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Zenosense’s MIDS Cardiac Could Revolutionize Cardiac Troponin Testing

07/16/2018


OTC:ZENO

Zenosense, Inc. (OTC:ZENO) is a healthcare technology company located in Valencia, Spain.  The company’s main focus is a novel hand-held point-of-care (POC) cardiac diagnostic device called MIDS Cardiac.  Incorporating proprietary sensors and lab-on-a-chip technology, MIDS Cardiac is being developed to provide results as accurate (or better) than that of current lab analyzers but in only a fraction of the time.  If successfully developed as designed, MIDS Cardiac would be revolutionary in the diagnosis and triage of people suspected of having suffered a heart attack.  

MIDS Cardiac is being developed through MIDS Medical Ltd. (MML), a joint venture (JV) formed in the summer of 2016 between ZENO (which has a 40% interest) and a “third party medical detection device developer”.  MIDS Medical is located in the U.K. at Sci-Tech Daresbury, which, per the Sci-Tech website, is “internationally recognized for world-class science, innovation and enterprise.”   

MIDS Cardiac
MML has designed MIDS Cardiac to detect very low levels of key cardiac markers (troponin, CK-MB and myoglobin) and address the shortcomings of currently-available myocardial infarction blood testing.  Specifically, it is anticipated that MIDS Cardiac will provide highly sensitive and accurate results, do so in approximately three minutes and at a lower cost than traditional laboratory-based troponin testing.    

Relative to the technical aspects of MIDS Cardiac, per ZENO’s website, the “MIDS patented technology not only uses a bespoke optical sensor like other devices, but also utilizes miniaturized, highly sensitive custom built “Hall Effect” magnetic sensors embedded within a test strip as a Lab-On-Chip device. This patented technology can detect extremely low levels (nano-Tesla) of magnetic field disturbance caused by discrete test particles; In simple terms, instead of optically reading “clumps of particles” by standard methods, magnetically identifying the signature of discrete particles is expected to produce a substantially more accurate test result within minutes.”   

 

View Exhibit I - MIDS Cardiac Device


Diagnosing Heart Attacks

Approximately six to eight million Americans visit emergency departments and critical care centers each year as a result of chest pain, most of which undergo diagnosis to determine whether they have suffered a heart attack.  This has created a big market for cardiac diagnostic testing, which is estimated to be worth between $2B and $6B per year in the U.S. and more than twice that worldwide.  

In addition to electrocardiogram, standard protocol to determine whether someone has had an acute myocardial infarction (i.e. heart attack) is to test the person’s blood for the presence (and quantity) of troponin T or troponin I.  Troponin is a protein associated with heart muscle that is released in the bloodstream immediately following the onset of a heart attack.  The more severe the heart attack, the more troponin can be expected to be in the bloodstream.

The way troponin testing has been done for the last 20+ years is with a laboratory analyzer.  A patient’s blood is drawn, which is then transported to the lab where a trained technician performs the test and then results are relayed back to the emergency room or attending physician.  This process is done immediately (i.e. at presentation), and in order to rule out false negatives, must then be repeated at least once more – this confirmatory test is done three to six hours (post-presentation) for traditional troponin lab tests, and one to three hours for the new high sensitivity troponin lab tests.  

With Cardiac Testing, Time Is of The Essence…

Speedy diagnosis in order to determine the most appropriate treatment (i.e. triage) is key for people that are suspected of having suffered an acute cardiac event as, following a heart attack, there is very limited time until the heart muscle begins to expire.  When blood flow to the heart is restricted, irreversible damage to the tissue and muscles can begin in less than 30 minutes.  After six hours, most of the heart can be irreparably injured.   It is well documented that the one-hour period following the onset of a heart attack, known as the Golden Hour, is the most critical period for someone that has suffered myocardial infarction.    

Heart attack victims receiving accurate diagnosis and treatment within the golden hour are significantly more likely to suffer fewer adverse consequences than those receiving delayed treatment.  This fact is part of the basis for the joint guidelines issued by the American Heart Association and American College of Cardiology which states that blood tests for the diagnosis of myocardial infarction should be available within one hour and ideally within 30 minutes.

