Shares of Orthovita Inc. (VITA) hit a four-year high Monday after the company announced it had received marketing approval from the U.S. Food and Drug Administration for its bone-augmentation material, Cortoss, which is expected to become the medical device maker's lead product in the next few years.

Analysts say Cortoss, which is injected in the spine to repair vertebral compression fractures, is superior to the only existing treatment on the market - polymethylmethacrylate cements - and should quickly start racking up solid revenues.

A representative from Orthovita wasn't immediately available for comment.

Orthovita shares recently gained 4.6% to $4.61 after earlier rising as high as $5.45 - an intraday price the stock hasn't surpassed since July 2004. The stock has made steady gains in the last few weeks, rising 28% in June, as investors anticipated the FDA approval of Cortoss.

Stryker Corp. (SYK), down 2.2% at $39.59, and Zimmer Holdings Inc. (ZMH), down 1.9% at $42.64, are among the giant medical-technology companies that sell polymethylmethacrylate cements.

Analysts say Orthovita has prepared itself well for the FDA approval of Cortoss, with an extensive sales force already in place to market the product. Orthovita is expected to have Cortoss on the market as soon as next month.

Cortoss mimics the cortical bone, which is the exterior, weight-bearing component of bones, and analysts say it has several advantages over polymethylmethacrylate cements, one of which is that it requires much less preparation time for doctors. Cortoss also has a lower risk of causing bone fractures in vertebrae adjacent to the one being fixed, Canaccord Adams analyst William Plovanic noted.

Plovanic said he expects Cortoss to post $3 million in U.S. sales this year, with the figure jumping to $20 million in 2010, and to double that figure in 2011.

Roth Capital analyst Matt Dolan said he expects Cortoss to capture $10 million in sales in its first 12 months on the market, with the potential to hit $100 million in sales in its first five years of commercialization.

Dolan added that in addition to having major revenue potential, Cortoss is likely to help Orthovita's bottom line by capturing a gross margin of 80%, well above the company's overall gross margin of 68% in the latest quarter.

-By Jennifer Hoyt Cummings, Dow Jones Newswires; 201-938-2474; jennifer.cummings@dowjones.com