This is Gaalen Engen, Stockhouse.com Tech Correspondent. I’m sitting with CardioComm Solutions CEO, Etienne Grima. CardioComm Solutions (TSX: V.EKG, Forum), a Canadian med-tech firm based out of Toronto, Ontario, is a provider of innovative device-agnostic software solutions in the cardiovascular medicine and telemedicine space. The company, currently trading on the Venture Exchange with the ticker, EKG, is gaining traction and was just recently highlighted in the Globe and Mail, a well-respected Canadian national periodical. Part of what is generating this growing interest is the company’s world-leading proprietary GEMS™ WIN Global ECG Management System and GEMS™ WIN Air | Wireless Global ECG Management System platforms.
Etienne would you briefly describe what these platforms offer to the medical community and what makes them unique within the space?
Sure, thank you very much. GEMS™ is a software program that’s been developed by CardioComm Solutions that’s been classified as a Class II medical device. People may be more familiar with medical devices being a piece of hardware and the associated software is buried inside of under the hardware application. Where we’re unique, is that our software clearances require no associated hardware component. We are cleared with all our software solutions as Class 2 medical devices in Canada and the United States. We also have medical device clearances globally. The software is manufactured, r designed, updated and maintained under ISO Standards, and that’s unique in our business. We are one of the few companies internationally that has a medical device clearance on software related to ECG management.
I would also say that we are unique in our capacity to offer the medical community software that is device agnostic that can be sold into hospitals, doctors’ offices, and now we have a version that can be sold to consumers. Being device agnostic would offer our customers flexibility to acquire medical devices manufactured by different companies and which will be purchased based on price and desired functionality which provided our customers a competitive advantage and provides us a unique offering.
Speaking of which, there is a fundamental shift taking place in regards to portability of technology which is democratizing many of the processes and functions we once depended on third-party professionals for, like doctors or medical technicians. CardioComm has obviously seen this and currently offers a ground-breaking handheld ECG monitor, the HeartCheck™ Pen. What makes this device so special and just what is its potential?
You are correct. There is a big move to take medical technology and put it into the hands of consumers. Unfortunately, companies stop short many of the times with such developments and making them wellness based products instead like what is seen in Smart Watches and Smartphone Health Apps. These are wellness products that are not qualified or capable of rendering clear medical indications through their use There’s a real need to bring medical credibility to wellness devices which means these devices have to be built and be tested against higher standards. Now what really controls these devices and what would give them credibility is the software they are associated with. Anything that sits on a smartphone can’t be a medical device unless the app itself has a Class 2 medical clearance which is hard to do. So what we’ve done is we’ve taken what we know about the medical world and medical software, and we have found hardware to pair with that was capable of meeting our standards. Now hardware isn’t hard to find, but good hardware that works with good software is.
ECG readings and ECG technology has been around since the turn of the 19
th century, and certainly we’re seeing better and better devices being built on a continuous basis. Devices are becoming smaller, smarter, cheaper and more efficient, but the software that controls the device and the data generated must keep pace. So we’ve taken what we know in the medical world with good hardware and basically released a consumer grade medical software solution that allows you, the consumer, to acquire your electrocardiogram, or ECG, by holding a device in your hand. This device reads the electrical activity through the skin of your hands not unlike the electrodes they stick on your chest.
Our software enables the device to move those files that have been recorded into a computer environment that can credibly, reliably and accurately show an ECG waveform to a consumer and enable a consumer to take those recordings and pass them on off to a medical professional through a cloud-based ECG reading service we run or print the report and take it to their doctor. That report is based on our medical software, so it is something the doctor has to look at as it was all prepared under a Class 2 medical device environment. This HeartCheck™ solution is actually quite an exciting way, like you said, of bringing medical credibility to the ease of consumer use.
Now just for some clarification. A patient or prospective buyer that is intending to buy the HeartCheck™ pen, they don’t need to have a prescription to do that, do they?
