InspireMD Secures Partner for Intended Registration and Distribution of CGuard EPS in Mainland China

Rhea-AI Summary

InspireMD has announced a partnership with Chinese distributors, including Shanghai Micro Medical, to market its CGuard™ Embolic Prevention System in mainland China. This agreement includes conducting registration trials for regulatory approval and grants an eight-year exclusive distribution right in China. Additionally, QIDI Asia Medical will invest $900,000 in a private placement of the company's stock. This move positions InspireMD to expand in a rapidly growing market, with stroke being a significant health issue in China.

Positive

• Agreement with Chinese distributors aims to establish CGuard EPS market presence in China.
• Investment of $900,000 from QIDI Asia Medical will strengthen InspireMD's financial position.
• Exclusive distribution rights for eight years can enhance revenue potential.

Negative

• None.

New Chinese Distributor Will Also Invest in At-The-Market Private Placement

TEL AVIV, Israel, Feb. 03, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ 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.

About the CGuard^® EPS
The CGuard^® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke. CGuard’s unique MicroNet^® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional and next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure.  InspireMD’s CGuard™ has created a new dimension in the protected treatment of carotid artery disease and has the potential to establish a new standard of care for the management of carotid artery disease and stroke prevention.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet^® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com

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¹ https://www.prnewswire.com/news-releases/peripheral-stent-implants-market-to-close-in-on-us-6-bn-by-2030-driven-by-increasing-peripheral-artery-disease-patient-pool-worldwide---persistence-market-research-301206261.html
² Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011; 42:3651–3654.
³ 2017 Health Research International Market Report

 

FAQ

What is the significance of InspireMD's partnership with Chinese distributors?

The partnership will enable InspireMD to distribute its CGuard EPS in China, a rapidly growing market for medical devices.

How much is QIDI Asia Medical investing in InspireMD?

QIDI Asia Medical is investing $900,000 in InspireMD's common stock.

What are the terms of the distribution agreement in China?

The agreement provides for exclusive distribution rights in China for eight years, contingent on completing necessary registration trials.

What health issue is InspireMD addressing in China with its product?

InspireMD's CGuard EPS aims to prevent strokes, which are a leading cause of death in China.

When is the transaction expected to close?

The transactions are anticipated to close in February 2021.