Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the device.
The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain. The device won 510(k) clearance from the FDA last June for treating primary and secondary brain tumors, vascular abnormalities, intraventricular tumors or cysts.
Data from the studies was published in the journals Neurosurgery and Operative Neurosurgery, the Indianapolis-based company said.
“The consistency of outcomes is a result of our dedication and the neurosurgeons’ willingness to attend advanced training courses held across the United States. During these 1-day events, physicians are educated on a unique minimally invasive parafascicular approach that allows for safe access and near complete evacuation, and they are taught techniques for managing the bleeding blood vessel so it doesn’t re-bleed after exiting the surgical site. The BrainPath Approach offers a predictable formula for predictable outcomes,” CEO Jim Pearson said in a press release.
Both studies, a prospective single-center study and retrospective multi-center study, reported only a single death that was unrelated to the company’s BrainPath approach, the company said.
Data from the studies indicated a 94% ate of functional recovery in patients who had functional mRS scores at follow-up between 0-3, indicating moderate disability while maintainting the ability to walk unassisted.
“Hemorrhagic stroke appears to be following in the footsteps of ischemic stroke, with these significant clinical advancements now being published in well-respected neurosurgery journals. What’s emerging is unique and there is no other technology available that allows for access to the brain using a trans-sulcal surgical approach. We can see the market of treatable patients evolving and getting larger for hemorrhagic stroke because now we can intervene quickly and stop the active bleed – something not possible before,” Pearson said in a prepared statement.
Nico said that data from both studies “validate the importance of appropriate patient selection and standardizing the approach to early surgical intervention of hemorrhagic stroke.”
“The inertia has been against aggressive surgical intervention for this disease, but there has also been a constant pressure for progress for this group of patients who have had very bleak recovery or survival odds. There has been a need to have data supporting this approach in order to take the big jump for changing how quickly we address hemorrhagic stroke and how we approach it. This is the first step,” Dr. Mark Bain of the Cleveland Clinic wrote in the prospective study published in Operative Neurosurgery.
The company said the results are consistent with a previous multi-center study of 39 patients which reported 90% clot reduction in 72% of patients, and a median GCS improvement from 10 to 14 with no mortalities as a result of the surgery.
In February, Nico Corp. said it raised $15 million of a hoped-for $18 million funding round, led by prior backers River Cities Capital Funds and the Rose-Hulman Institute of Technology, for its BrainPath neurosurgery device.
Nico said in a regulatory filing that 41 investors participated in the round, which nearly doubled its previous fundraising efforts.
The company said it plans to use the proceeds to grow its commercial footprint and conduct a study on using BrainPath for early surgical intervention in spontaneous intra-cerebral hemorrhages, compared with a “watch and wait” approach.
