Matricelf Receives FDA Feedback Supporting Key Elements of Proposed First in Human Clinical Trial for NewRal Spinal Cord Injury Program
FDA feedback supports the proposed patient population, single arm open label trial design, primary safety assessments and exploratory efficacy measures
Written regulatory feedback provides guidance as Matricelf advances preparations toward a future IND submission for NewRal
NESS ZIONA, Israel, Sept. 3, 2026 /PRNewswire/ -- Matricelf Ltd. (TASE: MTLF), a regenerative medicine company developing a personalized, autologous neural tissue transplant for the treatment of spinal cord injury, today announced that it has received written feedback from the U.S. Food and Drug Administration, FDA, Center for Biologics Evaluation and Research, CBER, regarding the proposed design of the Company's first in human clinical trial of NewRal.
NewRal is Matricelf's investigational personalized neural tissue transplant being developed for patients with traumatic spinal cord injury.
The FDA feedback was provided through a Written Response Only, WRO, interaction and was based on a limited clinical trial synopsis submitted by the Company.
Based on the information provided, the FDA expressed agreement with several key components of Matricelf's proposed first in human clinical trial design, including:
- Proposed patient population: Adult patients with chronic, complete traumatic thoracic spinal cord injury classified as AIS A.
- Clinical trial design: An open label, single arm trial with an initial 12 month follow up period as a reasonable design for the initial evaluation of safety and tolerability in humans.
- Clinical assessments: The proposed primary safety assessments, as well as exploratory efficacy measures including ISNCSCI, MAS and SCIM III.
These exploratory measures are designed to evaluate, among other parameters, neurological changes, spasticity and patients' level of functional independence. The FDA noted that these measures relate to efficacy evaluation, while the proposed early-stage clinical trial is primarily focused on safety and tolerability.
The FDA also requested that Matricelf address several additional matters as part of a future Investigational New Drug, IND, submission, including trial stopping rules, objective patient discharge criteria, additional details regarding the surgical procedure and imaging criteria for patient selection.
Matricelf believes the written feedback provides important regulatory guidance as the Company continues preparing its planned IND package and advances NewRal toward clinical development.
Gil Hakim, Chief Executive Officer of Matricelf, commented:
"The FDA's feedback represents another important step in Matricelf's transition toward clinical development. The FDA's agreement with key elements of our proposed first in human trial, including the patient population, trial structure, safety assessments and the use of exploratory efficacy measures, gives us valuable regulatory guidance as we prepare for a future IND submission. We will now incorporate the FDA's comments and continue advancing NewRal toward the clinic."
About NewRal
NewRal is Matricelf's investigational personalized neural tissue transplant designed to repair damaged neural tissue following spinal cord injury. The Company's platform combines patient derived cellular components, including induced pluripotent stem cells, with a biomaterial scaffold derived from the patient's own tissue to create an autologous engineered neural tissue transplant.
NewRal remains investigational, has not been approved by the FDA or any other regulatory authority, and has not yet been evaluated in humans.
About Matricelf
Matricelf Ltd. is a regenerative medicine company developing personalized, engineered tissue therapies intended to restore function following severe tissue injury. The Company's lead program, NewRal, is being developed as an autologous engineered neural tissue transplant for traumatic spinal cord injury.
Matricelf's technology is based on research originating from Tel Aviv University and combines patient derived cells with an extracellular matrix scaffold derived from the patient's own tissue.
Matricelf is publicly traded on the Tel Aviv Stock Exchange under the symbol MTLF.
Forward Looking Statements
This press release contains forward looking statements, including statements regarding the significance of the FDA feedback, completion of requested modifications and additional information, preparation and potential submission of an IND, regulatory review of any future IND, commencement and timing of clinical trials, clinical development of NewRal and the potential safety or efficacy of the Company's technology.
Forward looking statements are based on current expectations and information available to Matricelf as of the date of this release and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks include, among others, the possibility that the FDA may request additional or different information following review of a complete IND submission, delays or difficulties in product development or clinical manufacturing, results of additional studies and testing, regulatory requirements and the Company's need for additional financing.
The FDA feedback described in this release was based on a limited clinical trial synopsis and does not constitute review or clearance of a complete IND application or authorization to initiate a clinical trial. There can be no assurance that an IND will be submitted, that the FDA will permit the proposed clinical trial to proceed, or that any clinical trial will begin according to the Company's anticipated timeline, if at all.
CONTACT INFO:
Gil Hakim
CEO
Matricelf
Tel: +972-52-5263351
[email protected]
SOURCE Matricelf Ltd.
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