STOCK TITAN

Regentis Biomaterials Appoints Dr. Galit Reske as Chief Medical Officer: Brings Strong Track Record of Success in Cartilage Repair

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Positive)
Tags

Regentis (NYSE:RGNT) on February 19, 2026 appointed Dr. Galit Reske as Chief Medical Officer to advance GelrinC clinical and regulatory strategy. Dr. Reske led CartiHeal's IDE pivotal trials across 30+ sites, helped secure U.S. FDA approval of Agili-C in 2022, and supported CartiHeal's $330 million acquisition.

Regentis cites her experience in clinical operations, regulatory submissions, and global commercialization as directly aligned with planned European launches and pursuit of FDA approval for GelrinC.

Loading...
Loading translation...

Positive

  • Led IDE pivotal trials across >30 U.S., EU, and Israel sites
  • Contributed to FDA approval of Agili-C in 2022
  • Played role in CartiHeal $330 million acquisition by Smith+Nephew (2023)

Negative

  • GelrinC has not yet received U.S. FDA approval

News Market Reaction – RGNT

+0.25%
1 alert
+0.25% News Effect
+$55K Valuation Impact
$22M Market Cap
0.1x Rel. Volume

On the day this news was published, RGNT gained 0.25%, reflecting a mild positive market reaction. This price movement added approximately $55K to the company's valuation, bringing the market cap to $22M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

CartiHeal acquisition value: $330 million CartiHeal tenure: 2017 to 2026 Clinical trial sites: more than 30 sites +2 more
5 metrics
CartiHeal acquisition value $330 million Acquisition of CartiHeal by Smith+Nephew in 2023
CartiHeal tenure 2017 to 2026 Period Dr. Reske served as Director of Clinical Operations
Clinical trial sites more than 30 sites IDE Pivotal Study sites across U.S., Europe, and Israel
Agili-C FDA approval year 2022 Year U.S. FDA approval of Agili-C was secured
CartiHeal acquisition year 2023 Year CartiHeal was acquired by Smith+Nephew

Market Reality Check

Price: $3.70 Vol: Volume 5,112 is 0.31x the...
low vol
$3.70 Last Close
Volume Volume 5,112 is 0.31x the 20-day average of 16,262, indicating relatively light pre-news trading. low
Technical Shares at $4.00 are 52.1% below the $8.35 52-week high and trading below the $6.33 200-day MA.

Peers on Argus

No peers were flagged in the momentum scanner and no same-day peer headlines wer...

No peers were flagged in the momentum scanner and no same-day peer headlines were provided, suggesting this move is stock-specific rather than part of a broader sector rotation.

Historical Context

5 past events · Latest: Feb 17 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Feb 17 EU site expansion Positive -10.5% Expanded European clinical site network to support GelrinC launch and programs.
Feb 04 CFO/CBO appointment Positive -0.2% Named new CFO and Chief Business Officer as GelrinC nears EU launch.
Jan 29 US site expansion Positive -4.8% Expanded U.S. Phase III GelrinC trial network with leading orthopedic centers.
Jan 20 MRI outcome data Positive +0.0% Reported MRI data showing regenerated cartilage structure comparable to native tissue.
Jan 06 Phase II durability data Positive -2.3% Released 24‑month Phase II GelrinC durability results using quantitative MOCART imaging.
Pattern Detected

Recent GelrinC-related and expansion news has generally been positive but followed by flat or negative 24h price reactions, indicating a pattern of muted or contrary trading responses.

Recent Company History

Over the past two months, Regentis highlighted strengthening clinical and commercial foundations for GelrinC®. Data from a Phase II study showed durable cartilage regeneration with a mean MOCART score of 88.8/100 at 24 months, and long-term MRI results confirmed native-like cartilage structure. The company expanded Phase III U.S. clinical sites and European networks ahead of a 2026 EU launch, while adding a CFO/Chief Business Officer. The new CMO appointment aligns with this trajectory of building leadership and infrastructure around GelrinC’s clinical validation and commercialization plans.

