Renalytix Share Discussion Threads

[wan] 20/7/2023 10:44

I have tried to amend the link with variations and shortened ULR's etc, but to no avail. So for now, just copy and past the title - Why this AI diagnostics company is building a St. Pete lab....... into Google to access the whole story.

[wan] 20/7/2023 10:26

An interesting story -

Published 16 hours ago on July 19, 2023
By Veronica Brezina

Why this AI diagnostics company is building a St. Pete lab

Site selection consultant Mike Gilson, a former exec at global medtech firm Smith+Nephew, worked with McLain on securing a temporary facility on Pasadena Avenue. In the coming months, Renalytix will move into a permanent site near the OneBlood center in South St. Pete.

“OneBlood has all the people and talent to support large-scale blood-processing samples. We want to be close to them and the programs that support this type of business,” McLain said.

The company is working on additional products to measure changes in kidney health over time, identify the most effective therapy for a specific patient and monitor their response to therapy.

McLain explained that Renalytix will build a wet lab space to conduct clinical experiments. The team would also create a research and development hub, training rooms and offices for its back-of-office and corporate operations.

Prior to scouting sites in the Tampa Bay area, the team considered expanding to North Carolina’s Research Triangle, Tennessee or Indiana.

“These cities have regional Medicare administrative contractors who make decisions on health care coverage,” he said.

Medicare administrative contractors are private health care insurers who process claims in assigned territories. Medicare patients make up the majority of Renalytix’s consumer base.

The company has a lineup of existing Florida-based executives, including a lab supervisor, a lab tech and a vice president of sales, market access and a chief medical officer. With the St. Pete location, McLain said there will be additional positions in customer service and billing.

McLain said he has connected with the University of South Florida and the CareerSource organization about building a talent pipeline.

Renalytix has partnerships and contracts with health care systems such as Trinity Health, a not-for-profit Catholic health system operating 92 hospitals in 22 states, and the Orlando VA Medical Center. McLain said he is interested in working with the local VA centers, BayCare Health and AdventHealth.

“We are close to running our 10,000th blood test and are preparing to submit our first Medicare patient samples from Florida in the next few weeks,” McLain said.

Full story - [...]

[wan] 19/7/2023 10:33

I note that EVERSANA recruitment efforts are underway in a number of US territories, the following is for one of those territories (I note that some may have been filled) -

EVERSANA logo
Direct Hire - Account Executive - Kidney Health - Staten Island/Brooklyn/Queens Territory
Brooklyn, NY, United States
Full-time
Compensation Min: $100,000
Compensation Max: $120,000
Department: Sales
Job Family: Sales - Outside

Job Description
Direct Hire - The "Account Executive" is a field-based role with direct customer engagement. This individual will be responsible for the Brooklyn, Queens, and Staten Island territory. Reporting to the Regional Sales Director, the Kidney Health Account Executive will be primarily responsible for engaging and educating healthcare professionals in dialogue about approved indications, clinical evidence, and product accuracy/efficacy to support the appropriate use of KidneyIntelX and future products

Our client, Renalytix, is an in-vitro diagnostics and laboratory services company that is the global founder and leader in the new field of bioprognosis™ for kidney health. The leadership team, with a combined 200+ years of healthcare and in-vitro diagnostic experience, has designed its KidneyIntelX laboratory developed test to enable risk assessment for rapid progressive decline in kidney function in adult patients with T2D and early CKD (stages 1-3). We believe that by understanding how disease will progress, patients and providers can take action early to improve outcomes and reduce overall health system costs.

As an Account Executive, you will:
Full description -

[wan] 18/7/2023 09:30

Keeping an eye on the potential from international expansion:

The poor outcomes and costs associated to the current trend toward the late diagnosis of CKD is increasingly being recognised, and thus the calls and recommendations are growing internationally for earlier interventions in detection, identifying and treating risk factors for chronic kidney disease -

Medscape
12 hours ago — Madrid
Experts Call for Early Screening for Chronic Kidney Disease

Scientific societies are therefore advocating for screening at younger ages to reverse this trend and slow the progression of the disease.
Worth reading (registration required)

[wan] 13/7/2023 16:08

But as I have pointed out in previous posts:

others have failed to achieve what Renalytix has done 'ahead' of FDA approval. From one of my previous posts (2171) -

AdvaMed to CMS: “Patients Are Still Waiting—But We’re Encouraged Congress No Longer Wants to Wait”
Government & Legislative AffairsMay 10, 2023

“Increasingly, medical technology innovators are confronting a ‘valley of death’ where their technologies have received FDA authorization, but often no CMS or insurance coverage is in place to allow patients to gain access to them. Simply put, America’s seniors and patients across the country are all too often not getting timely access to critical medical technologies for many years, if ever.


