Roche commences tender offer for all shares of 89bio, Inc. for $14.50 per share in cash, plus a non-tradeable contingent value right for up to $6.00 per share in cash

Roche commences tender offer for all shares of 89bio, Inc. for $14.50 per share in cash, plus a non-tradeable contingent value right for up to $6.00 per share in cash




Roche commences tender offer for all shares of 89bio, Inc. for $14.50 per share in cash, plus a non-tradeable contingent value right for up to $6.00 per share in cash

Basel, 1 October 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has commenced a tender offer for all of the outstanding shares of common stock of 89bio, Inc. (89bio) (NASDAQ: ETNB) at a price of $14.50 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain milestone payments of up to an aggregate of $6.00 per share in cash. The tender offer is being made pursuant to the previously announced merger agreement dated as of September 17, 2025, among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Bluefin Merger Subsidiary, Inc., a wholly owned subsidiary of Roche Holdings, Inc., and 89bio.

The tender offer period will expire at one minute after 11:59 p.m., New York City time on October 29, 2025, unless the offer is extended.

Roche has filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission (SEC). Bluefin Merger Subsidiary, Inc. is the acquirer in the tender offer. The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.

89bio has also filed a Solicitation/Recommendation Statement with the SEC on Schedule 14D-9, which includes the unanimous recommendation of the 89bio board of directors that 89bio stockholders tender their shares in the tender offer. The closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and there being validly tendered and not validly withdrawn a majority of the outstanding shares of 89bio common stock. The offer is not subject to any financing condition. Following successful completion of the tender offer, any shares not acquired in the tender offer will be acquired in a second-step merger at the same price of $14.50 per share, plus the CVR. The closing of the transaction is expected to take place in the fourth quarter of 2025.

The complete terms and conditions are set out in the Offer to Purchase, which was filed with the SEC today, October 1, 2025. 89bio stockholders may obtain copies of all of the offering documents, including the Offer to Purchase, free of charge at the SEC’s website (www.sec.gov) or by directing a request for the Solicitation/Recommendation Statement on Schedule 14D-9 to 89bio’s website at www.89bio.com or the Offer to Purchase and the other related materials to MacKenzie Partners, Inc., the Information Agent for the offer, toll free at (800) 322-2885 (or please call (212) 929-5500 if you are located outside the U.S. or Canada) or via email at tenderoffer@mackenziepartners.com.

Before making any decision with respect to the Offer, investors are urged to read the Offer to Purchase and related documents, as well as the Solicitation/Recommendation Statement, because they contain important information about the Offer.

About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. 89bio is in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.
 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This communication may include statements that are not statements of historical fact, or “forward-looking statements,” within the meaning of the federal securities laws, including with respect to Roche’s proposed acquisition of 89bio. Any express or implied statements that do not relate to historical or current facts or matters are forward-looking statements. These statements are generally identified by words or phrases such as “believe”, “anticipate”, “expect”, “intend”, “plan”, “will”, “may”, “should”, “estimate”, “predict”, “project”, “strategy”, “potential”, “continue” or the negative of such terms or other similar expressions. Such statements include, but are not limited to, the ability of Roche and 89bio to complete the transactions contemplated by the merger agreement, including each party’s ability to satisfy the conditions to the consummation of the offer contemplated thereby and the other conditions set forth in the merger agreement, statements about the expected timetable for completing the transaction, the parties’ beliefs and expectations and statements about the benefits sought to be achieved in Roche’s proposed acquisition of 89bio, the potential effects of the acquisition on both Roche and 89bio and the possibility of any termination of the merger agreement. These statements are based upon the current beliefs and expectations of Roche and 89bio’s management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable, if at all. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements, and you should not place undue reliance on these statements.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the offer and the subsequent merger; uncertainties as to how many of 89bio’s stockholders will tender their shares in the offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the offer and the merger contemplated by the merger agreement may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the tender offer or the subsequent merger; the ability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing; the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on 89bio’s business; the possibility that the milestones related to the contingent value right will never be achieved and that no milestone payments may be made; and the risk of legal proceedings being brought in relation to the transactions and the outcome of such proceedings, including the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability. The foregoing factors should be read in conjunction with the risks and cautionary statements discussed or identified in 89bio’s public filings with the SEC, including the “Risk Factors” section of 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q, Form 8-K and in other filings 89bio makes with the SEC from time to time as well as the tender offer materials filed by Roche and its acquisition subsidiary and the Solicitation/Recommendation Statement to be filed by 89bio, in each case as amended by any subsequent filings made with the SEC.

Neither Roche nor 89bio undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law.
 

