Renalytix Share Discussion Threads

[mr roper] 19/4/2023 07:06

Another solid piece of rwe published today.

All eyes on the fda and the test run rate now

[hashertu] 12/4/2023 11:36

wan. Thanks.
Mind boggling sums of money being spent to treat the end state.

[wan] 12/4/2023 09:49

Renalytix launched their latest blog to coincide with the 2023 National Kidney Foundation’s Spring Clinical Meeting in Austin.

Among other things, they discuss why kidney disease is still not keeping pace with other chronic diseases relative to diagnosis and treatment and the importance (and relatively simple implementation) of early-stage screening, especially in high-risk populations.

An important and informative read that's well worth reading -

Why are there so many barriers to
diagnosing and treating kidney disease?
By Elise Wilfinger
11th April 2023

[wan] 12/4/2023 09:19

Given the results from testing on novel medication prescription in a diverse patient population and the subsequent increased use of SGLT2i's(in accordance with guideline recommendations), a rational question might be, what key player/manufacturer of Sodium-Dependent Glucose Co-Transporter 2 (SGLT2), 'wouldn't', subject to FDA approval, want to recommend or partner with KidneyIntelX version 1 (other tests are in the pipeline, which might also be of interest to partners)?

For context: Janssen Pharmaceutical, Eli Lilly, AstraZeneca Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals are the major companies operating in North America Sodium-Dependent Glucose Co-Transporter 2 (SGLT2) Market.

[wan] 12/4/2023 07:44

E Poster details and links -

Impact of KidneyIntelX testing on novel medication prescription in a diverse patient population

Richard Lord1,Jennifer Houlihan1,Terry Williams1,Steve Coca2,Barry Freedman1.
1. Atrium Health Wake Forest, Winston-Salem, NC, United States.
2. Renalytix, New York City, NY, United States.

INTRODUCTION
Use of risk stratification to guide treatment plans and population health initiatives have potential to prevent complications and improve equity. The KidneyIntelXTM bioprognostic test is a multiplex immunoassay of 3 plasma biomarkers combined with 7 clinical variables to generate an individual risk categorization (High, Intermediate or Low) for progressive decline in kidney function over 5 years in diabetic kidney disease (DKD). KidneyIntelX was recently introduced into the Wake Forest-Atrium Health System to assess early impact on DKD management.

Full details -

Diabetic kidney disease epidemiology in US veterans

Kibum Kim1,2,3,Jacob Crook2,3,Chao-Chin Lu2,3,Heather Nyman2,Joanne LaFleur2,3.
1. University of Illinois Chicago, Chicago, IL, United States.
2. University of Utah, Salt Lake City, UT, United States.
3. Salt Lake City VA Healthcare System, Salt Lake City, UT, United States.

INTRODUCTION
Chronic kidney disease (CKD) carries a significant burden on the Veteran’s Health Administration, with annual costs of $18 billion.[1] Because type 2 diabetes (T2D) is a leading cause of CKD, contemporary epidemiology of diabetic kidney disease (DKD) is essential to define the gaps in current DKD management. Progressive decline in kidney function (PDKF) is a predicted signal for early intervention.[2] We summarized the epidemiology of DKD in US veterans and examined the PDKF as a predictive indicator for early intervention.

Full details -

[wan] 12/4/2023 06:55

More supportive data announced today and being presented at a major conference also bodes well in my view for FDA approval, which is currently under review and active FDA discussion.

[wan] 03/4/2023 07:00

edit to the above post: not to mention a steep (and long!) learning curve and in-depth experience with the FDA.

[wan] 03/4/2023 06:53

Yes, and as I previously remarked, a catalyst for a steep increase in the testing run rate would be partnering with a large diagnostic player, Dialysis player (Davita?), and/or large pharma. In my view it is likely that two or all of those will occur due to KindneyIntelX having a meaningful impact on a market that is too large for those entities to ignore! Such partnering would also negate not only funding requirements, but also the salesforce requirement.

As an additional attraction, in what is obviously a world where AI is increasingly being deployed/integrated, I also see Renalytix expertise in AI & ML development and integration (also beyond kidney disease), not to mention a steep (and long!) learning curve and in-depth experience with the FDA, being of interest to those potential partners too.

