TMRW Life Sciences receives CE mark for ‘next-generation’ fertility cryobank

The US fertility technology company TMRW Life Sciences has received a CE mark for its automated platform for the management and storage of frozen eggs and embryos.

The platform, also known as CryoRobot Select (CRS), aims to modernise the management and storage of frozen eggs and embryos by combining hardware and software to track, monitor and store frozen eggs and embryos.

The innovation is hoped to reduce potential points of failure by 94 per cent compared to manual specimen management and storage systems and help fertility clinics reduce the risk of specimen mix-up, error, and loss.

The European designation follows clearance by the US Food and Drug Administration and will allow TMWR to commercialise the product across the European Union, United Kingdom and other CE mark-required regions.

“The CE Mark represents a significant step in making TMRW’s industry-leading technology platform commercially available in Europe and the United Kingdom, and it demonstrates that the product meets the highest levels of safety and efficacy to fertility clinics and the patients they serve,” said Louis Villalba, chief executive officer at TMRW.

“This milestone underscores our commitment to raising the standard of care in fertility care across the globe.”

Thanks to advances in assisted reproductive technology, more people are building families and storing frozen eggs and embryos than ever before.

TMRW says that growing volume of frozen specimens is overwhelming the legacy storage systems that fertility clinics have relied upon for decades.

Fertility clinics now want new solutions to upgrade, optimise, and safely scale egg and embryo management and storage, the company argues.

“In 2015, there were less than one million patients with frozen eggs and embryos worldwide. By 2025 there will be tens of millions. The manual systems relied upon for decades can’t safely keep up with the rapid scale of fertility clinics frozen specimens under management,” explained Villalba.

“TMRW’s automated platform provides fertility clinics with a long-awaited solution to safely scale.”