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 79 407 72 58
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Phone: +41 79 771 05 25
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Phone: +41 79 568 24 95

 

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Roche Investor Relations

Dr Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
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Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

 

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Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
 

Attachment

TOMI Environmental Solutions Appoints Harold W. Paul to Its Board of Directors

TOMI Environmental Solutions Appoints Harold W. Paul to Its Board of Directors




TOMI Environmental Solutions Appoints Harold W. Paul to Its Board of Directors

– Brings Over 40 years of Legal, Securities, and Board Leadership Experience Across Multiple Industries –

FREDERICK, Md., Oct. 01, 2025 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination utilizing its premier Binary Ionization Technology (BIT) platform through its SteraMist brand of products, today announced the appointment of Mr. Harold W. Paul to its Board of Directors, effective immediately. He succeeds Ms. Kelly J. Anderson, who has resigned from the Board effective as of September 30, 2025.

Mr. Paul brings more than 40 years of legal and securities expertise, along with extensive board leadership experience across technology, financial services, and other industries. He previously served as a member of TOMI’s Board from 2009 to 2021, including as Corporate Secretary from 2013 to 2021. Over his career, Mr. Paul has advised numerous publicly traded companies as outside legal counsel and has served on the boards of six public companies. He holds a Bachelor of Arts from the State University of New York at Stony Brook and a Juris Doctor from Brooklyn Law School, and is admitted to practice law in New York and Connecticut.

Dr. Halden Shane, Chief Executive Officer of TOMI commented, “We are pleased to welcome Harold back to TOMI’s Board of Directors. His deep knowledge of securities law, corporate governance, and experience across multiple public company boards will bring valuable perspective to TOMI as we continue to advance our strategy and expand our impact in critical industries. I also want to express my sincere appreciation to Ms. Kelly Anderson for her dedicated service to TOMI. We wish her every success in her future endeavors.”

TOMI™ Environmental Solutions, Inc.: Innovating for a safer world®  
TOMI™ Environmental Solutions, Inc. (NASDAQ:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology ® (BIT™) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT™ solution utilizes a low percentage hydrogen peroxide as its only active ingredient and uses patented ionized Hydrogen Peroxide (iHP™) technology in all SteraMist systems to create superior disinfection. TOMI products are designed to service a broad spectrum of use sites, including, but not limited to, hospitals and medical facilities, biosafety labs, pharmaceutical facilities, commercial and office buildings, schools, restaurants, meat and produce processing facilities, and police and fire departments. 
  
For additional information, please visit http://www.steramist.com/ or contact us at info@tomimist.com  

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995  

This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These forward-looking statements include, without limitation, statements relating to TOMI’s board of directors. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These factors include, but are not limited to, our ability to maintain and manage growth and generate sales, our reliance on a single or a few products for a majority of revenues; the general business and economic conditions; and other risks as described in our SEC filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by us with the SEC and other periodic reports we filed with the SEC. The information provided in this document is based upon the facts and circumstances known at this time. Other unknown or unpredictable factors or underlying assumptions subsequently proving to be incorrect could cause actual results to differ materially from those in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and we undertake no duty to update such information, except as required under applicable law.

INVESTOR RELATIONS CONTACT:  
John Nesbett/Rosalyn Christian  
IMS Investor Relations  
tomi@imsinvestorrelations.com  

Castle Biosciences’ Founder, President and CEO Derek Maetzold Honored with the CEO of the Year Award by The CEO Magazine

Castle Biosciences’ Founder, President and CEO Derek Maetzold Honored with the CEO of the Year Award by The CEO Magazine




Castle Biosciences’ Founder, President and CEO Derek Maetzold Honored with the CEO of the Year Award by The CEO Magazine

Maetzold recognized among 586 applicants to The CEO Magazine’s 2025 Executive of the Year Awards — United States program

Derek Maetzold, Founder, President & CEO, Castle Biosciences

FRIENDSWOOD, Texas, Oct. 01, 2025 (GLOBE NEWSWIRE) — Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that its founder, president and chief executive officer Derek Maetzold has been awarded the CEO of the Year by The CEO Magazine. The Executive of the Year Awards program recognizes senior executives driving measurable impact, innovation and inspiration.

“This honor affirms what we at Castle have long known: Derek is a visionary leader whose ability to pair scientific innovation with a people-first approach has made a marked impact on patient care and our company,” said Frank Stokes, chief financial officer of Castle Biosciences. “His leadership has grown Castle from a startup into a leading diagnostics company, while fostering a culture that inspires and empowers nearly 800 employees. His unwavering commitment to improving patient outcomes and advancing the standard of care make him truly deserving of this recognition as CEO of the Year.”

