divendres, 25 de març del 2016

CSI reups supply deal with Fresenius

Cardiovascular Systems Inc.Cardiovascular Systems (NSDQ:CSII) said last week it extended its supply deal with Fresenius (NYSE:FMS) for its ViperSlide lubricant, extending the agreement through April 4, 2021.

The extension to the agreement also gives Cardiovascular Systems final purchase rights upon the termination of the agreement or if Fresenius stops production of ViperSlide.

St. Paul, Minn.-based Cardiovascular Systems said the extended agreement included an update to the product pricing schedule as well, according to an SEC filing.

Earlier this month, Cardiovascular Systems said it agreed to an $8 million settlement with the plaintiff in a False Claims Act lawsuit based on allegations from a former sales rep that the company ran kickbacks and an off-label marketing scheme to boost sales of its orbital artherectomy devices.

The deal calls for Cardiovascular Systems to pay the $8 million over 3 years, not including plaintiff Travis Thams’s legal costs. The company said the final terms of the deal must still be ironed out.

The lawsuit, filed in 2013 and unsealed 2 years later, accuses CSI of inducing physicians to use its products by offering free, all-expense-paid training programs “followed by explicit demands by CSI employees that attendees use CSI products on future patients,” giving away product for free, 3rd-party referral channel marketing, and “sham Speaker Bureau payments for high-prescribers and others whom CSI sought to cultivate,” according to the complaint filed in the U.S. District Court for Western North Carolina.

Thams worked for CSI as a district sales manager from 2012 to 2013, according to the complaint.

In February, A Cardiovascular Systems shareholder filed a purported class action lawsuit, accusing the medical device company and its management of misleading investors about an alleged off-label promotion scheme she claims spurred a -70% plunge in the value of CSI’s stock.

“Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (1) CSI distributed illegal kickbacks to health care providers; (2) CSI engaged in the off-label promotion of its medical devices; and (3) CSI violated the Food & Drug Administration’s laws and regulations in connection with its medical devices. As a result of the foregoing, the company’s public statements were materially false and misleading at all relevant times,” plaintiff Caroline Paradis alleged in a lawsuit filed in the U.S. District Court for Central California.

The post CSI reups supply deal with Fresenius appeared first on MassDevice.



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