Core Insights - BioTissue Holdings, Inc. has completed the sale of its non-ocular Surgical and Wound Care business to BioStem Technologies, Inc., allowing BioTissue to focus on ocular market leadership and innovation in eye care solutions [1][2][3] Company Overview - BioTissue specializes in utilizing human birth tissue for regenerative healing, particularly in treating acute and chronic ocular surface conditions [4] - The company has developed a portfolio of cryopreserved amniotic membrane products using proprietary CryoTek® technology, which preserves the tissue's structural and functional integrity [4] - BioTissue has conducted over 1 million human procedures with its products and has over 420 peer-reviewed publications supporting its technology [4] Strategic Focus - Following the divestiture, BioTissue will concentrate on advancing interventional therapies for ocular conditions, including products like Prokera, CAM360 AmnioGraft, and AmnioGuard [2][3] - The company aims to prioritize product innovation, professional education, and comprehensive customer support within the eye care market [2] Partnership with BioStem - BioStem Technologies will acquire exclusive rights to BioTissue's Neox and Clarix product lines, integrating BioTissue's surgical sales team into its commercial organization [2][3] - BioStem's CEO highlighted the complementary strengths of BioTissue's portfolio to their existing business, indicating a strong potential for growth and improved patient outcomes [3]

Core Insights - BioStem Technologies has acquired the surgical and wound care business of BioTissue Holdings for approximately $15 million, with potential additional payments based on regulatory milestones and royalties [7][8] - This acquisition significantly enhances BioStem's commercial capabilities and expands its product offerings in the acute wound care market [5][6] Group 1: Acquisition Details - The acquisition includes BioTissue's Neox® and Clarix® product lines, along with its commercial infrastructure, which consists of a nationwide sales network and key GPO contracts [4][5] - BioTissue's surgical and wound care business generated approximately $29 million in sales in 2025 and is expected to contribute positively to BioStem's EBITDA in 2026 [8] Group 2: Strategic Implications - The acquisition allows BioStem to diversify into new markets, particularly in acute wound care and soft-tissue repair, thereby broadening its existing product lines [5][6] - Barry Hassett has been promoted to Chief Commercial Officer to lead the integrated commercial team, leveraging his extensive experience in the industry [9] Group 3: Financial Overview - The upfront cash payment for the acquisition is approximately $15 million, with potential additional payments of up to $25 million based on regulatory and commercial milestones [7] - Post-acquisition, BioStem's cash and restricted cash balance is approximately $16 million [8]

Accelerates expansion of BioStem’s commercial organization through integration of an experienced national sales force Expands access to major GPO networks, strengthening BioStem’s position across hospital settings Barry Hassett promoted to Chief Commercial Officer Conference call scheduled for tomorrow, January 22nd at 8am ET POMPANO BEACH, Fla., Jan. 21, 2026 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercializatio ...

Decision ensures continued patient access to VENDAJE® and VENDAJE AC® POMPANO BEACH, Fla., Jan. 07, 2026 (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 commented on the withdrawal of all seven of the Centers for Medicare & Medicaid Services’ (“CMS”) Local Coverage Determinations (“LCD”) for skin substitute grafts/cellular and tissue-based produc ...

Status Quo designation preserves DFU/VLU reimbursement eligibility for 2026, ensuring continued patient access to BioStem technology Coverage for the majority of BioStem’s non-acute revenue, treatment for pressure ulcers, also remains unaffected by CMS LCD updates POMPANO BEACH, Fla., Dec. 18, 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 ...

