Healthcare Industry News:  joint replacement 

Devices Orthopaedic FDA

 News Release - April 6, 2006

FDA Approval for Portland Orthopaedics’ Knee Replacement

Portland to sell primary knee and soon release revision knee products

Sydney, Australia, April 6 (HSMN NewsFeed): Portland Orthopaedics Limited (ASX:PLD) knee supplier has been granted US FDA (Food and Drug Administration) approval to sell its Beacon Primary Knee System in the US. As most hip replacement surgeons also replace knees this places Portland in a much stronger market position as a supplier of a suite of joint products.

This Primary Knee has been licensed from US-based Signal Medical Corporation and is used as a first time knee replacement for patients who are most likely sufferers of osteoarthritis and rheumatoid arthritis. The implant will relieve pain and increase mobility.

The knee replacement market is like the hip replacement market and is very substantial. In 2003 there were 732,000 knee replacements worldwide, an increase of 13 percent over the previous year. The US accounts for 59 percent of procedures.

“The knowledge that many surgeons performing hip operations also perform knee operations is the compelling reason for Portland’s Beacon Primary Knee. This product will be sold with minimal R&D investment or marketing expenses,” said Mr David Sekel, CEO of Portland Orthopaedics.

“Portland is using the Beacon Primary Knee and a $1.9 million AusIndustry grant to develop Portland’s revision knee. The revision knee will be a niche knee product designed for people with very poor bone quality who need the greater modularity and fixing capability. This will be a higher margin product with distinct points of difference in the market.”

“Once approved and released into the market the revision knee will be the only system of its kind available in the global market,” said Mr Sekel.

Portland Orthopaedics is also expecting imminent CE Marking European regulatory approval that will trigger sales of the Beacon Primary Knee in Australia and Europe.

Manufacturing of the Beacon Primary Knee has commenced and will be the manufacturing platform for the revision knee.

Portland currently holds a number of approvals for various hip products which have been implanted in over 1800 people. Recently major US distributor Plus Orthopedics Inc entered an exclusive distribution agreement with Portland that includes distribution of the Revision Knee System. While surgeons depend on standard implant designs there is increasingly awareness of special products for special cases to avoid high rates of revision surgery. Portland’s hip and knee implants are innovative and should result in increased durability.

Enquiries:

David Sekel
Portland Orthopaedics
0411 120 744

Rudi Michelson
Monsoon Communications
0411 402 737

About Portland Orthopaedics : Listed on the ASX in December 2005, Portland (ASX:PLD) is a developer and manufacturer of specialist hip and knee joint replacements. Portland’s first product, the DTC Hip, was conceived in 1991 as standard hip implants proved inadequate in cases with substantial bone loss especially where a hip implant had already been inserted. Portland’s first hip implant was trialled in 1997 and so far more than 1,700 implants have been sold, the majority in the US and Australia.

Portland has regulatory approval to sell a range of primary, revision and tumour hip replacement products in the US, Europe, Australia, New Zealand and Israel.

Portland is expanding its business from a single product focus into a multi-product orthopaedics company. The Equator Plus cup and a second and complementary range of primary hip replacements are due for market launches in 2006. A fourth product range of total knee replacement products is also due for release in 2006. The core technologies are all patented and future applications include shoulders, ankles and other joints.


Source: Portland Orthopaedics

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Please address inquiries directly to the issuing company.



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