Market Pulse Summary

This announcement underscores Regentis’ focus on strengthening clinical and regulatory leadership as...
Analysis

This announcement underscores Regentis’ focus on strengthening clinical and regulatory leadership as GelrinC® progresses through a pivotal U.S. Phase III study and toward European commercialization. The new CMO brings experience in securing U.S. FDA approval and supporting a $330 million acquisition, complementing earlier additions to the executive team and network expansions. Investors may watch upcoming clinical milestones, regulatory interactions, and launch execution to gauge how this leadership depth translates into adoption and revenue.

Key Terms

fda approval, cartilage repair, osteochondral, ide pivotal study, +4 more
8 terms
fda approval regulatory
"key role in FDA approval of cartilage repair product Agili-C"
FDA approval is the U.S. Food and Drug Administration’s formal authorization for a drug, vaccine, or medical device to be marketed and sold after reviewers determine it meets standards for safety and effectiveness. For investors it’s a pivotal milestone because it opens the door to legal, large-scale sales and can sharply boost revenue potential while reducing regulatory uncertainty—like receiving a safety certificate that lets a new bridge carry traffic and tolls.
cartilage repair medical
"FDA approval of cartilage repair product Agili-C"
The medical process of restoring or replacing damaged joint cartilage to relieve pain and improve movement, using surgical techniques, cell-based therapies, implants or biological injections. For investors, cartilage repair matters because successful treatments can create sizeable markets, drive clinical-trial milestones, regulatory approvals and reimbursement decisions, and influence a company’s growth prospects—think of it as patching or resurfacing the cushioning in a machine to extend its useful life and performance.
osteochondral medical
"cartilage repair and osteochondral treatments."
Osteochondral describes anything involving both the bone and the adjacent cartilage, typically where a joint bears weight. Think of it as the hard foundation (bone) and the soft padding (cartilage) that work together to let joints move smoothly; damage to that combined unit matters to investors because treatments, devices, or drugs targeting osteochondral problems often require different development steps, clinical evidence, and regulatory paths than therapies aimed only at bone or only at cartilage.
ide pivotal study regulatory
"she led the company's IDE Pivotal Study, managing clinical trials"
An IDE pivotal study is a large, final clinical trial conducted under an Investigational Device Exemption (IDE) that tests whether a medical device is safe and effective enough for regulatory approval and widespread use. For investors, it matters because the study’s results often determine whether a device can reach the market; think of it as the device’s “road test” or final exam where passing opens commercial revenue and failing can halt or delay value creation.
clinical trials medical
"managing clinical trials across more than 30 sites"
Clinical trials are carefully controlled studies that test whether a new drug, device or treatment is safe and effective in people, moving through successive stages that increase the number of participants and the rigor of testing. Investors care because trial outcomes determine whether a product can be approved and sold, shaping a company’s future revenue, valuation and risk profile—think of it as proof-of-concept testing that decides if a prototype becomes a market-ready product.
regulatory submissions regulatory
"managing regulatory submissions and interactions in the European Union"
Regulatory submissions are formal packages of data, documents and plans companies send to government agencies to get approval or permission for a product, service, or change—common in areas like drugs, medical devices, and securities filings. Investors care because these submissions determine whether a product can be sold, a trial can proceed, or a business action can occur; think of them as permit applications whose approval or rejection can significantly change a company's revenues and risk profile.
phase i-iv clinical studies medical
"managed global Phase I-IV clinical studies across multiple therapeutic areas"
Phase I–IV clinical studies are the sequential stages of testing new drugs or medical treatments in people: Phase I checks safety and dosage in a small group, Phase II tests whether it works and refines dosing, Phase III compares it to current care in large groups to confirm effectiveness, and Phase IV monitors long‑term safety after approval. Investors watch these stages like milestones on a product road map because each stage greatly affects the chance of approval, timelines, costs and potential future sales.
regenerative medicine medical
"a regenerative medicine company focused on innovative tissue repair solutions"
A field of medical treatments that aims to repair, replace or regenerate damaged tissues and organs using approaches such as cell or gene therapies, engineered tissues, and biologically active materials. It matters to investors because successful regenerative therapies can create entirely new, high-value markets and replace chronic treatments, offering large potential returns but also long development timelines, heavy regulation and high technical risk—like betting on a promising new technology that could either revolutionize care or fail in trials.

AI-generated analysis. Not financial advice.

