Cleveland Clinic spinout targets stroke recovery with deep brain stimulation EDEN first-in-human trial published in Nature Medicine 9 of 12 patients improved on DBS + rehab $10.3M Series B1 raised January 2026 RESTORE pivotal trial now enrolling Interim results expected mid-2027 Cleveland Clinic spinout targets stroke recovery with deep brain stimulation EDEN first-in-human trial published in Nature Medicine 9 of 12 patients improved on DBS + rehab $10.3M Series B1 raised January 2026 RESTORE pivotal trial now enrolling Interim results expected mid-2027
Company Profile  /  Neurotechnology  /  Cleveland, Ohio

Enspire DBS Therapy

Rewiring stroke recovery: pairing deep brain stimulation with rehabilitation to help patients move an arm, a hand, a life - again.

Founded 2010 Clinical-stage medtech $27.9M raised ~11 employees
Enspire DBS Therapy company logo

Enspire DBS Therapy, Inc. - the wordmark of a Cleveland Clinic portfolio company betting a decade of neuroscience on a single idea: stimulate the brain while it relearns to move.

The Dispatch

A brain implant, aimed at the aftermath of stroke

Every year, stroke leaves millions of people with a weakened arm or hand that never fully recovers. Physical therapy helps, but for many survivors the gains plateau and the limb stays stubborn. Enspire DBS Therapy, a clinical-stage medical device company in Cleveland, Ohio, is testing a different premise: that recovery can be pushed further if the brain is electrically encouraged while the patient does the hard work of rehabilitation.

The company's therapy combines deep brain stimulation - the same broad approach used for years to treat Parkinson's disease - with structured physical therapy. Rather than targeting the motor cortex, Enspire stimulates the dentate nucleus, a structure deep in the cerebellum that helps fine-tune voluntary movement. The idea is to "re-establish neurological input" during rehab, opening a window in which the brain is more receptive to relearning motor tasks.

Enspire was spun out of Cleveland Clinic Innovations in 2010 and remains a Cleveland Clinic portfolio company. It commercializes technology built on more than a decade of preclinical research led by Cleveland Clinic scientists Andre Machado and Kenneth Baker. In 2017, a Cleveland Clinic team performed what was reported as the nation's first deep brain stimulation procedure for stroke recovery. The work has been slow, deliberate, and unusually evidence-driven for a young device company.

By The Numbers

The scoreboard

2010
Founded (Cleveland Clinic spinout)
$27.9M
Total venture funding
9/12
EDEN patients who improved
2027
RESTORE interim results (mid)
How It Works

DBS + Rehab, step by step

Enspire's therapy is not a replacement for rehabilitation - it is meant to make rehabilitation work harder. Here is the basic sequence.

1

Implant

A commercially available DBS system places an electrode into the cerebellar dentate nucleus.

2

Stimulate

Targeted stimulation re-establishes neurological input, priming motor pathways.

3

Rehabilitate

Patients do structured physical therapy, weekly, while stimulation is active.

4

Recover

The goal: measurable gains in arm and hand motor function that stick.

The Evidence

What the early data showed

Figures below are drawn from Enspire's public statements and preclinical reporting. The EDEN feasibility trial is small (12 patients) - encouraging, not conclusive. The pivotal RESTORE trial exists precisely to test these signals rigorously.

Preclinical & feasibility signals

Reported figures - directional, not FDA-cleared claims
EDEN patients improved
9 / 12
Motor gain vs. sham (preclinical)
30-50%
Synapses vs. sham (perilesional)
~2x
Best-case score improvement
~3x

Note: bars are scaled for visual comparison. "~3x" reflects reported near-tripling of baseline scores among patients with at least minimal preserved distal motor function at enrollment.

"This financing represents an important milestone for Enspire as we advance RESTORE through pivotal clinical development."
- Scott Kokones, CEO and Co-Founder
Who It's For

The patient, and everyone around them

End Beneficiaries

Stroke survivors

People living with chronic upper-extremity impairment - a weakened arm or hand that has not recovered through conventional rehab. Stroke is a leading cause of long-term adult disability, and this group has few options once standard therapy plateaus.

Clinical Stakeholders

Neurosurgeons & rehab teams

Neurosurgeons, neurologists, physiatrists and stroke rehabilitation programs at academic and trial centers deliver the therapy. Enspire's RESTORE trial is currently enrolling participants at no cost to them.

The problem Enspire is trying to solve is narrow and stubborn: rehabilitation after stroke has a low ceiling. By re-establishing neurological input while the patient trains, the company is betting it can raise that ceiling - turning a plateau into progress for people who have run out of other options.

The Landscape

Where Enspire fits

Stroke recovery is a crowded field of ideas and a thin field of proven treatments. Enspire's approach is distinct in one important way: it goes deep.

What makes it different

Most emerging stroke-recovery neuromodulation is peripheral (vagus nerve stimulation) or non-invasive (TMS, tDCS). Enspire is one of the few applying implantable deep brain stimulation, and it targets the cerebellar dentate nucleus rather than the cortex - a bet grounded in over a decade of Cleveland Clinic neuroscience.

