| |
It’s been a busy two months for CardioComm Solutions, Inc. We have been fortunate enough to conclude a series of meetings with organizations in Toronto as well as within the United Arab Emirates (two visits in as many months) and the Peoples’ Republic of China.
Prior to this meeting-driven travel, CardioComm Solutions attended conferences held by the Heart Rhythm Society in Boston, the American Telemedicine Association in San Jose and the American College of Cardiology in Chicago.
The net effect of these meetings and discussions has been several business leads and potential collaborations with respect to the provisioning of ECG screening service solutions and devices under a variety of community and physician-based initiatives. We have been focusing on the following priorities:
- Securing distributors for the HeartCheckTM devices, Smart Monitoring services and GEMSTM software. The geographic areas of initial focus have been the United States, the Middle East and Asia. Next we will address product interest from India and South America. Canadian and European channels will be developed as country clearances are secured.
- Introduction of the HeartCheckTM ECG Monitor into arrhythmia screening initiatives for the reduction of stroke risk. There has also been interest globally to this opportunity being included in screening athletes.
- Production readiness for the HeartCheckTM PEN.
- Infrastructure readiness for HeartCheckTM PEN ECG analysis requests.
- Contracting of a US-based fulfilment house for product distribution and planning for a similar service in Europe.
- Expansion of wireless cardiac monitoring outside the USA.
Perhaps the most important development was the Philips telemedicine announcement that was released on May 9th. This was the second phase of the original contract that we announced in February 2012. Philips is now ready to engage large independent diagnostic testing facilities in the United States for the cardiac arrhythmia monitoring services market and they are in an excellent position to assume a dominant role given their infrastructure and access to the CardioComm Solutions’ GEMSTM software technologies.
Our first order of HeartCheckTM PENs is expected to be delivered to our Victoria, British Columbia offices by early July. Smaller production runs will be received earlier for the purposes of performing extensive quality assurance reviews and to ensure the GEMSTM Home software and Smart Monitoring call centeresolution is working according to specification. We will also be initiating limited market evaluations for the HeartCheckTM PEN, including a real world tests utilizing pre-registrants of the HeartCheckTM PEN.
In this regard we will be requesting participants in the HeartCheckTM PEN, GEMSTM Home and Smart Monitoring evaluation to execute a Non-Disclosure Agreement (“NDA”) to ensure the findings from the testing phase are held in confidence until we are able to complete all phases of this project. Participants will complete a questionnaire indicating their health status, existence of co-morbid conditions as well as identification of medications they may be taking. The entire project will maintain adherence to both the NDAs executed and required HIPAA regulations. The project will run in parallel to our production efforts and is envisioned to take four months to complete. A requirement to those who do agree to participate will be to purchase the HeartCheckTM PEN at a special price of $100. The rationale for charging for the HeartCheckTM PEN is to ensure that anybody who agrees to participate in this extremely important undertaking has “some skin in the game,” will comply with the requirements of the project and ensure that they will submit their ECG test readings for review over the entire duration of the project. This may reduce the number of interested participants but it will better ensure a robust/complete sample size and better protect data integrity such that the study may lead to a publication in the scientific literature.
Based on the initial work with the Heart and Stroke Foundation of Canada in February, CardioComm Solutions is now recognized as a corporate sponsor for our in kind contributions within the Heart and Stroke Foundation Stroke prevention campaign website entitled Atrial Fibrillation – Be Pulse Aware.
During the summer we will be focusing on the HeartCheckTM PEN production schedule, which we have publicly stated is anticipated to be launched in the US towards the end of the summer/early fall 2012. Our regulatory reviews in Canada and in Europe continue on schedule and we look forward to being able to announce the projected launch schedules in those regions shortly.
For your reference we do not execute press releases for NDAs nor letters of intent that are signed since performance under these preliminary agreements is not a guaranteed outcome. To date we have executed 45 non-disclosure agreements related to the HeartCheckTM PEN. The NDA completion is our first step in qualifying potential business collaborations and product distributors. Once an NDA is completed, market access, prior business experience and sales targets are discussed. A distribution agreement would then be drafted for the territory of interest or target market share. We hope to be able to report soon regarding our efforts in the Middle East and US markets.
On the topic of press releases, all releases containing “material” information must be sent to the regulators for review who will examine potential materiality and provide direction as to whether a stock should be halted or not in advance of the release being published. If the regulators and the company determine that a halt is advisable, then the stock is halted for the dissemination of an announcement. We have taken the position that an ample opportunity should be provided for each press release containing material information to be reviewed by current, past or potential shareholders. Accordingly, we have erred on the side of caution and requested halts. As the velocity of trading has calmed, we have allowed some releases to be made without a halt.
Finally, we are preparing for our Annual General Meeting (AGM) in Toronto and have invited our shareholders to let us know if they intend to participate in this public event. In the past, we have been running these AGMs in our offices; however, we believe given the number of inquiries that we receive from the general public, consultants, media as well as interested and current shareholders, that we will require more meeting space to accommodate potential attendees. You may email us through the website to notify of your intent to attend.
We will provide more updates as they become available and as always press releases will be made as soon as we have confirmation on deals being executed.
The staff at CardioComm Solutions continues to work to establish our company as an international provider of ECG solutions and have a very busy schedule set over the coming summer months. During this time we wish our shareholders and interested parties a safe summer and look forward to an in person introduction at the AGM to be held at 1:00 p.m. (EST) on Wednesday, June 27, 2012, at Days Hotel & Conference Centre – Toronto Don Valley, 185 Yorkland Road, Toronto, Ontario.
With best regards,
Etienne
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.
|
