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Excellent posts from both. Really puts the potential in black and white comprehensively - and unbiased / independent .
EV of £2.8m truly a farce, its just so few are aware - glued to crap like MATD etc !!!
Well played NickE. This is what attracted me to RUA years ago!
Bill Brown once told me that the last great feeding frenzy in this market was around 2015 when TAVI was the breakthrough (feeding the valve into the body via artery and catheter). Several technologies were bought by all the majors for those nine figure numbers way before official trials. Edwards made hay with that.
Polymer (ie, non animal derived) materials are likely to be the next. Whilst Foldax has some pure polymer valves already in patients in early tests (IDE - Investigational Device Exemption (IDE)FDA (.gov)https://www.fda.gov › medical-devices › investigational-... ), RUA have pushed on from their own pure polymer prototypes to create a composite material which is textile based and mixed with Elast-Eon polymer to create a material far stronger and thinner than pure polymer.
Thus, if the major sees this for itself after testing, the prospects here are good. Given that other majors are swimming in the same pool, they might want to pay well to secure the technology.
ChatGPT part 4
Key Sources and Validation
Rua Life Sciences - Elast-Eon™ Technology: This source details the general applications and biocompatibility features of Elast-Eon™, including its use in FDA-approved devices
FDA Approvals and Clinical Data: Evidence from FDA-approved devices using Elast-Eon™ supports its validated biocompatibility and safety .
Clinical and Preclinical Studies: Published studies on devices using Elast-Eon™ further confirm its biocompatibility and safety through clinical outcomes and long-term implant data .
Summary
Elast-Eon™ has been thoroughly validated for biocompatibility and safety in structural heart applications. It has undergone rigorous testing, including cytotoxicity, sensitization, systemic toxicity, hemocompatibility, and calcification resistance. Its use in FDA-approved cardiovascular devices, such as annuloplasty rings and transcatheter components, underscores its suitability and reliability for heart valve applications.
ChatGPT part 3
Has Elast-Eon™ already been validated for biocompatibility and safety in other structural heart applications
Elast-Eon™, a proprietary polymer developed by Rua Life Sciences, has indeed been validated for biocompatibility and safety in various structural heart applications. This material has undergone extensive testing to meet regulatory standards and has been successfully used in several cardiovascular devices. Here’s a detailed overview:
1. Biocompatibility Validation
Tests Conducted:
Cytotoxicity: Elast-Eon™ has been tested for cytotoxicity to ensure that it does not induce cell death or inhibit cell growth. This is crucial for materials that come into prolonged contact with body tissues (50Wheel).
Sensitization and Irritation: The material has undergone testing for sensitization and irritation to confirm that it does not provoke allergic reactions or localized irritation (Blackbird).
Systemic Toxicity: Evaluations have been conducted to ensure that Elast-Eon™ does not produce systemic toxic effects when implanted in the body
Hemocompatibility: Elast-Eon™ has been tested for compatibility with blood, including assessments for thrombogenicity (tendency to cause blood clots) and hemolysis (destruction of red blood cells)
Calcification Resistance: Elast-Eon™ is known for its resistance to calcification, which is critical for maintaining the functionality of heart valves over time
2. Safety Validation
Testing and Applications:
Long-Term Implant Studies: Elast-Eon™ has been evaluated in long-term implantation studies to demonstrate its durability and stability within the body
Use in FDA-Approved Devices: The material is already employed in FDA-approved devices for cardiovascular applications, such as annuloplasty rings, which confirms its safety profile
Clinical Data: Clinical data from devices using Elast-Eon™ support its safety, showing favorable outcomes and minimal adverse reactions in patients
3. Applications in Structural Heart Devices
Specific Uses:
Annuloplasty Rings: Elast-Eon™ is used in annuloplasty rings, devices that are employed to reshape and support the valve annulus during valve repair procedures (Blackbird) (MASV).
Transcatheter Devices: It has been incorporated into components of transcatheter devices, where its durability and flexibility are advantageous.
