InspireMD wins Peruvian nod for CGuard, MGuard

InspireMD (NYSE:NSPR) said yesterday it won regulatory approval from Peru’s Ministry of Health for its CGuard embolic prevention system and MGuard Prime.

The Israel-based company said it inked an exclusive distribution agreement with Peru-based medical device distributor Dispositivos Medicos E.I.R.L.

“We have been working closely with InspireMD in order to educate key opinion leaders and top hospital chains in preparation for marketing clearance, which we have now secured. The clinical data from both of these products is quite impressive and we expect our physicians to start using the products very quickly,” Dispositivos Medicos E.I.R.L. GM Maximiliano Arboleda said in a prepared statement.

InspireMD said that both it and Dispositivos Medicos collaborated to pursue regulatory approval for both the CGuard and MGuard devices in the country, and that sales on both will commence immediately.

“We are excited to officially launch our commercial efforts in Peru following an extensive regulatory review and approval by the Peruvian health authorities. The approval of both CGuard EPS and MGuard Prime in Peru is further recognition of the importance of our products and supports our expansion into Latin America. With a population of more than 30 million and solid GDP growth, Peru is an attractive market and Dispositivos Medicos E.I.R.L is a great partner, as it represents many of the leading global medical device manufacturers in Peru,” InspireMD chief commercial officer and EVP Agustin Gago said in a press release.

Last month, InspireMD said it pulled the trigger on a 1-for-35 reverse stock split.

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