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MEDIGARD'S (ASX:MGZ) unique blood collection device is yet to hit shelves, despite two announcements that initial sales for the medical instrument would commence in March of this year.
The Gold Coast company, which has again delayed the launch, says it is a result of market resistance to primary packaging and unexpected delays occurring while trying to implement a solution.
Although significant resources had been employed to produce a blood collection device (BCD) that requires no primary packaging, it is now expected that sales for the BCD will commence in June.
Medigard says at the time of announcing a March launch date it was convinced the changes made to the device to allow it to be manufactured and distributed without primary packaging would not cause significant further delays.
"Although the changes are not obvious from appearance, the subtle design changes and the changes to the materials used for the moulding of some key components has also meant that manufacturing equipment has had to be modified," says Medigard in a statement to shareholders.
"As is the nature of medical device design changes, there has had to be changes to the regulatory approvals for the BCD. Both of these factors have caused unexpected delays."
Small-scale manufacture is currently under way and the BCD is expected to launch in Taiwan and Asia Pacific in June and the US and Europe in July.
Medigard says 300,000 BCDs are currently in production and will be distributed for clinical evaluations. A clinical study is to be coordinated in the UK.
The Medigard BCD features vacuum technology to capture the needle after blood has been collected. This is expected to prevent needle-stick injury by eliminating human contact with used needles and avoids potential aerosoling, a dangerous spray of fluid getting into the air when a needle is retracted.
In 2013, Medigard secured an exclusive license agreement with Shanghai Sol-Millennium Medical Products Co to manufacture and distribute its BCD and Blood Flash Needle.
Medigard has patents for the BCD in Australia, the US, Japan, Canada and Europe while the 3ml vacuum retractable syringe has patents in South Africa, the US, Australia, China, Japan and Canada.
Medigard was floated in 2004 and its board includes Don Channer as chairman and Peter Clark as director.
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