AI is moving from experiments to production in the places that matter most for people’s lives. That shift is exciting, and it is also unforgiving. In life sciences, you cannot trade speed for safety. You have to deliver both. The missing piece has been modern infrastructure that makes rigorous compliance feel native to how teams build.

That is why we are excited to share our investment in Ketryx’s $39 million Series B, led by Transformation Capital. Ketryx is an AI-native compliance platform that helps life sciences teams release safer products faster by automating validation, traceability, and regulatory workflows. The company’s software overlays the tools teams already use and produces FDA and EU MDR-ready documentation as they work, so compliance is not a scramble at the end of a release. According to customer reports, that approach can cut documentation time by up to 90 percent and compress release cycles by more than 10x. It is the kind of step change you feel in day-to-day engineering.

Speed and safety, no tradeoffs

Every regulated company is trying to figure out how to use AI responsibly. Large language models open new possibilities, but they also raise tough questions about provenance, performance, and auditability. Legacy systems were not designed for the pace or complexity of today’s development. Teams need an infrastructure layer that captures end-to-end context in real time and turns it into regulator-grade artifacts. Ketryx does that. It meets teams where they are, then gives them the safety rails to move faster with confidence.

That change is not unique to healthcare and life sciences. Defense, aerospace, automotive, and energy teams wrestle with the same tension between innovation and compliance. The need is the same: a live, auditable system of record that keeps up with modern software development. Ketryx’s approach is built to serve those environments as well. 

Why we invested

First, proof at scale. Ketryx is already used by three of the top five global medtech companies, several Fortune 500 organizations, and AI-driven innovators like DeepHealth, Heartflow, and Aignostics. That is a rare signal for a platform that sits in the most demanding environments. Second, product fit. Compliance is not a sidecar here. It is built into the development lifecycle, with real-time traceability and documentation that keep quality and speed tightly linked. Third, the team. Founder and CEO Erez Kaminski has spent the last decade at the intersection of AI and life sciences. The company’s leadership understands both the letter and the spirit of regulation, which shows up in the product’s design decisions. We also see clear room to expand. The architecture is industry agnostic, so any regulated software team that needs validation, traceability, and documentation can benefit from the same backbone. 

Our job at 53 Stations is to back founders building mission-critical infrastructure and to be a useful partner as they scale. For Ketryx, that means helping connect with customers across medtech and pharma, supporting hiring in Boston and Austria, and sharing what we have learned from other companies that sell into complex, regulated markets. We pay close attention to the places where friction slows real progress. Ketryx is removing that friction for an industry that cannot afford to slow down.

The road ahead

If you believe the next decade of healthcare innovation will be shaped by trustworthy AI, you have to care about the systems that make trust measurable. Ketryx is becoming the standard for how regulated teams build with AI. More products shipped, more safely, and with less overhead is good for engineers, for quality leaders, and ultimately for patients.

Congratulations to Erez and the Ketryx team on this new chapter. We’re excited to build together.