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Matricelf Reports Statistically Significant Motor Function Improvement in Preclinical Efficacy Study of Chronic Spinal Cord Injury

The Week 12 responder rate was approximately 5.5 times higher with treatment, but statistical significance of that comparison has not been established.

(Very High)

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Matricelf (MTRLF) reported statistically significant motor function improvements following engineered human neural tissue transplantation in rats with chronic spinal cord injury. At Week 12, mean BBB scores, measuring hindlimb motor function, were 9.0 versus 5.4 in controls. Improvements were statistically significant separately in males and females at every assessment from Weeks 9 through 12.

At Week 12, 63.0% of treated animals (17 of 27) improved at least five BBB points from baseline, versus 11.5% of controls (3 of 26). Statistical significance of this responder comparison has not been established in the information presented. The overall study included 96 rats; additional functional, sensory and tissue analyses remain ongoing. Matricelf plans an application to initiate a human clinical trial. The transplant has not been tested in humans, and these findings do not establish human therapeutic efficacy.

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Positive

  • Minor pointWeek 12 mean BBB motor scores reached 9.0 versus 5.4 in controls, a statistically significant difference.
  • Minor pointWeek 12 responders reached 63.0% (17 of 27) versus 11.5% (3 of 26), approximately 5.5 times higher.
  • Minor pointTreated animals meeting the response threshold increased from approximately 22% at Week 7 to 63% at Week 12.
  • Minor pointMotor benefits were statistically significant separately in both sexes at every assessment from Weeks 9 through 12.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Matricelf plans an application to initiate a human clinical trial following its final preclinical development work.

Negative

  • Minor pointResponder-rate comparison statistical significance has not been established in the information presented.
  • Minor pointAdditional functional, sensory and tissue analyses remain ongoing.
  • Minor pointResponder analysis excluded missing values, combining sexes with available observations at each assessment.

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  • 63% of treated animals achieved at least five points of motor function improvement versus 11.5% of controls, representing an approximately 5.5 times higher responder rate

  • Statistically significant motor function benefits demonstrated in both sexes at every assessment from Week 9 through Week 12

Ness Ziona, Israel--(Newsfile Corp. - November 5, 2026) - Matricelf Ltd. (TASE: MTLF), a biotechnology company developing personalized engineered neural tissue for spinal cord injury, today announced positive results from its comprehensive preclinical efficacy study, demonstrating statistically significant improvements in motor function following transplantation of its engineered human neural tissue.

The treatment benefit was demonstrated separately in male and female animals and remained statistically significant at each of the final four assessment points, Weeks 9 through 12.

The findings reinforce Matricelf's earlier pilot results and further strengthens the scientific foundation for its planned transition into human clinical trials.

Key Results

  • Statistically significant improvement in average motor function scores: At Week 12, the combined male and female treatment group achieved a mean BBB score of 9.0, compared with 5.4 in controls, a statistically significant difference. Standard deviations were 3.0 and 3.6, respectively.

  • Approximately 5.5 times higher responder rate: At Week 12, 63.0% of treated animals, 17 of 27, achieved an improvement of at least five BBB points from their individual baseline, compared with 11.5% of controls, 3 of 26.

  • Increasing response over time: The proportion of treated animals meeting the response threshold increased from approximately 22% at Week 7 to 63% at Week 12.

  • Consistent benefit across both sexes: Statistically significant motor function improvements were demonstrated separately in males and females throughout the final four weeks of follow up.

  • Blinded assessment: Motor function was evaluated by specialists who were unaware of the animals' treatment assignments.

"These results mark an important milestone for Matricelf as we advance toward clinical development," said Gil Hakim, CEO of Matricelf. "The statistically significant motor function improvements in both sexes, together with an approximately 5.5 times higher responder rate at Week 12, strengthens our confidence in the potential of our engineered neural tissue. We remain focused on translating these findings into a rigorously designed clinical program for people living with spinal cord injury, where the need for new treatment options remains substantial."

"These findings build on the positive results of our earlier pilot study and strengthen the scientific foundation for our engineered neural tissue approach," said Dr. Tamar Harel Adar, CTO of Matricelf. "The consistent motor function benefit observed in both sexes and sustained throughout the final four weeks of follow-up reinforces our confidence in its therapeutic potential. Our ongoing analysis of the remaining study measures will help further characterize the transplant's effects and guide the next stage of development."

Supporting the transition into clinical development

The overall study included 96 male and female rats in a contusion model of chronic spinal cord injury. Transplantation was performed during the chronic stage of injury, consistent with Matricelf's planned treatment approach in humans. Immunodeficient rats were used to enable transplantation of human neural tissue.

The study forms part of Matricelf's final preclinical development work ahead of a planned application to initiate a human clinical trial. Its design was based on a framework discussed with the U.S. Food and Drug Administration during the company's pre-IND interactions.

Additional analyses ongoing

The results announced today relate to the Basso, Beattie and Bresnahan (BBB) locomotor rating scale, which assesses hindlimb motor function in rats following spinal cord injury. Additional functional, sensory and histological analyses remain ongoing.

The responder analysis combines males and females with available observations at each assessment; missing values were excluded. Reported statistical significance relates to BBB motor function scores; statistical significance of the responder rate comparison has not been established in the information presented.

These preclinical findings do not establish therapeutic efficacy in humans. Matricelf's investigational neural tissue transplant has not yet been tested in humans.

About Matricelf

Matricelf is a biotechnology company developing personalized regenerative therapies for spinal cord injury. Its investigational approach combines patient derived cells and biological material to create engineered neural tissue intended for transplantation into the injured spinal cord.

Forward Looking Statements

This press release contains forward looking statements regarding Matricelf's development plans, the potential of its investigational treatment and progression toward human clinical trials. These statements involve risks and uncertainties, including completion of ongoing analyses, further development and regulatory review. Actual outcomes may differ materially. There can be no assurance that the company will complete product development or obtain authorization for clinical trials or marketing approval.

Investor Contact
Hanover International
Kathy Cusumano, President
ka@hanoverintlinc.com

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/322724

FAQ

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What did Matricelf's chronic spinal cord injury study show at Week 12?

Mean BBB motor function scores were 9.0 with treatment versus 5.4 in controls, a statistically significant difference. Standard deviations were 3.0 and 3.6, respectively. At least five points of improvement from individual baseline occurred in 63.0% of treated animals versus 11.5% of controls; statistical significance of that responder comparison has not been established in the information presented.

How was Matricelf's preclinical spinal cord injury study conducted?

The overall study used 96 male and female immunodeficient rats with chronic spinal cord injury caused by contusion. Human neural tissue was transplanted during the chronic injury stage. Specialists assessing motor function were unaware of treatment assignments. The study design used a framework discussed with the U.S. Food and Drug Administration before an investigational new drug application.

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