InspireMD Announces Third Quarter Earnings, Still On-Track to Submit CGuard EPS IDE in 2019
InspireMD ($NSPR) announced results for the third quarter, bringing in $769,000 in revenue compared to $718,000 during the same period in 2017. The revenue increase was primarily due to increased sales of InspireMD's CGuard EPS as the company transitioned from a prior exclusive distribution partner in Europe to local distributors, while also expanding into new geographies such as India, Mexico and Vietnam.
In the release, the company also provided YTD revenue, booking $2,779,000 compared to $1,927,000 for the same period in 2017.
In breaking out YTD CGuard EPS revenue through September 30, the company sold $2,300,000 million compared to $1,300,000 million for the comparable period in 2017, an increase of 72%.
InspireMD's gross profit for the third quarter was $198,000 compared to $153,000 for the same period in 2017. Gross margin increased to 25.7% in the three months ended September 30, 2018 from 21.3% in the same period in 2017, driven mainly by a higher average sales price of MGuard Prime EPS and a reduction in costs of one of the main components of CGuard EPS.
InspireMD ended the quarter with cash and cash equivalents of 11,247,000.
From a clinical perspective, InspireMD announced preliminary cumulative three-year CGuard Embolic Prevention System (EPS) safety and efficacy data at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 Conference that showed no stroke or stroke-related deaths between 24 and 36 months and the absence of any device related issues in the first 93 patients who had reached the three year follow up in the ongoing PARADIGM-Extend trial.
“We had an eventful and productive third quarter during which we believe we made significant progress in expanding the global commercial availability of CGuard™ EPS and bringing it one step closer to becoming the standard of care in stroke prevention following treatment for carotid artery disease,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “The 36-month data that was presented at the TCT conference adds to the growing and compelling body of clinical evidence that has been compiled regarding CGuard’s long-term sustained benefits to patients relative to conventional carotid stent procedures and, together with ever increasing Key Opinion Leader support, are driving increased traction across our multi-faceted growth strategy.”
The company also confirmed that they are still on-track to file a U.S. IDE for CGuard EPS in mid-2019
“In addition to continued growth in key existing commercial territories, we remain on-track to file a U.S. IDE expected in mid-2019, and our new program to educate vascular surgeons about the advantages of CGuard EPS through our Centers of Excellence are having a positive impact on awareness,” Dr. Barry continued. “With our strong balance sheet we believe we have set the stage for a truly transformational 2019.”
What is InspireMD's CGuard EPS?
InspireMD's CGuard EPS is a minimally invasive treatment for carotid artery disease designed around their proprietary MicroNet technology to dramatically reduce or even eliminate the incidence of stroke following carotid artery disease procedures. The product is CE Mark approved and is currently not approved for sale in the U.S.