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Wright Medical Finally Wins FDA OK For Hip Resurfacing

By Jon Kamp, Of DOW JONES NEWSWIRES

Wright Medical Group Inc. (WMGI) said Monday the Food and Drug Administration has finally approved the company's "Conserve Plus" system for bone-saving hip- resurfacing surgery, capping a protracted wait.

Shares of the Arlington, Tenn., company rose on the news and were recently up 8.7% to $19.10. Analysts have long considered approval of the Conserve Plus system a potential positive catalyst for Wright's stock.

The question for years, however, was when this would actually happen. The company filed for FDA approval in early 2004 and has been in regulatory limbo since then, with little explanation behind the reason for delay. Regulatory reviews are typically wrapped up much more quickly if there are no major issues.

Wright said the FDA approved the original Conserve Plus system specified in the company's application. The company plans to incorporate enhancements that are now available outside the U.S. through an FDA pathway for application supplements.

Wright said surgeon training for the system is expected to start immediately.

Hip resurfacing is a repair procedure for worn out hips that preserves more bone atop the femur than traditional hip-replacement implants. Manufacturers and surgeons believe this is helpful for younger patients by keeping bone available for repeat surgery they may need down the road.

While all major replacement-joint manufacturers have hip replacement systems outside the U.S., the U.S. market includes just two products from two U.K. firms, including Smith & Nephew PLC (SNN) and Corin Group PLC (CRG.LN). Smith & Nephew dominates in the U.S., where resurfacing has taken off more slowly than Wall Street expected.

Smith & Nephew officials have said they expect more growth once competitors win FDA approval for their resurfacing systems, which means they'll be backing the technology rather than marketing against it.

Stryker Corp. (SYK) markets the Corin resurfacing system in the U.S. Stryker, Zimmer Holdings Inc. (ZMH) and Johnson & Johnson (JNJ) are heavyweights in the $ 11 billion market for replacement hips and knees, where Wright is a small player.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

(Updates to add analyst comments, updates share price)

By Jon Kamp

Of DOW JONES NEWSWIRES

Wright Medical Group Inc. (WMGI) said Monday the Food and Drug Administration has finally approved the company's "Conserve Plus" system for bone-saving hip- resurfacing surgery, capping a protracted wait.

Shares of the Arlington, Tenn., company rose on the news and were recently up 6.3% to $18.67 after hitting $19.30 earlier. Analysts have long considered approval of the Conserve Plus system a potential positive catalyst for Wright's stock.

The question for years, however, was when this would actually happen. The company filed for FDA approval in early 2004 and has been in regulatory limbo since then, with little explanation behind the reason for delay. Regulatory reviews are typically wrapped up much more quickly if there are no major issues.

Monday's gains are "a good indication that a lot of expectations around Conserve Plus" were no longer built into the stock price, said Jeff Johnson, an analyst at Robert W. Baird.

Finally clearing this regulatory hurdle off the books could also bolster Wright's profile as a potential takeover target in the orthopedics market, where the company is a small player.

Wright said the FDA approved the original Conserve Plus system specified in the company's application. The company plans to incorporate enhancements that are now available outside the U.S. through an FDA pathway for application supplements.

Wright said surgeon training for the system is expected to start immediately.

Because it could take six months or so to win FDA approval for the most up-to- date Conserve Plus components, the system could start having a positive impact on Wright sales in the back half of 2010, analyst Johnson said.

"It could be a meaningful double-digit growth driver to their hip business over the next couple years as it ramps up," he said.

Hip resurfacing is a repair procedure for worn out hips that preserves more bone atop the femur than traditional hip-replacement implants. Manufacturers and surgeons believe this is helpful for younger patients by keeping bone available for repeat surgery they may need down the road.

While all major replacement-joint manufacturers have hip replacement systems outside the U.S., the U.S. market includes just two products from two U.K. firms, including Smith & Nephew PLC (SNN) and Corin Group PLC (CRG.LN). Smith & Nephew dominates in the U.S., where resurfacing has taken off more slowly than Wall Street expected.

Smith & Nephew officials have said they expect more growth once competitors win FDA approval for their resurfacing systems, which means they'll be backing the technology rather than marketing against it.

Stryker Corp. (SYK) markets the Corin resurfacing system in the U.S. Stryker, Zimmer Holdings Inc. (ZMH) and Johnson & Johnson (JNJ) are heavyweights in the $ 11 billion market for replacement hips and knees.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

  (END) Dow Jones Newswires
  11-09-091117ET
  Copyright (c) 2009 Dow Jones & Company, Inc.