News & Events

International Recognition – Matricelf Awarded a Grant from the UK-based Walk Once More Foundation for the Development of Solutions for Spinal Cord Injury (https://www.walkoncemore.org/)

On July 1st, 2025, the company received a research grant of approximately 138,000 NIS from the UK-based Walk Once More Foundation, an organization dedicated to accelerating the development of curative therapies for spinal cord injury. The grant will fund a preclinical animal study aimed at evaluating the safety of Matricelf’s therapy at the chronic stage of injury, representing a key step toward regulatory and clinical advancement. The award followed a detailed review by the foundation of Matricelf’s technology and encouraging preclinical data. During the one-year grant period, the company will submit progress and financial reports outlining the study’s development and use of funds.

Walk Once More is a 100 percent volunteer-led UK charity committed to a future in which spinal cord injury becomes a temporary and repairable condition. With minimal overhead and a focused mission, the foundation supports promising research worldwide to help reverse the long-term consequences of SCI and bring real therapeutic solutions to patients.

Matricelf to Present at Premier 2025 Spinal Cord Injury Conference

Matricelf Ltd. (TASE: MTLF), a biotechnology company pioneering autologous regenerative implants for spinal cord injury (SCI), is pleased to announce its upcoming presentation at a leading international SCI conference taking place virtually on June 27, 2025.

This high-profile event convenes the global SCI ecosystem, featuring thought leaders in clinical research, rehabilitation, and neurotechnology, as well as patient advocates and biopharmaceutical innovators. Matricelf has been selected to present among a distinguished group of preclinical companies advancing transformative approaches for spinal cord injury.

Gil Hakim, CEO of Matricelf, will present the company’s proprietary technology: engineered neural tissue implants derived from a patient’s own cells. His talk will focus on Matricelf’s mission to restore function in individuals with chronic, complete SCI—where the unmet need is greatest and conventional solutions are limited.

“Our participation in this key industry forum reflects the growing recognition of our technology and its potential impact,” said Hakim. “We are proud to be contributing to the next generation of SCI therapies, with a clear path toward First-in-Human clinical trials.”

The event includes scientific discussions on clinical trial design, rehabilitation standards, pain management, and neuroregeneration, and brings together leading institutions, companies, and individuals with lived experience in SCI.

Formation of Clinical Advisory Board to accelerate First-in-Human trial strategy

In June 2025, the company established a Clinical Advisory Board (CAB) composed of world-renowned neurosurgeons and rehabilitation specialists to help guide Matricelf’s transition to clinical stage.

The CAB will support the company’s scientific strategy and advise management and the board on the design of its First-in-Human clinical trial, including patient population selection, outcome metrics, and clinical implementation. Members include internationally recognized experts in spinal cord injury and regenerative medicine.

The CAB complements Matricelf’s existing Scientific Advisory Board and includes:

• Prof. Michael G. Fehlings, University of Toronto – global leader in spinal cord injury research and neuroregeneration
• Prof. Allan D. Levi, University of Miami – pioneer in cell-based therapies for SCI with over 250 clinical studies
• Prof. Nicholas Theodore, Johns Hopkins – expert in minimally invasive and robotic spinal surgery
• Prof. Ran Harel, Sheba Medical Center – spine surgeon specializing in trauma and tumors, also serving on the Scientific Advisory Board
• Dr. Moshe Bondi, Sheba Medical Center – head of neurological rehabilitation and expert in SCI recovery and pain management

The diverse expertise of the CAB enhances the company’s clinical readiness and strengthens the foundation for initiating human trials.

Patent registration in the U.S. for the company’s technology – particles based on unique omentum tissue for therapeutic applications

On May 27, 2025, the company received confirmation from the U.S. Patent Office of the registration of its new patent (U.S. Patent No. 12,311,075), valid until January 21, 2039. The patent, licensed from Tel Aviv University, covers a unique technology using decellularized omentum tissue particles for developing functional implants combined with biological cells. It expands on a previous 2022 patent by broadening the clinical applications to include the use of iPSCs and spinal cord neurons, supporting diverse uses in regenerative medicine, especially for neural injuries such as spinal cord injury.

Receiving approval from the Helsinki Committee of Sheba Tel Hashomer Medical Center – First step towards compassionate treatment of spinal cord injuries

Matricelf announced that the Helsinki Committee at Sheba Medical Center has approved a medical study to collect blood samples from 8 patients with complete spinal cord injuries (ASIA-A, T12–T2). These samples will be used to generate induced pluripotent stem cells (iPSCs) for producing personalized, autologous neural implants as part of a compassionate use program.
The treatment combines iPSCs derived from the patient’s blood and a hydrogel made from the patient’s omentum tissue to create engineered neural tissue tailored to each individual. Final implant production will require additional ethical and regulatory approvals, including omentum sampling and Ministry of Health consent.
Matricelf is completing final animal studies and establishing clinical manufacturing infrastructure, aiming to meet regulatory standards for human use.

