Cardiokeeper- Preventing cardiac Death

According to the American Heart Association, more than 356000 cases of out of hospital cardiac arrests occur annually in the USA, 90% of which are fatal with somewhat similar numbers in Europe. 

Unfortunately, no such ability still exist. The disorder, despite being one of the leading causes of death across the globe, it is still unpredictable and thus unpreventable, until my development.

A novel biomarker for sudden cardiac arrest was found. Early non invasive identification of those individuals who face high risk to encounter such future event enables to take preventive means and spare their lives. 

My past achieved results demonstrated such ability, yet with a small number of a-symptomatic individuals. If my findings are corroborated in a larger sample with double blind experimental design, population screening may become possible for the first time, domestically as well as globally.

The major problem with cardiac arrest nowadays is that the pathological processes leading to the devastating event and death are still not clear enough thus it remains unpredictable and unpreventable among asymptomatic individuals. 

The scale of the the problem involves some 10000 individuals annually in Israel, some 365000 in the USA and somewhat similar number of people in Europe.

My solution supplies novel understandings (inclusive of scientific results thus evidence based solution) as to the pathological mechanisms involved. Moreover, a biomarker which enable to early monitor functional aspects of the nervous system engaged thus making it possible to early allocate the individuals who risk to encounter the disorder in their future was found, despite being considered "healthy" at the time of diagnosis. This awareness paves the road to take precautions solely among people who are at high risk and hence to save their lives.

My development is based on finding specific brain circuits that potentially are capable to cause heart arrhythmic events and death. Moreover I was able to demonstrate that such pathological circuits may be found in asymptomatic individuals who were considered "healthy" prior to my diagnosis. 

I allocated a novel biomarker for these circuits which allowed me to further develop a non invasive biophysical test used to early monitor asymptomatic people for these circuits which are used for diagnosis of future cardiac arrest and death.

A large data set was collected and is the basis for the smart algorithm used nowadays to differentiate healthy from "at risk" tested individuals from the age of three month to eighty years.

The novel finding of a biomarker for sudden cardiac arrest along with the development of a non invasive biophysical method to early diagnosis of a- symptomatic individuals has several merits. The major gain seems to encompass the shift from idiopathic unknown devastating phenomenon claiming thousands of lives annually across the globe to a recognizable medical disorder which could be prevented.  As cardiac arrest presumably is stationed at the base of a number of disorders nowadays declared idiopathic, such a discovery may lend an understanding and rectification of those fatal disorders e.g. Sudden Infant Death Syndrome (SIDS), Sudden Unexpected Death In Epilepsy (SUDEP). 

As these syndromes strike suddenly, without warning signs they are unpredicted nor prevented and still, up to this development leaving all of us helpless and  vulnerable. The fear factor of those fatalities are marked for many. The ability to early recognize the risk as well as create a methods to mitigate the threat and possibly its consequences has the potential to help enormously for many people.   

The target populations who might benefit from such novel understanding are mainly young couples planning to raise a family and have a baby,  young children intending to fulfill their adulthood years as athletes, young adults turning forty years and everyone having Epilepsy. 

The diagnosis should be filed for reimbursement and should be open for all individuals globally disregarding any limiting factors such as financial status etc..  

The challenge: Solve seeks solutions that:

• Strengthen disease surveillance, early warning predictive systems, and other data systems to detect, slow, or halt future disease outbreaks.

My proposed development answers the need to find an early diagnostic mean (presently non existent) to future sudden cardiac arrest and novel opportunity to rectify the disorder, all of which are to be employed to asymptomatic individuals. 

Running  population screening surveys firstly supplies disease surveillance as well as an early warning predictive system to mitigate and rectify the disorder and thus align with the challenge. 

The development has been previously tested with a cohort of sixteen families of past Sudden Infant Death Syndrome babies who underwent this event in their past, along with four aborted sudden cardiac arrest patients (who were asymptomatic prior to the event) and 566 controls.

All tests were conducted in the "Gene Plus", clinic for applied neuropsychology, Rehovot,  Israel.

Limitations to the above described results are the relatively small number of patients and the constrains of the open design structure employed (clinically) contrary the preferred double blind experimental design needed (research). Because the clear cut results supporting and validating the theoretical infrastructure and the importance and potential of this method I am submitting the project at this present developmental stage. 