Under Maetzold’s leadership, Castle has become a recognized innovator in the diagnostics field, with a portfolio of proprietary tests addressing critical challenges in skin cancers, Barrett’s esophagus and uveal melanoma. Beyond scientific and commercial success, Maetzold and the leadership team have cultivated a people-first culture, earning Castle four consecutive years of recognition as a Top Workplace USA, driven solely by employee feedback. His commitment to patients, innovation and culture has positioned Castle as both a leader in personalized medicine and a role model for values-driven corporate growth.

Earlier this year, Maetzold was named one of just 10 finalists selected from a pool of 586 applicants to the Executive of the Year Awards program. On Oct. 1, 2025, The CEO Magazine announced Maetzold as its CEO of the Year.

About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedInFacebookX and Instagram. 

DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

About the Executive of the Year Awards
The CEO Magazine’s Executive of the Year Awards is a prestigious program recognizing outstanding senior executives who drive success and make a meaningful impact across industries. Now in its second year in the United States, the awards celebrate leadership excellence with winners announced online.

Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com

Media Contact:
Allison Marshall
amarshall@castlebiosciences.com

Source: Castle Biosciences Inc.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/06ba54e7-69f3-410b-a863-2ff1b4e6da4e

Silo Pharma Announces Closing of $2.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Silo Pharma Announces Closing of $2.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules




Silo Pharma Announces Closing of $2.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

SARASOTA, FL, Oct. 01, 2025 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 2,857,143 shares of common stock at a purchase price of $0.875 per share. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 2,857,143 shares of common stock at an exercise price of $0.75 per share that are immediately exercisable upon issuance and will expire five years from the effective date of a registration statement registering for resale the shares of common stock underlying the warrants.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were approximately $2.5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-276658) that was declared effective by the Securities and Exchange Commission (the “SEC”) on January 30, 2024. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering was filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Silo Pharma

Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including statements pertaining to the intended use of proceeds from the offering, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.

Contact

800-705-0120
investors@silopharma.com

NANOBIOTIX Announces First Data From Phase 1 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Esophageal Cancer

NANOBIOTIX Announces First Data From Phase 1 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Esophageal Cancer




NANOBIOTIX Announces First Data From Phase 1 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Esophageal Cancer

  • Treatment was well-tolerated and injection feasibility was confirmed in 13 patients with locally advanced adenocarcinoma of the esophagus
  • 85% (11/13) disease control rate (DCR)
  • 69% (9/13) objective response rate (ORR); 6 complete responses and 3 partial responses
  • Recruitment of 17 additional patients is ongoing as planned

Data presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) on October 1st

PARIS and CAMBRIDGE, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) — NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced first data from cohorts 1 and 2 of the dose escalation part of a Phase 1 dose escalation and dose expansion study evaluating JNJ-1900 (NBTXR3) combined with photon chemoradiation (cohort 1) or proton chemoradiation (cohort 2) followed by surgery, if medically indicated, for patients with locally advanced adenocarcinoma of the esophagus (“EADC”). The study is sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and results were presented by Principal Investigator Steven Lin, MD, PhD, Professor of Radiation Oncology at MD Anderson at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO).

ABSTRACT # 1113: ENDOSCOPIC ULTRASOUND FINE NEEDLE INJECTION OF NBTXR3 ACTIVATED BY RADIOTHERAPY WITH CONCURRENT CHEMOTHERAPY FOR ADENOCARCINOMA OF THE ESOPHAGUS: FEASIBILITY AND SAFETY OF THE PHASE 1 DOSE ESCALATION PART FOR THE PHOTON-BASED COHORT
Steven H. Lin, Emmanuel Coronel, Saumil Gandhi, Julianna Bronk, David Qian, Joe Y. Chang, Michael O’Reilly, Matthew Ning, Aileen Chen, Quynh Nguyen, James Welsh, Diana Amaya, Christina Hoang, Wayne Hofstetter, Mariela Blum-Murphy, Albert C. Koong, Zhongxing Liao
MD Anderson Cancer Center, Houston, Texas, USA

Esophageal cancer is the eighth most common cancer worldwide with an estimated 572,000 new cases and 508,600 deaths each year. Radiotherapy is a cornerstone of treatment and neoadjuvant chemoradiotherapy (“CRT”) followed by surgery is the standard of care. However, there is some controversy as to whether the toxicities of neoadjuvant CRT will lead to increased postoperative complications. Moreover, surgical removal of large segments of the esophagus (esophagectomy) is associated with significant comorbidities and negative impact on patients’ quality of life. Treatment strategies that enhance local control, reduce the need for surgery, and improve survival outcomes are an important unmet need.