Cellino and Matricelf Announce Global Collaboration to Scale Personalized Spinal Cord Injury Treatments

Cellino and Matricelf announced a strategic collaboration to advance the scalable production of personalized spinal cord injury treatments by combining Cellino’s AI-driven Nebula™ platform with Matricelf’s autologous regenerative technology.
Cellino successfully produced and delivered autologous iPSCs from four donors, which Matricelf used to generate functional neural tissues showing synchronized electrical activity and key neural markers. This validates the compatibility and performance of Cellino’s iPSCs with Matricelf’s platform.
The collaboration supports Matricelf’s plan to file an IND application in 2026 for clinical trials, aiming to address the urgent unmet need in spinal cord injury treatment. Both companies emphasize the importance of international collaboration in driving innovation and making next-generation regenerative therapies clinically accessible.

Final Approval by the U.S. Patent Office – Patent for 3D Bioprinting of Tissues and Organs

The USPTO has granted U.S. Patent No. 12,221,621, covering a novel support medium for high-resolution 3D bioprinting of tissues and organs. The technology uses calcium-alginate hydrogel particles to stabilize complex biological structures during printing, with easy post-print removal. Valid until June 2039, the patent supports applications in tissue engineering and regenerative medicine. It enabled the world’s first 3D-printed human heart structure in 2019. The patent is fully owned by Ramot Ltd. and licensed to the company.

Initiation of Comprehensive GLP Animal Safety Study for Engineered Neural Tissue to Treat Spinal Cord Injuries – A Key Milestone Toward FDA-Compliant Human Clinical Trial

On January 13, 2025, the company began its final preclinical safety study for its engineered human neural tissue product for spinal cord injury. The GLP-compliant study, conducted in immunodeficient rats, evaluates safety, tumorigenicity, and biodistribution, as required by the FDA for IND-enabling studies.
The 39-week study involves 166 rats across treatment and control groups, using iPSC-derived neural tissue from two donors. Weekly clinical evaluations and in-depth assessments at key intervals (weeks 4, 17, and 39) will be performed.
Interim results are expected in Q3 2025, with final results anticipated in Q1 2026. Completion of this study is a key step toward FDA approval to begin human clinical trials.

Successful Proof of Concept (POC) for Generating Engineered Neural Tissues from Stem Cells Using AI-Based Technology from U.S. Biotech Company Cellino

On January 8, 2025, the company successfully completed a joint proof-of-concept (POC) study with U.S.-based Cellino Biotech. Using Cellino’s AI-driven automation platform, induced pluripotent stem cells (iPSCs) from four donors were provided and used to generate engineered neural tissues in the company’s Israeli labs.
The tissues met predefined specifications, showing neural markers and functional electrical activity. This marks a significant milestone, highlighting the potential of combining AI automation with advanced tissue engineering to enable scalable, cost-effective personalized regenerative therapies.

Successful Safety Results – Preclinical Study in Rats

The company completed a preliminary (pilot) efficacy and safety study in immunodeficient rats to simulate spinal cord injury treatment using its engineered neural implant. The study, using a standard contusion injury model, showed that all treated animals maintained normal neural behavior with no signs of tumor formation or abnormal pathology. Implants remained present in some animals, supporting long-term safety.
These results strengthen previous safety data and support the planned compassionate use program, following initial agreements with the Ministry of Health. Additional histological data to further understand the implant’s mechanism of action are expected in Q1 2026.

Preliminary Agreements with the Ministry of Health for Use of the Company’s Product Under a Compassionate Use Program

The Israeli Ministry of Health has approved Matricelf’s proposed framework for compassionate use of its spinal cord injury (SCI) treatment in patients with severe trauma-related disabilities. This follows a preliminary request submitted in October 2024.
The approved plan includes CMC documentation, results from preclinical pilot studies in animals (safety and efficacy), and outlines for clinical monitoring and timelines. The company is now working with neurosurgery experts to obtain ethics committee approvals, with authorization to treat up to 8 patients under the compassionate use program.

Success in Rat Study – Final Results of Efficacy Evaluation

Matricelf reported final results from a preclinical pilot study evaluating the efficacy of its neural implant in a rat model of spinal cord injury. The study demonstrated statistically significant improvement in motor function in treated rats compared to untreated controls.

Key findings:

• Average BBB score (a standard measure for motor recovery) improved from 2.5 post-injury to 9.1 in the treated group, versus 5.8 in controls.
• 80% of treated rats showed a significant improvement (>5 BBB points), compared to 20% in the control group.
• Some treated rats achieved scores indicating coordinated walking.
• CatWalk XT gait analysis confirmed improved walking patterns, with longer, faster, and more stable steps in the treated group.

Histology results are pending and will be reported separately. The results support continued development toward human clinical trials.

Approval by the Helsinki Committee and launch of activity in the field of 3D printing of autologous human tissues for medical applications

Matricelf announced it received approval from the Helsinki Committee at Herzliya Medical Center to conduct a clinical study collecting blood and omentum samples. The goal is to develop bio-ink for 3D printing of autologous human tissues for medical use.

This marks the launch of a new development track focused on biological 3D printing, leveraging the company’s proprietary support medium, human-derived cells, and extracellular matrix components to create functional, complex living tissues.

The study will begin pending hospital director approval. The company views this initiative as a key part of its strategic plan to position itself for future partnerships with global 3D printing leaders, aiming to address severe tissue and organ damage through advanced tissue engineering.