Receiving Helsinki Committee and Institutional Approval from Loewenstein Medical Center – Advancing Preparation for Matricelf’s First-in-Human Clinical Trial

Matricelf announced that it has received approval from the Helsinki Committee and the Director of Loewenstein Medical Center to collect blood samples from patients with complete spinal cord injuries (ASIA-A, T2–T12). The blood samples will be used to generate induced pluripotent stem cells (iPSCs), which are intended to serve as the cellular component of the Company’s personalized autologous neural implants.

The approval enables Matricelf to begin identifying and enrolling suitable patients as part of its preparations for the Company’s first-in-human clinical trial. It does not constitute approval to perform implantation in humans or to initiate the clinical trial itself, both of which remain subject to additional regulatory and ethical approvals, including Ministry of Health authorization.

This milestone builds on the Company’s recent achievements, including the initiation of GMP clinical manufacturing activities, completion of its comprehensive GLP safety study, and ongoing efficacy studies, further strengthening Matricelf’s systematic progress toward clinical development.

Matricelf advances toward first in human spinal cord injury trial following successful completion of GLP safety study

On June 17, 2026, Matricelf Ltd. announced the successful completion of its comprehensive GLP safety study for the Company’s personalized engineered neural tissue implant, achieving all predefined study endpoints with no abnormal findings and marking another significant milestone on the path toward clinical development.

The study evaluated key safety parameters, including toxicology, tumorigenicity, and biodistribution, in 248 animals monitored for up to 39 weeks following implantation. Results demonstrated no treatment related toxicity, no evidence of tumor formation, and no migration of the implant to distant organs or tissues. The findings support the safety profile of Matricelf’s lead therapeutic program and provide important validation of the Company’s personalized regenerative medicine platform.

The GLP study was designed as an IND enabling safety program and represents a critical step toward regulatory submission and initiation of a planned first in human clinical trial. The successful completion of the study provides a key component of the Company’s future regulatory package and reflects continued progress across Matricelf’s preclinical, regulatory, and clinical development roadmap.

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 the successful completion of ongoing preclinical studies, regulatory approvals, and financing requirements, Matricelf intends to seek authorization to initiate its first clinical trial in humans. This achievement represents another important step toward bringing Matricelf’s personalized regenerative medicine platform from preclinical development into clinical application.

Matricelf initiates IND enabling efficacy study to support first in human spinal cord injury trial

On June 15, 2026, Matricelf Ltd. announced the initiation of a pivotal preclinical efficacy study evaluating the Company’s personalized engineered neural tissue implant for the treatment of chronic spinal cord injury. The study is designed to generate efficacy data supporting Matricelf’s preparations for a first in human clinical trial and is intended to serve as an IND enabling efficacy study.

The study builds upon previously reported positive preclinical results demonstrating improvements in motor function, sensory recovery, and tissue regeneration following treatment with Matricelf’s engineered neural tissue implant. The new study is designed to further validate the therapeutic potential of the technology using a comprehensive efficacy framework aligned with regulatory requirements for future clinical development.

The study will be conducted in 96 animals with chronic spinal cord injury and will evaluate motor and sensory recovery using established functional and behavioral assessments, including BBB, CatWalk, Mechanical Allodynia, and Thermal Allodynia testing, alongside detailed histological analyses of tissue repair and regeneration at the injury site. The study design is based on a development framework previously discussed with the U.S. Food and Drug Administration (FDA) as part of the Company’s regulatory planning activities.

Matricelf expects to receive interim results during the fourth quarter of 2026 and final results during the first quarter of 2027. The study represents a key component of the Company’s regulatory and clinical development strategy and is expected to provide important data supporting future submissions for human clinical testing.

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 intends to seek authorization to initiate its first clinical trial in humans. The initiation of this efficacy study marks another important milestone in advancing the Company’s regenerative medicine platform toward clinical application for spinal cord injury patients.

Matricelf initiates GMP manufacturing program, advancing toward first in human spinal cord injury trial

On June 7, 2026, Matricelf Ltd. announced the initiation of GMP engineering runs at the Advanced Biotherapy Center (ABC) at Sheba Medical Center, marking another significant milestone in the Company’s transition toward clinical development.

The engineering runs are designed to validate Matricelf’s clinical manufacturing process under GMP conditions and represent a critical step toward the production of its personalized neural tissue implants for use in future human studies. The program includes clinical scale manufacturing activities for the cellular component of Matricelf’s implant platform and is intended to demonstrate the robustness, quality, safety, and reproducibility of the Company’s manufacturing process ahead of a planned first in human clinical trial.

The milestone follows the strategic collaboration established with Sheba Medical Center earlier this year and reflects continued progress across Matricelf’s clinical, manufacturing, and regulatory roadmap. Matricelf expects to complete the full engineering run program during Q1 2027 while continuing to advance its preclinical development activities and preparations for regulatory submission to support a planned first in human clinical trial for patients suffering from paralysis caused by spinal cord injury.

