Renalytix Share Discussion Threads

[wan] 30/12/2019 07:47

II...Thanks for the heads-up.

I would raise awareness though to the potential 'beyond' the 40 million who have CKD (who will obviously benefit from KidneyIntelX™). It's worth considering that for a high percentage of the 40 million, CKD has occurred as a result of type 2 diabetes.

So, in my opinion, it's also worth considering the significant efforts underway to revolutionise identifying kidney disease early among high-risk patient populations and to better manage and thus reduce the national rate of kidney failure. e.g. In the United States, 30 million individuals have diabetes, 84 million adults have prediabetes (are at high risk for type 2 diabetes), and 75 million adults have high blood pressure.

Put another way, KidneyIntelX™ could ultimately be used for much wider testing beyond those already diagnosed with CKD in order to find those who have yet to be diagnosed with CKD, and therefore better manage by earlier intervention and thus reduce the national rate of kidney failure.

In any regard, if you do the maths based on the 40 million with CKD, even a small percentage in terms of market penetration and a price per test of $950 equates to significant revenues!

[intrinsicinvestor] 29/12/2019 12:11

https://www.thisismoney.co.uk/money/investing/article-7832547/MIDAS-SHARE-TIPS-lifesaver-Health-tester-Renalytix-gives-investors-50-boost.html

[wan] 24/12/2019 11:40

Merry Christmas and a healthy and prosperous New Year to all!

[wan] 17/12/2019 12:34

As detailed further above, there is a very good chance of further news flow this year. but in any regard, 2020 looks set to be a transformational year for Renalytix.

[holtenhenk] 17/12/2019 10:41

Pre Christmas rally??

[jsredbird] 13/12/2019 19:08

If true, I would assume that this would be due to possible acquisition? The company has been pretty visible in terms of their projects and existence, unless there is something I am missing?

[wan] 11/12/2019 10:01

Staying with Janssen (a Johnson & Johnson company).

Renalytix has established a New York laboratory operation via a lease with Johnson & Johnson Innovation, LLC – JLABS.

So, during some recent research and given that Renalytix is anticipating applying to New York State for clearance to operate as a clinical laboratory able to report testing results as early as the end of calendar year 2019 and prior to an FDA clearance decision, I thought I would take look JLABS New York.

There are 40 emerging companies within JLABS New York facility, but when you run a search you only get 34 company results (via a downloadable excel spreadsheet), but Renalytix does not show up on the list or search results. However, when you get the results from the search, JLABS state that "the company count may be lower than expected since it may be excluding some companies due to JLABS reporting requirements i.e. stealth-mode, acquisitions, etc."

So, given the imminent application for laboratory clearance mentioned above, I assume that Renalytix is one of the "cloaked" companies in stealth-mode?

[wan] 11/12/2019 09:13

Interesting article....interesting timing (Q1 2020)-

Janssen's INVOKANA (canagliflozin) Gets Boost Over Competitors with FDA Approval for Diabetic Kidney Disease and a Newly Minted Collaboration with Renal Giant, Vifor Pharma

Nov. 25, 2019 /PRNewswire/ --

It is well-documented that nearly half of patients with type 2 diabetes will eventually develop diabetic kidney disease (DKD), which is the most common cause of kidney failure in the United States. INVOKANA, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is the first agent shown to slow the progression of DKD since the standard of care (angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers) was introduced nearly 20 years ago. INVOKANA was initially approved for the treatment of type 2 diabetes in March 2013 and thus has amassed significant post-marketing data. Following the FDA approval on September 30, 2019, Janssen entered into a commercial collaboration with Vifor Pharma on November 4th to promote the new indication to nephrologists. Presently, Vifor Pharma has an active renal sales force promoting VELTASSA (patiromer FOS) for hyperkalemia.

Spherix will be tracking the DKD launch of INVOKANA in a quarterly series, RealTime Dynamix™: Diabetic Kidney Disease, which will kick off in Q1 2020 and will follow promotion levels, messaging, trial rates, experience, and shifting treatment patterns for the SGLT2 inhibitors, in addition to perceptions about pipeline DKD assets and where they are likely to fit in the DKD treatment algorithm.

