Innovation India: Agatsa’s SanketLife Device Takes ECG Monitoring to the Next Level

Disruptive technologies often emerge when gaps within a sector become deficits. For example, the struggling telecom sector was transformed when it was liberalized in 1991, and today, India has one of the lowest call tariffs in the world. The Internet revolution is also already well on its way in India after citizens have paid high charges for a unit of data for more than a decade. Similarly, the pharma and automobile industry in the country has gone through massive innovative breakthroughs to cater to the huge unmet demand for medicines and personal vehicles, respectively, over the last decade.

According to IBEF (India Brand Equity Foundation), the Indian health care sector, which stood at USD 110 billion in 2016 will grow to USD 280 billion by 2020, representing a CAGR of 16%. There is an even greater opportunity for growth in the health care sector, but considering abysmally low public health expenditure, limited insurance coverage, and a lack of health infrastructure, there is a need for a disruption in the market through public-private partnerships for the industry to express its full potential.

One of the major gaps in the Indian health care sector is early disease diagnosis. Health care startups are mushrooming in this high-growth space and are trying to deploy solutions that will transform the market. One of the really interesting startup stories is the journey of Agatsa's SanketLife, a leadless pocket-sized ECG machine.

According to DRG’s Ambulatory ECG Monitoring Devices report, the revenue earned by monitoring companies was over a billion dollars in the US in 2016 and growing double digits for the next few years. In India, the market (although smaller) is expected to grow at an even higher rate. On one hand, in case of chronic diseases, continuous remote monitoring can reduce untimely hospitalization frequency and duration, therefore helping to improve the quality of life of patients. On the other, in emergency situations, these devices can transmit data over the Internet to physicians for immediate diagnosis and first aid before the patient reaches treatment facilities, thus ensuring advanced medical care.

Particularly for heart monitoring purposes, in an emergency situation, an ECG test should be done within the "golden hour", but in India, it takes about 6 to 8 hours on average. Also, more than half a million people die of heart attacks each year because of a lack of immediate medical attention. With about 70% of the Indian population living in rural areas, diagnostic centers or hospitals are quite far from the places where people live. This makes the requirement of remote monitoring devices even more pronounced.

SanketLife is a credit card-sized, mobile-based leadless ECG machine, offered by a company called Agatsa. Placing both thumbs on the slots on the device gives a reading comparable to a single-lead ECG with a 98% accuracy. Not only is SanketLife able to perform a single-lead ECG reading for emergency purposes, like AliveCor’s popular Kardia Mobile ECG monitor, but also has built-in provision to take 12 lead readings as a conventional ECG machine, which makes it a complete 12-lead ECG solution that is remote, easy-to-handle, cost-effective, without any lead or wire and accurate.

The technology of SanketLife allows it to measure electrical activity of the heart through sensors and to transfer the data to a mobile phone using low-energy Bluetooth technology. There are 3 sensors on the device that are used to take complete 12-lead ECGs by contact with the skin. After signal processing, the data is displayed as a PDF report on an associated phone-based application that can be shared with anyone for consultation. This type of device has high favor with US physicians. At present, heart rhythm doctors often advise their patients to buy the Kardia Mobile in the US and there will be a lot of interest in SanketLife as and when it is launched in the US, sync it with a smartphone, and send readings whenever the patient is unwell.

The present features of the application include display of the ECG report and evaluating stress levels. The next iteration of the technology will enable it to send data to a panel of doctors for a quick review. Efforts are also being made to integrate analytics to internally predict 17 diseases by observing the pattern of the ECG. Additional features will include monitoring blood pressure and blood sugar levels, potentially through additional accessories.

Agatsa has been taking initiatives to perform clinical studies to increase credibility of SanketLife in the Indian market, as well as to generate evidence to obtain CE and FDA approval, efforts for both of which are underway. In this direction, a pilot comparison study of SanketLife (a 6-lead version ECG) against the 12-lead GE2000 ECG system has been performed in collaboration with Medanta Medicity, a hospital based in Gurgaon, with a random sample of 28 cardiovascular patients in 2016. SanketLife's ability to correlate to several cardiovascular diseases—such as left-axis deviation, right-axis deviation, ischemia, left atrial hypertrophy, first-degree heart block, and myocardial ischemia—was high. Statistical analysis of the data also revealed a sensitivity and specificity of 83.3% and 70%, respectively, suggesting that the device can detect abnormalities with substantial accuracy. In 2017, a pivotal study has been performed in Jayadeva Cardiac Hospital in Bengaluru comparing the 12-lead version of SanketLife with a 12-lead conventional ECG machine where preliminary results show SanketLife to be 99% sensitive.

Also, an on-field pilot study was performed in 39 primary health care centers in Tripura in 2016. The feedback received on the SanketLife device has been very positive. Dr. Rinku Das at Matinagar PHC has said that the product is very useful in emergency cases and provides quick ECG readings, which helps in treating cardiac patients immediately. Similarly, many doctors have lauded the portability, ease-of-use, and expressed that the device is essential in emergency settings.

Having said that, the SanketLife device has faced some challenges, and the efforts to improve its features are already in progress. One of the major challenges, at present, is the need for Internet connectivity to generate the results, as well as to send information to the physicians. In most of the rural areas in India, either there is no Internet or the signals are very weak, which limits device functionality. One solution is to collaborate with the government and build the infrastructure to connect each primary health care center with Internet; however, the device will need to have built-in near-field communication modalities for information exchange between the device and mobile phones. Agatsa is also focused on improving the modalities associated with information exchange and wants to make the device independent of the requirement for Internet connection. Also, there is an effort to develop a mechanism to improve the reading of the thumb when a patient is unstable or unconscious because any movement interferes with the ECG readings.

SanketLife is among first movers in the portable 12-lead ECG space although there is an increasing competition in 1-lead emergency ECG monitor market, especially in the US. As Senior Analyst Erik Bracciodieta detailed on MDO Online, there is a veritable plethora of companies offering ambulatory ECG monitoring services in the US from local mom and pops to slick national firms with convenient patch monitors. Considering the advanced features of SanketLife which enable it to take a 12-lead ECG, companies like Alivecor’s should watch out.

From a cost perspective, conventional ambulatory ECG monitor costs about USD 1300 in the US. SanketLife is way ahead in pricing competition. The product at present is being sold on Amazon marketplace in India at a retail price of USD 150. Continuing efforts in manufacturing cost reductions are aimed at a target price of USD 100 in the next few years.

Considering the huge market demand, the positive clinical evidence, the acceptance of the device by the medical community, continuous efforts of the team to improve the product design, this product will revolutionize the diagnosis and management of chronic and emergency heart diseases not only in India but perhaps even globally.

 

DRG’s Ambulatory ECG Monitoring Devices Report provides a view on this dynamic market no one else can. It provides quantitative insight on patient populations prescribed these monitoring devices, the types of monitoring used, and market shares. Discover how you fit into this diverse market and what opportunities – or threats – await you.

 

Follow @RTangri_DRG, @ErikB_DRG, @agatsa1, @rastogi_neh on Twitter for more insight on the Ambulatory ECG Monitoring Devices market

 


Contributors: Raghav Tangri, Analyst, Medtech Insights
Published on: 06 July, 2017