But that goal is often not met.  A large study (Novis DA et al. Arch Pathol Lab Med. 2004 Feb;128(2):158-64) which evaluated turnaround times of more than 7k laboratory-based cardiac troponin tests found that 90% of the tests evaluated were completed within 75 minutes and average turnaround time was about one hour.  This speaks to the significant unmet need for an accurate and much speedier testing platform such as MIDS Cardiac, which is expected to have a turnaround time of less than five minutes. 

Cardiac Marker Testing Turnaround Time Is Significantly Shorter with POC vs Central Lab…
Given the number of processes that are involved and the relatively complicated nature of laboratory tests, turnaround time can suffer.  Unlike ZENO’s (as-envisioned) MIDS Cardiac test, which is being developed with simple ease-of-use (similar to traditional blood-glucose monitors), operable at the point-of-care (e.g. in the emergency department) and requires just a finger-prick blood sample, cardiac marker laboratory tests require (relatively) large blood draws, interaction between physician and lab, and highly trained personnel to conduct the test, operate the complex equipment and interpret the results.  All of this creates abundant opportunities for delays.      

Unfortunately for many people that go to the emergency room (including those with chest pain), slow laboratory turnaround time is often the cause of delayed treatment and increased length of stay (Hawkins R. Clin Biochem Rev Vol 28 November 2007).  As testing speed can have significant influence on patient outcomes and healthcare costs, laboratory turnaround times, and ways to improve upon it, has long been a subject of great interest.  

Given the importance of the Golden Hour, much of the interest in testing turnaround times has focused on cardiac marker testing.  Caragher (et al. J Emerg Med. 2002 Jan;22(1):1-7) compared sample-to-results turnaround times of cardiac marker (troponin I, myoglobin, and CK-MB) testing done with a POC device to that done with central lab testing.  Results of the observational study, which was conducted at a single community-based care facility and included 205 patients, found POC testing turnaround times were 55% shorter (39 minutes vs 87 minutes) than those done at a central laboratory. 

Another study (Singer AJ, et al. Ann Emerg Med. 2005 Jun;45(6):587-91), conducted at the emergency department of a university hospital, compared troponin I testing done with POC versus that done with central lab on three turnaround measures; blood sample-to-results, admission-to-bed control and emergency department length of stay.  On all three of these measures POC was significantly more time-efficient.  Testing turnaround time averaged 15 minutes with POC, 82% less than the 83-minute average with clinical lab.  Admission-to-bed control averaged 2.7 hours with POC, 43% less than the 4.7-hour average with clinical lab.  And, emergency department length of stay averaged 5.2 hours with POC, 27% less than the 7.1-hour average among patients tested by central lab.

Current POC Troponin Testing is Lacking…

While POC testing is advantageous due to its faster turnaround time as compared to central lab testing, current POC troponin tests falls short in sensitivity and specificity.  In addition to lower accuracy, other drawbacks of current POC troponin tests include that they must be re-baselined to that of central lab tests and user-error is also often problematic (Montgomery J. Clin Lab News, April 2018).   

High Sensitivity Troponin Testing Is an Improvement, But Not a Panacea

In addition to slow turnaround times, false-negatives, or incorrectly diagnosing that a heart attack has not occurred when it actually had, is another drawback of lab-based troponin tests.  High sensitivity troponin tests address some, but not all, of these issues.  

The first high sensitivity troponin assay was approved by FDA for sale in the U.S. last year (high sensitivity troponin tests had been available outside the U.S. for many years prior).  These tests can detect much smaller concentrations of troponin than their traditional counterparts and, therefore, can provide an earlier diagnosis and more accurately determine whether a heart attack has actually occurred.  Higher sensitivity also allows for confirmatory testing to be performed sooner than with conventional troponin assays.  All of this means that high sensitivity assays may be able to reduce false-negatives, reduce length of stay in the emergency department and improve triage decision-making.

But despite the advantages of high sensitivity assays, they are not a panacea to the inefficiencies of laboratory-based testing and resultant delays that can seriously negatively affect patient outcomes.  Until there is a highly accurate troponin diagnostic that can be performed at the point-of-care, the unmet need will remain for a test that can provide for more-informed and earlier diagnosis of patients suspected of having suffered a heart attack.  Coupled with the large and growing market for cardiac biomarker testing, this offers an attractive opportunity for ZENO, MIDS Medical and their MIDS Cardiac device.

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