Welcome to our dedicated page for Biostem Tech news (Ticker: BSEM), a resource for investors and traders seeking the latest updates and insights on Biostem Tech stock.
BioStem Technologies, Inc. (OTC: BSEM) generates news that reflects its role as a MedTech company focused on placental-derived allografts for advanced wound care and regenerative therapies. Coverage of BSEM often centers on clinical trial milestones, reimbursement developments, financial reporting, and operational updates related to its BioRetain®-processed product portfolio, which includes brands such as AmnioWrap2™, VENDAJE®, VENDAJE AC®, VENDAJE OPTIC®, American Amnion™, and American Amnion AC™.
Investors and healthcare professionals following BSEM news can expect updates on randomized controlled trials and other clinical studies evaluating BioRetain-preserved placental allografts in chronic wound indications like diabetic foot ulcers and venous leg ulcers. The company has reported top-line clinical results from a multicenter randomized controlled trial in non-healing diabetic foot ulcers, as well as comparative studies versus standard of care and competitor products, and these types of announcements are key components of its news flow.
Another major theme in BioStem’s news is reimbursement and policy. The company regularly comments on Centers for Medicare & Medicaid Services (CMS) rules and Local Coverage Determinations affecting skin substitutes and cellular and tissue-based products. News items have addressed the placement of VENDAJE and VENDAJE AC in a “12-Month Status Quo” category under certain LCDs, the withdrawal of specific LCDs, and the inclusion of these products on Florida Medicaid’s list of covered skin substitutes, along with coverage in multiple state Medicaid programs.
Financial and corporate developments also feature prominently. BioStem has issued press releases on quarterly financial results, restated financial statements related to the treatment of bona fide services fees in a distribution agreement, and the appointment of a new independent registered public accounting firm. Operational news has included the purchase of land in the Research Park at Florida Atlantic University in Boca Raton, Florida, for a future headquarters, as well as partnerships to serve the U.S. Department of Veterans Affairs and community initiatives supporting veterans.
By monitoring this news page, readers can follow BioStem’s clinical evidence generation, reimbursement positioning, financial reporting, and strategic initiatives as they relate to its placental-derived advanced wound care products and BioRetain processing technology.
BioStem Technologies (OTC: BSEM), a MedTech company specializing in placental-derived biologics for advanced wound care, has scheduled its first quarter 2025 financial results announcement for May 12, 2025.
The company will host a conference call and webcast at 4:30 PM ET, featuring presentations from CEO Jason Matuszewski and CFO Michael Fortunato. Investors can participate through:
- North America Toll-Free: (800) 715-9871
- International Toll: +1 (646) 307-1963
- Conference ID: 9695874
Interested parties can register for the webcast through the provided link and stay updated by joining BioStem's distribution list and following their social media channels on X and LinkedIn.
BioStem Technologies (OTC: BSEM), a MedTech company specializing in placental-derived products for advanced wound care, has announced its participation in the upcoming Centri Capital Conference at Nasdaq headquarters in New York City.
CEO Jason Matuszewski will deliver a presentation on April 22, 2025, at 10:30 AM ET and conduct one-on-one meetings with interested parties. The company's core technology, BioREtain®, is their proprietary processing method focused on maintaining growth factors and preserving tissue structure.
BioStem's portfolio includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC® products, all processed at their FDA registered and AATB accredited facility in Pompano Beach, Florida. The company maintains quality management systems and standard operating procedures accredited by the American Association of Tissue Banks, following current Good Tissue Practices and Good Manufacturing Processes.
BioStem Technologies (BSEM) reported record preliminary Q4 2024 financial results with net revenue of $102.9 million and full-year revenue of $301.8 million, marking a 1,709% increase from 2023. The company achieved $15.5 million in Q4 GAAP net income ($0.94 per share), its fourth consecutive profitable quarter.
Q4 gross profit reached $99.3 million (97% margin), driven by the nationwide launch of Vendaje AC® and continued demand for AmnioWrap2®. Operating expenses increased to $90.9 million due to expanded headcount and higher service fees.
Recent milestones include initiating three clinical trials for diabetic foot ulcers and venous leg ulcers, securing national CMS pricing for Vendaje AC®, and receiving a patent allowance for placental allografts. The company is currently undergoing SEC review for a planned Nasdaq uplisting.
