Core Insights - BioStem Technologies, Inc. has completed patient enrollment for a clinical trial comparing BioREtain® Amnion Chorion (BR-AC) to standard care for non-healing diabetic foot ulcers (DFUs) [2][3] - The BR-AC-DFU-101 study aims to evaluate the effectiveness of BR-AC in achieving complete wound closure over a 12-week period [3][5] - Topline results from the study are expected in Q4 2025, with the trial initiated in Q4 2024 across 11 sites in the U.S. [3][4] Company Overview - BioStem Technologies focuses on developing, manufacturing, and commercializing placental-derived products for advanced wound care [2][10] - The company utilizes a proprietary BioREtain processing method that preserves the natural properties of perinatal tissue [8][10] - BioStem's quality management systems are accredited by the American Association of Tissue Banks and adhere to Good Tissue Practices and Good Manufacturing Processes [11] Clinical Trial Details - The primary objective of the BR-AC-DFU-101 study is to determine if the combination of standard care and BR-AC leads to a higher probability of complete wound closure compared to standard care alone [5] - Secondary outcome measures include comparing treatment group differences in wound closure rates, wound area, and volume [7] - The study has enrolled 71 patients, exceeding the initial target of 60 [3][4] Market Context - Diabetic foot ulcers affect approximately 15% of individuals with diabetes, with 6% requiring hospitalization due to complications [5] - The economic burden of DFUs in the U.S. is significant, with annual treatment costs estimated between $9 billion and $13 billion [6] - In 2023, 2.2 million patients received treatment for DFUs, with numbers projected to rise [6]

Award celebrates bold leaders shaping the future through the world’s most ground-breaking companiesPOMPANO BEACH, Fla., June 17, 2025 (GLOBE NEWSWIRE) -- Ernst & Young LLP (EY US) announced that Jason Matuszewski, CEO and Chairman of the Board of BioStem Technologies (OTC: BSEM), was named an Entrepreneur Of The Year 2025 Florida Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. For 40 years, EY US has celebrated ambit ...

POMPANO BEACH, Fla., May 29, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, announces that the company will participate in the Goldman Sachs 46th Annual Global Healthcare Conference, which is taking place in Miami. Jason Matuszewski, the Company’s CEO, will participate in a fireside chat and will be available for one-on-one meetings. For conferen ...

Expanding patent portfolio reinforces the Company's commitment to wound care innovation, with 55 issued patents and 52 pending applications Join BioStem's Distribution List & Social Media: To follow the latest developments at BioStem, sign-up to the Company's email distribution list HERE, and follow us on X and LinkedIn. About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, a ...

Core Insights - BioStem Technologies, Inc. reported a record first quarter in 2025, with revenue increasing by 73% year-over-year to $72.5 million, driven by strong performance in its wound care portfolio, particularly the Vendaje AC product [2][7][13] - The company is focused on transitioning more customers to Vendaje AC to enhance brand consistency and is also working on reducing selling, general, and administrative expenses by phasing out licensing fees associated with AmnioWrap2 [2][3] - BioStem has received IRB approval for a new clinical trial for its BioREtain Amnion Chorion product aimed at treating venous leg ulcers, marking its third prospective clinical trial [3][4] Financial Performance - Preliminary net revenue for Q1 2025 was $72.5 million, a 73% increase from $41.9 million in Q1 2024 [7][13] - Gross profit reached $71.7 million, representing a gross margin of 99%, compared to 95% in the same quarter of the previous year [7][13] - Operating expenses increased to $66.4 million from $35.1 million in Q1 2024, primarily due to higher sales and marketing costs [7][13] Clinical Trials and Product Development - BioStem launched the BR-AM-DFU clinical trial to evaluate Vendaje for non-healing diabetic foot ulcers, aiming to validate the clinical efficacy of its BioREtain technology [4] - The company has expanded its intellectual property portfolio, holding 55 issued patents and 52 pending patents, reinforcing its innovation leadership in regenerative medicine [5] Market Position and Strategic Focus - The company is actively pursuing an uplisting to Nasdaq and is currently under SEC review regarding its Form 10 registration [2][7] - BioStem aims to strengthen its position in the chronic wound care market while maintaining a focus on clinical evidence to support product adoption [2][3]

Company to co-exhibit with strategic partner Venture Medical, LLC, highlighting collaborative innovation in chronic wound care managementThree accepted scientific posters will feature BioStem’s advanced allograft portfolio POMPANO BEACH, Fla., May 01, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced its agenda for the Symposium for ...