Minnesota medical device giant Medtronic (NYSE:MDT) confirmed today that it recalled certain of its already-troubled Infuse spinal fusion surgery kits after learning of possible contamination in sponges manufactured by Integra Lifesciences.
Swedish orthopedic trauma products maker Bonesupport won CE Mark approval in the European Union for its next-generation Cerament|G injectable antibiotic-eluting bone substitute.
The Cerament|G product is an osteoconductive, ceramic substance designed to promote bone healing while preventing bone infection, or osteomyelitis The resorbable bone graft substitute is designed to remodel into healthy bone within 6-12 months while preventing colonization of microorganisms, especially in cases of deep bone infection.
Cerapedics said it closed a Series C equity round worth $19 million, led by new investors MedImmune Ventures and CVF LLC, an affiliate of Henry Crown & Co.
Existing backers OrbiMed Advisors and NGN Capital also participated, according to a press release.
Plymouth, Mass.-based cellular therapy manufacturer Harvest Technologies landed expanded CE Mark approval for its bone marrow aspiration concentration system product in point-of-care cell concentrate preparation for treatment of no-option critical limb ischemia.
Clinical studies used to support expanded CE Mark showed that the BMAC2 system could reduce risk for amputation as well as improve "rest pain" in patients with critical limb ischemia, according to the company.
Orthofix International (NSDQ:OFIX) said it’s making strides toward resolving a trio of outstanding legal issues with the U.S. government.
The Lewisville, Texas-based orthopedic device maker is finalizing agreements to close criminal and civil matters related to its bone growth stimulation business and is reaching agreements in principle to settle violations of the Foreign Corrupt Practices Act and investigations into its Blackstone subsidiary for potential violations of the False Claims Act.
Stryker Biotech agreed to cough up $15 million and and pleaded guilty to a single misdemeanor today, ending federal charges that it ran an illegal off-label promotion scheme.
British orthopedic titan Smith & Nephew (NYSE:SNN) shuffled its business deck yet again with the spinout of its biologics and clinical therapies division in a joint venture with venture capital firm Essex Woodlands.
Essex will own 51% of the new business, named Bioventus LLC, with Smith & Nephew holding the remainder.
SNN will also get $98 million in cash, which it plans to use to pay down debt, and a $160 million, 5-year note from Bioventus, according to a press release.