Periodic Reporting for period 1 - iNNOGING (Remote and Offline Ultrasound Image Analysis Platform) Reporting period: 2019-08-01 to 2020-01-31 Summary of the context and overall objectives of the project Every week around 10 million medical ultrasound examinations are performed globally. Surprisingly, despite being by far the most used imaging modality, it is the most-error prone diagnostic technology.The problem is that ultrasound is very much operator dependent: approximately 90% of ultrasound procedures are done by an operator who is not the physician who actually writes the diagnosis - he captures the “image freeze” picture or video clip of the area of interest (i.e. the scan) and delivers it to the expert physician in charge - the radiologist - who “off-line” (even some days after) analyses the scan and elaborates the diagnosis.This workflow conceals the Pandora’s box of inefficiencies and, even worse, misdiagnoses in ultrasound imaging: the radiologist is only a viewer and the static images or video clip of the case available do not allow him/her to see what he might really want to see, preventing a further investigation of the site and losing crucial data only available in real time during the patient’s scan.This leads to patients’ recalls, adoption of more expensive imaging techniques (e.g. CT or MRI) or, in the worse cases, misdiagnoses.iNNOGING's mission is to revolutionise the medical ultrasound workflow by providing a novel solution to enable every doctor to remotely see and analyse offline ultrasound scans as if he was next to the patient, transforming data taken from the ultrasound machine into a 3D representation of the scanned area that can be manipulated, analyzed and evaluated – just like an actual ultrasound examination (offline like Realtime). iNNOGING's solution changes the way the organ is presented to the doctor, who can now observe it from every angle, even those that were not presented to him in the original study. The solution includes hardware and software: the hardware is made of proprietary probe and pad, which coupled with our image processing algorithms provide radiologists with seamless data of the actual ultrasound exam.This Phase 1 project focused on studying key technological and business enabling factors for the commercialization of the system. To this scope, at the current stage of development it is crucial to validate the User Experience of the full system (hardware, software and Graphic User Interface) with world renowned radiologists mainly from Europe, who can give us feedback on the system performances as well as become first testimonials of the iNNOGING's innovation. Besides, we need to produce evidence-based data on the economic and societal benefits for the National Healthcare Systems when adopting the iNNOGING's technology with respect to current practices and workflows. Finally, we need to run an in-depth customer validation (PACS and ultrasound equipment manufacturers), to ensure full interoperability of iNNOGING with their products and to figure out the optimal sales and marketing strategy. This will allow us finalizing the business plan for the market introduction in 2021. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far The first activity was focussed on completing the system design for ensuring that the product is ready for the clinical validation phase.This meant obtaining the so-called “system design freeze”, collecting information and feedback with a direct interaction with key stakeholders as radiologists, operators and key opinion leaders from the medical device industry.This allowed having a comprehensive view of the characteristics and functionalities desired by the intended users, as well as a validation of the product in terms of regulatory requirements for CE and FDA approval.The final outcome of this task was the consolidated design of the system, with all components and software features defined and prototyped.Then, in order to validate the “customers’ willingness to pay”, we have carried out a light Health Technology Assessment, taking into consideration those countries where the procedure is mostly carried out by sonographers, analysing the error rate or the repeated exam rate and the overall direct costs for National Healthcare Services.The analysis helped having an initial quantification of the economic impact of the current inefficiencies, also giving us a framework for defining the pricing strategy.In terms of business feasibility, we have identified the countries where we do expect more market traction due to the existing procedures and innovation readiness, and we have assessed the potential market demand.Finally, we focussed on pinpointing the competitive advantage over the alternatives, first analysing the gold standard procedures and tools and then looking at competitors proposing substitutive products. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Ultrasound diagnostics continues to increase every year due to the aging global population, resulting in a demand for greater workflow and throughput. An average of 125 million ultrasound examinations are given annually in the US and additional 400 million worldwide, representing a huge market potential for the companies operating in the segment. At the same time, every radiologist worries about missing a diagnosis or giving a false-positive reading. The retrospective error rate is approximately 30%, 3%-5% of which relate to real-time errors in daily radiology practice. This shows that the standard error rate for traditional off-line interpretation is by far the greatest contributor to misdiagnoses. This is why the latest innovations in the field are mostly focused on increasing the accuracy of the diagnosis.To give an overview of the state of the art in this industry, we refer to a competitor analysis we carried out analyzing the hardware and software suppliers operating globally in the field. The result is that there is currently no solution in the market, which is focused on improving the ultrasound workflow giving radiologists a seamless replica of the examination as proposed by iNNOGING Medical.In terms of innovation recently launched by the companies operating in the field and that are potentially integrable with the iNNOGING's technology, the focus is on the following areas:- Increased mobility: Siemens (Acuson Freestyle) and Philips (CX50) have long been working on more compact and portable hand-held devices, which include wireless ultrasound probes. The focus is not only on improving the point of care at hospitals, but also the public’s access to medical imaging, especially in developing regions where it is needed. This trend reinforces iNNOGING's value proposition, as the possibility to remotely analyze the ultrasound analysis carried out by an unprofessional user in the field particularly in rural settings or developing countries, would contribute to increase the accuracy of the diagnostic and therapeutic path.- Enhancements to Traditional Ultrasound: Other recent technological trends in ultrasound include advances for contrast-enhanced imaging, volume imaging and elastography. In addition to providing real-time imaging of internal anatomy, these advances in ultrasound allow doctors to image blood perfusion and blood flow, view real-time 3-D imaging of structures, and more easily differentiate malignant tumors from the benign, among other functions.This competitive analysis ensures that the product is well positioned to overcome the competitors and paves the way to the next steps in the development roadmap, which are focussed on the clinical validation through multicentric clinical trials, certification in EU and US and commercialisation within 2022. iNNOGING process
