Premium Fertility's EIC Accelerator Automates Embryo Transfer

Everything in IVF is done under a microscope until the last step, when a clinician pushes a catheter through the cervix and releases the embryo by feel. That step has been manual for more than 40 years and depends on the operator's touch and experience, as the CORDIS summary of Premium Fertility's EIC project puts it, and failed implantation is the main reason cycles fail. The company, based in the technology park at Paterna near Valencia, has built the TD System: optics, microfluidics and automation that place the embryo into the endometrial tissue under live view, independent of the operator.

The EIC Accelerator selected the project at its October 2024 cut-off for blended finance, and CORDIS records a grant of €2,499,999 from July 2025 to July 2027 for development, clinical validation and regulatory work in the EU and US. The ambition stated in the project is a pregnancy rate of up to 90%, against a live birth rate the company puts at about 30% per IVF cycle today.

Macaques, then human tissue, then patients

The company's roadmap is unusually explicit about how a device like this gets built. Design and specifications from 2018 to 2020. An alpha prototype tested in macaques in the United States, where the company says the device navigated the cervix and achieved embryo implantation, leading to a second trial in five animals. Then preclinical work in 2021 and 2022 with the Hospital Clínic of Valencia, implanting animal embryos into human endometrial tissue outside the body at a controlled depth, with live observation during implantation and identification of the embryos in the tissue afterwards.

The current step is the first study in people, coordinated by Carlos Simón and Xavier Santamaria at Spanish assisted reproduction centres, approved by an ethics committee and the Spanish medicines agency. The device is an investigational product and is not approved for commercial use.

A study that cannot prove the headline number

The design matters here. The company describes the trial as prospective, open-label, non-randomised and uncontrolled, a before-and-after study in fifty patients at a single centre; the registration for NCT06744049 lists 80 participants across four sites over 123 weeks. Either way, there is no control group, which means the study can establish safety and feasibility but cannot by itself show that the TD System produces more pregnancies than a conventional catheter.

That is the gap between the trial and the claim. A 90% pregnancy rate against a 30% baseline would be the largest improvement in IVF in decades, and nothing in the current study is designed to demonstrate it. CORDIS shows no periodic report for the project.

1. Working prototypeValidatedTRL 6 per CORDIS, with primate and ex-vivo tissue testing.
2. Regulatory clearance to study in humansGrantedEthics committee and AEMPS approval for PF-TDS-XS-23-01.
3. Evidence of higher pregnancy ratesNot designed inThe study is uncontrolled and non-randomised.
4. CE marking and FDA approvalNot obtainedNamed as the next milestone in the project.

A grant and no disclosed investors

Premium Fertility has announced no venture round, and the EIC grant of €2.5 million is the only funding visible in public records. The award was blended finance and no EIC Fund equity has been announced. Its team page lists engineering, quality and regulatory managers alongside the clinical founders, which is the staffing of a company preparing a submission rather than running a laboratory. Its accounts were not obtained for this article.

Europe's fertility clinics as the first market

The project's framing is demographic: infertility affects one in six couples and more than 186 million people, populations are ageing fastest in the US and EU, and the number of patients needing assisted reproduction is expected to rise. European IVF clinics are numerous, concentrated and used to buying devices, which makes them a plausible first market for a Class IIa device. The EIC grant pays for the two things a medical device company at this stage cannot fund from revenue: the trial and the regulatory file.