Resources

IP & Regulatory Pathway

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Intellectual Property

• Patented in U.S., China, EU

• Trademarked in the U.S.

• Additional claims under review (USPTO)​

Regulatory Status​

• FDA Class II Medical Device (under pre-submission)

• Mittal Consulting guiding FDA clearance process

Roadmap

• Preparing Q-Submission for FDA review

• Clinical validation in Q1-Q2 2026