Full article -

[wan] 04/12/2019 07:26

2020 is shaping up to be a transformational year for Renalytix.

Staying with 2020 -

2020 World Kidney Day theme - 2020 campaign highlights the importance of preventive interventions to avert the onset and progression of kidney disease

Kidney Health for Everyone Everywhere – from Prevention to Detection and Equitable Access to Care

Burden of kidney disease

Kidney disease is a non-communicable disease (NCD) and currently affects around 850 million people worldwide. One in ten adults has chronic kidney disease (CKD). The global burden of CKD is increasing, and is projected to become the 5th most common cause of years of life lost globally by 2040. Chronic kidney disease is a major cause of catastrophic health expenditure. The costs of dialysis and transplantation consume 2–3% of the annual healthcare budget in high-income countries; spent on less than 0.03% of the total population of these countries. In low-income and middle-income countries, most people with kidney failure have insufficient access to lifesaving dialysis and kidney transplantation.

Crucially, kidney disease can be prevented and progression to end-stage kidney disease can be delayed with appropriate access to basic diagnostics and early treatment. However, while national policies and strategies for NCDs in general are present in many countries, specific policies directed toward education and awareness about kidney disease as well as CKD screening, management and treatment are often lacking. There is a need to increase the awareness of the importance of preventive measures throughout populations, professionals and policy makers.

What we call for

This year World Kidney Day continues to raise awareness of the increasing burden of kidney diseases worldwide and to strive for kidney health for everyone, everywhere. Specifically, the 2020 campaign highlights the importance of preventive interventions to avert the onset and progression of kidney disease.

Full details -

[wan] 03/12/2019 07:49

Excellent news regarding confirmation of the pricing for KidneyIntelX.......with even more very good news and potential contained within the announcement -

"In Q4 calendar 2019, RenalytixAI achieved initial revenues from its KidneyIntelX(TM) pharmaceutical testing programme and expects testing revenue growth to build in the second half of the financial year ending June 2020, subject to approval of its New York based clinical laboratory by the State of New York to report testing results. The Company also expects additional strategic initiatives to be implemented which will further expand distribution and accessibility for KidneyIntelX(TM). These additional strategic initiatives will be announced in the coming months as appropriate."
(END)

Cue, perhaps, the last two paragraph's in my post 101 above!

[wan] 22/11/2019 07:30

It's also worth noting the indicated pricing of $950 for KidneyIntelX (in view of the potential market the test could address) and the fact that confirmation of pricing is due from Medicare this month -

30 September 2019

CMS Issues Preliminary Medicare Pricing Determination for KidneyIntelX™

Renalytix AI plc (AIM: RENX), a developer of artificial intelligence enabled clinical diagnostics for kidney disease, announces that for Medicare & Medicaid Services (“CMS”) has published its preliminary determination for national Medicare pricing for the Company’s KidneyIntelX™ test to be included in the national 2020 Clinical Laboratory Fee Schedule1. The preliminary determination sets a price of $950 for each test. CMS considered recommendations received through an open meeting and brief comment period along with the consensus of an independent advisory panel.

A public comment period follows the publication of these preliminary determinations with comments accepted by CMS up until October 27. Final pricing determinations are expected to be published in November 2019 and will become effective on January 1, 2020. The price set for KidneyIntelX will be effective for a three-year period, ending on December 31, 2022. The Company intends to pursue coverage determinations from both Medicare and private insurance payors at this pricing level beginning in 2019 for patients with kidney disease and Type 2 diabetes.

This announcement follows confirmation of the vote in favour of recommending ‘crosswalk’ pricing for KidneyIntelX by the independent Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests as referenced in the Company’s results release dated September 3, 2019.

A further announcement is expected in November following confirmation of the final pricing determination for KidneyIntelX from Medicare.

Full announcement -

[wan] 21/11/2019 08:17

Regarding Tuesday's announcement that Renalytix was participating in a London based event focused on Kidney Health.

