TEL AVIV, Israel, May 8, 2012 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) (the "Company" or "InspireMD"), a medical device company focusing on the development and commercialization of its proprietary stent platform technology for use in patients with Acute Myocardial Infarctions, today announced financial results for the quarter ended March 31st 2012.
Ofir Paz, Co-Founder and CEO of InspireMD, said: "The quarter was marked by continued positive momentum across financial, operational and clinical areas. Demand for MGuard™ increased in the majority of our international markets. We strengthened our senior management, and additional positive data on MGuard™ was reported. We also recently raised gross proceeds of $11 million in a private placement, which strengthened our balance sheet for the global launch of MGuard™."
Eli Bar, Vice President of R&D added: "We continue to make excellent progress in the MASTER trial, which is now more than 85% enrolled. We remain committed to completing enrollment in the second quarter and releasing preliminary top line results in the third quarter of 2012. A successful outcome in this trial could lead to MGuard™ becoming the standard of care for patients with acute myocardial infarctions."
Achievements in 1Q 2012
Recent (Post Period) Developments
CONSOLIDATED STATEMENTS OF OPERATIONS (1)(U.S. dollars in thousands, except per share data)Three months endedMarch 31,2012
$1,686Cost of Revenues
787Operating Expenses:Research and development
343Selling and marketing
428General and administrative
1,186Total operating expenses
1,957Loss from Operations
(1,170)Financial (income),expenses net
715Loss before tax expenses
$(1,895)Net loss per share - basic and diluted
$(0.04)Weighted average number of shares of common stock used in computing net loss
per share - basic and diluted
50,798,900 CONSOLIDATED BALANCE SHEETS (1)(U.S. dollars in thousands)March 31,
2011ASSETSCurrent Assets:Cash and cash equivalents
110Total current assets
9,830Property, plant and equipment, net of accumulated depreciation and amortization
420Other non-current assets:Funds in respect of employees rights upon retirement
215Deferred issuance costs
25Total other non-current assets
$10,465 March 31,
2011LIABILITIES AND EQUITYCurrent liabilities:Current maturities of long-term loans
$94Accounts payable and accruals:Trade
2,217Advanced payment from customers
25Total current liabilities
3,441Long-term liabilityLiability for employees rights upon retirement
270Total long-term liabilities
270Commitments and contingent liabilities -Total liabilities
3,711Equity:Common stock, par value $0.0001 per share; 125,000,000 shares authorized;
68,178,946 shares issued and outstanding at March 31, 2012
and December 31, 2011.
7Additional paid-in capital
6,754Total liabilities and equity
$10,465(1) All 2012 financial information is derived from the Company's 2012 unaudited financial statements and all 2011 financial information is derived from the Company's 2011 audited financial statements, as disclosed in the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission.
About MGuard™ Coronary StentMGuard™ 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).
MGuard™ is currently being investigated in the multi-center international MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial. This study has been designed to evaluate the MGuard™ stent compared to commercially-approved BMS or DES products in STEMI patients undergoing primary angioplasty. Preliminary top line results are expected in the third quarter of 2012. Plans for a registration study in the US are also at an advanced stage.
About InspireMD, Inc.InspireMD is a medical device company focused 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's common stock is listed on the OTC BB under the ticker symbol "NSPR".
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) 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 (xii) 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 Registration Statement on Form S-1 filed with the SEC on April 25, 2012. 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.
Office Phone: (646) 597-6979
|SOURCE InspireMD, Inc.|
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