Emerging Technologies: Developing a Practical, Noninvasive Method to Monitor Patients

In this interview we speak with Bernard Klocman, President and CEO of Emergency Medical Technologies, about their WriskWatch^™ device, which is a watch-sized device worn on the wrist to detect loss of pulse.

Tell us about the components of the WriskWatch^™ device.

Our developers actually pulled it off. The first watch was the size of a clock on your wrist, so I insisted it should look and feel like a fashionable watch that people would wear. The developers were able to put the proprietary technology consisting of piezoelectric disc, a microprocessor with software algorithms to measure pulse in an actual watch. The prototype uses Bluetooth, but in the final design, we plan to incorporate Qualcomm’s wireless cell phone chip with GPS to make it totally self contained, instead of communicating through a cell phone.

How does the WriskWatch™ work?

A person wears it on their wrist like a regular watch, and when loss of pulse and movement is detected (typical of sudden cardiac arrest), it sends a signal via the self-contained cell phone to our servers. The servers can call up to 300 people (all you need is a few) on your call list, providing them with an actual voice message speaking the location of the SCA victim wearing the watch and the location of the nearest AED device. Imagine being in an apartment and having an AED in the lobby where all of your neighbors as well as 911 can be informed and can promptly react. The Sudden Cardiac Arrest Association (SCCA) provides a national AED registry. AEDs are required to be registered by most municipalities, including their location. Our server disseminates that information and literally allows everyone that responded to the message to be placed in a conference call to communicate directly with each other. This eliminates the one-way communication typically performed by an operator in a call center. This is the only closed-loop system that allows a non-witnessed SCA victim to have a better chance of survival.

How did the device come about?

It is a pretty interesting story. In my previous life, my partner Louis Katchis invented and patented the memory loop cardiac event monitor. We provided a call center for this technology, and the biggest complaints we received were from patients who did not want to wear electrodes (typically for one month) because they were uncomfortable. To eliminate the electrodes, we developed a prototype t-shirt, with the University of Miami’s Biomedical Engineering Department through a grant we received from DARPA (Defense Advanced Research Projects Agency), that accurately detected arrhythmias. I was introduced to Bruce Kusens who, after selling his company, had a fascination with AEDs and started selling them. Bruce explained that he constantly heard objections from people saying “what good would an AED do if I were unconscious without anyone knowing I had a sudden cardiac arrest, and even worse, if no one knew where to locate an AED?”. Just in the US, approximately 300 to 500 people die each year from sudden cardiac arrest, but in a casino (eg, The Casino Project), an SCA victim has a 70% survival rate because AEDs are readily accessible. I told him about my t-shirt prototype, and we immediately realized that by sending such information to 911, it might be too late. Instead, why not develop a system that could call people around you with your location and the location of the AED? That way if someone responds quickly with such information, they have a better chance of saving an SCA victim. We soon found that people didn’t want to wear a t-shirt (even though it was washable) 24/7, so we began exploring if we could achieve this using a wrist watch. We found a group of scientists that were able to measure the pulse on rats for the research market, and worked with them to measure a pulse on a human wrist using a wrist watch. Now we have the third-generation prototype in which you can wear the WriskWatch^™ comfortably, and it looks like a fashionable wrist watch. Our clinical trials were recently completed at the Cleveland Clinic in Ohio.

Tell us about the differences between the Alert, Broadcast, and Coordinate Service Levels.

We plan to roll out the services in three options that offer three pricing levels:

• The Alert plan is the least expensive option. By pressing two buttons on the side of the WriskWatch^™, or if you lose pulse and movement, anyone on your call list will be notified by an actual voice message giving your location. Everyone that accepts the message can be placed on a conference call to directly communicate and truly manage the emergency.
• The Broadcast option allows everyone to know where the nearest AED is, to give an SCA victim a better chance of survival. 
• The Coordinate plan places an AED in your home environment, but because no one likes to have an AED in their living room, our message delivers the location of the AED (such as if it is stored in the closet). Also, if for example you are walking on the street, and the local Starbucks has an AED, our servers through the AED Global Link interface (subject to availability through 911 systems) will notify verified responders in Starbucks of your location if there is an emergency.

Describe the phase I study evaluating the WriskWatch^™. What were the findings? Explain the testing methods.

The phase I study aimed to evaluate different real-life scenarios to determine sensitivity and specificity in detecting a loss of pulse. The study consisted of 34 patients: 24 hospitalized patients and 10 presenting for implantable cardioverter-defibrillator (ICD) testing. We simulated loss of pulse in our hospitalized patients via blood pressure cuff inflation to occlude the brachial arterial pulse at random times in 20 subjects with no inflations in 4 while the patients were instructed to keep perfectly still. Of the 10 patients undergoing ventricular fibrillation (VF) induction during ICD testing, the exact times of VF induction were recorded. This portion of the study truly simulated someone in sudden cardiac arrest. A blinded reviewer determined if and when motion and pulse was lost in all patients using only data from the device. Dr. John Rickard, the principal investigator of the study, concluded that the WriskWatch^™ is a novel device that shows promise as a tool to hasten activation of emergency medical systems and facilitate early defibrillation in patients with cardiac arrest.¹ This clinical trial showed very favorable results for what we aimed to achieve, and will be published in the December issue of Heart Rhythm. It is available for download on PubMed. A poster presentation of the study was presented at the last American College of Cardiology meeting, and the abstract was published in their publication. 

What types of patients is the WriskWatch™ best suited for?

We want to target the “worried well” — this includes anyone who fears suffering a sudden cardiac arrest and/or who wants to use it as a next-generation personal emergency response system (PERS). Naturally, anyone with cardiovascular disease would be a candidate. We intend to provide the WriskWatch^™ to hospitals to be used as an inexpensive “Life Monitor.” Often patients cannot be placed in a monitored bed because it is very expensive. Studies show that there are high incidences of inpatient sudden cardiac arrests, and patients who require a monitored bed cannot be properly admitted if a monitored bed is not available.

The WriskWatch^™ provides that solution, and the patient can leave the hospital with the WriskWatch^™ because it will be priced in a very cost-effective manner.

What device design changes are expected before phase II testing? When is phase II testing expected to begin?

We want to incorporate the Qualcomm cellular chip as well as manufacture fashionable watches for both men and women. Our servers are already developed. Phase II testing is expected to begin in nine months; however, it is predicated on the company acquiring operating capital. 

Describe the accuracy of the device, including the false-positive rate.

Based on the clinical trials conducted at the Cleveland Clinic, the sensitivity of the watch to detect pulse status (based on 15-second intervals) was 99.9% and the specificity was 90.3%. To address the false-positive rate, the WriskWatch^™ will vibrate when it senses no pulse or movement. If the wearer is alive and conscious, they can shake their wrist within five seconds to disable the servers from being activated and to give time to address a false alarm.

Is there anything else you’d like to add?

We are very pleased to see how much we accomplished by making the WriskWatch^™ comfortable to use, and have solved most of the technical and marketing issues. Based on our consultants, we feel we will be able to obtain a 510K clearance through the FDA, which is closely monitoring this exploding mHealth market. Our goal now is to raise enough capital to help take us to market.

Reference

1. Rickard J, Ahmed S, Baruch M, et al. The utility of a novel watch-based pulse detection system to detect pulselessness in human subjects. Heart Rhythm. 2011 July 27.