Monteris Medical Announces the Publication of Positive Clinical Data for its NeuroBlate® Laser System for Patients with Brain Metastasis
PLYMOUTH, Minn. – November 12, 2018 – Monteris Medical, a pioneer and leader in the emerging market for minimally invasive, image-guided laser ablation systems, announced that the favorable results of its LAASR (Laser Ablation After Stereotactic Radiosurgery) clinical study have been published in the Journal of Neurosurgery. A prospective, multi-center clinical study conducted by leading academic medical centers, LAASR confirmed the beneficial outcomes of Laser Interstitial Thermal Therapy (LITT) in a group of 42 patients with brain lesions that recurred following stereotactic radiosurgery (SRS) for metastatic brain tumors.1
The LAASR clinical study enrolled patients with brain lesions that recurred following stereotactic radiosurgery for metastatic brain cancer. The recurring lesions—which ranged in size from 0.4 cm3 to 38.6 cm3—were ablated with the Monteris Medical NeuroBlate System. This patient population often has complex progressive medical issues and limited options, often leading to debilitating neurologic symptoms and deteriorating cognitive function causing progressive decline in their quality of life. The options for these patients, including open surgery and steroid drug therapy, may be limited and are often associated with high levels of morbidity. The LAASR study results demonstrated that the potential benefits of LITT for this patient population include stabilizing the quality of life and cognitive function of this challenging patient population. Additional benefits included reduced or eliminated steroid usage and short length of hospital stay. The study confirmed that LITT can be effective in controlling both recurrent brain metastases and radiation necrosis, as shown by the primary outcome results of the trial on progression-free survival (PFS) of 74 percent at last follow-up (12-26 weeks) and overall survival (OS) of 72 percent at 26 weeks. No unanticipated adverse events related to the device/procedure were seen. Neurological complications related to the LITT procedure were shown in 12 percent of the patients and included intracerebral hemorrhage, headache, and new or worsened neurological deficits such as motor weakness. The paper is available at www.monteris.com/LAASR.
Veronica L. Chiang, M.D., co-principal investigator, Department of Neurosurgery, Yale University, commented, “Given the side effect profile of alternative options for this patient population, the stabilization in the Karnofsky Performance Scale, preservation of quality of life, and reduction in steroid usage all represent positive outcomes of the LAASR study.”
Manmeet Ahluwalia, M.D., co-principal investigator, of the Cleveland Clinic’s Brain Tumor and Neuro-Oncology Center, added, “SRS is an effective first-line treatment for patients with metastatic brain cancer. However, for patients with recurrent disease that may not be appropriate for additional SRS or surgical resection, the LAASR study results indicate that LITT can be an effective option.”
Monteris is exclusively focused on advancing both LITT technology and clinical research to serve the unmet needs of neurosurgeons and their patients. The company’s NeuroBlate System is a minimally invasive, MRIguided laser ablation tool for brain lesions, including brain tumors and epileptic foci. In addition to its recently published LAASR study, the Monteris commitment to high quality clinical data is continuing with its LAANTERN2 prospective, multi-center registry that has enrolled over 300 patients.
Martin J. Emerson, president and CEO of Monteris Medical, commented, “The Monteris Medical team is proud to have supported this first-of-its-kind prospective, multi-center clinical trial for the treatment of metastatic brain tumors with LITT. We appreciate the commitment of the physician investigators and their research teams who were involved in LAASR, as we fully recognize the critical importance of key opinion leader collaboration in developing and establishing new minimally invasive options for patients.”
Monteris Medical will be exhibiting at the Society for Neuro-Oncology annual meeting in New Orleans, Nov. 1518. Visit booth 101 to see a full demonstration of the NeuroBlate System.
For more information about Monteris and full prescribing information for the NeuroBlate System, please visit www.monteris.com.
About Monteris and the NeuroBlate System
Monteris Medical is a privately held company that develops and markets innovative MRI-guided, laser-based systems for the ablation of brain lesions. Current investors include Versant Ventures, SightLine Partners, Birchview Capital and BDC Capital. The Monteris NeuroBlate System, including the Mini-Bolt, is the only minimally invasive cranial access system that enables a robotic interface for the precise and safe delivery of laser energy. The NeuroBlate System is a tool (as opposed to a “treatment”) and is not intended to treat any specific disease. Physicians should use their clinical judgment and experience when deciding whether to use NeuroBlate.
Monteris Medical, Inc.
Chief Financial Officer
1 Published online May 4, 2018; DOI: 10.3171/2017.11.JNS171273
2 Laser Ablation of Abnormal Neurological Tissue using Robotic NeuroBlate System (“LAANTERN”)