First Patient Dosed in Clinical Study of Neuro-Innovators' Neurorestorative Pharmacotherapy for Chronic Stroke Recovery

Spaulding Rehabilitation Hospital study evaluates NIV-001, a combination pharmacotherapy, with intensive rehabilitation in chronic stroke survivors

BOSTON, MA, UNITED STATES, August 4, 2026 /EINPresswire.com/ -- Neuro-Innovators, Inc., a biotechnology company advancing therapies designed to promote neurological recovery following injury and disease, today announced that the first patient has been dosed in an investigator-initiated clinical study at Mass General Brigham’s Spaulding Rehabilitation Hospital evaluating the company's neurorestorative pharmacotherapy in individuals living with chronic stroke-related disability.

The study evaluates Neuro-Innovators' proprietary therapeutic regimen, combining telmisartan, metformin, and cilostazol (NIV-001), in participants undergoing intensive robot-assisted upper-extremity rehabilitation. The primary endpoint is the Fugl-Meyer Assessment, a validated measure of motor recovery that the FDA accepted for the clearance of a stroke rehabilitation device.

Stroke is the leading cause of long-term disability worldwide. While rehabilitation can improve function for survivors, it is rarely enough to affect independence, daily activities, and overall quality of life.

Dosing the first patient represents an important milestone in the clinical advancement of NIV-001, Neuro-Innovators' investigational combination pharmacotherapy designed to support multiple biological pathways associated with recovery. The milestone follows the company's recently filed patent application enhancing the protections of its multi-mechanism approach to promoting neuroplasticity and functional recovery following neurological injury. Neuro-Innovators believes its NIV-001 may help therapy to noticeably improve daily lives.

“Today marks an important step forward for Neuro-Innovators as we advance NIV-001 into clinical evaluation,” said Howison Schroeder, Chief Executive Officer of Neuro-Innovators. “While there have been advances in rehabilitation, many stroke survivors continue to experience long-term disability. We think NIV-001 represents a compelling opportunity to explore whether concurrently managing multiple biological pathways involved in recovery may create an improved environment for neurological restoration.”

The therapeutic approach being evaluated was developed around the concept that recovery following neurological injury involves multiple interconnected biological processes. NIV-001 is designed to simultaneously support biological pathways associated with recovery, including neurogenesis, angiogenesis, and bioenergetics, while modulating inflammation. The goal is to enhance the brain's ability to adapt, repair, and recover function, or neuroplasticity.
The investigator-initiated study evaluates whether a polytherapeutic regimen combined with intensive rehabilitation, including robot-assisted therapy, holds the potential to improve stroke recovery.

“Moving NIV-001 into its first clinical evaluation is an important translational milestone,” said LTC (ret.) Peter Doyle, M.D., Co-Founder and Chief Medical Officer of Neuro-Innovators, Inc. “We are encouraged by the opportunity to work alongside leading rehabilitation researchers, and we look forward to generating insights that may help advance the field of neurorestorative medicine.”

“Recovery following stroke is one of the greatest unmet challenges in rehabilitation medicine,” said Paolo Bonato, Ph.D., Director of the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. “This study represents an important opportunity to evaluate whether combining a biologically targeted therapeutic approach with intensive rehabilitation can enhance neuroplasticity and, thereby, improve functional recovery. Advancing treatments that meaningfully restore function has the potential to significantly improve quality of life for stroke survivors.”
Spaulding Rehabilitation Hospital is actively recruiting for this study (up to 50 subjects) to evaluate the potential for a combination pharmacotherapy to improve stroke therapy outcomes in patients with chronic stroke-related disability. The study is registered on ClinicalTrials.gov under identifier NCT07588932.

About Neuro-Innovators

Neuro-Innovators is a first in class clinical-stage pharmaceutical company focused on developing compound therapies designed to support biological pathways associated with neurological recovery following stroke, brain injury, and other neurological conditions. The company’s mission is to improve functional outcomes for patients while reducing the long-term personal and societal burden of neurologic disability.

Healing Brains with Neuroplastic Medicine™

For more information, please visit www.neuro-innovators.com or follow us on LinkedIn (https://www.linkedin.com/company/neuro-innovators).

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Madelyn De Los Santos
Putnam Insights LLC
madelyn@putnaminsights.com

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