Renalytix Share Discussion Threads

[toffeeman] 19/5/2021 09:29

So RENX is going to be getting large numbers of patient samples - can they share these with VRCI?

If so could be very big for VRCI!!!

[mr roper] 19/5/2021 08:37

I’m wondering if we’ll get an update on the Da Vita partnership soon. Supposed to launch this year.

[mr roper] 19/5/2021 08:36

Yup, the partnership model is giving them a large bed of patients for KidneyIntelX. Almost better for them to focus on driving revenue from these partnerships in the remainder of the calendar year before mcit is passed and the patient quantity increases hugely.

[faz] 19/5/2021 08:30

There is a guaranteed income here: "patients with chronic kidney disease will receive the KidneyIntelX test as part of a comprehensive care solution to drive quantifiable improvements in patient outcomes. KidneyIntelX will also be made broadly available to patients with both private and government insurance" IN exchange Renx is to provide R&D and educational support, mainly human resourses. LOoks win-win. 37 hospitals, 7 million people.

[mr roper] 19/5/2021 08:09

Yup, yet another partnership. Mgmt are delivering to the letter here. Should get a Q1 update in a fortnight or so.

[wan] 19/5/2021 08:05

More excellent news announced and today -

NEW YORK, CHARLOTTE AND WINSTON-SALEM, N.C., May, 19 2021 -- Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), Atrium Health , Wake Forest Baptist Health and Wake Forest School of Medicine announced a partnership to implement an advanced clinical care model designed to improve kidney health and reduce kidney disease progression and kidney failure in high-risk populations.

The KidneyIntelX bioprognostic platform for early-stage diabetic kidney disease risk assessment will be available through Atrium Health's electronic health record (EHR) system, providing access to primary care physicians, endocrinologists, nephrologists and care teams throughout 37 hospitals and more than 1,350 care locations across the Carolinas and Georgia. Charlotte, North Carolina-based Atrium Health serves more than 7 million people in the region, providing care under the Wake Forest Baptist Health name in the Winston-Salem, N.C. region and Atrium Health Navicent in Georgia.

The partnership with Renalytix enables focused population health initiatives in kidney disease and will provide real-world evidence of optimized delivery of care, improved quality of life, and reduced healthcare costs.

[wan] 18/5/2021 08:51

A relevant post from the EKF thread -

Yes indeed, Trellus is yet another example and result of the managements foresight and efforts in providing returns to shareholders via the dividend in specie and IPO route, which the management see as providing shareholders with a far greater reward than just paying a cash dividend.

So, it's worth bearing in mind that EKF are aiming to do one investment and one floatation per year, and are thus hoping to do another spin off next year (technology investment yet to be revealed/decided, but one would obviously expect an announcement on such a decision/investment to be well in advance of a spin-off for next year).

With new technologies and spin-offs firmly in mind, and food for thought, I do wonder what might be in store for Kantaro Biosciences -

We ensure that high-quality diagnostics tests for critical health challenges are accessible.

Kantaro is a joint venture of the Mount Sinai Health System and RenalytixAI (NASDAQ:RNLX).

We specialize in the rapid scale up of groundbreaking diagnostic innovations and the creation of partnerships to bring these crucial technologies to the market. Together with our partners, we provide academically rigorous, validated and results-driven diagnostics with the goal to advance the well-being of people, communities and society.

[wan] 18/5/2021 05:08

As expected -

CMS again delays breakthrough device payment rule in nod to skeptics
Published May 17, 2021

Dive Brief:
CMS has delayed implementation of its contentious breakthrough payment rule until December 15 depriving the medtech industry, at least for now, of a policy once hailed as a "significant" tailwind.

CMS' action is a negative for the near-term commercial prospects of some medtech companies. In January, analysts at J.P. Morgan hailed MCIT as "a significant commercial tailwind" for companies such as Abbott, Johnson & Johnson and Medtronic.

Cowen analysts acknowledged the delay as a blow but attempted a positive spin.

"Although the delay is a disappointment for the med tech industry, the silver lining is that the policy was not withdrawn. The implementation delay could give CMS time to address some of the concerns, which may or may not involve the agency reissuing a proposed rule. If delayed long enough, MCIT could also be addressed in the next iteration of the 21st Century Cures Act (Cures 2.0) or the reauthorization of FDA user fees in 2022," the analysts wrote.

Mark Leahey, CEO of the Medical Device Manufacturers Association, said in an emailed statement that MDMA is disappointed that CMS decided to continue to delay the implementation of the MCIT final rule.

Leahey contends that MCIT has strong bipartisan support in Congress and MDMA will continue to work with CMS to implement the final rule to "help ensure that Medicare beneficiaries get timely access to new medical procedures and therapies."

Full story -

[fardistanthills] 17/5/2021 09:21

Just to add my thanks for your explanation wan

[welshborderer] 16/5/2021 01:17

>>> Toffee

Many thanks, that makes it clearer.

[mr roper] 15/5/2021 18:54

Looks broadly very positive to me. Especially the focus on rwe. Suspect this puts Renx at the front of the pack. May now. Another partner and q1 results due b3fore end of June. Then we are in to the start of the business end of things in H2. Fda, mcit Plus partnerships. I suspect we end 2021 closer to 3000p than 1000p imho

[toffeeman] 15/5/2021 12:03

>> Welsh

There were EIS funds which invested in q3 2018 and if there was no AIM listing, l their investors would lose the 30% tax relief on investment.

