CRS is an automated platform that reduces potential aspects linked to failure by 94% compared to manual specimen management and storage systems, and helps fertility clinics safely scale to address the growing patient demand
TMRW CryoRobot Select receives CE mark. (Credit: PRNewswire/ TMRW Life Sciences)
US-based fertility technology company TMRW Life Sciences has received the CE mark for its next-generation automated platform, CryoRobot Select (CRS), for the safe management and storage of frozen eggs and embryos.
The CE mark approval follows the US Food and Drug Administration (FDA) approval, granted in November last year.
TMRW said that its updated CRS is an automated platform that combines unique, advanced hardware and software to safely track, monitor and store frozen eggs and embryos.
The platform reduces potential aspects linked to failure by 94% compared to manual specimen management and storage systems.
Also, it helps fertility clinics safely scale to address the growing patient demand by reducing the risk of specimen mix-up, error, and loss, said the fertility technology company.
TMRW CEO Louis Villalba said: “The CE mark represents a significant step in making TMRW’s industry-leading technology platform commercially available in Europe and the UK.
“It demonstrates that the product meets the highest levels of safety and efficacy to fertility clinics and the patients they serve.
“This milestone underscores our commitment to raising the standard of care in fertility care across the globe.”
TMRW said that the CE mark approval indicates that its new-gen CRS platform meets all the requirements of the European Medical Devices Regulation.
The company can now commercialise its product across the European Union (EU), the UK, and other regions that accept the CE mark.
Furthermore, TMRW said that the advances in assisted reproductive technology made more people store frozen eggs and embryos, while fertility clinics are still using legacy systems.
Villalba added: “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. TMRW’s automated platform provides fertility clinics with a long-awaited solution to safely scale.”