The clinical team at Maputo General Hospital have demonstrated an exemplary attitude and enthusiasm and their commitment to being part of groundbreaking innovations to make a positive impact on healthcare outcomes is truly commendable. Newborn Solutions is deeply grateful for their involvement in the project and their dedication to advancing the development of clinical trials as they embark on phase II of the multi-centric trial.

We were lucky to count on the expert guidance of Quique Bassat, our clinical lead and ICREA Researcher at ISGlobal, present during our trip in Mozambique.

Acute bacterial meningitis poses a significant threat to children under 5 years old, with a staggering 1.5 million cases and over 150,000 deaths reported worldwide each year. Prompt diagnosis and treatment are crucial for better prognoses, but delays in these crucial steps often lead to devastating consequences.

The gold standard diagnostic technique for meningitis is the lumbar puncture (LP), an invasive procedure not without its risks, particularly among neonates. Unfortunately, in low-income countries, the lack of resources, trained personnel, and available laboratories to test cerebrospinal fluid (CSF) hinders the widespread use of LPs.

Newborn Solutions’ disruptive device, Neosonics, offers a solution to this pressing issue. It’s a non-invasive ultrasound-based device that utilizes deep learning algorithm models to count white blood cells in the cerebrospinal fluid. This technique shows great promise in screening for meningitis in neonates and infants with an open fontanelle.

Key advantages of Neosonics include:

– High sensitivity and specificity, aiding clinicians in accurately identifying potential cases of meningitis, especially in patients with nonspecific clinical presentations.

– Reducing the need for unnecessary LPs in high-income countries, streamlining diagnostic processes, and minimizing invasive procedures for patients.

– Serving as an efficient screening tool in low-income countries, optimizing the use of scarce resources and enabling timely interventions for affected infants and children.

The successful training in Maputo is a significant step forward in advancing the deployment of non-invasive screening, diagnosis and monitoring of infant meningits and improving healthcare access and outcomes for vulnerable populations. Newborn Solutions remains committed to collaborating with clinical partners and healthcare institutions worldwide to create impactful solutions that save lives and improve patient care.

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The focus of the presentation was on the potential of non-invasively detecting an elevated number of white blood cells in the peritoneal fluid during peritoneal dialysis with Newborn Solutions’ first-in-class non-invasive white blood cell counting device, Neosonics®. The device offers an innovative application of ultrasounds and AI for the detection of serous fluid infections through white blood cell counting, by using deep learning models to classify images and provide accurate results.

Results of a deep learning model trained on in-vitro data of peritoneal dialysis bags presents exceptional accuracy in image classification, with an impressive 99.14% success rate. The primary objective of the study was to determine the device’s ability to classify images into infection and non-infection classes. The results are highly promising, with the model demonstrating a sensitivity of 100% and a specificity of 98.80%. This signifies the device’s ability to effectively distinguish between infected and non-infected states, showcasing its potential in detecting peritonitis during home-based peritoneal dialysis.

We also presented a complementary proof of concept research that explores the use of digitally generated images in conjunction with the deep learning model. By training a Generative Adversarial Network (GAN) model for data augmentation and subsequently integrating these digital images into the classification model, we aim to accelerate the device’s validation while maintaining accuracy and reliability. By generating images that closely resemble real data, we will optimize clinical study resources and potentially expedite the product’s approval process. Moreover, this approach holds promise for other applications of the Neosonics device that are being simultaneously developed, such as screening and monitoring meningitis in newborns and infants with an open fontanelle, and uveitis in adult patients.

A multi-centric clinical study now involving Bellvitge University Hospital in Barcelona, and Navarra University Hospital in Pamplona by October 2023, is currently underway to evaluate the device’s ability to detect peritonitis in home-based peritoneal dialysis with high accuracy.

