Regentis to Commence European Surgeon Training for GelrinC in Knee Cartilage Repair as Commercial Launch Preparations Accelerate

Regentis (NYSE American:RGNT) plans to begin European surgeon training for GelrinC, an off-the-shelf, cell-free hydrogel implant for knee cartilage repair, in Q3 2026.

Rhea-AI Summary

Regentis (NYSE American:RGNT) plans to begin European surgeon training for GelrinC, an off-the-shelf, cell-free hydrogel implant for knee cartilage repair, in Q3 2026. GelrinC holds CE Mark approval in Europe and uses a single-step, ~10-minute implantation procedure.

Initial hands-on training will be at Humanitas Research Hospital in Milan, with additional European sessions and a network of Centers of Excellence supporting education and adoption. Regentis is targeting an estimated $3 billion U.S. market of about 470,000 annual knee cartilage repair cases. Clinical data have shown roughly 100% greater pain improvement versus microfracture, MRI-confirmed near-native cartilage regeneration, and multi-year durability.

Positive

• CE Mark approval enables GelrinC commercial rollout in European markets
• European surgeon training to begin in Q3 2026, starting in Milan
• Network of European Centers of Excellence to support adoption and education
• Clinical data show ~100% greater pain improvement vs microfracture
• MRI-confirmed near-native cartilage regeneration with multi-year outcomes
• Targeting estimated $3 billion U.S. market with 470,000 annual procedures

Negative

• None.

Argus Jun 8 session

-3.03% close to close Open Argus

Details

News Market Reaction – RGNT

In the Jun 8 session, RGNT declined 3.03%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement describes Regentis moving from preparation to execution in Europe, with surgeon tr...

Analysis

This announcement describes Regentis moving from preparation to execution in Europe, with surgeon training for GelrinC beginning in 3Q 2026 and leveraging existing CE Mark approval. The company targets a roughly $3 billion U.S. market with about 470,000 annual knee cartilage repair cases, citing clinical data with approximately 100% greater pain improvement versus microfracture. Recent history shows progress in manufacturing, trial enrollment, and site expansion, while investors may watch upcoming commercialization milestones and financing disclosures for signals on execution risk.

Key Figures

Procedure time: 10 minutes Pain improvement: approximately 100% greater Target market size: $3 billion +5 more

Procedure time

10 minutes

Single-step GelrinC implantation procedure

Pain improvement

approximately 100% greater

GelrinC vs standard microfracture pain improvement

Target market size

$3 billion

Estimated U.S. knee cartilage repair market

Annual cases

470,000 cases

Estimated annual U.S. knee cartilage repair procedures

IPO proceeds

$10.0 million

Capital raised in 2025 IPO

Cash balance

$7.4 million

Cash as of December 31, 2025

Pivotal trial enrollment

47 of 80 patients

GelrinC pivotal IDE trial enrollment in F-1 filing

Registered shares

3,333,334 shares

Ordinary shares in F-1 firm commitment offering

Historical Context

5 past events · Latest: Apr 16

5 events

1. Apr 16

   European collaboration

   24h Move

   +3.2%

   Collaboration with Humanitas and expert leadership for EU Centers of Excellence.

2. Mar 17

   Manufacturing process

   24h Move

   +5.9%

   New solvent-free process boosting GelrinC production yield by 400% for launch.

3. Feb 24

   2025 earnings update

   24h Move

   +0.8%

   Reported 2025 results, IPO proceeds, cash balance, and Phase III enrollment status.

4. Feb 19

   New CMO appointment

   24h Move

   -2.3%

   Appointment of experienced CMO to drive GelrinC clinical and regulatory plans.

5. Feb 17

   Clinical network expansion

   24h Move

   -10.5%

   Expansion of European clinical sites to support GelrinC commercial and clinical work.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

hydrogel implant, knee cartilage repair, microfracture, cell-based therapies, +4 more

8 terms

hydrogel implant medical

"off-the-shelf cell-free hydrogel implant for knee cartilage repair"

A hydrogel implant is a soft, water-containing medical device made from a jelly-like polymer that is placed into the body to replace or support tissue, cushion structures, or slowly release medicines. For investors it matters because these implants can open new treatment markets or revenue streams but also carry clinical trial, regulatory approval, manufacturing and reimbursement risks; think of it as a sponge-like patch inside the body whose success depends on safety, effectiveness and adoption.

knee cartilage repair medical

"hydrogel implant for knee cartilage repair, is approved for sale"

Knee cartilage repair is a set of treatments that restore the cushioning tissue inside the knee, using injections, implanted scaffolds, cell therapies or surgical grafts to reduce pain and improve movement. For investors, progress in these treatments matters because better, longer‑lasting fixes can expand patient demand, change how insurers pay for care, and create revenue opportunities for medical device makers, biotech firms and healthcare providers—like a widely adopted car upgrade that increases sales across an industry.

