InspireMD

The CGuard embolic prevention system. [Image courtesy of InspireMD]InspireMD (Nasdaq:NSPR) announced today that it received CE mark approval for its CGuard embolic prevention carotid stent system (EPS).

The Tel Aviv, Israel-based company designed CGuard for the prevention of stroke. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes.

InspireMD highlighted the importance of the transition to the new European Medical Device Regulations (EU MDR).

“We are very pleased to have now received formal recertification of our CE mark under MDR, allowing us to continue to work to make CGuard EPS the standard of care for carotid artery revascularization in our existing commercial territories while also advancing our new product pipeline using the pathway provided under MDR,” said CEO Marvin Slosman.

The company continues working on an FDA premarke…

InspireMD (NYSE:NSPR) this week announced it appointed Andrea Tommasoli as chief operating officer.

Tommasoli was previously the company’s senior VP of global sales and marketing since November 2020. Prior to joining InspireMD, Tommasoli was most recently the senior sales director of indirect markets at Integra Lifesciences.

“Andrea has been instrumental in expanding the footprint of CGuard EPS across our approved markets in the EU and, as we advance toward potential U.S. approval with our ongoing U.S. Investigational Device Exemption (IDE) clinical trial, and as our business requirements shift toward operational capacity to support our commercial growth, we believe his background and skill set make him an ideal candidate to assume the role of chief operating officer of the company at this important time,” CEO Marvin Slosman said in a news release. “On behalf of the entire InspireMD team, I would like to congratulate Andrea on this promotion and look forw…

InspireMD (NYSE:NSPR) this week posted third-quarter results that beat the overall consensus on Wall Street.

The Tel Aviv, Israel-based company reported net losses of $4.5 million, or -58¢ per share, on sales of $1.43 million for the three months ended Sept. 30, for a sales growth of 33.61% compared with Q3 2021.

Earnings per share were 15¢ ahead of The Street, where analysts were looking for sales of $1.4 million.

“During the third quarter, we continued to gain share in our key European markets, contributing to nearly 40% CGuard revenue growth over the prior year period. We continue to work with our Notified Body to secure our CE Mark certification under the MDR, which currently expires November 12, while preparing our customers and distributors with sufficient inventory to mitigate as best as possible any potential delay in the recertification process,” CEO Marvin Slosman said in a news release.

“At the same time, our U.S. IDE trial now ha…

InspireMD (NYSE:NSPR) posted second-quarter results this week that beat the earnings consensus on Wall Street but missed revenue estimates.

The Tel Aviv, Israel-based carotid stenting company reported losses of $3.5 million, or -46¢ per share, on sales of $1.03 million for the three months ended June 30, for a sales growth of 231.63% compared with Q2 2020.

InspireMD’s earnings of -46¢ were 17¢ ahead of The Street, where analysts were looking for $1.1 million in sales.

“We are pleased with our second-quarter results that showed strong procedural recovery and market demand of CGuard EPS. Our ultimate goal is to change the standard of care in the treatment of carotid artery disease away from surgical endarterectomy to the minimally invasive use of CGuard EPS carotid stent system,” CEO Marvin Slosman said in a news release.

The company did not offer financial guidance for the 2021 year.

Shares in NSPR were up 4.04% to $4.12 apiece i…

InspireMD (NYSE:NSPR) shares slid today despite first-quarter results that topped the consensus forecast.

The Tel Aviv, Israel-based company posted losses of -$3.2 million, or -53¢ per share, on sales of $1 million for the three months ended March 31, 2021, for a -64% bottom-line slide on a sales decline of -2.7%.

InspireMD’s EPS of -53¢ came in 7¢ ahead of Wall Street, where analysts were looking for sales of $900,000.

“Our persistent and tireless focus on execution continues as we build on our quest to change the standard of care in the treatment of carotid artery disease and stroke prevention, with CGuard EPS and our novel Micronet mesh,” InspireMD CEO Marvin Slosman said in a news release. “Our Q1 achievements have set up 2021 to be a meaningful year of progress toward our goals of global expansion, commercial revenue growth, progress toward FDA approval, growing our unmatched body of clinical evidence, and differentiating CGuard as…

InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System.

The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S.

Get the full story on our sister site, Medical Tubing + Extrusion.

InspireMD (NYSE:NSPR) posted second-quarter results today that beat the consensus on Wall Street.

The Tel Aviv, Israel-based company reported losses of $2.5 million, on sales of $313,000 for the three months ended June 30, for a sales loss of -76.9% compared with Q2 2019.

Earnings per share were -20¢, 15¢ ahead of The Street, where analysts were looking for sales of $203,000.

“COVID-19 placed significant pressure on the operations of healthcare facilities worldwide, resulting in interruptions in elective procedure volumes, including critical carotid artery treatments. However, we are encouraged by the gradual resumption of these crucial procedures in a growing number of our key markets in Europe and other territories, and we look forward to this expansion taking hold in South America as well. We are also buoyed by the scientific validation we continue to receive in both peer-reviewed publications and opportunities to present at medical conferences where …