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Biotech / Medical : Spectranetics (SPNC): Any info? -- Ignore unavailable to you. Want to Upgrade?

To: mahler_one who wrote (52)	4/15/2004 11:46:08 AM
From: mahler_one	Read Replies (1) \| Respond to of 60

Decision from the FDA within a month according to SPNC management. Another negative vote would be....well, let's say very unfavorable... m1 Press Release Source: Spectranetics Corporation Spectranetics Expects FDA Decision Within 30 Days on 510(k) Application of a Laser-Based Treatment for Blockages in the Leg Thursday April 15, 4:00 am ET COLORADO SPRINGS, Colo., April 15 /PRNewswire-FirstCall/ -- Spectranetics Corporation (Nasdaq: SPNC - News) announced today that it expects a decision within 30 days from the U.S. Food and Drug Administration (FDA) regarding the status of the company's 510(k) application to treat total occlusions (blockages) in the leg not crossable with standard guidewires. "We have worked closely with the FDA officials who are reviewing our 510(k) application, and have had recent discussions with them regarding the status of our application," said John G. Schulte, Spectranetics' president and chief executive officer. "Based on the interactive review and recent communications with the FDA review team, we expect their decision will be made and communicated to us within 30 days." About Spectranetics Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Our CVX-300® excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of our FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. The Company is currently seeking 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries. Safe Harbor Statement This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include increasing price and product competition, increased pressure on expense levels resulting from expanded marketing and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, the potential size of market opportunities associated with new products, market acceptance of new products or applications, product defects, price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise. Spectranetics and CVX-300 are registered trademarks of The Spectranetics Corporation. For further information please contact: John Schulte, Chief Executive Officer, or Guy Childs, Chief Financial Officer, both of Spectranetics Corporation, +1-719-633-8333; or Bruce Voss or Ina McGuinness, both of Lippert/Heilshorn & Associates, Inc., for Spectranetics Corporation, +1-310-691-7100. -------------------------------------------------------------------------------- Source: Spectranetics Corporation m1