Regenerative Therapies
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BioTissue Holdings, Inc Strengthens Strategic Focus on Ocular Innovation with Sale of Surgical and Wound Care Business to BioStem Technologies
Prnewswire· 2026-01-21 23:00
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]
Adia Nutrition Inc. Receives Notification from SEC: Form 10 to Become Effective on February 3, 2026
TMX Newsfile· 2026-01-20 14:30
Core Viewpoint - Adia Nutrition Inc. has received notification from the SEC that its Form 10 registration statement will automatically become effective on February 3, 2026, marking a significant milestone in its transition to full SEC reporting status [1][2][4]. Group 1: SEC Registration and Reporting - The Form 10 was originally filed on December 5, 2025, and its effectiveness will enhance transparency for investors through regular audited financial disclosures, including annual reports on Form 10-K and quarterly reports on Form 10-Q [2][4]. - The notification from the SEC is seen as a major step forward for Adia Nutrition, as it will provide investors with increased confidence and transparency starting February 3 [3][4]. Group 2: Business Operations and Growth Strategy - Adia Nutrition focuses on delivering innovative healthcare solutions through its divisions, including Adia Med clinics that specialize in advanced stem cell therapies and Adia Labs that provide biologic products to healthcare providers [5][7]. - The company generates revenue through service fees, product sales, equity stakes, and billing insurance for healthcare treatments, while also investing in aligned businesses like Cement Factory LLC [8]. Group 3: Future Prospects and Strategic Partnerships - The effectiveness of the Form 10 will trigger standard SEC reporting obligations, aligning Adia with best practices in public company disclosure and positioning it to meet eligibility requirements for potential listing on a national exchange [4]. - The company encourages clinic owners and healthcare practitioners to explore licensing the Adia Med name or integrating its regenerative therapies into their practices, indicating a focus on strategic partnerships to expand access to advanced stem cell solutions [6].
Adia Med Kicks Off Recruitment Today for Innovative Autism Stem Cell Study
TMX Newsfile· 2026-01-13 15:16
Winter Park, Florida--(Newsfile Corp. - January 13, 2026) - ADIA Nutrition Inc. (OTCQB: ADIA), today announced that its subsidiary, Adia Med of Winter Park, LLC., has officially begun the recruitment process for a groundbreaking clinical study evaluating the potential benefits of stem cell therapy in children with Autism Spectrum Disorder (ASD). The 24-month randomized interventional study, officially titled "Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study" and listed on ClinicalTrials. ...
BioStem Technologies Comments on Withdrawal of CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes
Globenewswire· 2026-01-07 21:05
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 ...
Adia Nutrition Inc. Announces Landmark Autism Spectrum Disorder Clinical Study Now Live on ClinicalTrials.gov
TMX Newsfile· 2026-01-05 15:21
Winter Park, Florida--(Newsfile Corp. - January 5, 2026) - Adia Nutrition Inc. (OTCQB: ADIA), an emerging leader in regenerative medicine through its subsidiary Adia Med, today announced that its patent-pending clinical study targeting Autism Spectrum Disorder (ASD) has gone live on ClinicalTrials.gov, marking a significant advancement in the company's research pipeline.Clinical trial NCT07304440To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/10520/279460_adi ...
BioStem Technologies® to Debut American Amnion™ at the 2025 Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference
Prism Media Wire· 2025-12-10 12:01
Core Insights - BioStem Technologies has launched a new product line, American Amnion, aimed at enhancing wound care for veterans, showcasing its commitment to serving this underserved population [1][3][6] Product Overview - American Amnion and American Amnion AC are placental-derived allografts designed to improve chronic wound healing through enhanced structural integrity and cell preservation [2][4] - American Amnion AC consists of full thickness dehydrated human amnion and chorion membrane, while American Amnion is made from dehydrated human amnion membrane, both utilizing BioStem's proprietary BioRetain technology [4] Clinical Performance - Clinical studies indicate that allografts produced with BioRetain technology show superior performance, with a 53% probability of wound closure compared to 31% for standard care [5] - The BioRetain-preserved DHACM demonstrated a 14% reduction in time to closure and required 27% fewer applications than a leading competitor [5] Market Context - The use of placental-based products in the VA system has increased by 50% over the last five years, highlighting a growing demand for advanced wound care solutions [6] - The introduction of American Amnion is positioned as a significant advancement in the standard of care for veterans with chronic, non-healing wounds [6] Community Engagement - BioStem Technologies is actively involved in community support, exemplified by its sponsorship of the Florida Panthers' Heroes Among Us program, which honors military veterans [7] Company Background - BioStem Technologies specializes in placental-derived biologics for advanced wound care, focusing on innovative solutions that leverage the natural properties of perinatal tissue [8] - The company’s products are processed at an FDA registered and AATB accredited facility in Pompano Beach, Florida, ensuring compliance with industry standards [8]
BioStem Technologies Expands Product Access in Medicaid
Globenewswire· 2025-11-25 13:59
Florida Medicaid Adds BioStem’s VENDAJE® and VENDAJE AC® to Covered Skin Substitutes ListPOMPANO BEACH, Fla., Nov. 25, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company specializing in placental-derived biologics for advanced wound care, today announced expanded reimbursement with the inclusion of VENDAJE® and VENDAJE AC® in Florida Medicaid’s list of covered skin substitutes. This expansion marks a significant milestone in BioStem’s national reimbursement strategy, ...
BioStem Technologies Reports Third Quarter 2025 Financial Results
Prism Media Wire· 2025-11-13 21:02
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]
BioStem Technologies Provides Comments on CMS CY 2026 Final Medicare Reimbursement Rule Changes for Skin Substitutes
Globenewswire· 2025-11-05 21:05
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]
Celularity and DefEYE, Inc. Partner to Advance Growth of Regenerative Therapies in Eye Care
Globenewswire· 2025-10-30 12:00
Core Insights - Celularity Inc. has formed a strategic partnership with DefEYE, Inc., focusing on regenerative therapies in eye care through an exclusive license and pricing arrangement [1][3] - DefEYE aims to leverage Celularity's expertise and biologics portfolio to enhance its offerings in the ophthalmic market, with a significant sales growth of nearly 70% in 2024 compared to the previous year [2][3] - The partnership is expected to facilitate the launch and scaling of decellularized biologic solutions for eye care, with Celularity serving as the exclusive contract manufacturer for DefEYE's products [2][5] Company Overview - Celularity Inc. specializes in regenerative and aging-related cellular medicine, developing advanced biomaterial products and cell therapies derived from postpartum placenta [5] - DefEYE, Inc. is focused on transforming therapeutic approaches in eye care, delivering innovative decellularized biologic solutions for various ocular conditions [6] Strategic Implications - The collaboration is seen as a strategic opportunity for both companies, aligning their capabilities to drive innovation in the eye care sector [3][5] - Celularity's investment and licensing agreement reflect its commitment to expanding into new markets and enhancing its portfolio of commercial products [3][5]