PEB-Pacific Edge

[Greekwatchdog]

Novitas Proposes Expert Panel in Response to 2025 AUA Guide

15/09/2025, 09:03 NZST, GENERAL
Novitas Proposes Expert Panel in Response to 2025 AUA Guideline

DUNEDIN, New Zealand – Pacific Edge (NZX, ASX: PEB) today announces it has received notification from Medicare Administrative Contractor (MAC) Novitas that it intends to convene an expert panel to consider coverage for tests mentioned in the 2025 update to the American Urological Association (AUA) microhematuria guideline, including Cxbladder Triage.

The panel — known as a Contractor Advisory Committee (CAC) — is likely to be convened in early 2026. It will be comprised of urology subject matter experts and will be tasked with considering how to bring Medicare policy into alignment with the 2025 update to the AUA guideline.Pacific Edge notes that under the Medicare Program Integrity Manual, CAC meetings are initiated by the MAC and generally precede the draft issuance of a new or substantially revised Local Coverage Determination (LCD).

Pacific Edge Chief Executive Dr Peter Meintjes said: "We are pleased that Novitas has acknowledged the importance of the AUA microhematuria guideline and is taking a robust and credible approach to policy development by convening a panel of urologists who understand the latest update to the guideline. It is also recognition of the important role that randomized controlled trials like our STRATA1 study and guidelines play in the development of medical policy like LCDs."

[LoungeLizard]

Novitas Proposes Expert Panel in Response to 2025 AUA Guide

15/09/2025, 09:03 NZST, GENERAL
Novitas Proposes Expert Panel in Response to 2025 AUA Guideline

DUNEDIN, New Zealand – Pacific Edge (NZX, ASX: PEB) today announces it has received notification from Medicare Administrative Contractor (MAC) Novitas that it intends to convene an expert panel to consider coverage for tests mentioned in the 2025 update to the American Urological Association (AUA) microhematuria guideline, including Cxbladder Triage.

The panel — known as a Contractor Advisory Committee (CAC) — is likely to be convened in early 2026. It will be comprised of urology subject matter experts and will be tasked with considering how to bring Medicare policy into alignment with the 2025 update to the AUA guideline.Pacific Edge notes that under the Medicare Program Integrity Manual, CAC meetings are initiated by the MAC and generally precede the draft issuance of a new or substantially revised Local Coverage Determination (LCD).

Pacific Edge Chief Executive Dr Peter Meintjes said: "We are pleased that Novitas has acknowledged the importance of the AUA microhematuria guideline and is taking a robust and credible approach to policy development by convening a panel of urologists who understand the latest update to the guideline. It is also recognition of the important role that randomized controlled trials like our STRATA1 study and guidelines play in the development of medical policy like LCDs."

The stars are aligning. Sounds very much like Novitas finally recognise that non-coverage is out of step with medical evidence and the governing urological body. Can't see how bringing things into "alignment" could mean anything less than granting coverage. Great news for holders!

[raW tent Buffer]

SP nearly doubled since the SPP... Great month for holders and those who believed enough to throw down some more $$$.

[LoungeLizard]

SP nearly doubled since the SPP... Great month for holders and those who believed enough to throw down some more $$$.

Yep, great times for those that kept the faith. Having said that, those arriving late at the party could still reap a substantial reward when coverage is finally re-instated.

[lorraina]

Those who have kept the faith have found the tithe rather costly.



Disc .Luckily never had the PEB faith.

[LoungeLizard]

Those who have kept the faith have found the tithe rather costly.



Disc .Luckily never had the PEB faith.

How do you figure that? Those (like me), that participated in the 10c cap raise only 6 weeks ago have doubled their money. Those (like me) that kept the faith before that and averaged down have done even better.

It's been a long, bumpy ride for sure, but it's also been good to support a terrific, well run NZ company that has developed an internationally recognised, cutting-edge diagnostic tool that literally saves lives. PEB deserve the success that is (hopefully) coming their way. Likewise, long-suffering investors!

[lorraina]

A friend of mine loved the story a good few years ago and she bought in at around 80 cents.

[And from memory paid even more in one of their numerous capital raises.]

 

[Greekwatchdog]

Did this friend bail out when the shares were $1.60? Lots of options at play since then.

Ultimately its called investing, everyone has a story to tell.

Funny thing, PEB is just started another chapter..

[lorraina]

Third time trying to reply.
No she kept the faith.
Starting another chapter.?
Not so.Book 2 in the PEB trilogy series of novels.

[Greekwatchdog]

Third time trying to reply.
No she kept the faith.
Starting another chapter.?
Not so.Book 2 in the PEB trilogy series of novels.

You had a Gin or maybe 3 before tea then?
Good on her.
Yes.
PEB more like the bible. You read Sword of Shannara series? I think its up to 27 novels.....

[lorraina]

No like PEB I would avoid them...

[Greekwatchdog]

Just as well we spend our own money the way we like then whether it be investing or purchasing books.

[Highgate]

No like PEB I would avoid them...

[Highgate]

Seems to me lorraina you are showing yourself up as being illinformrd. If you have followed this company closely and the news flow of the past 3 years I think you would have a different sentiment at this time. I admit that the situation PEB finds itself in is disappointing and they are an easy target given the length of time taken and the patience required by shareholders. However given the amount of real world evidence from various jurisdictions, and now most importantly the AUA 'A'grade approval, there is no question that their products work and are poised to make a step change in the standard of care for patients presenting with hematuria. They are now in the strongest position in their long history to convert the opportunity for shareholders. The US market is significant and the rest of the world awaits! Why don't you do some homework! It's not too late!!

[Left Field]

Seems to me lorraina you are showing yourself up as being ill-informed. If you have followed this company closely and the news flow of the past 3 years I think you would have a different sentiment at this time.

I admit that the situation PEB finds itself in is disappointing and they are an easy target given the length of time taken and the patience required by shareholders. However given the amount of real world evidence from various jurisdictions, and now most importantly the AUA 'A'grade approval, there is no question that their products work and are poised to make a step change in the standard of care for patients presenting with hematuria.

They are now in the strongest position in their long history to convert the opportunity for shareholders. The US market is significant and the rest of the world awaits! Why don't you do some homework! It's not too late!!

Indeed.

Lorraina/Percy's comments just show different strokes for different folks.

Lorraina/Percy more aligned to dividend and retail stocks I suspect.

Other investors are aligned more to little Kiwi companies that can take on the world outside NZ....some also welcome the prospects of significant tax free capital gains.... some examples.

XRO was deemed a risky stock for a many years and the SP has shown some huge historical fluctuations on the path to success. When I first purchased XRO it was a $40 share, then the SP fell as low as $15. I did my research and backed XRO buying more at lower SPs until my av holding SP was in the low $20s...... fast forward to XRO today....... you get the idea.

I've now followed pretty much the same route with; ATM, GTK, IFT, TWR, FPH, IKE etc....(some still in my portfolio and some now gone.)

The trick is to do your research, buy your shares in small increments and continually work at improving your average holding SP by buying more in the 'lows' (but only if you are confident in the products and management's skills.)

Before Novitas my PEB av holding SP cost was $0.40..... this was fine when PEB climbed to around $1.40 and all was rosey...however when Novitas decision crashed the SP, it was a case of not panicking, waiting to see how management handled the issue, then acting... Once I determined that the downside risk was minimal compared to the upside I  gradually increased my PEB holding by 500% buying in around the 10c mark...... and I am now reaping the rewards.

I think the current iteration of PEB is the best it has ever been and the prospects ahead are exciting. Even the TA looks promising.

Holders are now well positioned IMO...... however there will always be other investors who differ.