Wright Medical Group, Inc. (WMGI) recently received the Food and Drug administration (FDA) approval to market its CONSERVE Plus Total Hip Resurfacing System in the U.S. The new system, which has received FDA approval, provides surgeons with a bone-conserving alternative to traditional total hip replacement.   With the FDA approval, Wright Medical can now market CONSERVE Plus in the original femoral and acetabular component configuration in the U.S. as specified in its PreMarket Approval (PMA) application with the FDA. The company also intends to develop additional enhancements to the system. Wright Medical is already marketing its CONSERVE Plus system, which has received FDA approval, with additional features in the international markets.   The CONSERVE Plus system, which has received FDA approval, offers pain relief and restoration of normal hip functions while retaining  maximum of the healthy bone. It preserves future surgery options, including a primary total hip replacement. It ...

Conmed Corporation (CNMD) reported third quarter 2009 earnings per share of 28 cents, surpassing the Zacks Consensus Estimate of 17 cents. However, earnings per share were lower than the year-ago earnings of 37 cents. Sales Net sales for the reported quarter were $175.5 million, declining roughly 2.2% year over year. Excluding an unfavorable foreign currency translation (FX), net sales increased marginally by 0.4% year over year. Single-use and reposable sales contributed roughly 75% to total sales and declined 0.4% year over year. Capital equipment sales contributed the balance and declined 7.1% year over year. The decline in net sales can be primarily attributed to the current economic turbulence that resulted in patients deferring their elective procedures. The decline was broad-based across major products. Arthroscopy sales declined 1.2% year over year to $68.7 million. Powered Surgical Instruments sales declined 3.9% year over year to $37.3 ...

Zimmer Holdings Inc. (ZMH) today reported earnings per share of 88 cents in the third quarter of 2009, beating the Zacks Consensus Estimate of 86 cents. However, earnings per share declined by 9.3% year over year in the reported quarter.  Net Sales  Net sales in the reported quarter increased 2.4% year over year to $976 million. Excluding an unfavorable foreign currency translation (FX), net sales increased 3.6% year over year. On a geographic basis, U.S. sales represented approximately 60% of total revenues and increased 4% year over year. Europe revenues declined 3% year over year to $242 million. Asia-Pacific contributed $149 million of revenues and increased 8% year over year.  Excluding Dental, growth in net sales was witnessed across all the product categories. Reconstructive sales represented roughly 76% of total revenues and increased 1% year over year. The Spine segment registered a strong growth of 24% ...

Stryker Corporation (SYK) yesterday reported third quarter earnings per share of 69 cents, in line with the Zacks Consensus Estimate and higher than the year-ago earnings of 66 cents. Net sales were flat year over year at approximately $1.7 billion. An unfavorable foreign exchange translation (FX) negatively affected net sales in the quarter.  Excluding FX, net sales increased 1.2% year over year. On a geographic basis, U.S. sales contributed roughly 65% of total sales and increased 0.2% year over year. International sales declined 0.3% year over year. In terms of business segments: Orthopaedic Implants sales increased 5.5% year over year to $1.0 billion. Growth was contributed by all the products, such as Hips, Knees, Trauma, Spine, and Craniomaxillofacial.  MedSurg Equipment sales declined 7.7% year over year to $637 million. The decline can be primarily attributed to lower capital spending by hospitals due to the current economic turmoil. Gross ...

Integra LifeSciences Holdings Corporation (IART) recently launched a smaller configuration of the innovative Accell Evo3 Demineralized Bone Matrix. This provides surgeons with the flexibility to use the device in surgical procedures where smaller amounts of demineralized bone matrix are required. The device was initially introduced as a bone void filler for large orthopedic reconstructive procedures. Bone grafts stimulate new bone production and bone fusion in the patient’s body. Accell Evo3 may be used as a bone graft extender in the spine, extremities and pelvis, thereby eliminating the need for additional surgery. The new product presents an opportunity to Integra to tap the fast-growing bone graft market. It is estimated that the U.S. market size for bone-graft substitutes in orthopedic spinal procedures is approximately $1.4 billion. Last year, an estimated 880,000 orthopedic procedures were performed in the United States, including over 500,000 spinal fusions. ...

