PEB-Pacific Edge

[Left Field]

This very patient holder is pleased to see a worthy appointment to replace David Levison in a crucial role for PEB.

https://www.nzx.com/announcements/463478

[Left Field]

New Chair announced......

https://www.nzx.com/announcements/463929

[Pierre]

Interest in PEB seems to have picked up a little recently and the SP has crept up to 18.1cps at opening today.
 
Maybe some punters are positioning themselves for positive news at the Novitas CAC meeting on 19 February?

While a Medicare coverage decision won't be announced immediately, the tone of the meeting should give a pretty good clue as to the likely eventual outcome.

[Left Field]

Latest update from PEB.

https://api.nzx.com/public/announcement/466143/attachment/460697/466143-460697.pdf

Lab tests continue to struggle...... much resting on the 20th Feb LCD/CAC meeting. Also interesting to hear progress on PEB's ongoing legal case to pursue compensation for all Cxbladder Triage tests denied reimbursement.

"This ALJ hearing is a determinative stage of the Medicare appeals pathway we are pursuing for all eligible Cxbladder Triage tests that have been denied Medicare reimbursement since the Cxbladder non-coverage determination took effect in April 2025...... Consistent success in overturning denials could materially influence FY26 and FY27 revenue, by establishing a precedent for the more than 1,650 tests that have been denied reimbursement to date."

[LoungeLizard]

Very positive update regarding the engagement with Novitas prior to the meeting in February. One gets the sense that all the ducks have been lined up and the LCD decision should be a formality. Timely news also that another provider ( Avalon Healthcare Systems) has endorsed Cxbladder Triage.

[HAWKDOG]

PEB - stock on the ASX briefs podcast this week.

[Greekwatchdog]

For those interested, Link to ASX interview

https://ausbiz.com.au/media/the-small-cap-awaiting-its-medicare-moment?videoId=46361&sectionId=1885

[LoungeLizard]

Sent to investors today:

Kaiser Study Backs Triage Ahead of Medicare Panel


Dear Investor,

Pacific Edge welcomes the publication in the journal Urology Practice of a Kaiser Permanente study demonstrating the real-world Clinical Utility of Cxbladder Triage in the largest ever urine-based biomarker study on patients presenting with hematuria1.

The publication, which used a 3,353-patient risk-matched cohort (n=6,706) to determine the real-world reduction in cystoscopies and imaging (CT scans), concluded that Cxbladder Triage avoided 952 cystoscopies and 70 CT scans reinforcing the previously published findings of 59% relative reduction in cystoscopies from the prospectively enrolled, randomized controlled STRATA Study2.

This publication comes at an important time for Pacific Edge, because peer-reviewed publications can be considered by the Contractor Advisory Committee (CAC) that Novitas, our Medicare Administrative Contractor, will use to develop coverage language when it publishes a draft local coverage determination (LCD) that governs Medicare reimbursement for Cxbladder tests. The CAC has been tentatively scheduled by Novitas for 6pm on 19 February 2026 (US ET).

Pacific Edge Chief Executive, Dr Peter Meintjes, said: "Real-world evidence from one of the largest integrated healthcare systems in the US is significant, but in this case particularly so, because the study has a sample size of 3,353 risk-match patients, unequivocally demonstrating reduction in cystoscopy at scale.

"The study reinforces the existing clinical evidence that Cxbladder Triage can safely reduce unnecessary invasive procedures for low and intermediate risk patients and help clinicians focus cystoscopies and imaging on those at higher risk."

The retrospective study considered patients evaluated according to the new clinical pathway that includes Cxbladder Triage against a risk-matched cohort of patients from the same time period that did not receive Cxbladder Triage. The primary endpoints of the study were to compare the number of cystoscopies and imaging procedures (CT scans) between the new standard of care incorporating Cxbladder Triage and the prior standard of care, while monitoring cancer detection rates. Its key findings were:
The cystoscopy rate of patients classified by Cxbladder Triage as having a 'Low Probability' of urothelial cancer, was just 3.8%, compared with 46.5% in the risk-matched group.

The cystoscopy rate in patients with 'High Probability' Triage scores was 73.4%, versus 45.7% in the standard-of-care group, indicating more appropriate use of invasive procedures in those most at risk.

Overall bladder cancer detection rates between the Cxbladder Triage patients and the standard-of-care patients were similar (0.6% vs 0.7%), confirming that unnecessary procedures were reduced without compromising cancer detection.
The authors concluded: "Cxbladder Triage testing significantly decreased cystoscopy and imaging utilization among low-risk microscopic hematuria patients while simultaneously increased use among higher-risk patients. Cancer detection was consistent among patients in both groups."

Dr Meintjes said such a retrospective study and the evidence generation are uniquely available in the Kaiser Permanente system. It underscored the value of Pacific Edge's partnership with the healthcare provider and the shared commitment of both organizations to improving patient outcomes.

"The study publication provides powerful, independent confirmation of Cxbladder's value in everyday clinical practice. That is a compelling message for payers, providers, those attending the CAC in February and, most importantly, for patients who may otherwise face an invasive procedure they do not need," Dr Meintjes said.

[Greekwatchdog]

Just more great news, be interesting to see how the share price treks heading into 20th Feb meeting with Novitas.

[Habitz]

Trading at 20 cents each

[Greekwatchdog]

Trading at 20 cents each

Not today, closer to the 20th as we head to a Non Trading period whilst the meeting goes on.

[LoungeLizard]

With just over three weeks to the meeting, where a favourable outcome is almost certain, you would have to think that there should be a bit of lift in the SP leading up to 20 Feb, as new investors/traders move in for a quick doubling (at least) of their stake.

[Left Field]

This study and results is truly impressive......and nice to see the market reaction today.

However I'm not expecting an answer to all PEB's prayers immediately after the 20th Feb meeting.

Just saying, things may take longer (as we've seen before with PEB) and best to remain wary of the USA medicare systems under the current admin.

So 'well positioned', and 'cautious optimism' are my thoughts at the moment.

[Greekwatchdog]

Just wondering out loud. When do the remainder of the KP buisness empire switch the lights on and adopt CX Bladder Triage +?

You would think after this there must be a number of wheels turning..

[bulltrap]

As a patient holder, the news release and price action are welcome.

But I'm also tipping a clip around the ear from the market overseers, since a 15%+ intraday rise today suggests that this should've been a market news release rather than shareholder email and (presumably) press release, and furthermore should've been marked as price-sensitive.