microfracture medical

"alternative to traditional microfracture and complex cell-based therapies"

A microfracture is a surgical technique used to repair damaged joint cartilage by creating tiny holes in the underlying bone to trigger the body’s natural healing response, like aerating soil so new tissue can grow. It matters to investors because the procedure affects demand for orthopedic devices, implants, biologic treatments and rehabilitation services, influences clinical outcomes and reimbursement decisions, and can shape the commercial prospects of related medical products.

cell-based therapies medical

"alternative to traditional microfracture and complex cell-based therapies"

Therapies made from living cells that are given to patients to replace damaged tissue, turn off harmful immune responses, or stimulate healing; they are produced, tested, and administered much like medicines but are alive and can act in the body over time. Investors watch them because successful products can create large, long-lasting markets—think of them like breakthrough tools that could transform treatment—yet they also carry high scientific, regulatory and manufacturing risks that can make outcomes unpredictable.

orthopedic surgeons medical

"designed to train orthopedic surgeons in the use of GelrinC"

Orthopedic surgeons are medical doctors who diagnose and surgically treat problems of the bones, joints, muscles, ligaments and tendons, performing procedures such as joint replacements, fracture repairs and minimally invasive joint surgeries. They matter to investors because their choices determine which implants, instruments and surgical techniques become standard of care—acting like gatekeepers whose preferences and volume of procedures drive sales, market adoption and revenue for medical device makers and hospitals.

implantation procedure medical

"providing practical experience with the implantation procedure"

An implantation procedure is a medical operation—surgical or minimally invasive—in which a device, tissue graft, or other material is placed into the body to restore function, deliver therapy, or replace damaged tissue. Investors care because the safety, effectiveness, regulatory approval, and ease of performing the procedure determine how widely the treatment will be adopted, its cost and reimbursement, and ultimately the commercial market potential—like how a reliable part installation affects a machine’s value and demand.

cartilage lesions medical

"cell-free implant for the treatment of knee cartilage lesions"

Cartilage lesions are areas where the smooth, rubbery tissue that cushions joints becomes damaged or worn away, like the worn-out padding in a car’s suspension that makes rides rougher. For investors this matters because such damage drives demand for treatments, surgeries, and medical devices, influences clinical trial results and regulatory decisions, and can affect health-care costs and the commercial prospects of drugs or technologies aimed at repairing or replacing joint cartilage.

MRI-confirmed medical

"MRI-confirmed regeneration of near-native cartilage and durable outcomes"

An outcome or diagnosis labeled “MRI-confirmed” means a magnetic resonance imaging scan—a detailed, noninvasive picture of internal tissues—was used to verify the result. For investors, MRI confirmation signals that a medical claim rests on objective, visual evidence rather than only patient reports or subjective assessments, which can strengthen the credibility of clinical data, affect regulatory review, and reduce uncertainty about a treatment’s effectiveness much like an independently taken photograph supports a claim.

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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

HERZLIYA, ISRAEL / ACCESS Newswire / June 8, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, announced today that in the third quarter of 2026, the Company plans to commence its European surgeon training activities, as it advances preparations for the commercial rollout of GelrinC^® in Europe, where it has CE Mark approval.

The hands-on training program is designed to train orthopedic surgeons in the use of GelrinC, providing practical experience with the implantation procedure and supporting physician readiness ahead of market launch. The first training activities are expected to take place in Milan, Italy, at Humanitas Research Hospital, one of Europe's leading academic medical centers in orthopedics and sports medicine. Additional sessions are planned in other European markets.

GelrinC is a cell-free implant for the treatment of knee cartilage lesions. The procedure utilizes a ready-to-use implant and a straightforward single-step implantation process, which takes approximately 10 minutes, and fits into the surgeon's workflow.

"The initiation of surgeon training activities represents an important commercial milestone for Regentis in Europe," said Dr. Ehud Geller, Chief Executive Officer of Regentis. "With commercialization activities now underway, physician training is a critical next step. Building surgeon experience and confidence with GelrinC will support market adoption and help bring this technology to patients throughout Europe."

As part of its European strategy, Regentis is establishing a network of European Centers of Excellence designed to support surgeon education, clinical guidance, and knowledge sharing around cartilage repair and the use of GelrinC. These centers are intended to serve as leading clinical hubs where experienced orthopedic surgeons will help train and support other physicians across Europe as the technology is introduced into clinical practice.

Regentis is targeting an estimated $3 billion U.S. market of 470,000 annual knee cartilage repair cases, where no approved off-the-shelf regenerative solution currently exists. Clinical data have shown approximately 100% greater pain improvement versus standard of care microfracture, alongside MRI-confirmed regeneration of near-native cartilage and durable multi-year outcomes.

