NM-101

Industry’s first FDA clearance for the analysis of neuromelanin MRI

NM-101 is a cloud-based software platform that has now received FDA clearance to analyze neuromelanin MRI scans, and is the first and only FDA cleared medical device for this indication. NM-101 enables access to previously unattainable adjunctive data which may aid neuroradiologists in assessment and differential diagnosis.

NM-101 is a cloud-based software platform that has now received FDA clearance to analyze neuromelanin MRI scans, and is the first and only FDA cleared medical device for this indication. NM-101 enables access to previously unattainable adjunctive data which may aid neuroradiologists in assessment and differential diagnosis.

Dopamine

Dopamine

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Iron

Iron

Iron

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Neuromelanin

Neuromelanin

Neuromelanin MRI

Neuromelanin is a molecule associated with dopamine and norepinephrine neurons in the brain. Over the last two decades, researchers have elucidated its possible role as a biomarker for neurological and psychiatric disorders [1-6].

Seamless integration into existing workflows brings the potential of neuromelanin MRI to patients and neuroradiologists

NM-101’s cloud-based service integrates into existing hospital picture archiving systems (PACS) to process post-acquisition brain MRI sequences.  MRI images can be sent to NM-101 directly through the PACS and a full analysis report returned in under an hour.

Novel technology enables the fully automated analysis of neuromelanin associated signal in both the substantia nigra and locus coeruleus

Terran’s NM-101 post-acquisition software uses both validated voxel-based and segmented based methods to process and analyze post-acquisition MRI images. NM-101 automatically calculates and visualizes the levels and volumes of neuromelanin associated contrast to noise ratio (CNR) signal in the substantia nigra and locus coeruleus regions of the brain and creates a neuromelanin report. NM-101 delivers clinically relevant information such as tissue volumes, qualitative parametric maps, and degree of neuromelanin associated CNR signal in the midbrain. Changes in brain levels and volumes of neuromelanin associated CNR signal can be tracked over time, for use as an adjunct to diagnosis.

Cross-scanner variability in neuromelanin MRI solved with harmonization

Historically, the standardization of neuromelanin measurement has been difficult due to variability in results among scanners, including from those of the same manufacturer and model. However, the NM-101 platform now provides the automated harmonization of neuromelanin MRI scans necessary to allow for the comparison of neuromelanin associated signal between two different scanners [7].

Historically, the standardization of neuromelanin measurement has been difficult due to variability in results among scanners, including from those of the same manufacturer and model. However, the NM-101 platform now provides the automated harmonization of neuromelanin MRI scans necessary to allow for the comparison of neuromelanin associated signal between two different scanners [7].

Key advantages

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scan time

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scan time

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scan time

  • No radiation exposure

  • No IV infusion and no contrast agent required

  • Fast scan time: can be added onto a standard non-contrast brain MRI

  • Uses a standard brain MRI spin sequence: Turbo Spin Echo

  • Adjunctive tool to aid neuroradiologists in the differential diagnosis and monitoring of dopamine-related diseases

Citations

1.Okuzumi, A., et al. "Neuromelanin or DaT‐SPECT: which is the better marker for discriminating advanced Parkinson's disease?." European journal of neurology 26.11 (2019): 1408-1416.

1.Okuzumi, A., et al. "Neuromelanin or DaT‐SPECT: which is the better marker for discriminating advanced Parkinson's disease?." European journal of neurology 26.11 (2019): 1408-1416.

1.Okuzumi, A., et al. "Neuromelanin or DaT‐SPECT: which is the better marker for discriminating advanced Parkinson's disease?." European journal of neurology 26.11 (2019): 1408-1416.

2.Pavese, Nicola. "Is neuromelanin the imaging biomarker for the early diagnosis of Parkinson's disease that we were looking for?." Parkinsonism & Related Disorders 58 (2019): 1-2.

2.Pavese, Nicola. "Is neuromelanin the imaging biomarker for the early diagnosis of Parkinson's disease that we were looking for?." Parkinsonism & Related Disorders 58 (2019): 1-2.

2.Pavese, Nicola. "Is neuromelanin the imaging biomarker for the early diagnosis of Parkinson's disease that we were looking for?." Parkinsonism & Related Disorders 58 (2019): 1-2.

3.Prasad, Shweta, et al. "Motor asymmetry and neuromelanin imaging: Concordance in Parkinson's disease." Parkinsonism & Related Disorders 53 (2018): 28-32.

3.Prasad, Shweta, et al. "Motor asymmetry and neuromelanin imaging: Concordance in Parkinson's disease." Parkinsonism & Related Disorders 53 (2018): 28-32.

3.Prasad, Shweta, et al. "Motor asymmetry and neuromelanin imaging: Concordance in Parkinson's disease." Parkinsonism & Related Disorders 53 (2018): 28-32.

4.Liu, Yu, et al. "Optimizing neuromelanin contrast in the substantia nigra and locus coeruleus using a magnetization transfer contrast prepared 3D gradient recalled echo sequence." Neuroimage 218 (2020): 116935.

4.Liu, Yu, et al. "Optimizing neuromelanin contrast in the substantia nigra and locus coeruleus using a magnetization transfer contrast prepared 3D gradient recalled echo sequence." Neuroimage 218 (2020): 116935.

4.Liu, Yu, et al. "Optimizing neuromelanin contrast in the substantia nigra and locus coeruleus using a magnetization transfer contrast prepared 3D gradient recalled echo sequence." Neuroimage 218 (2020): 116935.

5.Wang, Xiangming, et al. "The diagnostic value of SNpc using NM-MRI in Parkinson’s disease: meta-analysis." Neurological Sciences 40 (2019): 2479-2489.

5.Wang, Xiangming, et al. "The diagnostic value of SNpc using NM-MRI in Parkinson’s disease: meta-analysis." Neurological Sciences 40 (2019): 2479-2489.

5.Wang, Xiangming, et al. "The diagnostic value of SNpc using NM-MRI in Parkinson’s disease: meta-analysis." Neurological Sciences 40 (2019): 2479-2489.

6.Sulzer, David, et al. "Neuromelanin detection by magnetic resonance imaging (MRI) and its promise as a biomarker for Parkinson’s disease." NPJ Parkinson's disease 4.1 (2018): 11.

6.Sulzer, David, et al. "Neuromelanin detection by magnetic resonance imaging (MRI) and its promise as a biomarker for Parkinson’s disease." NPJ Parkinson's disease 4.1 (2018): 11.

6.Sulzer, David, et al. "Neuromelanin detection by magnetic resonance imaging (MRI) and its promise as a biomarker for Parkinson’s disease." NPJ Parkinson's disease 4.1 (2018): 11.

7.Wengler, Kenneth, et al. "Cross‐scanner harmonization of neuromelanin‐sensitive MRI for multisite studies." Journal of Magnetic Resonance Imaging 54.4 (2021): 1189-1199.

7.Wengler, Kenneth, et al. "Cross‐scanner harmonization of neuromelanin‐sensitive MRI for multisite studies." Journal of Magnetic Resonance Imaging 54.4 (2021): 1189-1199.

7.Wengler, Kenneth, et al. "Cross‐scanner harmonization of neuromelanin‐sensitive MRI for multisite studies." Journal of Magnetic Resonance Imaging 54.4 (2021): 1189-1199.