# Enspire DBS Therapy, Inc.

> Enspire DBS Therapy is a Cleveland-based, clinical-stage medical device company commercializing deep brain stimulation (DBS) paired with physical rehabilitation to restore arm and hand function in people living with chronic impairment after a stroke. Spun out of Cleveland Clinic in 2010, the company builds on more than a decade of research targeting the brain's dentate nucleus to re-establish neurological input during rehab. Its DBS-plus-rehab approach showed encouraging results in the first-in-human EDEN trial published in Nature Medicine, and Enspire is now running RESTORE, a multicenter pivotal study aimed at FDA marketing authorization.

- **Founded:** 2010
- **Headquarters:** Cleveland, Ohio, United States
- **Founders:** Scott Kokones (CEO and Co-Founder), Andre Machado (Co-Founder / Chief Scientific Officer (Cleveland Clinic principal investigator)), Kenneth Baker (Scientific Co-Founder (Cleveland Clinic principal investigator))
- **Team size:** 11 (approx.; fewer than 25 employees)
- **Products:** DBS + Rehabilitation System, RESTORE Pivotal Clinical Trial, EDEN Early Feasibility Trial
- **Notable:** Performed the nation's first deep brain stimulation procedure for stroke recovery (Cleveland Clinic, 2017), Published first-in-human EDEN trial results in Nature Medicine (2023), 9 of 12 EDEN participants showed improvement in motor impairment and function; some patients nearly tripled baseline scores

## Products & services

- **DBS + Rehabilitation System** — An implantable neuromodulation therapy that stimulates the cerebellar dentate nucleus to re-establish neurological input during physical rehabilitation, enhancing recovery of upper-extremity motor function after stroke. Uses a commercially available DBS system.
- **RESTORE Pivotal Clinical Trial** — A multicenter, pivotal Phase 2/3 study evaluating the safety and effectiveness of DBS plus structured rehabilitation for chronic upper-extremity impairment due to stroke, with a five-month blinded comparison phase and interim results anticipated mid-2027.
- **EDEN Early Feasibility Trial** — First-in-human study (Electrical stimulation of the DEntate Nucleus) demonstrating safety and feasibility of DBS plus rehab; results published in Nature Medicine.

## Achievements

- Performed the nation's first deep brain stimulation procedure for stroke recovery (Cleveland Clinic, 2017)
- Published first-in-human EDEN trial results in Nature Medicine (2023)
- 9 of 12 EDEN participants showed improvement in motor impairment and function; some patients nearly tripled baseline scores
- Raised $27.9M in total venture funding
- Advanced to a multicenter pivotal RESTORE trial targeting FDA authorization
- Awarded ~$5M NIH funding (2016) to study DBS for stroke recovery

## Latest updates

- **2026-01** — Announced $10.3M Series B1 financing led by Genesys Capital to continue enrollment in the RESTORE pivotal trial; Jamie Stiff joined the board.
- **2023-08** — Published EDEN early feasibility trial in Nature Medicine and announced $17.6M Series B led by Cleveland Clinic.

## Links

- Website: https://enspiredbs.com
- LinkedIn: https://www.linkedin.com/company/enspire-dbs-therapies-inc.

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Last updated: 2026-07-21