The Company welcomes CMS’ efforts to reform skin substitute payment policy and will continue to engage with CMS and other stakeholders to optimize the proposed changesPOMPANO BEACH, Fla., July 17, 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, comments on the Centers for Medicare and Medicaid Services (“CMS”) release of the Calendar Year (“CY”) 2 ...

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]

Company Overview - BioStem Technologies is a leading MedTech company focused on improving the lives of patients with chronic, non-healing wounds through innovative solutions [3][14] - The company develops and manufactures placental-derived allografts using proprietary BioREtain® technology, which preserves tissue's native properties and optimizes clinical outcomes [3][15] - BioStem's products are used by clinicians nationwide to address the growing demand for advanced wound care solutions [3][14] Leadership Recognition - Jason Matuszewski, CEO and Chairman of BioStem Technologies, was awarded the Entrepreneur Of The Year 2025 Florida Award by Ernst & Young LLP [1][4] - The award recognizes leaders who demonstrate long-term value creation, entrepreneurial spirit, and significant growth and impact [2][5] - Matuszewski emphasized the collective effort of the BioStem team in achieving this recognition, highlighting their commitment to innovation and patient care [3][4] Future Aspirations - As a Florida award winner, Matuszewski is eligible for the Entrepreneur Of The Year 2025 National Awards, with winners announced in November [4] - The National Award winner will compete for the EY World Entrepreneur Of The Year™ Award in June 2026 [4][8] - BioStem aims to expand its impact and continue advancing its platform in the healthcare system [3][14]

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 ...

Core Insights - BioStem Technologies, Inc. has expanded its patent portfolio with 55 issued patents and 52 pending applications, emphasizing its commitment to innovation in wound care [1] - The United States Patent and Trademark Office (USPTO) has granted a Notice of Allowance for two design patents and one utility patent related to BioStem's fenestrated human placental allograft designs [2][3] - The unique design of the allografts allows for effective drainage of wound exudate while maintaining allograft area, enhancing the healing environment [2][3] Patent Details - The newly allowed patents include Design Patent Application No. 29/860,417 and No. 29/860,420, which focus on fenestrated human placental allograft designs using the BioREtain process [2] - Patent Application No. 18/926,867 covers sterile human placental allografts with multiple slits and openings, improving wound treatment efficacy, particularly for diabetic foot ulcers and dental wounds [3] Company Strategy - The CEO of BioStem Technologies highlighted the importance of these patents in advancing next-generation placental allograft technologies and reinforcing the proprietary nature of the BioREtain process [4] - The BioREtain process is designed to preserve the structural and molecular integrity of placental tissue, which is crucial for better clinical outcomes [4] Company Overview - BioStem Technologies specializes in the development, manufacturing, and commercialization of placental-derived products for advanced wound care [6] - The company’s quality management system is accredited by the American Association of Tissue Banks and adheres to current Good Tissue Practices and Good Manufacturing Processes [6]

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 ...