Untill today, there does not exist any marker to cardiac arrest which could be used to allocate people who are at high risk to encounter such disorder in asymptomatic "healthy" individuals.

Finding such biomarker as in my development, opens for the first time the possibility to early allocate those who are at risk with utilizing a novel medical biophysical test prior to symptom accumulation. Since the data collection is simple, straight forward, fast, accurate and cheap I postulate it would drastically change the market of cardiac diagnostics. Moreover, it opens novel ways to mitigate the disorder which as well, would change the therapeutic market drastically. 

Utilizing my development would make diagnosis early, more accurate, a lot faster and cheaper and would save many many lives. It could be expected to yield better diagnostic results minimizing false-positive results obtained today leading to hospitalization and expensive AED installation.  

Presently my development, still being in research, doesn't serve the general population.

Present = 0 

Following corroboration of my past achieved results yet under double blind experimental design and a FDA approval, the system will be introduced both to the cardiological professionals and institutions, the general population as well as insurance companies for reimbursement plans. 

It is expected to serve at the order of thousands in the first year of operation with an exponential growth rate  in the following years.

As my results and professional understandings are yet distributed in the "clinic Gene Plus" with my privately treated patients, for many years I practice a habit of having one patient receiving treatment pro bono in order to promote toward reduced social inequalities.

Having only a restricted scope of influence I presently open my findings to scientific as well as general consumer worlds for scrutiny which I hope could lend novel needed help to an unresolved health enigma.

Succeeding in putting a double blind corroboration experiment with some moderate financial support enabling to approach the FDA for approval would be considered a major  progress.

1. CEO and Founder, Neuropsychologist and Chief scientist, Entrepreneur, full time.

2. CFO, Hattis&Grinbaum Ass., part time.

3. Advocate, part time.

Holding a wide clinical-rehabilitation and educational neuropsychologist background along with a broad knowledge in biochemistry and biophysics graduating the Weizmann institute of science (Ph.D.), I put up the "Gene Plus" clinic for applied neuropsychology and treated many people with a broad spectrum of disorders for many years. 

Moreover, holding such clinical as well as research backgrounds and interests qualified me to serve as the Israeli representative in the Tourette International Consortium ("TIC").

The above mentioned points in my professional suitcase seem to enable me to advance this project in its academic-research phases. Reaching initial commercialization phases I look forward to partner with experts in the field to cover these aspects.

That part seems to be fairly easy to address since the foundations to these issues were thoroughly discussed among the Spiritus Rectors of the project namely,  Dr. Yaron Nofar (Deceased) and myself. 

The firm will prioritize young inexperienced skilled personals or at the other pole seniors toward retirement or retired personals. Moreover, priority will be given to women, professionals with disabilities and people coming from underrepresented communities or ethnic groups (as Arabs in our part of the world for instance).

Salary differences from bottom to top levels will be at the range of 15% only, roughly 20% of the net income will be returned and directed to research and another 3-5% of the total income will be directed to a charity fund aiming to enable everyone to use the firm's technology regardless of their economic capabilities.  

Solve can help Cardiokeeper effort to corroborate my earlier findings by connecting us to relevant stakeholders (medical partners, followed by funding partners, technology development partners, industry authorities, policymakers, regulatory agencies, and more).

Help could be particularly emphasized by

Technology Mentorship 

Impact Measurement Validation and Support 

Media Visibility and Exposure 

Grant Funding 

The first development for the project should validation of past acheived results yet in a double blind design. Backwards analysis indicates need to organize for this step patients and controls after receiving a Helsinki agreement (Institutional committee agreement) as well as funding.

If the results are corroborated then stage 2 is set and the project will start by recruiting a professional CEO, board members up to generating revenues. 

Familiarized only with the scientific arena I herewith apply to receiving MIT-solve help. 

1. Academic or medical institutions driving start ups development (MAYO clinic, Harvard, Mass. General, MIT, NIH, etc.).

2. Industrial  entities ( Medtronic PLC, Boston Scientific Corp., Abbott,   LivaNova PLC, Physio-Control, Inc. USA, Philips N.V.).