1. Getinge disappoints on earnings—again
Getinge stock took a nearly 10% tumble last week after releasing earnings that Reuters says lagged analyst expectations for the 7th straight quarter. Fourth-quarter sales were up slightly year-over-year, to 9.5 billion Swedish krona (about $1.08 billion), but profits were down nearly 5% to 952 million krona (about $108 million). The Swedish medical device company is still awaiting an FDA action plan for its Hechingen, Germany plant.
2. Cardinal Health wins $2.25B DoD contract
Cardinal Health has won a nearly $2.25 billion contract to provide brand name and generic medical surgical supplies to the U.S. military. Owens and Minor Distribution is receiving an additional $1.125 billion as part of the U.S. Defense Department contract. The Defense Department says its Medical Surgical Prime Vendor Generation V program received six offers for the contracts, which have a 30-month base with an up-to 5-month implementation period. Surgical supplies will go to the Army, Navy, Air Force, Marines, Coast Guard and federal civilian agencies.
3. Zimmer Biomet wins expanded FDA approval for Gel-One
FDA has approved an expanded 26-week efficacy claim for Zimmer Biomet’s Gel-One cross-linked hyaluronate, a single-injection viscosupplement to treat osteoarthritis-related knee pain. “The expanded efficacy claim not only strengthens our competitive positioning, but reinforces our commitment to alleviating pain and restoring mobility for patients at every stage in the continuum of musculoskeletal care, including conservative and non-surgical options,” David Nolan, a Zimmer Biomet group president, said in a Feb. 1 news release.
4. Biogen closes separation of hemophilia biz
Biogen on Feb. 1 announced that it has complete the spinoff of its hemophilia business, which is now called Bioverativ and is trading on the Nasdaq under the symbol BIVV. Bioverativ’s extended half-life therapies for hemophilia brought in $888 million in sales last year. “We are fortunate to launch in a strong financial position, with two innovative products for hemophilia that are continuing to show strong growth, significant capital to fund investment in future innovation, and a foundation of truly remarkable science on which we hope to develop the next generation of therapies for patients,” said Bioverativ CEO John Cox.
5. FDA clears Cambridge Cognition’s touchscreen memory test
Cambridge Cognition Holdings, a digital health company focused on neuroscience, has won FDA 510(k) clearance to sell its Cantab Mobile product as a medical device, the company said Jan. 25. Cambridge designed Cantab Mobile to detect clinically-relevant memory impairment in older people.
6. Biolase wins FDA nod for Epic Pro dental laser
Dental laser company Biolase says FDA has cleared its new Epic Pro laser system. Biolase officials boast that the Epic Pro offers higher laser power than most diode lasers in dentistry. Biolase developed the laser with IPG Medical Corp., a subsidiary of IPG Photonics Corp. “The Epic Pro with IPG Medical’s super pulse diode laser offers all new computer-controlled thermal super pulsing capability with real-time tip temperature monitoring and automatic power control designed to assist dentists in performing procedures quickly and with great precision,” PG Medical President Gregory Altshuler said in a Jan. 23 news release.
7. FDA clears Precision Spine’s ShurFit ACIF 2C system
Precision Spine announced Jan. 18 that FDA has granted 510(k) clearance to its ShurFit ACIF 2C anterior cervical interbody system. Precision Spine makes the ShurFit system from medical grade polyetheretherketone, coating it with both commercially pure titanium and hydroxyapatite. The biomaterials combination is meant to better achieve biologic fusion.