The story behind the product
It may look like some bright morning, a person’s heart simply fails without any advance warning. In reality, things happen quite differently: any cardiac failure is preceded by many minor events and special signs, and if these are reported in time – it is possible to save millions of lives each year.
The problem is that at present, these signs can be identified only partially: hospitals and clinics offer intermittent measurement, using cumbersome, invasive and heavy medical equipment – which offers only limited monitoring for a limited period of time. But cardiac arrest is not a momentary occurrence, but rather the peak of a continuous process, which includes a rise in pulse together with fibrillation. Identifying these symptoms at the onset of the event could prevent its tragic end.
The world of medicine is at present witnessing a breakthrough: after many years of development, CardiacSense presents a smartwatch that can monitor cardiac activity continuously and identify arrhythmias, which may lead to cardiac arrest or stroke, and even perform simple and continuous blood pressure monitoring – without any additional devices.
The smartwatch is based on unique optical and mechanical technologies, supported by smart sensors, protected with the company’s registered patents, including a unique, world-first sensor that measures blood pressure with no need for an inflatable cuff. It offers the level of accuracy of an EKG device and allows continuous and convenient measurement for months and years, under all conditions – whether static or mobile.
The potential is huge: any person diagnosed with a heart condition suffers from uncertainty and the constant, daily fear of the moment when everything might break down. For such people, the knowledge that you are monitored by the right medical staff, who will recognize whenever something out of the ordinary takes place, in real time, and even find you to administer first aid to save your life – this knowledge in invaluable, and cannot be measured in money.
This smartwatch makes the company one of its kind, anywhere in the world, in a market that comprises 20 million people in the USA alone. In terms of money, this is a potential market of approx. 3 billion USD per year in the USA, and approx. 10 billion USD globally. Do you wish to invest in the future of humanity? The solution is right here before you.
The Actual Product
This is a revolutionary smartwatch that continuously measures and monitors cardiac activity, and can recognize arrythmia, which may lead to cardiac arrest, stroke or other life-threatening events.
The smartwatch performs EKG and PPG tests, which can point to arrythmia. The data is measured continuously and sent to a medical center for 24/7 monitoring. In its advanced version, the smartwatch will also feature a GPS component, which, if necessary, will help the medical staff reach the exact location to administer lifesaving aid. In addition, the smartwatch measures blood pressure when worn on the wrist, with no need for an inflatable cuff.
The smartwatch features a level of accuracy comparable to EKG devices and inflatable-cuff blood pressure devices, and performs monitoring continuously and conveniently – for months and years.
- High-quality, continuous monitoring, on a level of accuracy on par with hospital equipment, wherever the user may be.
- The device allows treatment of a cardiac event at its onset, and helps prevent cardiac arrest or stroke.
- Continuous measurement, unlimited in time (unlike the currently available alternatives).
- Convenient and accessible, for any person, at any place – requires no other device or component except for the smartwatch itself.
- Noninvasive, and includes a unique EKG sensor for the purpose of double identification of arrythmia.
Market and potential
Markets: The solution offered by the smartwatch answers the needs of several markets, with a total value of billions of New Israeli Shekels
- Continuous long-term monitoring (at present performed only by invasive devices) – This market is valued at approximately USD 1 billion.
- Medium-term monitoring (at present performed by Holter monitors and adhesive patches) – This market is valued at approx. USD 1 billion per year.
- Blood-pressure monitors (at present, performed in a cumbersome and inconvenient manner using an inflatable cuff) – This market is valued at approximately USD 3 billion per year.
Target audience: Any person at a high risk of atrial fibrillation (including people who suffered a cardiovascular event, or who are over the age of 70 and suffer from diabetes or high blood pressure), or any person already diagnosed with this condition:
- USA market size: USD 3 billion per year (over 20 million people).
- Global market size: USD 10 billion.
The current invasive solution for long-term monitoring is at present provided to only approx. 100 thousand people per year – approx. 3% of the potential market – at annual cost of approx. USD 1 billion. This field begs for a more effective and easily implementable solution.
Alternatives and competitors
None. CardiacSense is the only company in the world that can identify arterial fibrillation on the level required by the FDA.
