Healing the brain: Biotech to test new therapy for stroke

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June 6

By Kris B. Mamula, Pittsburgh Post-Gazette

A 3-year-old Sewickley, Pennsylvania, biotech firm is partnering with a Boston hospital to test a new drug combination, which has the promise of helping people debilitated by stroke.

Neuro-Innovators LLC is collaborating with Spaulding Rehabilitation Hospital to evaluate the effectiveness of Neuro-Innovators' NIV-001 therapy to enhance and restore mobility and function lost through a burst or blocked vessel in the brain, which causes stroke. Some 750,000 people suffer strokes each year in the U.S. and two-thirds of more than seven million stroke survivors are left disabled, according to the Stroke Awareness Foundation, a Campbell, California-based nonprofit.

Spaulding is part of the Mass General Brigham health care system and the lead investigator for the study is Qing Mei Wang, a physician investigator in the Department of Physical Medicine and Rehabilitation at Mass General Research Institute.

Neuro-Innovators' three-drug combination will be administered in a once-a-day pill to 40 people with motor disabilities who are recovering from stroke. They will be taking the medicine while undergoing standard rehabilitation protocols for stroke.

The three drugs used in the therapy have already been approved by the Food and Drug Administration, which will speed commercialization of the new product. Neuro-Innovators will pursue an FDA fast-track pathway for product approval, which is designed to enhance the brain's neuroplasticity and healing after trauma. The company estimates the size of the market at more than $20 billion.

"It's a huge unmet need," said veteran entrepreneur and CEO Howison Schroeder, who founded Neuro-Innovators with physician Peter Doyle. "Nobody has put these drugs together."

Dr. Doyle also serves as chief medical officer at the company.

Neuro-Innovators employs eight part-time workers. The company raised $100,000 in a seed round last year, but has not yet turned a profit.

Schroeder previously served as CEO and board member of O'Hara-based Neuro Kinetics Inc., a brain injury assessment tool. Toronto, Canada-based Neurolign Technologies Inc. acquired Neuro Kinetics in 2019. Terms were not disclosed.