Leading Fertility Company TMRW Life Sciences Receives FDA 510(k) Clearance for Next-Generation Technology to Safely Manage and Store Frozen Eggs and Embryos

TMRW's integrated software and hardware platform is the only FDA-cleared automated solution that digitally tracks, monitors, and stores frozen eggs and embryos in IVF

NEW YORK, Nov. 7, 2022 /PRNewswire/ -- TMRW Life Sciences, Inc. (TMRW), a fertility technology company modernizing and automating specimen management, announced today that its newest innovation, the CryoRobot Select (CRS), has received FDA 510(k) clearance. The CryoRobot Select marks the latest milestone in the company's continued expansion of its technology-enabled portfolio.

Advances in assisted reproductive technology allow more people to build families when they otherwise may have been unable to do so. Estimates predict that by 2100, hundreds of millions will owe their lives to IVF. Clinics are at, or approaching, inflection points when it comes to their ability to safely manage frozen eggs and embryos. Meanwhile, antiquated, manual tools prone to human error and inconsistency compromise the standard of care. With its cutting-edge in-clinic and off-site portfolio of solutions, TMRW's advanced technology offers transparency, automation and standardization to a system that is increasingly challenged to keep up with those volumes of specimens under management.

TMRW's CryoRobot Select is the only FDA-cleared automated solution that digitally tracks, monitors and manages frozen eggs and embryos used in IVF. Fully integrated with TMRW's proprietary ivfOS^Ⓡ software, which assigns a unique identifier for each specimen, the CryoRobot Select represents a new standard in the management and storage of frozen eggs and embryos, capturing inventory in real-time and reducing a majority of the manual, potential points of failure within the current cryogenic process.

TMRW's entire portfolio is supported by round-the-clock cloud-based monitoring via TMRW Overwatch^Ⓡ, which conducts thousands of health checks each day and generates proactive data analytics for all critical system components and environmental conditions. Real-time data from TMRW Overwatch^Ⓡ empowers the TMRW Operations Center with leading indicators and advanced insight to drive optimal system performance and specimen safety.

"Until recently, we didn't ask how our frozen eggs or embryos were managed, unaware of how manual and archaic the systems have been until this point. Today, patients and clinicians are demanding innovations to make the process safer, more transparent, and more accurate," said Tara Comonte, TMRW's chief executive officer. "TMRW meets the rapidly growing need by designing new integrated technologies to modernize specimen management. Innovation is core to the industry's future, and we are proud to lead the way."

Automated off-site and on-site specimen management and storage, digital tracking and monitoring, and increased safety and efficiency enable higher standards of care. TMRW's integrated software and hardware systems for clinics and patients ushers in a new era in fertility care — where cutting-edge technology and automation are not the exception but the norm.

Founded in 2018, TMRW Life Sciences, Inc. is a life sciences technology company that provides safety and transparency to modernize and transform the fertility industry. For the first time, frozen eggs and embryos can be digitally identified and tracked, safely managed with automated robotics, and remotely monitored 24/7. With proprietary RFID-enabled labware and an integrated software management solution, TMRW safeguards life's most precious cells. TMRW, named Fast Company's #1 Most Innovative Biotech company in 2022, has been adopted by leading clinics across the US and will soon be available in the UK and Europe. With significant continued growth in fertility services and the projected number of IVF births on the rise, TMRW provides a scalable solution for clinics bringing the care of frozen eggs and embryos into the 21st century. For more information, visit www.tmrw.org.

SOURCE TMRW Life Sciences

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