Pacific Edge builds platform and prepares for launch of Cxbladder in USA
Key customers in the United States are already being primed for the launch of Pacific Edge's novel diagnostic test for bladder cancer, Cxbladder on track for March 2013.
The commercial launch in the US of the non-invasive test, for bladder cancer is anticipated following successful registration by the CLIA regulatory authority of Pacific Edge's purpose built testing laboratory and the bladder test Cxbladder, in Hershey, Pennsylvania.
As part of the launch programme, the company is working with key urologist customers to establish the commercial requirements Cxbladder will need to fulfil. The company has also recently appointed Premier Source as its billing and reimbursement agent and surveyed Chief Medical Officers from a number of large private payor companies to ensure that the reimbursement system will meet the criteria of their reimbursement system.
"The United States is the largest and most comprehensive market for medical products in the world and it is essential that Pacific Edge fully complies with all the commercial and regulatory requirements from the outset," Chief Executive Officer David Darling says.
"Establishing a presence in the US is not an easy process and it takes time to fully understand the many layers and inter-relationships of the commercial and regulatory requirements. In this regard we have drawn upon the assistance of potential customers in trialling Cxbladder in their clinical setting."
Pacific Edge recently appointed Jackie Walker to lead the rollout and management of the company's diagnostic business in the US. "We are thrilled to have Jackie. She has a demonstrated track record of success in the life sciences and medical device industry spanning global companies and start-ups. With a strategic and results orientated focus, Jackie has exactly the kind of background that will drive Pacific Edge's success in the USA."
Pacific Edge is now in the process of making further senior appointments in the United States to build the sales and marketing team. "We are now confident that the core elements are either in process or are in place to launch Cxbladder in the US in March 2013."
Multi-centre, international clinical trials have shown that Cxbladder is highly reliable in identifying 100% of late-stage tumours and 95% of high-grade tumours in those patients with haematuria (blood in urine).
Expenses associated with the commercialisation and impending launch of Cxbladder into the US and the establishment of licensing agreements for Australia, Spain and Portugal and for Auckland and Northland in the last financial year form a significant component of the investment in the business during the preceding year. As a result of these investments in product and commercialisation the company reported a $4.1 million net loss after tax for the 2011 financial year as detailed in the Annual Report to Shareholders released today.
"The transformation of Pacific Edge from a research and development focus to a world leading molecular cancer diagnostics company is underway. Funds raised by way of a rights issue last year are underpinning this transition and we believe should provide the required buffer until tangible revenues are received from, New Zealand, Australia, Spain and most importantly, the US."
Pacific Edge will hold its annual shareholders meeting in Dunedin on 23 August 2012.« Back