Regentis Biomaterials Ltd

Agreement with Israel's leading orthopedics distributor includes minimum purchase commitments; Revenue contributions expected to begin during 2027

AMI Technologies brings an established orthopedic sales and distribution network with strong ties to leading surgeons serving leading Israeli hospitals and clinics.

GelrinC is approved in Israel and Europe for knee cartilage repair, and is currently in a pivotal U.S. Phase III trial

Engagement with leading orthopedic surgeons and cartilage repair specialists highlights growing awareness of GelrinC's off-the-shelf regenerative technology

GelrinC is CE Mark approved in Europe, where Regentis is expanding its network of Centers of Excellence to support surgeon training and commercialization efforts

European clinical sites also support the Company's ongoing U.S. FDA pivotal Phase III trial

RGNT to present at ThinkEquity Conference Oct. 15, 2026 in New York. Learn about GelrinC knee cartilage implant and one-on-one investor meetings

Advances GelrinC^® U.S. pivotal trial with 43 patients treated; Completion of enrollment expected by approximately year end 2026

Expands European commercialization readiness, including surgeon training and regulatory approval of new manufacturing process that improves production yield 400%

Strengthened balance sheet with $6.5 million private placement in June 2026

Patent expands intellectual property protection in one of the world's largest cartilage repair markets

GelrinC is a cell-free hydrogel delivered in a single ~10-minute procedure eliminating the need for cell harvesting, lab processing, and surgeries-potentially setting a new standard of care for knee cartilage repair

European Notified Body approves next-generation manufacturing process that increases production 5-fold, lowers manufacturing costs, improves safety and enables scalable commercial production

GelrinC^®, which is approved for sale in the European Union, is pioneering knee cartilage repair with an off-the-shelf cell-free hydrogel implant

Regentis Biomaterials (RGNT) raises $6.5M via private placement at $3.50/share to fund GelrinC clinical trial and FDA pre-market approval submission.

GelrinC®, positioned as the first off-the-shelf cell-free hydrogel implant for knee cartilage repair, is approved for sale in the European Union

Regentis is growing its network of European Centers of Excellence designed to support surgeon education, clinical guidance, and knowledge sharing around cartilage repair and the use of GelrinC

GelrinC's 10-minute procedure offers a safe and effective alternative to traditional microfracture and complex cell-based therapies addressing a $3 billion U.S. market

Collaboration with leading European orthopedic center in Italy supports GelrinC^® clinical adoption

Renowned cartilage regeneration expert Prof. Elizaveta Kon to help lead Regentis Centers of Excellence network

Strengthens surgeon engagement and expands Regentis' European commercialization infrastructure

Breakthrough manufacturing process comes in preparation for upcoming commercial launch in Europe planned for later this year

Proprietary process is already patented in several countries and is pending in the U.S.

$7.4 million in cash expected to provide runway to complete site expansion process and patient enrollment as part of pivotal Phase III FDA trial for GelrinC

Already approved in Europe, GelrinC is expected to be rolled out in clinics across the continent in 2026

GelrinC is positioned to be the first ready-to-use, off-the-shelf product in the U.S. for knee cartilage repair

Dr. Reske has proven leadership in clinical development and regulatory affairs following key role in FDA approval of cartilage repair product Agili-C leading to CartiHeal's $330 million acquisition

With CE Mark approval, GelrinC is slated for commercial launch in Europe in 2026

New clinical sites to support engagement with leading orthopedic surgeons and centers of excellence in key European markets, strengthening Regentis' positioning for commercial launch and broader clinical adoption

GelrinC, the only restorative product for knee cartilage repair, has CE Mark approval in Europe and is currently at the midpoint of a pivotal FDA Phase III trial in the U.S.

Ori Gon brings substantial public company, medtech, and capital markets experience

New sites expected to further accelerate patient enrollment, which surpassed 50% in Phase III study, as well as support future clinical programs

GelrinC is set to transform cartilage repair market with off-the-shelf regenerative products

2 years after treatment, GelrinC-treated patients demonstrated layered cartilage architecture similar to native hyaline cartilage - widely regarded as the gold standard for durable joint function

This rare outcome in cartilage repair suggests true biological cartilage regeneration, not merely defect filling

Unlike traditional scaffolds, GelrinC limits fibrotic tissue overgrowth, supporting smoother joint motion and preserving natural biomechanics

Marks a world-first as Regentis uses MOCART, a quantitative standard to measure regeneration of cartilage in a clinical trial, as a predefined endpoint

New peer-reviewed data published in the scientific journal Cartilage uses the complete set of follow-up data from GelrinC's Phase II study, which establishes GelrinC as a leader in long-term durable cartilage repair, using objective, quantitative MOCART assessment to demonstrate morphologic outcomes that consistently outperform other treatment modalities

The data presented by Regentis show that two years after treatment, the repaired cartilage appears very close to normal healthy cartilage, highlighting the long-term durability of GelrinC and reinforcing its competitive superiority in the cartilage repair landscape

GelrinC is already approved in Europe and currently in a pivotal Phase III U.S. FDA study

Patent protects ready to use liquid formulation of GerlinC which improves efficiency and focus for surgeons, resulting in a 10-minute procedure

Robust IP portfolio includes 35 issued patents to date worldwide

GerlinC is in a pivotal FDA trial, has received regulatory approval in the EU, and is the world's first off-the-shelf regenerative treatment for knee cartilage repair

• Lead product GelrinC^®, a hydrogel synchronized erosion and resorbable implant, the only restorative product for knee cartilage repair, is a breakthrough effective and economical procedure to address a large unmet need

• GelrinC is approved for knee cartilage repair in the European Union and is currently at midpoint in a pivotal FDA trial for the same indication to address a U.S. market of more than 470,000 potential cases annually

• Upcoming expected catalysts include commercial launch in Europe and submission to FDA for approval in U.S.