In her presentation titled “Can Artificial Intelligence Surpass the Clinical Eye Today?” at the symposium, Paula Petrone – associate research professor at ISGlobal and data science advisor to the Newborn Solutions team-, highlighted our focus on ultrasound images of cerebrospinal fluid in newborn fontanelle, where AI algorithms are employed to classify and interpret intricate patterns. She defended that by leveraging deep learning algorithms, AI can effectively classify and interpret subtle patterns in these images that may go unnoticed by the human eye alone.
In addition, Paula emphasized the need for explainable machine learning, a concept also known as AI explainability or XAI. Trustworthy AI algorithms should not only make predictions but also provide explanations for those predictions, shedding light on the underlying factors and potential biases present in the data. XAI enables us to interpret and understand the reasoning behind AI’s predictions, promoting transparency and accountability in healthcare. A manuscript, cowritten by the Newborn Solutions Data Scientists, Beatrice Jobst and Francesc Carandell, and ISGlobal Data Science Team, is in preparation. The paper will detail thoroughly on the above mentioned XAI we use in the deep learning models we create and train for our application for infant meningitis. Paula concluded her presentation by invoking the famous de Saint-Exupéry‘s Little Prince quote “What is essential is invisible to the eye,” suggesting that AI has the potential to enhance our vision and provide us with invaluable insights in medical diagnostics.

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At Newborn Solutions, we take great pride in sharing our advancements and preliminary results with the remarkable community of professionals present at the ESPID conference. This annual scientific gathering brings together healthcare experts, researchers, and practitioners in the field of pediatric infectious diseases from Europe and around the world.

Sara’s presentation, titled “Meningitis Screening Based on a Novel, Non-Invasive, Transfontanellar Ultrasound Device: A Proof-of-Concept Study,” showcased our revolutionary transfontanellar ultrasound-based and AI powered device, Neosonics. The objective of the study was to validate this technique for meningitis screening, designed to identify white blood cells in cerebrospinal fluid in patients with lumbar puncture criteria.

Conducted in three prominent and high volume Spanish hospitals – University Hospital La Paz and Quirónsalud in Madrid, and Sant Joan de Déu Children’s Hospital in Barcelona – the results from the study are incredibly promising. With a sensitivity of 100% and specificity of 90%, the device has demonstrated the ability to detect all cases of meningitis and spare 90% of unnecessary lumbar punctures.

Dr. Ajanovic stated, “We are already progressing with great momentum, as we are currently conducting a phase I trial in Spain, Morocco, and Mozambique, with over 170 patients already recruited. The Neosonics device operates similarly to a billirubinometer, providing the number of white blood cells per milliliter on a small screen, revolutionizing meningitis screening.”

During the ESPID conference, Dr. Ajanovic also presented other significant results from ISGlobal projects, including clinical trials in malaria and the Febrile Illness Evaluation in a Broad Range of Endemicities (FIEBRE). FIEBRE, coordinated by the London School of Tropical Medicine and Hygiene (LSHTM), studies fever in sub-Saharan Africa and Southeast Asia to investigate the leading causes of fever in children and adults.

Newborn Solution’s presentation took place during a session focused on prognosis markers and new technologies, which attracted a full room of approximately 350 distinguished members of the medical community. The outcome was overwhelmingly positive, with lots of constructive feedback and collaboration offers that we are actively considering.

We are thrilled to have received such positive feedback from the medical community, and we look forward to sharing more results as we approach the end of 2023.

We remain committed to advancing medical technology and accelerating non-invasive screening, diagnosis and monitoring of serous fluid infections, worldwide.

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The programme is focused on enabling European start-ups to explore the Indian market, validate their offering, learn about sector-specific opportunities, regulations and best practices, and collaborate with key Indian stakeholders, through a series of courses, workshops and mentor guidance programmes on the know-hows of the Indian market.

After taking part in an introductory training programme in September 2022, that provided valuable tools and insights to increase international business strategy with a particular focus on the Indian market, we were selected in the 6th cohort (Feb. 27/2023 May 15/2023) of the “Explore and Validate” phase of the programme that consists of 10 weeks discovering and exploring the Indian market, and localizing offering to meet local needs.
Ultimately it is providing invaluable insights on how the Indian consumer/buyer thinks and operates, and on how to adapt our business model for India. During the course of the programme, the participants are given access to a trusted local network to validate our offer for the needs of this new market and work for pilots and first customers with the aim of building the pillars of an Indian market entry strategy. The programme will help us understand the stakeholders that are involved in the healthcare ecosystem and how to craft a value proposition that can actually resonate with the Indian market.

