VALENCIA, SPAIN--(Marketwired - Sep 19, 2016) - Zenosense, Inc. (OTC PINK: ZENO) ("Zenosense", the "Company"), a healthcare technology company primarily focused on the development and commercialisation of MIDS Cardiac™, a Point of Care ("POC") hand held device for the early detection of certain cardiac event biomarkers to significantly accelerate the triage, diagnosis, treatment and disposition of patients reporting chest pain and with suspected Acute Myocardial Infarction ("AMI", "heart attack"), here provides an update.
On July 20, 2016 the Company entered into a joint venture in MIDS Medical Ltd ("MML") a UK Limited company, by way of a subscription and shareholder agreement whereby the Company was awarded equity in return for its participation and funding support for the development of a universal immunoassay detection technology, initially focusing on the development of MIDS Cardiac™. Full details of the transaction can be found on our form 8K filed on June 23, 2016 with the Securities and Exchange Commission.
Development commenced in July, 2016 and aims to deliver MIDS Cardiac™ with the following key features and benefits:
- A step change in POC sensitivity and accuracy improvement, equal or superior to high sensitivity cardiac biomarker assays performed on central laboratory analyzers
- Patient friendly, finger prick sample rather than treated venous blood draw
- An industry leading tiny 5 microliter blood sample, 3 to 400 times smaller (1 assay) than existing POC devices for cardiac marker tests
- Test times 3 to 7 times faster (1 assay) than existing POC devices
- Capable of 3 multiplexed assays (3 cardiac biomarkers in a single test strip)
- Automated operation by minimally trained personnel even in an ambulatory setting
- Considerably more cost effective for healthcare providers than existing test devices
Over the past 10 years troponins T and I (cTnT and cTnI) have emerged as the cardiac biomarkers of choice for the diagnosis of AMI. Evidence shows that high sensitivity troponin is emerging as one of the most powerful prognostic biomarkers for the assessment of cardiovascular risk in the general population. Studies have demonstrated that high sensitivity troponin ("HS cTn") assays carried out on state of the art central laboratory analyzers ("CL Analyzers") have enormous advantages in the diagnosis of AMI. These HS cTn tests are in clinical use in many parts of the world outside of the US, where they are currently awaiting approval by the FDA.
MML is applying its Magnetic Immunoassay Detection System ("MIDS technology") Intellectual Property held under license to the MIDS Cardiac™ development, intended to perform HS cTn tests (and for other cardiac biomarkers) at the POC. The patented MIDS technology is, as far as the Company is aware, the first miniaturised technology suitable for a POC device to have demonstrated the effective magnetic detection of test nanoparticles of medical assay size.
CL Analyzers and POC devices generally rely on optical technology to detect assay nanoparticles while performing immunoassays but only around 30% of assay particles can be detected in this way. CL Analyzers mitigate this issue by using additional technology such as state of the art two dimensional cameras and by running multiple tests simultaneously to conduct HS cTn sensitivity assays. However, CL Analyzers have a slow results turnaround time ("TAT") when minutes are often crucial in the diagnosis of patients showing symptoms of AMI, are very costly and are not always available. POC devices, due to their considerably smaller size, cannot effectively miniaturise CL Analyser technologies, and lack accuracy and reliability. Consequently there are no POC devices available which are capable of coming anywhere close to conducting HS cTn assays down to levels of 5ng/L troponin or below. They do, however, benefit from a much faster TAT than CL Analyzers and their complementary use for the standard detection of cardiac biomarkers is already widespread as a triage diagnostic tool, in conjunction with other tests.
The MIDS technology applies a bespoke optical sensor like other devices, but will also utilize miniaturised, highly sensitive, custom built "Hall Effect" magnetic sensors embedded within a test strip as a Lab-On-Chip device. This is capable of detecting extremely low levels (nano-Tesla) of magnetic field disturbance caused by assay test particles, allowing detection on a three dimensional level. We believe this should allow an order of magnitude of accuracy improvement at the POC and sensitivity equal to or superior to high sensitivity assays carried out on CL Analyzers, in a POC handheld reader. The goal is the delivery of a single biomarker test in less than 3 minutes and a three panel, multiplexed test in less than 8 minutes, using a single finger stick blood sample on an automated microfluidic test strip.
Device and strip development is being carried out by the MML team who have world class expertise in the application of high sensitivity Hall Effect sensors and cumulatively thirty years' experience in nano-magnetic measurement and Hall Effect sensor design, specifically in magnetic nanoparticle applications in the POC field. This in depth experience is further backed up by a number of key subcontractors. We believe that a POC handheld device which can match or exceed the accuracy of high sensitivity cardiac assays performed on CL Analyzers has the potential to be a true game-changer in this field and will also open up opportunities to apply the technology to a host of other immunoassay tests.
About Zenosense, Inc.
Zenosense Inc.'s primary focus, through our joint venture ownership in MIDS Medical Ltd., is the development of a cost-effective, hand-held Point of Care rapid cardiac diagnostic device, MIDS Cardiac™, and is also the holder of an exclusive global license agreement to develop and market effective medical devices for use in hospitals and primary healthcare settings targeting the early detection of both deadly bacteria and certain cancers in the exhaled breath of patients.
To find out more about Zenosense (OTC: ZENO), visit our website at www.zenosense.com.
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, 2015 filed on filed on May 23, 2016, 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. Respective statements concerning the development of both MIDS Cardiac™ and other devices under development have been made based on information obtained from MIDS Medical Ltd. and Zenon Biosystem, which the Company believes to be accurate, but have not been independently verified.