PEB Investor Update – May 2020

DEAR SHAREHOLDER

The last few months have been a time of significant challenge for people and businesses around the
world. As we all navigate the restrictions created by COVID-19, I hope you and your loved ones are
staying well and safe. Our thoughts are with those who have been affected by this pandemic.
We have continued to operate as an essential business
Pacific Edge has been operating as an essential business during this period, playing an important role
in supporting medical practitioners by providing timely evaluation and diagnosis of bladder cancer.
Ensuring our people remain safe while continuing to work is a priority. Our laboratories in New
Zealand and the USA already operate under very high standards of hygiene and safety, and we have
also established separate teams, safe distancing and extra cleaning and sanitisation. I would like to
acknowledge and thank all our people who are continuing to provide important diagnostic services to
our communities during this time.

Growing recognition of the benefits of Cxbladder’s in-home sampling solution
The COVID-19 global pandemic and the stay-at-home restrictions that have been subsequently
introduced, have resulted in many healthcare providers and urologists around the world grappling
with how to provide the best quality care for their patients. As a result, urologists have been
increasing their use of telehealth and video consulatations where possible, with procedures and
consultations continuing for high risk patients or being delayed for those considered lower risk.
However, patient concern is also something that urologists are taking into account with many patients
saying they don’t want to wait a long period of time to get the reassurance they require.
Cxbladder’s in-home sampling programme is proving itself to be a unique solution, allowing for in-
home testing for patients, with a minimum of face to face contact. Based on their test results, many
patients are able to defer having further assessment and invasive procedures to a later date. This
allows patients to stay safe in their ‘bubbles’ at home and also frees up essential healthcare capacity.
To highlight this growing interest, at the end of this newsletter, we have included some recent
examples of how the Cxbladder in-home sampling programme is currently being referenced to great
effect in the USA.
The clinical utility provided by in-home testing for haematuria and for patients being evaluated for the
recurrence of bladder cancer is also being recognised in New Zealand, with two large public
healthcare providers having recently commenced in-home sample collection using Cxbladder (see
further details below).
MAY 2020

Pacific Edge Limited Investor Update May 2020

New Zealand’s public healthcare providers add further Cxbladder tests to their
commercial use
Cxbladder is already being commercially used by 11 of the 20 District Health Boards (DHBs) in New
Zealand, covering approximately 62% of New Zealand’s population and we are working hard to get the
remaining DHBs up and running.
Extended Use of Cxbladder Tests
In April, two of New Zealand’s largest public healthcare providers (Counties Manukau Health and
Waitematā District Health Board), increased their commercial use of Cxbladder by adding a second
Cxbladder test to mainstream use. Counties Manukau Health has added Cxbladder Monitor to its
existing use of Cxbladder Triage and Waitematā District Health Board has added Cxbladder Triage to
its existing use of Cxbladder Monitor. Together, these two DHBs cover a population of more than 1.1
million people (approximately 23% of New Zealand’s population).
In-Home Sampling
In addition, three public healthcare providers in New Zealand have also commenced their use of
Cxbladder for in-home sample collection. Counties Manukau Health, Waitemata and MidCentral
DHB’s, (who combined serve a population of approximately 1.4 million people), are having Pacific
Edge dispatch the Cxbladder test sample systems directly to patients at home, for in-home collection
of their urine sample and return to the Pacific Edge laboratory by courier. Based on their Cxbladder
results, many patients can have a cystoscopy procedure avoided completely or deferred to a later
date. This means that many urologist appointments and procedures will be avoided at a time when
public healthcare resources are being prioritised and people are being asked to ‘stay at home’.

Review of clinical evidence by Novitas for inclusion in the Local Coverage
Determination (LCD)
In February, a peer-reviewed paper was published in BMC Urology that provided further real world
evidence of significant gains in clinical utility from the commercial adoption of Cxbladder Monitor
(CxbM). Three public healthcare providers in New Zealand measured the performance of CxbM on a
population of 309 bladder cancer patients monitored over a 35-month period. The paper concluded
that CxbM accurately ruled out 78% of all patients and reduced the average number of annual
cystoscopies by approximately 39%. During 35 months of follow-up, no patients progressed to
invasive disease or metastases and there was no cancer-specific mortality.
Based on these published data, several of New Zealand’s public healthcare providers have integrated
CxbM into their routine clinical surveillance of patients for recurrence of bladder cancer.
This type of real world clinical utility evidence is also required for positive coverage decisions by
reimbursement agencies in the US. Significantly, we were able to add this latest piece of peer-
reviewed evidence into the clinical evidence dossier that is currently being reviewed by our Medicare
Administrative Contractor (Novitas) as part of their ongoing consideration of our Local Coverage
Determination application.

Pacific Edge Limited Investor Update May 2020

Annual results to be released by end-May 2020
We are now underway with the preparation of our year-end accounts, for the twelve months ended
31 March 2020. We expect to announce our results to the market by end-May 2020, followed by an
investor conference call. Details of this will be provided to the NZX.
In the meantime, we hope you all stay safe.
Kind regards

Chris Gallaher David Darling
Chairman Chief Executive Officer



(1) Bladder Cancer Advocacy Network (BCAN) WEBINAR: BCAN in the USA provides thousands of patients,
caregivers and the medical community with the educational resources and support services they need to
navigate their bladder cancer journey. In a recent BCAN webinar for patients and families, leading US urologist,
Dr Sia Daneshmand, specifically talks about in-home testing using “Cxbladder as an option for patients who are
not considered to be high or low risk, but want to do something to get reassurance. In-home testing is also being
investigated as a feasible solution for urology care beyond COVID-19”.
(2) UroToday video: Urotoday has added a video to their website with two leading US urologists (Dr Neal Shore and
Dr Sima Porten) discussing alternative strategies to deliver bladder cancer investigation during COVID-19 and
beyond.
Dr Shore and Dr Porten comment on how they are currently using Cxbladder’s in home sampling programme for
the benefit of both their patients and their respective clinics. The video also includes a brief summary of Cxbladder
and our in-home sampling programme from Dr Thomas Nifong – the VP of Lab Operations and Medical Director of
Pacific Edge Diagnostics USA Ltd.
The discussion provides a timely overview of the benefits of using Cxbladder to identify at-risk patients for non-
muscle invasive bladder cancer (NMIBC) in the at-home setting.
(3) LUGPA Website: Reference to Cxbladder’s in-home sampling programme has also been added to the COVID-19
information hub as a cancer resource on the Large Urology Group Practice Association website in the USA.
LUGPA is the only nonprofit urology trade association in the US and represents approximately 2,400 urologists.

Pacific Edge Limited Investor Update May 2020


STAY IN TOUCH

ENEWS FOLLOW US
We encourage our shareholders to sign up to
receive email notification of news and
announcements from Pacific Edge.

Sign up here or visit the Investor Centre on our
website www.pacificedgedx.com.

www.facebook.com/PacificEdgeLtd/
www.facebook.com/Cxbladder/
www.twitter.com/PacificEdgeLtd
www.twitter.com/Cxbladder
www.linkedin.com/company/pacific-edge-ltd
www.bladdercancer.me

KEY DATES CONTACT US
FY20 Financial Year End: 31 March 2020 87 St David Street
P O Box 56, Dunedin, New Zealand
T +64 3 479 5800
E enquiries@pelnz.com
www.pacificedgedx.com