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 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.
BioStem Technologies (OTC: BSEM) has launched the BR-AM-DFU clinical trial to evaluate its Vendaje® product against standard care for treating non-healing diabetic foot ulcers (DFUs). The multicenter, randomized study will enroll 60 patients across twelve U.S. sites, assessing wound closure over a 12-week treatment period.
This marks the company's second active clinical trial, following the BR-AC-DFU-101 trial initiated in October 2024 for AmnioWrap2™. The trials aim to demonstrate the effectiveness of BSEM's proprietary BioREtain® technology in wound care. According to market statistics, approximately 15% of diabetic patients develop foot ulcers, with treatment costs ranging from $9-13 billion annually in the U.S. In 2023, 2.2 million patients received DFU treatment.
BioStem Technologies (OTC: BSEM) has announced that CEO Jason Matuszewski will present a corporate overview at the Biotech Showcase 2025 conference in San Francisco. The presentation is scheduled for Monday, January 13, 2025, at 2:30 PM PT on Track Yosemite-C and will be available via webcast.
The conference, now in its 17th year, brings together biotechnology investors and pharmaceutical executives from around the world. BioStem's senior management will also be available for one-on-one meetings during the event, which runs from January 13-15, 2025.
BioStem Technologies specializes in developing and manufacturing placental-derived products for advanced wound care using their proprietary BioREtain® processing method. The company's portfolio includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®, all processed at their FDA registered and AATB accredited facility in Pompano Beach, Florida.
BioStem Technologies (OTC: BSEM) has received a Notice of Allowance from the USPTO for its patent application covering sterile human placental allografts with slits, openings, and fenestrations. The patent (No. 12,144,831) will grant on November 19, 2024, marking the first patent granted for tabular fenestrated allografts. The technology features flaps that allow exudate escape while maintaining surface area, suitable for acute and chronic wound care. The company's IP portfolio now includes 42 issued patents and 27 pending applications. The product, utilizing BioStem's BioREtain® process, is under development and will follow the HCT/P regulatory pathway.
BioStem Technologies (OTC: BSEM) has signed a Letter of Intent to acquire commercial-stage products and development technologies from ProgenaCare Global. The acquisition includes ProgenaMatrix, the first commercially available human keratin matrix for wound care, and revyve Antimicrobial Wound Gel. The deal aims to expand BioStem's wound care portfolio and leverage its commercial infrastructure. ProgenaMatrix is FDA 510(k) cleared for various indications including venous stasis ulcers and diabetic foot ulcers. The transaction is expected to be finalized within 60 days, subject to regulatory approvals and Board consent.