It’s a true opportunity to build with a vastly vibrant economy like India’s, to understand the specificity of needs, abilities and tools we need to expand our innovative solutions, with the aim to have global impact for a more sustainable healthcare.

About InnoCenter EU-India:
The consortium is formed by 6 complementary companies with extensive experience and high credibility in programme development in Europe and abroad. The Indian representatives are Mantra Launchspace and 91springboard and the European partners are Civitta, German Entrepreneurship GmbH, DutchBasecamp and uGlobally. The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 101004815.
More information on their website: https://euindiainnocenter.eu/

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Newborn Solutions has developed Neosonics, a non-invasive medical device that automatically counts white blood cells in the cerebrospinal fluid directly below the infant’s fontanel in a matter of seconds. The device uses high-resolution ultrasound, novel coupling materials and artificial intelligence (AI) algorithms to accurately rule out or confirm meningitis in neonates and infants quickly, easily and cost-effectively.

The safety of the Neosonics device has been validated in an international clinical trial involving three hospitals in Spain (Hospital Universitario La Paz and Hospital Univeristario Quirónsalud in Madrid and Hospital Sant Joan de Déu in Barcelona) and two centers in Mozambique (CISM: Manhiça Health Research Center and Maputo Central Hospital). In the efficacy phase, after receiving authorisation from the Moroccan Ministry of Health, the Hôpital d’Enfants in Rabat will be incorporated.
The first results of the clinical trial will be presented during the second quarter of this year. The results of the proof-of-concept test show 100% sensitivity, 90% specificity in vivo and 92% accuracy in vitro.

Our collaboration with the Hôpital d’Enfants in Rabat -which is part of the Ibn Sina University Hospital (CHU)- began in 2020 within the framework of a programme funded by the Spanish Agency for International Development Cooperation (AECID) and led by the Barcelona Institute for Global Health (ISGlobal), to develop the future implementation of the Neosonics device in the Moroccan healthcare system in its application for the screening and monitoring of childhood meningitis. Over the course of these two years, training of healthcare personnel in the use of the device has been carried out.

A historic authorisation in Morocco
“This approval represents the overcoming of a high-risk regulatory barrier and says a lot about our ability to adapt to this process and the good work carried out with our partners at ISGlobal”, says Javier Jiménez, CEO of Newborn Solutions. “It has been a year-long process, as, until now, no other company had applied for authorisation to conduct a clinical trial with a medical device in Morocco, so the authorities (Direction des Médicaments et Pharmacies of the Moroccan Ministry of Health) have established with us the requirements for the application. In fact, the most complicated requirement was to obtain a legal representative in the country who was either a distributor or manufacturer of the medical device, as this was one of the criteria to be met,” adds Rita Quesada.

Thanks to the support of the Catalonia Trade & Investment’s office in Casablanca, the identification of a distribution company in Morocco was facilitated, as well as specific knowledge of the local market.

ISGlobal and Newborn Solutions, an essential alliance
ISGlobal has been present in Morocco for more than 20 years and being able to rely on the institution’s local network has facilitated the development of the project for the Newborn Solutions team. “Obtaining the first DMP approval for the rigorous evaluation of a medical device in Morocco is a giant step forward that will undoubtedly contribute to reducing the huge mismatch between the burden of infectious diseases and the few research resources dedicated to them in the country”, says Quique Bassat, ICREA research professor at ISGlobal, who is leading the project at the institution. Bassat, Clinical Lead in the Newborn Solutions team, has played an essential role in establishing the collaboration and strengthening the current relationship with the Hôpital d’Enfants de Rabat and the Moroccan Ministry of Health. “In fact, future collaborations with the same hospital for different applications are already being considered,” adds Rita Quesada.
“This approval and the start of the clinical trial marks a historic precedent for the clinical team involved in the project and for the hospital, which gains recognition and visibility. It will undoubtedly be a reference for future research teams and will make it possible for new project opportunities and collaborations to arise” explains Sara Arias, ISGlobal researcher in Rabat, whose role has been key to the implementation of the project, both in strengthening the relationship with the clinical team, as well as with the administrative arrangements with the local authorities and the distribution company.

