Enspire DBS Therapy, a Cleveland-based clinical-stage medical device company developing an implantable neuromodulation approach for post-stroke recovery, has raised $10.3 million in a Series B1 financing to support pivotal clinical development of its deep brain stimulation-enabled rehabilitation program. The round was led by Genesys Capital, which joined as a new investor, with participation from existing backers Cleveland Clinic and JobsOhio Ventures. As part of the financing, Genesys Capital Managing Partner Jamie Stiff will join Enspire’s board of directors.
Enspire said proceeds will be used primarily to continue enrollment in the RESTORE pivotal clinical trial, a multicenter study evaluating deep brain stimulation paired with a structured outpatient rehabilitation program for patients living with chronic upper-extremity impairment following stroke. The company is positioning the RESTORE trial as the key data package intended to support a future U.S. Food and Drug Administration marketing authorization, with interim results expected in mid-2027.
The RESTORE study is designed to evaluate the safety and effectiveness of a “DBS + Rehab” approach against rehabilitation alone. Enspire said the therapy is being studied under an FDA-approved Investigational Device Exemption, and each participant is implanted with a commercially available third-party DBS system before completing a five-month outpatient rehabilitation program.
Trial design includes a blinded, randomized five-month comparison period between DBS plus rehabilitation and a rehabilitation-only control arm. Participants initially assigned to the control group then cross over to receive DBS and complete an additional five-month therapy phase, enabling all enrolled patients to eventually receive the investigational stimulation component while still preserving a controlled comparison window.
Enspire is developing the therapy to address a persistent unmet need in stroke recovery, where many survivors experience long-term neurological deficits that can limit independence and quality of life. The company cited U.S. stroke incidence of roughly 800,000 cases annually and said nearly half of survivors require assistance with daily activities.
Founded in 2010, Enspire is a Cleveland Clinic portfolio company focused on translating neuroscience research into therapies intended to restore function for people living with disability after stroke. Genesys Capital, based in Toronto, invests in early-stage life sciences across biotechnology, pharmaceuticals, and medical technology, and said it targets areas of significant unmet medical need.
KEY QUOTES:
“This financing represents an important milestone for Enspire as we advance RESTORE through pivotal clinical development. With strong continued support from Cleveland Clinic and JobsOhio Ventures, and the addition of Genesys Capital as a new lead investor, we are well positioned to execute our clinical strategy and advance a potential first-in-class brain therapy for stroke recovery.”
Scott Kokones, Chief Executive Officer, Enspire DBS Therapy
“Genesys Capital invests in companies developing transformative therapies across biotechnology, pharmaceuticals, and medical technology. The Enspire team has made remarkable progress advancing DBS-enabled rehabilitation for patients with neurological deficits following stroke. I am excited to join the Board and support the continued clinical progress of RESTORE and the company’s long-term vision.”
Jamie Stiff, Managing Partner, Genesys Capital
