NZX ANNOUNCEMENT: Released 10 February 2014

Health Innovation Hub signs commercial agreement for entry of Cxbladder to DHB’s

The Health Innovation Hub (HIH) has signed a commercial agreement to engage DHBs in the adoption of Pacific Edge’s non-invasive bladder cancer detection system Cxbladder, making it accessible for nearly one out of every two New Zealanders.

As a result of the agreement Cxbladder will be considered for use to evaluate patients presenting with hematuria, a symptom of possible bladder cancer, in clinics operated by the four largest District Health Boards (DHBs), Auckland, Waitemata, Counties Manukau and Canterbury.

The HIH is a recently formed government enterprise with a mandate to enable technology commercialisation into and out of the country’s four largest DHBs.

Pacific Edge Chief Executive Officer David Darling says the agreement with HIH is especially poignant.

“Cxbladder has been clinically tested in some of these DHBs, in conjunction with their respective urologists who work in both the public arena and private practice. The decision of HIH to now assist the adoption of Cxbladder is a strong endorsement of its ability to deliver sound clinical outcomes for patients and significant savings in time and expense for DHBs.”

Cxbladder has recently also completed a blinded User Program in both Waitemata and Canterbury DHB's with outstanding results validating Cxbladder in these clinical settings.

“It was particularly pleasing to see such great results from these blinded studies, confirming the outcome of the large clinical study published in the Journal of Urology in the United States in September 2012,” says David Darling.

The Health Innovation Hub Chief Executive Officer Frances Guyett says identifying and forming strategic relationships with key external partners to accelerate commercialisation by enabling access to DHBs is one of the HIH’s key objectives.

""Pacific Edge is an innovative New Zealand company with demonstrated export potential. The Health Innovation Hub is passionate that New Zealanders should benefit from access to the same innovative health products that international markets do. Cxbladder is an exciting innovation with the potential to bring benefits to millions of people who show the symptoms of or need monitoring for bladder cancer.""

The agreement with HIH builds on a momentous 12 months for Pacific Edge. During 2013 the Dunedin-based cancer diagnostic company attained regulatory approval from CLIA, for both their Dunedin commercial laboratory and its purpose built Cxbladder testing laboratory in Hershey, Pennsylvania. In the United States, the world’s largest healthcare market, Cxbladder has been commercially launched, achieved sales and signed agreements with several large national provider networks to give more than 50 million Americans access to the bladder cancer diagnostic system. Other milestones included an agreement with Mid Central DHB based in Palmerston North to use Cxbladder to evaluate patients presenting with hematuria.

Cxbladder detects nearly 100 per cent of urothelial carcinomas, in preference to cytology for the detection and monitoring of patients who may have bladder cancer.

Pacific Edge Chief Executive Officer David Darling says the Government must be congratulated for creating the Health Innovation Hub in 2011 as a catalyst for the commercialisation of new innovative medical technologies coming from, and entering the health technology sector. There are a number of significant changes taking place in the procurement and adoption of step-change technology in the healthcare system New Zealand and part of those changes is a more expedient process for adoption of technology that will lower cost and or improve patient outcomes.

“New Zealanders will be the real winners of this initiative. Half the population are now able to more expediently access Cxbladder technology providing a highly accurate and efficient alternative to the other diagnostic techniques now commonly used. The option of patients being able to give a urine sample at home and for clinicians to receive the results a few days later has the potential to offer DHBs significant cost benefits by reducing the number of patients requiring a full clinical work-up.”

In addition to Pacific Edge's own subsidiaries offering Cxbladder in the United States and NZ, Cxbladder is being marketed in Australia by Healthscope, a leading healthcare provider, and is due to be launched in Spain, which has one of the highest incidences of bladder cancer, this year.

ABOUT New Zealand Health Innovation Hub

The New Zealand Health Innovation Hub’s purpose is to build a healthier world through smart innovation by becoming a world leader in accelerating health-related innovations from ideas to market through the establishment and on-going development of strategic partnerships, accelerateing product and service realisation, and leveraging the capilities and resoureces within the public healthcare sector and particpating DHB’s to optimise healthcare benefits.

innovation.health.nz

Editor’s note: The combined population of Auckland, Waitemata, Counties Manukau, Canterbury and Mid Central DHBs is 2.208 million – source DHB websites