CIC nanoGUNE launches new spin-off with technology for safer childbirth

This disruptive technology arose out of a need identified in daily clinical practice by medical professionals in Osakidetza (the Basque Health System) and who are linked to its Health Research Institute, IIS Biogipuzkoa; it led to collaboration with nanoGUNE and seeks to achieve a solution to improve the monitoring of babies' vital signs –including perinatal asphyxia or lack of oxygen– during childbirth.  

The currently most widespread method for assessing fetal well-being during childbirth is cardiotocography (CTG), which continuously records fetal heart rate and uterine contractions. This method allows stress in the fetus to be identified; but it is indirect, subject to interpretation, and not sufficient for detecting perinatal asphyxia. That is why when stress is identified in the fetus, recourse is usually made to other techniques, such as taking a blood sample from the baby; the sample has then to be analyzed to measure pH and/or lactate levels. It is obtained from the baby's scalp during childbirth, and after analysis, obstetric teams have the information they need to decide whether immediate removal needs to be carried out. The disadvantage of this second step is that it is an invasive, discontinuous procedure in which the analysis only provides information about a specific moment and, what is more, requires a total measuring time that is sometimes too long.

To meet the challenge posed by the Obstetrics and Gynecology research group of IIS Biogipuzkoa, which comprises health professionals from the OSI Donostialdea of Osakidetza and research staff from Biogipuzkoa, the nanoGUNE Nanoengineering group, led by Ikerbasque Research Professor Andreas Seifert, began working on the development of a photonic device that could detect biochemical changes, such as changes in pH or lactate, simply through contact with the skin of the fetus. The information provided, assisted by artificial intelligence, would thus help to identify possible episodes of hypoxia-ischemia in real time, thus facilitating rapid decision-making. “We developed a PhD thesis on the basis of this idea and the results obtained in preclinical studies were very encouraging,” explained Andreas Seifert; “so much so that we filed a patent application in co-ownership with the Basque health service (through the BIOEF) to protect the technology. We were on to a very early prototype capable of carrying out non-invasive, continuous monitoring in real time; it represented a tangible competitive advantage over existing methods,” added Andreas Seifert.

That prompted the start to explore the idea of setting up a new enterprise, which could continue the development of the new technology. “BIC Gipuzkoa selected the project to conduct a market and feasibility study that allowed exploitation strategies to be prioritized,” said Ainara García-Gallastegui, nanoGUNE's head of Technology Transfer. More recently, the project has been selected by Basque Tek Ventures, a new initiative led by the Basque Government and SPRI, in collaboration with the Venture Capital Society of the Basque Country, BRTA and the BICs network, aimed at supporting and accompanying the setting up of new technology-based companies (deeptech) underpinned by technologies generated by the centers belonging to the Basque Research & Technology Alliance (BRTA). “This final step has made it possible to incorporate the enterprise Optec4Life, which is being kick-started this year and which has the exclusive license to exploit this technology,” she added.

Towards a new standard of care

The new nanoGUNE spin-off now faces the challenge to develop and validate this new technology to turn it into a tool that will directly benefit medical teams, babies and mothers.

“The technology aims to recognize any type of perinatal physiological anomaly which will allow medical decision-making to be speeded up, thus minimizing the risk for both mother and baby,” said Francesc Paris-Huguet, CEO of Optec4Life. From the clinical point of view, “it will mean a change in the way of acting, in other words, a change in the current protocol or standard of care, since all this additional information will be of great help to the medical staff”, added the CEO of Optec4Life. “At the first suspicion, the medical teams will be able to analyze the relevant values through an intravaginal probe, similar to an ultrasound scanner, to get instant data without having to take a sample, and for as long as they deem necessary,” said Paris-Huguet.   

The design and prototyping tasks of the final device will be carried out in collaboration with other players in the Basque Science, Technology and Innovation Network, and internationally. The validation stage will then involve performing the first tests with the device on adults and newborns, before obtaining certification of the device for clinical use and marketing purposes.

Disruptive technology

The device to be developed by Optec4Life is underpinned by a new technology based on Raman spectroscopy, which involves combining a specific Raman probe with machine learning algorithms that take into account the overall clinical picture of any physiological variations or abnormalities. “Unlike the state of the art in which a single parameter such as pH is analyzed for decision-making purposes, this new technology offers a much broader view for as long as necessary,” said Jaione Etxebarria, head of technology development at Optec4Life. “Raman spectroscopy is a highly specific vibrational spectroscopic method that enables biochemical changes to be detected directly or indirectly. Using machine learning and taking the whole physiological picture into consideration, it is possible to achieve greater sensitivity and a stable classification of the metabolic state and a prediction of the parameters,” added Jaione Etxebarria.

Awards

The technology has received several awards: Winner of the 2020 “Pitch me up” program of the European Technology Platform Nanomedicine (ETPN) and the HealthTechTAB initiative of the same platform; winner of the BBK Venture Philanthropy and Manuel Laborde awards organized by the University of the Basque Country (UPV/EHU), each in their 2020 editions. Under the name “Intrapartum monitoring”, this project was also selected to participate in a qualitative assessment study and has recently been awarded a Txekintek-Ekintzaile grant, both with the support of BIC Gipuzkoa.