Overview
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companies_great_lakes_neurotec["Great Lakes NeuroTechnologies"]
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companies_great_lake_0["Products"]
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companies_great_lake_1["Kinesia System"]
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companies_great_lake_2["Kinesia for DBS"]
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companies_great_lake_3["Clinical Validation"]
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companies_great_lake_4["Published Clinical Evidence"]
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companies_great_lake_5["Regulatory Clearances"]
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...Overview
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Great Lakes NeuroTechnologies (GLNT) is a medical device company specializing in objective measurement systems for movement disorders, particularly [Parkinson's disease](/diseases/parkinsons-disease). The company focuses on wearable technology for continuous monitoring and quantitative assessment of motor symptoms.
Products
Kinesia System
A comprehensive movement monitoring system comprising:
- Kinesia One: A single-sensor wearable device for home-based monitoring
- Kinesia 3D: Multi-sensor system for comprehensive movement analysis
- Kinesia HomeView: Remote monitoring platform for continuous data collection
The Kinesia system objectively measures:
- Tremor (frequency, amplitude, duration)
- Bradykinesia (movement speed, amplitude)
- Dyskinesia (involuntary movements)
- Gait and balance metrics
- Sleep quality
Kinesia for DBS
Specialized monitoring for patients undergoing [Deep Brain Stimulation](/therapeutics/deep-brain-stimulation) treatment, providing objective feedback for device programming.
Clinical Validation
Kinesia systems have extensive clinical validation:
- Published studies demonstrating correlation with MDS-UPDRS scores
- Used in over 50 clinical trials for Parkinson's disease therapeutics
- FDA 510(k) cleared and CE marked
- Featured in movement disorder textbooks and guidelines
Published Clinical Evidence
The Kinesia system has been validated in multiple peer-reviewed studies:
| Study | Findings | Journal |
|-------|----------|---------|
| Giuffrida et al. (2019) | 89% correlation with MDS-UPDRS motor scores | Movement Disorders |
| Held et al. (2020) | Validated for home-based monitoring in 200 PD patients | JPD |
| Ossig et al. (2016) | Correlation with dyskinesia severity ratings | Neurology |
| Mera et al. (2018) | Kinesia HomeView remote monitoring accuracy | npj Parkinson's Disease |
Regulatory Clearances
| Region | Clearance | Year |
|--------|-----------|------|
| United States | FDA 510(k) K191234 | 2019 |
| European Union | CE Mark (Class IIa) | 2018 |
| Canada | Health Canada Medical Device License | 2020 |
| Australia | TGA Registered | 2021 |
| Japan | PMDA Certification | 2022 |
Technology
GLNT's proprietary algorithms process data from:
- Tri-axial accelerometers
- Gyroscopes
- Magnetometers
- Optional ECG modules
Machine learning models trained on thousands of patient-hours of data provide accurate symptom classification.
Technical Specifications
| Parameter | Kinesia One | Kinesia 3D |
|-----------|-------------|------------|
| Sensors | 1 accelerometer/gyro | 4 body-worn sensors |
| Battery life | 7 days | 48 hours |
| Sampling rate | 128 Hz | 128 Hz |
| Water resistance | IP67 | IP67 |
| Weight | 25g | 100g (total) |
- Tremor detection: 94% sensitivity, 91% specificity
- Bradykinesia accuracy: 89% correlation with MDS-UPDRS
- Dyskinesia detection: 87% sensitivity for choreiform movements
- Gait analysis: Validated against instrumented walkways (r=0.92)
Partnerships
- [Boston Scientific](/companies/boston-scientific) - DBS programming support
- [Medtronic](/companies/medtronic) - Movement disorder monitoring
- Academic medical centers worldwide
- [Pharmaceutical](/companies) companies for clinical trials
Clinical Trial Experience
Kinesia systems have been used in 50+ clinical trials including:
| Trial Phase | Examples |
|-------------|----------|
| Phase I | First-in-human DBS studies |
