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Real Results from Real Innovators
See how we help startups achieve market success, secure funding, and overcome complex barriers.
Class III Neuromodulation Device
Sector:
Medical Device
Therapeutic Area:
Chronic Lower Back Pain
Challenge:
A novel neuromodulation device startup needed comprehensive FDA correspondence support, clinical trial design, and investor materials to advance their Class III device through regulatory approval and secure Series A funding.
Solution:
EMF Consulting developed an integrated regulatory and commercial strategy, aligning clinical trial protocols with both FDA requirements and investor expectations. We provided ongoing FDA correspondence support and created compelling investor materials highlighting the device's clinical differentiation.
Outcome:
The company successfully navigated pre-submission meetings with FDA, optimized their clinical trial design to reduce time and cost, and secured significant Series A funding to advance through pivotal trials.
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