IntelliAM aiming for significant growth with £5 million Aquis IPO. Watch the video here.
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It’s a small part of the business, but an update on the in-house testing of the heart valve might generate interest. It will give us a guide to the possibilities of the major manufacturers taking an interest.
Absolutely Intra. And with RUAs current SP the merest of green shoots could yield the most disproportionate change in SP. Or not, of course! Maybe the only prediction I can make with any accuracy is that we will get an RNS this month! I wait to be humiliated.
The imminent final results should afford the company the chance to lay out in some detail what progress has been made in all of the divisions. Until then, we wait with anticipation!
Lol, the 'new strategy' RNS which was something and nothing sent the shares to about 38p, all I know is it could go anywhere at any time, the low price is mostly based on scepticism on what they can achieve. An actual bit of good news instead of hopes will change that. I'm remain a keen investor because the best case scenario will be an outrageous gain but a good start would be to land a large contract manufacturing order.
My guess...we should touch 15p before results..lol
Such an exciting prospect though I’d still be in the red
Firstly, apologies for getting this wrong in the past.
RUA has a proven ability to protect its IP. To me this makes its present ongoing patent application re heart valve material and manufacture more likely to be accepted and approved quickly.
So my question is, would a major manufacturer choose a JV or simply a takeover? Tesla took over Maxwell in 2019, then sold them in 2021. All they wanted, and all they kept, was the IP to dry electrode technology. Would a major manufacturer consider something similar here? They might not want the manufacturing side, but would rather have everything and then pick and choose what really gives them added value?
GLA
https://pv-magazine-usa.com/2021/07/30/tesla-sells-maxwell-technologies-but-keeps-its-dry-cell-tech-for-lithium-ion-batteries/
People simply haven’t understood the potential. They see a polymer producing company that’s making a loss, even though the figures are improving. The DYOR behind medical devices is different to that for biotech pharmaceuticals. They move on, if they bothered to stop at all.
That needs to change. The next good news RNS needs to get spread far and wide. MSM and medical media need to get behind a home grown success.
I really appreciate your posts mate
Shocks me we are at this level!
It’s potentially useful to both. If the world turns against fluoropolymers, they will need a replacement. These facts already sell the HVR:
“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".“
The fact it’s fluorine free is icing on the cake!
GLA
Thanks ctsfo ... whats does this mean for RUA and CPX in real time and us investors please ...
Read this on the CPX bb.
“The best supercapacitor binder material has traditionally been PTFE due to its insulating properties and hydrophobicity towards the electrolyte. Due to these features, the active material has a higher internal resistance and is less effective [43]. There is a growing demand for eco-friendly, fluorine-free alternatives to commonly-used fluorinated thermoplastic binders like PTFE [44].”
Potentially important for us. Goretex grafts are the present standard within healthcare. Made out of PTFE. There’s a significant pressure within NHS to consider the environmental impact of healthcare. The anaesthetic agent desflurane has stopped being used because of its greenhouse effect.
Not sure what the other polymer added to Elast Eon is in the HV material. But if it’s fluorine free, this is an important point going forward.
GLA.
Too much trading in and out I’m doing a detox!!
I’m here for the bitter (sweet) end now
Impatience for victory ensures defeat- Louis XVI - very profound and relevant- that said, good to have churn, gives the re- rate a stronger foundation. GLA
A bit of upwards momentum - I’ll take any consolation!
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.