“Esophageal cancer remains one of the most difficult contexts for both patients and clinicians, where existing standards of care can create significant burdens for patients,” said Louis Kayitalire, Chief Medical Officer at Nanobiotix. “We believe that JNJ-1900 (NBTXR3), through its broadly applicable mechanism of action, could offer a novel approach—one designed to enhance local control and potentially reduce the need for highly invasive procedures such as esophagectomy.”

Safety and Feasibility

Treatment was well-tolerated and feasible in the study population (n=13):

  • Feasibility of endoscopic ultrasound-guided intratumoral injection was confirmed in 9 EADC patients with treated JNJ-1900 (NBTXR3) combined with photon CRT in cohort 1 and 4 EADC patients treated with JNJ-1900 (NBTXR3) combined with proton CRT in cohort 2
  • The recommended Phase 2 dose (“RP2D”) for JNJ-1900 (NBTXR3) combined with photon CRT was established at 33% of gross tumor volume (GTV)
  • In total, 13 patients experienced treatment-emergent adverse events (“TEAEs”) of any grade related to the overall treatment (Chemotherapy, RT, JNJ-1900 (NBTXR3), and injection procedure)
    • Of which, 6 patients experienced TEAEs of any grade (1, 2, or 3+) related to JNJ-1900 (NBTXR3) and 2 patient experienced TEAEs of any grade related to the injection procedure
      • Of these patients, 2 experienced grade 3+ TEAEs related to JNJ-1900 (NBTXR3) and 0 experienced grade 3+ TEAEs related to the injection procedure
  • No periprocedural or delayed adverse events were observed

Signals of Efficacy

Promising initial clinical response and outcomes:

  • 85% (11/13) disease control rate (DCR)
  • 69% (9/13) objective response rate (ORR), including 6 biopsy-confirmed complete responses (CRs) and 3 partial responses (PRs)
  • 6 patients in the study were medically indicated for and underwent surgery after treatment with CRT and JNJ-1900 (NBTXR3)
    • 2 of these patients had pathological complete response (pCR)
    • 4 of these patients had major pathologic response (≤10% viable cells)

“These early results support our hypothesis that intratumoral injection of JNJ-1900 (NBTXR3) in combination with chemoradiation is both technically feasible and generally well-tolerated in patients with locally advanced esophageal adenocarcinoma,” said Steven Lin, MD, PhD, Professor of Radiation Oncology at MD Anderson. “Importantly, we observed encouraging rates of disease control and complete response that suggest this novel approach could help improve local tumor control while potentially sparing patients from the risks and long-term consequences of esophagectomy. These early findings provide a strong foundation for further investigation.”

Importantly, this evaluation in locally advanced esophageal cancer could potentially open a new indication for JNJ-1900 (NBTXR3) and provide support for the investigational radioenhancer in combination with proton radiation therapy as an additional activation modality beyond standard (photon) radiation therapy. Recruitment for dose escalation cohort 1 is complete. 5 additional patients are being recruited for dose escalation cohort 2, which will be followed by recruitment of 12 additional patients for the dose expansion part of the study.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.

Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.

For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2025 which are available on the SEC’s website at www.sec.gov and on the AMF’s website at www.amf.org. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.

Contacts

Nanobiotix
Communications Department
Brandon Owens
VP, Communications
+1 (617) 852-4835
contact@nanobiotix.com

Investor Relations Department

Joanne Choi
VP, Investor Relations (US)
+1 (713) 609-3150
investors@nanobiotix.com

Ricky Bhajun
Director, Investor Relations (EU)
+33 (0) 79 97 29 99
investors@nanobiotix.com

Media Relations
France – HARDY
Caroline Hardy
+33 06 70 33 49 50
carolinehardy@outlook.fr   
Global – uncapped Communications
Becky Lauer
+1 (646) 286-0057
nanobiotixteam@uncappedcommunications.com

Attachment

Cirtec Medical Appoints Steven Chevillotte to its Board of Directors

Cirtec Medical Appoints Steven Chevillotte to its Board of Directors




Cirtec Medical Appoints Steven Chevillotte to its Board of Directors

BROOKLYN PARK, Minn., Oct. 01, 2025 (GLOBE NEWSWIRE) — Cirtec Medical, a global leader in design, development, and manufacturing of complex Class II and III medical devices, is pleased to announce that Steven Chevillotte has been appointed to its Board of Directors, effective immediately.

Steven brings over two decades of international leadership experience spanning the life sciences, aerospace, and advanced manufacturing sectors. Known for driving growth in highly regulated, highly engineered environments, Steven has developed a strong track record in operational excellence, M&A, and post-merger integration.

