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Company Financials: Orthopaedics and Spine

aap Implantate
€29.2MM (~US $38.9MM), +6% (U.S. $4.4MM, +77%)

  • U.S. sales driven by bone cement
  • Signed bone cement development contract with undisclosed orthopaedic company
  • Launched LOQTEQ trauma product family, expecting FDA clearance during 2012

Bacterin
$30.1MM, +96%
4Q11 revenue: $9.1MM, +72%

  • 2-year study results demonstrated equivalence of OsteoSponge bone scaffold to rhBMP-2 in spinal fusion
  • OsteoSponge used in >100,000 procedures to date
  • Signed distribution agreement with Jeil for LeForte craniomaxillofacial system, expecting full product launch 2Q12
  • Hospital accounts increased to 616 facilities, +27% from 4Q10
  • 2012 product launches include different shapes, prefilled syringes
  • Pursuing FDA clearance for OsteoSponge SC for cartilage regeneration scaffold: enrollment of 75 patients will take ~2 years
  • Salesforce ~56 reps strong, will add 15-20 during 2012
  • ~150 distributors worldwide

China Kanghui
RMB 327.0MM (~US $52MM), +35% (Domestic +32%, International +49%)Ÿ

    • Trauma $32MM, +31%
    • Spine $15.8MM, +46%
    • ŸOEM $4.1MM, +29%

4Q11 revenue: RMB 96.6MM (~$15.3MM), +34% (Domestic $11.1MM, +27%; International $3.5MM, +106%)Ÿ

    • Trauma $10.1MM, +45%
    • Ÿ
    • Spine $4.5MM, +28%
    • OEM $0.7MM, -30%
  • 4Q International growth supported by further penetration of existing channels in Asia, South America
  • Obtained FDA 510(k) clearance for TGM Medical’s Helicon Hip, Milestone Knee, related instruments
  • Launched 4 new products in 2011
  • Added 34 distributors in China, total 297
  • Integration of Wei Rui Li continues smoothly, expecting to introduce knee product in China during 2012
  • Reiterating plan to launch FDA-cleared hip and knee implants from Consensus under own brand internationally during 2012, in China by 2014
  • Other 2012 product launches include cannulated pedicle screw, anterior plate, proximal femoral locking plate, etc.

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