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

Projektinformationen

INTRA

ID Finanzhilfevereinbarung: 868629

DOI

10.3030/868629

Projekt abgeschlossen

EK-Unterschriftsdatum 23 April 2019

Startdatum 1 April 2019

Enddatum 30 September 2019

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

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)

Berichtszeitraum: 2019-04-01 bis 2019-09-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

- 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.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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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