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

Información del proyecto

INTRA

Identificador del acuerdo de subvención: 868629

DOI

10.3030/868629

Proyecto cerrado

Fecha de la firma de la CE 23 Abril 2019

Fecha de inicio 1 Abril 2019

Fecha de finalización 30 Septiembre 2019

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

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)

Período documentado: 2019-04-01 hasta 2019-09-30

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

- 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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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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