The alternatives

Competing paths include MicroTransponder's Vivistim (vagus nerve stimulation for stroke rehab), non-invasive brain stimulation, and intensive robotic rehabilitation. Enspire's wager is that a proven, deep-brain platform can deliver gains those approaches can't reach.

Reuse what's proven

Rather than engineer bespoke hardware, Enspire uses a commercially available DBS system - the same class of device with a long safety record in Parkinson's disease. The innovation lives in the target and the therapy, not the silicon.

The business model

Clinical-stage and venture-funded, Enspire develops and validates its therapy through trials toward FDA marketing authorization and eventual commercialization to hospitals and stroke-rehab centers. As a Cleveland Clinic portfolio company, it licenses technology from the institution's research arm.

Products & Programs

From feasibility to pivotal

Therapy - since 2017

DBS + Rehabilitation System

An implantable neuromodulation therapy stimulating the dentate nucleus to enhance recovery of upper-extremity motor function after stroke, delivered alongside structured physical therapy.

Trial - published 2023

EDEN (feasibility)

The first-in-human study - Electrical stimulation of the DEntate Nucleus - showing safety and feasibility. Results were published in Nature Medicine; 9 of 12 participants improved.

Trial - enrolling

RESTORE (pivotal)

A multicenter pivotal study of DBS plus rehab for chronic upper-extremity stroke impairment, featuring a five-month blinded comparison phase. Interim results are anticipated mid-2027.

Goal

FDA authorization

RESTORE is designed to generate the safety and effectiveness data needed to support a future application for FDA marketing authorization and commercialization.

The Money

Who is backing it

Roughly $27.9M raised to date - patient capital for a long-horizon device company, drawn largely from within the Cleveland ecosystem.

Series B1  /  Jan 13, 2026
$10.3M
Led by Genesys Capital. Existing investors Cleveland Clinic and JobsOhio Ventures participated. Managing Partner Jamie Stiff joined the board.
Series B  /  Aug 2023
$17.6M
Led by existing investor Cleveland Clinic, with the JobsOhio Growth Capital Fund and an undisclosed investor.
Timeline

Fifteen years, one target

2010

Founded as a Cleveland Clinic spinout

Cleveland Clinic Innovations established Enspire DBS Therapy to commercialize DBS-for-stroke research.

2016

NIH backs the science

Cleveland Clinic awarded nearly $5M to study deep brain stimulation for stroke recovery.

2017

Nation's first DBS-for-stroke procedure

Cleveland Clinic performed the first-in-human deep brain stimulation for stroke recovery.

2023

EDEN in Nature Medicine + $17.6M Series B

First-in-human feasibility results showed promise, and the company closed a Series B led by Cleveland Clinic.

2024

RESTORE pivotal trial launches

Enspire began its multicenter pivotal study of DBS plus rehabilitation.

2026

$10.3M Series B1

Genesys Capital led new financing to continue RESTORE enrollment; interim results expected mid-2027.

The People

Who's behind it

CEO & Co-Founder

Scott Kokones

Leads Enspire's strategy and clinical development. Has steered the company through its Series B and B1 financings and the transition from feasibility to pivotal trials.

Chief Scientific Officer

Andre Machado, MD, PhD

Cleveland Clinic principal investigator whose research underpins the therapy. Co-led more than a decade of preclinical work on DBS for stroke; holds equity in Enspire.

Cleveland Clinic scientist Kenneth Baker, PhD, co-led the foundational research alongside Machado. Enspire operates as a small, mission-driven team - roughly eleven people - inside the Cleveland Clinic innovation ecosystem, blending neuroscience rigor with medtech commercialization.

Worth Knowing

Five things that stand out

FAQ

Common questions

What does Enspire DBS Therapy do?

It develops an implantable deep brain stimulation (DBS) therapy that, combined with physical rehabilitation, aims to restore arm and hand movement in people with chronic impairment after a stroke.

Is the therapy approved by the FDA?

Not yet. Enspire is a clinical-stage company; the therapy is investigational and being evaluated in the RESTORE pivotal trial to support a future application for FDA marketing authorization.

What is the RESTORE trial?

RESTORE is Enspire's multicenter pivotal study evaluating the safety and effectiveness of DBS plus structured rehabilitation for chronic upper-extremity stroke impairment, with a five-month blinded phase and interim results anticipated mid-2027.

How is Enspire connected to Cleveland Clinic?

Enspire was spun out of Cleveland Clinic Innovations in 2010 and remains a Cleveland Clinic portfolio company, commercializing technology developed by Cleveland Clinic researchers Andre Machado and Kenneth Baker.

How much funding has Enspire raised?

Approximately $27.9M in total, including a $17.6M Series B in 2023 and a $10.3M Series B1 in January 2026, with backing from Cleveland Clinic, JobsOhio and Genesys Capital.