Monteris Medical said today it won FDA investigational device exemption to explore the use of its NeuroBlate system in patients newly diagnosed with glioblastoma multiforme.
The NeuroBlate system is designed to ablate, necrotize or coagulate soft tissue during neurosurgery procedures through laser thermotherapy, and is not intended for any specific disease or lesion type, the company said.
With the investigative approval, Plymouth, Minn.-based Monteris said it expects to launch a new study of its device in the 4th quarter of this year, with enrollment slated for 5 sites in the U.S.
“Glioblastoma multiforme continues to be one of the most lethal cancers, and new approaches for managing this disease are urgently needed. Preliminary data suggest that LITT may have potential in newly diagnosed GBM cases, and the FLAG study will further our understanding of its potential in improving the care and outcomes for patients. Additionally, we anticipate LITT’s minimally invasive approach may have benefits over open craniotomy for this population,” Dr. Eric Leuthardt of the Barnes-Jewish Hospital said in a press release.
The 12-month study aims to examine the safety, feasibility and effectiveness of the NeuroBlate system in combination with standard of care radiation and chemotherapy for patients with newly diagnosed GBM.
“Although complete tumor resection in GBM is associated with improved survival, traditional open surgery is not optimal for patients with difficult to access deep seated lesions, and it also carries an increased risk of damage to adjacent healthy tissue. Data from a preliminary first in human study evaluating laser thermotherapy to treat recurrent GBM demonstrated clinical potential and we expect ongoing research will help us better understand how patients with newly diagnosed GBM respond to this type of intervention,” Dr. Kris Smith of Phoenix’s Barrow Neurological Institute said in a prepared statement.
“Monteris Medical is committed to addressing unmet medical needs by evaluating new options for patients with severe neurological disorders, and the IDE process enables us to do so in a carefully regulated, clinically rigorous environment. We are optimistic that results from the FLAG study will expand our knowledge of LITT in this patient population,” clinical affairs veep Daryle Petersen said in prepared remarks.
In April, Monteris Medical said it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy.
The company said it will initiate a multicenter, open-label study looking to enroll 45 patients at up to 8 clinical sites in the U.S. The trial aims to evaluate 30 patients using laser interstitial thermal therapy for treating drug-refractory medial temporal lobe epilepsy.
Last November, Monteris Medical said a pair of new backers joined a $30 million Series B round it plans to use to expand the commercial footprint of its NeuroBlate robotic brain tumor laser.
Monteris in April 2013 won 510(k) clearance from the FDA and a nod from Health Canada for the minimally invasive NeuroBlate device, which allows physicians to use an MRI-guided laser system to heat and kill brain tumors.