He currently serves as Chief Executive Officer of SaniSure, a global leader in the design and manufacture of single-use equipment for bioprocessing. Since taking the helm in 2022, he has led initiatives to strengthen global operations, accelerate Voice-of-Customer-based innovation, and expand go-to-market strategies worldwide. Prior to becoming CEO, he served as Chief Financial Officer of SaniSure, from June 2021 to June 2022.

Steven’s leadership background includes senior executive roles in both finance and operations. He previously served as Chief Financial Officer at Integrated Polymer Solutions and Consolidated Aerospace Manufacturing, where he played a critical role in driving revenue growth from $240 million to $400 million in under three years, culminating in the company’s successful $1.5 billion acquisition by Stanley Black & Decker.

Earlier in his career, Steven spent nearly a decade at ZEISS Surgical Ophthalmology, where he held progressively senior roles including Vice President of U.S. Operations, Chief Financial Officer, and ultimately President of ZEISS North America. His work helped advance ZEISS’s integrated surgical platform in areas such as cataract, refractive, retina, and corneal surgery.

“Steven has consistently demonstrated the kind of visionary leadership and operational discipline that drives real, measurable value,” said Rich Relyea, Partner at 3i. “I’ve seen firsthand how Steven fosters growth, drives efficiency, and builds high-performing teams. I’m confident his experience will add significant value to the Cirtec Medical board as it enters its next phase of growth.”

“Steven’s proven leadership in complex global environments and his ability to bridge technical depth with financial and operational acumen make him a valuable addition to our board,” said Shar Matin, CEO of Cirtec Medical. “We’re excited to benefit from his insights as we continue to scale our business, invest in technologies and innovate for our customers.”

“I’m honored to join the Board of Directors at Cirtec Medical,” said Steven on his appointment. “I look forward to contributing to the company’s continued success and supporting the team in achieving its mission and delivering long-term value for customers, employees, and stakeholders.”

About Cirtec Medical

Cirtec Medical is a global leader in design, development, and manufacturing of complex Class II and III medical devices, specializing in active implant systems, interventional devices, and precision components. Since 1987, Cirtec Medical has built extensive in-house capabilities that enable the company to serve as a single-source partner and collaborate with customers to transform their technology into innovative medical devices across a wide array of therapies, including cardiology, neurology, orthopedics and other minimally invasive device applications. Cirtec Medical’s deep expertise in precision component design and manufacturing supports every stage of the product lifecycle, ensuring uncompromising quality and performance. With 11 global facilities and a vertically integrated approach, Cirtec Medical aims to expedite time to market, reduce risk, and accelerate revenue generation for our partners. Learn more at CirtecMed.com.

For Media Inquiries:

Abby Kupka
Sr. Manager, Marketing
Cirtec Medical
(763) 235-8835

Smith+Nephew launches CORIOGRAPH™ Pre-Op Planning and Modeling Services for total shoulder arthroplasty

Smith+Nephew launches CORIOGRAPH™ Pre-Op Planning and Modeling Services for total shoulder arthroplasty




Smith+Nephew launches CORIOGRAPH™ Pre-Op Planning and Modeling Services for total shoulder arthroplasty

Completes the CORIOGRAPH Services portfolio which also includes solutions for knee and hip arthroplasty

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces the launch of its CORIOGRAPH Pre-Op Planning and Modeling Services for total shoulder arthroplasty, now available in the United States. This innovative software offers image-based planning capabilities that enable surgeons to create a patient-specific plan for shoulder replacement procedures by using enhanced clinical decision-making through advanced biomechanical simulation that accounts for scapulothoracic motion.1-6

The first procedures using CORIOGRAPH Services for Shoulder were recently completed by Dr. Christopher Klifto, Shoulder Surgeon at Duke University. He commented, “CORIOGRAPH Services help choose the proper components to help ensure the best plan for my patients. Cases are precisely planned by dedicated planning engineers according to surgeon preferences and can be easily modified by the surgeon using the web planner as a final check when needed. The Activity of Daily Living function has the potential to optimize range of motion based on patient needs and is unique in the shoulder arthroplasty space. CORIOGRAPH Services has given me greater confidence to plan my cases and provide optimal care for my patients.”

Key capabilities of CORIOGRAPH Pre-Op Planning and Modeling Services for total shoulder arthroplasty include: 

  • Supports 3D CT-based planning, giving surgeons the ability to visualize implant options and optimize component positioning and sizing with patient-specific anatomical modeling.1-6
  • Designed to minimize impingement through personalized service and surgeon planning tools.1-6
  • Range-of-motion and impingement simulation, designed to help surgeons optimize implant placement based on patient-specific shoulder kinematics through real-time modeling of Activities of Daily Living that account for scapulothoracic motion.1-6  
  • Seamless integration with Smith+Nephew’s full portfolio of AETOS Shoulder System implant solutions.  

