Terran Biosciences, a biotech platform company focused on developing therapies and technologies for individuals with neuropsychiatric disorders, has received FDA clearance for the release of NM-101. NM-101 is a cloud-based software platform designed to analyze neuromelanin-sensitive MRI scans, making it the sole FDA-cleared software dedicated to this purpose worldwide. The platform seamlessly integrates into existing hospital and imaging center workflows, allowing healthcare professionals to transmit neuromelanin MRI images to Terran through the hospital's picture archiving and communication system (PACS). Subsequently, NM-101 generates a comprehensive report within an hour.
Utilizing the expertise of neuroradiologists, NM-101 provides valuable insights to aid in identifying neuromelanin associations, serving as a supplementary diagnostic tool. Neuromelanin, a molecule associated with specific brain cell populations, has gained recognition as a potential biomarker for neurological disorders, particularly Parkinson's disease. Despite being known since the 19th century, recent research has highlighted its significance in the last two decades. Neuromelanin MRI, facilitated by NM-101, offers advantages such as a quick scan time (under 10 minutes), no need for injections, minimal radiation exposure, and cost-effectiveness by seamlessly integrating into the standard MRI workup.
Furthermore, NM-101 demonstrates potential applications beyond Parkinson's disease, extending to conditions like Alzheimer's disease and schizophrenia. Despite these advantages, the absence of FDA-approved devices for neuromelanin MRI analysis has persisted due to challenges in automation and standardization, limiting widespread clinical use. NM-101 addresses this issue by incorporating algorithms that enable fully automated analysis and cross-scanner harmonization of neuromelanin MRI scans, overcoming historical difficulties associated with variability among MRI scanners, even those of the same make and model.
Source: https://www.businesswire.com/news/home/20231220798881/en/Terran-Biosciences-Receives-FDA-Clearance-for-NM-101-the-industry%E2%80%99s-first-software-for-the-analysis-of-neuromelanin-sensitive-MRI
