Renalytix Share Discussion Threads

[wan] 14/3/2021 13:55

FarDistantHills...Thank you for the complimenting the threads contributors. To be clear, I was not implying that that announcement was anything other than 13th Jan 2021 (which is recent in my book!), but more that it complimented my post and explanation directly above.

[fardistanthills] 14/3/2021 08:54

Deleted

My very humble apologies to both Wan and mginvestor! I can only assume after having been isolated for a year that I am losing the plot. I am totally embarrassed - both the RENX press release and the James Mccullough interview are very recent.

[wan] 14/3/2021 06:28

Exemplified by the following recent announcement -

NEW YORK, January 13, 2021 - Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, notes that the Centers for Medicaid & Medicare (CMS) announced the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway (RIN: 0938-AT88) to provide a coverage pathway for Medicare beneficiaries nationwide to have faster access to new, innovative medical devices and diagnostic tests designated under the Breakthrough Device review program and with market authorization by the U.S. Food and Drug Administration (FDA). Under MCIT, national Medicare coverage can become effective on the date of FDA approval or clearance of a breakthrough designated device and will continue for a period of four years. After a four-year period, continued coverage for Medicare beneficiaries will be based on one of three methods, 1) case-by-case coverage, 2) a local coverage determination, or 3) a national coverage determination.

"Having a clear path to national Medicare coverage for innovative products like KidneyIntelX provides a major catalyst to drive the robust research and clinical development programs necessary to address major unmet medical needs such as kidney disease," stated Tom McLain, President, RenalytixAI. "MCIT will also encourage early engagement with FDA in developing new diagnostic tests and leverage the many benefits of Breakthrough Designation including priority review of needed technology. We appreciate the opportunity to work with FDA and CMS to tackle the critical issue of early-stage prognosis to help slow or prevent kidney disease progression. This new coverage pathway will facilitate accelerated access to KidneyIntelX for Medicare beneficiaries and their primary care doctors to help assure a better quality of life and save lives."

Full release -

[wan] 14/3/2021 06:06

That's indeed correct, and the CEO stated recently that FDA approval is not a rate limiting factor. This is because KidneyIntelX is a laboratory developed test (LDT), 'initially' indicated for adult patients with type 2 diabetes and existing CKD (DKD).

KidneyIntelX has already been granted a common procedural terminology, or CPT code, and national Medicare pricing and positive coverage determinations from insurance payors and preferred provider organizations, and they are advancing commercial discussions with additional insurance payors and providers (watch this space!).

One of Renalytix stated goals is indeed to obtain FDA Clearance for KidneyIntelX to 'further' drive commercial adoption in the United States. While not required for commercialisation as an LDT, Renalytix is seeking marketing authorisation from the FDA through the de novo classification process, as 'part' of their strategy to produce a product capable of becoming the new, long-term standard of care for patients with CKD.

So, FDA Approval will accelerate commercialisation, as opposed to being dependant upon it.

Diabetic Kidney Disease (DKD), is the most common type of CKD, and affects approximately 12.6 million adults in the US. Based on the Centers for Medicare & Medicaid Services, national price for KidneyIntelX of $950 per reportable test, this represents a potential market opportunity of approximately $12 billion assuming one test per patient (but one assumes that multiple tests per patients may, in some cases, be necessary).

However, expanded indications for KidneyIntelX to individuals with general chronic kidney disease, including the underserved African ancestry and Hispanic population groups, would increase the U.S. total addressable market for KidneyIntelX to an estimated 37 million patients.

Europe (and beyond) is offering an additional large growth opportunity, in the fullness of time.

[nimbo1] 13/3/2021 17:48

That’s not true - testing has already started and fda approval isn’t a requirement for that. It’s much better to have fda approval than not of course as helps with rollout and perception.

[rampmeister] 13/3/2021 13:30

It seems that FDA approval of their KidneyIntelX platform will be pivotal. In that only after approval can they begin the rollout.

RM

[wan] 13/3/2021 10:46

It's even more staggeringly large when you start to consider the potential for expanded indications, which Renalytix has also mentioned.

I note that the shares in the US ended the day at an equivalent, in sterling terms, of over £11.

[mr roper] 13/3/2021 10:41

Agree, dp. Could easily go from 5m to 300m+ revenues in the next 12mths

[donald pond] 13/3/2021 10:21

I listened to the bioutah piece and was impressed. He's an American and they don't really do "sailing off on a yacht" in great numbers there. He is a businessman rather than a scientist and can see the opportunity here. I'm unclear about the margins but let's say they can get 100,000 patients at $925 a pop with a 60% margin. That would lead to profits of around $50m while testing less than 1% of the addressable US market. Is that reasonable and what is a realistic timescale for getting there? Because when you do the maths the figures quickly become staggering

[mr roper] 12/3/2021 14:54

Would’ve agreed but listening to him on the bioutah podcast I think he’s seeing this as a once in a lifetime opp.

[trickydicky1] 12/3/2021 11:50

“Decacorn̶1;.

Was my initial response to McCulloch's comment during the IPO roadshow that he was aiming at unicorn.

Still think he is a part-timer wanting to sail off in a yacht, but will send him nice case of champagne if he proves me wrong.

Not investment advice. To be clear. Most likely -100% given number of hoops to be jumped through still. But if it works ... Never risk more than you can afford to lose.

[mr roper] 12/3/2021 11:44

I think Renx could be a hundred bagger. It’s already done the first 10 and if/when it gets fda approval I could see it doing another 10 in 24-36 mths

[mr roper] 11/3/2021 18:53

New trial.about to kick off...kidneyintelix and ckd
hxxps://newsfilter.io/a/ea8cd18eb38aa7f7ac39a5dbd92d7619

[toffeeman] 11/3/2021 09:21

>> wan

TVM - works a treat

[wan] 11/3/2021 04:58

I have added a link for the NASDAQ RNLX chart, but I am not sure if that will suffice.

[welshborderer] 11/3/2021 01:05

Tradertrev: as an interim measure is this of any good to you?

[tradertrev] 10/3/2021 18:50

wan, any chance we can get the US daily chart in the header please?

[wan] 10/3/2021 16:39

Thanks also mginvestor for the radio interview link.

[mginvestor] 10/3/2021 16:32

Thanks Mr Roper,

The whole interview is worth a listen but for those who are sitting on the sidelines and working out the potential here and whether we will achieve it, have a listen from the 48min mark.

The energy and enthusiasm of Jim is infectious

@mginvestor

[sspurt] 10/3/2021 16:29

Wan - that Sara Barrington is a busy woman, she is also CEO at Verici. I know they are from the same stable but even so..

[charlieej] 10/3/2021 16:13

10 quid is irrelevant. It will hold or not dependent on the us price action.

[toffeeman] 10/3/2021 16:10

Tenner holding for now

[mr roper] 10/3/2021 15:43

Thank so for that, mg. listening now. Very good indeed

[cambridgedon] 10/3/2021 15:41

Kantaro Biosciences Named to Fast Company's Annual List of the World's Most Innovative Companies for 2021 and Ranked First in the Joint Ventures Category.
Just seen this on FT site. Can't do any harm!
CD