Muscloskeletal News Roundup 16-Jul-09
BY LAUREN UZDIENSKI, JULY 16, 2009
Earnings
Biomet reported FQ4:09 sales of $639.3 million, representing a 7% increase over the year-ago period. Among segments, hip increased 9%; knee increased 11%; extremity increased 18%; dental decreased 13%; fixation increased 5%; and spine increase 18%. All growth rates exclude the effects of currency.
Johnson & Johnson reported 2Q:09 revenues of $15.2 billion, beating estimates by $200 million and representing a 1% decrease from 2Q:08. EPS was $1.15, down from $1.17 in 2Q:08 and beating estimates by $0.04. DePuy reported 2Q:09 sales of $1.3 billion, reflecting a 6% increase over 2Q:08. Among segments, hip increased 5%; knee increased 4%; spine was up 11%; and sports medicine increased 10%. All growth rates exclude the effects of currency.
Trans1 pre-announced 2Q:09 sales in the range of $7.9 to $8.0 million, below guidance of $8.7 to $9.0 million and missing analyst projections of $8.8 million. Second quarter sales increased 33% over 2Q:08. President and CEO Rick Randall attributed the "confusion in the marketplace" about AxiaLIF reimbursement, which declined by as much as a third after the AMA gave AxiaLIF a new-technology CPT code.
Funding
ConforMIS raised $50 million in a Series D round from several private equity and sovereign wealth funds in the U.S., Asia, Europe and the Middle East. The company develops patient-specific knee resurfacing devices and instruments based on CT or MRI scans.
Vidacare Corporation closed a $7.6 million Series D1 financing led by Piper Jaffray, who was joined by Tullis Health Investors, Incyte Venture's Targeted Technology Fund I and the existing investor base. Funds will be used to support the launch of the company's hematology/oncology product, the OnControl Bone Marrow System, and its OnControl Bone Access System for spinal surgical procedures.
M&A
Stryker Orthopaedics purchased BioDuct, a meniscal repair device, from BioAvascular Solutions. According to the company, the device can repair damaged tissue without removing it. Transaction terms were not disclosed.
Regulatory
K2M received 510(k) clearance to market its ALEUTIAN Spacer Systems as intervertebral body fusion devices. The devices are made from PEEK-OPTIMA and designed for a number of approaches and anatomies, including ALIF, Small-Anterior (Cervical), PLIF, Anatomically Narrow (AN) and TLIF.
Orthofix received the CE mark for its Advent cervical disc, which is composed of titanium endplates and a flexible elastomer core. The company will begin a limited rollout of the device in Europe in 4Q:09.
Product Introduction and Update
Cayenne Medical launched the CrossFix System for meniscal repair. According to the company, the system consists of a suture-only device that enables an all-inside meniscal repair. It includes a cannula and depth limiter to control needle penetration, which reduces the risk of neurovascular injury. The company adds that pull-out forces are equivalent to open suture techniques.
Integra LifeSciences introduced a smaller configuration of its Integra Mozaik Osteoconductive Scaffold strip. The product is designed to fill bone voids or gaps in the skeletal system of the extremities, spine and pelvis.
Integra also announced that they will release extensions to its Uni-CP Compression System, a line of compression plates and staples designed for the correction and stabilization of osteotomies and fusions in the foot. The new additions will offer surgeons new plate and fixation options.
Intellectual Property
Cytori Therapeutics received a notice of allowance from the U.S. Patent and Trademark Office protecting the use of the Celution system for the treatment of bone-related disorders, specifically relating to seeding devices with adipose-derived stem and regenerative cells.
Investigations
The DOJ is investigating cases of inpatient billing for kyphoplasty for possible violations of the False Claims Act. The probe stems from a whistleblower lawsuit from two former sales and reimbursement managers, who alleged that Kyphon urged hospitals to perform kyphoplasty as an inpatient procedure. In the absence of comorbidities or other factors, kyphoplasty is largely performed on an outpatient basis.
License Agreements
TheraCell, Inc. licensed certain stem-cell-related technologies from the Yissum Research Development Company, the technology transfer arm of the Hebrew University of Jerusalem. TheraCell will further develop and commercialize the technology for a number of regenerative applications, including spinal fusion.
Distribution Agreements
Integra LifeSciences entered into an agreement with Organogenesis, Inc. whereby Integra will to distribute Organogensis' FortaFlex Technology as Inforce Reinforcement Matrix. The company says FortaFlex was the first collagen-based biomaterial to be 510(k) cleared for reinforcement of all tendons of the human body.
Appointments
Pioneer Surgical Technology appointed Thomas J. McLeer to the role of Chief Marketing Officer & General Manager of Spinal Operations. Mr. McLeer jointed the company from Archus Orthopedics, where he was Vice President of Sales & Marketing.
Disc Dynamics CEO Steven J. Healy is resigning from the company and will join Lumen Biomedical as CEO. Upon leaving, Healy said, "I truly believe in the Disc Dynamics product, DASCOR, because it is unique and has demonstrated significant pain relief in European and early U.S. clinical trials." Disc Dynamics appointed David Stassen of Split Rock Ventures as Chairman of the Board to fill Healy's vacancy.