Newborn Solutions innovates to have a global impact on health
At the request of key opinion leaders, Newborn Solutions is working on the development of other applications of the device for non-invasive screening and monitoring of infections in serous body fluids. Specifically, clinical trials have been initiated to demonstrate its proof of concept in uveitis (with Hospital Germans Trias i Pujol, Badalona, Barcelona) and peritonitis (with Hospital Bellvitge, L’Hospitalet de LLobregat, Barcelona). Early data for these applications are very promising.

The Newborn Solutions team innovates to have a global impact on health with platform technologies and exponential scalability, both in medical devices based on ultrasound and machine learning, and in the development of predictive software based on AI algorithms in order to facilitate and democratise early detection, screening, diagnosis and treatment globally.

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Our participation as member of the programme is to incorporate those highly integrated and cost-effective MEMS technologies in order to improve our affordability for widespread use of our solutions, for instance outside the hospital and in developing countries. The research results can help to globally achieve better screening and monitoring for serous fluid infections, with a major impact in developing countries.

Growing demand for MEMS-based acoustic transducers (microphones, ultrasonic transducers) in medical and industrial devices are creating a new high demand for miniaturized low power sensors. In combination with an intelligent signal processing system, algorithms and customized packaging, these technologies will be the key to achieve performant, low power consuming, miniaturized and cost-saving systems.

This will contribute to reinforcing the Union’s strategic autonomy in electronic components and systems to support future needs of vertical industries and the economy at large. The growth of both microphone market and Ultrasound sensing modules market should be predominantly covered with acoustic sensors made in Europe. The double transition of European Union toward digital and greener society there poses a high demand for reliable and secure data. Listen2Future’s integral acoustic sensor solutions responds to these needs and is mapping the acoustic senses and perceptions in this direction.

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This new funding opportunity will allow to continue investigating our device Neosonics, a non-invasive screening and monitoring for infant meningitis as well as developing our AI-based predictive software for LMIC countries. All in all, with the aim of validating our device and software for hospital use and peripheral clinical centers.

Read more on ISGlobal’s website :
https://www.isglobal.org/en/-/el-proyecto-neosonics-busca-mejorar-el-cribado-y-el-diagnostico-precoz-de-la-meningitis-infantil

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We warmly welcome you to visit our booth in Hall 9, booth number B16.

MEDICA trade fair is one of the world most important medical events for professionals, Europe’s largest medical trade fair for medical technology, electro-medical equipment, laboratory equipment, diagnostics and pharmaceuticals.

We are really excited about taking part this year as an exhibitor and connect with the vibrant community of professionals. Having an exhibition booth of our own is a fantastic way to share our recents achievements and ongoing developments. Stop by and meet with us for a showcase of a demo of our device Neosonics.

Interested in booking an appointment? Please write to us info@newborn.solutions or contact via the official MEDICA App, we’d love to talk about the future of non-invasive and cost effective screening, monitoring and diagnostics of infections in serous fluid!

Javier Jimenez, CEO of Newborn Solutions, will  also be a speaker at the MEDICA Connected Healthcare Forum in the MEDICA DISRUPT Session : Pushing the frontiers of diagnostics, Thursday, November 17th from 13.30 to 13.40 Hall 12, Stand 12E37.The Forum promotes open innovation and business development, accelerating market access and implementation of innovations and connects health innovators, tech entrepreneurs, investors, and industry experts.

We hope to see you there are looking forward to exchange about our technology and vision for the future.

