Clinical Development Program Appropriate for Rolling BLA Submission Expected by the End of 2025 CANTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the successful completion of a planned Type-B meeting with the Food and Drug Administration (FDA) resulting in co ...

Winter Park, Florida--(Newsfile Corp. - December 15, 2025) - Adia Nutrition Inc. (OTCQB: ADIA), a leader in regenerative medicine through its Adia Med subsidiary, today announced that the independent Institutional Review Board (IRB) BeyondBound has approved the company's patent-pending clinical study protocol focused on Autism Spectrum Disorder (ASD).IRB Approval EmailTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/10520/278050_adia_irb_approved_screenshot.jp ...

Core Insights - Regenerative Medical Technologies Group, Inc. has launched its CELLGENIC Peptide Pen product line, enhancing its position in the regenerative medicine market [1] - The introduction of this product line aims to simplify and modernize peptide therapy, aligning with trends in longevity medicine [1] - The new product line is expected to generate additional revenue through the company's established physician distribution network across over 30 countries [1] Company Overview - Regenerative Medical Technologies Group, Inc. is recognized as a global leader in regenerative medicine solutions [1] - The company is actively expanding its product offerings to meet the growing demand for innovative medical therapies [1] Market Impact - The launch of the CELLGENIC Peptide Pen is positioned to create new revenue streams, indicating a strategic move to capitalize on the expanding market for peptide therapies [1] - The product line's introduction during the ISSCA Global Summit highlights the company's commitment to innovation and leadership in the field [1]

Core Insights - ADIA Nutrition, Inc. has filed a provisional patent application for a novel medical protocol aimed at enhancing regenerative outcomes, marking a significant advancement in the field of regenerative medicine [1][2]. Company Overview - ADIA Nutrition, Inc. is based in Winter Park, Florida, and is publicly traded, focusing on advanced healthcare solutions, particularly in stem cell and regenerative products [5]. - The company operates through its lab division, AdiaLabs LLC, and is expanding its offerings to include insurance-billable wound care products [5][6]. Innovation and Intellectual Property - The newly filed provisional patent represents a proprietary protocol that utilizes unique procedural and biological mechanisms not previously explored in clinical practice, positioning the company as a leader in regenerative medicine [2][3]. - Securing this patent is a crucial step for the company to protect its intellectual property and accelerate the development of next-generation health solutions [3]. Strategic Development - The patent pending status allows ADIA to pursue research, partnerships, and commercialization opportunities over the next 12 months while maintaining confidentiality [3]. - The company is actively seeking strategic partnerships and encouraging clinic owners and healthcare practitioners to integrate its regenerative therapies into their practices [4]. Revenue Generation - ADIA generates revenue through service fees, product sales, equity stakes, and billing insurance for healthcare treatments [6]. - The company is also investing in aligned businesses, such as Cement Factory LLC, which focuses on health and wellness [6].

Core Insights - Visionary Holdings Inc. has officially launched its medical-grade stem cell anti-aging product line, targeting the Chinese mainland and broader Asian markets [1][2] - This launch follows the company's entry into the stem cell and medical aesthetics sector and a strategic partnership with Jiangsu Yike Regenerative Medicine Co., Ltd. [2][3] Product Lines and Value Model - The anti-aging product portfolio includes three major categories: Life Rejuvenation Program, Precision Repair Package, and Premium Personalized Program [6] - The Life Rejuvenation Program combines mesenchymal stem cells, NK cell therapy, and AI-based diagnostics, aimed at high-net-worth individuals [6] - The Precision Repair Package integrates targeted stem cell therapy and blood purification for clients with specific conditions [6] - The Premium Personalized Program offers full-genome sequencing and customized health management for ultra-high-net-worth clients [6] Commercialization Strategy - The new products will be operated through the Asia-Pacific headquarters in Hong Kong, initially launching in Hong Kong, Singapore, and the Chinese mainland [4] - The company plans to establish a joint venture for localized manufacturing and validation of stem cell products [7] - A cross-border sales and distribution network will be built, covering mainland China, Hong Kong, Southeast Asia, and expanding into Canada, the United States, and Mexico [7] Management Perspective - The CEO of Visionary Holdings emphasized that the launch marks a significant milestone in converting technological assets into commercial value [4] - The company anticipates that this product line will drive profitability in upcoming fiscal years and enhance its visibility in global capital markets [5]

Core Insights - Adia Nutrition Inc. has formed a strategic partnership with AxiaMD to enhance the delivery of regenerative therapies to chiropractic clinics across the United States under full physician oversight [1][2][3] Partnership Details - AxiaMD's network will provide Adia Labs' regenerative products to clients, while Adia Nutrition's clinics will benefit from AxiaMD's compliance and oversight services, ensuring operations are fully compliant across all 50 states [2][3] - This collaboration allows chiropractic clinics to perform advanced regenerative procedures with regulatory compliance, creating a scalable national platform for transformative therapies [3][4] Financial Performance - Adia Nutrition reported over 200% revenue growth in Q3 2025, indicating strong momentum leading to its OTCQB uplisting and potential Nasdaq eligibility [4] Product Offerings - Adia Labs specializes in FDA-compliant stem cell products, including AdiaVita and AdiaLink, and is expanding its offerings to include insurance-billable wound care products [5][7] - Adia Med clinics provide specialized regenerative treatments such as stem cell therapies, platelet-rich plasma (PRP), and advanced treatments like therapeutic plasma exchange (TPE) [5] Revenue Generation - 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]

