Matricelf Ltd. (TASE: MTLF) Reports 2025 Milestones and Outlines 2026 Strategic Roadmap Toward First-in-Human Spinal Cord Implantation

Rhea-AI Summary

Matricelf (TASE:MTRLF) reported 2025 progress shifting from advanced preclinical work to clinical readiness and outlined a 2026 roadmap toward first-in-human spinal cord implantation. Key 2025 achievements include an initial implant safety study, interim positive GLP animal safety results, AI-aided engineered neural tissue production, Helsinki Committee approval for blood collection, new patents through 2039, and a NIS 24.4 million private placement with warrants.

Planned 2026 objectives: complete final animal efficacy studies, transfer to GMP manufacturing, build clinical infrastructure, prepare regulatory submissions, identify eligible patients in 2026, and target first clinical implantation in 2027; Nasdaq evaluation initiated.

Positive

• Initial implant safety study showing a preliminary safety profile
• Interim positive results in GLP large-scale animal safety study
• Private placement raised approximately NIS 24.4 million
• Multiple US patents granted extending protection through 2039
• Agreement for GMP clean rooms at Tel Aviv Sourasky Medical Center

Negative

• Final GLP animal results required before regulatory submissions (due H1 2026)
• First human implantation targeted for 2027 but not guaranteed
• Potential dilution from warrants that could raise ~NIS 36.6 million
• Nasdaq listing is preliminary with no final decision or timing

NESS ZIONA, Israel, Feb. 26, 2026 /PRNewswire/ -- Matricelf Ltd. (TASE: MTLF), a biotechnology company developing personalized regenerative therapies for spinal cord injury, today issued a shareholder update summarizing its 2025 achievements and outlining key strategic milestones for 2026 and beyond.

2025: Transition from Advanced Preclinical Development to Clinical Infrastructure

During 2025, Matricelf marked a clear transition from advanced preclinical development toward building the operational and clinical infrastructure required for its first-in-human study.

The company completed an initial safety study demonstrating a preliminary safety profile for its implant. In parallel, a large-scale GLP compliant safety study in animals is currently underway and has shown positive interim results. Final results are expected in the 1st half of 2026 and are intended to support regulatory submissions ahead of first-in-human clinical trials. On the technological front, Matricelf demonstrated, in collaboration with US-based Cellino Biotech, the production of engineered neural tissue using stem cells generated through artificial intelligence based technology. This achievement highlights the potential for scalable manufacturing and cost reduction, supporting broader future patient accessibility.

From a clinical readiness perspective, the company received Helsinki Committee approval at Sheba Medical Center to collect blood from patients with complete spinal cord injury, marking a formal step toward human treatment. In addition, Matricelf established a clinical advisory board comprised of leading neurosurgeons and rehabilitation physicians to guide trial design, patient selection criteria, endpoints, and follow-up protocols. To support GMP compliant clinical manufacturing, Matricelf signed an agreement with Tel Aviv Sourasky Medical Center (Ichilov) for the use of dedicated clean rooms in preparation for its first clinical study.

The company also significantly strengthened its intellectual property portfolio, receiving multiple US patent grants extending protection for certain patents through 2039, covering both spinal cord injury applications and broader tissue regeneration indications.

Strengthened Financial and Organizational Position

In 2025, Matricelf completed a private placement raising approximately NIS 24.4 million, including warrants that, if exercised, may generate an additional approximately NIS 36.6 million for the company. The financing strengthened the company's balance sheet as it prepares for the transition to the clinical stage. Additionally, Mr. Ron Miron, former CEO of Teva Israel, joined the company as active Chairman of the Board. His managerial and strategic experience is expected to support the company's next growth phase.

2026 Strategic Plan: Toward First Human Implantation

In 2026, Matricelf will focus on completing its advanced preclinical program and preparing for its first implantation in a human patient, either under a compassionate use framework or as part of a clinical trial. This milestone represents a major value inflection point for the company.

Planned 2026 milestones include:

• Completion of final animal efficacy studies
• Technology transfer to clinical grade GMP manufacturing in clean rooms
• Establishment of full clinical infrastructure
• Regulatory submissions in preparation for human studies

The company expects to begin identifying eligible patients during 2026, with the goal of completing the first clinical implantation during 2027.

Exploration of Nasdaq Listing

Looking ahead, Matricelf has initiated a preliminary evaluation of a potential Nasdaq listing. Subject to progress in preparations and receipt of required approvals, management aims to complete a Nasdaq listing during 2027. At this stage, no final decision has been made, and there can be no assurance regarding timing, terms, or whether such listing will be completed.

"Matricelf enters 2026 with strong momentum and a clear roadmap toward a first-in-human clinical study that is unprecedented in the field," said Gil Hakim, CEO of Matricelf. "We believe the coming years hold significant regulatory and partnership milestones that can drive substantial value creation for our shareholders."

About Matricelf Ltd.

Matricelf Ltd. (TASE: MTLF) is a regenerative medicine company developing personalized, autologous engineered neural tissue implants for the treatment of spinal cord injury. The company's technology is designed to repair damaged spinal cord tissue using patient-specific biological materials, with the goal of restoring neural conductivity and improving functional outcomes.

Forward Looking Statements

This press release contains forward looking statements, including statements regarding strategic plans for 2026, completion of preclinical studies, initiation and completion of first clinical implantation, potential warrant exercise proceeds, and potential Nasdaq listing. These statements are based on current expectations and assumptions and are subject to risks and uncertainties, including those detailed in the company's periodic reports, which may cause actual results to differ materially.

CONTACT INFO:
Gil Hakim
CEO
Matricelf
Tel: +972-52-5263351
GIL@MATRICELF.COM 

 

 

 

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SOURCE Matricelf Ltd.

FAQ

What 2025 safety data did Matricelf (MTRLF) report for its spinal implant?

Matricelf reported an initial safety study demonstrating a preliminary safety profile for its implant. According to the company, a large-scale GLP animal safety study is underway with positive interim results and final results expected in the first half of 2026.

When does Matricelf (MTRLF) expect to complete GLP animal results and regulatory submissions?

Matricelf expects final GLP animal study results in H1 2026, supporting regulatory submissions thereafter. According to the company, those final results are intended to enable filings ahead of first-in-human clinical trials.

What is Matricelf's (MTRLF) timeline for first human spinal cord implantation?

The company aims to identify eligible patients in 2026 and target the first clinical implantation in 2027. According to the company, implantation could occur under compassionate use or as part of a formal clinical trial, subject to approvals.

How did Matricelf (MTRLF) strengthen financing and what shareholder impact exists?

Matricelf completed a private placement raising approximately NIS 24.4 million and issued warrants that could raise ~NIS 36.6 million if exercised. According to the company, this financing strengthens the balance sheet but may result in shareholder dilution if warrants are exercised.

What manufacturing and clinical infrastructure steps has Matricelf (MTRLF) taken for human studies?

Matricelf secured an agreement for dedicated clean rooms at Tel Aviv Sourasky Medical Center and plans GMP technology transfer. According to the company, these steps aim to enable clinical-grade manufacturing and full clinical infrastructure ahead of human studies.

Is Matricelf (MTRLF) pursuing a Nasdaq listing and what is the status?

Matricelf has begun a preliminary evaluation of a potential Nasdaq listing with a target window of 2027. According to the company, no final decision has been made and there is no assurance regarding timing, terms, or completion.