Category: Medical Devices

Spectranetics Announces Resolution of Federal Investigation

Spectranetics Corporation (“Company”) (Nasdaq: SPNC) today reported the settlement of matters related to the federal investigation initiated by the Food & Drug Administration and U.S. Immigration and Customs Enforcement, which was previously announced in a press release dated September 4, 2008.

The resolution includes a non-prosecution agreement and a civil settlement agreement with the United States Department of Justice, as well as a Corporate Integrity Agreement with the Office of the Inspector General for the United States Department of Health and Human Services. Significant terms of the agreements, subject to certain conditions outlined therein, include an agreement not to prosecute the Company, a $4.9 million payment in consideration of a release from certain civil or administrative monetary claims resulting from certain alleged conduct associated with the federal investigation, and a separate agreement that specifies certain corporate integrity obligations.

In addition, the Company has agreed to a forfeiture of $100,000 in cash or property to be executed in the near future. There are no criminal charges against the Company.

Emile J. Geisenheimer, Chairman, President and Chief Executive Officer, stated, “I am pleased that we have resolved our issues with the government. I believe that our level of cooperation and responsiveness and our demonstrable efforts at compliance, much of which preceded the onset of the federal investigation, were critical components that led to the resolution of this matter with no charges filed against Spectranetics.”

About Spectranetics

Spectranetics manufactures and markets the only Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. Nearly 900 Spectranetics laser systems are used in hospitals worldwide.

The Company’s Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.

The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.

For more information, visit www.spectranetics.com.

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 adverse results of the FDA and Immigration and Customs Enforcement investigation, adverse results of the securities litigation or the stockholder derivative litigation in which the Company or any of its officers or directors is a party, insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with those proceedings, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital and has rendered our investments in auction rate securities illiquid, market acceptance of excimer laser atherectomy technology, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development 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, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, market acceptance of new products or applications, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with the Company’s relocation and consolidation of its manufacturing operations, and 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 Corporation
Guy Childs, Chief Financial Officer
(719) 633-8333
or
Investor Contacts:
Lippert/Heilshorn & Associates, Inc.
Don Markley or Bruce Voss
(310) 691-7100
This email address is being protected from spambots. You need JavaScript enabled to view it.