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Thursday, August 03, 2017 2:06:50 PM
1111 W. Georgia Street, 14th Floor
Vancouver, British Columbia
V6E 4M3
August 1, 2017
Dear xxxxx xxxxxxxx,
As we advance toward pivotal clinical trials and our FDA submission, I have had several questions arise regarding progress, share valuation, and overall project health. I would like to take this opportunity to address these topics, and believe that by doing so, your conviction in the future and potential of this project will be reaffirmed.
The topic of most interest to individuals is the progress of clinical trials and the overall impact to the project timeline. Currently, the clinical trials being conducted at Thomas Jefferson University Hospital are progressing exceptionally, and will continue to gain speed as additional devices and locations have been and are being added. I personally, and the rest of CVR leadership, are extremely pleased with the TJU clinical report which was recently released.
We understand shareholder concern over the perceived length of time taken to ramp up tertiary clinical trials at TJU, but this has actually worked to the advantage of the project. With the primary purpose of the tertiary trial being the validation of both hardware and software updates recently made, there is now a diminished need for additional patients beyond those enrolled, resulting in significant savings to our organization. Additionally, CVR is finalizing the details for Internal Review Board (IRB) review at several other esteemed universities and hospitals to initiate clinical trials, which will support expedited clinical data acquisition and marketing plan traction moving forward.
I would now like to address shareholder interest and concern over share valuation and news flow associated with the progress of the company. To all extent possible, I have personally attempted to communicate to all prospective investors that CVR is first and foremost a medical device company, and not a short-term market trading opportunity. I did this in an effort to clarify that the true potential and valuation of the investment would be realized in twenty-four months or greater. The company is not functioning with immediate share price as the primary goal, instead it is working to build and develop the foundation necessary to produce long-term and lasting return on investment. Unlike consumer goods, a medical device falls under a much higher level of regulatory scrutiny by the FDA and other global regulatory enforcement groups. This, combined with the requirements of the TSX, force CVR management to be very careful in what is disseminated and how it is communicated. Management is very confident in its business plan, and believes we will be able to hit all requisite milestones necessary to dramatically increase shareholder value. I personally believe that the CVR shareholders will be very pleased with the assortment of upcoming news releases, announcements, and actions of the board.
My hope is that this update answers your questions and reinforces your understanding of the legitimacy and magnitude of this endeavor. We are nearing the destination on this journey and are proud to have your support as we advance medicine. Thank You.
Sincerely,
Peter Bakema
Chairman of the Board / Chief Executive Officer
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