Today, the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium in Washington, D.C. proved to be a momentous day for InspireMD Inc (NYSEMKT:NSPR), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, and its investors. The question echoing through everyone’s thoughts: What has sent the stock on a tremendous double-and-above rise? Answer: A key presentation of follow-up data from investigator-led clinical 12-month Paradigm-101 trial of the CGuard Embolic Prevention System (EPS).
A bit of backstory: The biotech firm designed EPS to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels. This specific trial assessed the use of CGuard EPS in 101 consecutive patients with carotid artery stenosis.
The results? It is crystal clear investors like what they heard, as NSPRS shares were soon sent soaring 128%.
A shining spot of the study revealed zero device-related adverse events at the 12-month marker. Second, the CGuard EPS device and procedure success each scored a high 99.1%, with the device underscoring stellar precision in terms of placement, as there was no foreshortening or elongation in sight. Third, the peri-procedural death/major stroke/myocardial infarction (MI) was 0%.
Over the past year, this is a stock that has seen its fair share of obstacles, confronting a practically 94% year-to-date dip. Therefore, these scientific symposium presentations were a real game-changer for the firm, who has gone from zero to hero in just a day, on back of a bolstered tide of clinical data of robust safety and efficacy profiles indicating CGuard could prove to be a valuable treatment for patients suffering from carotid artery disease.
As Dr. Piotr Musialek, hailing from the Jagiellonian University Department of Cardiac & Vascular Diseases in Krakow, Poland explains, “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.”
Can InspireMD shares “fundamentally alter the paradigm” for the treatment of asymptomatic and symptomatic patients alike in a closer examination of carotid artery disease? This remains to be seen. Yet, clearly, the firm is reaping the benefits of today’s data read-outs and after a year-long’s worth of negative investor sentiment struggles, the stock is finally emerging victorious today.