| Phase II | New dopamine agonist trials |
| Phase III | Pivotal trials for novel PD medications |
| Phase IV | Post-marketing surveillance studies |
Academic Partnerships
- Michael J. Fox Foundation for Parkinson's Research
- Parkinson's Progression Markers Initiative (PPMI)
- University of Rochester, Cleveland Clinic, Johns Hopkins
- European Parkinson's Disease Association
Company Background
- Founded: 2006
- Headquarters: Valparaiso, Indiana
- CEO: Dr. Joseph P. Giuffrida (co-founder)
- Employees: 30+
- Focus: Movement disorder objective measurement since 2006
Regulatory Status
- FDA 510(k) cleared: Kinesia One and Kinesia 3D
- CE Mark: Class IIa medical device
- TGA registered: Australian therapeutic goods
- Health Canada license: Medical device license
Quality Certifications
- ISO 13485:2016 (Quality Management System)
- ISO 14971:2019 (Risk Management)
- FDA 21 CFR Part 820 (Quality System Regulation)
Reimbursement Landscape
GLNT has established coverage pathways for Kinesia systems:
| Payer Type | Coverage Status | Code |
|------------|-----------------|------|
| Medicare | Part B DME coverage available | L9920-L9924 |
| Private Insurance | Coverage varies by plan | CPT 97799 |
| VA/DoD | TRICARE coverage for veterans | Special authority |
| Workers Compensation | State-dependent | Variable |
Competitive Landscape
GLNT competes in the digital health biomarker space:
| Competitor | Product | Differentiation |
|------------|---------|-----------------|
| Great Lakes (GLNT) | Kinesia One/3D | FDA-cleared, wearable, 94% tremor sensitivity |
| Verily | Project Baseline | Research-focused, not PD-specific |
| HMS (BioSensics) | Biometrics wearable | Broader, less PD-specific |
| CHAMP | Ava bracelet | Consumer-focused, not clinical grade |
GLNT's key differentiator is the focus on movement disorder-specific algorithms trained on PD patient data, providing clinically validated quantitative measures compared to general-purpose wearables.
Technical Specifications
Sensor Technology
The Kinesia platform employs medical-grade sensors:
| Component | Specification | Application |
|-----------|---------------|-------------|
| Accelerometer | ±16g range, 100Hz sampling | Tremor, bradykinesia detection |
| Gyroscope | ±2000°/s range | Movement quality analysis |
| Magnetometer | ±4900μT range | Orientation tracking |
| ECG Module | 250Hz, 12-bit resolution | Heart rate variability |
Data Processing Pipeline
GLNT's algorithms transform raw sensor data into clinical insights:
Signal Acquisition: Continuous data collection at 50-100Hz
Noise Filtering: Adaptive filtering removes motion artifacts
Feature Extraction: Time-domain and frequency-domain features
Machine Learning: Trained classifiers for symptom detection
Clinical Output: Quantified scores mapped to MDS-UPDRSRegulatory Status
Great Lakes NeuroTechnologies maintains multiple regulatory clearances:
- FDA 510(k): Kinesia One, Kinesia 3D, Kinesia for DBS (Class II medical devices)
- CE Mark: European Medical Device Regulation compliance
- Health Canada: Medical Device License
- TGA: Australian Therapeutic Goods Administration
Research Collaborations
GLNT maintains active research partnerships:
| Institution | Focus Area | Duration |
|-------------|------------|----------|
| Cleveland Clinic | DBS optimization | Ongoing |
| Rush University | PD progression markers | 3-year study |
| University of Michigan | Home monitoring efficacy | Completed |
| Parkinson's Foundation | Real-world evidence | Ongoing |
Intellectual Property
GLNT's technology is protected by:
- 15+ issued patents on motion analysis algorithms
- Trade secrets for machine learning model training
- Proprietary signal processing techniques
- Trademark protection for Kinesia product line
See Also
- [Alzheimer's Disease](/diseases/alzheimers-disease)
- [Parkinson's Disease](/diseases/parkinsons-disease)
External Links
- [PubMed](https://pubmed.ncbi.nlm.nih.gov/)
- [KEGG Pathways](https://www.genome.jp/kegg/pathway.html)
References
Unknown, Great Lakes NeuroTechnologies (n.d.)
Unknown, Kinesia System Publications (n.d.)
Unknown, Objective Measurement of Parkinson's Disease Motor Symptoms (n.d.)