No, there are some devices that you can buy on the market that don’t require a prescription, but ours’ is the only one that has Canadian and US clearances to show an ECG waveform. So you can buy things that monitor your heart rate without a prescription, but ours’ is the only one cleared that can show you an ECG repeatedly and on your own without a doctor’s prescription, either to buy or see those ECGs. That makes us unique in North America. Others may claim they are allowed do this but they likely cannot, just look it up for yourself in the FDA website at
www.fda.gov and type in a company name. You will see what is allowed and not allowed.
Now with this technology you’ve developed for the HeartCheck™ pen, you can leverage this IP and push even further into the Health and Wellness sector to cover other diagnostic metrics, can’t you?
Yes we can. It’s not a straight shot from the HeartCheck™ pen, but we have the technology already cleared where we can use our software to interact with multiple biometric devices that can read signals from your body.
Whether those bio signs involve temperature, respiratory rate, ECGs, glucose levels, oxygen saturation or tidal volume, they can be collected by our software. We already have an FDA clearance to have this software used and we can have algorithms as part of that clearance that can give automated feedback based on what it’s seeing. So this is a platform to build a multi-disease monitoring system with automated feedback that can give credibility to a medical-wellness monitoring solutions, it’s cleared as a Class 2 medical device.
This can allow devices that have sat in the wellness market the potential to move into the medical wellness market through an association with our technologies.
So essentially, your technology could offer a certain sense of legitimacy to the health and wellness sector, correct?
Well, what it could do is offer those wellness products that people have invested a lot of time and care into developing an opportunity to become classified as medical devices. If they’re manufactured well and they work well, there are ways that we, with our ISO clearances and our FDA clearances, can create an umbrella effect over them. We can bring them in and qualify them according to all these regulations and standards using systems that we already have in place which could bring new devices into medical compliance and therefore, clearance for medical devices, faster than would be possible without a company like us.
We can also work with companies that already have devices that wish to move into the medical credibility side of wellness monitoring with lower costs and less time. Basically, they wouldn’t have to worry about the software side.
So all of this opens up even more possibility for blue sky potential beyond just the HeartCheck™ ECG PEN itself, if your company chooses to head in that direction.
Absolutely, we’ve already issued a press release recently that we have the HeartCheck™ PEN Bluetooth prototype in the works. But really what we’ve done with the HeartCheck™ PEN, is bring the first consumer ECG viewable medical device that ever been cleared to market and that first device was brought forward without a predicate device. Anyone coming to market after us would likely be using our products as the standard for comparison. So now we have basically set the landscape and it’s time to bring in better devices, newer devices. Like I mentioned before – sexier, smarter and cheaper. The difference is the barrier to entry for people who want to do this will be related to the software, especially for ECG systems. It’s a highly regulated and very difficult software to develop and that will definitely be a challenge for new companies to manage. .
So because your ground-breaking provision is supported by software with a medical Class 2 clearance which is an industry first, you’re going to be well ahead of the competition when other players join the space.
That’s what we believe and we’d like to offer the opportunity to work with groups with strengths where we don’t have them; in devices, in development of hardware devices. We can work to develop them ourselves, but if the idea is to bring new products to market faster and a collaborative effort is going to be more suited to that than trying to do it on your own.
Okay, let’s back up and tackle some history. Over the last 16 years, CardioComm Solutions has built itself to become a respected global supplier of ECG viewing platform solutions. Some traders will look at this and be excited because of the established market footprint, the developed sales networks and distribution channels. However, other traders are going to look at this and ask the question, why did it take 16 years for CardioComm to hit the road and really start running. Do you have any answers to give to individuals asking this question?
Yes, and that’s something we hear often. So our history is a strength and a weakness. It’s a strength because we have shown that we understand the market. We have been able to develop customers, customer bases and a solid reputation across many countries. We continue to have loyal customers on the medical side. The challenge has been that as technology changes and markets change, the companies must change as well. In response to this, we decided a few years ago to bring the HeartCheck™ consumer products forward which takes time, resources and R&D.
Also there was a large change with Microsoft in support of their prior operating systems, which has in many cases with medical software companies, turned the industry on its side. To us this meant we needed to write new GEMS™ based software products to be valid on these new operating systems which consumed more time and resources between 2013 and 2014.
