Rua Life Sciences Share Discussion Threads

[buywell3] 16/12/2021 19:22

POST REMOVED

[langland] 16/12/2021 13:22

That was old heart valve tech. They started from scratch in 2018 or so.

[74tom] 16/12/2021 12:58

They had the heart valve tech when the market cap was about £2m, if it takes them a year to get the comparatively simple vascular graft onto the right regulatory pathway then what chance do they have of commercialising the more complex heart valve?

[sicilian_kan] 16/12/2021 12:34

It also needs to be borne in mind that this is not the only tech here. I have always thought that the heart valve tech will be the real earner here.

[74tom] 16/12/2021 12:18

They are prioritising the 510k route because it's 'much simpler', does that mean it's the right route? Or does it mean they were trying not to go down the PMA route because they knew it would be more expensive & difficult?

I also raise the question that I posted this morning again; why didn't they state in Monday's RNS that human trial data will be needed? This is surely price sensitive information?

[sicilian_kan] 16/12/2021 11:38

Every 510k has something novel in it. If it were identical to the existing device, it wouldn't need 510k approval. What is important is substantial equivalence.

It appears that the FDA are saying that the novel part of the application (the incorporation of Elast-Eon(TM) on the outside of the graft to ensure that it is sealed) is unproven. That therefore requires proof, i.e. in this case, evidence by means of human clinical data.

Needing to prove up a novel component does not mean that there is per se no substantial equivalence if the data is then obtained. I think you are conflating the two points.

At the moment the company is clear that it is still pursuing the 510k point:

"The standard of data required to support the 510(k) is therefore higher than if the Company was producing a true like-for-like product."

"Rather than withdraw the 510(k), the Company has mutually agreed with the FDA to convert its 510(k) submission to a pre-submission or Q-sub. This Q-sub is an interactive discussion between RUA and the FDA to determine the regulatory pathway to approval in the US and allows the Company to negotiate with the FDA over the data required to support a future 510(k) clearance. Through this route, the Company will receive a full written response from the FDA in January 2022, which will allow detailed discussions to take place thereafter with the FDA."

So it looks like all options remain open, 510k and other routes and that 510k is the route the company is prioritising and which the FDA has not at this point ruled out. We will also hopefully know if the novelty can be kept within the 510k route, or if it has drifted too far from substantial equivalence if proven up. We will know more within 6 weeks, which is not long to wait.

[74tom] 16/12/2021 11:15

I'm absolutely baffled that anyone would invest further cash based on this morning's RNS.

"Having provisionally reviewed the Company's application, the FDA has highlighted that the Company's products introduce novel technology which is unproven in this application"

510k vs PMA:






"If the device is a high risk device (supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury) and has been found to be not substantially equivalent (NSE) to a Class I, II, or III [Class III requiring 510(k)] device, then the device must have an approved PMA before marketing in the U.S."

Also note the following from an RUA RNS issued last year;

"As previously announced on 5 August 2020, RUA Vascular recently reached the important milestone of achieving design freeze on its vascular graft products. This allowed grafts to enter the regulatory testing phase in advance of 510k submission to the FDA. The 510k process, or "Pre-Market Notification", is a much simpler regulatory path than the more stringent "Pre-Market Approval" process and is available to medical devices that can claim "Substantial Equivalence" to legally marketed equivalent devices that are for the same intended use and have the same technology or different technology that does not raise new questions regarding safety or effectiveness. The RUA Vascular graft was designed with the 510k process in mind and the testing of the recently "frozen" design is to demonstrate this "Substantial Equivalence". RUA anticipates the 510k data package to be submitted early Q2 of 2021."

So FDA says it contains 'Novel technology that is unproven in this application'. and yet RUA are still hoping to go down the 510k route of proving Substantial Equivalence? What are they going to compare it against?!

[greedy rooster] 16/12/2021 10:29

Interest and demand obviously significant. I'd forgotten that European clearance required clinical data. Annoying obviously, but perhaps in the end this simply delays the global, inevitable conversion to non-biogenic.

[sicilian_kan] 16/12/2021 10:24

Particularly when one also considers that they are due to get £1.6m revenues this coming year.

[sicilian_kan] 16/12/2021 10:15

Thanks langland and I agree with your views about vulnerability to predators at this market cap.