Core Insights - Organogenesis Holdings Inc. reported record revenue performance in Q3 2025, driven by strong execution and customer relationships, positioning the company well for future growth opportunities [3][4]. Financial Performance - Net product revenue for Q3 2025 was $150.5 million, a 31% increase from $115.2 million in Q3 2024, with Advanced Wound Care products contributing $141.5 million (up 31%) and Surgical & Sports Medicine products contributing $9.0 million (up 25%) [4][7]. - Gross profit for Q3 2025 was $114.2 million, representing 76% of net product revenue, compared to $88.4 million (77%) in Q3 2024, marking a 29% increase [5]. - Operating expenses for Q3 2025 were $130.1 million, up 19% from $108.9 million in Q3 2024, with significant increases in cost of goods sold and selling, general, and administrative expenses [6]. - Net income for Q3 2025 was $21.6 million ($0.11 per share), compared to $12.3 million ($0.09 per share) in Q3 2024, reflecting a $9.2 million increase [9]. - Adjusted EBITDA for Q3 2025 was $30.1 million, up from $13.4 million in Q3 2024, indicating strong operational performance [10]. Year-to-Date Results - For the nine months ended September 30, 2025, net product revenue was $338.0 million, down 5% from $355.4 million in the same period of 2024, primarily due to a 6% decrease in Advanced Wound Care products [11]. - Gross profit for the nine months was $250.4 million (74% of net product revenue), down from $270.7 million (76%) in the prior year [12]. - Operating expenses for the nine months decreased by 3% to $357.2 million compared to $366.9 million in 2024 [13]. - The company recorded a net loss of $6.7 million for the nine months, slightly improved from a loss of $6.8 million in the same period of 2024 [15]. Guidance and Future Outlook - The company updated its revenue guidance for the fiscal year 2025, expecting net product revenue between $500.0 million and $525.0 million, representing a year-over-year increase of 4% to 9% [20]. - The guidance includes expectations for Advanced Wound Care products to generate between $470.0 million and $490.0 million, and Surgical & Sports Medicine products to generate between $30.0 million and $35.0 million [20].

Core Insights - Organogenesis Holdings Inc. commends the Centers for Medicare & Medicaid Services (CMS) for its payment reform for skin substitutes and cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule [1][2] Group 1: Payment Reform - The new payment methodology includes FDA classifications and a per centimeter square payment approach for both physician offices and hospital outpatient settings [2] - This reform is expected to enhance access to PMA products and address issues of abuse in the current payment system [2] Group 2: Company Positioning - Organogenesis believes it is well-positioned in the skin substitutes market for 2026 and beyond, leveraging over forty years of leadership in regenerative medicine [2] - The company has a diverse, evidence-based portfolio with technologies across all FDA categories, which supports its competitive stance in the market [2]

Core Insights - Organogenesis Holdings Inc. has granted inducement awards to its newly hired Chief Technology Officer, Michael Catarina, consisting of non-statutory stock options and restricted stock units [1][2][3] Summary by Sections Inducement Awards - The inducement awards include non-statutory stock options to purchase 82,542 shares and restricted stock units for 47,962 shares of Class A common stock [1] - The stock options have an exercise price of $4.17 per share, which is the closing price on October 29, 2025 [2] - Both the stock options and restricted stock units will vest annually in substantially equal installments over four years, contingent on Mr. Catarina's continued employment [2] Compliance and Regulations - The awards were granted as an inducement material to Mr. Catarina's acceptance of employment, in accordance with Nasdaq Listing Rule 5635(c)(4) [3] Company Overview - Organogenesis Holdings Inc. specializes in regenerative medicine, focusing on advanced wound care and surgical & sports medicine markets [4] - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [4]

Core Insights - Cryoport, Inc. has achieved ISO 21973:2020 certification, marking it as the first global supply chain solutions company to do so, which emphasizes its commitment to safety and traceability in the cell and gene therapy supply chain [1][3]. Group 1: Certification and Standards - The ISO 21973 standard provides guidelines for managing environmental control, equipment, processes, logistics, and information in transporting therapeutic cells, which is critical for maintaining the effectiveness of living cells [2]. - Cryoport Systems was involved in the development of the ISO 21973 requirements, showcasing its leadership in establishing industry standards [2][3]. Group 2: Industry Impact - The certification reinforces Cryoport's position as a pioneer in the life sciences industry, particularly in regenerative medicine, and highlights its integrated supply chain solutions [3]. - Cryoport Systems applies the ISO 21973 standards across various life sciences sectors, including reproductive medicine and animal health, demonstrating its broad applicability [3]. Group 3: Company Overview - Cryoport, Inc. specializes in temperature-controlled supply chain solutions for life sciences, focusing on minimizing risk and maximizing reliability for biopharmaceutical companies and research organizations [3]. - The company has a global presence with operations across the Americas, EMEA, and APAC, supporting a comprehensive suite of services and products [3].