The AETOS Shoulder System is purposefully designed to work as a cohesive solution, enhancing the surgical experience through streamlined* intraoperative flexibility.7-9 With fewer instruments for a primary Meta Stem procedure†9 and fewer steps when converting from anatomic to reverse,†9 the AETOS Shoulder System is designed to support a more efficient operating room environment.9 When paired with CORIOGRAPH Services, surgeons can plan their cases in advance, empowering confident, real-time decision making and an efficient overall workflow.

“With the addition of shoulder pre-op planning to the CORIOGRAPH Services platform, we are completing our vision of truly personalized orthopaedic care across hip, knee, and shoulder replacements,” said Mayank Shandil, Global SVP of Reconstruction and Robotics Marketing for Smith+Nephew. “As we continue to invest in data-driven and patient-centric tools, surgeons are better equipped to deliver a personalized plan for each patient every time.”

 To learn more about CORIOGRAPH Pre-Op Planning and Modeling Services for total shoulder arthroplasty, please visit here.

 

– ends –

 

Media Enquiries 

Dave Snyder          +1 (978) 749-1440 

Smith+Nephew      david.snyder@smith-nephew.com 

 

References 

  1. Smith+Nephew 2025. 10152295 REVA. Shoulder Modeler TR – Session Management & Notifications/Warnings/Errors
  2. Smith+Nephew 2025. 10152290 REVA. Shoulder Modeler TR – CORIOGRAPH Plan Page
  3. Smith+Nephew 2025. 10152289 REVA. Shoulder Modeler TR – General Features
  4. Smith+Nephew 2025. 10152294 REVA. Shoulder Modeler TR – Report Page
  5. Smith+Nephew 2025. 10152293 REVA. Shoulder Modeler TR – Implant Planning
  6. Smith+Nephew 2025. 10152196 REVB. CORIOGRAPH Modeler Unit Test Execution Report
  7. Smith+Nephew 2023. AETOS Inlay Design Features. Internal Report. ER-04-0990-0017.
  8. Smith+Nephew 2024. AETOS Short Stem Stability Report. Internal Report. ER-04-0990-0008 REV AC
  9. Smith+Nephew 2023. AETOS Instruments & Trays. Internal Report. ER-04-0990-0020 REV B

*Intraoperative flexibility via an anatomic metaphyseal shape and neck cut that is universal to both stemless and Meta stem, and streamlined instrumentation that allows for ease of convertibility from stemless to Meta Stem and TSA to RSA

Compared to a competitive shoulder system

      

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 17,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Founded in Hull, UK, in 1856, we now operate in around 100 countries, and generated annual sales of $5.8 billion in 2024. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.

 

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew’s most recent annual report on Form 20-F, which is available on the SEC’s website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew’s expectations.

 

Trademark of Smith+Nephew. Certain marks registered in US Patent and Trademark Office.

CAP Promotes Daniel Cavanaugh to Senior Vice President of Business Development Amid Record Membership Growth

CAP Promotes Daniel Cavanaugh to Senior Vice President of Business Development Amid Record Membership Growth




CAP Promotes Daniel Cavanaugh to Senior Vice President of Business Development Amid Record Membership Growth

LOS ANGELES, Oct. 01, 2025 (GLOBE NEWSWIRE) — The Cooperative of American Physicians, Inc. (CAP) announced the promotion of Daniel Cavanaugh to Senior Vice President of Business Development, recognizing his exceptional leadership during a period of unprecedented membership growth.

Since stepping into his role as Vice President of Membership Development in 2018, Mr. Cavanaugh has helped the organization surpass 13,000 physician members, the highest in its 50-year history. As Senior Vice President, he will lead a newly unified business unit that brings together Membership Development, Membership Programs, and Marketing and Corporate Communications, aligning CAP’s core growth and engagement functions under one strategic umbrella.

“Dan’s contributions have been central to CAP’s growth,” said CAP CEO Sarah Scher. “His ability to connect with physicians and healthcare organizations, guide strategic initiatives, and foster collaboration has strengthened our sales efforts and extended our reach. As Vice President, he helped drive significant membership increases. And in his new role, he’ll continue to move our business development efforts forward with focus and innovation.”

By combining comprehensive medical professional liability coverage with membership programs tailored to the needs of independent medical practices, CAP continues to stand out as a trusted leader in the marketplace.

“It’s an honor to take on an expanded role during this significant period of growth for CAP,” said Mr. Cavanaugh. “I’m proud of what we’ve achieved in broadening our impact and deepening our support for physicians across California. I look forward to building on our success to deliver even greater value to our members.”

