About MGuard™ Embolic Protection Coronary Stent
MGuard™ EPS combines 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 is integrated with the stent. The MGuard EPS is designedto provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard EPS is CE Mark approved. MGuard™ is not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.
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 (SEC), including the Company's Transition Report on From 10-K/T 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.
CONSOLIDATED STATEMENTS OF OPERATIONS [(1)] (U.S. dollars in thousands, except per share data) Three months ended September 30, 2012 2011 Revenues $509 $1,986 Cost of Revenues 230 801 Gross Profit 279 1,185 Operating Expenses: Research and development 946 547 Selling and marketing 402 302 General and administrative 2,212 2,486 Total operating expenses 3,560 3,335 Loss from Operations -3,281 -2,150 Financial (income),expenses net 4,218 108 Loss before tax expenses -7,499 -2,258 Tax Expenses 7 25 Net Loss ($7,506) ($2,283) Net loss per share - basic and diluted ($0.11) ($0.04) Weighted average number of shares of common stock used in computing net loss per share - basic and diluted 68,296,940 64,300,685
CONSOLIDATED BALANCE SHEETS [(2)] (U.S. dollars in thousands) June 30, June 30, ASSETS 2012 2012 Current Assets: Cash and cash equivalents $8,297 $10,284 Restricted cash 37 37 Accounts receivable: Trade 1,078 1,824 Other 408 264 Prepaid expenses 56 93 Inventory: On hand 2,076 1,744 On consignment 22 63 Total current assets 11,974 14,309 Property, plant and equipment, net of accumulated depreciation and amortization 463 462 Other non-current assets: Funds in respect of employees rights upon retirement 304 282 Deferred debt issuance costs 874 961 Total other non-current assets 1,178 1,243 Total assets $13,615 $16,014
September 30, June 30, LIABILITIES AND EQUITY 2012 2012 Current liabilities: Accounts payable and accruals: Trade $556 $441 Other 2,628 2,925 Advanced payment from customers 169 174 Deferred revenues 10 10 Total current liabilities 3,363 3,550 Long-term liabilities: Liability for employees rights upon retirement 394 354 Convertible loans 5,635 5,018 Contingently redeemable warrants 4,979 1,706 Total long-term liabilities 11,008 7,078 Total liabilities 14,371 10,628 Equity: Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 68,596,903 and 68,160,161 shares issued and outstanding at September 30, 2012 and June 30, 2012. 7 7 Additional paid-in capital 50,464 49,101 Accumulated deficit -51,227 -43,722 Total equity (capital deficiency) -756 5,386 Total liabilities and equity (capital deficiency) $13,615 $16,014 (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 unaudited financial statements, as disclosed in the Company's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. (2) All September 30, 2012 financial information is derived from the Company's 2012 unaudited financial statements and all June 30, 2012 financial information is derived from the Company's 2012 audited financial statements, as disclosed in the Company's Transition Report on Form 10-KT, filed with the Securities and Exchange Commission.For additional information: