A Medical Device Daily
Spectranetics (Colorado Springs, Colorado) said it has been slapped with several securities class-action lawsuits alleging that the company and some members of its management made false and misleading statements and omissions in violation of the federal securities act. The company said the claims appear to relate to the matters it believes are being investigated by the FDA and the U.S. Immigration and Customs Enforcement (ICE), which was first reported earlier this month. "The company intends to defend itself vigorously against these lawsuits," Spectranetics said in a statement released yesterday.
The Colorado Springs Police Department and ICE agents raided Spectranetics earlier this month, requesting information and correspondence relating to products used in the treatment of in-stent restenosis, such as catheter guidewires and balloon catheters made by certain third parties outside the U.S. The company said that federal authorities are also seeking information on two post-market studies completed during the period from 2002 to 2005 and payments made to personnel in connection with those studies, as well as on compensation packages for certain company employees (Medical Device Daily, Sept. 8, 2008).
Spectranetics also said it has received a request from the Denver office of the Securities and Exchange Commission for the voluntary production of certain documents. The company said it intends to cooperate fully with the inquiry.
Spectranetics makes an excimer laser approved in the U.S., Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The company's disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads.
In other legalities:
• CryoCath Technologies (Montreal) said it resolved all outstanding patent suits between it and Boston Scientific (Natick, Massachusetts), its subsidiary CryoCor (location), and CryoCor's co-plaintiff/co-defendant AMS Research Corporation (location). The companies have a number of court actions pending involving cryoablation systems in the U.S. and Canada and an International Trade Commission investigation, each of which they have agreed to terminate.
The settlement was reported last week, the same day Medtronic (Minneapolis) said it had agreed to pay $380 million to buy CryoCath (MDD, Sept. 26, 2008).
The companies agreed to mutual covenants that provide for all of the existing litigation to be withdrawn and an agreement by all parties not to sue each other in regards to certain other cryoablation-related intellectual property over the next twelve years. CryoCath also agreed to the payment of royalties on certain future products for a limited time. The companies have also agreed to permit the two Interference proceedings pending with the U.S. Patent and Trademark Office board of patent appeals and interferences to proceed, but regardless of the outcome, the surviving patent will be subject to the covenants not to sue.
• Isolagen (Exton, Pennsylvania) said it has agreed to settle its securities class action lawsuit and its two derivative actions against it and some of its officers.
Payments for all settlements will be funded entirely by the company's liability insurance, Isolagen said. A payment will be made to the putative class in the securities action lawsuit. In the two derivative action settlements, a payment will be made for plaintiffs' attorney fees. In connection with the proposed settlement of the securities class action, Isolagen is to receive a release of indemnification claims asserted by the underwriters of certain securities offerings who were also named as defendants in the lawsuit. Also, in connection with the settlements, Isolagen is to receive a final payment of $500,000 from it liability insurance carrier for reimbursement of any and all current and future defense costs.
Isolagen is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies. Its technology platform includes the Isolagen Process, a cell processing system for skin and tissue rejuvenation which is currently in clinical development for a broad range of aesthetic and therapeutic applications including wrinkles, acne scars, burns and periodontal disease.