[wan] 01/4/2023 11:20

Just in case some readers hadn't seen/heard the answer to a Renalytix question that was put to EKF management during the Q&A section of their Preliminary Results Presentation, which provides an informed and very positive view on the recent FDA update at 33m:39secs in -

[mikemine1] 01/4/2023 11:04

If they get paid $950 for each test that equates to $1,425,000 which could be around $7-8mn for the year depending on how well the sales grow.If it really takes off the $10mn plus could be on the cards but they would need to go some to reach that figure I reckon.

Just speculation on my part of course.

[mr roper] 31/3/2023 08:12

Interesting investor call.

Fda response due in q2.

CEO describes 2023 as "crossing the rubicon". Sinai switching to full commercial contract and seeing payments coming in from diversified sources.

Tests were 1500 for last quarter, by q4 I'd hope that would be doubled to 3000.

Exciting times

[wan] 30/3/2023 08:57

A broadly positive Half-year Report today, with very encouraging indications that testing adoption and testing volumes is set to materially increase.

Obviously Renalytix gave an business update recently (27 March 2023) highlighting further expansion of insurance coverage base for KidneyIntelX, and I also noted on here back in January that according the KindneyIntelx website the coverage for Commercial Health Plans and PPO Networks now extends to 32(possibly more).

I note that coverage has now increased to 36 -

[angus17] 22/3/2023 08:59

Oh ok. I can but hope. Buying a few more today anyway. I like the fact it's below the placing price.

[wan] 22/3/2023 07:56

Not really, as it's standard text from Renalytix for their notice of results.

[angus17] 22/3/2023 07:46

results next week to discuss new partnerships and strategic direction. Do you think we will be hearing about these sometime between now and next week?

A good time to top up I wonder.

[angus17] 21/3/2023 15:26

what we need to give this a boost is a trading update so that we can see what sales are doing. It's a dramatic fall the share price has had in a few weeks and I guess the BOD will be desperate to get it above the recent placing price. I am hoping that those that bought in at the recent placing price have been told that some good news is pending.

[hashertu] 21/3/2023 11:12

hxxps://www.rimsys.io/blog/de-novo-classification-process-a-beginners-guide

wan. This source is marginally easier to read.
Let's hope that delay is nothing more than that.

[wan] 21/3/2023 09:28

Todays RNS can be read several ways, it would thus be good to get further clarification. To my mind/interpretation, the following appears to be the most relevant/likely case as to what is happening -

Reclassification Process Described in Section 513(f)(3) of the FD&C Act
Devices that were not available on the market before the enactment of the Medical Device Amendments to the FD&C Act, on May 28, 1976 (generally referred to as postamendments devices), are automatically classified into class III under section 513(f)(1), without any FDA rulemaking process and regardless of the risks they pose.

Under section 513(f)(3) of the FD&C Act, the reclassification of these devices may be initiated by the FDA itself or it may be in response to a petition from a manufacturer or importer. As with the 513(e) reclassification process described above, to change the classification of the device, it is necessary that the proposed new class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. If the FDA receives a petition requesting a reclassification, it may ask a device classification panel to review the information and make a recommendation on the petition. After all information is considered, the FDA will issue an order approving or denying the petition. If the FDA approves the petition, the order will describe the reasons for reclassification and identify the risks to health (if any) presented by the device type.

[wan] 17/3/2023 07:58

Renalytix

Join us for a discussion with Dr. Joseph Vassalotti on March 30th at 5:30pmET. It is a rare opportunity to hear directly from the Chief Medical Officer of National Kidney Foundation with the latest evidence on the importance of early risk assessment in chronic kidney disease. Register today!

Diabetic Kidney Disease: Importance of Diagnosis and Early Risk Assessment for Optimal Outcomes

Thu, Mar 30, 2023 10:30 PM - 11:15 PM BST

Clinicians are faced with multiple barriers to address the complex management needs of patients with chronic diseases, including diabetic kidney disease (DKD). Until recently, treatment options for DKD were limited. Large-scale clinical trials have demonstrated that novel therapeutics, like SGLT-2 inhibitors, can significantly slow progression of kidney disease by 25-40% and reduce the risk of cardiovascular events, heart failure and death.

