Announcement • Jul 09
Matricelf Ltd. Receives Approval to Begin Patient Identification and Blood Collection for Planned First-In-Human Spinal Cord Injury Study Matricelf Ltd. has received approval from the Helsinki Committee (Institutional Review Board) and the Director of Loewenstein Rehabilitation Medical Center to begin collecting blood samples from eligible patients with complete thoracic spinal cord injury (AIS A, T2–T12). The collected blood samples will be used to generate induced pluripotent stem cells (iPSCs), which are intended to serve as the cellular component of Matricelf's personalized autologous neural implant. The approval enables the Company to begin identifying and preparing eligible patients for its planned first-in-human clinical study. Collaborating with one of Israel's spinal cord injury rehabilitation centers provides access to a highly specialized multidisciplinary clinical team and a concentrated population of potential study candidates, supporting efficient patient identification and future clinical execution. The approval is limited to blood collection and does not authorize implantation in humans or initiation of the clinical trial, both of which remain subject to additional regulatory and ethics approvals, including authorization from the Israeli Ministry of Health. The announcement follows a series of significant milestones achieved by the Company in recent months, including: Successful completion of its GLP IND-enabling safety study, achieving all predefined safety endpoints. Initiation of GMP clinical manufacturing activities for the Company's personalized autologous neural implants. Continued advancement of efficacy studies supporting the therapeutic potential of the platform. Ongoing regulatory interactions supporting the Company's planned first-in-human clinical program. Establishment of clinical collaboration with Loewenstein Medical Center, one of Israel's spinal cord injury referral centers, supporting patient identification and future clinical execution. Collectively, these milestones represent continued execution of Matricelf's clinical development strategy and further reduce operational risk as the Company advances toward first-in-human studies. Matricelf's investigational therapy is designed as a personalized engineered neural tissue implant combining patient-derived induced pluripotent stem cells (iPSCs) with a proprietary extracellular matrix hydrogel generated from the patient's own omentum tissue. The implant is intended to replace damaged neural tissue using entirely autologous biological components, with the goal of restoring neurological function while minimizing the risk of immune rejection. Announcement • Jun 25
Matricelf Initiates Ind Enabling Efficacy Study for Engineered Human Neural Tissue Implant in Chronic Spinal Cord Injury Matricelf Ltd. announced the initiation of a pivotal preclinical efficacy study evaluating its engineered human neural tissue implant for the treatment of chronic spinal cord injury. The study is designed to generate efficacy data supporting the Company's preparations for a first in human clinical trial. The study is being conducted in accordance with a development framework previously discussed with the U.S. Food and Drug Administration (FDA) and is intended to serve as an IND enabling efficacy study. The program will evaluate functional, behavioral, and histological endpoints that are widely accepted as key measures of therapeutic efficacy in spinal cord injury research. The newly initiated study builds upon previously reported preclinical results demonstrating significant improvements in motor function, sensory recovery, and tissue regeneration following implantation of Matricelf's engineered neural tissue in spinal cord injury models. The current study is designed to further validate the therapeutic potential of the technology using a comprehensive efficacy framework intended to support future regulatory submissions and clinical development. The study will include 96 animals with chronic spinal cord injury and will assess motor and sensory recovery using established outcome measures, including BBB, CatWalk, Mechanical Allodynia, and Thermal Allodynia testing, alongside comprehensive histological analyses of tissue repair and regeneration at the injury site. The study is expected to continue for approximately 12 weeks. Matricelf anticipates receiving interim results during the Fourth Quarter of 2026 and final study results during the First Quarter of 2027. Matricelf is developing a personalized neural tissue implant designed to treat patients suffering from paralysis following spinal cord injury. The Company's technology combines patient derived cells and biomaterials to create an autologous engineered implant tailored to each individual patient. Subject to successful study outcomes, completion of ongoing development activities, regulatory approvals, and financing requirements, Matricelf plans to seek authorization to initiate its first clinical trial in humans. Announcement • Jun 17
Matricelf Completes GLP Safety Study for Engineered Neural Tissue Implant Matricelf Ltd. announced the successful completion of its comprehensive GLP safety study for its engineered neural tissue implant, achieving all predefined study endpoints with no abnormal findings. The study evaluated key safety parameters including toxicology, tumorigenicity, and biodistribution in 248 animals monitored for up to 39 weeks following implantation. Results demonstrated no treatment related toxicity, no evidence of tumor formation, and no migration of the implant to distant organs or tissues, supporting the safety profile of the Company's lead therapeutic program. The GLP study was designed as an IND enabling safety program and represents a significant milestone in Matricelf's preparations for a first in human clinical trial. The successful completion of the study provides an important component of the Company's future regulatory submissions and advances its clinical development roadmap. Matricelf is developing a personalized neural tissue implant designed to treat patients suffering from paralysis following spinal cord injury. The Company's technology combines patient derived cells and biomaterials to create an autologous engineered implant tailored to each individual patient. Subject to successful completion of ongoing preclinical studies, regulatory approvals, and financing requirements, Matricelf plans to seek authorization to initiate its first clinical trial in humans. 
