Austrian-American Ketryx announced a $39 million Series B funding round led by Transformation Capital, bringing the AI-powered compliance platform company's total funding to over $55 million. The investment will accelerate the development of AI-native infrastructure designed to help life sciences companies navigate regulatory requirements while maintaining innovation velocity.
Addressing Critical Industry Challenge
Life sciences teams face mounting pressure to balance strict compliance requirements with the accelerating pace of innovation. Despite advances in cloud tools and large language models, most organizations still rely on infrastructure not built for rapid technological change, creating bottlenecks in product development cycles.
Ketryx addresses this gap by automating validation, traceability, and regulatory workflows, including FDA and EU MDR-ready documentation, across the entire product development lifecycle. The platform enables teams to release safer products faster, with customers reporting up to 90% reduction in documentation time and release cycles more than 10 times quicker.
"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."
Enterprise Adoption and Market Position
The company's platform has gained significant traction among large-scale organizations, with three of the top five global medtech companies, several Fortune 500 organizations, and AI-powered companies such as DeepHealth, Heartflow, and Aignostics already using the system. This enterprise adoption positions Ketryx as an emerging key AI infrastructure layer for product development in regulated industries.
Bill Hawkins, former CEO of Medtronic and new Ketryx investor, emphasized the platform's unique value proposition: "In medtech, long-term success depends on balancing innovation with the uncompromising demands of safety and compliance. This balance has historically been hard to achieve. Ketryx has built the infrastructure that allows both to advance together."
Investment Leadership and Strategic Direction
The Series B round included participation from existing investors Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures, and 53 Stations. As part of the investment, Vinay Shah, Partner and Founding Team Member at Transformation Capital, will join Ketryx's board.
"Medtech teams are leading the way in applying artificial intelligence to improve patient outcomes, creating products that meet the highest safety and regulatory standards," Shah said. "In our diligence, Fortune 500 giants and fast-growing innovators consistently praised Ketryx for proving that compliance can accelerate, rather than slow, technological progress."
Expansion and Growth Plans
The funding will support Ketryx's continued global expansion, acceleration of its product roadmap, and rapid hiring across both its Boston and Austria offices. The company aims to scale its AI-native compliance infrastructure to meet growing demand from regulated industries seeking to integrate artificial intelligence into their workflows and products.
Kaminski highlighted the strategic value of the partnership: "Having Transformation Capital, the pre-eminent digital health VC & growth equity firm, as our lead partner, gives us more than just capital. They understand exactly what it takes to build and scale healthcare technology companies."
By enabling real-time traceability and documentation, Ketryx integrates zero-lag compliance into product development processes, helping teams release safer products faster and at enterprise scale. The platform overlays existing tools to automate documentation, create traceability, and accelerate release cycles without disrupting established workflows.
