SOURCE: Zenosense, Inc

October 21, 2014 09:32 ET

Zenosense, Inc.; Protocol Design -- Lung Cancer Detection Tests

VALENCIA, SPAIN--(Marketwired - Oct 21, 2014) - Zenosense, Inc. (OTCQB: ZENO) ("Zenosense", the "Company"), a healthcare technology company primarily focused on developing and marketing devices to detect the MRSA "Super-Bug" and to detect signs of lung cancer in exhaled breath, is pleased to announce the completion of protocol design of a significant lung cancer detection trial to be carried out in a clinical setting.

The trial, designed in conjunction with external cancer and pneumonologist specialists, is planned for the near future, subject to agreements with a suitable co-operating hospital(s).

The trial is designed to test the ability of a prototype Zenosense lung cancer detector ("Device"), which is currently under development, to detect lung cancer. Clinical tests will examine a 400 subject population split into four groups to cover smokers, non-smokers, and those suffering from lung cancer and Chronic Obstructive Pulmonary Disease.

Numerous scientific studies indicate that lung cancer causes alterations in cellular metabolism, due to oxidative stress, resulting in the production of a number of distinctive Volatile Organic Compounds in exhaled breath. The aim of the trial is to focus on the identification of these known lung cancer biomarkers and to determine the efficacy of the Device to detect these biomarkers, compared to conventional laboratory analysis.

Key protocol elements:

Multiple breath samples will be taken from each subject using an industry standard breath sampler. They will be captured, stored and analysed to a strict protocol taking into account ambient air samples. These samples will be analysed in parallel in two ways;

  • by conventional laboratory methods including Gas Chromatography ("GC") and Mass Spectrometry ("MS"); and
  • by two prototype Devices of the same design, to ensure reproducibility of Device results.

GC will be used to identify the biomarkers and a combination of GC, and MS used to determine the VOC biomarker signature to be detected in parallel by the Device. The trial aims to determine;

  • the correlation between biomarker identification and the incidence of lung cancer at its different stages, particularly early stages; and
  • the correlation between the accuracy of conventional laboratory biomarker detection and Device detection of the same biomarkers, including reproducibility.

A preliminary commercial target for Zenosense, based on the prospective trial results, will be to establish whether the Device can meet or exceed the accuracy of low dose CT scanning to detect early stage lung cancer, the only realistic method for mass screening and which is relatively expensive and problematic compared to the proposed Device.

The Company continues to believe that a cost-effective lung cancer detector that meets or exceeds the accuracy of low dose CT scanning will have wide appeal and be in significant demand.

About Zenosense, Inc.

Zenosense, Inc. is a detection device development company based in Valencia, Spain. Its mission is to develop effective medical devices targeting the early detection of both deadly bacteria and certain cancers in the exhaled breath of patients and market and sell these products to hospitals and primary healthcare facilities. Two devices are currently under development; a device intended to detect the Methicillin-resistant Staphylococcus aureus "Super-Bug" (MRSA); and a device intended to detect Lung Cancer. Using a common Electronic Nose technology platform, the devices analyze Volatile Organic Compounds (VOCs) which are present in the exhaled breath of patients, scanning for certain biomarkers which can indicate the presence of infection/illness.

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Forward-Looking Statements

Statements in this news release that are not statements of historical fact are forward-looking statements, which are subject to certain risks and uncertainties. Forward-looking statements can often be identified by words such as "expects," "intends," "plans," "may," "could," "should," "anticipates," "likely," "believes" and words of similar import. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined and assumptions of management. Actual results may differ materially from those expressed or implied by forward-looking statements due to a variety of factors that may or may not be foreseeable or within the reasonable control of the Company. Readers are cautioned not to place undue reliance on such forward-looking statements. Additional information on risks and other factors that may affect the business and financial results of the Company can be found in filings of the Company with the U.S. Securities and Exchange Commission, including without limitation the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2013 filed on filed on March 26, 2014, and in Company reports filed subsequently thereto. Except as otherwise required by law, the Company disclaims any obligations or undertaking to publicly release any updates or revisions to any forward-looking statement contained in this news release to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. Statements concerning the development of both the MRSA device and the lung cancer device have been made based on information obtained from Zenon Biosystem, which the Company believes to be accurate, but have not been independently verified.

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