From Leeds lab to global market: Dental tech startup achieves MHRA and FDA approval

Leeds-based dental technology innovator – Mimetrik – has achieved FDA, MHRA and MDSAP approval to distribute its world first Cubit360 scanner across North America and Europe, marking a significant milestone in the company’s international expansion.

Founded in November 2020 at innovation hub Nexus, Mimetrik has progressed from conception to commercial sales of a medically regulated product in just two years, securing regulatory approval across the EU, UK and US markets.

Clinically led innovation

The company’s initial product, Cubit360, is the world’s first desktop dental scanner with full six degrees of freedom, offering the fastest scanning times and highest accuracy currently available. Designed for dental laboratories and practices, the device enables complete upper, lower and occlusion scans without cumbersome metal mounting frames.

“We’re a clinically led company solving problems that we as dentists have identified in our day-to-day practice,” says Dr Alyn Morgan, CEO (co-founder) at Mimetrik. “Our focus has always been on improving dental outcomes through intuitive technology that integrates seamlessly into existing workflows, creating efficiencies for dentists, technicians and our patients.”

The North American market entry follows positive feedback from the Canadian and American dental industry at one of the largest dental trade fairs recently held in Chicago with initial sales secured and key opinion leaders currently trialling the technology.

Professor Andy Keeling, Mimetrik Chief Technology Officer and Lead Academic Founder (co-founder), and Dr Cecilie Osnes, Chief Scientific Officer (co-founder), added: “Our years of pioneering research at Leeds have enabled us to develop technology that addresses real clinical challenges. The Cubit360 represents a genuine step forward in digital dentistry.”

Made in Yorkshire 2026 Awards – Winners

Manufactured entirely in Yorkshire, Mimetrik won the prestigious award for Biotechnology Manufacturer of the Year at the Made in Yorkshire Awards 2026.

The company’s success is underpinned by a highly experienced management team combining over 60 years of clinical experience with more than 100 years of medical device and dental product commercialisation expertise.

Rob Milnes, Mimetrik’s Chair notes: “The ability to manufacture a world-leading product here in Yorkshire, supported by the University of Leeds and organisations like Nexus, demonstrates the strength of the region’s innovation ecosystem.”

The company is now focused on scaling production and expanding its presence across international markets whilst maintaining its Yorkshire manufacturing and R&D base. With several products expected to be introduced into the market over the next two years, Mimetrik intends to change the way digital dentistry is delivered.