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FDA Approval for Portland Orthopaedics' Knee Replacement
Portland to sell primary knee and soon release revision knee products
06 / 04 / 2006
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
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