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Bone Biologics Highlights 2025 Key Operational, Scientific, and Corporate Milestones and Provides 2026 Outlook
Globenewswire· 2026-01-08 13:00
Key accomplishments include expanded rhNELL-1 shelf life, advanced NB1 development, strengthened balance sheet, and maintained Nasdaq complianceBURLINGTON, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Bone Biologics Corporation ("Bone Biologics" or the "Company") (NASDAQ: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, today summarized key corporate, scientific, and operational milestones achieved during 2025 and outlined its strategic outlook for 2026. “We executed with discipline ...
EUDA Accelerates Longevity Strategy with Launch of Comprehensive Stem Cell Therapy Platform and First Clinic in Shenzhen
Globenewswire· 2025-12-23 12:00
SINGAPORE, Dec. 23, 2025 (GLOBE NEWSWIRE) -- EUDA Health Holdings Limited (NASDAQ: EUDA) “EUDA” or “the Company”, a Singapore-based non-invasive healthcare provider in Asia focused on Singapore, Malaysia, and China, today announced a significant acceleration of its longevity and regenerative medicine strategy with the launch of a comprehensive stem cell therapy platform and establishment of its first clinic in Shenzhen, China. This strategic advancement builds on the Company’s earlier acquisition of distrib ...
Celularity Reaches Binding Term Sheets on Financing Transactions to Support Its Strategic Vision
Globenewswire· 2025-12-18 19:10
The contemplated financing transactions would provide up to $12 Million in capital to support Celularity’s strategic priorities around longevity and preservation of human performance. FLORHAM PARK, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today announced that it has entered into two binding term sheets for a senior secured term loan and a secured convertible note finan ...
Adia Labs Launches Turnkey Clinic Model for Chiropractic Practices with BoldMD
TMX Newsfile· 2025-12-17 14:48
Winter Park, Florida--(Newsfile Corp. - December 17, 2025) - Adia Labs, a division of Adia Nutrition Inc. (OTCQB: ADIA), today announced a strategic marketing partnership with BoldMD, a leading medical marketing and AI technology company focused on longevity and wellness. The partnership is designed to accelerate the nationwide expansion of Axia MD's innovative chiropractor-hosted pop-up longevity clinics.This collaboration builds on Adia Labs' recently announced partnership with Axia MD, which provides na ...
Regentis Biomaterials Ltd. Announces Closing of Initial Public Offering
Globenewswire· 2025-12-05 21:10
Herzliya, Israel, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Regentis Biomaterials Ltd. (NYSE American: RGNT) (“Regentis”, or the “Company”), a regenerative medicine company dedicated to developing innovative tissue repair solutions that seek to restore the health and enhance the quality of life of patients, today announced the closing of its initial public offering (the “Offering”) of 1,250,000 ordinary shares (“Ordinary Shares”) at a public offering price of $8.00 per Ordinary Share, for aggregate gross proceeds o ...
FibroBiologics Receives HREC Approval for Phase 1/2 Clinical Trial for CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers
Globenewswire· 2025-11-20 13:00
Core Viewpoint - FibroBiologics has received necessary regulatory approvals for a Phase 1/2 clinical trial of CYWC628 aimed at treating refractory diabetic foot ulcers, marking a significant milestone in the company's development of fibroblast-based therapies [1][5]. Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics for chronic diseases using fibroblast cells and fibroblast-derived materials. The company holds over 270 patents issued and pending across various clinical pathways [1][11]. Clinical Trial Details - The approved clinical trial is a prospective, multicenter, randomized study designed to evaluate the safety, tolerability, and efficacy of CYWC628, a topically administered allogeneic fibroblast cell-based therapy for refractory diabetic foot ulcers. The trial will enroll 120 patients across 10 sites in Australia [1][3]. - Participants will receive treatment for up to 12 weeks, either with standard of care plus a low or high dose of CYWC628, or standard of care alone [3][10]. Trial Management - Southern Star Research, a full-service Australian CRO, will manage all aspects of the CYWC628 trial, continuing its partnership with FibroBiologics [2]. Expected Outcomes - The trial will assess wound healing outcomes, efficacy of response, and safety parameters through regular clinical and imaging evaluations. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to evaluate primary safety and efficacy endpoints [4][10]. - The study aims to provide key clinical data supporting CYWC628 as a novel therapy for chronic wound management, addressing a significant unmet need in this area [5].
