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Healthcare & Devices

Cardiovascular Consumable · Angel US$6M

2028Shanghai / Boston
Cardiovascular Consumable · Angel US$6M

By laying out the NMPA registration path and FDA 510(k) timeline in parallel, the team avoided duplicate validation and compressed an 18-month regulatory path to 11 months.

Regulatory path cut

-39%

First clinical sites

8

Valuation multiple

5.7x

The team originally planned for NMPA only. The platform's policy scan found a 70% overlap between NMPA and FDA in device classification and clinical-dataset definitions.

The platform delivered a dual-track registration timeline + clinical-site priority (by enrollment speed × data compliance) and connected the team to 3 CROs experienced in dual-track filings.

Outcome: 65% data reuse between NMPA Class III and FDA 510(k), saving $1.2M of duplicate clinical budget.

Closed a $6M angel round at a $36M pre-money valuation.

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