First, when I took the reigns as CEO, I was committed to focusing on the operations of the company and building the company as opposed to focusing on M&A, which in my experience, can be totally unpredictable. After eighteen months, I believe we are now very well positioned in the market, and this is evidenced by our stronger year-over-year growth. As you may recall, for the third quarter of 2017, we achieved a 90% year-over-year increase in sales of CGuard™ EPS. As announced this morning, I’m pleased to report preliminary unaudited CGuard sales of $606 thousand for the fourth quarter of 2017 which represents approximately a 211 % increase compared to the fourth quarter of 2016. The preliminary unaudited overall sales, including MGuard, for Q4 2017 are $833 thousand which represents approximately a 159% increase compared to the fourth quarter of 2016. Based on these numbers, we believe our strategy is working, we have momentum and we are poised to continue our turnaround. At this point, as we head into Q1 2018, we expect another strong quarter for CGuard.
Just last week, we announced we received regulatory approval for CGuard™ in India and that we had signed Hester Diagnostics as our exclusive distributor. This partnership comes on the heels of similar distribution agreements across Asia, including Hong Kong, Taiwan, Australia, New Zealand and Vietnam.
In addition, CGuard™ continues to be featured in leading publications and at the leading clinical conferences across both western and eastern Europe and the Middle East.
GOOD NEWS
We recently announced the preliminary 24-month follow-up results in the PARADIGM 101 Clinical Study. Professor Musialek presented these long-term follow-up results at both the 2017 VEITH Symposium and the 2017 ICI Meeting.
The results from this trial are consistent with four other published CGuard™ studies, and further demonstrate the sustained benefits of CGuard™ out to two years. To the best of our knowledge, this is the longest known clinical follow-up with any such carotid devices to date. And most importantly, without CGuard™, the majority of these patients would have otherwise had to undergo a carotid endarterectomy, an invasive surgical procedure to treat their carotid artery disease.
Patient enrollment is also continuing in an investigator initiated trial in Russia led by vascular surgeon Professor Karpenko comparing Abbott’s RX ACCULINK Carotid Stent Versus CGuard™ EPS. The objective of the trial is to assess the superiority of CGuard™ EPS versus the market leading conventional carotid stent in patients at high risk for Carotid Endarterectomy or surgery.
