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.
About BioStem Technologies, Inc. (BSEM)
BioStem Technologies, Inc. (OTC: BSEM) is a pioneering MedTech company specializing in the development, manufacture, and commercialization of placental-derived biologics for regenerative therapies. Headquartered in Pompano Beach, Florida, BioStem leverages the natural properties of perinatal tissue to create innovative solutions that address critical healthcare needs, particularly in advanced wound care. The company’s proprietary BioREtain® processing method preserves the biological properties of placental tissue, maintaining growth factors and tissue structure to enhance healing outcomes. Accredited by the American Association of Tissue Banks (AATB) and compliant with FDA regulations, BioStem is committed to delivering high-quality, life-changing products.
Core Product Portfolio
BioStem’s product portfolio is centered around its placental tissue allografts, which are processed using its patented BioREtain® method. Key products include:
- AmnioWrap2™: A minimally manipulated dehydrated tissue allograft designed to promote wound healing and closure.
- VENDAJE® and VENDAJE AC®: Advanced wound care solutions that act as protective barriers to support the body’s natural healing processes.
- VENDAJE OPTIC®: A specialized product targeting ocular applications.
These products are widely used in treating chronic wounds, such as diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and surgical wounds. Clinical trials and peer-reviewed studies have validated the efficacy of BioStem’s solutions, demonstrating superior outcomes compared to traditional treatments.
Market Position and Growth
Operating within the rapidly expanding regenerative medicine market, BioStem is strategically positioned to capitalize on the growing demand for advanced wound care solutions. The global stem cell and wound care markets are projected to reach billions in valuation by the end of the decade, providing significant opportunities for BioStem’s innovative products. The company’s focus on securing Medicare reimbursement and forming strategic partnerships, such as its collaboration with Venture Medical, has expanded its market reach across all 50 states.
Strategic Initiatives
BioStem has undertaken several initiatives to drive growth and enhance shareholder value:
- Clinical Trials: Ongoing studies, such as BR-AC-DFU-101, aim to demonstrate the clinical superiority of BioStem’s products over standard care, further validating their efficacy.
- Regulatory Milestones: The company has achieved Medicare reimbursement for key products and is working towards Nasdaq uplisting to increase market visibility and access to capital.
- Acquisitions: Strategic acquisitions, like the planned integration of ProgenaCare’s product portfolio, are expected to broaden BioStem’s offerings and strengthen its position in the hospital-based market segments.
Competitive Advantages
BioStem’s competitive edge lies in its proprietary BioREtain® technology, which ensures the preservation of critical biological properties in its allografts. This innovation, combined with its focus on clinical validation, regulatory compliance, and strategic partnerships, positions BioStem as a trusted name in regenerative medicine. Additionally, the company’s robust quality management system, accredited by AATB, underscores its commitment to excellence and reliability.
Commitment to Innovation and Excellence
Led by a visionary leadership team, BioStem continues to invest in R&D, clinical trials, and strategic collaborations to advance its mission of improving patient outcomes. The company’s dedication to leveraging cutting-edge science and maintaining the highest standards of quality and compliance ensures its long-term success in the competitive MedTech landscape.
Conclusion
BioStem Technologies, Inc. represents a compelling opportunity within the regenerative medicine sector. With its innovative product portfolio, strategic growth initiatives, and unwavering commitment to quality, BioStem is poised to make a lasting impact on advanced wound care and beyond.
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.
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.
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