Ketryx, the AI-driven compliance platform that helps life sciences companies bring safer products to market faster, announced it has raised $39 million in a Series B funding round led by Transformation Capital. Existing investors, including Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures, and 53 Stations, also participated in the round. This latest funding increases Ketryx’s total capital raised to over $55 million, with Vinay Shah, Partner and Founding Team Member at Transformation Capital, joining Ketryx’s board.
The company addresses one of the life sciences industry’s most pressing challenges: accelerating product innovation without compromising safety or regulatory compliance. The urgency has intensified as organizations integrate AI into highly regulated workflows and products.
“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.”
Life sciences teams face mounting pressure to comply with strict regulatory standards while keeping pace with rapid innovation. While cloud-based solutions and advanced large language models (LLMs) are transforming capabilities, traditional infrastructure often struggles to keep up with the speed of change.
Ketryx’s AI-native compliance platform is purpose-built for this environment. It automates validation, traceability, and regulatory workflows including FDA and EU MDR-ready documentation throughout the product development lifecycle, enabling faster, safer product releases. Customers report up to a 90% reduction in documentation time and over 10x faster product release cycles.
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“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.”
Already adopted by three of the top five global medtech companies, several Fortune 500 organizations, and AI-driven innovators such as DeepHealth, Heartflow, and Aignostics, Ketryx is rapidly establishing itself as a foundational AI infrastructure layer for regulated product development.
“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, Partner and Founding Team Member at Transformation Capital. “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.”
Kaminski added, “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. With their backing and industry connections, we’re continuing our global expansion, accelerating our product roadmap, and hiring rapidly in both Boston and Austria.”
With its real-time traceability and documentation capabilities, Ketryx enables “zero-lag compliance” at the core of product development, empowering life sciences teams to launch more products safely and faster than ever before.