I thought readers might be interested in how that was reported elsewhere -

“Capital Markets Day for Kidney Health will build on the momentum from the ‘Executive Order on Advancing American Kidney Health,’ which President Donald J. Trump signed this summer,” said ASN Executive Vice President Tod Ibrahim. “ASN is excited to showcase how the executive order’s bold goals and clear objectives—as well as the Kidney Health Initiative and KidneyX (which are public-private partnerships between ASN and the US Department of Health and Human Services)—will transform kidney care.”



In 2019, RenalytixAI expects to launch KidneyIntelXTM, an artificial intelligence in vitro diagnostic product intended to support physician decision making by improving identification, prediction, and risk stratification of patients with progressive kidney disease.

The U.S. Department of Health and Human Services (HHS) announced on 7th October 2019 its vision for advancing kidney health to revolutionise the way patients with chronic kidney disease and kidney failure are diagnosed, treated, and most
importantly, live.

The following then, is well worth readers/investors attention. It is a long, but worthwhile read (for the w/end perhaps), and well worth the effort of reading PAST the Executive Summary -

ADVANCING AMERICAN KIDNEY HEALTH
07/10/2019


In view of the above, Renalytix addressable market in the US could be much larger than the circa 40 million currently suffering from CKD. The Renalytix product could ultimately be used for much wider testing beyond the initially targeted high-risk groups in order to find those who have yet to be diagnosed with CKD.

I say this based on the drive and efforts to also revolutionise identifying kidney disease early among high-risk patient populations and to better manage and thus reduce the national rate of kidney failure. e.g. In the United States, 30 million individuals have diabetes, 84 million adults have prediabetes (are at high risk for type 2 diabetes), and 75 million adults have high blood pressure.

The above document details how the necessary changes will be catalysed.

[the stigologist] 25/10/2019 12:19

#PYC Mkt Cap £2m

'In discussions with several companies with established presence in the sector'

#SENS Mkt Cap £160m

Google Deepmind $500m+

Benevolent AI $2000m+

[volsung] 25/10/2019 11:57

Got bored with these and sold. Probably soar now. Hang in there patient ones!

[wan] 17/10/2019 07:26

15th October 2019

CDPHP Medicare Plans Receive High Star Ratings, Exclusive New Benefits

CDPHP is thrilled to announce that the Centers for Medicare & Medicaid Services (CMS) have yet again ranked its Medicare HMO plan and Medicare PPO plan* with overall Star Ratings of 4.5 out of 5 stars, among the highest in New York state and the nation.

[wan] 17/10/2019 07:21

Great news today regarding an important milestone for opening market access to KidneyIntelX!

[wan] 14/10/2019 09:27

I note that whilst I was away RenalytixAI/EKF Diagnostics won the AIM Transaction of the Year Award -

Impressive addition to the board today, who I note has achieved a great deal in terms of kidney disease research, including acute kidney injury (AKI) and advanced regulatory approvals of kidney injury biomarkers.

Renalytix has initially focused on products to address the chronic kidney disease (CKD) market

[volsung] 14/10/2019 08:39

Would be nice to see some northerly movement with this appointment

[wilsonst1] 01/10/2019 08:52

Thanks for all your thoughts Wan

[wan] 01/10/2019 08:12

9Degrees...It's hard to imagine that anyone who inherited RENX shares, or indeed took part in the fund raise are in anyway unhappy with progress thus far.

Anyway, as today's news demonstrates, it's back to further progress and business as usual!

[9degrees] 30/9/2019 19:21

why did Chris mills get so many votes against his reappointment?

[sspurt] 30/9/2019 15:08

CMS has set the price of KidneyIntelX for Medicare at a level higher than analysts expectations, $950 vs $750. A preliminary determination but a positive step nevertheless. Final determination slated for Nov.

[toffeeman] 30/9/2019 09:01

I hope one of the lists isn't - Short Tracker :)

[wan] 30/9/2019 08:44

Very good progress being maintained.

[wan] 29/9/2019 06:24

Renalytix is on 4 shortlists -

Best AIM companies of 2019 named here
by Andrew Hore from interactive investor | 27th September 2019

With the 2019 AIM awards fast approaching, our award-winning AIM writer guesses the winners.



This year, the awards will be held in London on 10th October