InspireMD Stents Meet Endpoint and Outperform Standards of Care Today

The biotechnology sector, as well as the healthcare sector, have been some of the strongest performers throughout 2012 even though biotech Exchange Traded Funds are cooling over the past week which has carved away at some of the yearly gains. For example, the SPDR S&P Biotech Index ETF (XBI) is still holding gains above 30 percent for the year after being as high as nearly 50 percent gains a few weeks ago.  iShares Dow Jones U.S. Medical Devices (IHI) as slipped from highs as well after being up more than 20 percent and is still outpacing the gains of the broad markets.

Simply, healthcare and biotechnology are hot and look to remain strong in the future as they are not as susceptible to macro-economic financial conditions that are an anchor to many other industries.

A strong up-and-comer in the medical device space worthy of a closer look is InspireMD, Inc. (OTCBB: NSPR).   With headquarters in Germany and Israel, the company is focused on the development and commercialization of its proprietary stent platform technology, MGuard.  Acute myocardial infarction (heart attack) patients run a high risk of plaque of thrombus breaking free during a stent implantation causing downstream blockages which can, in some cases, lead to death.  InspireMD’s MGuard Embolic Protection Stent (EPS) combines a coronary stent merged with an embolic protection specifically designed for acute myocardial infarction patients that prevents unstable arterial plaque and clots from breaking loose.   The new technology addresses risks associated with distal embolization and no-reflow while simplifying primary percutaneous coronary intervention (PCI) and saphenous vein graft (SVG) interventions that typically carry a high risk of periprocedural myocardial infarction.

MGuard has its CE mark for marketing in Europe and is working towards receiving clearance in the United States.

Three clinical trials have been completed with two more ongoing proving-up the benefits of MGuard. Today, the company released encouraging news that the MGuard™ EPS was shown to be significantly superior when compared to standard bare metal and drug eluting stents in achieving complete ST resolution (a marker of myocardial and microvascular reperfusion) and restoring normal blood flow in a major study of 432 randomized patients undergoing emergency coronary intervention for potentially fatal heart attacks.

The data from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial, which was reported today at the Late Breaking Trials Session at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting in Miami, FL, showed that MGuard EPS provides a significant acute advantage and, as a result, may hold the potential to lower the incidence of adverse sequela and prolong survival of heart attack victims, according to a corporate statement. Details of the MASTER trial were also published online today in the Journal of American College of Cardiology.

The MASTER trial randomized 432 patients to MGuard EPS (217) and to either bare metal or drug eluting stents (216).  Fifty centers in nine countries participated in the trial. Patients are being followed for one year.

The study met its primary endpoint (proportion of patients with ST segment resolution of≥ 70%, measured at 60 to 90 minutes post procedure), showing the MGuard EPS recorded a 29% relative improvement compare to the control arm of bare metal and drug eluting stents in the treatment of heart attack patients.

Significant improvement were also demonstrated in coronary artery blood flow, lower mortality at 30 days and smaller infarct size as measured by post procedure cardiac MRI.

“I was impressed with the performance of the MGuard Embolic Protection Stent in the MASTER trial,” said Dr. Gregg W. Stone, the study’s chairman and the Director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.  ”Compared to standard stents, the MGuard is the first stent in a randomized trial shown to restore complete ST-segment resolution in a higher proportion of patients, a key predictor of myocardial salvage and long-term survival in STEMI (ST segment elevation myocardial infarction) patients.”

Readying for commercialization, AspireMD has recently renegotiated its product design licensing agreement with Svelte Medical Systems, Inc. of New Providence, NJ, to lower the royalty on MGuard Prime stent sales from 7 percent outside the U.S. and a high of 10 percent after FDA approval to 2.9 percent on worldwide sales, in return for issuing Svelte $1,763,000 of InspireMD common stock.  This prescient move should improve gross margins on future earnings.

With the good news, shares of NSPR are surprisingly trading down by 3 percent at $1.83 as the day winds towards the closing bell.  With $5 million in cash and equivalents, the company is in a fine position to begin commercializing the stents in the near term.  Additional due diligence is, as always, encouraged.

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InspireMD (NSPR) Stock Quote and News:

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