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- Release Date: 29/06/12 18:35
- Summary: GENERAL: PEB: PEB builds platform and prepares for launch of Cxbladder
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PEB
29/06/2012 16:35
GENERAL
REL: 1635 HRS Pacific Edge Limited
GENERAL: PEB: PEB builds platform and prepares for launch of Cxbladder
Pacific Edge builds platform and prepares for launch of Cxbladder in USA
29th June 2012
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.
For further information please contact:
David Darling
Chief Executive Officer
Pacific Edge Limited
Phone: +64 21 797981
End CA:00224480 For:PEB Type:GENERAL Time:2012-06-29 16:35:06