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We are thrilled to announce that we have successfully fulfilled the three rounds of the application process and have been selected for the 2022 EIC Accelerator’s first cut-off.
Here is the link to the EIC’s news article.
The European Innovation Council (EIC) is Europe’s flagship innovation programme to identify, develop and scale up breakthrough technologies and game changing innovations. The EIC has been established under the EU Horizon Europe to support innovations throughout the lifecycle from early-stage research, to proof of concept, technology transfer, and the financing and scale up of start-ups and SMEs. Concretely, the EIC Accelerator supports companies (SMEs, start-ups, spin-outs) to bring their innovations to market and scale up.

The EIC Accelerator’s selection is a challenging and highly selective process
In this cut-off, out of the over 1060 companies that presented their proposal at the first stage, over 260 companies reached the final interview stage. Out of those 260, 74 were finally selected. In other terms, only around 30% of the companies that made it to the final interview were successfully selected, and overall, around 6% of the companies made it successfully through to the three stages of the application.

Among the 74 high potential startups selected, 4 are from Spain and 3 of those are based in Catalonia. Newborn Solutions is the only Spanish company belonging to the healthcare sector in this cut-off.

A milestone as we keep on growing
Being one of those 74 companies is a true recognition of the work we have done since Newborn Solutions was founded, and an encouragement of our vision and strategy for the years ahead. We are truly grateful and honoured to be acknowledged as a European innovation leader and are certain that the EIC Accelerator’s support will be essential to reach the goals that we have as a team, and with our partners and collaborators. It is a privilege to count on the EU’s support for innovation in deep tech, and to be part of a larger vision of improving healthcare through disruptive and global impact technologies.

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Challenge
On February 10, 17 and 24, after visiting the exhibition, high school groups participated in a Challenge that we created specifically to raise awareness of the disease, particularly its consequences and the importance of vaccination. We took the opportunity to present our activity as a startup of non-invasive medical devices to detect and monitor infections in serous fluids, with a focus on infant meningitis.
The activity was problem solving in groups of 5 to 6 students. The challenge was to find innovative ideas to quantify the number of people affected by meningitis in Spain. The groups had 10 minutes to brainstorm ideas and then presented them in common, highlighting the pros and cons of each proposal.
We were very pleased with the enthusiasm of the students when proposing ideas, digital communication campaigns and in traditional channels, awareness campaigns in public spaces, contact tracking as a “census” or public forms, through collaborations with traditional media, influencers, or healthcare institutions.
While the issue of data protection related to health and medical records of citizens arose, a topic of special importance and relevance for our team, it was very interesting to be able to engage in the debate.

The faces of meningitis, a traveling exhibition of the Spanish Association against Meningitis
In October 2020 the World Health Organization (WHO) published the document “Defeating meningitis by 2030: a global road map” in which it called on all member states to commit to implement all necessary measures to defeat meningitis by 2030. These measures include curing meningitis survivors and its sequelae.
The exhibition “The Faces of Meningitis” shows how the after-effects of meningitis are lifelong. These sequelae generate many costs: personal, physical, and psychological, economic, social, etc. The reality is that meningitis has repercussions not only for those affected but also for society as a whole: the patient, healthcare personnel, family members and, in short, society as a collective.
The incidence of meningitis is low in Spain and developed countries, there are few cases annually, but the long term physical and psychological effects are permanent, for life. For this reason, the accumulation of people affected year after year has a very strong impact on society. It is for this reason that we feel it is very important to quantify how many people are affected by meningitis in Spain and to find a solution that allows us to measure it and shed a light on those affected by meningitis. The work of raising awareness combined with support for those affected and their families is one of the pillars of the tireless work carried out by the AEM. We were proud to coordinate the hosting of the exhibition at the PCB, and to bring the scientific community closer to the people behind the disease.

In the picture, from left to right: Mireia – Ambassador of the AEM.  Maria Terrades – Barcelona Science Park director. Valentine Pironneau –  Newborn Solutions Communication director. Elena Moya – Vice-president of the Spanish Association against Meningitis (AEM).

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