Part 2
Total Timeframe for Mechanical and Physical Testing
The combined timeframe for comprehensive mechanical and physical testing of Elast-Eon™ in a new heart valve product is estimated to be 8 to 12 months. This includes:
Fatigue Testing: 3-6 months
Hydrodynamic Performance: 2-4 months
Wear and Tear Testing: 3-6 months
Regulatory Compliance Documentation: 1-2 months
This accelerated testing schedule leverages prior biocompatibility data and focuses solely on performance metrics crucial for heart valve functionality.
Conclusion
Focusing on mechanical and physical testing for Elast-Eon™ in new heart valve applications, given its established biocompatibility in other devices, streamlines the evaluation process to around 8 to 12 months. This approach assesses the material’s performance, durability, and compliance with heart valve standards without redundant biocompatibility testing.
ChatGPT again:- part 1
Mechanical and Physical Testing: Overview and Timeframe
**1. Mechanical Durability Testing
Tests Involved:
Fatigue Testing: Evaluate the material’s endurance under repetitive stress, simulating the cyclic loading experienced by heart valves .
Tensile and Compressive Strength: Measure the material’s resistance to stretching and compressing forces .
Flexibility and Elasticity: Determine how well the material can flex and return to its original shape without damage
Timeframe:
Duration: Typically, mechanical durability testing takes about 3-6 months, depending on the complexity of the tests and the need for long-term cyclic loading studies (50Wheel) (Blackbird).
**2. Hydrodynamic Performance Testing
Tests Involved:
Effective Orifice Area: Measure the valve’s opening size and flow characteristics to ensure efficient blood flow.
Regurgitation Testing: Assess the backflow of blood through the valve to ensure minimal leakage
Pressure Drop: Evaluate the pressure difference across the valve to ensure it does not impede blood flow .
Timeframe:
Duration: Hydrodynamic performance testing can be completed in approximately 2-4 months. This includes setting up test protocols, running tests under various conditions, and analyzing the data .
**3. Wear and Tear Testing
Tests Involved:
Abrasion Resistance: Test for material degradation due to friction and wear (50Wheel).
Long-term Simulation: Simulate the material’s performance over extended periods to ensure it withstands the conditions of use (50Wheel) (Blackbird).
Timeframe:
Duration: Wear and tear testing typically requires 3-6 months, as it involves long-term exposure and repeated testing to simulate years of use (Blackbird).
**4. Compliance with Regulatory Standards
Tests Involved:
ISO 5840 Compliance: Ensure that all mechanical tests meet the standards for heart valve devices, particularly those set by the ISO 5840 series .
Timeframe:
Duration: Documentation and compliance checks can add another 1-2 months to the overall timeline, depending on the complexity of the regulatory requirements .
Total Timeframe for Mechanical and Physical Testing
The combined timeframe for comprehensive mechanical and physical testing of Elast-Eon™ in a new heart valve product is estimated to be 8 to 12 months. This includes:
Fatigue Testing: 3-6 months
Hydrodynamic Performance: 2-4 months
Wear and Tear Testing: 3-6 months
Regulatory Compliance Documentation: 1-2 months
Part 2
**3. Intellectual Property (IP) and Exclusivity:
The strength and scope of Elast-Eon™'s patents, along with exclusivity rights in specific medical applications, would significantly impact the deal’s value. Comprehensive IP protection can enhance the bargaining position of Rua Life Sciences.
**4. Stage of Development and Regulatory Approval:
The level of clinical validation and regulatory approval (e.g., FDA, CE mark) achieved for Elast-Eon™ in heart valve applications affects its market readiness and, consequently, its valuation.
3. Estimated Valuation Range
**1. Sale of Rights:
Estimated Value: $150 million to $400 million.
Context: Based on the strategic importance of Elast-Eon™ in structural heart applications and comparable deals in the medical technology space.
**2. Licensing Agreement:
Upfront Payment: $30 million to $100 million.
Milestone Payments: Up to an additional $200 million, contingent on achieving specific development and sales targets.
Conclusion
Rua Life Sciences could potentially receive a valuation in the range of $150 million to $400 million for selling the rights to use Elast-Eon™ in heart valve applications, based on comparable sales and licensing deals. Licensing the technology could also provide substantial immediate and future revenue, combining an upfront payment with milestone-based earnings.
