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

Project Information

INTRA

Grant agreement ID: 868629

DOI

10.3030/868629

Project closed

EC signature date 23 April 2019

Start date 1 April 2019

End date 30 September 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

INTELLIGENZA TRANSPARENTE S. R. L.
Italy

Periodic Reporting for period 1 - INTRA (The first ultrasound-compatible cranial prosthesis enabling diagnostic and therapeutic use of ultrasound in brain pathologies)

Reporting period: 2019-04-01 to 2019-09-30

Summary of the context and overall objectives of the project

Brain treatment, and in particular brain tumor treatment, still remains a current clinical challenge. Options are nowadays still limited by the presence of the blood brain barrier, a selective vascular filter that protects the brain from dangerous substances but also limits the effectiveness of drugs, and the characteristic of the skulls, that hampers options available for other organs, such as HIFU (High Intensity Focused Ultrasounds). Intra is the first implantable prosthesis that allows ultrasounds (US) to cross the skull after a neurosurgical procedure. This innovation will enable the use of diagnostic and therapeutic ultrasounds and the safe and homogenous opening of the blood brain barrier, allowing specific treatment such as chemotherapy and immunotherapy to more effectively reach the brain.

Intra has been widely validated through in vitro and in vivo tests on animals, and a compassionate implant on one man who has been effectively followed-up through ultrasound imaging. We scouted several clinical, commercial and technical partners and defined a detailed operational plan to run a preclinical and clinical study propaedeutic to the product certification and commercialization.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

- Technical feasibility: further in vitro characterization of the prosthesis through bench tests at various ultrasound frequencies and in vivo implants on animals

- Follow up on human subject after compassionate implant

- Definition of the operation plan for running a preclinical and clinical trial

- Tuning of the cost-benefit analysis, pricing strategy and business model based on data collected through interviews

- Scouting of possible technical/clinical/commercial partners

Results of technical feasibility evaluation have been included in a scientific international publication now in press.

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)

Nowadays, after craniotomy, the skull is repaired with the native bone or by using a plastic or titanium prosthesis. Both these solutions do not enable the use of diagnostic or therapeutic ultrasounds. INTRA is the first US transparent prosthesis that allows US based diagnosis and therapies such as HIFU. Moreover, by allowing BBB opening it permits specific treatment such as chemotherapy or immunotherapy to more effectively reach the brain.

This opens a new frontier to brain tumors and neurodegenerative diseases treatment, creating new concrete possibilities for the improvement of the living conditions and the prolongment of the life expectancy of patients suffering from brain diseases.

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