Healthcare Industry News:  total knee 

Devices Orthopaedic

 News Release - July 27, 2006

Portland Orthopaedics Wins US FDA Approval to Market New Primary Hips

First US sales order expected within weeks

Sydney, July 27, 2006 --(HSMN NewsFeed)-- Portland Orthopaedics Limited (ASX:PLD) has been granted US Food and Drug Administration (FDA) approval to market the companyís new M-COR primary hip in the US. The company will now ramp-up its manufacturing in preparation for delivery of its extended orthopaedic range to its exclusive US distributor, Plus Orthopedics Inc.

Portlandís M-COR primary hip has the advantage of modular design and a distinct neck component, that improves the fit and adjustability of a primary hip replacement and which can lead to increased longevity of the implant. The M-COR primary hip is fixed in the thigh bone (femur) with a traditional hammer and nail method that is very familiar to orthopaedic surgeons, but has unique and patented methods for assisting the surgeon to obtain ideal fit for each personís anatomy.

ďThis is a major regulatory milestone for Portland. It is a green light for Portland to sell and implant its most important hip product throughout the US. The hybrid design of the M-COR includes some of the innovative features of Portlandís revision hip while keeping the familiar interference fit method. This product is based on four years of market experience and has attracted significant interest from Plus and a small sample of US surgeons.Ē said Mr David Sekel, Managing Director of Portland Orthopaedics.

ďPortland will now be equipped to service revision hip replacement surgery as well as mass market primary hip replacements. Importantly, this makes Portland much more attractive to global hip and knee distributors as now we have a more complete suite to offer.Ē

The product and instrumentation was principally designed by Portlandís US Clinical Advisory Panel but will be manufactured in Sydney, Australia.

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. Portlandís 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. Portlandís 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 due for release in 2007. The core technologies are all patented and future applications include shoulders, ankles and other joints.


Source: Portland Orthopaedics

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