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The past few weeks have been very busy for CardioComm Solutions.
On October 17th we went live with our SMART Monitoring services utilizing the new SunGard Enterprise Cloud Services (ECS) solution in support of the HeartCheck™ PEN units that had been sold. This had followed several weeks of specialized customizations to the ECS environment to meet the monitoring requirements of our service. Our launch of US based sales of the PEN started in mid September under a special pricing promotion. Canadian sales were started soon after, once Health Canada approval was secured. Discounted pre-sales of the PEN were halted and the commercial launch of the HeartCheck™ PEN was initiated in mid October in association with completion of all fulfillment house workflow certifications and our go live at SunGard.
Just as the first product to roll off an assembly line is the most costly and time intensive, our first shipment of PENs required a real world application for establishing customs clearances from China, packaging logistics for shipment and US customs and FDA inspection audits. This is the first time such a product has been received into the USA and with this distinction came extra vigilance from the regulators. We are pleased to say that we have established all workflow requirements and consumer PEN orders are being fulfilled in both Canada and the USA.
We have also commenced shipping PENs to our product and service evaluation group. The deadline for the return of surveys was October 19th. Participants were selected during the week of October 22nd and those participants accepted to participate have been completing their final steps this past week.
With respect to product promotion, we attended the International Tourism and Travel Show in Montreal (October 19th - 21st) as well as the Zoomer Show in Toronto (October 27th - 28th) as part of the Heart and Stroke’s Atrial Fibrillation awareness booth. We also were permitted a unique opportunity to be present during the Canadian Cardiovascular Society meeting that was held in Toronto (October 29th - 30th) and we had the opportunity to be present within the booth of Boehringer Ingelheim, one of the exhibiting pharmaceutical companies. We were commissioned to demonstrate the HeartCheck™ ECG Monitor and HeartCheck™ ECG PEN “firsthand” to attending delegates for use as a point of care device for ECG reading acquisition. The presentation clearly placed the utility of HeartCheck™ devices in the context of atrial fibrillation detection, commencement of anticoagulation therapy and ultimately stroke prevention. Finally, this weekend our staff will be traveling to Calgary for the second-to-last Heart & Stroke Afib Awareness event.
We were also pleased to be invited to attend the Gartner ITXPO on October 24th in Orlando. CardioComm Solutions was a select VIP guest invited to participate in an analyst-based review of technology use in remote patient monitoring. Gartner (NYSE: IT) is a technology research and advisory company that delivers insight to CIOs and senior IT leaders in corporations and government agencies, business leaders in high-tech and telecom enterprises and professional services firms, and technology investors covering 12,000 distinct organizations across 85 countries through 5,200 associates, 1,280 research analysts and consultants.
With respect to our technologies, the second milestone of our FDA Market Clearance for GUAVA II is one step closer to completion this month with confirmation that our 1,200 page submission was screened, accepted and the clearance review process has begun. This will be a significant undertaking for both the FDA as well as CardioComm Solutions. We also completed an external audit by DQS Medizinprodukte GmbH as a required element for CE mark registration of the HeartCheck™ device brand.
As we look toward the global marketing and sales of the HeartCheck™ PEN and SMART Monitoring service, it is important to be able to confirm to the market and our future customers that our ECG triaging and arrhythmia screening services are operating at the highest possible medical diagnostic level. As a final note, on October 22nd, CardioComm Solutions issued a news release outlining the results from a public ECG screening initiative undertaken in partnership with the Chinese Canadian Council of Heart and Stroke Foundation of Canada. The data were also reviewed by academics from two University of Toronto teaching hospitals with areas of emphasis in public health, stroke and cardiology. This public disclosure affirmed that CardioComm Solutions’ technology, its call centre infrastructure and our HeartCheck™ PEN and HeartCheck™ ECG Monitor can deliver a new point of care ECG acquisition and arrhythmia detection solution for use by patients and consumers. Most importantly it also confirms that the accuracy of our technicians to provide ECG triaging equivalent to the ECG diagnostic accuracy of a cardiologist has been established.
November will be just as busy with business meetings set to occur during the American Heart Association meeting in Los Angeles and at MEDICA in Dusseldorf. We will report on the material outcomes of those meetings as information becomes available.
We thank you for your continued support and look forward to sharing news with you shortly.
Yours very truly,
Etienne Grima
Chief Executive Officer
This release may contain certain forward-looking statements with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.
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