrated design allows wound exudate to pass through the graft without sacrificing allograft area, facilitating drainage and creating a more conducive healing environment. - These patents strengthen BioStem's intellectual property portfolio, which now includes 55 issued patents and 52 pending applications, reinforcing their position in advanced wound care innovation. - The technology specifically targets treatment of diabetic foot ulcers, dental wounds, and other topical wounds while preserving the structural and molecular integrity of amnion and chorion tissues.
- BioStem Technologies initiates BR-AM-DFU clinical trial to evaluate Vendaje® against standard of care in treating diabetic foot ulcers, marking a significant advancement in wound care research. - The company recently reported record preliminary Q4 2024 net revenue of $102.9 million, with full-year revenue projected to reach $301.8 million, demonstrating strong commercial growth. - BioStem's placental-derived product portfolio expansion is supported by a new USPTO patent allowance for sterile human placental allografts in the fenestrated wound care market.
- 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.
- 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 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.