So the earliest they would ditch the UK listing would be q1 2022.

[welshborderer] 15/5/2021 09:59

Thanks wan for explaining so succinctly to me, for one, what is happening in the States and the reasoning behind the late price surge yesterday.

It remains to be seen whether the news will trickle through to the London Stock Market which brings up a lingering thought of mine triggered from previous comments as to whether the company should now be considering a complete move away from AIM or is it still needing this dual listing for future fund raising purposes?

Neither market is safe from the movement of monies from short term, uncommitted investors, but the Americans appear more savvy as to what the company is doing. Is anyone aware of dual listing benefits that trump the access to funding one?

[wan] 15/5/2021 06:59

The MCIT rule is being delayed until the end of the year, but that looks to still be inline with the guidance from Renalytix, and the delay appears to be for positive development/amendments, as opposed to cancelation -

Medicare Program: Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary; Delay of Effective Date

This document is unpublished. It is scheduled to be published on 05/18/2021.

But you can down load the unpublished version, from which I have pulled a few excerpt/paragraphs from -

Other manufacturers that have FDA breakthrough designated devices but generally have yet to receive market authorization were supportive of a MCIT policy that would be more comprehensive and that includes specified guidance and expedited processes for benefit category determination, coding, and payment. These manufacturers support a delay of the MCIT/R&N final rule to the extent that such a delay would lead to a more comprehensive policy than the one that would be effective in May 2021.

Comment: Manufacturers acknowledged the need to develop evidence to achieve long-term coverage, and many indicated their intent to develop real world evidence(RWE).
Some stated that MCIT would incentivize manufacturers to develop RWE following market authorization and sought guidance from CMS on desired elements.

The additional delay announced in this rule will provide an opportunity to ensure that the objections to the rule are adequately considered. We will consider ways to diminish uncertainty with respect to Medicare coverage by building upon the evidence foundation established during the market authorization process or combining that evidence with other approaches like CED to expedite coverage in appropriate instances.

Response: The FDA criteria to determine whether a device is designated as a breakthrough is different from the criteria and evidence CMS reviews to determine
appropriateness for the Medicare population. The FDA does not routinely require data on Medicare patients. The relevant data is key for Medicare national coverage decision-making to ensure that Medicare is paying for devices that are beneficial to Medicare patients. While the goal of the MCIT/R&N final rule was to expedite coverage to speed access to innovative treatments, the immediacy of coverage must be balanced with ensuring that the Medicare program is covering appropriate devices for the Medicare population. Without any data or minimal clinical data to make this determination, it is challenging to ensure that breakthrough devices are beneficial to the Medicare population. We will further consider public comments seeking modifications to MCIT that might allow for expedited coverage while seeking to ensure devices are safe for Medicare patients even when those breakthrough devices do not have an evidence base that is generalizable to Medicare beneficiaries.


Investors will already be aware that RenalytixAI expects the MCIT rule, as is or amended, will become effective within the expected 2021 FDA review and clearance period for KidneyIntelX and will have no material effect on the RenalytixAI business plan.

Clearly Real-world evidence and population studies will be an important factor. And in this regard Renalytix is in front of the curve (in coordination with the FDA) and is already generating clinical evidence assessing the value KidneyIntelX in prospective utility studies. This significant and growing body of real-world evidence data is being designed to serve as a model for informing clinical teams and health systems on how to maintain kidney health and improve outcomes while reducing the burden of kidney failure in these at-risk populations.

Furthermore, during the quarter ended December 31, 2020, Renalytix began clinical testing experience with KidneyIntelX within the Mount Sinai Health System. And this real-world experience has met or exceeded targeted quality metrics and physician and patient satisfaction measures.

So, in my view this delay looks broadly positive for many reasons, and I note the positive price action in Renalytix shares yesterday in the US.

[mr roper] 14/5/2021 08:16

I’m not sure politicians ever feel embarrassed

[busterdog2] 14/5/2021 08:12

Embarrassing for them if they delay again.

[mr roper] 13/5/2021 18:38

hxxps://www.medtechdive.com/news/lawmakers-industry-urge-cms-to-push-breakthrough-payment-rule-as-may-15-de/600105/

[mr roper] 13/5/2021 18:34

Suspect that’s been driving the weakness.

[busterdog2] 13/5/2021 18:05

MCIT ruling tomorrow?

[busterdog2] 07/5/2021 16:03

So they dropped the price 42p and it's got a 40p spread. And at the close it popped back up a bit. That's what they do. So what?

[spittingbarrel] 07/5/2021 15:53

Hmmm offered at 10.64 now.

[mr roper] 07/5/2021 12:59

Super tight spread again today. 1070-1080p. Something is definitely afoot.

[mr roper] 07/5/2021 08:06

Renx tweeting this cnbc op ed



One week to go until mcit is hopefully brought into law.

[mr roper] 06/5/2021 15:20

Crikey, tightest spread I can remember seeing. Almost like the market makers have remembered they have a job to do

[wan] 06/5/2021 10:26

hpcg...I totally agree that Kantaro is somewhat of a side issue atm in terms of near term potential, but it could get quite interesting if Kantaro secure access/get regulatory approvals etc for additional tests.

So, and for now, it's KideneyIntelx approval and additional partnerships that will move the needle!