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CollPlant Expands its rhCollagen Distribution Capabilities in the United States and Canada
Prnewswire· 2025-10-27 11:01
Core Insights - CollPlant Biotechnologies is expanding its distribution capabilities in North America by establishing a new logistics center in the U.S. to support its rhCollagen and BioInk product lines [1][3][4] Group 1: Expansion and Infrastructure - The new logistics center will provide cGMP-compliant storage and distribution services, enhancing logistical efficiencies for CollPlant's operations in the U.S. and Canada [1][2] - The facility features advanced infrastructure, including a cloud-based temperature monitoring system, AI-powered security, and remote inventory management, ensuring reliable and secure distribution [2] Group 2: Strategic Commitment - The establishment of the U.S. logistics center reflects CollPlant's long-term commitment to the North American market and is seen as a significant milestone in advancing its regenerative medicine products [3] - By maintaining local inventory, the company aims to improve efficiency and reduce shipping times, thereby enhancing customer access to its products [3] Group 3: Company Overview - CollPlant focuses on regenerative and aesthetic medicine, utilizing its proprietary recombinant human collagen technology for various applications, including tissue repair and organ manufacturing [4] - The company has previously entered into a global commercialization agreement for dermal and soft tissue fillers with Allergan, a leader in the dermal filler market [5]
Hemostemix Granted Trademark "KNOW YOUR HEALTH" in Japan, International Registration No. 1744775 Covers Stem Cell Preparations and Research in Classes 1, 5, 42
Newsfile· 2025-10-22 14:04
Core Viewpoint - Hemostemix Inc. has been granted the trademark "KNOW YOUR HEALTH" in Japan, enhancing its intellectual property and global branding strategy in regenerative medicine and personalized health innovation [2][3]. Trademark Grant Details - The trademark registration covers Classes 1, 5, and 42, which include chemicals for scientific research, pharmaceutical preparations, and technological services in regenerative medicine [6]. - The registration number is International Registration No. 1744775, issued by the Japanese Patent Office [6]. Strategic Significance - The trademark aligns with Hemostemix's clinical programs, particularly the ACP-01 treatment for various ischemic and cardiopulmonary diseases, reinforcing the synergy between brand identity and product pipeline [5]. - The registration strengthens Hemostemix's global intellectual property portfolio, particularly in Japan, a leading market for medical research [10]. - The trademark allows for expanded therapeutic coverage, reflecting Hemostemix's leadership in developing autologous cell-based treatments for vascular and degenerative disorders [10]. - It provides a platform for global collaboration, enabling licensing and commercialization of innovations within Japan's regulatory framework for regenerative medicine [10]. CEO Commentary - The CEO expressed honor at the trademark grant, highlighting its importance for the company's commitment to improving patient health through autologous stem-cell therapy and enhancing partnerships with institutions in Asia [7]. Company Overview - Hemostemix is an autologous stem cell therapy platform company founded in 2003, known for its VesCell™ (ACP-01) treatment, which has shown significant clinical results in various studies [8]. - The company has completed seven clinical studies involving 318 subjects, demonstrating the safety and efficacy of ACP-01 for treating multiple ischemic conditions [8].
Visionary Holdings Launches Toronto-Based Joint Venture to Drive Global Commercialization of Innovative Stem Cell Therapy for Diabetes Remission, Targeting a $150 Billion Market Opportunity
Prnewswire· 2025-10-22 13:30
Core Viewpoint - Visionary Holdings Inc. has signed a strategic cooperation agreement with Jiangsu Yike Regenerative Medical Technology Co., Ltd. to establish a joint venture, Visionary Yike Stemcell Technologies Inc., aimed at advancing stem cell research and commercialization globally [1][5]. Group 1: Joint Venture Details - The joint venture will focus on stem cell therapy, immune cell engineering, and AI-supported anti-aging diagnostics, leveraging Yike's proprietary platform and GV's global market infrastructure [3]. - GV will hold an 85% equity stake in the joint venture, while Yike will hold 15% [3]. - The joint venture aims to create a vertically integrated regenerative medicine enterprise encompassing R&D, trials, manufacturing, and global sales [3]. Group 2: Location and Infrastructure - The headquarters for the joint venture is proposed to be located at GV's property in Toronto, which spans over 40,000 square meters [2]. - The parties are evaluating the feasibility of developing cleanrooms, low-temperature biostorage, and related infrastructures to support future operations [2]. Group 3: Strategic Importance - The establishment of the joint venture is seen as a transformative milestone for GV's global health strategy, with potential for long-term value creation [4]. - This collaboration is expected to enhance GV's positioning in the North American stem cell sector and reflects a commitment to global innovation and shareholder value [5]. Group 4: Company Background - Visionary Holdings Inc. is a technology-driven multinational enterprise focused on innovative education, AI applications, and high-tech healthcare solutions, operating across North America and Asia [6]. - Jiangsu Yike Regenerative Medicine specializes in regenerative medicine and precision anti-aging technologies, holding numerous international patents and certifications [7].
