2011年4月20日星期三

Musculoskeletal News Roundup 21-Apr-11

Centinel Spine announced that 1Q:11 sales increased by 47% over the year-ago period. The company named adoption of the STALIF TT interbody device, which is intended for use in anterior lumbar surgery, and the STALIF C, which is intended for cervical indications, among the growth drivers.

Johnson & Johnson reported 1Q:11 sales of $16.2 billion, up 2% over the year-ago period and beating estimates by $356.9 million. Listed among a number of growth drivers were DePuy's sports medicine business. DePuy contributed $1.5 billion to sales, up 2% over 1Q:10. As discussed on the earnings call, hip sales declined by 2%, and knee was down by 4%. Spine was up by 1%. Growth rates exclude the effects of currency. Adjusted net earnings for 1Q:11 were $3.7 billion, or $1.35 per share, up 5% over the year-ago period and beating estimates by $0.09 per share.

Stryker reported 1Q:11 sales of $2.0 billion, up 10% over the year-ago period and beating estimates by $13.4 million. Recon sales were flat at $911.0 million, which the company attributed to lower shipments in knee and unnamed other implant systems offsetting higher shipments in hip and trauma and extremities. Among recon segments, hip was up 2%; knee was down 2% and trauma and extremities was up 2%. Spine and neuro sales contributed $340.3 million to total revenues, up 4% organically over the year-ago period. Spine sales were up 1% to $161.6 million. Growth rates exclude the effects of currency. Adjusted net earnings for the quarter were $322.0 million, or $0.90 per share, up 13% over the year-ago period and beating estimates by a penny.

Funding
AOI Medical raised $2.9 million of a planned $5.6 million funding round. The company is developing the Ascendx device for the treatment of vertebral compression fractures.

Benvenue Medical raised $35.5 million in a Series C round of financing co-led by new investors Domain Associates and Technology Partners, who were joined by current investors Versant Ventures and DeNovo Ventures. The proceeds will be used to complete KAST (Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial) and execute on the company's commercialization strategy in the U.S. and Europe. The company says KAST, which is being conducted in support of a 510(k) submission, is the "largest randomized study versus balloon kyphoplasty to date." The Kiva system consists of a PEEK-OPTIMA cylindrical implant that is inserted in a continuous loop fashion; bone cement is delivered through the implant's lumen and into the vertebral body.

Carmell Therapeutics raised a Series A financing led by Harbor Light Capital Partners, who were joined by Newlin Investment Company, the PLSG Accelerator Fund, LLC, Innovation Works, Ariel Savannah Angels, Blue Tree Allied Angels and individual investors. The company will use the funds to establish a pilot manufacturing facility and collect data on the company's platelet-rich plasma products. The company says their materials incorporate both platelet and plasma-derived regenerative factors and are "sterile, ready-to-use, easy to handle, shape and suture and exhibit mechanical properties designed to match the repaired tissue."

Regulatory
StelKast received FDA 510(k) clearance for their EXp Acetabular Liners, which are comprised of antioxidant and highly cross-linked polyethylene technology. The company plans to launch the EXp Acetabular System in July.

Product Introduction and Update
Medtronic launched the MARROWMAX Bone Marrow Aspiration Needle Kit. The product features a multi-holed cannula, which "allows for simultaneous marrow draws at the same position thereby reducing aspiration time and the need for sometimes painful repositioning of the needle."

Legal
Genzyme filed a patent infringement suit against Seikagaku and a Zimmer subsidiary that distributes Seikagaku's HA products in the U.S. The suit alleges that Seikagaku's HA technology, recently approved in the U.S. by the FDA and branded Gel-One, infringes patents for Synvisc.

Collaborations
RTI Biologics signed an agreement to provide spinal allograft implants to Alphatec Spine. Under the agreement, which is effective immediately and has a three-year term with the option to renew, RTI will process allograft implants for use in spine and made from assembled cortical allograft.

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