InspireMD Inc (NYSEAMERICAN: NSPR) is making a run for the top in the market this morning, and for good reason. The company announced that the FDA has approved the company’s pivotal clinical study. Here’s what’s going on:
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NSPR Stock Rockets On FDA Trial Approval
In the press release, InspireMD announced that the FDA has granted it approval to move forward with a pivotal clinical trial. The trial surrounds the company’s CGuard Carotid Stent System and will be known as CARENET-III.
In the study, NSPR will assess its CGuard Carotid Stent System as a way to prevent stroke in high-risk patients. 315 subjects will be involved in the study, which will take place in up to 40 institutions within the United States.
In a statement, Marvin Slosman, CEO at NSPR, had the following to offer:
This is a key milestone in the history of our company as it helps pave the way for us to initiate a clinical trial of CGuard EPS for addressing Carotid Artery Disease and preventing stroke in the United States market. This will be the first U.S.-based study of CGuard which is a cornerstone of our global expansion plans.
A pivotal trial of this kind requires significant preparation and allocation of resources and we have already begun to move pieces into place in order to plan the initiation of our CARENET-III study. The FDA approval of the IDE represents an important step in enabling us to conduct a pivotal clinical trial to demonstrate the potential for CGuard EPS against carotid artery disease, which accounts for more than 6.2 million deaths worldwide, and a cost burden of more than $34 billion in the U.S. alone.
This News Is Huge
The news released by InspireMD proved to be overwhelmingly positive. The company is moving into a pivotal trial for an indication that has blockbuster potential.
Think about it this way, the stroke market is expected to grow to be worth more than $36 billion annually by the year 2023. Insurers are more likely to want to pay the lower cost of preventative medicine, making this a perfect product for great insurance coverage.
Should this trial go well, there’s a huge opportunity here. No, I’m not saying that NSPR will take the entire $36 billion by 2023, or anything close. The company currently trades with a market cap of around $13 million, an opportunity to get even a small piece of a $36 billion market is massive for this company, making NSPR stock one to consider.
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