TMRW Life Sciences, a New York-based company specializing in fertility technology has received a CE Mark for its its CryoRobot Select (CRS) platform. This regulatory approval follows the platform’s clearance by the U.S. Food and Drug Administration (FDA) in November 2022, making it compliant for commercial use both in the United States and in CE Mark-required regions, including the EU and the UK.
The CryoRobot Select is an automated platform designed to revolutionize the management and storage of frozen eggs and embryos in IVF labs. The system employs a combination of proprietary hardware and software to track, monitor, and store these specimens. Compared to traditional manual specimen management systems, the CRS reduces potential points of failure by 94%.
The CE Mark signifies that the CryoRobot Select meets the stringent requirements set by the European Medical Devices Regulation. This allows TMRW Life Sciences to commercialize the product across CE Mark-required regions, which represent more than 22% of global in-vitro fertilization (IVF) cycles. The FDA clearance and the CE Mark collectively affirm the platform’s regulatory and clinical compliance, setting it up as a global standard for the safe management and storage of frozen eggs and embryos.
The need for automated and secure storage solutions is more urgent than ever, as advancements in assisted reproductive technology have led to a sharp increase in the number of people storing frozen eggs and embryos. Louis Villalba, the CEO of TMRW, shares: “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. TMRW’s automated platform provides fertility clinics with a long-awaited solution to safely scale.”
He continues: “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. This milestone underscores our commitment to raising the standard of care in fertility care across the globe.”
Market Impact
In the United States, TMRW Life Sciences has already contracted with over 50 commercial clinic partners, accounting for roughly 20% of the country’s annual patient cycles. The CE Mark paves the way for the company to expand its footprint in the European and UK markets, offering a state-of-the-art solution to the growing demands of fertility clinics in these regions.
Conclusion
The CE Mark approval for TMRW Life Sciences’ CryoRobot Select is a significant regulatory milestone that underlines the platform’s safety and efficacy. It is poised to set a new standard in fertility care by offering an automated and reliable system for the management and storage of frozen eggs and embryos. This comes at a time when the industry is grappling with the challenges posed by rapid increases in the volume of stored specimens, making it a timely and essential innovation.
For more information, visit the TMRW Life Sciences website.
