Regulatory Submission Management pioneer invests in new way for regulatory affairs and risk management teams to maximize speed and success of their submissions
LOS ANGELES, May 2, 2023 — Essenvia, the pioneer in regulatory submission management for the MedTech industry, today 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. The company announced the appointment of Wavemaker360 partner Kwame Ulmer and BGV Partner Yashwanth Hemaraj to Essenvia’s board of directors.
“Investing in Essenvia was an easy decision,” said Kwame Ulmer, Partner at Wavemaker360. “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.”
According to the FDA, 71% of regulatory submissions are rejected, costing manufacturers an estimated $1.8M in lost revenue for every 6-8 weeks in delay – the statistic holds true even for MedTech companies with less than 50 employees. This burden puts regulatory affairs teams squarely in a position to either accelerate or stifle the market potential of new devices.
“Enterprise 4.0 businesses are reshaping the fundamentals of automation-led value creation,” explains BGV partner Yashwanth Hemaraj. “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.”
Essenvia’s fundamentally different approach to regulatory submission management is being rapidly adopted by MedTech organizations worldwide. 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. The 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. 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.
“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,” said Soumya Mahapatra, Essenvia’s Co-founder and CEO. “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.”
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
Read more about this announcement on our blog.
To learn more, visit Essenvia.com.
About Essenvia
Essenvia is the pioneer in regulatory submission management for the MedTech industry. 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. The 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. This saves regulatory professionals dozens of painfully 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 backed by leading venture capital firms including Wavemaker360 and Benhamou Global Ventures. Learn more at www.essenvia.com.
About Wavemaker 360
Wavemaker Three-Sixty Health (Wavemaker 360) is the nation’s leading seed-stage healthcare pure-play venture fund in the U.S., focused on disruptors in the areas of health-tech, digital health, medical device, telehealth, artificial intelligence, pharma-tech, science and marketplaces. Wavemaker 360 stands apart as one of the few venture funds in the U.S. that discovers, vets and invests solely in healthcare startups at the seed funding stage. The fund connects its portfolio companies to a network of 300 Limited Partners (LPs), comprised of healthcare entities and executives in virtually every area of healthcare. Headquartered in Pasadena, CA, Wavemaker 360 is led by a cross-functional, bi-coastal team of eight visionary partners, with additional guidance from a distinguished Council of Strategic Advisors.
About BGV
BGV is a venture capital firm with deep Silicon Valley roots and an exclusive focus on global Enterprise 4.0 technology innovation. The partnership sources companies from innovation hubs around the world and deploys financial and human capital from seed stage to IPO. With offices in Palo Alto, Tel Aviv, Paris, and Mumbai, BGV has championed a cross-border venture investing model with a portfolio representing businesses in the US, Israel, Europe, and India.
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