Exton, PA-based Kensey Nash has acquired the assets of Synthes' Norian subsidiary for $22 million in cash. As the Philadelphia Inquirer notes, that price tag is only about $1 million less than Synthes paid last year to settle the criminal case alleging its unit had conducted an illegal "test market" for bone cement.
The Norian portfolio consists of approximately a dozen biomaterial-based surgical products. In as statement, Kensey Nash says the addition of Norian's orthobiosurgery and other key biomaterial products should allow it to further its penetration into the regenerative medicine markets encompassing soft tissue surgical repair, orthopaedics, sports medicine, spine and neurosurgery.
"This acquisition, along with the supply and research and development agreements with Synthes, will enable Kensey Nash to significantly expand our presence in the regenerative medicine market and should provide us with an immediate and long-term positive financial impact for our fiscal year 2012 and beyond in both revenues and earnings per share," explained Joseph Kaufmann, president and CEO of Kensey Nash, in a statement. "In addition, this transaction will further strengthen and fortify the successful and mutually beneficial partnership we currently have in place with Synthes," he added.
The buy comes roughly eight months after Synthes agreed to divest Norian subsidiary as part of a settlement related to the conduct of a clinical trial for the bone cement. The government maintained that between May 2002 and Fall 2004, Norian conspired to conduct unauthorized clinical trials of Synthes' Norian XR in surgeries to treat vertebral compression fractures of the spine. These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use. Pilot studies had demonstrated that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research done in a pig also showed that such cement-caused clots became lodged in the lungs.
The company still marketed the product for VCFs without putting it through required testing. It also failed to stop marketing the product until after a third patient had died on the operating table. And even after the third death, the companies didn't recall Norian XR from the market, but instead made false statements to the FDA during an official inspection in May and June 2004, the government maintains.
- check out the Kensey Nash release
- see the Inquirer's story