TMRW Life Sciences, a fertility technology company automating the IVF lab,  announced that it has received a CE Mark for the CryoRobot Select (CRS). The European designation follows clearance by the U.S. Food and Drug Administration, and the two regulatory achievements demonstrate that TMRW's automated platform for the safe management and storage of frozen eggs and embryos is now the global standard.

The CRS modernizes a critical aspect of the IVF lab – the management and storage of frozen eggs and embryos. The CRS is an automated platform that combines proprietary, state-of-the-art hardware and software to safely track, monitor and store frozen eggs and embryos. The TMRW platform reduces potential points of failure by 94% compared to manual specimen management and storage systems, and it helps fertility clinics safely scale to meet growing patient demand by helping reduce the risk of specimen mix-up, error, and loss.

The CE Mark designation demonstrates that TMRW's CRS platform meets all of the applicable requirements established by European Medical Devices Regulation, allowing TMRW to commercialize the product across the European Union, United Kingdom and other CE Mark-required regions, which represent more than 22% of global IVF cycles. To earn the certification, the CRS was developed with state-of-the-art standards and met rigorous clinical safety and efficacy requirements established by European Medical Device Regulations. 

The CRS earned FDA clearance in November 2022, a first in the industry. Both further highlight TMRW's strong regulatory and clinical track record.

"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. That growing volume of frozen specimens is overwhelming the legacy storage systems that fertility clinics have relied upon for decades. Fertility clinics want new solutions to upgrade, optimize, and safely scale egg and embryo management and storage. And patients deserve the highest levels of safety, security, and transparency for their precious cells. 

"In 2015, there were less than 1 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," said Villalba. "TMRW's automated platform provides fertility clinics with a long-awaited solution to safely scale."

TMRW is meeting those needs for clinics and patients alike with more than 50 contracted commercial clinic partners in the United States that collectively account for ~20% of national annual patient cycles. Now with its CE Mark designation, TMRW is poised to make a significant impact in the United Kingdom and Europe as well.