Benzinga | Feb 3, 2021 08:37AM EST

InspireMD Partner For Intended Registration And Distribution Of CGuard EPS In Mainland China

TEL AVIV, Israel, Feb. 03, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE:NSPR), developer of the CGuard(tm) Embolic Prevention System (EPS) for the prevention of the stroke caused by carotid artery disease, today announced a transaction intended to achieve distribution of CGuard EPS in mainland China.



InspireMD's agreement with three China-based investment partners, including Shanghai Micro Medical (SMM) and QIDI Asia Medical, stipulates that the Chinese partners will be responsible for conducting all necessary registration trials for commercial approval, followed by an eight-year exclusive distribution right in China. In addition, QIDI has agreed to make a $900,000 investment in InspireMD's common stock at the closing price on the day immediately prior to entering into the transaction in a private placement. The transactions are expected to close this month. Following announcement of the transaction the Chinese partners plan to initiate the process of securing registration with Chinese regulatory authorities to establish distribution.

"One of our pillars of growth is global expansion of CGuard EPS into significant markets of opportunity and this step in China establishes a foundation for our overall Asia plan. China, believed to be the second fastest growing market for peripheral stent procedures1, establishes a foundation for Asia and builds on our goal to establish market leadership throughout the world. This step, combined with our efforts to achieve commercial registration in the United States, positions us to expand into the two largest markets outside of those currently served with true global presence for our vascular portfolio. We are pleased to have formed a partnership with an established leader in the medical device field in this important market," said Marvin Slosman, CEO of InspireMD.

Stroke is the leading cause of death in China2. In contrast with the United States and most European countries, the Asia-Pacific region performs more stenting procedures as a proportion of overall carotid artery revascularizations than any region in the world.3

"The opportunity to distribute InspireMD's CGuard EPS stent platform represents a significant opportunity to provide leading technology to the Chinese market. We believe the superior clinical results and growing and consistent body of evidence from CGuard will provide a foundation for success and an optimal solution for our portfolio to address this significant and ever-growing medical need," said Tony Liu, Chairman of Shanghai Micro Medical, one of the investment partners.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.