Rua Life Sciences Share Discussion Threads

[bones] 24/6/2022 11:35

Hedgehog11, to quote the recent trading update: ”On a positive note, it was confirmed that RUA can still follow the 510(k) route to the US market, provided that supplementary clinical data are generated to support the Vascular Graft range. A clinical trial has now been designed to demonstrate the safety and efficacy of Elast-Eon as a graft sealant. The trial design has been submitted to the FDA in a further pre-submission to ensure alignment with the FDA's expectations. These discussions are expected to be completed by the third quarter of this year.” The share price was battered by news that a clinical trial was required but the above would suggest that, provided the trial is a success, the 510k route is accepted. It seems we are now at the stage of agreeing the finer points of the trial structure prior to it going ahead. The spectre of a PMA requirement seems to be absent from the tone of the update comments.

[hedgehog11] 24/6/2022 11:19

Is the classification of the device a bit of a distraction. Class 2 requires more input but that is still a 510K route, human trials are already know and classification is based on risk. I think that it is obviously class 2. My concern is how much money will be needed to get approval and where will the shortfall come from, I'd say a low expectation (a large cost) is already priced in and the next test for Rua is the quality of their IP and ability to raise the money. Class 1&2 is 510K, Class 3 is PMA. Rua will already know the classification, so it causes suspicion that they haven't announced it unless they consider it too much detail for an RNS. I'd like it if RUA came up with some more detail though. Currently expecting to have to wait until the third quarter for anything meaningful.

[buywell3] 23/6/2022 09:20

buywell makes no bones about it No ramps please till some worthy posts what medical class device RUA Vascular is It is a rather important matter imo As the costs change somewhat

[bones] 21/6/2022 08:53

It’s not for me to sort anything out. This is a forum for discussion, that is all it is. Investors are grown ups and should be responsible for their own research and decisions. Anyone can call the company if they have a question. I would say there is no “ramping or deramping” here anyway. Some may be of a more optimistic mind than others but I think most contributors here are sensible and offer reasonable views without getting out of order. My last post stands. Information will be released in July with the final results and there’s an AGM to attend. If all an investor relies on is views on a bulletin board, they are not helping themselves. The company clearly has challenges to face and that is obvious, hence the share price. I await their updates like the rest.

[buywell3] 21/6/2022 00:57

The Heart Valve will certainly be viewed by the FDA as a Class 1 medical device What about the RUA Vascular medical device ? It really is pointless trying to ramp/deramp this share on a BB which some are doing till this is clarified Bones you ought to sort this out imo

[bones] 16/6/2022 13:04

It’s easy to sound off on a bulletin board. The AGM is in August. As a shareholder, you have the right to attend and ask all of those questions of the management. Hopefully, the final results release in July will have addressed a lot of these matters but the AGM is there for you. I hope to be there myself. I have a solid investment in RUA so the cost to attend is a relatively small business expense. I’ll have an open mind approaching it.

[cfb2] 16/6/2022 12:45

RUA never had sufficient funds to get their heart valve through to approval. For years they have been saying they expected a major would buy the technology before any trials. But unless RUA can get another round of funding we can expect development on the heart valve to slow and competitors to overtake them. I have started to wonder what potential buyers of RUA's heart valve are making of the mess going on with their patch and graft approval. This may be far more damaging than just the delay in their revenue stream and the additional costs of unused production facilities.

[the surgeon] 16/6/2022 11:42

Not really. The silence is deafening and not golden. I feel we should have had some information by now on a. Progress on the level required by the FDA for approval and B. How the funds will be raised to do this research. And c. By now it is obvious RUA does not have sufficient funds to get the heart valve approval so how far are the negations going in respect of selling the heart valve technology or in a joint venture.

[buywell3] 16/6/2022 09:26

hTtps://www.youtube.com/watch?v=n03g8nsaBro

[semper vigilans] 09/6/2022 09:06

Could do with some info and clarity.

[buywell3] 09/6/2022 08:58

So has anyone asked the BoD for clarification on whether RUA Vascular is viewed by the FDA as a Class 2 or Class 3 medical product ? This is rather important

[bones] 07/6/2022 17:14

At least another 50k gone today. Hopefully breaking the back of the Amati overhang vertebra by vertebra.

[aykon] 02/6/2022 17:16

Agree Bones that any doubts about funding are priced in and hence the share price is sitting in 40s. The other thing is not to confuse the funding required for the vascular graft clinical trial for FDA 510(k) approval versus the funding required for the structural heart valve which would be a much much bigger cost than the former. The previous poster also confuses the issue with regard to the fact that RUA are progressing 2 aortic valve designs in parallel:one with 100% polymer leaflet and one composite. The latter would be a safer bet as durability if fabric leaflets is already proven and Elasteon coating would improve their durability as well as possibly avoiding the need for anticoagulation post implant. There is no doubt that the structural heart valve project will require some sort of partnership with one of the “big players” to progress through in-vivo and in-vitro trials!

[bones] 02/6/2022 14:46

These are all known doubts, not news. That’s why the share price is near 40p rather than the 140p it was near when the FDA view was first advised. The £10.2M market cap today represents all of the huge potential of the company’s IP and prospects very heavily discounted for all the risk out there on funding and execution. The bear argument is represented by the price you can buy at now. Easy to argue by how much and make an even worse case but to what end? The $30M quoted in that USA based opinion piece is opposed by those that say £3M is too high for the simple product that RUA are developing. Opinions, opinions…̷0;..

[the surgeon] 02/6/2022 11:55

Thank you for a very informative piece. Since the company is valued at around £11 million one wonders how RUA will raise $30 million to complete the in vivo studies to achieve FDA approval. In addition I thought the design for the heart valve had been decided but according to RUA’s latest statement they are still deciding between two designs. In any case RUA do not have the funds to take it to regulatory approval so will need to sell it or get a joint venture.since it is in a relatively early stage in comparison to Foldax who is already putting their valve into patients I fear we may be disappointed on what we can achieve financially. I will be interested in your responses.

[bones] 30/5/2022 16:37

Thanks Aykon.

[aykon] 30/5/2022 16:32

Yes Bones, that would be my guess. The devices will not be costly (100s and not 1000s like stent grafts. If the expertise in designing and analysing the clinical trial outcomes is in-house rather than 3rd party then this should also save money. If the cost is in the region £5000-10000 per patient enrolled then depends on total number required by FDA.The numbers may be 50-100 in each group….one with established old device (gelatin or albumin coated) and one with RUA device.

[bones] 30/5/2022 14:44

So, could be a lot less than £3M, Aykon?

[aykon] 30/5/2022 10:33

Device trials are not as expensive as drug trials as the number of patients needed is much smaller. The following link gives an idea of what might be involved in terms of clinical trial design: https://www.fda.gov/media/87603/download

[sicilian_kan] 30/5/2022 08:01

Depends on the numbers needed which we will find out in the not too distant future. If I was to put down a hope rather than a guess I would say £3m.

[langland] 30/5/2022 07:49

Don't tell them, Pike!

[buywell3] 30/5/2022 02:12

Yes, please do tell us s_k

[divmad] 29/5/2022 22:21

S_k, what do you estimate the cost will be to Rua of the 501(k) clinical trial to its full conclusion?