Currently, there is no other FDA-cleared software indicated for the analysis of neuromelanin MRI on the market, making Terran’s technology the world’s first
NM-101 is a cloud-based analysis platform that is able to seamlessly integrate into existing workflows at hospitals and imaging centers. (Credit: National Cancer Institute on Unsplash)
Terran Biosciences, a biotech platform company developing therapeutics and technologies for patients with neuropsychiatric illnesses, has received FDA clearance to market NM-101, a cloud-based software platform to analyze neuromelanin-sensitive MRI scans.
Currently, there is no other FDA-cleared software indicated for the analysis of neuromelanin MRI on the market, making Terran’s technology the world’s first.
NM-101 is a cloud-based analysis platform that is able to seamlessly integrate into existing workflows at hospitals and imaging centers.
The device allows doctors to send neuromelanin MRI images to Terran directly through the hospital picture archiving and communication system (PACS) and receive a full report back in under an hour.
When interpreted by a neuroradiologist, NM-101 can provide information useful in determining neuromelanin association as an adjunct to diagnosis.
“This is a big moment for us and our collaborators and we’re thrilled to bring this new tool to doctors where it can begin benefiting patients,” said Terran Biosciences Founder and CEO Sam Clark, MD, PhD. “We were excited to partner with leading researchers in the field and conduct the key development steps necessary to bring it through to FDA clearance. We believe this technology could become very important in the clinical workflow of patients with neurological and psychiatric disorders.”
Neuromelanin is a molecule associated with certain cell populations in the brain. While neuromelanin was first described in the 19th century, researchers have elucidated its possible role as a biomarker for neurological disorders such as Parkinson’s disease in the last two decades.
Studies show that neuromelanin MRI may provide useful adjunctive information to aid in the evaluation of Parkinson’s disease, and avoids the disadvantages of current adjunctive imaging modalities such as DaT-SPECT, which requires a five-hour procedure, intravenous radiation exposure, and can cost well over $3,000.
A recent meta-analysis of 12 clinical neuromelanin MRI studies comprising 403 patients with Parkinson’s disease and 298 control participants concluded that neuromelanin MRI provided a “favorable diagnostic performance in discriminating patients with Parkinson’s disease from healthy controls.”
Source: Company Press Release