InspireMD Announces Year-to-Date 2011 Progress Company Completes $11.1 Million in Financing, Funding FDA Trials
TEL AVIV, Israel, May 17, 2011 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ mesh protective stent system, today announced that it has filed its Form 10-Q for the three months ended March 31, 2011 with the U.S. Securities and Exchange Commission. The Company provided an update on progress year-to-date:
Fiscal Year-to-Date Highlights
- During March and April 2011, InspireMD completed financing transactions totaling $11.1 million, comprised of $10.4 million in cash and $0.7 million worth of debentures that were converted.
- InspireMD announced a distribution agreement with Indian distributor, Kirloskar Technologies (KTPL), making MGuard available in India. KTPL has already closed an initial order for the MGuard stent in India.
- InspireMD scheduled a cocktail reception and scientific symposium in conjunction with the Company's appearance at the EuroPCR conference. The symposium is scheduled for Wednesday, May 18th at 6:30 p.m. adjacent to the EuroPCR conference at the Concorde Lafayette Hotel, Paris, Grande Etoile D'Or Hall. The symposium will be chaired by Dr. Martin Leon and the meeting faculty includes Drs. Alexandre Abizaid, Antonio Colombo, Dariusz Dudek, Eberhard Grube, Chaim Lotan, Sigmund Silber.
Dr. Asher Holzer, Co-Founder of InspireMD and the Company's President, commented, "We have made tremendous progress thus far during 2011 in being able to develop and commercialize our patent-pending mesh net technology. This mesh net wraps a stent, providing embolic protection and filtering debris to prevent major adverse cardiac events and reducing vessel injury by spreading strut pressure. Our recently completed financings provide us with the resources to pursue approval with the United States Food and Drug Administration (FDA) to sell our product in the United States and to further develop additional products beyond MGuard. Our focus is on expanding our clinical data to support our mesh protective stent system and assembling the necessary internal resources to support our growth worldwide. We are excited about our progress, and confident that we are on the right path."
Mr. Ofir Paz, Co-Founder and CEO of InspireMD, commented, "The financings completed during the first quarter enable us to accelerate our clinical efforts, and simultaneously build out our infrastructure, including recruiting seasoned sales and marketing leadership to further grow our global distribution while our clinical trials are underway. We are proceeding with our FDA approval efforts, in collaboration with the Harvard Clinical Research Institute (HCRI), an international leader in design and conduct of coronary device trials. Simultaneously, we are continuing our MASTER Randomized Trial, chaired by Dr. Gregg Stone, Director of Cardiovascular Research and Education from Columbia University in New York, which will enroll 432 patients with a primary endpoint of a complete ST segment resolution post-procedure. I am proud of our clinical progress and continue to believe we are on the right path to develop and commercialize a robust platform technology that will position InspireMD as a leader in the cardiology industry."
On May 16, 2011, InspireMD filed its Form 10-Q for the three months ended March 31, 2011 with the U.S. Securities and Exchange Commission. For the period, total revenue was $1.7 million compared to $2.1 million during the same period in 2010. The change in revenue was primarily attributed to a one time significant revenue recognition of previously recorded deferred revenues in the first quarter of 2010. On a product delivery basis, shipments increased during the first three months of 2011 versus the same period in 2010. The first quarter was impacted by a one-time, non-cash expense of approximately $600,000 for the revaluation of a convertible loan at fair value.
The Company completed the quarter with cash and cash equivalents of approximately $9.6 million, as compared to $0.6 million at the same period in 2010. The Company utilized approximately $400,000 in cash for operating activities during the first quarter. Additional financial details, including financial statements, are contained in the Form 10-Q.
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 payers 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 assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Partner, Hayden IR