Shares of InspireMD Inc. (NYSEMKT: NSPR) more than doubled in Tuesday’s session after the company announced follow-up data from its Paradigm-101 trial of the CGuard Embolic Prevention System (EPS). This is an investigator-led clinical study evaluating the use of CGuard EPS in 101 consecutive patients with carotid artery stenosis. Ultimately the results were incredibly favorable and investors sent the stock even higher.
A couple of the key highlights from the study were zero device-related adverse events at the 12-month mark, as well as CGuard EPS device and procedure success were each 99.1%. Also the peri-procedural death/major stroke/myocardial infarction (MI) was 0%.
The data presented at Transcatheter Cardiovascular Therapeutics 2016 scientific symposium added to a growing body of clinical evidence validating the use of the CGuard as a proven treatment for both symptomatic and asymptomatic patients with carotid artery disease.
Excluding Tuesday’s move, InspireMD has underperformed the broad markets, with the stock down 93.5% year to date. Over the past 52 weeks, the stock was down about 94%.
Piotr Musialek, M.D., D.Phil., FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases, in Krakow, Poland, commented:
These data further reinforce the strong safety and efficacy profiles reported in previous trials of the CGuard EPS, and validate the system as an important option for endovascular management of patients with carotid artery disease. Importantly, the very low incidence of peri- or post-procedural complications and stroke create a positive risk-benefit profile for CGuard EPS in patients with asymptomatic carotid artery disease. These patients are frequently denied intervention due to fear of the complications associated with conventional intervention, and are left with a substantial risk of stroke when treated only with medication. Our study found that CGuard EPS is applicable in up to 90% of all-comer patients with carotid stenosis. These data indicate that CGuard EPS may fundamentally alter the paradigm for managing patients with carotid artery disease, whether they have symptoms or not.
Shares of InspireMD were trading up nearly 150% at $3.59 Tuesday morning, with a 52-week trading range of $1.41 to $29.50.