Member Info for MR.Spacetomato

Hi Doppo. You are welcome. As of now, there is no publicly available information confirming the specific date when Polarean submitted their request to the FDA for approval of their product for use in children aged 6 to 12 years. While it is known that the company has been actively pursuing regulatory approvals, including discussions with the FDA, details about the submission timeline for pediatric indications have not been disclosed in accessible sources.

In general, the FDA requires sponsors to submit an Initial Pediatric Study Plan early in the drug development process, typically within 60 days after the end-of-phase 2 meeting. The review and agreement process for an iPSP can take up to 210 days, encompassing FDA review, sponsor revisions, and final confirmation.

Given the absence of specific information regarding POLX’s submission for the 6–12-year-old age group, it’s advisable to monitor official communications from Polarean Imaging, such as press releases or investor updates, for the most accurate and current information.

Sorry I couldn't help than what I know and from info I got on the web.

ST

Polarean Imaging – A Proper Look

Right, I’ve gone through the full transcript of Polarean’s Virtual Investor Day (12 March 2025), and here’s my take for anyone considering a stake in this medtech outfit.

In short? It’s a small company with a genuinely disruptive product, a growing customer base, clean financials, and — crucially — a path to recurring revenue. It’s still early, yes, but it's not blue-sky biotech nonsense. This thing works, is FDA-approved, and already in use.

They’ve got the only FDA-approved inhaled contrast agent for lung function MRI, using hyperpolarised Xenon gas. Sounds exotic, but what it means is: they can scan lungs in a way no one else can — picking up dysfunction where CT, X-ray, or spirometry completely miss the problem (especially in the so-called "silent zone"). If you're breathless and undiagnosed, this could change your life.

Now, here’s the key bit: reimbursement is already in place, and hospitals are starting to bite because it's fast, non-invasive, radiation-free, and gets better results. Oh — and it runs on existing MRI hardware. That’s a big win.

They’ve already got 22 clinical customers, mostly in the US. The big hitters like Cincinnati Children’s are on board. Clinical use is expanding, particularly in asthma, COPD, lung cancer, and bone marrow transplants, with paediatric use coming next. (They expect FDA approval to lower the age to 6 this summer — that unlocks over 1 million more patients.)

There’s also movement on the pharma front — they’ve signed with a major pharma player to use their platform in a multicentre clinical trial. That’s a whole new revenue stream, and not just product sales — this is service-based imaging-as-a-platform stuff. Much higher margins, and it scales.

Financials?

2024 revenue: ~$3.1M (unaudited), which beat guidance.

Consumables grew >50% YoY. That’s recurring income — the good kind.

Cash: $12.1M, no debt. Funded through Q1 2026.

No daft spending. Tight cost control while commercialising.

Backed by Bracco Imaging and Nuchem (Xenon supplier). So not alone.

They’ve got over 20 patents, Philips as a strategic partner, and US-wide reimbursement. If this was still pre-FDA or pre-revenue, I'd stay away. But they’ve cleared those gates. Now it’s about execution and uptake.

Risks?

Sure. It’s early-stage. It needs to scale. Adoption in hospitals is slow by nature. Xenon supply is concentrated. And right now, they’re US-focused — international expansion hasn’t started yet.

But for once, you’ve got a microcap where the tech is real, the customers exist, the cash isn’t evaporating, and the addressable market is bloody massive — over

Fellow shareholders, today's RNS marks a significant milestone for Polarean and its expansion into pharma-sponsored research with Xenon MRI. A leading global pharmaceutical partner has chosen Polarean’s Xenon MRI clinical trial support services for a multicenter study, validating the company’s positioning in this crucial sector.

This new revenue-generating service model aligns with Polarean’s strategic focus, demonstrating that Xenon MRI is increasingly recognized as an advanced imaging modality for evaluating lung function in clinical trials. The ability to provide harmonized imaging acquisition, quality controls, and biomarker analysis offers pharma partners a more efficient way to test respiratory therapies, potentially reducing trial sizes and accelerating new drug approvals.

