LAWRENCE, Mass.—Australia’s Therapeutic Goods Administration has approved NxStage Medical’s System One home hemodialysis machine.
In addition, NxStage has signed a five-year agreement, the first year of which is exclusive, with Regional Health Care Group (RHCG), which is a medical products distributor in Australia and New Zealand.
"NxStage is pioneering home hemodialysis and will be an important addition to our portfolio. In Australia and New Zealand there are more than 12,000 people receiving dialysis treatment, and both countries are recognised as leading the world with home hemodialysis programs, achieving some of the highest 'at-home' patient rates internationally," said Stephen Doorey, General Manager of Regional Health Care Group (RHCG). "We look forward to combining NxStage's product portfolio with RHCG's extensive distribution network to give patients and providers access to the life-changing benefits possible with the System One."
Under the terms of the agreement with RHCG, the NxStage System One and PureFlow dialysate preparation system will be available to dialysis centers throughout Australia and New Zealand through RHCG, which also has the option to make Medisystems bloodlines and ButtonHole needles available to their customers in the region.
"We continue to put the building blocks in place to increase our presence in the international market," said Jeffrey H. Burbank, NxStage CEO. "I'm pleased to expand our reach to Australia and New Zealand with both regulatory approval for the System One and a new distribution agreement with RHCG, a premiere distributor of medical products in this region. With increased strategic focus, we expect international to be a more meaningful driver of our long term growth beyond 2011."