Development Status
- Design freeze complete
- Software validation complete
- First-in-human pilot successfully completed
Industry Classifications
- FDA: Class III (PMA Required)
- EU MDR: Class IIb (2017/745)
- ICD-10: G47.3 (Sleep Apnea)
- CPT: 95800-95811 (Sleep Studies)
Categories
- Device Type: Active Medical Device
- Technology: Electrical Stimulation + Software Control
- Risk Class: High-Risk/Novel Technology
- Clinical Area: Sleep Medicine & ENT
- Use Setting: Home Healthcare & Professional
Market Position
- Sleep Centers: 7,500+ (US/EU)
- Home Care Providers: 12,000+
- ENT/Dental Practices: 25,000+
- Potential Patients: 22M+ in covered markets
- Sleep Apnea CAGR: 12.1%
- Digital Health Integration: 15.3% growth
- Remote Monitoring: 18.7% CAGR
- Connected Device Adoption: 24.2% annual growth
Protection Status
- Hungarian Patent: Through 2040
- Know-how Package: Comprehensive
- Manufacturing Process: Defined
- IP Extension Strategy: Defined
Performance Metrics
- Global Patient Pool: 1B+ affected
- Undiagnosed Rate: 80%
- CPAP Intolerant: 35%
- Alternative Treatment Seeking: 40%
Option: Full Acquisition
- Hungarian market rights
- Manufacturing rights
- Technical support package
- Know-how transfer
- IP extension support
- Regulatory pathway assistance
- Market access support
- Timeline: 12-18 months
Due Diligence Package
- Technical Design File
- Verification Data
- IP Strategy
- Regulatory Strategy