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) 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.
BioStem Technologies (BSEM) reported record Q3 2024 revenue of $82.6 million, up from $3.5 million in Q3 2023, marking their third consecutive quarter of record growth. The company achieved $199.0 million in revenue for the first nine months of 2024, with a gross profit margin of 94.9%. Q3 net income reached $6.8 million ($0.42 per share), compared to a loss of $1.5 million in Q3 2023. The growth was primarily driven by strong sales of AmnioWrap2® allografts. The company has filed for Nasdaq uplisting and initiated nationwide launch of Vendaje AC® following Medicare reimbursement approval.
BioStem Technologies (OTC: BSEM) announces nationwide launch of Vendaje AC® with Venture Medical following Medicare reimbursement approval across all MAC regions, effective October 1, 2024. This marks the company's second product available nationwide for treating chronic, non-healing wounds. The launch will begin in Q4 2024, leveraging Venture Medical as the exclusive sales and marketing partner. Vendaje AC®, manufactured using the BioREtain® process, retains important placental tissue elements for wound healing, including structural components, growth factors, and anti-inflammatory cytokines.
BioStem Technologies (OTC: BSEM), a MedTech company specializing in placental-derived biologics for advanced wound care, has scheduled its Third Quarter 2024 financial results release for Tuesday, November 12, 2024. The company will host a conference call and webcast at 4:30 PM ET, featuring CEO Jason Matuszewski and CFO Michael Fortunato discussing quarterly results. The event will be accessible via phone and webcast, with both domestic and international dial-in options available.
BioStem Technologies (OTC: BSEM) announces its participation in the 17th Annual LD Micro Main Event, scheduled for October 28-30, 2024, at the Luxe Sunset Boulevard Hotel in Los Angeles. Jason Matuszewski, Founder and CEO, will deliver a live presentation on October 30 at 9:30 AM PT and conduct one-on-one meetings.
The company has reported significant achievements in 2024, including record-breaking revenue of $116 million in the first six months. Recent milestones include breakthrough results in diabetic foot ulcer studies, establishing national pricing for Vendaje AC®, initiating the BR-AC-DFU-101 clinical trial, filing Form 10 with SEC, submitting a Nasdaq uplisting application, and receiving IRB approval for Vendaje® clinical study.
BioStem Technologies (OTC: BSEM) has announced that the Center for Medicare Services (CMS) has established national pricing for its allograft product, Vendaje AC® in all Medicare Administrative Contractor (MAC) regions, effective October 1, 2024. This allows BioStem to begin marketing Vendaje AC nationwide within the MAC regions.
The company will commercialize Vendaje AC through Venture Medical , a premier commercialization provider in the U.S. wound care market. Venture Medical, which has an extensive wound care sales team, is currently supporting BioStem with the successful launch of AmnioWrap2® and will now lead the distribution and marketing efforts for Vendaje AC nationwide.
BioStem Technologies has initiated the BR-AC-DFU-101 clinical trial to evaluate its BioREtain technology against standard care for non-healing diabetic foot ulcers (DFUs). The study involves 60 patients at 10 U.S. sites, with a completion target by the end of 2025. The trial aims to demonstrate that weekly applications of BioREtain will result in a higher rate of complete wound healing within 12 weeks compared to standard care alone.
Primary outcomes focus on the probability of complete wound closure, while secondary outcomes measure time to closure, wound area reduction, and the number of applications needed. BioStem aims to leverage successful results to enhance insurance coverage and market growth, building on its record revenue of over $100 million in the first half of 2024. DFUs are a significant health issue, affecting 15% of diabetics, with substantial risks for amputation and high treatment costs.