Notably, this study will investigate an investigational lung therapy, using Xenon MRI to assess ventilation, membrane conductance, and red blood cell transfer, with scans taking place at sites in the U.S. and Canada later this year.

This announcement reinforces Polarean’s commercial growth trajectory, moving beyond just system sales and gas blends to offering imaging services as a scalable business model. It also follows last year’s selection of Xenon MRI as the primary endpoint in a single-site pharma trial, showing consistent momentum in the space.

With VIDA Diagnostics as a partner, Polarean is positioning itself as the go-to imaging platform for pulmonary drug trials, making Xenon MRI a compelling biomarker for pharmaceutical research.

💡 Key takeaways:

✔ Polarean has secured a major pharma collaboration for Xenon MRI clinical trial services

✔ New revenue stream from pharma-sponsored trials

✔ Strengthens long-term adoption of Xenon MRI in drug development

✔ Significant validation of Xenon MRI's role in respiratory medicine

The upcoming Virtual Investor Day on March 12th will be one to watch, as management may provide further insights into this deal and Polarean’s evolving strategy.

Exciting times ahead—let’s see how this plays out in the months to come.

DYOR. GLA.

ST

Ah, the usual AIM circus—good news drops, and somehow the share price follows gravity instead of logic. Market makers are likely playing their usual tricks, widening spreads, triggering stop losses, and hoovering up cheap shares from impatient sellers before letting the price recover. Add in the usual "buy the rumor, sell the news" brigade, short-term traders cashing out, and the perpetual fear of dilution, and you’ve got the perfect storm for an illogical drop. The lack of institutional support means retail sentiment alone can’t hold the line, and when expectations outrun reality, even solid progress isn’t enough to spark a rally.

But I’m not here for MM games or the small traders flipping for pennies. I’m staying with the holders that need a TR1 when they buy or sell—and for PolX to flourish.

I have switched off here and patiently waiting.

ST

Absolutely, Mike, and I appreciate your insight on budget cycles in this sector—it’s a crucial point that often gets overlooked. Biotech and medical device adoption isn’t just about having a great product; it’s about navigating procurement timelines, demonstrating value to stakeholders, and aligning with institutional budget allocations.. Visibility and education are key steps before securing large-scale adoption.

Given the traction we've seen with increased revenue and strategic collaborations, it seems PoLx has been laying the groundwork effectively. Now, with a larger sales force and growing awareness, we’re hopefully moving into the phase where those early efforts start transslating into tangible sales.

Looking forward to the investor meeting as well—it should give us a clearer picture of where we stand in that transition.

ST

Dear Gordon G., I understand your concerns regarding the pace of progress at Polarean Imaging (POLX). It's important to recognize that in the biotech and medical device sectors, development timelines are inherently lengthy due to rigorous testing, regulatory approvals, and the need for substantial financial investments.

For context, the average time to bring a new drug from initial discovery through regulatory approval is approximately 10 to 15 years. Even the preclinical phase alone can span several years. While Polarean focuses on medical imaging devices rather than pharmaceuticals, similar complexities and regulatory hurdles apply, contributing to extended development periods.

Despite these challenges, Polarean has demonstrated notable progress. In the first half of 2024, the company reported revenues of $1.1 million, a significant increase from $0.1 million in the same period of 2023, indicating growing commercial traction. Additionally, Polarean has expanded its sales team and secured $12.6 million in funding to accelerate the commercialization of its XENOVIEW technology and pursue strategic growth initiatives.

Collaborations have also been a key aspect of Polarean's strategy. The partnership with VIDA Diagnostics aims to streamline the adoption of advanced MRI lung imaging, combining expertise to deploy a new xenon-129 MRI platform.

It's worth noting that other companies in the biotech sector have experienced similar timelines. For example, Moderna, founded in 2010, took a decade of research and development before achieving significant breakthroughs with its mRNA technology.

In summary, while the development process in the biotech and medical device industries can be protracted, Polarean's recent achievements and strategic initiatives suggest a positive trajectory. Patience is often required in this sector, but the company's advancements indicate potential for meaningful progress in the near future.