With new risk assessment tools, clinicians can simply and accurately identify those early-stage patients who are at highest risk for progression to rapid kidney function decline and failure. Implementation of KidneyIntelX in the primary care setting will allow clinicians to optimize the therapeutic management and specialist referrals of patients with early-stage DKD, improving outcomes and quality of life for patients.

Join Dr. Joseph Vassalotti, MD, Chief Medical Officer of the National Kidney Foundation (NKF) and Clinical Professor of Medicine, in the Division of Nephrology, at Icahn School of Medicine at Mount Sinai who will share his focus on implementation of evidenced-based clinical practice guidelines from the perspective of a practicing nephrologist.

[wan] 15/3/2023 08:03

There's a tool to help address those survey findings that revealed Physicians Agree on Need for Earlier Testing and Increased Transparent Communication for People Diagnosed With Chronic Kidney Disease Associated With Type 2 Diabetes -

A tool that yields a simple-to-understand, custom risk score, predicting which adult patients with type 2 diabetes and with chronic kidney disease stages 1-3b are at low, intermediate or high risk for rapid progressive decline in kidney function. KidneyIntelX is available across the country, where all patient tests are processed by a Renalytix Clinical Laboratory.

[supernumerary] 14/3/2023 17:11

Taken up by the media:



With billions of dollars on the line, Bayer survey finds flaws in kidney disease communication, diagnosis
By Nick Paul Taylor Mar 14, 2023 08:05am

Chronic kidney disease (CKD) should be among the top health concerns of diabetes patients. Yet, while around 1 in 3 adults with diabetes has CKD, a Bayer survey of healthcare professionals shows that people are often unprepared for their diagnosis and that communication needs to improve.

Bayer, which won approval for Kerendia in CKD associated with Type 2 diabetes in 2021, worked with market research company MedSurvey to survey 1,000 healthcare professionals (HCPs). The survey found that 84% of HCPs agree patients with Type 2 diabetes are often unprepared for their diagnosis of CKD, and that 88% of HCPs see a need for clearer and more transparent language about kidney disease risks.

The failings of current efforts to educate patients about CKD risks are clear in the survey data. Most, 89%, of the polled HCPs said people don’t understand their increased cardiovascular risk once they are diagnosed with CKD. Bayer has linked Kerendia to reduced risk of cardiovascular death.

If Bayer is to fulfill its $3 billion sales forecast for Kerendia, it will need a flow of new CKD patients. The survey suggests there is room to improve the patient pipeline, with most HCPs agreeing that the medical community could diagnose people earlier.

Sixty-two percent of primary care physicians are using estimated glomerular filtration rate blood tests to assess kidney function at least every few months. However, use of urine albumin-creatinine ratio (UACR) tests is rarer, with 30% of primary care physicians and 57% of nephrologists regularly using the tests. U.S. guidelines call UACR the easiest way to screen for albuminuria, a key factor in diagnosing CKD.

Bayer framed its generation and publication of the survey data as part of a push to improve diagnosis and ensure people receive optimal care. Establishing Kerendia as part of the go-to treatment regimen in the indication would boost Bayer’s prospects at a time when it is seeking to establish new growth drivers to offset the loss of exclusivity on its blood thinner Xarelto and eye drug Eylea.

Sales of Kerendia hit (PDF) 107 million euros ($115 million) in 2022, its first full year on the market. Bayer is going up against SGLT2 inhibitors, namely AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana, and ran its first TV ad last year to support its push for market share.

