In order to break the blood-brain barrier for drug treatment, NaviFUS Corp. announced that it has signed a licensing agreement with Bracco, the world's leading ultrasound contrast brand, to develop a microbubble product to be used in conjunction with the NaviFUS system for drug delivery to the brain, and the microbubble product will be included in the first recurrent brain tumour (rGBM) trial being prepared by NaviFUS.
Due to the blood-brain barrier in the brain, 98% of existing therapeutic drugs are unable to penetrate the brain, and most existing brain drug delivery systems or therapeutic techniques are associated with high risks of being highly invasive, non-topical and causing permanent brain damage, making successful drug treatment for brain diseases extremely difficult.
In a strategic partnership with Bracco, the world leader in ultrasound contrast, NaviFUS has signed a licensing agreement for Bracco's microbubble products to be used in conjunction with NAviFUS's system to develop drugs for delivery to the brain for the treatment of central nervous system related diseases such as brain cancer or Alzheimer's disease. Bracco will provide its microbubble products and licenses, while NaviFUS will perform clinical trials, regulatory filings and commercialisation; the two companies have also agreed on the price of supplying the microbubbles and the percentage of sales once they are available.
Bracco Group is an Italian multinational company active in the healthcare industry, producing and selling imaging products for diagnostic imaging, including X-ray, CT, MRI, ultrasound and other imaging products. Bracco has 1,800 patents, seven R&D centres and nine plants.
Microbubbles are necessary for the opening of the blood-brain barrier by ultrasound. They are created by the cavitation effect of ultrasound machinery, which causes the bubbles to oscillate, contract and expand to compress the endothelial cells of the blood vessels, resulting in the widening of the cellular space to allow the passage of drugs, especially protein drugs, antibodies, therapeutic genes or cells. The size, density and composition of the microbubbles will affect the effectiveness of the blood-brain barrier opening, therefore, a stable and reliable supply of microbubble products will be the key to the commercialisation of blood-brain barrier therapy in the future.
The partnership is a milestone in the commercialisation of the company's products. In addition to the inclusion of microbubbles in the company's product portfolio and their registration for testing, Bracco's branded microbubbles will be sold as part of the consumables for the NaviFUS system. The partnership between NaviFUS and Bracco symbolises the future of ultrasound therapy, which has been recognised by Bracco as a world leader and will contribute to the company's revenue and business model.
In this collaboration, Bracco's microbubble product will be included in the first trial for recurrent brain tumour (rGBM) being prepared by NaviFUS, and it is expected that Bracco will be responsible for the supply of this consumable for the treatment and authorise NaviFUS to sell the microbubble consumable shortly after the first marketing approval is obtained. The two parties have also agreed on a long-term complementary collaboration, including research and development, for the expansion of the international market for brain drug delivery.