TEL AVIV, Israel, May 5, 2011 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ mesh protective stent system, announced today that it has been approved by FINRA to have its stock quoted on the Over-the-Counter Bulletin Board (OTCBB) under the symbol "NSPR".
In addition, on March 31, 2011, InspireMD concluded a $9.7 million PIPE offering in which (i) it raised approximately $9.0 million of cash and (ii) approximately $0.7 million worth of debentures were converted. In connection with the PIPE, InspireMD issued 6,454,002 shares of common stock and five year warrants purchasing up to 3,226,999 shares of common stock at an exercise price of $1.80 per share. On April 18, 2011, InspireMD raised an additional $1,425,000, issuing 950,000 shares and 475,000 warrants.
Palladium Capital Advisors LLC, acted as the placement agent for the capital raise and advised the company on the merger.
InspireMD, through its subsidiaries, is a high growth medical device company focusing on the development and commercialization of its proprietary stent platform technology: MGuard™. The Company has created a patent-pending micron mesh technology that wraps a stent, addressing embolic protection thereby reducing Major Adverse Cardiac Events [MACE] by filtering debris and minimizing vessel injury by distributing strut pressure. MGuard™ has been implanted in thousands of patients with encouraging clinical results in Europe and Latin America. MGuard™ is a solution for high-risk Acute Coronary Syndrome (heart attack) patients - a market of over two million patients per year. The Company received CE Mark approval in Europe and has distribution agreements in more than 30 territories, including Europe, Asia, Australia, Brazil, the Far East, India, and South America. The Company is currently conducting a randomized trial in Europe, Latin America and South Africa, chaired by Dr. Gregg Stone, to support its regulatory approval efforts.
"InspireMD has made tremendous progress, deploying over 12,000 stents and distributing our novel technology to more than 30 territories," commented Asher Holzer, co-founder and President of InspireMD. "Today, we take the next major step in our evolution. The equity financing and our emergence as a public company is a milestone event for InspireMD, providing us with the resources necessary to complete requisite clinical trials in the United States. As a U.S. listed public company, we believe that we will enjoy increased visibility, improving our ability to penetrate the market. The proven management team of InspireMD is committed to creating shareholder value and extending our technology to ultimately save lives."
"InspireMD is targeting the fastest-growing segment of the stent market which is for acute MI, currently estimated to exceed $2.3 billion annually with limited competition for InspireMD," commented Ofir Paz, CEO and co-founder of InspireMD. "The addressable market for MGuard's micro net technology exceeds four million patients per year, and most of these patients are currently treated with inadequate solutions. In addition, InspireMD has started to develop additional products that address additional indications. Some of these products are peripheral stents, drug eluting mesh, and carotid stents."
InspireMD is seeking FDA approval to sell its products in the U.S., and is collaborating with the Harvard Clinical Research Institute (HCRI), an international leader in design and conduct of coronary device trials, for U.S. FDA trials.
Acute myocardial infarction (AMI)
Acute myocardial infarction (AMI), commonly known as a heart attack, is the interruption of blood supply to a part of the heart's muscle, causing cells to die. Blood flow is interrupted most commonly due to a thrombus (a blood clot) in a coronary artery following the rupture of a vulnerable (loose) atherosclerotic plaque, thereby preventing enough oxygen from getting to the heart's muscle. As a result, part of the heart muscle dies and becomes permanently inactive.
About MGuard™ Coronary
MGuard™ presents a novel combination of a coronary stent merged with an embolic protection specifically designed for Acute MI patients. The embolic protection is comprised of an ultra-thin polymer micron net that wraps the stent. The MGuard™ stent provides outstanding and lifelong embolic protection, without affecting deliverability. MGuard™ is CE Mark approved. Mesh-based protection is now recommended for use in the recent Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC).
About InspireMD Inc.
InspireMD is an innovative medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard™. InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD is traded on the over-the-counter bulletin board (OTC BB) under the ticker "NSPR".
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) intense competition in the medical device industry from much larger, multi-national companies, (v) product liability claims, (vi) our limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payors for our products, (viii) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers for certain product components, (xi) 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 (xi) 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, including the Company's Current Report on Form 8-K filed with the SEC on April 6, 2011. Investors and security holders are urged to read these documents free of charge on the SEC's web site at www.sec.gov. The Company assumed no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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