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A new brain-dedicated Positron Emission Tomography (PET) system to identify β-amyloid biomarker for the early diagnosis of Alzheimer’s disease and other causes of cognitive decline

Periodic Reporting for period 1 - CAREMiBRAIN (A new brain-dedicated Positron Emission Tomography (PET) system to identify β-amyloid biomarker for the early diagnosis of Alzheimer’s disease and other causes of cognitive decline)

Reporting period: 2014-10-01 to 2015-03-31

Oncovision (OCV) is a technologic start-up company specialised in molecular vision, and focused on: (1) cancer diagnosis and treatment, and (2) advanced research in neurology, oncology and cardiology. Since its creation, OCV has been working in the development of molecular imaging technologies applied to health sciences. Currently it produces and commercialises two products based on Positron Emission Tomography (PET) systems: ALBIRA (system for pre-clinical research) and MAMMI (PET mammograph).

Alzheimer’s disease is the most relevant neurodegenerative disease. Worldwide, nearly 36 million people have Alzheimer’s or a related dementia which will double every 20 years to 115.4 million in 2050 (Handels et al. 2012), and in Europe affects about 7.5 million people (75% of all dementia cases) and is expected to increase up to 10.5 million in 2030, with a reported prevalence rate of 6.2% for all those aged 60 years and over.

The overall objectives of this project if to market an innovative brain-dedicated PET system to early diagnosis of Alzheimer’s disease (AD) based on the detection of β-amyloid biomarker in the brain using two 18F-labelled tracers recently approved by FDA and EMEA for their clinical use and to validate the clinical performance of this new diagnostic device. This new brain-dedicated PET system, targeted to Mental Disorder Units and Nuclear Medicine Units of hospitals in Europe, USA and Japan; is unique in the market and offers several advantages compared to the whole-body PET systems such as higher resolution, three times higher sensibility, a competitive price (up to three times lower), needs smaller hospital facilities, lower radiotracer dose to the patient that leads to a lesser cost to the healthcare system. Due to this improved characteristics, the new brain-dedicated PET system will help to allow an early detection of Alzheimer’s disease and other causes of cognitive decline and to use this business opportunity to ensure profitability and growth of ONCOVISION.

The expected outcomes of the business proposal are the clinical validation and commercialisation of a new brain-dedicated PET system that will push the resolution to the physical limit (sub-millimetrical scale: around 0.7 mm, voxel size: 0.3 mm3) while increasing its sensitivity three times with respect to current whole-body PET systems; and offering a competitive price, three times lower than other whole-body PET systems developed by large manufacturers.
In order to reach the clinical validation and a full commercialisation of the new brain-dedicated PET, the following specific objectives have been accomplished in the feasibility study:

Viability of the clinical performance validation:

• The brain-dedicated PET has been fully characterised through an extensive set of measurments of the physical performance features
• A preclinical validation has already been accomplished
• A clinical investigation in six hospitals in Europe and USA has been planned
• Different key technical milestones have been achieved, improving the characteristics of the equipment

Technical risk analysis of the product:

• A technical risk analysis of the brain-dedicated PET system has been performed in order to obtain the CE and FDA 510(k) marks to be able to commercialise the product in the European and US markets and to assure its adequacy to the needs of the experts on mental disorders, Alzheimer’s disease units and Nuclear Medicine units.

Market characterisation and description:

• We have collected and analyzed information about main indicators and characteristics of the molecular imaging devices market, as well as special features of geographical areas of interest (i.e. Europe, USA, and Japan).
• We have studied the of different segments of users/customers involved in the CAREMiBRAIN business.

Marketing and commercialisation strategy:

• Analysis of the first commercialisation targets
• Identification of other key strategic partners
• Study of competing solutions
• Design of the commercialization strategy
• Detail of the different communication measures
• Definition of an IPR strategy

Detailed operational plan:

• Analysis of all the product costs, production facilities, human resources and other investments needed to produce and commercialize CAREMIBRAIN

Financial plan

• Analysis of the potential sales and different financial ratios
The expected outcomes of this project are the clinical validation and commercialisation of a new PET system that will push the resolution to the physical limit (sub-millimetrical scale: around 0.7 mm, voxel size: 0.3 mm3) while increasing its sensitivity three times with respect to current whole-body PET systems; and offering a competitive price, three times lower than other whole-body PET systems developed by large manufacturers as General Electric, Siemens and Philips. This system could be used in different clinical situations as brain and paediatric imaging. Therefore, this brain-dedicated PET needs smaller and, for that reason, cheaper hospital facilities to perform its diagnostic function. Other advantage related to its high sensitivity is the need of a lower radiotracer dose that has an impact on reduced tracer cost, less radiation to the patient, and the possibility of an early AD diagnosis.
Mock-up of CAREMiBRAIN device
Amyloid deposits in mouse brain detected with CAREMiBRAIN device before and after amyloid-β cleaning