Grant will enable firm to use neuromodulation system in stroke recovery study

An Illinois-based neuro tech company has announced the reception of a multimillion-dollar grant to support a post-stroke recovery study at the Cleveland Clinic with its novel micro-neuromodulation platform.

According to a release from Realeve, the study is expected to utilize the company’s Pulsante system, the first externally powered implantable neuromodulation device which aims to stimulate the sphenopalatine ganglion (SPG), and in conjunction with hyperbaric oxygen, enhances blood circulation to minimize brain damage.

The handheld remote-controlled wireless system is comprised of a miniature bioactive implant inserted orally, which is paired with an external, handheld controller that stimulates the SPG, which controls the autonomic nervous system. Once in place, the targeted therapy provides both pain relief and vasodilation along with medication delivery to the central nervous system, per the release.

Pulsante, which according to the company has been clinically proven in more than 700 patients with brain-related disorders, had been granted breakthrough device designation by the FDA. Realeve plans to continue development with a goal of obtaining FDA approval and CE Mark to treat cluster headaches in 2024.

"We are excited to leverage the power of this external implant that has been clinically proven with 700+ patients in enhancing post-stroke and cluster headache recovery,” Realeve founder and President Peter Bonutti, MD, said in the release. “We are also exploring its applications in other central nervous system disease conditions and excited about the potential.”