Core Insights - BioStem Technologies reported a significant decrease in net revenue for Q3 2025, totaling $10.5 million, which is a 43% decline compared to Q3 2024, primarily due to lower volume in the wound care portfolio amid reimbursement uncertainties and increased competition [7][9] - The company remains focused on strategic initiatives, including advancing clinical programs, expanding payer access, and evaluating potential acquisitions to diversify its product offerings [5][9] Financial Highlights - Net revenue for Q3 2025 was $10.5 million, down from $18.4 million in Q3 2024, reflecting a 43% decrease [7] - Gross profit was $9.3 million, representing 88.5% of net revenue, compared to $14.2 million or 77.0% of net revenue in Q3 2024, indicating a shift towards products without licensing fees [7] - Operating expenses increased to $7.8 million from $4.9 million in Q3 2024, driven by higher clinical trial activities and infrastructure investments [8] - GAAP net income was $0.8 million or $0.05 per share, down from $6.8 million or $0.42 per share in Q3 2024 [8] - Adjusted EBITDA for the quarter was $2.7 million, a decline from $10.4 million in Q3 2024, reflecting lower revenue and higher operating expenses [8] Business Developments - BioStem achieved a 40% growth in product volume quarter-over-quarter [9] - The company published positive results from the BioREtain® trial in the International Journal of Tissue Repair and completed FDA reinspection with no observations [9] - BioStem secured land for a new headquarters in Boca Raton and established a partnership with a Service-Disabled Veteran-Owned Small Business to enter the VA market [9] - The company reported restated financials in accordance with US GAAP, reflecting adjustments to the accounting treatment for bona fide services fees paid to its commercial partner [9][10] Cash Position - As of September 30, 2025, cash and cash equivalents totaled $27.2 million, providing a solid financial foundation for future operations [10]

Core Insights - BioStem Technologies, Inc. has filed restated interim financial statements for Q1 2024 through Q2 2025 and annual financial statements for 2023 and 2024, aligning with US GAAP revenue recognition standards [3][12]. Financial Restatement - The restatement is a significant milestone for the company, resulting from a comprehensive review of US GAAP revenue recognition guidance, particularly regarding the distribution agreement with Venture Medical [4][12]. - Bona fide services fees previously recorded as Sales and Marketing expenses will now be classified as contra revenue, reducing gross revenue but not impacting EBITDA, net income, or cash flow [5][12]. - The restated financials will affect percentage-based metrics such as gross margin and EBITDA margin due to the change in revenue reporting [5]. Balance Sheet Adjustments - Amounts owed to Venture Medical related to bona fide services fees will now be netted against Accounts Receivable, effectively offsetting the liabilities between the two companies [6]. Business Outlook - The company maintains that the underlying strength of its business remains unchanged, continuing to deliver clinically validated wound care products [7]. - The independent audit led by KPMG is expected to be completed by the end of Q1 2026, which will support the company's plans to uplist and enhance investor transparency [8][12].

Core Insights - BioStem Technologies, Inc. supports the CMS's final rule on the Physician Fee Schedule for 2026, which aims to create a more transparent and sustainable reimbursement system for skin substitutes [2][4] - The new reimbursement model is expected to restore market balance and reward clinical performance, aligning with BioStem's goals for its BioREtain-processed placental allografts [2][3] Company Positioning - BioStem's BioREtain manufacturing process offers lower cost of goods sold (COGS) and scalable production, which is expected to maintain robust product margins under the new reimbursement model [3] - The company is well-positioned to thrive in the evolving reimbursement environment due to its clinically validated products and efficient cost structure [4] Clinical Validation - BioStem's commitment to scientific validation is highlighted by a Level 1 randomized controlled trial demonstrating superior patient outcomes with its products compared to standard care [2] - The company collaborates with clinical partners and policymakers to ensure that the reimbursement framework supports innovation and optimal patient care [4]

Core Insights - BioStem Technologies, Inc. will release its third quarter 2025 financial results on November 13, 2025, and will host a conference call and webcast at 4:30 PM ET [1][2] Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing placental-derived products for advanced wound care [1][3] - The company utilizes its proprietary BioREtain processing method, which is designed to maintain growth factors and preserve tissue structure [3] - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and complies with current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP) [3] Product Portfolio - The company's product brands include AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited site in Pompano Beach, Florida [3]

Core Insights - BioStem Technologies, Inc. has appointed KPMG LLP as its new independent registered public accounting firm, replacing Marcum LLP, effective October 22, 2025 [1][2] - The transition to KPMG is part of the company's strategy to support long-term growth and its planned uplisting to the Nasdaq Capital Market [2][3][4] Company Strategy - The company aims to proceed with its uplisting to the Nasdaq following the completion of audits for the fiscal years 2024 and 2025 [3] - Uplisting is considered a key priority for the company, expected to enhance visibility, improve stock liquidity, provide accurate market valuation, and attract top talent [4] Company Overview - BioStem Technologies focuses on developing, manufacturing, and commercializing placental-derived products for advanced wound care, leveraging its proprietary BioREtain processing method [4] - The company’s quality management system is accredited by the American Association of Tissue Banks and complies with current Good Tissue Practices and Good Manufacturing Processes [4]