PEB-Pacific Edge

[Pierre]

Supporters of the recent CR will be happy that their investment is worth 22% more with todays closing price of 12.2c.*

How high will the SP go when Novitas approval for Medicare reimbursement is finally received? What's your guess?

*Disc: Includes me.

[LoungeLizard]

Supporters of the recent CR will be happy that their investment is worth 22% more with todays closing price of 12.2c.*

How high will the SP go when Novitas approval for Medicare reimbursement is finally received? What's your guess?

*Disc: Includes me.

Likewise. Increased my holding by 10% and if it wasn't for being overweight already I might have bought more. Institutions/ Executives are piling in - a good sign that the smart money knows there's some good news coming.

How high will the SP go when the positive Novitas news hits the boards? Jeez, that a tough one. You've got to think that the SP will hit 50c very quickly - a matter of days or a week at most. But should the decision go their way, PEB will be in a better position than they were when they were at their peak all those years ago. I think the SP got to about $1.56 from memory and since then they have passed further extensive trials and been adopted by the AUA. Plus the re-imbursement level is about a third higher, so becoming cash flow positive would be on the cards.

I don't see any reason why PEB shouldn't eventually get back to that sort of level - $1.50-$2.00 - within 12-18 months of the favorable Novitas decision. It's complete guesswork of course, and nothing has been plain sailing with PEB. It's still high risk stock but I genuinely feel that the odds of a BIG payday are now in PEB's favour.

[Greekwatchdog]

Supporters of the recent CR will be happy that their investment is worth 22% more with todays closing price of 12.2c.*

How high will the SP go when Novitas approval for Medicare reimbursement is finally received? What's your guess?

*Disc: Includes me.

The million dollar question.

PEB certainly in a better position than they ever have been with AUA guidelines inclusion all sorted.
Its just a matter of knocking and signing contracts. The biggest in the short term would be Novitas. If that happens I expect to see $0.50/$0.60 very quickly. We also see some profit taking which could hold the share price back a little.

I thought the ASM was very positive. Directors have taken shares instead of cash for extra cash payments for their time.

Anatole Masfen quoted that he has never seen PEB in a better decision. He is not a dumb investor.
CEO looked bullish without saying the obvious.

PEB's time for commercial success has started, just a matter of joining the dots.

[LoungeLizard]

Huge buy side, and very few sellers. 13c today?

[Greekwatchdog]

Huge buy side, and very few sellers. 13c today?

And just like that, $0.13 taken out.

[LoungeLizard]

Very interesting post from the other site:

AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech

Coverage & Payment
Diagnostics
Digital Health
Government & Legislative Affairs
Health Access
Regulatory Affairs
August 20, 2025

WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology.
In a letter to CMS Administrator Dr. Mehmet Oz, the 67 organizations noted medtech enables remarkable patient outcomes, yet FDA-designated, authorized breakthrough medtech faces years of delays in Medicare coverage.
"Despite this remarkable impact and the continuous pace of innovation, Medicare patients face a significant and unacceptable barrier to accessing innovative medical technology," the letter states. "A recent study alarmingly revealed that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life."
A streamlined, predictable Medicare coverage pathway for medtech the FDA has deemed useful, safe, and effective would "demonstrate CMS' commitment to patient-centered care and ensure that Medicare beneficiaries can benefit from the rapid advancements in medtech without unnecessary delays, helping make for a stronger, healthier country," the letter continues.
"FDA is the global gold standard with its rigorous medtech safety and efficacy standards," said Scott Whitaker, AdvaMed president and CEO. "When FDA has identified a medtech solution as a 'breakthrough' and cleared it as safe and effective for patients, we believe Medicare should cover it. As this Administration and AdvaMed work toward our mutual goal of making Americans healthy again, I want to thank Dr. Oz and Commissioner Makary for their commitment to improving Medicare beneficiaries' access to the breakthrough medtech that could improve their health and even save their lives."
The letter, including the list of signatories, is available here.
The effort to achieve breakthrough coverage is gaining momentum. In a recent interview, FDA Commissioner Marty Makary said he and CMS Administrator Dr. Oz were working on automatic coverage of FDA-authorized breakthrough medtech to avoid a "repeat, duplicative approval process."
U.S. senators have introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage."

[Greekwatchdog]

Very interesting post from the other site:

AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech

Coverage & Payment
Diagnostics
Digital Health
Government & Legislative Affairs
Health Access
Regulatory Affairs
August 20, 2025

WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology.
In a letter to CMS Administrator Dr. Mehmet Oz, the 67 organizations noted medtech enables remarkable patient outcomes, yet FDA-designated, authorized breakthrough medtech faces years of delays in Medicare coverage.
"Despite this remarkable impact and the continuous pace of innovation, Medicare patients face a significant and unacceptable barrier to accessing innovative medical technology," the letter states. "A recent study alarmingly revealed that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life."
A streamlined, predictable Medicare coverage pathway for medtech the FDA has deemed useful, safe, and effective would "demonstrate CMS' commitment to patient-centered care and ensure that Medicare beneficiaries can benefit from the rapid advancements in medtech without unnecessary delays, helping make for a stronger, healthier country," the letter continues.
"FDA is the global gold standard with its rigorous medtech safety and efficacy standards," said Scott Whitaker, AdvaMed president and CEO. "When FDA has identified a medtech solution as a 'breakthrough' and cleared it as safe and effective for patients, we believe Medicare should cover it. As this Administration and AdvaMed work toward our mutual goal of making Americans healthy again, I want to thank Dr. Oz and Commissioner Makary for their commitment to improving Medicare beneficiaries' access to the breakthrough medtech that could improve their health and even save their lives."
The letter, including the list of signatories, is available here.
The effort to achieve breakthrough coverage is gaining momentum. In a recent interview, FDA Commissioner Marty Makary said he and CMS Administrator Dr. Oz were working on automatic coverage of FDA-authorized breakthrough medtech to avoid a "repeat, duplicative approval process."
U.S. senators have introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage."

