HOUSTON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the Treatment of Re ...

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].

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]

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]

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]

Core Viewpoint - CollPlant Biotechnologies has announced the development of the first fully humanized 3D bioprinted skin model using its proprietary plant-derived recombinant human collagen (rhCollagen), which offers a sustainable alternative to animal testing for preclinical research and has broad applications in cosmetic and pharmaceutical testing, disease modeling, and drug development [1][7]. Group 1: Technology and Innovation - The 3D bioprinted skin model integrates CollPlant's rhCollagen-based bioinks with essential human skin cell types, enabling the evaluation of drug delivery in a non-animal model [2][7]. - The use of plant-derived rhCollagen allows for high-throughput production of personalized human skin models, which can be applied in regenerative medicine and other medical fields [2][3]. Group 2: Company Overview - CollPlant is focused on regenerative and aesthetic medicine, utilizing 3D bioprinting technologies for tissue repair and medical aesthetics, with products based on its proprietary rhCollagen [4]. - The company has a development and commercialization agreement with Allergan, an AbbVie company, for dermal and soft tissue fillers, indicating its strategic partnerships in the market [5]. Group 3: Market Implications - The innovative skin model represents a significant advancement in reducing animal testing and enhancing the ethical standards of preclinical research, which could lead to broader acceptance and application in the cosmetic and pharmaceutical industries [1][7]. - The results from Mayo Clinic's research validate the potential of rhCollagen-based bioinks for various applications, including in vitro 3D models and regenerative medicine [3].

Innovation & Technology in Healthcare - Innovation involves combining existing elements in novel ways, differentiating leaders from followers [6] - The speaker's health challenges spurred the development of innovative surgical tools and techniques, including a specialized stool for operating despite physical limitations [7] - The speaker pioneered Asia Pacific Gyne robotic surgery using yogaras in 2022 [8] Addressing Infertility with Regenerative Medicine - Infertility significantly impacts couples emotionally, physically, and psychologically [8] - Regenerative medicine, including activated PRP and stem cells, is used to improve egg quality and quantity in women facing early menopause or poor oocyte quality [12] - Regenerative medicine is utilized to treat thin endometrium, improving the chances of successful implantation [10] - The speaker's team successfully used regenerative medicine to save pregnancies threatened by premature rupture of membranes and large fibroids [13][14] Personal Resilience & Vision - Overcoming chronic illnesses, including heart failure and a rare autoimmune disorder, has been a significant part of the speaker's journey [3][5] - The speaker emphasizes the importance of self-belief, challenging oneself, and continuous learning and training [15] - The speaker advocates for finding tailored solutions and pushing boundaries to achieve what seems impossible [16][17]

Core Insights - Avant Technologies, Inc. has formed a Joint Venture and License Agreement with Art-Islets Pte. Ltd. and Austrianova to develop innovative diabetes treatments using stem cell and encapsulation technologies [1][2][3] Company Overview - Avant Technologies is a Nevada-based technology company focused on advancing innovative technologies and strategic partnerships in the biotech sector [6] - Art-Islets specializes in stem cell differentiation for insulin-producing cells and aims to address global diabetes challenges through its proprietary technology [9] - Austrianova is a leading biotechnology company in Singapore, known for its cell encapsulation technology and GMP-grade cell products, with over 50 peer-reviewed publications [7] Joint Venture Details - The collaboration aims to research, develop, manufacture, and commercialize advanced diabetes treatments using encapsulated stem cells [2] - The partnership may establish a new U.S.-based entity to support clinical trials while maintaining the same ownership structure as the Joint Venture [2] - Exclusive licenses granted by Art-Islets and Austrianova will enable the Joint Venture to tackle significant health challenges related to diabetes [2] Leadership Statements - Avant's CEO, Chris Winter, expressed excitement about the partnership, highlighting the potential for groundbreaking diabetes treatments that could impact millions [3] - Austrianova's CEO, Brian Salmons, emphasized the promise of cell-based therapies and the collective strengths of the partnership [5] - Art-Islets' CEO, Kristmundur Sigmundsson, noted that their proprietary technology represents years of research aimed at addressing diabetes [5] Funding and Milestones - Avant Technologies will provide initial funding over the next eight months to achieve the first three milestones outlined in the agreement [7] - The company plans to leverage its resources to secure further funding to advance the Joint Venture towards a potential Phase 1 clinical trial in the U.S. or equivalent territory [7]

Core Insights - Sernova Biotherapeutics has appointed John L. Brooks III as Chair of the Board of Directors, which is seen as a significant move for the company as it advances its Cell Pouch Bio-hybrid Organ for type 1 diabetes (T1D) treatment [1][2] Company Overview - Sernova Biotherapeutics is a clinical-stage company focused on developing regenerative medicine therapeutics, specifically the Cell Pouch Bio-hybrid Organ, aimed at treating T1D and thyroid disorders [4] - The Cell Pouch integrates human donor cells or stem-cell derived islet-like clusters to create bio-hybrid organs, representing a novel approach to treating chronic diseases [4] Leadership Appointment - John L. Brooks III brings extensive experience in T1D, venture capital, and early-stage company development, which is expected to be invaluable as Sernova progresses in its clinical trials [2][3] - Brooks has a notable background, including serving as Chair and CEO of the Joslin Diabetes Center and co-founding several life science companies, including Insulet Corporation [2][3] Clinical Development - The company is currently advancing its Cell Pouch Bio-hybrid Organ into the final cohort of its ongoing phase 1/2 clinical trial, with the potential to significantly improve islet cell transplantation through novel immunotherapies [2][3]

Group 1 - Sana Biotechnology Inc. (NASDAQ:SANA) is recognized as a promising emerging technology stock focused on next-generation cell and gene therapies, including ex vivo engineered cells and in vivo delivery technologies [1] - The company aims to develop medicines that can repair or control genes and replace damaged cells, positioning itself at the forefront of regenerative medicine [1] - Following the second-quarter 2025 results, H.C. Wainwright analyst Emily Bodnar reaffirmed a Buy rating on Sana Biotechnology with a price target of $11 [2] Group 2 - The UP421 program has shown encouraging results in islet cell survival and function for type 1 diabetes patients without immunosuppression, validating Sana's hypoimmune (HIP) platform [3] - The company is also advancing SC451, a one-time iPSC-derived HIP-modified islet cell therapy, with positive feedback from a pre-IND FDA INTERACT meeting, paving the way for an IND filing in 2026 [3] - Sana's financial position is strong, with a cash balance of approximately $177 million, providing a solid foundation to pursue development milestones [4] Group 3 - The scalability and immunosuppression-free profile of SC451 present a significant market opportunity for the company [4]