So, Renalytix has done a lot of the ground work forming an effective bridge over the valley of death! Plus the deal with EVERSANA will extend and accelerate that progress. Hence the market should 'very much' appreciate FDA approval, which will hopefully come in June.
(END)

In short, Renalytix has put in place wide regional insurance coverage 'ahead' of FDA approval. Hence; "Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals"

And I would add that given FDA approval is widely recognised beyond the US, I think it's natural to expect that additional international regulatory approvals will follow in due course.

[hsdeo1] 13/7/2023 15:44

Fda does not mean sales. Too many companies fall short in that regard.i had agl and that did not end well.

[sos100] 13/7/2023 14:56

not sure how that's much of an issue (even if it happened)considering the FDA news?🤔

[hsdeo] 13/7/2023 13:55

to me it seems that if no deal is announced in next three months or money comes in then there will have to be a fund raise. happy to be proven wrong.

[mikemine1] 13/7/2023 13:11

Correct me if I'm wrong but RENX has reached practically all it's milestones now except breakeven point. FDA was the last major hurdle even though that didn't stop the company gaining multiple insurance acceptances and recognition of the validity of it's product without it. It even has a link up with a huge sales outlet that should propel the revenue stream quicker than RENX could do themselves.

It's all good to me and we only need to have a bit more patience to see what happens in the next 6 months. I also note the increased interest which has pushed the share price to the £1.40 mark from sub £1.00.

Lots of reasons to be happy IMHO and lots of potential upside for the share price I reckon.

[hsdeo] 13/7/2023 11:36

Please enlighten me. thanks

[hsdeo] 13/7/2023 10:58

Operating expense for the three months ended March 31, 2023 was $11.0 million

cash equivalents totalled $33.0 million as of March 31, 2023

so spending about 3.5m per month. which means cash ok until q1 2024.

Have I got this correct?

[mr roper] 13/7/2023 09:10

I'd expect this to re rate towards 10$ without news.

However it would be nice if if got an update on test run rate in late August. I'd have thought all focus should be on ramping up.mt sinai now. They have 90% of patients with insurance coverage there out of a pop of 50000. Fda approval and Mt sinai pushing the test I'd be hoping they are doing 1000 a month by end of year.

[hsdeo] 13/7/2023 08:54

I think there is news due shortly - the continued rise has a reason

[angus17] 13/7/2023 08:24

You wait until one of the strategic deals is announced that they were hinting at once FDA was awarded. Happy days then

[hsdeo] 13/7/2023 08:17

I think a £2 is on the cards in the next few weeks.

[mr roper] 13/7/2023 07:36

Just need a national medicare determination and the share price will be back to the highs before you can blink

[wan] 13/7/2023 07:18

I note the significant rise in Renalytix shares in the US yesterday/overnight.

And some very informative points contained within Renalytix recent blog -

Introduction

The FDA is responsible for advancing public health and its Center for Devices and Radiological Health’s (CDRH) stated goal is to “help bring innovative technologies to market and provide reasonable assurance that the medical devices already on the market continue to be safe and effective.”1

To realize this goal, the Agency’s approach is multi-pronged, including, but not limited to:

- Providing early regulatory assistance for innovators through info-share sessions
Innovators can familiarize the FDA review team about their ‘device’ and share differentiating benefits vs current practice and/or
Innovators can request FDA’s feedback during the product development and application processes
- Facilitating communication between innovators and payors to preempt/limit delays between FDA clearance or marketing authorization and coverage
- Giving information re: best clinical practice in research
- Training their own staff on new technologies and on the challenges that innovators face

Recently, I discussed the FDA’s progress in this area with none other than Alberto Gutierrez, currently a partner with NDA Partners, a ProPharma Company and a life sciences management consulting firm, where he advises companies in the device and diagnostic space. Alberto is an expert in preclinical and clinical testing of in vitro diagnostic devices, premarket notifications of devices, applications for FDA approval and post-marketing surveillance.

Notably, he also spent 25 years at the FDA in various executive roles, including, but not limited to being the Director of the Office of In Vitro Diagnostics & Radiological Health which included overseeing the Personalized Medicine Staff.

I know that you are aware of Renalytix’s KidneyIntelX test which was just granted De Novo Marketing Authorization from the FDA. How might this help the millions who suffer with kidney disease in the United States?

A test that can help identify the level of risk for kidney disease progression is a win. The corresponding ability for physicians to create custom treatment plans to improve patient outcomes…that’s an even bigger win.

Full interview -

[wan] 12/7/2023 15:24

AI is booming for good reason, and Renalytix is still somewhat under the radar in AI terms, but clearly it's starting to blip louder on some radar screens. So, it's likely we will see further increases in the sp, given the TAM, the wide moat and the huge potential from Renalytix platform technology.

[mr roper] 12/7/2023 15:06

Fomo about to kick in

[ny boy] 12/7/2023 15:03

Looks like a good AI play in the healthcare sector, I bought a small stay recently

[sos100] 12/7/2023 14:50

nice breakout

some large buys showing and nasdaq also up ,10% yesterday..