Orthocell has announced that the US Food and Drug Administration has granted regulatory clearance under the 510(k) pathway for the Company\u2019s nerve repair product, Remplir\u2122, paving the way to commence commercial operations into a US$1.6 billion addressable nerve repair market in the United States.<\/p>\n
The Company is well advanced in its US market launch preparations, with production ramp up underway, and outsourced warehousing, order processing and shipment in the US in place to deliver sales orders.<\/p>\n
Orthocell CEO and MD, Paul Anderson, said:<\/p>\n
\u201cI\u2019m delighted to announce we have received FDA clearance for our market-leading nerve repair product. We have been preparing in advance for this pivotal milestone, ramping up production from our facility in Perth and we have significant levels of inventory in place to deliver on early sales orders.<\/p>\n
Our sales, marketing and education team have made great progress identifying key opinion leaders, reputable reference sites and, most importantly, the distributors that we will work with to get Remplir into surgeons\u2019 hands.<\/p>\n
We expect strong product adoption in the US, having experienced rapid sales traction in existing markets driven by the excellent feedback from surgeons in Australia, New Zealand and Singapore\u201d<\/p>\n