This achievement represents another important step toward bringing Matricelf’s personalized regenerative medicine platform from preclinical development into clinical application.

Matricelf CEO Gil Hakim Featured in TV10 Israel Interview on the Future of Spinal Cord Repair

V10 Israel’s Weekend Edition featured an interview with Gil Hakim, CEO of Matricelf, discussing the company’s vision to transform the treatment of spinal cord injury through personalized regenerative medicine.

During the interview with Sophia Tupolev, Gil Hakim presented Matricelf’s proprietary technology platform, which utilizes a patient’s own cells to engineer personalized neural tissue designed to repair damaged spinal cord tissue. The discussion highlighted the significant unmet medical need faced by millions of people living with paralysis and the potential of regenerative medicine to restore function rather than manage symptoms.

The interview also covered Matricelf’s progress toward clinical implementation, including the company’s preparations for first in human studies and its commitment to advancing innovative therapies that could redefine the standard of care for spinal cord injury patients.

TV10 Israel highlighted the growing importance of biotechnology innovation in Israel and the potential impact of breakthrough regenerative technologies on patients, healthcare systems, and the broader life sciences industry.

Read the full interview here:

https://tv10.news/p/the-inaugural-weekend-edition-studio

Matricelf Featured in CEOCFO Magazine Interview

CEOCFO Magazine has published an in-depth interview with Gil Hakim, CEO of Matricelf, highlighting the company’s pioneering approach to personalized regenerative medicine for spinal cord injury.

The interview outlines Matricelf’s strategy to move beyond conventional treatments by developing autologous engineered neural tissue tailored to each patient. This innovative platform aims to address one of the most significant unmet needs in medicine by restoring function rather than managing symptoms.

Founded with the vision of transforming the treatment paradigm for spinal cord injury, Matricelf is advancing toward clinical translation with a scalable and differentiated technology. The company’s approach has the potential to reshape outcomes for patients living with paralysis and reduce the long-term burden on healthcare systems.

The CEOCFO editorial team noted the significance of Matricelf’s work in bringing personalized cell-based therapies closer to real world application, emphasizing its potential impact on both patients and the broader field of regenerative medicine.

Read the full interview here:

https://www.ceocfointerviews.com/matricelf0326.html

Matricelf signs agreement with Sheba Medical Center for clinical manufacturing and advancement of clinical program — a key milestone toward first-in-human spinal cord injury trial

On March 23, 2026, Matricelf Ltd. announced the signing of a strategic agreement with Sheba Medical Center, granting access to a cleanroom facility at the Advanced Biotherapy Center (ABC), marking a significant milestone in the company’s clinical development pathway.

The agreement enables Matricelf to initiate clinical-grade manufacturing of its autologous neural tissue implants under GMP conditions, while simultaneously advancing clinical readiness activities, including the development of the clinical trial protocol in collaboration with leading medical departments at Sheba.

The planned first-in-human clinical trial is expected to be conducted at Sheba Medical Center, integrating patient recruitment, manufacturing, surgical implantation, and rehabilitation within a single leading medical center.

This integrated approach is designed to enhance operational efficiency and support the execution of Matricelf’s clinical program for spinal cord injury treatment.

Matricelf Named Most Innovative Company of 2026 at Advanced Therapies Week in San Diego

Advanced Therapies Week is considered one of the leading global conferences in the field of advanced therapies and regenerative medicine, convening biotechnology and pharmaceutical companies, researchers, investors, and key opinion leaders from around the world. This year’s conference hosted more than 1,800 participants, including approximately 600 drug developers and global industry leaders.

Matricelf was selected by a professional judging committee for its groundbreaking approach to spinal cord injury repair and its rapid progress toward clinical-stage development. According to the competition organizers, Matricelf’s nomination stood out as a compelling example of a technology that demonstrates both significant potential patient impact and strong commercial promise.

The company outperformed hundreds of biotechnology and cell therapy companies from the United States and Europe. The award provides strategic exposure and access to leading global investors and potential partners, positioning Matricelf at the forefront of innovation in advanced therapies.

Final U.S. patent registration for the company’s 3D bioprinting technology, Omentum based scaffold and delivery system

On December 28, 2025, the company announced that the U.S. Patent and Trademark Office granted final approval and registration of its patent related to “Omentum based scaffold and delivery system.” The patent was registered as U.S. Patent No. 12,514,957, is expected to be published on January 6, 2026, and provides patent protection in the United States through 2034.

The patent, which is part of the commercialization license received from Tel Aviv University, relates to a proprietary technology enabling 3D biological printing of cardiac tissue structures using decellularized omentum tissue as the basis for generating bio ink for tissue printing.

This approval strengthens the company’s intellectual property position and joins an additional 3D printing patent already approved in the United States and Europe, supporting the company’s commercialization potential and international market expansion.

