Enspire DBS Therapy, Inc., (Enspire) a clinical stage company developing an implantable neuromodulation therapy for post-stroke recovery, announced today that it raised $17.6 million of committed capital in a Series B financing led by existing investor, Cleveland Clinic. Also participating in the round were JobsOhio Growth Capital Fund and an undisclosed investor.
The company plans to use the proceeds to initiate the RESTORE pivotal clinical trial using deep brain stimulation (DBS) and rehab therapy (DBS + Rehab) to treat patients with chronic upper extremity impairment due to stroke.
“The first trial in humans known as EDEN (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke), was a proof-of-concept study combining DBS with Rehab to help stroke patients regain function. The results from EDEN led to this Series B raise,” said Scott Kokones, Chief Executive Officer of Enspire, “With RESTORE, the company aims to generate the data necessary to demonstrate the long-term safety and efficacy of DBS+Rehab in Stroke patients to support marketing approval.”
“Cleveland Clinic Innovations is dedicated to supporting technologies to enhance patient outcomes. Our most recent investment in Enspire DBS aligns with our focus on innovative neuro-stimulation solutions addressing significant clinical challenges,” said JD Friedland, Managing Director of Ventures at Cleveland Clinic Innovations. “Enspire’s emphasis on operationalizing and advancing new technology matches the mission of Cleveland Clinic Innovations.”
About Stroke
Approximately 800,000 people in the United States suffer strokes yearly, which is the leading cause of long-term disabilities. While most patients will survive the acute phase, persistent neurological issues will likely jeopardize the quality of life and productivity, with approximately 50% of survivors still exhibiting disability severities that require assistance with daily activities.
About EDEN
The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke) conducted at The Cleveland Clinic enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper extremity because of a unilateral middle cerebral artery stroke 1-3 years prior.
Each participant was implanted with a DBS System, which involved the surgical implantation of electrodes into the cerebellum. Following discharge and recovery from the surgery, participants completed several months of physical therapy, first with the DBS device turned off for several weeks and then turned on for four-to-eight months.
DBS for stroke is investigational use; clinical studies for this indication are conducted under Enspire’s approved IDE from FDA.
About RESTORE
The RESTORE Stroke Pivotal Study will evaluate the safety and effectiveness of DBS + Rehab for treating arm weakness and reduced function after a stroke to support marketing approval of this therapy.
Each participant will be implanted with a commercially available third-party DBS system and receive a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, participants assigned to active-control treatment (Ct) (rehab only) will cross over to receive DBS treatment (Tt) and participate in a second five-month therapy program. For more information, see ClinicalTrials.gov ID NCT05701280. The RESTORE trial is actively recruiting. www.restorestrokestudy.com