ST

Just for the record, what I have as ownership of shares on POLX is this, which is very interesting; do you guys know any different?

Total shares in POLX 1,207,032,781.

Major shareholders:

NUKEM Isotopes GmbH holds the largest stake with 229.2 million shares (18.99%).

Bracco Imaging S.p.A. follows with 173.7 million shares (14.40%).

David and Monique Newlands own 60.5 million shares (5.02%),

Rathbones Investment Management Ltd holds 60.2 million shares (4.99%).

Unicorn AIM VCT has 38.1 million shares (3.16%).

Additionally, 19.1% of shares are not in public hands, meaning they are held by insiders or related entities.

Regarding ownership distribution:

Private companies hold 34.8% of the shares,

Institutions own 29.0%, and the general public holds 28.7%. Individual insiders account for 7.0%, while public companies have a small 0.5% stake.

The top 25 shareholders have, give or take, 66.77% of the company.

That's it. I am holding with the lot that issues TR1. :0)

Alright, fellow POLX shareholders, let’s break down this latest RNS with a bit of perspective and a dash of optimism.

First off, revenue for FY24 has come in strong—we’re talking $3.0M to $3.1M, smashing the upper end of guidance ($2.5M–$3.0M). That’s more than tripling last year’s figure of $891K. If anyone was questioning the commercial trajectory, well, here’s your answer: the sales machine is firing up.

We’ve now got 22 Xenon MRI platform customers, with seven clinical hyperpolariser systems either installed or pending. That’s a four-site increase, which means the adoption curve is steepening. More platforms out there = more consumable sales = recurring revenue growth. Speaking of which, sales of proprietary Xenon gas blend cylinders and other consumables jumped by over 50% YoY—a clear sign that usage is increasing.

On the personnel front, Dr. Alan Huang (VP of Sales, ex-MedTech heavyweight) was brought in during Q3 to push growth harder. With a six-person sales team covering the U.S., we’re seeing evidence that the pipeline is ramping up. More boots on the ground = more deals getting closed.

Now, the Taiwanese distribution deal with Sumtage is a significant moment. This marks Polarean’s first real expansion outside the U.S. While we await regulatory clearance, this signals the first steps into the APAC market, which is a massive growth opportunity.

Financially, cash reserves sit at $12.1M as of December 31, 2024, which gives us runway through Q1 FY26. That’s reassuring in the current market, especially given how much AIM companies love their placings.

What’s Next?

1. Virtual Investor Day on March 12—expect more commercial insights, pipeline updates, and potentially a bit more on the APAC expansion plans.

2. More clinical adoption and new site installs—if the Xenon MRI rollout keeps up this momentum, expect further revenue growth.

3. Regulatory approvals and new markets—Taiwan is just the beginning. If Polarean can push into other APAC or EU markets, the scale gets much bigger.

Bottom line: This is a solid update. Revenue is growing at pace, recurring sales are increasing, and the company is expanding its commercial footprint. Looking forward to more positive news—let’s see if we get some further big contract wins or regulatory approvals in the next few months.

HODL strong, comrades!

ST

[DRAFT LEGAL LETTER TO BARCLAYS STOCKBROKERS UK]

Subject: Request for Confirmation of Asset Status and Legal Protections

[Your Name]

[Your Address]

[Your Email]

[Your Phone Number]

[Date]

Barclays Stockbrokers UK

[Address]

Attn: Compliance & Legal Department

Re: Confirmation of Asset Status & Legal Protections – Evraz Shares Held in ISA Account

Dear Sir/Madam,

I am writing to formally request written confirmation regarding the legal and operational status of my Evraz shares currently held within my ISA account at Barclays Stockbrokers UK. Given the evolving regulatory landscape surrounding Russian-linked assets, I seek clarification on the security and accessibility of my holdings in compliance with UK law.

Specific Clarifications Requested:

1. Current Accessibility & Trading Restrictions:

Can you confirm that I retain full control over my Evraz shares, including the ability to sell, transfer, or withdraw funds from my ISA account?