Well that will be a big dot that will alomost certainly add alot of value to share price.
I wonder what market makes of news like this? Cerainly was an interesting week of trading last week thats for sure.

[LoungeLizard]

Well that will be a big dot that will alomost certainly add alot of value to share price.
I wonder what market makes of news like this? Cerainly was an interesting week of trading last week thats for sure.

This does seem like quite a significant intervention and condemnation of Medicare. It really highlights how the FDA and the US Senate now regard Medicare as being an actual impediment to granting patients access to clinically approved Medtech.
 
In view of this, together with the sheer weight of clinical evidence and AUA endorsement, it really seems  virtually impossible, in my view, for Medicare to contrive a way of turning down re-coverage of CXBladder.

Hard to say how the market will respond. PEB does seem to be on the market radar now with heavy trading most
days last week. I'm starting to think that the Novitas decision might come a lot sooner than expected this time around  

[Greekwatchdog]

This does seem like quite a significant intervention and condemnation of Medicare. It really highlights how the FDA and the US Senate now regard Medicare as being an actual impediment to granting patients access to clinically approved Medtech.
 
In view of this, together with the sheer weight of clinical evidence and AUA endorsement, it really seems  virtually impossible, in my view, for Medicare to contrive a way of turning down re-coverage of CXBladder.

Hard to say how the market will respond. PEB does seem to be on the market radar now with heavy trading most
days last week. I'm starting to think that the Novitas decision might come a lot sooner than expected this time around  

And then you can assume that there will be no issues around all Urologists using the approved products as per guidelines.

[Greekwatchdog]

Speeding ticket

https://www.nzx.com/announcements/457457

[LoungeLizard]

Speeding ticket

https://www.nzx.com/announcements/457457

Nothing to see here, is the response. All down to the reported positive meetings with Novitas, and the sense of inevitability in getting Medicare re-coverage.

[Greekwatchdog]

More good news

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes today that the recommended final 'Gapfill' price for Cxbladder Triage Plus has been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a US$1,328.32 price – a higher price than the US$1,018 draft price proposed in April this year.

The CMS price sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance for Triage Plus subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD), but Pacific Edge is preparing to submit a reconsideration request for Triage Plus shortly after the publication of the DRIVE Study that is currently in peer review.

Hematuria evaluation tests currently represent around 83% of Pacific Edge's total US laboratory throughput . The US$1,328.32 price is a meaningful increase compared to the US$760 CMS price of our existing tests and compared to the $1,018 draft price proposed by MolDX in April. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage to Triage Plus a priority, noting that Detect tests have already been migrated to Triage tests since the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.

Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that MolDX has recognized the novelty of Triage Plus in their pricing determination with an increase to $1,328.32 and that CMS has recommended this as a final price. 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."

The CMS final price for Triage Plus is still subject to 60 days of notice and comment but is typically not expected to change, and is expected to become effective from 1 January 2026.

[LoungeLizard]

More good news

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes today that the recommended final 'Gapfill' price for Cxbladder Triage Plus has been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a US$1,328.32 price – a higher price than the US$1,018 draft price proposed in April this year.

The CMS price sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance for Triage Plus subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD), but Pacific Edge is preparing to submit a reconsideration request for Triage Plus shortly after the publication of the DRIVE Study that is currently in peer review.

Hematuria evaluation tests currently represent around 83% of Pacific Edge's total US laboratory throughput . The US$1,328.32 price is a meaningful increase compared to the US$760 CMS price of our existing tests and compared to the $1,018 draft price proposed by MolDX in April. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage to Triage Plus a priority, noting that Detect tests have already been migrated to Triage tests since the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.

Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that MolDX has recognized the novelty of Triage Plus in their pricing determination with an increase to $1,328.32 and that CMS has recommended this as a final price. 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."

The CMS final price for Triage Plus is still subject to 60 days of notice and comment but is typically not expected to change, and is expected to become effective from 1 January 2026.

Nice little boost for the SP ahead of the main event - coverage being re-instated. The "gap fill" price of $1328 is nearly double the old amount representing a massive boost in revenue and margins.

And note that PEB dropped this into the announcement  "When coverage of Triage Plus is established..."  i.e such is their confidence they are not even saying "if" anymore.

[Greekwatchdog]

ASX trading is interesting..

Last Price / Today's Change
$0.185  +$0.054 (42.307%)

Volume
281,946

Bid / Offer Range
$0.140 - $0.185

[Left Field]

ASX trading is interesting..

Last Price / Today's Change
$0.185  +$0.054 (42.307%)

Volume
281,946

Bid / Offer Range
$0.140 - $0.185

Interesting thanks for posting.....some say today's SP rise is a tab too optimistic.

Some also say, it's not optimistic enough..... If today's news means a doubling of current revenue in 2026 (even without Novitas) then PEB's SP should be around $NZ0.20c.....?

Anyway whatever they say, it's been a nice day for holders.