Australian lambskin pressure care products granted FDA approval in the U.S.

Export opportunities into the lucrative American market have been thrown wide open for a unique South Australian range of medical lambskin products.

Called Shear Comfort, this revolutionary range of lambskin pressure care products has just been granted FDA (Food and Drug Administration) approval in the US - meaning multi-million dollars for the Adelaide business behind the product, Lanapelle Australia.

The world-leading range of lambskin products has been designed to prevent, relieve and even heal - the serious & costly medical problem of pressure ulcers (or “bed sores”).

The special technology behind Shear Comfort lambskin was developed in 2000 by Lanapelle and the product is now used internationally - shown in clinical trials to reduce pressure sores significantly.

Shear Comfort products offers patients globally both relief and prevention from pressure ulcers, which are common in many healthcare settings affecting all age groups and are costly in both human suffering and use of resources. It is reported that Australia spends annually around $350 million on treating pressure ulcers. The US spends annually $40 billion with approximately 2% of the US population having a pressure ulcer at any one time.

In a nutshell, Shear Comfort lambskins are designed to reduce pressure on the skin, minimise friction, prevent shear and absorb moisture - all leading to decreased incidence of pressure sores and faster healing of existing sores. Each fibre in Shear Comfort products acts as a spring and, when combined as a complete product, skin pressure (especially over bony prominences) is evenly distributed.

A 2004 study by the CSIRO found that the incidence of pressure sores could be more than halved by using a medical sheepskin as a mattress overlay. Lanapelle has gone one step further in the creation of Shear Comfort, with a special treatment and manufacturing process it has devised for the lambskins, effectively making them commercially viable for hospital and healthcare industry uses.

Years ago natural sheepskin was commonly used in healthcare to alleviate pressure sores but then its use was stopped because, when washed at high temperatures (which is necessary for killing bacteria), the sheepskins experienced shrinkage and lost their benefits. Hence, for the purposes of infection control, synthetic materials replaced natural sheepskins - but were not as effective in controlling pressure sores.

Now natural sheepskin is back, with Lanapelle’s specialised treatment that allows the lambskin to be washed industrially at 80 degrees Celsius (in order to kill bacteria) over and over again - hence maximising cost effectiveness for hospital use. In fact, Shear Comfort products come with a warranty of 50 industrial washes.

There are 17 products in the Shear Comfort range, including bed overlays, operating table overlays, footcare boots and slip-ons, products for wheelchair users, and more. Shear Comfort uses specially grown Australian lambs wool that has a 30mm wool height (most others have a 19-25mm height); has a 20-25 micron fibre thickness, and is urine resistant among other qualities.

“The use of Shear Comfort in hospitals can have excellent cost saving flow-on effects,” said Lanapelle Product Manager Mark Snelgrove. “Patients usually recovered faster when using one of our products during their stay, which means increased bed turnover - and increased bed turnover means hospital waiting lists are reduced. This benefits both hospitals and the community.”

The Shear Comfort overlay sheepskin recently came top in a trial of 12 mattress overlays, carried out by the UK Department of Health’s Medicines and Healthcare Products Regulatory Agency. The Shear Comfort overlay had a vapour transfer rate (the amount of sweat a product is able to absorb over a specific time) that was more than twice that of a standard NHS mattress.

Shear Comfort’s FDA approval in the US on April 22 was very significant - many thousands of applications are made each week, with only a very small percentage successful. Shear Comfort is currently the only medical sheepskin to have TGA (Therapeutic Goods Administration) approval in Australia; it also holds the CE mark (European certification).

“Due to the credibility that accompanies an FDA approval in the States, this basically means the doors have been opened for us,” Mr Snelgrove said. “We will be able to increase our US sales quite significantly now.

“Shear Comfort is currently sold in 16 countries - with the main buyers in Japan, Canada and Europe. We are close to securing contracts in another 12-14 countries and aiming to have increased export to around 30 countries by the end of 2006.”

Over the past 5 years Shear Comfort sales have grown on an average of 140% per year and as a result Lanapelle has increased its work force by 15% to cater for the demand. Around 24% of sales come from the Australian market with SA sales contributing around half to this percentage.

Shear Comfort products can be of benefit to a broad range of medical and healthcare areas such as neo-natal, occupational therapy and much more.

Michell Joint Managing Director and Lanapelle Chairman Peter Michell said Shear Comfort was “having a very tangible positive impact on many people’s lives and on the medical industry as a whole - that’s why we believe so strongly in the product and why we’ve invested in Lanapelle.”

According to new Australian Bureau of Statistics data, South Australian businesses are among the most innovative in the nation. Almost half of the state’s businesses (45.9%) are active in innovation - compared with 30 to 35% in other states.

http://www.lanapelle.com