Are there any existing or pending restrictions that would limit my ability to manage these holdings?

2. Potential Freezing or Seizure Under UK Sanctions Laws:

Has Barclays received any official notice from the UK government regarding potential asset freezes or seizure of privately held Evraz shares?

Can you confirm that any such action would be subject to clear legal authority and due process under UK law?

3. Legal Protections & Client Rights:

If Barclays imposes restrictions or freezes my holdings, will I be notified in advance and provided with an opportunity to contest such action?

Can you provide details of internal policies and legal protections in place to safeguard clients’ investments from arbitrary enforcement actions?

Legal Basis & Client Rights

As a UK resident and investor, my property rights are protected under UK law and Article 1, Protocol 1 of the European Convention on Human Rights (ECHR), which safeguards against unlawful expropriation. Additionally, Barclays, as a regulated financial institution, has an obligation to act transparently and provide clients with full disclosure regarding any potential regulatory risks.

Given the legal complexities surrounding sanctions and asset seizures, I expect a clear and written response within 10 working days from the date of this letter. If Barclays fails to provide adequate assurances or imposes undue restrictions, I reserve the right to escalate this matter through regulatory and legal channels, including but not limited to:

Filing a formal complaint with the Financial Ombudsman Service (FOS).

Seeking injunctive relief in the UK High Court if there is an attempt to seize or freeze my assets without due process.

Exploring international legal avenues under investment protection treaties and human rights law.

Please treat this as an urgent matter and provide a formal response by [Deadline Date – 10 working days from today]. Kindly direct your reply to me at [Your Email

Https://commonslibrary.parliament.uk/research-briefings/cbp-10034/

Sanctions, International Law, and Seizing Russian AssetsResearch Briefing

Published Thursday, 07 November, 2024

...continue

Option C: Wait for a Political or Legal Resolution

Laws can change, and if Evraz’s legal situation stabilizes, your shares could regain value.

If Russia and the West eventually reach a settlement, some sanctions may be lifted.

Evraz could restructure or delist from the UK market and offer a buyout at some point.

Option D: Join a Shareholder Class Action

If the UK does seize Evraz shares, expect a class action lawsuit from other affected shareholders.

You may not need to fund your own lawsuit—large institutional investors will fight this.

You can join the case and seek compensation without fronting legal fees.

---

What You Should Do Right Now:

1. Monitor Legal Developments:

Stay updated on UK government policies regarding seized Russian assets.

Check for exemptions that might let you sell the shares legally.

2. Get Legal Representation Ready:

A solicitor specializing in sanctions and property rights can prepare you to act quickly.

If the UK moves toward asset seizure, a legal challenge should be filed immediately.

3. Join Investor Groups & Lobbying Efforts:

Other investors will be pushing back. Aligning with them can strengthen your case.

Business groups might lobby the government to allow private investors to exit their holdings instead of confiscation.

---

Conclusion

Right now, you haven’t lost your shares, and the UK hasn’t made the legal leap to full expropriation. However, if they do, you have strong legal grounds to fight for compensation. Your best bet is to stay informed, be prepared to challenge any seizure in court, and look for legal pathways to divest your shares under existing sanctions laws.

I hope it helps.

ST

UK/EU seizing assets? Alright, let's approach this like a solid legal case. Your primary concerns are:

1. Can the UK legally strip you of your Evraz shares?

2. If seized, do you have any recourse for compensation?

3. What are your practical options to mitigate losses?

1. Can the UK Government Legally Seize Your Shares?

At present, your shares are frozen, not seized. That means you still own them, but you can’t sell, transfer, or receive dividends.

However, if the UK follows through with seizing Russian assets, they might attempt to expropriate Evraz shares as part of that process. That raises serious legal risks for them, including potential lawsuits from shareholders.

Legal Obstacles to Seizure:

The UK’s current laws on sanctions allow asset freezing, not outright confiscation.

