The first ultrasound-compatible cranial prosthesis enabling diagnostic and therapeutic use of ultrasound in brain pathologies

ended

260,000 craniotomies are performed each year in Europe and USA to remove brain tumours and treat brain lesions and injuries. The implants used to replace the flap bone are currently made in plastics and titanium mesh, which are not transparent to ultrasounds (US), meaning that US cannot trespass them. Intelligenza Trasparente is an Italian start-up specialized in biomedical engineering and neurosurgical image-processing which has developed and patented INTRA, the first implantable prosthesis that allows ultrasound (US) to trespass the skull after neurosurgical procedures. INTRA allows to replace MRI scans (the standard brain imaging method) with US scans for the diagnostic follow-up of the brain pathology (in particular) and for assessing the effectiveness of adjuvant cancer therapies, e.g. chemotherapy and radiotherapy. MRI machines and scans are very expensive, and they availability is limited, forcing patients to long waiting lists. US scans have the same imaging efficacy, but are much cheaper, and the machine are available in every hospital. The result is significant savings for National Health Systems. More importantly, INTRA will enable the use of effective treatments of both cancer and neurodegenerative diseases which are currently unavailable for brain due to the skull barrier to ultrasound, like HIFU, and will unleash the full potentiality of ultrasound for opening the Blood Brain Barrier (BBB). The Phase 1 project will be key to define and accurately plan the next certification steps required to commercialize the product (EU mark for medical device and FDA clearance in US). We will also consolidate the business model, precisely assess the expected benefits for the customers, analyse the potential market, and streamline the marketing and distribution strategy.