PEB
25/05/2015 15:54
GENERAL
PRICE SENSITIVE
REL: 1554 HRS Pacific Edge Limited
GENERAL: PEB: PE Agrees Settlement with FMA on Continuous Disclosure
25 May 2015
Pacific Edge Agrees Settlement with FMA on Continuous Disclosure
Cancer diagnostic company, Pacific Edge Limited (NZX: PEB), advises that the
FMA has issued it with a warning with regard to what FMA considers to be two
historical breaches of its continuous disclosure obligations, a copy of which
is attached.
Pacific Edge Chairman, Chris Swann said: "The delay of the announcements in
question was not made with an intent to breach continuous disclosure but
rather to meet the specific needs of the US contractual counterparties."
The events which resulted in the FMA warning date back to October 2013 and
are specific to the US market and the signing of two contractual agreements
with National Provider Networks where Pacific Edge was obliged to seek formal
approval from the contractual counterparties to announce to the NZX that the
agreements had been signed. This approval requirement, which Pacific Edge has
been advised is usual practice in the US market, led to a delay between
signing of the agreements and disclosure to the NZX.
Under a settlement reached with FMA, Pacific Edge has agreed to pay
compensation of $500,000 to shareholders who sold PEB shares during the
period of delay between signing of the agreements and the announcement to the
NZX.
Meeting continuous disclosure obligations remains a priority for Pacific
Edge's Board and management and it has since undertaken an audit review of
processes and policies and implemented recommendations.
Pacific Edge remains focused on generating long term shareholder value and
the company continues to make good commercial progress in the US and other
markets.
In the past six months, Pacific Edge has announced a number of significant
milestones including the launch of a second bladder cancer diagnostic test,
Cxbladder Triage and several patents issued for its cancer diagnostic
technologies.
ENDS
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
Pacific Edge
Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic
company specialising in the discovery and commercialisation of diagnostic and
prognostic technology for the early detection and monitoring of cancer. The
company is developing and commercialising its range of Cxbladder bladder
cancer tests. Its first commercial product, Cxbladder Detect, is now being
actively marketed to physicians and clinicians in New Zealand, Australia, and
the USA through the company's wholly owned subsidiaries and selected
commercial partners.
www.pacificedge.co.nz www.pacificedgedx.com
Cxbladder Detect
Cxbladder Detect is a proprietary, accurate molecular diagnostic test that
enables the non-invasive detection of bladder and other urinary tract cancers
from a small volume of urine. Cxbladder Detect is commercially available in
New Zealand, Australia and the USA. Cxbladder Detect is available in the USA
and NZ as a laboratory Developed Test (LDT) from the company's CLIA certified
laboratories, providing physicians and clinicians with a quick, cost
effective and accurate measure of the presence of the cancer, and provides
urologists with the opportunity to reduce their reliance on the need for
invasive tests such as cystoscopy. The Cxbladder Detect cancer detection test
has been validated by a multicentre, international clinical study.
www.cxbladder.com
Cxbladder Triage
Cxbladder Triage is a novel molecular test that combines the power of the
genomic biomarkers with extra phenotypic biomarkers to accurately identify
and remove patients with haematuria who have a low probability of bladder
cancer, from needing to have a full-urological work-up. This is a tool for
use by clinicians and physicians in the primary evaluation and will result in
a reduction of the number of patients needing an expensive and invasive
work-up for urothelial cancer.
www.cxbladder.com
About Bladder Cancer
Globally, bladder cancer has the 9th highest incidence and the 4th highest
incidence for men. One of the early symptoms of bladder cancer is the
presence of blood in the urine, haematuria. People with haematuria often
present to their general practitioner before being referred on to a
urologist.
Bladder cancer has a very high recurrence rate of approximately 50%-70% with
up to 30% of these recurring as later stage tumours. However, bladder cancers
are highly treatable, especially if detected in the early stages when there
is a much higher probability of survival. Timely detection and regular
surveillance and monitoring of this cancer is a key element of the clinical
process and of the individual's annual healthcare plan.
End CA:00264775 For:PEB Type:GENERAL Time:2015-05-25 15:54:48
