CSEM develops a pioneering implant to support reproductive medicine

Swiss-based start-ups Impli and Yalosys, along with the technology innovation centre CSEM, announce a significant milestone in women’s healthcare—CERES. This implantable biosensor for real-time fertility hormone monitoring is now set to undergo a transformation that will make it ready for human trials by 2025.

With Impli’s expertise, the biosensor has matured from a concept to a tangible solution that currently tracks fertility hormones in real-time. CSEM’s and Yalosys will now provide the technological development to refine and enhance the biosensor’s capabilities.

Since the birth of the first in vitro fertilisation baby in 1978, over 9 Million babies have been born using versions of Assisted Reproductive Technology (ART) like IVF. However, the journey to a successful pregnancy can be arduous, often requiring multiple (8+) cycles over several months. Currently one in six couples are facing difficulties conceiving. Women aged 20-44 are particularly affected, with 8-12% experiencing fertility problems. As infertility rates climb and in front of expensive and invasive IVF treatments, CERES emerges as a more accessible solution.

A game-changer in the field of real-time hormone monitoring

In the high-stakes realm of patient care, timely intervention is paramount. Clinicians are on a constant vigil, meticulously tracking the optimal moment to act. For women undergoing AMT this translates to frequent clinical visits—up to two to three times weekly—for vital blood tests.

These tests, while crucial, offer but a snapshot of a patient’s condition, a fleeting glimpse that may not fully capture the evolving medical narrative. The current alternatives—hormone monitoring through urine, saliva, and sweat—fall short in precision and immediacy, rendering them unsuitable for real-time clinical decision-making, and consequently they remain on the edges of clinical practice.

At this stage, there are no other monitors on the market that can capture data to the specificity and selectivity of the three hormones required for IVF. A richer, more comprehensive data stream could revolutionise the way clinicians determine both the timing and dosage for interventions, potentially transforming patient outcomes.

Impli is breaking the mould with CERES. The device taps into the subcutaneous (SC) interstitial fluid (ISF) for 30 days leveraging electrochemical sensing technology to deliver real-time hormone levels. “It’s a quantum leap from the invasive nature of blood sampling,” asserts Anna Luisa Schaffgotsch, Impli’s founder and CEO. “CERES offers a data stream with a resolution previously not capturable and remains unfazed by variances that can skew blood or urine-based readings. Moreover, being implantable, user error is minimised, while patient convenience is maximised. It’s a game-changer for hormone measurement accuracy.”

The first prototype devices have been manufactured by the consortium formed by Impli with Yalosys. Bench tests have been positively performed. Luigi Calabrese, co-founder and CEO of Yalosys, explains: “We aim to advance the current development by miniaturising the devices for the application in human studies. This will reduce the invasiveness and enable us to reach ISO compatible manufacturing steps.”

CSEM’s mastery in miniaturisation and life sciences: elevating CERES

The collaboration between Impli, Yalosys, and CSEM is dedicated to perfecting CERES. This precision device showcases CSEM’s miniaturisation prowess—a feat achieved through a blend of chemistry, surface engineering, and microprinting expertise. More specifically, CSEM’s contribution is threefold: first, the technology innovation centre screens, evaluates and compares different types of biosensing technologies for the detection of hormones; second, CSEM will set up a benchtop to mimic the human environment for the in vitro testing; and last, the Tools for Life Science team will optimise and transfer the process.

Samantha Paoletti, Head of R&BD of Life Science Technologies at CSEM, emphasises the collective expertise: “Our partnership is on track to deliver outstanding advancements within a 21-month initiative funded by Innosuisse. We are committed to meticulously enhancing CERES, elevating it to a sophisticated medical device. By integrating the latest technological innovations, we aim to achieve superior patient care and outcomes. This endeavour is a testament to the powerful synergy of CSEM’s scientific rigour and the dynamic innovation of start-ups, poised to transform the landscape of reproductive health.”

Broadening patient care

The true potential of this hormone monitoring device goes beyond the IVF market. As a regulated endocrinological device, it holds the promise of assisting various patient groups. This includes individuals living with Polycystic Ovary Syndrome (PCOS), those navigating natural pregnancy and conception, as well as those affected by miscarriage or transitioning through menopause.

Source: press release
Photo credit: ©Impli – CERES