BioStem Technologies (OTC: BSEM), a MedTech company specializing in placental-derived biologics for advanced wound care, has scheduled its Fourth Quarter and Full Year 2024 financial results announcement for April 14, 2025.
The company will host a conference call and webcast at 4:30 PM ET, featuring CEO Jason Matuszewski and CFO Michael Fortunato, who will provide an overview of the quarter. Participants can join via North America Toll-Free (800) 715-9871 or International Toll +1 (646) 307-1963 using Conference ID: 9695874.
BioStem Technologies (OTC: BSEM) has requested an extension for filing its 2024 annual report with the OTC. The delay is attributed to an ongoing SEC review process of the company's Form 10 registration statement, which could affect financial statements and disclosures.
The company expects to file the annual report by April 15, 2025, the extension period's deadline. Management indicates this review process is a necessary step in their planned Nasdaq uplisting. A webcast covering Q4 and year-end 2024 results will be announced following the completion of the SEC review.
BioStem Technologies (OTC: BSEM) has received Notice of Allowance from the USPTO for two patent applications, strengthening its intellectual property portfolio in advanced wound care technology. The company currently holds 43 issued patents and has 26 pending applications.
The first patent (No. 18/593,225) covers novel micronized human placental compositions for wound care, specifically designed for wound packing, irregular surfaces, weeping wounds, and dental/oral applications. The second patent (No. 18/290,914) pertains to sterile human placental allograft compositions manufactured with the BioRetain® process, aimed at treating conditions like diabetic foot ulcers and dental wounds.
BioStem Technologies (OTC: BSEM) announces its participation in the 24th Annual Needham Virtual Healthcare Conference, where CEO Jason Matuszewski will present on April 10, 2025, at 1:30 PM ET. The company will also conduct investor meetings during the conference.
BioStem Technologies specializes in developing and manufacturing placental-derived products for advanced wound care using their proprietary BioREtain® processing method. Their product portfolio includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®.
The company maintains AATB accreditation and operates an FDA-registered facility in Pompano Beach, Florida, following Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP). Their processing method focuses on maintaining growth factors and preserving tissue structure for optimal wound care solutions.
BioStem Technologies (OTC: BSEM) has received Institutional Review Board (IRB) approval for a clinical study evaluating its proprietary BioREtain® Amnion Chorion (BR-AC) for treating venous leg ulcers (VLU). The multicenter, randomized, controlled study will enroll at least 60 subjects across 15 U.S. sites, comparing BR-AC to standard care over 12 weeks.
The trial will focus on patients with non-healing, non-infected VLUs with confirmed venous reflux. Subjects will undergo a two-week run-in period with standard wound care before randomization. The primary objective is to assess whether BR-AC increases complete wound closure likelihood compared to standard care alone.
This marks BioStem's third prospective clinical trial across various wound indications. The company's BioREtain® technology is designed to retain tissue's native properties while maintaining the structure and matrix found in fresh perinatal tissue. The VLU market is growing at over 4% CAGR, affecting up to two million people annually in the United States.
BioStem Technologies (OTC: BSEM) announced preliminary financial results for Q4 and the full year ending December 31, 2024. Q4 net revenue is expected to be around $102.9 million, representing a 794% increase over Q4 2023. Full-year 2024 net revenue is projected at $301.8 million, a 1,702% increase from $16.7 million in 2023. Q4 gross profit is anticipated to be approximately $99.3 million, up 811% from $10.9 million in Q4 2023. Full-year gross profit is expected to reach $288.1 million, a 1,775% increase from $15.4 million in 2023.
This growth is driven by the adoption of AmnioWrap2 OneView™ and the launch of Vendaje AC®, supported by targeted strategies from Venture Medical, The Venture OneView™ platform has played a important role in market expansion and product adoption. CEO Jason Matuszewski highlighted the transformative year and the strategic initiatives that fueled the revenue growth. He also mentioned the potential finalization of an LOI with ProgenaCare, which would expand BioStem's product portfolio.
BioStem's proprietary BioREtain® method preserves the biological properties of placental tissue, enhancing its wound treatment capabilities. BioStem's products are developed following stringent quality standards, accredited by the American Association of Tissue Banks.