License Proven CASA Technology for Human Diagnostics

Field-validated in veterinary applications with 30,000+ tests. Defined regulatory pathway for human fertility diagnostics.

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Ongo Vision device analyzing a sample, connected to tablet showing live CASA microscopy

At a Glance

30,000+

Veterinary tests performed

Up to 85%

Cost reduction vs conventional laboratory CASA

11

Semen analysis devices cleared by FDA

Regulatory Pathway

EU — IVDR

Classification
Class B, Rule 3
Basis
Independent professional regulatory assessment
Requirements
Notified Body assessment, ISO 13485 QMS, clinical performance study
Status
Pathway defined, regulatory roadmap and clinical study design available

US — FDA

Classification
Class II, 510(k)
Product code
POV (Semen analysis device)
Predicates
11 cleared devices across 4 manufacturers
Portable precedent
Yes — smartphone-based and compact CASA devices cleared

Professional regulatory roadmap and clinical study design available for review.

Licensing Package

Patent Portfolio

  • US and EU patents granted through 2038
  • Coverage: 20 European countries + United States
  • Hardware platform design (optics, electronics, mechanical layout)

Hardware & Manufacturing

  • Complete design package: optics, electronics, firmware
  • Established manufacturing process with documented workflows
  • Documented supplier relationships and production workflow

Regulatory Assets

  • IVDR regulatory roadmap from independent consultancy
  • Clinical performance study design with statistical methodology and cost framework
  • Existing CE marking documentation (LVD, EMC)

Technical Support

  • Engineering support during technology transfer
  • Manufacturing guidance and quality documentation
  • Species-specific analysis algorithm documentation

Beyond Veterinary CASA

The same patented hardware platform supports applications beyond animal breeding — expanding the addressable market for a licensee.

Male Health Screening

Emerging clinical research links semen parameters to broader male health indicators. Point-of-care analysis enables screening outside the fertility clinic.

Treatment Monitoring

Pre- and post-treatment semen analysis for fertility clinics. Repeat testing at point of care instead of returning to the lab.

Research & Clinical Trials

Low-cost CASA for multi-site reproductive research. Portable form factor enables decentralized study designs.

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What happens next

1

We respond within 2 business days

2

Initial call to discuss your market and objectives

3

Detailed technical and regulatory documentation available under NDA

Know a diagnostic company that should see this? We welcome introductions.

YScope — License CASA Technology for Human Diagnostics