NRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Begins Training and Deployment of Zeta Surgical's FDA-Cleared Robotic TMS System
HOPE Therapeutics’ adoption of Zeta’s FDA-cleared robotic TMS system advances NRx’s SPARC-TMS Phase 2/3 trial in civilian and military settings.
Rhea-AI Summary
NRx Pharmaceuticals (NRXP) announced that subsidiary HOPE Therapeutics is deploying Zeta Surgical's newly FDA-cleared robotic TMS system in Florida clinics. HOPE is the first Interventional Psychiatry network to use the Zeta TMS Robotic System, with its clinical team completing orientation and training at Zeta Surgical's Boston headquarters ahead of deployment. The AI-driven platform adjusts the TMS coil in real time with submillimeter precision, extending the Zeta TMS Navigation System HOPE began using in June 2026. The rollout supports SPARC-TMS, NRx's FDA-approved Phase 2/3 trial of NRX-101 combined with robotic TMS, planned across an academic hospital, multiple HOPE clinics, and two military treatment facilities, with NRx selected by DARPA as prime contractor subject to contracting. NRx is also participating in a fireside chat at the 2026 Cantor Global Healthcare Conference, with a live webcast available on its investor relations website.
Positive
- First deployment of Zeta Surgical's FDA-cleared Zeta TMS Robotic System by an Interventional Psychiatry network
- AI-driven robotic TMS delivers submillimeter coil positioning and continuous motion tracking in clinical use
- Supports SPARC-TMS FDA-approved Phase 2/3 trial of NRX-101 with robotic TMS (NCT07227103)
- NRx selected by DARPA as prime contractor for SPARC-TMS, subject to completion of contracting
- Multiple planned trial sites spanning a leading US academic hospital, HOPE clinics, and two military treatment facilities
Negative
- DARPA prime contractor role for SPARC-TMS remains subject to completion of contracting, introducing execution uncertainty
Key Figures
- FDA clearance
- 510(k) clearance
- Zeta TMS Robotic System, July 2026
- Trial phase
- Phase 2/3
- SPARC-TMS trial of NRX-101 with robotic TMS
- Targeting precision
- Submillimeter precision
- Robotic TMS coil positioning and refocusing
- Military treatment facilities
- Two facilities
- Planned SPARC-TMS trial sites
Historical Context
-
Reported DARPA prime-contractor selection and robotic-TMS trial progress.
-
DARPA selected SPARC-TMS for contract negotiations, subject to definitive terms.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
510(k) clearance regulatory
abbreviated new drug application regulatory
breakthrough therapy designation regulatory
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinics
- The Zeta TMS Robotic System's AI-driven software adjusts the TMS coil in real time with submillimeter precision, building on the Zeta TMS Navigation System HOPE implemented earlier this summer
- Deployment supports SPARC-TMS, NRx's trial of NRX-101 with robotic TMS, for which NRx is initiating a project for the military, in partnership with Harvard McClean Hospital.
- NRx Pharmaceuticals is participating in a fireside chat at the 2026 Cantor Global Healthcare Conference today at 8:35 a.m. ET; a live webcast is available on the Events page of the Company's website at ir.nrxpharma.com/events
WILMINGTON, Del., Sept. 11, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that its subsidiary, HOPE Therapeutics, Inc. ("HOPE"), will be the first Interventional Psychiatry to deploy Zeta Surgical's newly FDA-cleared Zeta TMS Robotic System, with clinical staff now in training ahead of deployment in Florida.
"Deploying the first FDA-cleared robotic TMS system moves the HOPE model another step from concept to clinical reality," said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals and HOPE Therapeutics. "Not all TMS is delivered the same way, and the difference between precise, repeatable targeting and approximation is exactly what patients and clinicians should be asking about. With this advance, our clinicians will be able to deliver neurosurgical-grade precision to every patient, in every session, without depending on the patient staying perfectly still or on a technician precisely holding the coil. That same capability is the foundation of our now-FDA cleared SPARC-TMS trial to be conducted in military and civilian settings. Our goal is to achieve measurable, rapid, and durable remission from depression."
In June 2026, HOPE became the first commercial site in the United States to treat patients with the Zeta TMS Navigation System, which uses AI-driven image guidance to track the patient's head in real time and show the clinician exactly where the coil sits relative to the MRI-guided brain target. The Zeta TMS Robotic System, which received FDA 510(k) clearance in July 2026, builds on that foundation. It places the coil in a robotic arm, originally approved for neurosurgery, tracks the patient’s movement, and constantly refocuses the TMS energy with submillimeter precision.
The deployment supports SPARC-TMS, NRx's FDA-approved Phase 2/3 trial of NRX-101 in combination with robotic TMS (NCT07227103). NRx was selected by the Defense Advanced Research Projects Agency (DARPA) as prime contractor for SPARC-TMS, subject to completion of contracting. The trial is planned across a leading US academic teaching hospital, multiple HOPE Therapeutics clinics, and two military treatment facilities.
TMS is a non-invasive therapy used primarily for treatment-resistant depression, which affects approximately one-third of patients with major depressive disorder. Accurate and repeatable targeting of patient-specific treatment sites is an important component of treatment delivery.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.
About HOPE Therapeutics
HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP), is a provider of advanced psychiatric and neurological care, specializing in evidence-based treatments for major depressive disorder, anxiety, and other complex neurological conditions. Operating out of state-of-the-art clinics, HOPE Therapeutics focuses on improving patient outcomes through the application of modern medical technologies and clinical practices. For more information, please visit www.hopetherapeutics.com.
About ZETA SURGICAL
ZETA SURGICAL is redefining the standard of care for image-guided surgery and targeted neuro-therapeutics. Its navigation and robotics platform applies advanced artificial intelligence and computer vision to enable high-accuracy image guidance across virtually any point of care in minutes, unlocking less invasive and more precise targeted therapies. The Zeta Navigation System, Zeta TMS Navigation System, and Zeta TMS Robotic System are cleared by the FDA and commercially available in the United States. For more information, please visit www.zetasurgical.com.
Media Contact -- media@zetasurgical.com
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
For further information:
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(917) 653-5122
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FAQ
What preparation is HOPE Therapeutics undertaking before deploying the Zeta TMS Robotic System?
HOPE's clinical staff is completing orientation and training at Zeta Surgical's headquarters in Boston before the Zeta TMS Robotic System is deployed in HOPE's Florida clinics.
What is the SPARC-TMS trial and how is the Zeta system involved?
SPARC-TMS is an FDA-approved Phase 2/3 trial (NCT07227103) of NRX-101 in combination with robotic transcranial magnetic stimulation. The trial will use the Zeta TMS Robotic System to deliver precise, repeatable targeting of patient-specific treatment sites in both military and civilian clinical settings.
Where will the SPARC-TMS trial be conducted?
The SPARC-TMS trial is planned across a leading US academic teaching hospital, multiple HOPE Therapeutics clinics, and two military treatment facilities.
How is transcranial magnetic stimulation (TMS) described in this announcement?
TMS is described as a non-invasive therapy used primarily for treatment-resistant depression, which affects approximately one-third of patients with major depressive disorder. Accurate and repeatable targeting of patient-specific treatment sites is stated as an important component of treatment delivery.
How can investors access NRx Pharmaceuticals' appearance at the 2026 Cantor Global Healthcare Conference?
NRx Pharmaceuticals is participating in a fireside chat at the 2026 Cantor Global Healthcare Conference at 8:35 a.m. ET on the day of the announcement. A live webcast is available on the Events page of the company's website at ir.nrxpharma.com/events.