In 2018, 4,000 eggs and embryos were lost at a fertility clinic in Ohio when a freezer malfunctioned, and there have been cases of embryos being transferred to the wrong mother.
These events aren't common but when they happen, it can be catastrophic — and human error is often involved.
Now, a New York-based startup says it has developed technology that will help prevent future tragedies. Joshua Abram, co-founder and co-CEO of TMRW, says the company's mission is to automate IVF storage and management practices to keep the "eggs and embryos used in IVF absolutely safe ... protecting life's most precious cells."
Flash freezing
Over the last decade vitrification — a method of rapidly freezing eggs and embryos to around -196 degrees Celsius (-320 degrees Fahrenheit) for long-term storage — has become the industry standard.
According to Abram, this "cryopreservation" method has revolutionized the potential of IVF, by giving women "greater control over their fertility years."
The problem, he says, is that the backend infrastructure didn't keep pace. Tissue storage and management practices have remained largely unchanged for decades, he says, with instances of specimens being labeled by hand, and client data being held in insufficiently secure systems.
In response TMRW, which launched commercially in February and has raised $60 million in funding, has created what it claims is the world's first automated platform for the management, identification and storage of frozen eggs and embryos.
TMRW's system embeds radio frequency identification (RFID) chips into the vials used to store eggs and embryos. This allow the samples to be identified and tracked with complete accuracy, avoiding any possible mix ups, says Abram.
The vials are stored in liquid nitrogen in a "cryo-robot" tank equipped with sensors that detect small changes, such as variations in temperature and electricity consumption, which might signal a problem. Potential mishaps are identified before the point that the frozen tissues are affected, says the company, while patient details are kept secure using military-grade data encryption.
Peace of mind
Dr. William Schoolcraft, founder and medical director of CCRM, a fertility and IVF company with 25 clinics across the United States, has been trialing TMRW's technology for the last six months, using donated specimens. He says the tests — designed to assess if tissue survival was "at least as good as our existing technology" — were successful.
The responsibility of running a fertility clinic is a bit like "flying an airplane," he says. "It's great as long as it's great, but when things go bad, it's a full-on disaster."
Schoolcraft says CCRM's current security measures, which are typical of many fertility clinics, involve visual inspections of storage tanks to look for indicators of liquid nitrogen leaks such as condensation and frost accumulation. In addition, if a tank's temperature rises significantly, threatening the stored tissues, an alarm triggers automatic phone calls to different members of staff, until someone responds.
The TMRW system appeals because it offers constant, automated monitoring, with the ability to detect potential tank failures earlier than humans can, as well as extra levels of safety when it comes to identifying and tracking of tissues, says Schoolcraft. With CCRM planning to implement the platform in all its clinics by the end of the year, he hopes he will no longer be kept "awake at night" with worry.
A clinician places a container of eggs and embryos in TMRW's cryo-robot.
TMRW is launching into an established and growing sector. Over half a million IVF babies are born every year and significant growth is anticipated. Market research company Grand View Research predicts the global market will be worth $33.9 billion by 2028.
Other companies pioneering advanced IVF techniques include Denmark-based CooperSurgical, which uses artificial intelligence to improve genetic testing of embryos, and Israeli company Embryonics, which says its AI can more accurately predict the probability of successful implantation based on time-lapse videos of developing embryos.
Abram says TMRW operates a subscription revenue model, providing their hardware to clinics without cost and charging a fee per patient per month. Patients will need to pay an extra $25 to $30 monthly — "a reasonable cost" to avoid the potential disaster of eggs or embryos being lost, says Schoolcraft.
TMRW says its technology is already up and running in two US clinics and anticipates it will be operating in 30 locations by the end of the year. The company is pursuing regulatory approval in the United Kingdom and Europe with plans to open a showroom in London later this year and expand to Europe in 2022, says Abram.
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Cryo-robots could help prevent catastrophic losses of IVF eggs and embryos - CNN
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