TEL AVIV, Israel, June 22, 2026 /PRNewswire/ -- Matricelf Ltd. (TASE: MTLF), a regenerative medicine company developing personalized engineered tissue implants for spinal cord injury, 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.
Gil Hakim, CEO of Matricelf, added, "This study represents a key component of our strategy to advance a transformative treatment option for spinal cord injury patients. Building on our previously reported positive efficacy results, we believe this study may provide important validation of our technology's therapeutic potential and support our ongoing preparations for a first in human clinical trial."
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.
CONTACT INFO:
Gil Hakim
CEO
Matricelf
Tel: +972-52-5263351
[email protected]
SOURCE Matricelf Ltd.