Adia Nutrition Inc. Appoints Dr. Evan Thomas, MD, PhD, to Drive Adia Med's Specialized Treatment Revolution
Newsfile· 2025-10-21 13:00
Core Insights - Adia Nutrition Inc. has appointed Dr. Evan Thomas as Independent Medical Director for its medical division, Adia Med, to enhance specialized treatment offerings [2][5] - Dr. Thomas will oversee the Autologous Hematopoietic Stem Cell Transplantation (AHSCT) program and finalize protocols for patient intake [2][5] - The company aims to expand access to advanced stem cell solutions through strategic partnerships and licensing opportunities for clinic owners [6][8] Company Overview - Adia Nutrition Inc. is based in Winter Park, Florida, and is publicly traded, focusing on healthcare innovation [7] - The company specializes in stem cell and regenerative products, including AdiaVita and AdiaLink, and is expanding its lab division to include insurance-billable wound care products [7][8] - Adia Med clinics provide specialized regenerative treatments such as stem cell therapies, platelet-rich plasma (PRP), and therapeutic plasma exchange (TPE) [7][8] Leadership and Expertise - Dr. Evan Thomas is recognized for his expertise in oncology and has a significant background in central nervous system (CNS) and functional radiosurgery [4][5] - His leadership is expected to redefine Adia Med's impact on patient care and clinical operations [5] Revenue Generation - Adia Nutrition Inc. generates revenue through service fees, product sales, equity stakes, and insurance billing for healthcare treatments [8]
Healios K.K. to Present at Chardan’s 9th Annual Genetic Medicines Conference
Globenewswire· 2025-10-20 22:21
Company Overview - HEALIOS K.K. is Japan's leading clinical stage biotechnology company focused on regenerative medicine using stem cells [2] - The company was established in 2011 and has been listed on the Tokyo Stock Exchange since 2015 under the code 4593 [2] Product Development - Healios is developing MultiStem® (HLCM051), a proprietary cell product derived from multipotent adult progenitor cells (MAPCs) from healthy adult donors, which has shown anti-inflammatory and immunomodulatory properties [2] - MultiStem has been tested in hundreds of patients in late-stage clinical trials and is manufactured at scale in 3D bioreactors, demonstrating safety and suggested efficacy across multiple indications [2] - The company aims to advance MultiStem globally for conditions such as ARDS, trauma, and ischemic stroke [2] - In the iPSC regenerative medicine field, Healios has developed HLCN061, a next-generation NK cell treatment for solid tumors enhanced through gene-editing, showing robust anti-tumor efficacy in animal models [2] - HLCN061 benefits from a scalable 3D bioreactor manufacturing process and is being prepared for initial human testing in collaboration with Akatsuki Therapeutics [2] - Healios has established a proprietary gene-edited "universal donor" induced pluripotent stem cell line for developing next-generation treatments in various severe unmet medical needs [2] Upcoming Events - Richard Kincaid, Chief Financial Officer of Healios, will present at the Chardan 9 Annual Genetic Medicines Conference on October 21, 2025, at 2:00 PM Eastern Time [1]
Aurion Biotech Achieves All Primary, Secondary, and Exploratory Endpoints in AURN001 Phase 1/2 CLARA Trial at 12 Months
Businesswire· 2025-10-18 18:30
Core Insights - Aurion Biotech announced positive 12-month results from its Phase 1/2 CLARA trial, which assessed the safety, efficacy, and tolerability of AURN001 in patients with corneal edema due to corneal endothelial dysfunction [1] Company Summary - Aurion Biotech is a clinical-stage regenerative medicine company focused on restoring vision for millions of patients [1] - The trial evaluated AURN001, which consists of human corneal endothelial cells combined with Y-27632 rho-kinase inhibitor [1]
Mesoblast’s Ryoncil Gains Permanent CMS J-Code for Billing and Reimbursement
Yahoo Finance· 2025-10-16 20:33
