Overture Life’s DaVitri automated in vitro fertilisation (IVF) system has gained a CE mark in Europe, as use of the fertility treatment modality increases in reproductive healthcare.
DaVitri is a benchtop system designed to automate the process of vitrification, otherwise known as fast-freezing liquids into a glasslike state, for human mature oocytes in fertility clinics. By automating one of the most technically demanding steps in embryology, DaVitri aims to reduce operator variability to achieve more consistent embryo formation outcomes.
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Automation with DaVitri is achieved through a combination of microfluidics, robotics and cloud connectivity. The approach replaces the need for embryologists to conduct manual processes such as timing exposures and the pipetting of cryoprotectants (substances used to protect biological materials from damage during freezing and thawing) in lab settings.
Overture’s receipt of a CE mark sets the stage for the Spain-headquartered company to commercialise DaVitri in continental Europe and other countries such as the UK that accept CE marked products in an effort to reduce IVF bottlenecks.
Overture is currently also recruiting for a non-inferiority study of DaVitri in the US. The study will compare DaVitri to standard manual vitrification processes and use embryo’ success rate in developing to the blastocyst stage as the primary endpoint, according to an entry on Clinicaltrials.gov (NCT06853418).
A blastocyst is a five- to six-day-old embryo with 80-100 cells that have begun to separate into distinct layers. This developmental stage is often a goal for IVF because it indicates an embryo’s viability.
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By GlobalDataTechnological improvements in assisted reproductive therapies (ART) and factors such as growing infertility rates and a preference for delayed parenthood in Europe, are driving the uptake of ART’s such as IVF.
Data presented by the European Society of Human Reproduction and Embryology (ESHRE) in 2024, indicates that IVF uptake in Europe is on the rise. The consortium analysed ART treatment cycle data, including IVF, at 1,382 clinics across 37 European countries. It found that combined ART treatment cycles in Europe reached around 1.1 million patients in 2021, reflecting a 20% rise over 2020.
Overture’s CEO Hans Gangeskar called the company’s receipt of a CE mark a signal that Europe understands the “personal and demographic urgency” of reproductive freedom.
“The EU has shown its willingness to make long-term public investments in fertility infrastructure and support new technologies, and we hope to see other jurisdictions follow the same path,” the CEO continued.
Alongside automation, artificial intelligence (AI) is also serving to improve the effectiveness of IVF. Companies such as Alife Health are using the technology to assist embryologists in selecting the most viable embryos for transfer during IVF procedures.
According to GlobalData analysis, AI in healthcare is forecast to reach a $19bn valuation by 2027.
Overture’s R&D efforts are also centred on using AI in its broader ecosystem to improve IVF. Earlier this month, the company received a €20m ($23m) loan from the European Investment Bank (EIB) that will be used towards advancing AI’s use in Overture’s IVF ecosystem.
