InspireMD Receives Regulatory Approval for CGuard EPS, MGuard Prime in Ecuador

InspireMD Inc., a provider of embolic prevention systems (EPS)/thrombus management technologies, and neurovascular devices, has received regulatory approval for the CGuard Embolic Prevention System (EPS) and MGuard Prime from the Ministry of Health in Ecuador. Both of these devices utilize the company’s patented MicroNet technology.
 
In May of 2017 the company announced it had entered into an exclusive distribution agreement with CARDIOBENE S.A., a medical device distributor in Ecuador. The two companies have worked diligently to successfully secure these regulatory approvals. Sales for both products, CGuard EPS and MGuard Prime, will commence immediately in Ecuador.
 
Patricio Arboleda Erazo, CARDIOBENE S.A., commented, “We have been working with key opinion leaders as well as the top hospitals in the country in anticipation of these approvals in order to start selling the products. The clinical advantages for both of these products is compelling and we expect our physicians to start using the products very quickly.” 
 
“This approval enhances our footprint across Latin America,” said Agustin Gago, executive vice president and chief commercial officer of InspireMD. “We are very excited to work with CARDIOBENE, one of the most successful distributors of endovascular products in Ecuador.”
 
InspireMD seeks to utilize its proprietary MicroNet technology to make its products the industry standard for embolic protection and to provide a solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR.