InspireMD Inc (NYSEMKT:NSPR): What Just Happened, And What's Next

Back at the beginning of October, we highlighted an opportunity in InspireMD Inc (NYSEMKT:NSPR), noting that seasonal sales trends might translate to a short-term dip in the company's market capitalization, and that an entry on this dip could be an opportunity to load up ahead of a market realignment. We also pointed out that data was scheduled to hit from the company's lead development asset, the CGuard Embolic Prevention System (EPS), and that this could provide us with a binary event opportunity.The latter event just hit press, and the company has soared as a result. Here is our take on the numbers, and what to expect going forward from the company.So, let's kick things off with a quick introduction to the company and the product.Inspire focuses on medical devices designed to update standard of care options, with a current specific focus on the stent market. When a patient goes in for a stent fitting, a physician puts what essentially amounts to a small piece of mesh shaped tube into their blood vessels. This provides reinforcement for the vessels in question, and allows blood to flow freely through them. However, the current composition of these stents means that plaque particles can get trapped in the mesh, and cause blockages. These blockages lead to strokes. As a result, many at-risk patients don't qualify for stent fitting because of the stroke risk.Inspire has designed its CGuard as an alternative to SOC, the construction of which doesn't promote plaque blockages. The device was put through its paces in a trial called PARADIGM 101, and data from this trial hit late last year. The interim data was positive, but it was the longer term data that markets were looking to as indicative of efficacy. Why? Because efficacy here is measured in terms of adverse events – specifically, how many of the patients suffered strokes and a few other pre-defined AEs. Early data demonstrated a 100% placement success, but that was the easy part.The latest data is 12-month data from these patients. The first 12 months after fitting for the traditional device is generally regarded as being the prime period for stroke related issues in these patients.So what did the data show?Well, it couldn't really be any better.The study registered zero device-related adverse events at 12-months, and, in line with the early data, CGuard procedure success was at 99.1% (this figure also replicates for device success; that is, it does its job).Of great importance, the peri-procedural death/major stroke/myocardial infarction (MI) was 0%. Basically, no serious or high grade (treatment related) AEs across twelve months.So what's next? Well, the product is CE marked in Europe, but is as yet unavailable in the US. As such, we are looking for development on two fronts: the first, advancing sales in Europe, and the second, development pathway progress in the US.As we highlighted last time, the European sales will likely decline slightly when the company puts out its just-gone quarter earnings, and this presents an opportunity to get in cheap as markets attribute this decline to the company as opposed to seasonal stent trends. Starting final quarter, and heading into the first quarter next year, however, we want to see CGuard European sales pick up considerably, and offset the inevitable decline in the company's legacy, and soon to be secondary product, MGuard.From a US development pathway perspective, things are a little less clear.The company has had some issues with the FDA in the past (regarding the above mentioned MGuard product, specifically relating to late stage enrollment) but we don't see any such issues cropping up with CGuard based on the smooth regulatory pathway already traversed in Europe. Any indication as to when Inspire will file, and we are assuming it will be relatively near term since the company now has this follow-up data in hand, gives us a catalyst beyond financial data.We will be updating our subscribers as soon as we know more. For the latest updates on NSPR, sign up below!Disclosure: We have no position in NSPR and have not been compensated for this article.