Lineage Cell Therapeutics: OpRegen Makes It A Viable Speculative Buy
Seeking Alpha· 2025-11-13 09:10
Company Overview - Lineage Cell Therapeutics (LCTX) is a regenerative medicine company focused on utilizing pluripotent stem cells to create specialized human cells for organ tissue regeneration [1]. Technology and Applications - The company's platform aims to generate off-the-shelf human cells that can replace damaged tissues in various organs, including potential applications in regenerating the eyes, spinal cord, and auditory systems [1].
Game-Changing Alliance: Adia Labs and Axia
Newsfile· 2025-11-10 14:00
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]
Organogenesis (ORGO) - 2025 Q3 - Earnings Call Transcript
2025-11-06 23:00
Financial Data and Key Metrics Changes - Net product revenue for Q3 2025 was $150.5 million, up 31% year-over-year and up 49% sequentially, exceeding previous guidance [12][13] - Gross profit for Q3 was $114.2 million, or 76% of net product revenue, compared to 77% last year [13] - GAAP net income for Q3 was $21.6 million, compared to $12.3 million last year, an increase of $9.2 million [15] - Adjusted EBITDA for Q3 was $30.1 million, compared to $13.4 million last year [15] Business Line Data and Key Metrics Changes - Advanced wound care net product revenue for Q3 was $141.5 million, up 31% year-over-year [12] - Net product revenue from surgical and sports medicine products for Q3 was $9 million, up 25% [13] Market Data and Key Metrics Changes - The final Medicare physician fee schedule for 2026 was announced, which is expected to significantly impact the industry [4][5] - The new policy is anticipated to address rapid escalation in Medicare spending while ensuring consistent payment across care sites [5][10] Company Strategy and Development Direction - The company aims to leverage its strong brand equity and deep customer relationships to enhance market presence [10] - There is a commitment to work with CMS and other stakeholders to expand access to innovative technologies [5][10] - The company plans to advance its competitive position by focusing on clinical evidence and product efficacy [10][30] Management's Comments on Operating Environment and Future Outlook - Management noted that they are starting to see changes in clinician behavior regarding product utilization following the new fee schedule [23] - The company expects to regain market share lost in previous years and anticipates growth drivers in 2026 [30] - There is confidence in the potential approval of the Renew product based on combined efficacy data from trials [9][36] Other Important Information - The company amended its credit agreement to provide access to up to $75 million of future borrowings [16] - The updated revenue guidance for 2025 is between $500 million and $525 million, representing a year-over-year increase of 4% to 9% [17] Q&A Session Summary Question: How are conversations with the clinical community regarding physician behavior changes following the PFS? - Management indicated that changes in clinician behavior are starting to be observed, with contracts being processed for approved products [23] Question: What can the company do to generate awareness regarding products as volume opens up? - The company plans to leverage strong brand equity and focus on clinical efficacy to raise awareness [24] Question: How might the new rates impact margins for next year? - Management noted that while ASPs are expected to decline, the company is well-positioned with covered products that will be reimbursed at higher rates [30] Question: Are initial approval timelines for Renew still on the table? - Management believes there is still an opportunity to file for approval, with a potential two-month delay being reasonable [36]
BioRestorative Therapies to Report Third Quarter 2025 Financial Results and Host Conference Call on November 12, 2025
Globenewswire· 2025-11-05 21:30
Core Insights - BioRestorative Therapies, Inc. will release its third quarter 2025 financial results on November 12, 2025, after market close, followed by a conference call for a business update [1][2] Company Overview - BioRestorative is focused on regenerative medicine, particularly stem cell-based therapies and products [3] - The company has two main clinical development programs: the Disc/Spine Program and the Metabolic Program, along with a commercial BioCosmeceutical platform [3][4] Disc/Spine Program - The lead cell therapy candidate, BRTX-100, is derived from a patient's own cultured mesenchymal stem cells and is intended for non-surgical treatment of lumbosacral disc disorders [3] - BRTX-100 is currently in a Phase 2 clinical trial for chronic lower back pain due to degenerative disc disease and has received FDA IND clearance for chronic cervical discogenic pain [3] Metabolic Program - The ThermoStem® program aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells (BADSC) [4] - Initial preclinical research suggests that increased brown fat may enhance caloric burning and lower glucose and lipid levels, potentially reducing obesity and diabetes risk [4] BioCosmeceuticals - The company operates a commercial BioCosmeceutical platform, offering a cell-based secretome product designed to reduce fine lines and wrinkles [5] - Future plans include expanding the product line to include more cell-based aesthetic products and therapeutics, with the goal of obtaining FDA approvals [5]