Group 1 - Mesoblast Limited's product Ryoncil (remestemcel-L-rknd) received a permanent Healthcare Common Procedure Coding System (HCPCS) J-Code (J3402) from the US Medicare & Medicaid Services, effective October 1 [1][2] - The assignment of the J-Code is a significant commercial milestone, providing a standardized billing pathway that facilitates reimbursement by Medicare, Medicaid, and commercial payers, thus improving patient access to Ryoncil [2][3] - Ryoncil is the first mesenchymal stromal cell product approved by the US FDA for any indication and is specifically approved for pediatric patients aged 2 months and older with steroid-refractory acute graft-versus-host disease [3][4] Group 2 - Mesoblast develops allogeneic cellular medicines aimed at treating severe inflammatory conditions, utilizing a proprietary technology platform based on mesenchymal lineage cells [3][4] - The company operates in multiple regions, including Australia, the US, Singapore, and Switzerland, focusing on regenerative medicine products [4]
Adia Nutrition Paves Way for Nasdaq and New Investors Through SEC Form 10 Submission
Newsfile· 2025-10-14 13:00
Core Insights - Adia Nutrition Inc. is preparing to file its Form 10 registration statement with the SEC, marking a significant transition from OTC reporting to full SEC compliance, which enhances transparency and credibility [1][2][3] - The filing is expected to be submitted by the end of November 2025, with a 60-day SEC review period, aiming for full effectiveness by late January 2026 [2] - This move is crucial for meeting Nasdaq listing requirements, potentially attracting institutional and accredited investors [2][3] Company Overview - Adia Nutrition Inc. operates in two main divisions: a supplement division offering premium organic supplements and a medical division focused on advanced stem cell therapies [5] - The company aims to empower individuals through innovative healthcare solutions, particularly in regenerative medicine and clinical services [5] Strategic Partnerships - The company is open to strategic partnerships with clinic owners and healthcare practitioners interested in licensing the Adia Med name or integrating its regenerative therapies [4]
Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease
Globenewswire· 2025-10-14 12:45
Core Insights - Celularity Inc. announced the publication of its Phase 2 study on PDA-002, a placenta-derived cell therapy for diabetic foot ulcers (DFUs) complicated by peripheral artery disease (PAD), demonstrating safety and efficacy in treating serious wounds [1][6] - The study involved 159 adult patients and was conducted across 35 clinical sites in the U.S., showing that PDA-002 achieved higher rates of wound closure compared to placebo [3][4] Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on developing therapies derived from postpartum placenta to address age-related and degenerative diseases [10] - The company aims to provide effective, accessible, and affordable therapies targeting fundamental aging mechanisms [10] Study Details - The Phase 2 study included patients with chronic DFUs, with a primary efficacy endpoint of complete wound closure within three months, maintaining healing for at least four additional weeks [3] - PDA-002 was administered in three dosage levels (3×10⁶, 10×10⁶, or 30×10⁶ cells) or as a placebo, with the lowest dose showing the highest healing rates in patients with PAD [4] Economic Context - Approximately two million individuals in the U.S. are affected by DFUs annually, with an estimated economic burden of over $9 billion for treating DFUs alone [2] - There are currently no FDA-approved therapies specifically for DFUs complicated by PAD, highlighting the need for innovative treatments [2] Clinical Findings - In patients with PAD, 38.5% of ulcers healed completely with the lowest PDA-002 dose compared to 22.6% in the placebo group, indicating a significant improvement in healing rates [4] - PDA-002 demonstrated a favorable safety profile, with no serious side effects reported during the two-year follow-up [4][5] Future Implications - The positive results from the Phase 2 study position Celularity for a confirmatory Phase 3 trial, aiming to deliver the first FDA-approved targeted therapy for DFU/PAD patients [6] - The recent Florida law allows for expanded access to stem cell therapies like PDA-002, potentially providing new treatment options for patients in the state [7][8]
Apollo Biowellness, Inc., Merger Update
Newsfile· 2025-10-09 18:48
North Bergen, New Jersey--(Newsfile Corp. - October 9, 2025) -  Apollo Biowellness, Inc. (OTCID: KOAN) (the "Company"), is pleased to announce that it has completed the first step in the closing process with Revive Regenerative, Inc. The Company has secured the initial tranche of capital required in the amount of $500,000 as set forth in the merger agreement. In addition, the Company has finalized with GSS Capital to raise the additional $3,000,000 needed, with the terms agreed to by both sides. The partie ...