Key Points
- The company’s software – called Optim MRI – helps neurosurgeons identify operable brain regions in patients with Parkinson’s disease and essential tremor.
- The new clearance expands Optim MRI’s capabilities to include the inferolateral part of the VIM region of the brain.
Founded in 2021, RebrAIn is a French startup company that has developed software – called Optim MRI – to help neurosurgeons identify operable brain regions in patients with Parkinson’s disease (PD) and essential tremor (ET). Using an artificial intelligence (AI) algorithm and a collaborative registry of health data, RebrAIn simplifies and standardizes procedures with the aim of increasing the number of treated patients worldwide.
The company recently announced that it has earned its second US Food and Drug Administration (FDA) 510(k) clearance in the past year. The new clearance expands Optim MRI’s capabilities to include the inferolateral part of the ventral intermediate (VIM) nucleus region of the brain.
“Our extension to US customers to better plan targets for lesioning is a significant step in RebrAIn’s growth and strategic transformation,” said the company’s CEO David Caumartin. “The US market represents the largest opportunity to enable personalized targeting for neurological disorders, such as ET. The ability to offer AI clinical targeting to neurosurgical suites will open many collaborations nationwide, which today are treated with deep brain stimulation and MR-guided focused ultrasound.”
RebrAIn also held the first meeting of its Medical Advisory Board, which is composed of nine leading neurologists and neurosurgeons:
- Ausaf Bari, MD, PhD (University of California Los Angeles)
- Rees Cosgrove, MD (Brigham and Women’s Hospital)
- Lain Hermes González, MD (Clínica Universidad)
- Joohi Jimenez-Shahed, MD (Mount Sinai)
- Michael Kinsman, MD (University of Kansas Hospital)
- Shayan Moosa, MD (University of Virginia)
- Charles Munyon, MD (Charlotte Novant Health)
- Jean Régis, MD (Assistance Publique – Hôpitaux de Marseille)
- John Rolston, MD, PhD (Brigham and Women’s Hospital)
During the meeting, the group discussed the unique qualities of a lesion created with MR-guided focused ultrasound, including:
- It is an acute lesion, as opposed to radiosurgery.
- The location and size of the lesion must be controlled, unlike radiosurgery where only the location can be controlled.
- MRI scans at 24 hours post-procedure should be used to evaluate precise volume of the induced lesion.
The advisory board agreed that these particularities need to be considered when generating a specific algorithm for VIM lesions using focused ultrasound, and because few controlled studies exist, and it is important in the long term to design a prospective study on focused ultrasound lesioning of the VIM in ET.
Learn More about RebrAIn in our May 2024 Q&A with Mr. Caumartin.