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]

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, ...

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. 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 - 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]

Core Insights - Adia Nutrition has reported an extraordinary revenue growth of over 200% in Q3 compared to the previous quarter, alongside a net profit margin exceeding 20% [2] - The early release of Q3 financial results reflects the company's commitment to transparency and operational excellence, positioning it as a leader in the health and wellness industry [1][2] Financial Performance - The company achieved revenue growth of over 200% compared to the prior quarter, surpassing previously forecasted financial targets [2] - The net bottom-line profit margin for Q3 exceeded 20%, indicating strong financial health and effective cost management [2] Strategic Initiatives - Adia Nutrition is focused on expanding its product portfolio and creating value for customers and stakeholders through innovative strategies [2] - The company is actively seeking strategic partnerships with clinic owners and healthcare practitioners to license the Adia Med name and integrate regenerative therapies into their practices [3] Company Overview - Adia Nutrition Inc. specializes in stem cell and regenerative products, operating through its lab division, AdiaLabs LLC, and expanding its network of Adia Med clinics [4] - The company generates revenue through service fees, product sales, equity stakes, and insurance billing for healthcare treatments [5] - Adia Nutrition is committed to advancing healthcare through innovation and standardized, FDA-approved lab protocols [5]

Core Viewpoint - Regen BioPharma is addressing comments from the FDA regarding its Orphan Drug Application for HemaXellerate, aimed at treating aplastic anemia, a rare and serious bone marrow disorder [1][3]. Company Overview - Regen BioPharma, Inc. is a publicly traded biotechnology company focused on immunology and immunotherapy, advancing novel technologies through pre-clinical and Phase I/II clinical trials [8]. Product Details - HemaXellerate is a novel, cell-based therapeutic designed to stimulate bone marrow activity and restore hematopoietic function, representing a significant milestone in the company's mission to develop innovative therapies for patients with limited options [2][5]. - The product is an autologous mesenchymal stem cell product expected to reverse the effects of aplastic anemia-induced bone marrow suppression [5]. Regulatory Aspects - The Orphan Drug Application is a major step for the company, as receiving orphan drug designation from the FDA would provide regulatory and commercial advantages, including seven years of market exclusivity, tax credits for clinical testing, and exemption from certain FDA application fees [3][4]. Market Context - Aplastic anemia is characterized by insufficient blood cell production, leading to severe health issues such as fatigue and infections, with current treatment options being limited and often ineffective [4].

Core Insights - BioStem Technologies Inc. is a leading MedTech company specializing in placental-derived biologics for advanced wound care [1][4] - The company will present at the Morgan Stanley Global Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference in New York [2][5] - BioStem's proprietary BioREtain processing method is designed to maintain growth factors and preserve tissue structure, enhancing the efficacy of its products [4] Company Overview - BioStem Technologies focuses on the development, manufacture, and commercialization of allografts for regenerative therapies [4] - The company’s quality management system is accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP) [4] - BioStem's product portfolio includes brands such as AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [4]

Core Insights - BioStem Technologies, Inc. disclosed an insider purchase of common stock by Jason Matuszewski, the Chairman and CEO, indicating confidence in the company's future prospects [1][2] Group 1: Insider Transactions - Jason Matuszewski purchased a total of 15,500 shares on August 19, 2025, for approximately $100,000, with transactions executed at average prices of $6.28 for 2,500 shares and $6.51 for 13,000 shares [2] - Following these transactions, Mr. Matuszewski's total ownership in BioStem Technologies increased to 1,145,362 shares [2] Group 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, enhancing the effectiveness of its allografts for regenerative therapies [3] - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [3] - The company's product portfolio includes brands such as AmnioWrap2™, VENDAJE, VENDAJE AC, and VENDAJE OPTIC, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [3]

Core Insights - BioStem Technologies, Inc. reported preliminary financial results for Q2 2025, highlighting a sixth consecutive quarter of positive adjusted EBITDA despite facing revenue challenges due to increased competition and reimbursement uncertainties [4][9][11]. Recent Business Highlights - The company appointed Brandon Poe as the new Chief Financial Officer, bringing over 25 years of healthcare finance experience [4][8]. - BioStem completed enrollment in a clinical trial for BioREtain® Amnion Chorion aimed at treating diabetic foot ulcers, with data expected in Q4 2025 [8]. - The commercial organization is expanding with new direct representatives to access additional care sites [8]. - The intellectual property portfolio has been expanded with three new U.S. patent applications, totaling 58 issued and 68 pending patents [8]. Preliminary Financial Highlights - Net revenue for Q2 2025 was $49.3 million, a 34% decrease from Q2 2024, primarily due to lower volumes in the wound care portfolio [9][27]. - Gross profit was $48.6 million, representing 98.6% of net revenue, compared to $70.7 million or 95.0% of net revenue in Q2 2024 [10]. - Operating expenses decreased to $48.5 million from $61.9 million in Q2 2024, driven by lower revenue and reduced sales and marketing costs [10]. - Adjusted EBITDA for Q2 2025 was $2.5 million, down from $10.1 million in Q2 2024, reflecting lower gross profit but offset by reduced operating expenses [11]. - The company reported a GAAP net loss of $0.6 million or ($0.03) per share, compared to net income of $6.3 million or $0.39 per share in Q2 2024 [12][27]. - Cash and cash equivalents increased to $30.8 million as of June 30, 2025, up from $26.7 million as of March 31, 2025 [12][27]. Uplisting and Audit Update - BioStem is pursuing an uplisting to Nasdaq and is currently working through the audit of its historical financial statements [5][6]. - The company has clarified the accounting treatment for its distribution agreement with Venture Medical and is preparing to file an amended Form 10 to address SEC comments [5][6].