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Realeve

Realeve

Cleveland, United States· Est.
realeve.net
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Private Company

Total funding raised: $10M

Overview

Realeve is a private, clinical-stage medical device company pioneering a novel, externally powered neuromodulation platform. Its lead product, the Pulsante SPG microstimulation implant, is designed for minimally invasive surgical placement and is activated by a handheld external controller. While initially targeting the severe pain of cluster headaches with documented clinical use, the company is exploring broader CNS applications, including ischemic stroke and blood-brain barrier modulation. Founded in 2019 and based in Cleveland, Ohio, Realeve appears to be in a late-clinical or early commercial stage for its lead indication.

NeurologyPain Management

Technology Platform

Pulsante micro-neurostimulator system: a battery-free, wireless implantable device with a proprietary ASIC, activated by an external handheld radiofrequency controller to stimulate the sphenopalatine ganglion (SPG).

Funding History

1
Total raised:$10M
Series A$10M

Opportunities

The primary opportunity lies in addressing the severe unmet need in cluster headache with a surgically implanted, patient-controlled device.
The larger, transformative opportunities are expanding into the massive acute ischemic stroke market and developing the SPG stimulation platform as a means to transiently open the blood-brain barrier for enhanced drug delivery in neurology and oncology.

Risk Factors

Key risks include the regulatory and clinical trial hurdles for new indications like stroke, the challenge of achieving widespread physician adoption and insurance reimbursement for a surgical therapy, and competition from both established neuromodulation companies and emerging non-invasive technologies.

Competitive Landscape

Realeve competes in the neuromodulation for headache space against companies like Abbott (formerly St. Jude Medical) with occipital nerve stimulators and electroCore with non-invasive vagus nerve stimulation. For stroke and BBB modulation, it faces competition from both medical device and biopharma companies exploring neuroprotective agents and alternative BBB opening technologies. Its battery-free, externally powered implant is a key differentiator.

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