About the Cooperative of American Physicians, Inc.

The Cooperative of American Physicians, Inc. (CAP), established in 1975, offers superior medical professional liability coverage to California physicians through the Mutual Protection Trust (MPT), an unincorporated inter-indemnity arrangement organized under California Insurance Code section 1280.7. MPT has earned AM Best’s A+ (Superior) rating every year since 2006. CAP supports its members through offices in Los Angeles, San Diego, Orange County, and Walnut Creek. For more information, visit www.CAPphysicians.com.

Contact: Ernest Khirallah
EKhirallah@CAPphysicians.com  
213-473-8737

Her Natural Edge and In Her Corner Launch Conversational AI Companions to Support Menopause Awareness

Her Natural Edge and In Her Corner Launch Conversational AI Companions to Support Menopause Awareness




Her Natural Edge and In Her Corner Launch Conversational AI Companions to Support Menopause Awareness

Alexandria, VA, Oct. 01, 2025 (GLOBE NEWSWIRE) — Her Natural Edge and In Her Corner announced the launch of Valerie and Jordan, two conversational voice companions developed to provide information and support around the topic of menopause. Valerie is designed for women experiencing menopause, while Jordan is intended for the men in their lives, including partners, family members, and friends.

In Her Corner

In Her Corner

The introduction of these tools coincides with Menopause Awareness Month in October, a period dedicated to increasing public understanding of a life stage that affects millions worldwide. By creating separate companions for women and men, Her Natural Edge and In Her Corner aim to encourage open dialogue and shared learning about menopause, a subject that is often overlooked in family and community conversations.

Valerie and Jordan are structured to function as conversational companions that communicate in a relatable, human-like manner. Users can engage with the AI as they would with a trusted peer, receiving guidance drawn from publicly available health information sources, including the World Health Organization (WHO) and the National Institutes of Health (NIH). The tools are not substitutes for medical advice or treatment but are intended to promote awareness and understanding of menopause and its related challenges.

Focus on Shared Experience

While menopause is primarily a biological transition for women, its impact extends beyond the individual. Families, particularly partners and close relatives, are often directly affected by the physical and emotional changes associated with this stage of life. Jordan was created to provide men with context and perspective, enabling them to better understand and support women during this time.

Valerie, meanwhile, was designed to address the needs of women navigating menopause firsthand. By offering conversational guidance, the companion serves as an accessible entry point into information and resources that can help women prepare for discussions with healthcare professionals, family members, or support groups.

“The goal was to create tools that make it easier for both women and men to engage in conversations about menopause,” said Don Wallace, spokesperson for Her Natural Edge and In Her Corner. “These companions are designed to encourage openness and provide a safe space to ask questions and seek information.”

Privacy and Confidentiality

In designing the AI companions, the teams at Her Natural Edge and In Her Corner emphasized privacy as a core principle. Conversations with Valerie and Jordan are not stored, recorded, or shared, ensuring that users can speak freely.

By eliminating data storage, the companions distinguish themselves from many other AI-based tools, focusing on confidentiality as an essential part of their design. This decision was made to reduce barriers for individuals who may feel hesitant to discuss sensitive health topics openly.

Availability and Access

Valerie is available for women through www.hernaturaledge.com, while Jordan can be accessed by men at www.inhercorner.net. Both resources are publicly accessible online and require no data collection to engage in conversation.

The separation of platforms reflects a recognition that women and men may approach menopause-related information differently. By tailoring the companions to these perspectives, the two organizations seek to provide clear, accessible entry points for each group.

Addressing a Wider Gap in Health Communication

Health experts and organizations have long identified menopause as an area where public awareness and education remain limited. Many women report gaps in information and support, while men frequently lack resources to help them understand what their partners, relatives, or colleagues may be experiencing.

The release of Valerie and Jordan by Her Natural Edge and In Her Corner is part of a growing effort within the health sector to address these communication challenges. While not offering medical guidance, the companions can serve as supplemental tools to help individuals and families prepare for more informed conversations with qualified professionals.

Commitment to Responsible Use of AI

The development of Valerie and Jordan follows a broader trend of applying artificial intelligence to health communication. Her Natural Edge and In Her Corner emphasized that both companions have been built in alignment with responsible AI principles. This includes ensuring transparency about their purpose, avoiding the storage of user conversations, and grounding information in reputable health sources.

The companions are not intended to provide medical advice, diagnose conditions, or replace healthcare consultations. Instead, they function as informational guides designed to make discussions about menopause more approachable and less stigmatized.

