Periodic Reporting for period 1 - NEOSONICS (The first medical device for non-invasive detection and monitoring of infant meningitis)
Reporting period: 2022-12-01 to 2023-11-30
The main goal of the project is to industrialise, clinically validate, CE mark and market launch the Neosonics device. The device uses high-resolution ultrasound, coupling materials (consumable) and Artificial Intelligence algorithms to automatically count white blood cells to enable quick, easy and non-invasive screening and monitoring infections in serous fluids. With an initial focus on infants suspected with meningitis, the project has accelerated the clinical validation of the device for early detection of peritonitis in domiciliary peritoneal dialysis patients as well as of early detection and accurate quantification of uvetis and its degree of severity. By generating evidence of the wide scope of the project, the potential global societal and economic impact grows while the risks to access the market decreases.
The rapid validation of peritonitis, the outstanding results generated, the lower regulatory risks and the large market opportunity explain market launch of Neosonics be targeted towards the peritoneal dialysis market. Infant meningitis and uveitis applications following the same regulatory process will be registered and launch to market shortly after.
In addition to Neosonics device, we are working on the development and validation of an AI diagnostic and treatment support software that provides an estimate of what types of pathogens (virus vs bacteria, gram negative/positive, other pathogens subgroups) are causing the infection. This first development is being validated on infant meningitis patients and has potential to be extended to other applications within our scope. This stand alone software could minimise the use of antibiotics and, therefore of microbial resistance, caused by preventive and overtreatment treatment practices.
The rapid validation of peritonitis, the outstanding results generated, the lower regulatory risks and the large market opportunity explain market launch of Neosonics be targeted towards the peritoneal dialysis market. Infant meningitis and uveitis applications following the same regulatory process will be registered and launch to market shortly after.
In addition to Neosonics device, we are working on the development and validation of an AI diagnostic and treatment support software that provides an estimate of what types of pathogens (virus vs bacteria, gram negative/positive, other pathogens subgroups) are causing the infection. This first development is being validated on infant meningitis patients and has potential to be extended to other applications within our scope. This stand alone software could minimise the use of antibiotics and, therefore of microbial resistance, caused by preventive and overtreatment treatment practices.
Within the first reporting period, company has been working on achieving the complete device industrialisation and selecting those partners capable of device manufacture, consumables production, packaging and shipping of the solution. In addition to that, company has been also working on minimising and optimising costs linked to key components, which is expected to be completed before the end of the project.
From clinical point of view, both proof of concepts for peritonitis and uveitis were achieved showing impressive results and increasing business opportunities in these market segments. Nevertheless, the company will be still working on completing the validation of infant meningitis application, for that reason some mitigation actions have been implemented, like the recruitment of a Clinical Trial manager that will work on intensifying the sites involvement and training.
Regarding the regulatory aspects, gap analysis has been completed and ISO 13485 software is being gradually implemented for our Quality Management System. The notified body has been selected for certifying the device following the corresponding IVDR and MDR pathway depending on the application.
FDA filing for the peritonitis application will follow a 510(k) pathway, which presents a great opportunity to accelerate market access in the US. A QSub consultation will be requested to the FDA to determine aspects such as the required clinical evidence for the meningitis and uveítis applications, which will follow a De Novo pathway. As part of our commercialisation strategy, a usability study on uveitis in India will be conducted in collaboration with a globally renown eye clinic to also generate evidence of the global scalability of the business.
From clinical point of view, both proof of concepts for peritonitis and uveitis were achieved showing impressive results and increasing business opportunities in these market segments. Nevertheless, the company will be still working on completing the validation of infant meningitis application, for that reason some mitigation actions have been implemented, like the recruitment of a Clinical Trial manager that will work on intensifying the sites involvement and training.
Regarding the regulatory aspects, gap analysis has been completed and ISO 13485 software is being gradually implemented for our Quality Management System. The notified body has been selected for certifying the device following the corresponding IVDR and MDR pathway depending on the application.
FDA filing for the peritonitis application will follow a 510(k) pathway, which presents a great opportunity to accelerate market access in the US. A QSub consultation will be requested to the FDA to determine aspects such as the required clinical evidence for the meningitis and uveítis applications, which will follow a De Novo pathway. As part of our commercialisation strategy, a usability study on uveitis in India will be conducted in collaboration with a globally renown eye clinic to also generate evidence of the global scalability of the business.
The Neosonics device is a disruptive first-in-class device that presents a quicker, easier and more cost-effective solution than standard of care procedures and potential competing solutions. The reach of the device is global to democratise early detection and monitoring of infections.
Consequently, three PCT patent applications have been filed during the first year of the project that adds to an already granted PCT patent covering EU, US, Japan, China, Canada and India. More patent applications are planned for the second year of the project. In addition, the Company new brand Kriba has been registered and approved under an intern
Cost-efficacy studies have been generated on the infant meningitis application based on the clinical results obtained during clinical proof-of-concept studies. These studies are now being extended to the peritonitis and uveítis application. In all cases, international EU and US KOLs from reference hospitals are included together with mid-size and smaller hospitals where the device will also be most relevant.
During the second year of the project we will intensify conversations with distributors who have shown intent to commercialise in Spain, our launch market, as well as with potential venture capital and corporates with whom there is a strategic fit to invest and make an impact in the market.
Consequently, three PCT patent applications have been filed during the first year of the project that adds to an already granted PCT patent covering EU, US, Japan, China, Canada and India. More patent applications are planned for the second year of the project. In addition, the Company new brand Kriba has been registered and approved under an intern
Cost-efficacy studies have been generated on the infant meningitis application based on the clinical results obtained during clinical proof-of-concept studies. These studies are now being extended to the peritonitis and uveítis application. In all cases, international EU and US KOLs from reference hospitals are included together with mid-size and smaller hospitals where the device will also be most relevant.
During the second year of the project we will intensify conversations with distributors who have shown intent to commercialise in Spain, our launch market, as well as with potential venture capital and corporates with whom there is a strategic fit to invest and make an impact in the market.