Congratulations to Prof. Tal Dvir on His Election as a Fellow of the U.S. National Academy of Inventors

The National Academy of Inventors (NAI) has announced the appointment of Prof. Dvir as an NAI Fellow. Election to the rank of Fellow represents the Academy’s most prestigious recognition, honoring inventors whose innovations have demonstrated exceptional impact on quality of life, economic development, and societal well-being.

Founded in 2010, the NAI is dedicated to recognizing and promoting inventions with strong potential for U.S. patent protection and real-world application. The Academy comprises more than 1,850 members, including 260 fellows from academic institutions around the world.

The NAI selection committee noted:
“This prestigious appointment is awarded to Professor Dvir in recognition of his outstanding achievements as an inventor. His research and work have had a significant impact on innovation, economic development, and social welfare. His election reflects not only his accomplishments, but also his dedication to advancing technology, fostering innovation, and serving the greater good.”

Tune in to watch Matricelf’s VP R&D, Dr. Tamar Harel Adar, interviewed on Channel 10

Matricelf signs agreement with the Institute for Advanced Cellular Therapies (I-ACT) at Tel Aviv Sourasky Medical Center (Ichilov) for clinical manufacturing — a significant milestone towards the world’s first clinical trial for spinal cord injury treatment

On October 23, 2025, Matricelf Ltd. announced the signing of an agreement with Tel Aviv Sourasky Medical Center (Ichilov) for the use of a cleanroom at the Institute for Advance Cellular Therapies (I-ACT), marking a significant milstone toward the world’s first clinical trial for spinal cord injury treatment.

The agreement enables Matricelf to commence clinical-grade manufacturing of its autologous neural tissues implants under GMP conditions, as part of its preparation for first-in-human trials in paralyzed patients.

Matricelf Announces Closing of PIPE Financing of Approximately USD 24.8 Million 

Matricelf Ltd. a publicly traded regenerative medicine company developing personalized curative treatments for spinal cord injury today announced the closing of a private investment in public equity financing with total potential gross proceeds of approximately USD 24.8 million.

The PIPE was completed through a multi tranche private placement to a group of qualified and strategic investors via the issuance of non -tradable warrants convertible into ordinary shares of the company.

The financing consists of two components. Short term warrants are expected to generate approximately USD 9.0 million in near term proceeds, while long term warrants represent approximately USD 15.8 million in additional potential capital, reflecting investor alignment with both the company’s upcoming milestones and its long-term growth trajectory.

The structure of the transaction allows investors to participate in Matricelf’s near term value inflection points as well as its long-term platform potential and underscores strong confidence in the company’s technology clinical roadmap and execution capabilities.

Proceeds from the PIPE are expected to be used to support ongoing operations advance clinical and regulatory activities and accelerate development of Matricelf’s personalized neural tissue regeneration platform.

Gil Hakim Chief Executive Officer of Matricelf said

“This financing significantly strengthens our balance sheet and provides both near term and long-term capital to support our progress toward first in human clinical trials. We are pleased to welcome a strong group of high quality investors who share our long-term vision.”

The transaction was approved by the company’s board of directors including shareholder approval.

Appointment of Ron Mayron to the Company’s Board of Directors

On October 19, 2025, the Company’s Board of Directors approved the appointment of Mr. Ron Mayron, former CEO of Teva Israel, as a member of the Company’s Board of Directors, and decided to bring his appointment as Chairman of the Board for approval by the Company’s General Meeting of Shareholders.

Mr. Mayron brings with him decades of extensive experience in the biomedical industry in Israel and abroad, including proven expertise in leading international companies, managing complex organizations, formulating growth strategies, business development, and entering new markets. His senior positions at Teva, and particularly his tenure as CEO of Teva Israel, position him as one of the most experienced and influential figures in the industry.

Patent allowance in the U.S. for the company’s 3D printing technology – omentum-based scaffold and delivery system

On September 4, 2025, the company received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its new patent application (U.S. Patent Application No. 1A20200101198US), titled “System delivery and scaffold based Omentum.” The patent, licensed from Tel Aviv University, covers a unique technology enabling the 3D printing of cardiac tissue and blood vessels using decellularized omentum tissue as the basis for bio-ink in tissue and organ fabrication.

This patent expands the company’s existing intellectual property portfolio, further strengthening proprietary protection of its innovative 3D bioprinting technologies. The addition of this patent is expected to enhance commercialization potential and accelerate entry into international markets in the field of tissue and organ printing.

“World’s first spinal cord transplant to take place in Israel, could allow patients to walk again” (Jerusalem Post)

Matricelf’s CEO, Gil Hakim, interviewed at ‘Today’s Talk’ (Channel 13) about potential cure for paralysis

Matricelf featured on Channel 12’s primetime news

“Blue-and-white breakthrough: Israel to perform first-ever transplant of lab-grown spinal cord” (Ynet)

International Recognition – Matricelf Awarded a Grant from the UK-based Walkoncemore 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 Walkoncemore 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.

Walkoncemore 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.