Osteoradionecrosis

LITT allows for the prompt cessation of steroids and alleviates symptom burden in brain metastasis patients with radiation necrosis as supported by evidence from 90 patients treated with NeuroBlate laser ablation MINNETONKA, Minn. , April 18, 2023 /PRNewswire/ -- Monteris Medical announced today that a new publication on laser interstitial thermal therapy (LITT) using the NeuroBlate® System to treat patients with radiation necrosis (RN) has been published in the journal, Neuro-Oncology Advances. The largest prospectively-gathered dataset, collected through the company's LAANTERN (Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System) multi-center study and comprised of 90 patients with biopsy-proven RN, showed that LITT with NeuroBlate is a safe and highly effective minimally invasive option for the treatment of RN. The evidence also demonstrated that following the NeuroBlate procedure, patients tapered corticosteroid use rapidly, showed excellent symptom control and continued systemic cancer treatments, allowing for maximal survival benefit. The evidence gathered from this large cohort of pure RN continues to support the utilization of NeuroBlate LITT for the treatment of RN, an inflammatory process that can occur following stereotactic radiosurgery (SRS). These data showed that patients rapidly discontinued steroid use post-LITT (median time of 13 days), an important benefit, given steroid use may worsen survival rates, particularly for those on immunotherapy. Patients in the study who were undergoing chemotherapy and/or immunotherapy experienced little to no interruption in their treatments post-LITT. This is in contrast to craniotomy, which generally requires that patients pause systemic treatments to facilitate wound healing and recovery time. "LITT compares favorably to historical efficacy of craniotomy and resection yet has a degree of versatility when faced with deeper lesions or with those close to eloquent brain," said Dr. Michael D. Chan, lead author and professor of radiation oncology at Atrium Health Wake Forest Baptist in Winston-Salem, NC. "Compared to historical expectations with craniotomy, LITT has demonstrated favorable hospitalization times and favorable risk profile. It seems that LITT has truly carved itself a role in the management of post-SRS radiation necrosis alongside other tools including steroids, bevacizumab and open resection. I look forward to results of the ongoing prospective studies meant to validate the present findings." The use of stereotactic radiosurgery (SRS) has significantly expanded in recent years as brain metastases have become more common. This is due in part to advances in systemic therapy that enable the long-term control of extracranial disease. The growing use of radiotherapy has also resulted in the proliferation of post-SRS imaging changes, which may represent either RN or tumor growth, a diagnostic question best confirmed via biopsy. Laser interstitial thermal therapy with biopsy offers patients an immediate diagnostic confirmation of the disease process and is a highly effective treatment for RN with respect to local control and symptom management. "We are grateful to our investigators for their continued work to generate clinical proof that supports NeuroBlate as a surgical tool for early intervention for those patients with progressive brain metastases," said Martin J. Emerson, president and chief executive officer of Monteris. "As the leader in the LITT space, Monteris remains uniquely committed to delivering high quality evidence that physicians need when making critical patient care decisions. With more than 1,100 patients enrolled, our prospective LAANTERN study continues to demonstrate a distinct position for NeuroBlate as an evidenced-based, mainstay technology for brain tumors, radiation necrosis, and drug-resistant epilepsy." About LAANTERN LAANTERN (Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System) is a post-market study designed to evaluate the performance and utilization of the NeuroBlate® System in the standard of care, "real-world" setting. This is the first prospective multicenter laser ablation study. All sites operate under an IRB-approved protocol and undergo rigorous data management and monitoring practices to ensure data quality and consistency. The registry will follow up to 3,000 patients for five years evaluating safety, quality of life, health economics and procedural outcomes, including survival and seizure freedom. About Monteris and the NeuroBlate System Monteris Medical is a privately held company that develops and markets innovative MR-guided ablation systems to perform minimally invasive, robotically controlled brain surgery, commonly referred to as laser ablation, LITT (Laser Interstitial Thermal Therapy) or SLA (Stereotactic Laser Ablation). The Monteris NeuroBlate System is the only minimally invasive system that enables a robotic interface for the precise and safe delivery of laser energy. The Monteris Medical NeuroBlate System is a neurosurgical tool and is intended for ablating intracranial soft tissue, including brain structures such as brain tumors, radiation necrosis, and epileptic foci (as identified by non-invasive and invasive neurodiagnostic testing, including imaging). For more information, visit monteris.com.

Monteris Medical recently raised $35 million as it continues to advance its minimally invasive robotic brain surgery system. The Minnetonka, Minnesota–based company reported a $13.5 million raise in an SEC Form D filed on Sept. 15. But in an article published yesterday in the Star Tribune of Minneapolis, CFO Jim Erickson said the equity financing range was actually $35 million. “The first half of this year was more challenging than the year before. It took longer than we would have hoped,” Erickson told the Star Tribune. He later added that the life sciences space is proving to be a durable investment space, even amid the present economic hurdles. Monteris Medical is among a host of companies big and small that are seeking to innovate in a surgical robotics space that has long been dominated by Intuitive. [Intuitive CEO Gary Guthart will deliver a keynote at DeviceTalks West, Oct. 19–20, 2022, in Santa Clara, California. Register here.] Monteris designed its NeuroBlate minimally invasive surgical robot system for controlled laser thermotherapy, known as laser interstitial thermal therapy (LITT). More than 80 hospitals across the U. S. and Canada have used the NeuroBlate System since its market release in 2013. NeuroBlate uses MRI-guided laser light to ablate (destroy) brain lesions or unwanted tissue. Patients treated with NeuroBlate have had conditions including epilepsy, gliomas, brain metastases and radiation necrosis. New clinical trial kicks off for Monteris Medical Also in September, Monteris Medical announced the first patient enrolled in its REMASTer (Recurrent Brain Metastases After Stereotactic Radiosurgery [SRS] Trial) clinical trial. Researchers designed the randomized controlled study to investigate NeuroBlate-System-delivered LITT as an early intervention for radiographically progressive brain metastases. The goal of REMASTer is to provide Level I evidence to guide treatment. The company described the patient population in the space as complex.