About Her Natural Edge and In Her Corner

Her Natural Edge and In Her Corner are dedicated platforms designed to provide accessible resources, information, and support for women navigating menopause and for the men who support them. Their initiatives focus on bridging communication gaps, encouraging dialogue within families and communities, and reducing stigma through open, informed conversations.

Her Natural Edge

Media Contact

Her Natural Edge / In Her Corner
Contact Person: Don Wallace
Email: support@hernaturaledge.com
Phone: +1 (703) 495-3277
Country: United States
Website: www.hernaturaledge.com | www.inhercorner.net

CONTACT: Media Contact
Her Natural Edge / In Her Corner
Contact Person: Don Wallace
Email: support@hernaturaledge.com
Phone: +1 (703) 495-3277
Country: United States
Website: www.hernaturaledge.com | www.inhercorner.net

OPA: Compromising Safety in the Name of Access

OPA: Compromising Safety in the Name of Access




OPA: Compromising Safety in the Name of Access

TORONTO, Oct. 01, 2025 (GLOBE NEWSWIRE) — Ontario’s mental health system is already under immense pressure, and the Ontario Psychological Association (OPA) warns that lowering professional standards will only make things worse. Recent CPBAO proposals threaten to strip away educational standards and safeguards, flooding the system with undertrained clinicians and putting the public at risk. Studies show that poorly trained providers are more likely to use unproven treatments and practice outside of their scopes, a dangerous gamble when dealing with complex conditions like depression, PTSD, autism, or ADHD. Psychologists and Psychological Associates have the advanced training needed in diagnosis, evidence-based care, ethics, and supervision to protect Ontarians and deliver effective outcomes.

With youth mental health needs increasing and diagnostic presentations becoming more complex, now is the time to strengthen quality, not dilute it. Lowering standards is not just bad policy, it’s a direct threat to public safety. The OPA appreciates all efforts to advance an innovative strategy that strengthens both the quality and accessibility of mental health services in Ontario. However, the changes proposed by the CPBAO veer drastically from nationally recognized and well-respected high standards in Ontario and some other provincial jurisdictions. They significantly reduce the number of training hours for Master’s level clinicians, while simultaneously reducing the safeguards, such as the comprehensive ethics exam and eliminating entirely the oral licensing exam, arguably the most important gatepost before all registrants become fully licensed.

Why should Ontarians be concerned about the government and CPBAO accepting one of the lowest standards of training and weakening or eliminating licensing exams in Ontario? For complex mental health issues, Ontarians need access to highly trained psychologists and psychological associates who can accurately evaluate presenting symptoms, rule out other possible diagnoses, and provide evidence-based care. This expertise and advanced knowledge are what maximize the chances of effective treatment outcomes and protect the quality of mental health services people rely on.

Psychologists play a critical role in Ontario’s mental health system by offering evidence-based treatment and the diagnostic clarity that physicians, psychiatrists, and even the courts rely on in complex cases, such as in neuropsychological, custody, and forensic evaluations. Accurate diagnosis is essential, and the cost of misdiagnosis is high, both for individuals and the system. While increasing access to psychological services must remain a priority, simply expanding the number of practitioners without ensuring sufficient training risks more misdiagnoses, greater public confusion about provider qualifications, rising costs through title upgrades without substance, and increased disability claims from a flood of novice diagnosticians. The proper path forward is to expand access while maintaining the standards of care Ontarians deserve.

Any proposed regulatory reform to the profession must safeguard quality and prioritize public protection, especially given Ontario’s growing youth mental health needs. We need to balance this with enhanced access. Ontario deserves the best of both when it comes to its mental health.

Any calls to lower the standards in this province in the name of access do not make sense.

“The OPA welcomes open dialogue on improving access to mental health care, but lowering professional standards is not the answer. Psychology has long been one of Ontario’s most trusted professions in healthcare. The best way forward is to work together on solutions that expand services while safeguarding the safety, quality, and trust that Ontarians expect and deserve.”

Dr. Laura Nichols, OPA President

In spite of the College Council’s recent vote for changes designed to lower the standards, the OPA will continue to advocate for retaining training and accreditation standards that ensure psychologists will remain the trusted professionals the public has known. We welcome constructive dialogue with the College and Ministry.

ABOUT THE ONTARIO PSYCHOLOGICAL ASSOCIATION
The Ontario Psychological Association (OPA) is a not-for-profit organization and the voluntary professional association representing psychology in Ontario. Its diverse membership, comprising clinicians, academics, researchers, and students, is dedicated to improving the mental health and well-being of Ontarians. The OPA provides leadership to promote mental health and well-being, inspiring excellence in the profession of psychology through research, education, clinical excellence, and advocacy.

Contact:
Mr. Richard Morrison
CEO
opa@psych.on.ca
416-961-5552