Investor overview
Funding the next stage of development
Diagestics is raising a $3 million seed round to support a two-year runway spanning engineering optimization, prototype manufacturing, testing and validation, and commercialization preparation.
Current raise
$3M
Seed Round
Capital is intended to advance product development, pilot deployment, testing, validation, and manufacturing preparation.
Business model
90%
Projected revenue from cartridges*
The company deck models the cartridge as the recurring-revenue engine of the platform.
*Company projection; not a guarantee of future performance.
Use of funds
Focused on product readiness and validation
✓
Design & engineering
Optimization of the reader, cartridge, electronics, and overall product system.
Optimization of the reader, cartridge, electronics, and overall product system.
✓
Prototype manufacturing
Build and deployment of pilot units as the program advances toward limited trials.
Build and deployment of pilot units as the program advances toward limited trials.
✓
Testing & validation
Analytical and clinical work supporting the development and regulatory strategy.
Analytical and clinical work supporting the development and regulatory strategy.
Regulatory strategy
A staged path to market
The current deck outlines an initial wellness-device strategy followed by a planned FDA clearance program involving analytical and clinical validation and a 510(k) application.
Phase 1
Wellness device
- Faster market-entry objective
- Lower initial regulatory burden
- Early revenue objective
- Build customer base
Phase 2
FDA clearance
- Breakthrough Device Designation submission referenced in company materials
- Q-Submission process
- Analytical and clinical validation studies
- Planned 510(k) application
Contact
Start an investor conversation
For investment, clinical, manufacturing, or strategic partnership discussions, contact the Diagestics team.
Email: info@diagestics.com