#Israel #biotechnology #Spinal Cord Injury #NESS ZIONA #Matricelf Ltd.

Matricelf Ltd. Unveils Milestones and Future Plans

Matricelf Ltd., a biotech innovator listed on the Tel Aviv Stock Exchange, is setting the stage for groundbreaking advancements in spinal cord injury treatment. The company recently released an update detailing its major accomplishments in 2025 and laid out a vision for 2026 that centers around the first human implantation of its engineered neural tissue.

2025: A Year of Transition

In 2025, Matricelf transitioned decisively from advanced preclinical development to establishing the necessary operational and clinical infrastructure for its pioneering first-in-human study. A pivotal achievement was the completion of an initial safety trial, which demonstrated a promising safety profile for its spinal cord implants.

Concurrently, a large-scale safety study compliant with Good Laboratory Practice (GLP) is in progress, yielding encouraging interim findings. The final results are anticipated in the first half of 2026, paving the way for regulatory submissions to commence human clinical trials soon afterward.

In a notable technological leap, Matricelf joined forces with Cellino Biotech, showcasing the ability to produce engineered neural tissue from stem cells via artificial intelligence technology. This promising development could revolutionize the scalability and affordability of treatments, broadening patient access to these cutting-edge therapies.

Crucially, the company has secured Helsinki Committee approval from Sheba Medical Center, allowing for the collection of blood from patients with complete spinal cord injuries. This marks a significant milestone toward initiating human treatments. Matricelf has also convened a clinical advisory board with leading neurosurgeons and rehabilitation specialists to map out trial protocols and patient selection criteria.

To ensure compliance with Good Manufacturing Practices (GMP) for clinical manufacturing, Matricelf has partnered with Tel Aviv Sourasky Medical Center (Ichilov) to utilize dedicated clean room facilities, preparing thoroughly for their first clinical study.

Additionally, the company has fortified its intellectual property holdings, achieving several U.S. patent grants that will extend protection for its innovations until 2039, encompassing both spinal cord applications and broader regenerative therapy technologies.

Financial and Organizational Growth

Financially, Matricelf experienced a boost in 2025, securing around NIS 24.4 million through a private placement, with the potential for an additional NIS 36.6 million if warrants are exercised. The funding strengthens the company's financial foundation as it prepares for a pivotal clinical phase. In a strategic move, Mr. Ron Miron, the former CEO of Teva Israel, has assumed the role of active Chairman of the Board, lending his substantial experience toward guiding the company's growth.

Looking Ahead: The 2026 Strategic Plan

As 2026 unfolds, Matricelf's focus will shift toward completing its advanced preclinical program and gearing up for its initial human implantations—an event anticipated as part of either compassionate use protocols or formal clinical trials. This development is expected to significantly increase the company’s value.

Highlights of their strategic plan for 2026 include:

• - Completing final animal efficacy studies.
• - Transferring technology to GMP-grade manufacturing environments.
• - Establishing comprehensive clinical infrastructures.
• - Initiating regulatory submissions to facilitate human clinical studies.

The company aims to begin patient identification in 2026, with ambitions to complete its first clinical implant by 2027.

Future Aspirations: Achieving a Nasdaq Listing

In addition to their clinical ambitions, Matricelf has commenced early evaluations for a potential Nasdaq listing. Depending on the progression of their preparations and the receipt of necessary approvals, the management is eyeing a listing during 2027; however, no final decisions have been made, and outcomes remain uncertain.

CEO Gil Hakim expresses optimism as Matricelf enters 2026, highlighting the strong momentum and defined roadmap toward their unprecedented first-in-human clinical study. "We foresee an array of regulatory and partnership milestones that could substantially benefit our shareholders in the coming years," he stated proudly.

About Matricelf Ltd.

Matricelf Ltd. is at the forefront of regenerative medicine, focusing on personalized and autologous engineered neural tissue implants for spinal cord injury treatments. Their innovative approach harnesses a patient's own biological materials to repair damaged spinal cord tissues and restore neural functions effectively.

Matricelf's commitment to advancing spinal cord injury therapies is both groundbreaking and promising, as it works diligently towards the goal of helping those in need of innovative medical solutions.