Ketryx, the AI-powered compliance platform enabling life sciences companies to accelerate product development while maintaining safety standards, has closed a $39 million Series B funding round led by Transformation Capital. The round included participation from existing investors Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures, and 53 Stations, bringing the company's total funding to over $55 million. Vinay Shah, Partner and Founding Team Member at Transformation Capital, will join Ketryx's board of directors.
The Cambridge, Massachusetts and Vienna-based company addresses a critical challenge in life sciences: balancing rapid innovation with stringent compliance requirements. This need has intensified as organizations race to incorporate artificial intelligence into regulated workflows and products while maintaining safety standards required by regulatory bodies.
"I've spent the last decade at the intersection of AI and life sciences, watching it evolve from an emerging tool to a critical application for patients," said Erez Kaminski, CEO and founder of Ketryx. "It's now time to accelerate adoption and ensure AI is safe, reliable, and ready for regulated environments."
The platform automates validation, traceability, and regulatory workflows across the product development lifecycle, including FDA and EU MDR-ready documentation. Ketryx's AI-native infrastructure overlays existing tools without disrupting established workflows, enabling teams to maintain compliance while accelerating development cycles. Customer implementations have demonstrated significant operational improvements, with reported reductions in documentation time of up to 90% and release cycles accelerated by more than tenfold.
The company has achieved substantial enterprise adoption, with its platform currently deployed by three of the top five global medtech companies and several Fortune 500 organizations. AI-powered healthcare companies including DeepHealth, Heartflow, and Aignostics have also implemented the technology to streamline their compliance processes.
"In Medtech, long-term success depends on balancing innovation with the uncompromising demands of safety and compliance," said Bill Hawkins, former CEO of Medtronic and new Ketryx investor. "This balance has historically been hard to achieve. Ketryx has built the infrastructure that allows both to advance together. Their ability to deliver this level of rigor at true enterprise scale is why I'm proud to support them as they shape the future of regulated software."
"Medtech teams are leading the way in applying artificial intelligence to improve patient outcomes, creating products that meet the highest safety and regulatory standards," said Vinay Shah. "In our diligence, Fortune 500 giants and fast-growing innovators consistently praised Ketryx for proving that compliance can accelerate, rather than slow, technological progress. We believe Ketryx is defining the future of regulated infrastructure across industries and are proud to back them in their next stage of growth."
The funding will support global expansion, product roadmap acceleration, and rapid hiring across the company's Boston and Austria offices.
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