We were well-suited years ago when the company was originally founded as only a software company. As the market changed we started to look at new medial customer markets and that got us into a long R&D cycle. We are now at a point where our newly released GEMS™ medical software is selling well, it has a long and successful track record and accordingly has a great reputation, but today the market is focusing more on the newer products we have brought to market, the HeartCheck™ ECG PEN specifically. We understand that the market is also very used to seeing such new products associated with start-ups. So what we have come to appreciate is that when investors see our new HeartCheck™ products, they immediately associate us as a start-up. Then they check out our history and they see that we are not new, they question why we took so long to get to the release of the HeartCheck™ Devices and they may not even be aware that there is well developed medical software side to our organization.
The HeartCheck™ ECG PEN was a first of its kind at the time of its approval. When it was approved, it was at a time when Android phones weren’t well established and apple Smart phones has their Bluetooth connectivity locked off, so USB connectivity to a computer was needed. We understood at that time that consumers wanted to have more active roles in the management of their health and that’s when the market became apparent. This was before wearables, before the wellness market. So we started that at the right time, but it just happened to be by a company that had been around for years developing software.
What can investors look forward to as far as specific milestones that you may have over the next 24 months?
That’s a tricky question to answer because we’re publicly traded and we don’t want to be leading. So what I’m going to say is largely reflect on what we’ve said publicly. We have the intention to get into production the Bluetooth version of our HeartCheck™ ECG PEN., which, if you consider the increase in market size moving from a PC-based cable-connected device to a smartphone-based device while retaining a cable for the traditional base, we should see positive effects for the company.
We will continue to expand sales through pharmacies and we’re looking to introduce ECG screening services into pharmacies. This would represent a recurrent revenue service model apart from the opportunities for consumers buying our HeartCheck™ ECG PEN devices and accessing our SMART Smart Monitoring ECG Service on a pay-per-ECG model. All of this, as it grows, should bring us revenue that really hasn’t existed prior to 2015. So that’s new.
We want to continue to partner with other companies with whom we can enable their technologies to work with ours, whether they’re consumer devices, wellness devices or medical devices. This will give us the chance to have hardware sold through which our software will be sold in follow-up or we can sell hardware and make revenue as distributors while our software is being purchased.
We will also continue to push toward developing new products and technologies. Not as much emphasis on R&D will be places as we have had in the past, but we will still look for new integrations of technologies and as you have asked me about, we have our eyes on multi-biometric automated interpretation of bio-signs to give feedback to consumers as well as patients.
Where do you envision CardioComm in the next five years?
Well I would imagine that we would have established some important relationships with well-known brand names, because in five years there will be a convergence of wellness and health to try to bring medical certainty to the results that are being collected. Big data, the Internet of Things; these are all converging health monitoring markets and consumer information into large predictive databases. I would say with the medical data that our software collects and the consumer-facing solutions that we have and looking in a forward fashion to being multiple bio-sign and device agnostic software driven, we would plug in nicely to some of these initiatives by then.
So, Etienne, very excited by the potential for CardioComm, is there anything you think investors should know before we end this?
Well this company is very focused on bringing products to market that are going to make a difference in the quality of people’s lives by providing better diagnostic tools to physicians, enabling the advantages of mobile monitoring and leveraging all the information collected to break down some barriers that have prevented people from being more involved in managing their health, the health of those they care for and for the health of those they are responsible for. We want to empower people to be involved in preventative disease management, learning more about the status of their health and learning more about the medical conditions they are living with in order to try to reduce new adverse events or health deterioration where it can be avoided.
This is why we’re doing what we’re doing and we work diligently to look for appropriate technology opportunities to expand what we have now. In this respect, we’re proud of what we do. We’re hoping through opportunities to disseminate information as with Stockhouse now, we will raise awareness about our products, and not feel like we’re one of Canada’s best-kept secrets.
Thank you very much for sitting down and talking with me.
Thank you.
Again, this is Gaalen Engen for Stockhouse.com and I’ve been talking with Etienne Grima, CEO of CardioComm Solutions, trading on the TSX Venture Exchange with the ticker, EKG. You should check it out.
--Gaalen Engen
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FULL DISCLOSURE: CardioComm Solutions is a Stockhouse Publishing client.