Cleveland Clinic has led a $17.6 million financing round for Enspire DBS Therapy Inc. and its deep brain stimulation therapy that helps people recover from strokes.
JobsOhio Growth Capital Fund and an undisclosed investor also participated in the Series B fundraising for the clinical-stage company that was spun off from Cleveland Clinic in 2010, Enspire said on Tuesday.
Enspire plans to use its new capital to start a clinical trial to assess the safety and efficacy of its implanted deep brain stimulation (DBS) and rehabilitation therapy to treat stroke patients who have weakness and reduced function in their arms, the company said.
"The first trial in humans ... was a proof-of-concept study combining DBS with rehab to help stroke patients regain function," Scott Kokones, Enspire's CEO, said about his company's first clinical trial, which concluded in January.
In its next and pivotal trial, Enspire "aims to generate the data necessary to demonstrate the long-term safety and efficacy of its therapy in stroke patients to support marketing approval," Kokones said.
Cleveland Clinic's most recent investment in Enspire "aligns with our focus on innovative neurostimulation solutions addressing significant clinical challenges," said J.D. Friedland, managing director of ventures at Cleveland Clinic Innovations, the Cleveland health system's innovation commercialization organization, in the statement.
Stroke is the leading cause of long-term disabilities in the United States, Cleveland Clinic said in a 2017 article about Enspire's therapy. In spite of rehabilitation, one-third of stroke patients experience "long-term motor deficits severe enough to be disabling," the Clinic said.
Team members led by Dr. Andre Machado, a neurosurgeon and chairman of Cleveland Clinic's neurological institute, implanted the first Ensure system in a patient in October 2016, the Clinic said. Electrodes implanted in the patient's brain were connected to a pacemaker that provided small electric pulses to help the patient regain movement control during physical therapy.
Over seven years, a dozen patients were enrolled in the trial, according to a study record at ClinicalTrials.gov.
Machado patented the DBS method in stroke recovery, and Boston Scientific owns a license to those patents, the Clinic said. Boston Scientific also invested $2.5 million in Enspire DBS, the Clinic said in 2017.