[langland] 16/12/2021 10:06

You picked a good technical area here at 80, sk, as I'm sure you well know. As already mentioned here, the company looks very vulnerable to predators at a market cap around 18mn.

[bones] 16/12/2021 09:34

74tom, you can’t compare the periods. In 2017/18, they were flat broke and none of what has been achieved since, along with the purchase of RUA Medical, was in place back then!

The majors pay for top R&D and they’ve got lots now well developed to grab.

[sicilian_kan] 16/12/2021 09:14

Cash levels were higher than I was expecting. That human trials are needed is no surprise after the last RNS. The tech is valuable and the share price is now factoring in the delays and funding needs. I had a target entry price here - after the last rns - of around 80p and bought (edit as took a few more) 30k shares at 81.6p-82p this morning.

[someuwin] 16/12/2021 09:12

Yup human trial will take years and tens of millions imo.

[mustau] 16/12/2021 09:09

Thanks-bottom drawer!

[74tom] 16/12/2021 09:05

bones, the share price was 17p in early 2017 & they raised at 30p in mid 2018, so any major wanting the heart valve technology could have bought it for less than 20% of the current value...

@mustau, yes clinical data will increase the length of the process substantially, it'll take a number of years IMO.

[source] 16/12/2021 08:54

Cash levels may need topping up given the problems & delays to approval now probably. Waiting & watching. Hopefully no more shoes drop in the meantime.

[bones] 16/12/2021 08:32

Market cap under £20M. All that developed technology in grafts and heart valve sitting there along with the rights to Elasteon that cost £20M to buy in 1999. You couldn’t make it up.

RUA must be a sitting duck, an almost risk free purchase for peanuts for any major. Those guys have long tentacles when it comes to negotiations with FDA.

[mustau] 16/12/2021 08:18

With clinical data required -does the process now become lengthy?

[buywell2] 16/12/2021 08:17

Because if the graft is deemed Class III then the clinical device trials can be quite long, costly and involve various stages ?








dyor

[74tom] 16/12/2021 07:56

Why wasn’t that communicated on Mondays update?!

[edmonda] 16/12/2021 07:45

RUA Life Sciences interim results demonstrated the continued investment in the business and its new products. The highlight of the interims was the 33% increase in third-party contract revenues that were a result of a recovery in elective surgical procedures, particularly in the US. Clouding the interims were the implications of the regulatory delay to the 510(k) review of RUA’s large-bore vascular graft medical device, which we explore more in this note.



The deferral of RUA Vascular product revenues raises the spectre that bigger medical device companies, and even its potential OEM partners for the products, might sense an opportunity. The pressures that a delay to revenues could bring, and the extent of the investment cost already spent on the product’s development, means they could attempt a licensing transaction at a fraction of our £74m valuation of RUA’s Vascular products, or acquire the whole portfolio today for about half the price of RUA’s market capitalisation a year ago.



Our valuation remains at £122.9m or 554p per share since regulatory progress continues to be made on the vascular products even if revenues are delayed. There are, however, the emerging variables of the additional clinical costs for the vascular graft products, and time until approval. We have made minor updates to our FY 2022 forecasts of working capital and liabilities from the interim balance sheet but will revisit our forecasts and valuation once these variables are known.

[edmonda] 16/12/2021 07:44

RUA Life Sciences interim results demonstrated the continued investment in the business and its new products. The highlight of the interims was the 33% increase in third-party contract revenues that were a result of a recovery in elective surgical procedures, particularly in the US. Clouding the interims were the implications of the regulatory delay to the 510(k) review of RUA’s large-bore vascular graft medical device, which we explore more in this note.



The deferral of RUA Vascular product revenues raises the spectre that bigger medical device companies, and even its potential OEM partners for the products, might sense an opportunity. The pressures that a delay to revenues could bring, and the extent of the investment cost already spent on the product’s development, means they could attempt a licensing transaction at a fraction of our £74m valuation of RUA’s Vascular products, or acquire the whole portfolio today for about half the price of RUA’s market capitalisation a year ago.



Our valuation remains at £122.9m or 554p per share since regulatory progress continues to be made on the vascular products even if revenues are delayed. There are, however, the emerging variables of the additional clinical costs for the vascular graft products, and time until approval. We have made minor updates to our FY 2022 forecasts of working capital and liabilities from the interim balance sheet but will revisit our forecasts and valuation once these variables are known.