These figures are indicative and would ultimately depend on negotiations, the competitive landscape, and the specific strategic needs of the acquiring company.
Had a bit of fun with ChatGPT:-
ChatGPT
Estimating the potential value of Rua Life Sciences selling the rights to use Elast-Eon™ to a major heart valve company involves analyzing several factors, including comparative sales, market size, and the strategic importance of the material. Below is an overview of what Rua might expect, based on similar deals in the medical devices sector:
1. Comparative Sales and Licensing Deals
Recent Comparable Transactions in Medical Devices:
Gore’s Acquisition of Tactus Technology (2021):
Value: Estimated at around $300 million.
Context: Tactus developed a tactile feedback technology relevant to medical and consumer devices.
Implication: Significant value for proprietary technology applicable across multiple domains.
Medtronic’s Acquisition of HeartWare International (2016):
Value: Approximately $1.1 billion.
Context: HeartWare developed a heart pump technology, relevant to Medtronic's cardiovascular portfolio.
Implication: High valuation for a company with specialized heart technology, indicating premium value for strategic cardiovascular innovations.
Edwards Lifesciences’ Acquisition of CardiAQ Valve Technologies (2015):
Value: $350 million upfront, with additional milestone payments.
Context: CardiAQ developed transcatheter mitral valve replacement (TMVR) technology.
Implication: Illustrates substantial upfront payments and additional future incentives for promising cardiovascular technologies.
Licensing and Royalty Agreements:
Johnson & Johnson’s Licensing Agreement with Genmab (2017):
Value: Upfront payment of $50 million, potential for up to $1.5 billion in milestones.
Context: Rights to use Genmab’s proprietary technology in biopharmaceutical applications.
Implication: Significant potential earnings from initial licensing fees and milestones, applicable in a highly specialized medical field.
Boston Scientific’s Agreement with Baylis Medical (2016):
Value: Upfront payment and milestone-based payments totaling approximately $175 million.
Context: Licensing of proprietary technology for structural heart applications.
Implication: High value for technology enhancing existing product lines in the structural heart market.
2. Valuation Factors
**1. Market Size and Growth:
The global heart valve devices market was valued at approximately $8.4 billion in 2023 and is projected to reach around $12.1 billion by 2028, growing at a CAGR of 7.4% .
**2. Strategic Fit:
Elast-Eon™ has unique properties that enhance durability and biocompatibility, crucial for heart valve devices. A strategic buyer may place a high value on the ability to integrate this polymer into existing or new product lines, potentially reducing long-term development costs and improving product performance.
It wasn’t on RUA’s website when I first posted the original links three weeks ago. Just updating that fact especially as their commentary is noteworthy.
Isn't this sort of old news..well 3 weeks ago???
Further to my original post, RUA now have this achievement up in the RUA Medical website. I hope they are publicising it to the medical fraternity and journalists!
https://www.ruamedical.com/young-scottish-engineer-of-the-year-2024/
Yes, if ever there is anything that could be termed a realistic ten-bagger then RUA fits the bill. Doesn't mean it will happen of course but there is a decent chance.
With Foldax doing their last funding round at $135m valuation then it only take an offer of about half that solely for RUA Structural Heart to get a £60m plus valuation the other three divisions remaining to give further upside. It would make sense for any interested major player to buy Structural Heart and the relevant IP for the heart valve material rather than pay an upfront fee, milestones as it progresses through trials and ultimately royalties.
I am sure that would be managements preference and the wording of the options RNS certainly made sure investors were made aware of the possible prospect and benefits to directors who are now very much aligned to shareholder aspirations.
Going back to the question of whether a multibagger prospect is realistic I'd say that the material seems to solve some key issues that arise with existing products:- avoids the need for lifetime anti-coagulants , proven, at least internally, as more durable than mechanical valves and those using animal material and not subject to catastrophic failure.
So there is potentially a quick route to a ten bagger via the sale of RUA Structural Heart (say a £50m offer for this segment alone) and a less instant route to three to five bagger through RUA Medical doubling contract manufacturing revenues - say £20m to £35m m/cap once it transitions the Company as a whole to breakeven/profitability. I'd discount RUA Vascular but £7m value can be thrown in for RUA Biomaterials and it's circa £550,000 profit contribution.