About GelrinC^®

Regentis' lead product, GelrinC^®, is a cell-free, off-the-shelf hydrogel implant having synchronized erosion and resorption for the treatment of painful and debilitating injuries to focal articular knee cartilage. As an innovative regenerative medical product, GelrinC^® offers an unprecedented solution that gives surgeons and payers an off-the-shelf, ready to use, simple to perform, reliable, and cost-effective procedure that provides patients with a single, 10-minute procedure, faster recovery, sustained pain relief, and functional improvement for more than 5 years, based on clinical study results to date. No effective off-the-shelf, ready to use treatment for focal knee cartilage defects is currently available on the market. GelrinC^® has CE Mark approval in the European Union and is now being evaluated in a pivotal U.S. Food and Drug Administration (FDA) study, which has completed over 50% enrollment.

About Regentis Biomaterials

Regentis Biomaterials Ltd is a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore health and enhance quality of life. With an initial focus on orthopedic treatments, Regentis' Gelrin platform technology, based on synchronized, degradable hydrogel implants, regenerates damaged or diseased tissue including inflamed cartilage and bone. Regentis' lead product GelrinC^®, is a cell-free, off-the-shelf hydrogel that is eroded and resorbed in the knee, allowing the surrounding cells to regenerate the cartilage in a controlled and synchronous process. GelrinC^® aims to address a market of approximately 470,000 cases for cartilage knee repair annually in the U.S. where no off-the-shelf treatment is available.

Forward Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words, and include beliefs regarding Regentis' plans to commence European surgeon activities and the timing thereof. Forward-looking statements are based on Regentis' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the ability of our clinical trials to demonstrate safety and efficacy of GelrinC or any future product candidate, and other positive results; the timing and focus of our preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for of GelrinC or any future product candidate, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to accurately identify demand for product candidates; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain FDA approval for of GelrinC or any future product candidate and obtain and maintain regulatory approval; our ability to obtain market acceptance of GelrinC or any future product candidate from the medical community and third-party payors; our plans relating to the further development of GelrinC or any future product candidate, including additional disease states or indications we may pursue; existing regulations and regulatory developments in the United States and other jurisdictions; our plans and ability to obtain or protect intellectual property rights, including extensions of patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our dependence on third parties; our financial performance and our ability to repay our loans and debts; and our ability to negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and perform our obligations under such collaborations. For a more detailed description of the risks and uncertainties affecting Regentis, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the section titled "Risk Factors" in our Annual Report on Form 20-F filed with the SEC on February 24, 2026 and other public reports filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Regentis undertakes no duty to update such information except as required under applicable law.

Contact:

acarlquist@medicavp.com

SOURCE: Regentis Biomaterials Ltd.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Regentis (RGNT) announce about European surgeon training for GelrinC on June 8, 2026?

Regentis announced plans to start European surgeon training for GelrinC in the third quarter of 2026. According to Regentis, this hands-on program will prepare orthopedic surgeons for GelrinC’s single-step, 10-minute knee cartilage repair procedure ahead of its commercial launch in Europe.

When and where will Regentis (RGNT) begin GelrinC surgeon training in Europe?

Regentis expects to begin GelrinC surgeon training in Europe in Q3 2026, starting in Milan, Italy. According to Regentis, the first sessions will take place at Humanitas Research Hospital, followed by additional training activities in other European markets.

What is GelrinC and how does its knee cartilage repair procedure work?

GelrinC is a cell-free, off-the-shelf hydrogel implant for knee cartilage lesions. According to Regentis, the treatment uses a ready-to-use implant and a straightforward, single-step implantation process that takes about 10 minutes and is designed to fit into standard surgical workflows.

How does GelrinC’s clinical performance compare with microfracture in knee cartilage repair?

Clinical data reported by Regentis indicate GelrinC achieved approximately 100% greater pain improvement versus standard microfracture. According to Regentis, results also include MRI-confirmed regeneration of near-native cartilage and durable outcomes over multiple years, supporting its use as an alternative treatment option.

What market opportunity is Regentis (RGNT) targeting with GelrinC knee cartilage repair?

Regentis is targeting an estimated $3 billion U.S. market for knee cartilage repair with GelrinC. According to Regentis, this market includes about 470,000 annual procedures where no approved off-the-shelf regenerative solution is currently available, highlighting a potential unmet clinical need.

What are Regentis’ European Centers of Excellence for GelrinC and why are they important?

Regentis is creating European Centers of Excellence to support GelrinC education, guidance, and knowledge sharing. According to Regentis, these hubs will host experienced orthopedic surgeons who train and support other physicians, helping integrate the technology into clinical practice across Europe.

How might GelrinC’s 10-minute procedure benefit surgeons and patients compared with complex cell-based therapies?

GelrinC offers a single-step, approximately 10-minute implantation procedure using an off-the-shelf implant. According to Regentis, this simplicity may fit more easily into surgical workflows and provide an alternative to traditional microfracture and complex cell-based therapies for knee cartilage repair.