Transformation Capital leads round to scale AI-native compliance infrastructure trusted by top Life Science and Fortune 500 companies

CAMBRIDGE, Mass. and VIENNA, Sept. 4, 2025 /PRNewswire/ — Ketryx, the AI-powered compliance platform helping life sciences companies ship safer products faster, today announced a $39 million Series B led by Transformation Capital, with participation from existing investors including Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures, and 53 Stations. This latest round brings the company’s total funding to over $55 million, and Vinay Shah, Partner and Founding Team Member at Transformation Capital, will join Ketryx’s board.

Ketryx is solving one of the most difficult challenges in the life sciences: the need to accelerate product innovation without compromising safety or compliance. This challenge is more urgent than ever with teams racing to incorporate AI into 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 are struggling to balance rigorous compliance requirements amid the rapidly accelerating pace of innovation. While cloud-based tools and rapidly evolving LLMs are transforming what’s possible, these regulated teams are still operating on infrastructure not designed for this velocity of change.

Ketryx is an AI-native compliance platform built to meet this challenge. It automates validation, traceability, and regulatory workflows—including FDA/EU MDR-ready documentation—across the product development lifecycle to help teams release safer products faster. Customers report up to a 90% reduction in documentation time and over 10x faster release cycles.

“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.”

The company’s platform is built for the enterprise and already used by three of the top five global medtech companies, several Fortune 500 organizations, and AI-powered companies such as DeepHealth, Heartflow, and Aignostics. With adoption accelerating, Ketryx is emerging as the key AI infrastructure layer for product development in regulated industries.

“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 continued, “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 real-time traceability and documentation, Ketryx brings zero-lag compliance to the heart of product development, empowering teams to release more products, more safely, and faster than ever before.

About Ketryx
Ketryx transforms the product lifecycle of life science teams to deliver safer products, faster. Trusted by three of the world’s top five medical device manufacturers, its AI-powered compliance platform overlays existing tools to automate documentation, create traceability, and accelerate release cycles—without disrupting existing workflows. Ketryx AI Agents cut manual work by 90 percent and close compliance gaps, elevating speed and quality across the entire product lifecycle. For more information, visit www.ketryx.com.

SOURCE Ketryx

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