May 2, 2023, Los Angeles – Essenvia, a pioneer in the administration of regulatory submissions for the MedTech sector, revealed that it had closed a USD 4 million Pre Series A round of financing, including participation from Pasadena Angels, First Rays, and current investors Rebright Partners and Wavemaker360. The firm stated that the Wavemaker360 partner Kwame Ulmer and the BGV partner Yashwanth Hemaraj had been appointed to Essenvia’s board of directors.
The choice to invest in Essenvia was simple, according to Kwame Ulmer, Partner at Wavemaker360. “I’ve seen all of the challenges medical device manufacturers encounter while managing the complexity and velocity of regulatory changes to get their products to market. I’ve spent over 20 years in the industry and 12 years at the FDA. A recent flurry of rules about digital health has accentuated this divide. The only solution that has addressed every one of them is Essenvia, thanks to its compelling and user-friendly platform. Since no one else in the sector can make that claim, it is understandable why their clients have a 100% acceptance rate.
Even for MedTech companies with fewer than 50 employees, the FDA estimates that 71% of regulatory filings are denied, costing manufacturers an estimated $1.8M in lost revenue for every 6–8 week delay. The commercial potential of innovative products can be accelerated or suppressed due to this load, which puts regulatory affairs teams in a powerful position.
“Enterprise 4.0 businesses are reshaping the fundamentals of automation-led value creation,” says Yashwanth Hemaraj, a partner at BGV. “Essenvia is utilizing innovative data sets and disruptive AI technology to provide a vertically integrated solution that accelerates the work of MedTech regulatory experts. Their technology may deliver frictionless deployments that are seamlessly integrated into current workflows, resulting in quick gains for end users.
MedTech organizations worldwide are quickly embracing Essenvia’s fundamentally unique approach to managing regulatory submissions. Essenvia features zero technical implementation time and integrates smoothly with a regulatory team’s existing process, unlike typical Regulatory Information Management (RIM) tools, papers, or spreadsheets. The platform allows teams to natively work on 510(k), MDR, and IVDR submissions inside of submission, check them for errors, dynamically publish and re-publish them with a single click, and submit them right away utilizing the most recent agency-specific technical criteria. This eliminates submission errors and significantly cuts the time it takes for submissions to reach the market, saving regulatory experts dozens of tiresome hours lost on information discovery. 510(k)s, MDR, and IVDR tech files are just a few of the many complex global submissions for which Essenvia has a 100% acceptance rate.
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