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A Rapid Point-of-Care Breath Ammonia Sensor for Diagnosis of Helicobacter Pylori

Periodic Reporting for period 1 - AM-SENSE (A Rapid Point-of-Care Breath Ammonia Sensor for Diagnosis of Helicobacter Pylori)

Reporting period: 2015-10-01 to 2016-03-31

The company is developing a platform technology for the detection and diagnosis of disease, using an innovative rapid Point of Care breath sensing technology.

The core product uses new technology for ammonia sensing, specifically developed for the detection and diagnosis of Helicobacter Pylori (H. Pylori) a condition that can lead to gastric cancer from which there are 800,000 cancer deaths worldwide each year. H. Pylori is classed as a carcinogen by the World Health Organisation (WHO) and International Agency for Research on Cancer.

In North European and North American populations, a third of adults are infected with H. Pylori, whereas in south and east Europe, South America, and Asia, the prevalence of H. Pylori varies but mostly in the 50-90% range. The product is targeted for sale in Europe, North America and Asia with eventual access to a global market.

Currently, diagnostic procedures exist but require capital equipment and laboratory personnel which are deemed expensive and, in the case of endoscopy, are invasive. Clinicians have expressed a need for a clinic-based test for H. Pylori that is easy to use and delivers high sensitivity and specificity. AM-SENSE is based on an electrochemical sensor that measures increased levels of ammonia in breath. The AM-SENSE system is designed to address these unmet needs providing a rapid, easy to standard test procedure.

The conclusion from the market research gives evidence that AM-SENSE solves a pressing and global unmet need in the treatment of H. Pylori. Consequently, the business plan has been developed to support our funding requirements.
Status of Business Idea
The conclusion from the market research gives evidence that AM-SENSE solves a pressing and global unmet need in the treatment of H. Pylori. Consequently, the business plan has been developed to support our funding requirements.

Conclusion of Actions

Conclusion of Market Study and Financial Assessment
H. Pylori has been classified by International Agency for Research on Cancer (IARC) as a Group 1 carcinogen for humans and is considered to be the cause of 80% of all stomach cancers. The Working Group recommended that countries explore the introduction of population-based H. Pylori screening and treatment programmes to reduce the incidence of stomach cancer.

The experts strongly recommended that national health authorities in high-incidence countries consider conducting demonstration programmes of H. Pylori screening and eradication using designs that provide a comprehensive assessment of programme effectiveness and potential risks. Consequently, there is a clear and compelling need for an easy to use, cost effective point of care system (AM-SENSE) for the detection and diagnosis of H. Pylori.

Once this system is proven in the ‘test and treat’ market this will lead the way to expanded testing H. Pylori eradication and screening as a strategy for preventing stomach cancer. The market assessment provides strong evidence for the AM-SENSE system to be developed and launched.

Conclusion of Clinical Studies and Technical Tests
Clinical research studies conducted in key markets of the US and UK have provided evidence for AM-SENSE’s positioning in the market. A small survey of physicians in the US confirms that the low cost and high effectiveness of the system would “definitely satisfy an unmet need.” Further, the survey revealed new benefits such as saving physicians time in re-locating patients that get lost in the current diagnostic process.

Interview with expert consultants highlighted the need for and current activity in the Far East markets, in particular the large markets of Japan and China.

Equipped with this fuller understanding of the real medical challenges and opinions, Kanichi decided not to pursue the small scale trial at Manchester Royal Infirmary and instead have found the correct course of action and designed a programme with NHS National Institute of Health Research. This is a key activity in future development projects.

Conclusion of Partner Search
Kanichi worked with a number of partners during Phase1 and this partner list has been updated for future phases. For future development projects a number of partners and collaborators have been selected with the right set of skills and experience to support Kanichi in the development of AM-SENSE. Crucially, this means working with the right calibre of clinical professionals who can develop the correct pathway for generating first clinical acceptance in a world-respected centre (NICGDFD) that will also provide a dissemination pathway for first sales.
Main results of the grant :

• Better understanding of clients' needs
• Better knowledge about competitors
• Better understanding of IPR issues
• Better understanding of technical issues
• Better internal work organisation
• Better knowledge about marketing methods
• More strategic approach in change management
• More strategic approach for identifying risks and risk management
• Increased reputation/visibility of the company
• Better relation with local business support organisations

Flagship Product of the company: AM-SENSE (AM = Ammonia - SENSE = Sensor)

AM-SENSE, is a novel electrochemical sensor (electrode) based system that will measure the increased
levels of ammonia in breath following ingestion of a standard urea test meal. This innovative technology
will enable significant health care provider cost reductions, immediate diagnosis and greater usability,
thereby leading to better health outcomes via easier diagnosis and treatment of Helicobacter Pylori (H.
Pylori, which is linked to incidence of stomach cancer) and contribute to the sustainability of health care
systems in Europe and globally.

Key Benefits
The AM-SENSE device is being developed to provide a unique hand held portable system that can provide
diagnostic feedback at the point of use. This is especially relevant when used in the community setting,
bringing the benefit of an analytical laboratory into the hands of a clinician on-site in their own office/clinic.

In mature markets the system will provide user benefit and cost economies as well as presenting revenue
generation at the point of use. It is envisaged that the system will move quickly from the current acute health care providers, into the community setting through established health and social care dissemination and adoption channels.

Unique Selling Proposition
AM-SENSE offers a patent pending device that provides the following unique features:
• Unique sensor mechanism: there are no known electrochemical sensors for breath ammonia
diagnosis which encompass the required analytical range and high specificity.
• Portable: a hand-held electrochemical test is a completely new device that is manageable due to its
smaller size.
• Point of care: breath test can be done in less than 30 seconds (15 minutes including urea mealtime)
and multiple tests can be done on the spot/on-site.
• Low cost: Electrochemistry offers the advantage of low cost consumables and a low cost portable

From this grant we have been able to develop a clear business plan and overview of our product.