May 15, 2023

Essenvia – a pioneer in regulatory submission management for the MedTech industry – announced it closed $4M in Pre Series A financing led by Benhamou Global Ventures and Wavemaker360 with participation from existing investors First Rays, Rebright partners, as well as Pasadena Angels. And the company announced the appointment of Wavemaker360 partner Kwame Ulmer and BGV Partner Yashwanth Hemaraj to Essenvia’s board of directors. According to the FDA, 71% of regulatory submissions are rejected, costing manufacturers an estimated $1.8 million in lost revenue for every 6-8 weeks in delay: the statistic holds true even for MedTech companies with less than 50 employees. And this burden puts regulatory affairs teams squarely in a position to either accelerate or stifle the market potential of new devices. Essenvia’s fundamentally different approach to regulatory submission management is being rapidly adopted by MedTech organizations worldwide. And unlike conventional Regulatory Information Management (RIM) tools, documents, or spreadsheets, Essenvia has zero technical implementation time and works seamlessly with a regulatory team’s existing process. This platform empowers teams to natively collaborate on 510(k), MDR and IVDR submissions directly inside of a submission, error check them, dynamically publish and re-publish them with one click, and instantly submit using the latest agency-specific technical requirements. And this saves regulatory professionals dozens of tedious hours wasted on researching information, eliminates submission errors, and radically shortens submission time to market. Essenvia has a 100% acceptance rate across hundreds of different types of complex global submissions including 510(k)s, MDR and IVDR tech files. Essenvia is pioneering the regulatory submission management process with: — Market-leading submission editing and collaboration — One-click preview and publishing