Project description
Cranial implantable prosthesis allows ultrasounds to reach the brain
Craniotomy is a surgery in which a bone flap is removed from the skull to access the brain to treat brain lesions and injuries. The implants which replace the flap bone are made of plastics/titanium, blocking ultrasound (US). Italian Intelligenza Trasparente developed a prosthesis allowing US to penetrate the skull after neurosurgeries. It delivers diagnostic and therapeutic advantages: allowing the replacement of MRI scans with US scans for the follow-up of brain pathology, the assessment of the effectiveness of cancer chemotherapy/radiotherapy and, coupled with microbubbles, blood brain barrier temporary opening, enabling innovative pharmacological therapies for cancer and neurodegenerative disorders. The EU-funded INTRA phase 1 project will enable the next certification steps to commercialise this product and develop the business model.
Objective
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.
Fields of science
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
20900 MONZA
Italy
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.