[wan] 14/3/2023 15:27

I missed this late last week -

World Kidney Day: A Bayer Survey Reveals Physicians Agree on Need for Earlier Testing and Increased Transparent Communication for People Diagnosed With Chronic Kidney Disease Associated With Type 2 Diabetes

Nephrologists and primary care physicians each see their role as the lead healthcare professional in diagnosing and managing chronic kidney disease (CKD) in type 2 diabetes (T2D) patients1

Results also revealed challenges among physicians co-managing people with CKD associated with T2D1
March 09, 2023

“Research has shown that co-management between a primary care physician and a nephrologist is associated with improved quality of care, delayed dialysis and more frequent testing, but we wanted to more deeply understand some of the challenges the treatment team faced in an effort to incite conversations about how we can improve on them,” said German Guerrero, M.D., Executive Medical Director, Cardiorenal, Bayer.4 “At Bayer, we are working to ensure people with chronic kidney disease associated with type 2 diabetes receive optimal care that ultimately leads to earlier diagnosis and treatment and better outcomes.”

“These findings reinforce the importance of our commitment to identifying resources and programs aimed at better understanding the real-world management of chronic kidney disease and expanding screening and early care management,” said Dr. Guerrero. “Together—with healthcare professionals and the broader kidney community—we have an opportunity to improve the diagnosis and management of chronic kidney disease to truly advance care.”

Full release -

[wan] 14/3/2023 09:04

Food for thought -

Recall that back in May 2022 Davita and Medtronic announced the formation of joint venture forming a new kidney health technology company, with Medtronic spinning off its renal care business into the venture and each company investing $200 million into the joint venture.

"We're excited to collaborate with Medtronic and share our deep insight into patient and physician needs with the goal of accelerating the development and commercialization of scalable kidney care technologies," said Javier Rodriguez, CEO for DaVita. "DaVita is committed to best-in-class solutions that improve outcomes, access and the quality of life of our patients, and this is another way to provide more options to the market."


I note that Medtronic recently stated in their Q3 2023 Earnings Call
on Feb 21, 2023, that completing the creation of its new joint venture with DaVita will close in the current quarter, stating that "We expect to close our Renal Care joint venture with DaVita here in the fourth quarter".

According the following article, the new company is apparently going to be called Mozarc Medical(excerpts follow)-

Medtronic and DaVita’s dialysis venture appears to be called Mozarc Medical
Regulatory filings indicate a medtech CEO is involved in the new kidney care company.
MARCH 13, 2023 BY JIM HAMMERAND

Clues are pointing to Mozarc Medical as the name of the new kidney care company that Medtronic (NYSE:MDT) and DaVita (NYSE:DVA) are expected to launch this year.
The companies used “NewCo” as a placeholder when announcing the new company last year and said a renaming and rebranding would come when the deal closes sometime in 2023.

Since then, Medtronic has filed trademark applications with the U.S. Patent and Trademark Office for Mozarc and Mozarc Medical relating to dialysis products.

It’s not clear when Mozarc Medical will launch, but Medtronic’s recent voluntary early retirement package (VERP) offer specifically excluded employees who “are conveying with Mozarc Medical.” Eligible employees had until last week to accept that deal, which required retirement on or before April 28.

The Mozarc trademark applications cover a long list of goods and services:

Computer, processors, and mobile device software, algorithms, and methods used to manage, control, operate and display information from medical devices for the treatment of organ deficiencies, medical devices for renal and extra-renal therapies, medical devices for filtration of bodily fluids and plasma exchanges, dialysis machines, and blood filtering devices; machine learning both supervised and unsupervised for managing kidney prescriptions and monitoring same; cloud infrastructure and related management software to manage patient prescriptions and ordering of consumables, kits, service, and maintenance of equipment

Full article -

It will thus be interesting to see how this new company impacts the kidney health/diagnostic landscape (and not just dialysis).

[red171] 09/3/2023 16:11

I would not like to be out should any of the expectations set for delivery this quarter end materialise but am not at the stage of selling on the basis that none of them will happen.

FDA, replacement for Medicare Coverage of Innovative Technology pathway, a mass coverage tippining point causing revenue to jump ahead of $1m pQ, Mount Sinai start placing orders at higher rate, determinations, even some VA centres actually placing orders or indeed cost burn significantly reduce would all be positive enough but I presume JO Sterling CFO would have been adding to his shareholding by now if their combined impact would be a step change.

The trouble is if they have made over optimistic guidance in the past, given the prize, who can be confident that none of it happen now. Have they just been engaged in raising more capital to spend?