Other companies have tried and failed at this, the largest one being Apple that failed to distinguish quality data from false reports. The relative advantage of the smartwatch compared to the competition lies in its ability to distinguish real data out of all of the received data, especially when the monitored person is in movement. This capability is enabled thanks to unique optical and mechanical technologies, that neutralize the effects of movement on the sensors’ measurements. These technologies are all protected with the company’s registered patents.
As an innovator in this field – the technologies and precision offered by CardiacSense will set the standard in this field. Insofar as any competitors arise in the future – the FDA will require them to meet the standard set by the company, when they do not possess the unique patented technologies developed by the company. The forecast is exclusivity in this field, for many years to come.
How can we prevent cardiac arrest?
In half of the cases, a cardiac arrest begins with a sharp rise in pulse, for example when the pulse soars from 60-70 beats per minute to 150-160 beats per minute. The smartwatch identifies this change and issues an alert – and help is called at this moment. Up to 15 minutes will pass before the stage where a cardiac arrest ensues, and in this time, the pulse will rise to up to 300 beats per minute – and a few seconds afterwards, the patient will lose consciousness.
Cardiac arrests are responsible for one quarter of deaths in the world – over 90% occur at home, during sleep, when the patient is not in a state of awareness to allow him to call for help. Since the patient falls unconscious immediately, it is possible to save his life only by immediately using a defibrillator. The only way to save him is to identify the expected heart attack – and alert a medical professional.
At present, it is impossible to identify cardiac arrest at home. CardiacSense is the first and only company to conduct a clinical trial, at the Tel Aviv Sourasky Medical Center (Ichilov), which proved identification of cardiac arrest within a few seconds. This quick identification enables calling for help and administration of lifesaving aid.
What is arterial fibrillation and how is it treated?
Arterial fibrillation is the most common form of arrythmia. It causes large blood clots, and therefore failure to identify it in time and administer medication may lead to a fatal stroke, which in most cases leads to a severe disability or death. The cost of treatment during and after the stroke is huge (approx. USD 12 billion per year in the USA).
Patients suffering from arterial fibrillation, or people at risk of arterial fibrillation, must be monitored their entire life. This monitoring is required in order to identify the problem and save the patient’s life and adjust medication. Since at present it is impossible to perform continuous, long-term monitoring, the only solution for any person diagnosed with ventricular [arterial] fibrillation is permanent treatment with powerful blood thinners, which in themselves often cause internal hemorrhage and premature death.
In many cases, the patients do not feel the fibrillation, or the fibrillation appears with interruptions of months and even years. Diagnosing such patient requires continuous monitoring over months and years, when the only solution currently available is invasive monitoring – implanting a sensor in the patient’s chest, at a cost of approximately USD 8,000.
CardiacSense’s smartwatch provides permanent and high-quality monitoring, at a cost that is 10 times lower, without requiring any invasive operation, and also allows medication to be taken only as necessary.
Product status and forecast
The company is in the process of receiving approvals for sale from the US Food & Drug Administration (FDA) and in Europe (CE). Over the last year, extensive work has been performed with both organizations (including surveys conducted by the company), with significant progress. The forecast for receiving approvals:
- CE – Q1 2019
- FDA – Q3 2019
The smartwatch is in the clinical trial phase – The trial protocol is currently in the process of approval with the FDA. Trials will begin this August, and will end in early 2019, under FDA and EMEA (CE) approval. In a clinical trail that has been going for approximately 8 months, we have seen results that meet FDA requirements. The smartwatch is expected to be available in its commercial version starting 2019, and will be distributed through large companies with international retail chains, through which it will be sold to large institutions such as hospitals, healthcare providers, retirement homes, monitoring centers etc. In parallel the smartwatch will also be sold to large companies in versions customized for each such company.
Future versions of the product are planned to incorporate additional measuring capabilities, currently under development:
- Respiratory rate
- Blood pressure
- Saturation (blood oxygen level)
The smartwatch in its full version will serve as a miniature hospital, worn on the wrist, allowing measurement and reporting of all parameters taken at the hospital.