Yesterday, Wright Medical Group Inc. (WMGI) announced the launch of its direct Australian subsidiary subsidiary, Wright Medical Australia Pty, Ltd. The Australian Branch will manage the company’s extremity and biologics distribution for customers in Australia and New Zealand . The company also entered into an agreement with Australian company LSS Pty Ltd. LSS will distribute Wright’s reconstruction joint devices in the two countries from the fourth quarter of this year. The launch of a new subsidiary will not only enlarge Wright’s customer base but will also enable it to satisfy the needs of specific customer segments in that region by developing a wider range of products. Furthermore, the expansion will provide the global orthopaedic medical device company with enhanced control over distribution activities. The launch of the subsidiary comes close on the heels of the new product launched ...

Conmed Corporation (CNMD) has recently started the process of recalling certain products due to manufacturing defects. Products affected are PRO5 and PRO6 series battery handpieces manufactured before May 31, 2008. Also affected are certain lots of the MC5057 Universal Cable manufactured prior to Dec 1, 2006, that are used along with the company’s electric powered handpieces. All these products were manufactured by Conmed’s Linvatec unit. The company has sent letters to customers notifying about the defects and stating the process to return these products for rectification.  The PRO5 and PRO6 series battery handpieces have the risk of potential self-activating. Therefore, safe and efficient usage includes inserting the battery away from the operation site and not touching or coming into contact with moving parts while inserting the battery.  The MC5057 Universal Cable has the risk of an electric powered handpiece to potentially self-activate. Here the safe and ...

Conmed Corporation (CNMD) reported its second quarter results yesterday and lowered its outlook for the full year. GAAP EPS was $0.05, considerably lower than the year-ago EPS of $0.40. Non-GAAP EPS was $0.17, compared to the Zacks Consensus Estimate of $0.16 and the year-ago EPS of $0.43.   Sales   Net sales in the quarter were $164.6 million, declining roughly 15% year over year. The decline in net sales can be attributed to adverse foreign exchange rate fluctuations (FX) and economic turbulence leading hospitals to delay purchasing capital equipments. Excluding FX, net sales declined roughly 10% year over year.   All the business segments reported lower sales. In terms of the top three business segments: Arthroscopy sales declined roughly 20% year over year to $61.6 million. Powered Surgical Instruments sales declined roughly 16% year over year to $33.5 million. Electrosurgery sales declined 12% year over year to $22.7 ...

Zimmer Holdings, Inc. (ZMH) reported second quarter of 2009 results with EPS exceeding the street estimates. EPS was $0.98, compared to $0.99 in the year-ago quarter but higher than the street expectations of $0.96 (Source: Reuters estimates). Adjusted EPS was $1.00, compared to $1.03 in the year-ago quarter.  Net sales for the quarter were $1.02 billion, a decline of roughly 5.5% year over year but above the street expectation of $1.01 billion (Source: Reuters estimates). The company attributed the year over year decline in net sales to an unfavorable impact from foreign exchange translation (FX). We believe lower sales volume resulting from customer losses due to the current economic turbulence also contributed to the declining sales. Excluding FX, net sales declined only 0.6% year over year.  During the quarter, all geographic regions showed a decline in sales, with the largest in Europe. Average Selling Prices (ASPs) ...

Stryker Corporation (SYK), one of the world’s largest medical device companies operating in the global orthopedic market, reported its financial results for the second quarter of fiscal 2009. Net sales in the quarter were $1,634.3 million, a decline of 4.6% year over year. The company was hurt by a slowdown in MedSurg businesses and foreign currency (FX) headwinds. Excluding FX, net sales were roughly flat, compared to last year.

In terms of business segments: Orthopaedic Implants sales were roughly flat year over year at $1,014.2 million. The company witnessed strong U.S. sales buoyed by higher shipments of reconstructive, trauma, spinal and craniomaxillofacial implant systems. However, international sales were lower due to currency headwinds. MedSurg Equipment sales declined 11% year over year to $620.1 million. This segment was hurt by the global economic slowdown with patients delaying their surgical operations. Lower shipments of surgical equipment and surgical navigation systems, endoscopic, communications

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