Regentis Biomaterials IPO Closes, Raising $10M to Support Pivotal Trial in Orthopedic Tissue Repair

Regentis Biomaterials Ltd., a regenerative medicine company, announced the closing of its IPO on December 5, 2025. The company sold 1,250,000 ordinary shares at an initial public offering price of $8.00 per share. This raised gross proceeds of $10,000,000 before expenses.

Proceeds to the company before offering expenses totaled approximately $9.3 million.

Its ordinary shares were approved for listing on the NYSE American under the symbol “RGNT.” ThinkEquity served as the underwriter for the offering.

Based in Herzliya, Israel, Regentis focuses its orthopedic efforts on the Gelrin platform, which includes degradable hydrogel implants intended to support tissue repair. Regentis holds extensive intellectual property, with 34 granted patents and four pending patent applications covering compositions, delivery devices and surgical features.

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Regentis’ lead product is GelrinC, a cell-free, off-the-shelf hydrogel intended for the repair of focal articular cartilage defects in the knee.

GelrinC is delivered as a liquid that is cured in situ into an implant. The Gelrin technology is a hydrogel matrix composed of polyethylene glycol diacrylate and denatured fibrinogen.

The procedure takes about 10 minutes. It involves delivering liquid GelrinC directly into the cartilage defect. The liquid is then cured in place using UV light for about 90 seconds. The implant completely erodes and is resorbed in about six to nine months, a process the company says is designed to allow new hyaline-like cartilage to form as the implant recedes.

Knee cartilage injuries represent a significant orthopedic market in the US, estimated at $4 billion annually for 750,000 arthroscopic knee operations. According to Regentis, there is currently no approved off-the-shelf product in the US for cartilage repair.

In a 56-patient pilot study, the company reported that GelrinC showed improved outcomes compared with microfracture surgery, the current standard of care. The study showed about 100% greater improvement in KOOS and VAS pain scores (standard patient-reported measures of knee function and pain) over two years compared to historical microfracture data. Patients treated with GelrinC had an average recovery period of about two weeks of non-weight-bearing activity.

GelrinC offers procedural differences compared with competing cell-based therapies, such as Vericel’s MACI, which uses autologous cells. These procedures require two surgeries (biopsy and reimplantation), with cartilage first harvested from the patient for cell expansion, followed by a second surgery to implant the cultured cells and cost around $40,000 in the US.

In comparison, GelrinC is designed as a single, approximately 10-minute procedure with a short recovery period reported in clinical studies.

Regentis plans to use the net proceeds from the IPO mainly for development activities, which include completing its ongoing pivotal trial and preparing for the Pre-Market Approval (PMA) submission to the FDA.

The company has also stated that proceeds may be used for general corporate purposes, including repayment of certain debt and deferred compensation obligations.

Regentis expects to finish patient recruitment for the pivotal trial by the end of 2025. The trial needs 80 patients with two years of follow-up data for the PMA submission, and 47 patients have been recruited and participated in the trial so far.

No serious adverse events have been reported to date in the pivotal trial.

The company aims to submit its PMA by the end of 2027.

GelrinC is already approved as a device with a CE mark in Europe. Regentis plans to seek a strategic partner there while continuing to develop its Gelrin platform for new tissue regeneration opportunities in the ankle, wrist and elbow.

Regentis’ IPO comes as regenerative medicine and orthopedic technologies continue to attract industry and regulatory attention.

Recent corporate activity in the space includes Zimmer Biomet’s acquisition of Monogram Technologies to expand its robotic surgery capabilities and a private equity acquisition of a majority stake in Isto Biologics.

In the regulatory world, the FDA issued draft guidance in September 2025 titled Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, outlining regulatory pathways intended to support development of regenerative products for serious conditions.

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