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

HERZLIYA, ISRAEL / ACCESS Newswire / February 19, 2026 / Regentis Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced the appointment of Dr. Galit Reske, PhD, as Chief Medical Officer (CMO). Dr. Reske brings extensive experience in clinical development, regulatory strategy, and global clinical operations across the United States, Europe, and Israel, with a particular focus on cartilage repair and osteochondral treatments.

From 2017 to 2026, Dr. Reske served as Director of Clinical Operations at CartiHeal, where she played a central role in the clinical and regulatory advancement of Agili-C, a novel cartilage and osteochondral repair implant. During her tenure, she led the company's IDE Pivotal Study, managing clinical trials across more than 30 sites in the U.S., Europe, and Israel, and oversaw all aspects of clinical operations, clinical regulations, data management, and medical writing.

Dr. Reske was instrumental in securing U.S. FDA approval of Agili-C in 2022, as well as managing regulatory submissions and interactions in the European Union and Israel. Her leadership contributed directly to CartiHeal's successful acquisition by Smith+Nephew in 2023 for $330 million.

Prior, she held senior clinical positions including Manager of Clinical Department at TechnoSTAT, where she managed global Phase I-IV clinical studies across multiple therapeutic areas for pharmaceutical and medical device companies. She also served as Medical Product Specialist at Biovo Technologies and Clinical Trials Manager at CRO Consultants. Dr. Reske holds a PhD in Molecular Biology from the Hebrew University of Jerusalem.

"We are very pleased to welcome Dr. Reske to Regentis," said Dr. Ehud Geller, CEO and Executive Chairman of Regentis. "She brings a clear and demonstrated track record of success in cartilage and osteo therapies-from clinical development and pivotal trials through complex regulatory submissions and interactions that have resulted in global approvals, including with the U.S. FDA. Her experience is directly aligned with Regentis' mission as we advance GelrinC®'s clinical and commercial strategy."

"With all her experience, we expect Dr. Reske to play a leadership role in shaping our responsiveness to orthopedic surgeons' needs, our support of planned marketing and sales introductions in Europe, and conference presentations," Dr. Geller added.

Dr. Reske commented, "GelrinC® represents a true breakthrough in regenerative medicine. Based on the clinical data generated to date, GelrinC® has the potential to significantly improve treatment outcomes for patients with cartilage defects while offering a compelling value proposition for clinicians and healthcare systems. I am excited to join Regentis at this important stage and to help advance GelrinC® toward FDA approval, broader clinical adoption, and commercial success."

About GelrinC®

Regentis' lead product, GelrinC®, is a cell-free, off-the-shelf hydrogel synchronized erosion and resorbable implant for the treatment of painful 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 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' market positioning. 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 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 the final prospectus related to the public offering 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

Who is Dr. Galit Reske and what role will she have at Regentis (RGNT)?

Dr. Galit Reske is Regentis' new Chief Medical Officer responsible for clinical and regulatory strategy. According to Regentis, she will lead GelrinC's clinical development, regulatory interactions, and support planned European marketing and sales introductions.

How does Dr. Reske's experience with Agili-C impact Regentis (RGNT)?

She helped secure U.S. FDA approval for Agili-C and led pivotal trials across 30+ sites. According to Regentis, that track record informs GelrinC's regulatory pathway and trial design as the company pursues broader approvals and commercialization.

What specific clinical experience does Dr. Reske bring to Regentis (RGNT)?

Dr. Reske managed global clinical operations, clinical regulations, data management, and medical writing for pivotal studies. According to Regentis, her background spans Phase I–IV oversight and multi‑site pivotal trials in the U.S., Europe, and Israel.

What is the significance of the $330 million figure mentioned in the Regentis (RGNT) announcement?

The $330 million references CartiHeal's acquisition by Smith+Nephew in 2023, linked to programs Dr. Reske supported. According to Regentis, her contributions to Agili-C's regulatory milestones helped enable that commercial outcome.

Does Dr. Reske's appointment change GelrinC's U.S. regulatory status for Regentis (RGNT)?

Her hiring does not itself change regulatory status; GelrinC remains in the approval pathway. According to Regentis, Dr. Reske will help advance GelrinC toward U.S. FDA approval and broader clinical adoption.
Regentis Biomaterials Ltd

NYSE:RGNT

RGNT Rankings

RGNT Latest News

RGNT Latest SEC Filings

RGNT Stock Data

21.18M
1.25M