PEB-Pacific Edge

[LoungeLizard]

Sounds to me like they expected/wanted the amount to be higher?

Agreed, but they have a difficult path to negotiate. Too cheap isn't business-sustainable; too expensive and patients may not be prepared to pay. Never a dull moment with PEB.

[Left Field]

the re-imbursement price for cxbladder when it first gained coverage in 2020 was $USD760 so $US1018 for triage plus probably isn't all that disappointing.
All a bit moot though isn't it? until they can get coverage.

Here's what PEB were aiming for back in July 2024

"Pacific Edge has made what we believe is a compelling case for the Centers for Medicare and Medicaid
Services (CMS) to price Cxbladder Detect+ via 'Crosswalk', a process that acknowledges the advancement of
incorporating both RNA and DNA markers for the detection of bladder cancer in patient samples.

If CMS shares our view and agrees that Detect+ should attract a price of US$1,590, Pacific Edge
would gain significant upside to our existing market opportunity for hematuria evaluation."

So today's $1018 price better than the $760 they were getting, but not as high as they would have liked.

Can't help thinking a reason for the trading halt maybe that PEB could be evaluating a Cap Raise to allow them to progress based on this decision etc...... 

Pure speculation of course.

[LoungeLizard]

Here's what PEB were aiming for back in July 2024

"Pacific Edge has made what we believe is a compelling case for the Centers for Medicare and Medicaid
Services (CMS) to price Cxbladder Detect+ via 'Crosswalk', a process that acknowledges the advancement of
incorporating both RNA and DNA markers for the detection of bladder cancer in patient samples.

If CMS shares our view and agrees that Detect+ should attract a price of US$1,590, Pacific Edge
would gain significant upside to our existing market opportunity for hematuria evaluation."

So today's $1018 price better than the $760 they were getting, but not as high as they would have liked.

Can't help thinking a reason for the trading halt maybe that PEB could be evaluating a Cap Raise to allow them to progress based on this decision etc...... 

Pure speculation of course.

The tone of the release and the numbers themselves sound positive:


"Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline."

Clearly Triage Plus is the immediate focus and there is reason to be hopeful that eventually it will be covered under Medicare.
 Agreed that PEB may have to do a cap raise to bridge the funding gap in the short term. I can imagine it would be well supported as I feel PEB's products are gaining traction, the Novitas decision notwithstanding.
 

[Left Field]

More from PEB ..... sounding positive... (and no mention of a Cap Raise)

https://www.nzx.com/announcements/450711

Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.
 
 Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study , has already been submitted for publication.
 
 Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk.
 
 "The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics are used in our existing budget impact model we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most."

Onwards and upwards.........C'mon PEB you can do it!
 

[Greekwatchdog]

I suspect there will be more details coming out at the Full Year announcement next month. Be interesting to see what PEB have to say around expenditure to preserve cash and the prospect of a CR.

Unless they some how manage to come up with a solution I think it will be inevitable that a CR is needed within 12 months

[Greekwatchdog]

FYI posted on the other channel by 850man

Latest trial by Kaiser Permanente significantly involving 3353 patients, presented at the 2025 AUA conference. More info here:
https://www.urologytimes.com/view/cx...y-cystoscopies

[850man]

FYI posted on the other channel by 850man

Latest trial by Kaiser Permanente significantly involving 3353 patients, presented at the 2025 AUA conference. More info here:
https://www.urologytimes.com/view/cx...y-cystoscopies

I think this trial only needs peer review before it further adds to the evidence in favour of CXB