- Release Date: 25/05/15 15:54
- Summary: GENERAL: PEB: PE Agrees Settlement with FMA on Continuous Disclosure
- Price Sensitive: No
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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
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- Ann: GENERAL: PEB: PE Agrees Settlement with FMA on Continuous Disclosure
Ann: GENERAL: PEB: PE Agrees Settlement with FMA on Continuous Disclosure
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