It’s the deadliest type of stroke, where blood clots form quickly within the brain, requiring swift treatment in an acute-hospital setting.
Now, a Carmel-based company that is developing minimally invasive tools for brain surgery is hoping for a huge boost after a seven-year clinical trial concluded its devices are safe to treat the stroke, known as intracerebral hemorrhage.
The trials, led by Emory University and involving 300 patients who suffered a spontaneous hemorrhagic stroke, found that the tools made by NICO Corp. are safe, resulted in substantial clot evacuation and improved functional outcome.
“These are phenomenal results,” CEO Jim Pearson told IBJ. “When you look at the problem—30% to 50% of patients who have hemorrhagic strokes die in the first 30 days—and we have a clinical trial that shows our type of surgery works, this is big news.”
NICO—short for Neurosurgical Intervention Co.—has developed a line of products that allow surgeons to reach into the brain in a way that’s less intrusive than the traditional method of cutting through the inner “white matter” and pulling the delicate tissue apart with retractors to reach tumors, blood and other fluids that need to be removed.
In the trial, overall mortality at six months was 20% for patients treated with NICO’s minimally invasive tools and 23.3% for patients treated with traditional surgical tools.
The study also concluded that patients treated with NICO tools had higher functional outcome than patients treated with the standard of care.
The results of the trial, known as ENRICH, were presented Saturday at the annual meeting of the American Association of Neurological Surgeons in Los Angeles. The results will be published later this year. ENRICH is short for efficacy and safety of early minimally invasive removal of intracerebral hemorrhage.
“I believe this trial will change how we treat hemorrhagic stroke moving forward, and I look forward to sharing the further details of the ENRICH trial, which will be published soon,” Dr. Gustavo Pradilla, co-lead investigator and associate professor of neurosurgery at Emory University School of Medicine in Atlanta, said in written remarks.
Two million people suffer hemorrhagic strokes each year.
NICO has raised $62 million since it was founded in 2007 and has trained more than 1,200 surgeons at dozens of hospitals, including the Cleveland Clinic, Indiana University Health, University of Michigan Health and Stanford University Medical Center.
Over the past 15 years, surgeons have done about 40,000 procedures using NICO tools. About 30% of those have been what’s called hemorrhagic stroke, and the rest have been some form of tumor.
Yet NICO, with about 60 employees, has had trouble making deeper inroads. Its minimally invasive technique still accounts for less than 10% of brain surgery procedures done in the United States. Sales last year were about $18 million, up 14% from a year earlier.
Pearson said he is hoping the trial results will convince more brain surgeons to use the company’s minimally invasive tools.
“This was a high-level trial that was designed to produce what’s called level one evidence,” he said. “We were working on it for seven years. For that reason, we knew we needed better evidence to convince surgeons to intervene to help these patients.”
He added: “We have it now.”