Enspire DBS Therapy recently announced that it has raised US$17.6 million of committed capital in a Series B financing led by existing investor Cleveland Clinic Innovations. 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 rehabilitation therapy—DBS plus rehab—to treat patients with chronic upper extremity impairment due to stroke.
RESTORE will evaluate the safety and effectiveness of DBS plus rehab for treating arm weakness and reduced function after a stroke to support marketing approval of this therapy. Each study participant will be implanted with a commercially available, third-party DBS system and receive a five-month outpatient rehabilitation therapy programme. After five months of blinded randomised testing, participants assigned to active-control treatment (rehab only) will cross over to receive DBS treatment and participate in a second five-month therapy programme.
“The first trial in humans, known as EDEN, 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, CEO of Enspire. “With RESTORE, the company aims to generate the data necessary to demonstrate the long-term safety and efficacy of DBS plus rehab in stroke patients to support marketing approval.”
The EDEN trial, conducted at the Cleveland Clinic (Cleveland, USA), enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper extremity because of a unilateral middle cerebral artery (MCA) 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 4–8 months.
DBS therapy for stroke is currently approved under investigational use, and clinical studies for this indication are being conducted under Enspire’s approved investigational device exemption (IDE) from the US Food and Drug Administration (FDA)—as per a company press release.
