Enhanced Management Team
ENDRA has strengthened its management team by adding two experienced operators: Richard Jacroux as CFO and Ziad Rouag as Head of Clinical and Regulatory Affairs, both bringing significant expertise in transforming technology companies and navigating regulatory processes.
Strategic Regulatory Changes
The company is implementing a new FDA regulatory strategy, transitioning from retrospective data to a hypothesis-driven, statistically-powered prospective clinical trial, increasing the number of subjects from 20 to about 250 to achieve statistical power.
Significant Reduction in Operating Expenses
ENDRA reduced operating expenses by over $3 million, approximately a 26% reduction on an annualized basis, without impacting key deliverables, such as clinical data collection for FDA submission.
Strong Intellectual Property Portfolio
The patent portfolio now includes 81 issued patents globally, with 5 additional patents issued in Q2 2024, covering thermoacoustic technology and other applications.
Positive FDA Alignment
Positive feedback from an FDA meeting confirmed alignment on product configuration, clinical study design, and regulatory pathway, setting a clear path for the TAEUS liver device.