by Zuriñe Dopacio González

June 19, 2015

One Single Device to Diagnose a Set of 15 Medical Conditions

We interviewed the President and CEO of Cloud DX, Robert Kaul. At the WT | Wearable Technologies Conference in San Francisco he will be speaking and exhibiting Vitaliti, their latest wearable product. Robert has a vast experience leading companies within the healthcare industry. If you want to see the Vitaliti in person come by the Fort Mason Festival Pavilion on July 9-10th!

1.  Cloud DX was founded in 2014, prior to that you were the CEO of Biosign Technologies, what made you take the decision to found your own company?

The story of the formation of Cloud DX Inc. is interesting. In 2009, I founded a previous company in New York called Cloud Diagnostics LLC. This was a healthcare IT marketing company. In less than 9 months, we decided to sell all the assets of Cloud Diagnostics LLC to Biosign Technologies Inc, for approximately $3 million (www.clouddiagnostics.biz).  So that’s how I ended up working for Biosign. After the sale, I served as Executive Vice President and later became CEO. I served as CEO of Biosign for 2 years, and during that time the company acquired 4 separate, smaller software companies. This was really an intentional pivot from being a medical device manufacturer into being a healthcare software company. By 2014, the hardware business was no longer a good fit within Biosign, so along with three of my colleagues, I elected to acquire the hardware assets and re-formed Cloud DX Inc. This allowed Biosign to focus on its software lines, and we became a “pure” hardware manufacturer once again. So the short story is: I founded Cloud DX in 2009, sold it to Biosign in 2010, and bought it back in 2014!

2. You already have one market ready product, the Pulsewave, which is FDA cleared, can you tell us more about it?

Our first product to market is the Pulsewave® Health Monitor, a virtual medical device that records a pulse wave signal from the wrist, uploads it to the cloud, and derives the major vital signs. Pulsewave® is designed to be used to collect vital signs in the clinic, and also to be sent home so doctors can follow up remotely. It is the only FDA cleared, clinical & consumer health monitor that displays the actual heart beat in real time, derives 4 biological results from each noninvasive wrist cuff reading (Heart Rate, Blood Pressure, Respiration Rate and our unique Cardiac Anomaly Scores), includes statistical Confidence Intervals around key readings including Blood Pressure and Respiration, indicating the level of precision for each reading and allowing a user to re-take a reading that may be too imprecise to count. Only Pulsewave® is FDA cleared to show the 30-day TREND Gauge, and the 30-day AVERAGE Gauge so that users can understand at a glance how their health may be changing. The independent, 3rd party CCV Study* conducted at University of New Brunswick Heart Centre proposes that Pulsewave® readings can be correlated to match gold-standard readings from an inter-arterial catheter, creating a new non-invasive clinical tool precision Blood Pressure monitoring. Used for remote patient monitoring, it cuts the cost of hardware in the home by ~90%, and our encrypted APIs allow for easy integration with EMRs. Pulsewave® is for sale now in Canada & USA.

3. Currently you are also working on another product, Vitaliti, which will be capable of diagnosing a set of 15 conditions. How is that possible and how you came up with the idea?

Cloud DX Inc. is creating unique new medical devices as part of our aggressive Research & Development Program, spurred on by our status as finalists in the Qualcomm Tricorder XPRIZE competition. Our VITALITI™ continuous vital sign monitor is designed to be the ultimate consumer wearable device, so comfortable you forget it’s even on your body, yet capable of tracking 5 vital signs with clinical accuracy over a minimum of 72 hours. Testing to date has shown that VITALITI is comfortable to wear throughout the day, and can even be worn continuously as you sleep. This level of comfort will make VITALITI a valuable tool for motoring chronic conditions that worsen at night, including COPD, Congestive Heart Failure and Sleep Apnea. Part of the Cloud DX “Tricorder”, we are developing a proprietary wireless spirometer designed to quickly and easily measure lung function. One iteration of this new device will also contain a wireless high resolution camera, designed for self-examination in sites like the ear canal. Finally, our “Tricorder” will include a consumer-friendly in-vitro diagnostic platform, adapted to use our proprietary IVD rapid test cassettes to take tiny fluid samples and determine levels of several analytes. Cloud DX is working closely with global leaders in the IDV industry to develop consumer use rapid tests that will inform the Care Team on subjects like blood cell count, hormone levels, and even the presence of pathogens. In June 2015 we delivered 30 final VITALITI™ prototypes to the Qualcomm Tricorder XPRIZE evaluation team. Over the next 7 months, these prototypes will be extensively tested & evaluated. In January 2016 the three XPRIZE winners will be announced, out of the remaining seven competitor teams.

4. Is Vitaliti also in the process to be FDA cleared? Is there a way that people can support you?

VITALITI is really a platform made up of five medical devices: the Pulsewave®, the Spirotoscope™, the VITALITI™ IVD, the VITALITI™ wearable continuous vital sign monitor and of course the VITALITI Tricorder App which analyzes all the data from the devices and produces diagnoses for 15 separate medical conditions. Of these devices, the Pulsewave is already FDA cleared. We intend to begin submitting the VITALITI devices for FDA pre-market clearance in the fall of 2015. A select group of “beta-tester” enthusiasts will have a chance to pre-order a VITALITI™ device and participate in user-experience studies as part of our regulatory clearance process.

5.  What is your favorite wearable product (besides your own one)? 

One of the perks of my job is that I get to test lots of new technologies including fitness wearables. I’ve tried many of the main brands, and in my house we use both FitBit and Withings Pulse. In both cases the devices are durable & easy to use and the companion software apps are very good. However, I have not yet tried the Apple watch so I’ll get back to you on that!