Musculoskeletal News Roundup 29-Apr-10
BY LAUREN UZDIENSKI, APRIL 29, 2010
Earnings
CONMED reported 1Q:10 sales of $176.4, up 3% over the year-ago period and missing estimates by $2.4 million. The company noted "strong growth coming from our orthopedic and endosurgery single-use product lines," with arthroscopy sales increasing by 7%. Growth rates exclude the effects of currency. GAAP diluted EPS increased by 67% to $0.25, beating estimates by $0.02, during 1Q:10.
Exactech reported 1Q:10 revenues of $49.1 million, up 13% over the year-ago period and beating estimates by $1.6 million. Among segments, knee sales were up 13%; hip was up 1%; biologic and spine was up 4%; and extremity was up 22%. Net income increased 33% to $3.3 million, or $0.25 per share, beating estimates by $0.04.
MiMedx reported 1Q:10 sales $0.1 million, which compares to no revenues in 1Q:09. Net loss for the quarter was $2.6 million, improved by 11% from the year-ago quarter. Among recent highlights, the company launched the HydroFix Vaso Shield and Spine Shield products and is preparing to conduct animal studies to support FDA clearance of several new products. Additionally, the company has relocated its accounting and investor relations functions from Florida to its Marietta, Georgia headquarters.
Orthofix reported 1Q:10 revenues of $138.8 million, up 6% over the year-ago period and beating estimates by $1.6 million. In 1Q:10, spinal implants and biologics revenue increased by 3% to $29.8 million, which the company attributes to an increase in U.S. sales of lumbar and cervical spine implant devices, including the recently-launched Firebird pedicle screw system, Pillar SA interbody device and Ascent LE POCT system. Additionally, orthopedics sales increased 16% to $36.2 million, and sports medicine sales were flat compared to 1Q:09. All growth rates exclude the effects of currency. Net income for the quarter was $17.6 million, or $0.99 per diluted share, beating estimates by $0.15.
Ossur reported 1Q:10 revenues of $86.0 million, up from $77.0 million in the year-ago period, with prosthetics sales increasing by 11% and bracing and supports sales increasing by 6%. Net profit for the quarter was increased by 28% to $10.0 million compared to 1Q:09.
RTI Biologics reported 1Q:10 revenues of $37.8 million, down 3% over the year-ago period and missing estimates by $3.6 million. The company says revenue was impacted by a $4.0 million inventory reduction by their largest spine distributor. Net loss for the quarter was $0.05 million, or breakeven per fully diluted share, missing estimates by $0.03.
Synthes reported 1Q:10 revenues of $911.7 million, up 9% over 1Q:09 when excluding the effects of currency. Analysts had forecast revenues of $899.0 million. Synthes does not report product segment results, though the company called North American results "encouraging," noting that trauma was "solid" on "targeted sales initiatives and market acceptance of new products, specifically for the distal radius, fibula and clavicle." The company also describes a slowdown in spine from pricing pressure and delays in new product launches. Europe experienced double-digit growth across all product groups; Asia Pacific was "strong" despite government-mandated price cuts in Japan beginning in April 2009; and ROW benefited from sales performance in Brazil, which was "somewhat offset by a weaker performance in countries with distributorships."
Funding
Facet Solutions raised $2.1 million in a debt and warrant-based funding round. Prior investors include De Novo Ventures and Spray Venture Partners.
IMPLANET raised EUR 8.0 million ($11 million) from a number of investors, including CM-CIC Private Equity, Edmond de Rothschild Investment Partners, Wellington Partners, Seventures Partners and Auriga Partners. IMPLANET designs and manufactures hip, knee, spine and arthroscopy products exclusively in France and in Europe.
Product Introduction and Update
Aesculap Implant Systems launched the ProSpace DBM-D, a DBM available as a flowable paste or moldable putty. RTI Biologics manufactures ProSpace DBM-D for Aesculap.
DePuy launched the EXPEDIUM Vertebral Body Derotation Set, designed to "help surgeons correct spinal alignment and decrease rib rotation in patients with scoliosis." The system features the EXPEDIUM Derotation Quick Stick, an extension to pedicle screws to facilitate three-dimensional spine correction.
Intellectual Property
Applied Spine Technologies received U.S. patent No. 7,699,875 covering "Spinal Stabilization Device with Weld Cap," which claims geometry for a spring-based spinal stabilization device.
DFine received patent 7,678,116 relating to its StabiliT Vertebral Augmentation System.
Clinical
Applied Spine Technologies presented data from its IDE study on the Stabilimax Dynamic Spine Stabilization System at the Spine Arthroplasty Society (SAS) meeting in New Orleans this week. AST has enrolled more than 100 patients in its multi-center, randomized, controlled clinical trial in the U.S. to compare posterior dynamic stabilization using the Stabilimax Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar spinal stenosis.
Facet Solutions announced two-year data from its ACADIA pivotal study, noting "significant and sustained improvement in Oswestry Disability Index, VAS back pain and VAS leg pain." The company adds that there were no re-operations in any of the patients and all patients achieved ODI improvement. ACADIA is a motion-preserving treatment for lumbar stenosis.
Flexuspine received conditional approval from the FDA to begin its IDE for a feasibility study of its FSU device, a "Total Spinal Segment Replacement." The device is composed of an interbody disc component and posterior dynamic resistance component and is "designed as a system to restore the motion and natural kinematics of the affected spine segment." The company adds that this is the "first approved clinical study for a Total Spine Arthroplasty system in the U.S."
SI-BONE announced plans to present data on its iFuse Implant System for the sacroiliac joint at a number of 2010 spine meetings, including the World Congress of Minimally Invasive Spine Surgery & Technologies, NASS and the World Congress of Low Back & Pelvic Pain.
Vertiflex enrolled the 100th patient in its prospective, multi-center, controlled pivotal study evaluating the safety and efficacy of the Superion ISS compared to the X-STOP in patients with moderate lumbar spinal stenosis. The trial is being conducted at 23 U.S. sites and is expected to enroll approximately 330 patients.
Legal
Citing pre-emption, a federal judge dismissed a product-liability suit against Stryker. The complaint involved the failure of a Trident hip.
Education
Zimmer opened a new Zimmer Institute training center at its Trabecular Metal Technology facility in Parsippany, New Jersey. The company says the site is its first full-time BioSkills training center outside Warsaw, Indiana.
Appointments
Cayenne Medical appointed Randy Buness Chief Financial Officer. Most recently, Mr. Buness served as Chief Financial Officer of Routecloud, LLC, a mobile phone application developer and provider in Arizona. Additionally, he served as CFO at United Medical Network, a medical communications company acquired by Johnson & Johnson.
