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
— Real-time error analysis
— Dynamic reference and appendix building
— Secure file vault with PDF auto-conversion
— Native eStar submission
— No technical implementation – get started on day 1
KEY QUOTES:
“Investing in Essenvia was an easy decision. As someone who’s spent over 20 years in the industry as well as 12 years at the FDA, I’ve seen all of the pitfalls medical device manufacturers hit when navigating the complexity and pace of regulatory changes to bring their products to market. This gap has been amplified by a new wave of digital health regulations. Essenvia is the only solution that has actually dealt with every single one of them through its highly effective, easy-to-use platform. It’s no wonder their customers have a 100% acceptance rate – nobody else in the industry can claim that.”
— Kwame Ulmer, Partner at Wavemaker360
“Enterprise 4.0 businesses are reshaping the fundamentals of automation-led value creation. Essenvia is leveraging disruptive AI technologies with novel data sets to offer a verticalized solution that supercharges the work of MedTech regulatory professionals. By providing frictionless deployments that are embedded directly into existing workflows, their solution can generate immediate gains for end customers.”
— BGV partner Yashwanth Hemaraj
“Regulatory affairs professionals are on an unsustainable path of doing more with less, faster, with a significant impact on a MedTech company’s commercial goals. The only way to keep up is to change the paradigm with a platform that is built for the modern way they work and interact with their cross-functional teams and regulatory agencies. We’ve built just that – and we’re just getting started.”
— Soumya Mahapatra, Essenvia’s Co-founder and CEO