Could get both of course (a £50m sale of Structural heart and breakeven for the rest of the group) and get a 15 bagger but that's just being greedy!
I'd like to see another company do a MTA but, who knows, although there is no declared exclusivity with the current agreement, there might be a mutual understanding to wait for this Company's testing and decision within an undeclared but internally known and reasonable timeframe.
There’s not always a RNS giving a heads up that the final results will get published.
The day and dates since 2020 that Final Result RNSs have been released:
Monday 13th July 2020
Monday 12th July 2021
Monday 11 July 2022
Wednesday 26th July 2023
I’m guessing we’ll get this year’s on Monday 15th July 2024, though Monday 8th July is also a possibility, it doesn’t fit the 3rd week of the month pattern.
I’ve been thinking about this. We need to make it noticed. Time to write to the medical editors of the MSM. Give them a heads up. It’s the sort of story they love. Have the piece ready for when the RNS gets dropped about Elast Eon getting taken up.
It's just simply not noticed!!!
BUT a ten bagger feels realistic here and if you multiply your holding by that it makes the mouth water !
Last time I was this confident was buying HVO (ORPH) at 6p. That’s the only AIM stock I’ve ever succeeded on and the fundamentals there were, not dissimilar to RUA, a strong indicator for future success.
Being serious, we don’t know if anyone will take an interest in RUAs product and develop heart valves from it.
But
We’re a decent length of time into the trial and we haven’t had an RNS saying the major isn’t interested. So that’s good.
This is important:
“ That's what the global company are doing now and have been for the last 6 months - testing to ISO 5840 requirements.
They don't make up their own tests only to have to do another mandatory different set of tests - they ain't stupid by duplicating costs and time.”
RUA is 6 months ahead of the major with in-house data. If the major’s 6 month / 400 & 200 million cycle data is the same as RUA’s at the equivalent point - then the major may seek to see RUA’s most recent data covered by a NDA. It might accept the performance data will match for its valve extrapolated out. And be more interested in entering into a JV / merger / TO earlier rather than later.
When you remortgage the house and buy RUA with the cash!!!
When does “loading up” become irresponsible? I’m stopping myself buying any more - trying to moderate impulsive buying!
Couldn’t agree more. The potential for a takeover is very real here. RUA structural heart or the entire group? Personally I think a major buying everything makes most sense. Would this trigger a bidding war? Jimzi’s comments very important here as well. The potential to disrupt the source and supply chain of xenografts is very real. Whilst this product is cheaper and better. Another point, plenty of lab work being done on polymeric valves in universities. Echoing other posts, not sure how many others have the science to improve AND ability to upscale supply? I’ve got to repeat myself, this is a hidden gem. Tine to load up.
GLA.
Indeed let’s trust in a decent update with the finals.
The fact that, at this late stage, the board have positioned themselves and some employees via options to benefit from any takeover or return of capital seems significant. It’s rare for an options RNS to make a point about this when it would usually be a standard part of the option clauses. It’s almost like they want to avoid being accused of moving the goalposts at the time a later event like a takeover occurs.
I’m guessing the Final Results in July will include an update on the in-house testing of the heart valves. Approx another 6 months of data. That’s got to be close to double the minimum number of cycles ISO expect. Fingers crossed and the best of luck everyone.
APOLOGY AND EXPLANATION.
My post looks like it’s knocking the company a bit. I’m very sorry. That wasn’t the intention. It was a reply to:
“ I assume that means that if the heart valve company with the MTA wanted to move forward they could use RUA's material in their existing regulated valve products without having to go through regulatory trials. That's massive for RUA and no doubt a major factor on why they have embarked on a deal for material rather than create a heart valve for licensing”
Which I think suggested full testing wouldn’t be necessary. Sorry for not making this clear.
I don’t see how RUA’s product will be anything but game changing here.
And the supply chain risks are a massive tick for me. Reliance on one country to remain TB free for ever is a risk that must be addressed.