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Guys when are we expected to receive any updates ??
Heart Valve ?? FDA approvals ??
Tomorrow..definitely
I don’t know, Tiger, I’ve posted several times that RUA is not waiting on the FDA for anything right now and also it no longer plans to make its own heart valves.
The FDA is only in the background for approving marketing of a vascular graft (which is not a heart valve) made with Elast-Eon sealant but that needs £6M+ of financing by a partner (not yet found one) and will take a minimum of three years from when it starts trials (if it does).
RUA currently has a developed material that may be suitable for making a heart valve with and the material is being looked at by a major heart valve manufacturer under an MTA. We need this major to want to progress to some kind of licence.
Other than that, RUA has existing income from contract manufacturing of other medical devices for third party medtechs and earns royalties from legacy business signed years ago.
Until something significant happens on these fronts, you will need to be patient!
Dear Intravnus
Many thanks for our informative post and response to me , greatly appreciated ...
I would like most on here appreciate you opinion and understanding of my final questions to your good self ..
Have you invested ?
Do you believe this is a hidden gem and if the material for heart valves is approved then this will go rocket high?
finally what do you believe the sp should be now or will be soon and why ?
Tiger - intravenus has mentioned a few times he holds “a big lump of these”
Tiger, this might help. From the RNS in November 2023.
“ RUA Structural Heart
Structural Heart is exceeding management's expectations with regards to the development and testing of the Company's novel composite material for the creation of heart valve leaflets. The composite which benefits from Elast-Eon's biostability and blood contacting properties is designed to improve the durability of flexible leaflet heart valves. Recent testing results have surpassed key milestones.
· flex fatigue testing for durability passed 400 million cycles equivalent to 10 years in man.
· a heart valve made of the composite has achieved the key 200 million cycles required by ISO standards for a flexible leaflet heart valve.
· hydrodynamic testing demonstrated valve efficiency around 50% better than current technology.
· valve flow area is around 25% larger than similar sized valves in the market.
· Recent patent filing to protect the new IP entitled "Composite Material, Heart Valve and Method of Manufacture".
Rather than incur the full cost of developing a valve directly, our strategic focus is now to accelerate the commercial potential of RUA Structural Heart by making the composite available to the heart valve industry for incorporation into next generation valves. The Company expects to shortly formalise an agreement to provide composite material to a large heart valve company for its own testing and now that an attractive data pack is available on the composite, RUA intends to broaden this further through the industry.”
RUA Structural Heart is listed as a dormant company at Companies House. Nothing extraordinary or worrying about that. It just shows the development route RUA is taking at present. Let someone else do the heavy lifting.
Might as well chuck in my pennies worth...
Only my opinion.
There was a year end trading update released early June last year, so I am expecting similar this year. The SP can jump on the most meagre of positive statements, although they tend to fall back fairly quick. Final results are released late July, these are important as they will provide more information on how long the cash will last (the assumption on here being 3+ years).
Any developments in HV, grafts or Contract Manufacturing will be reported timely when they happen in a dedicated RNS - there's no telling when that could happen.
Despite the expectation of HV testing taking 6 months, realistically, that could take way, way longer. And if the major likes it who knows what the benefit to RUA will be, a small licensing contract or an IP purchase - your guess is as good as mine.
Grafts - I think they could be gently mothballing this rather than actively seeking a partner. If it is a good as they say it is then a six million investment should have suitors fighting each other for it. The lack of interest has me thinking it is risky.
For me the most important development and the best hope in the short term is securing a significant contract manufacturing contract for which they have charged a 'global enterprise' £100K for initial development work. The cost of 'initial development' work makes me think it is for RUA to lose. This alone would more than double the SP. This is important because it could make the business profitable and make the cash position less relevant which is a stronger position for negotiating with partners (it also means they may be able to fund grafts to some degree themselves). It would stop any sharks circling too.
The SP assuming positive developments in HV and grafts depend entirely on the benefit to RUA. The sky's the limit if the tech is a good as they say (if it was, it wouldn't take this long).
The SP is where it is because the risk is so high, this is no longer 'when not if' as Caroline Stratton frequently stated, it is definitely 'if not when'.
Yes, I am invested, far less than in the past and at a loss here. The risk and the reward are high! Capital definitely at risk!
All just my own thoughts and opinions!
Sensible thoughts and opinions tbf. 👊🏻👌
Excellent post, GreenEyes1
Of course every holder wants to see an rns that propels the shares to 50p plus over night but RUA is an unusual investment in that it has the blue sky upside of an oil play or exciting biotech going through clinical trials. However, it doesn't have the downsides because it has several years cash and two profitable segments.
So, whilst I await MTA progress from the heart valve company and any potential funder for vascular I do so with the knowledge that RUA is undervalued at current levels and it could even get to a much higher value of 40p to 50p on the profitable segments alone over time if they double contract manufacturing revenues as per their specified objective.
I see they have applied for a patent for the material in Structural Heart and they have specified it will go in that division rather than Rua Biomaterials. I assume that is because it makes licensing agreements easier and there is a chance the MTA heart valve company may want to purchase Rua Structural Heart as a distinct entity rather than the whole company.
As IntrVnus has correctly stated RUA are not attempting to create a commercial valve but have opted to license the material or do an outright sale. I just wonder where the recent news story regarding RUA developing a prototype heart valve (with the engineer winning an award) fits in. I can only assume it's because they need a valve for testing and are not developing it for commercialisation, quite curious though.
"Our 2024 Young Engineer of the Year Award (YEYA24) in partnership with The Incorporation of Hammermen of Glasgow was presented to Ross McPhillie of RUA Life Sciences for his role in developing a prosthetic heart valve prototype that is transitioning to commercialisation.22 May 2024"
https://www.scottishengineering.org.uk/meet-our-2024-annual-awards-winners/#:~:text=Our%202024%20Young%20Engineer%20of,that%20is%20transitioning%20to%20commercialisation
“And if the major likes it who knows what the benefit to RUA will be, a small licensing contract or an IP purchase“
And there are also other global players , there was no mention of exclusivity, probably as premature. But if that word does or doesn’t pops up in the event of things going well, it’s a kicker
Evening NickE, is this a possible scenario?:
The initial 400 million cycle test was possibly done on ‘simple’ Elast Eon samples. This produced a dataset that gets put into CAD/CAM plus genuine ability from the young engineer. A proof of concept HV is then designed, redesigned, built, redesigned, rebuilt… you get the picture, till they’re happy with what they have. This is a proof of concept device that interests the majors - enough for them to at least take Elast Eon seriously - if not the entire valve. This work gets the young engineer of the year award. They’re not lying / misleading with the comment re commercialising this.
What we don’t know is if the majors are simply testing Elast Eon (as stated), or if they are potentially interested in the HV RUA have developed as well?
Spent an hour looking for the RUA patent. I found the application number, but couldn’t find the details of the application. D’Oh!! It would be interesting to see if it’s just the polymer or polymer and manufacturing processes to make it HV compatible which is being patented.
Yes, it's an interesting one CTSFO. I sent a query over the weekend to RUA asking if they could explain the anomaly of why they are developing a heart valve given their official line is that they are focusing solely on the material and allowing potential licensees or buyers to develop their own valve.
I assume it is just for assisting with internal and external testing, but it's an interesting development.