Expropriation without compensation would violate property rights under the UK Human Rights Act and international investment treaties.

Even if they introduce new legislation to seize assets, you could challenge this as a breach of international law.

This means the UK government would either have to compensate shareholders or face legal battles.

2. If They Seize Your Shares, Can You Fight for Compensation?

Yes, and here’s how:

Human Rights Challenge:

The UK Human Rights Act (Article 1, Protocol 1 of the European Convention on Human Rights - ECHR) protects your right to property.

The UK must pay compensation if it expropriates private property.

A legal challenge could force the UK to provide fair market compensation for any seized assets.

Investor Protection Under Bilateral Treaties:

If you hold British citizenship, you can challenge this under UK investor protection laws.

If you were a foreign investor, you might have protection under Bilateral Investment Treaties (BITs) between your country and the UK.

Some shareholders could take cases to international arbitration courts.

3. What Are Your Practical Options to Mitigate Losses?

Since your shares are frozen but still technically yours, you have a few options:

Option A: Challenge the Seizure if It Happens

Prepare a legal case based on property rights and international law.

If the UK goes ahead with a seizure, you could demand fair market compensation.

The government would struggle to justify expropriating UK citizens' private investments without paying something.

Option B: Find a Legal Loophole to Sell Your Shares

Check if there are any exemptions for "innocent" shareholders. Some sanctions allow divestment under specific licenses.

Look for secondary markets. Some restricted assets can be sold through private placements, though legality is tricky.

Engage a specialist lawyer in sanctions law—they may find a way for you to offload the shares through third-party exemptions.

Option C: Wait for a Political or Legal Resolution

Laws can change, and if Evraz’s legal situation stabilizes, your shares could

POLX is having a bit of a moment, and for once, it’s not just wishful thinking from investors hoping their portfolio stops looking like a crime scene. The big news deal with SimonMed Imaging, one of the biggest outpatient imaging providers in the U.S. means their fancy Xenon MRI tech is actually getting out there, starting with Scottsdale, Arizona. So, real-world use, real patients, real money—basically, what a proper business is supposed to do.

And the buzz doesn’t stop there. They’ve got a virtual investor day on March 12, where the CEO and his crew will explain why this lung imaging magic is actually a game-changer, rather than just another overhyped tech. Ohh, and they dropped a post on X that’s got people talking—highlighting some solid clinical trial progress and a growing consensus that this thing might actually live up to the hype. So, for those who stuck around, it's finally looking like patience might pay off.

ST

Good Morning.

Just a quick observation: Even on the days of almost no trading, the would take ALL my shares at the top price. Yeah, as if I were going to sell. I am with TR1 shareholders here. No day trading.

GLA

My little contribution:

PolX Polarian: Shareholder Expectations for 2025

Ongoing Partnerships & Deals: We expect further developments in existing collaborations, particularly in expanding market reach and increasing commercial adoption.

Regulatory & Clinical Milestones: Progress on approvals, clinical trials, and key regulatory filings should solidify their positioning in the medical imaging space.

Revenue Growth & Commercial Expansion: Increased adoption of their technology should reflect in revenue acceleration, particularly in the US and European markets.

Technological Advancements & Product Development: New integrations or refinements in imaging technology could enhance market competitiveness and drive further adoption.

Strategic Acquisitions or M&A Activity: Potential partnerships or acquisitions could expand capabilities and strengthen Polarian’s market footprint.

Institutional Investment & Market Confidence: Growing institutional backing and analyst coverage should support stock stability and potential upside.

Operational Scaling & Cost Efficiency: Expansion of production capacity and optimization of operational costs should drive better margins and profitability over time.

Market Positioning & Competitive Edge: Continued efforts to establish Polarian as a leader in hyperpolarized imaging, ensuring long-term shareholder value.

The next 12 months will be pivotal in translating partnerships into revenue, regulatory approvals into market confidence, and innovation into sustained growth.

Of course, this is my understanding and means no investment advice. Anyone taking advice or tips from a BB must have their judgement questioned. DYOR. :0)

ST

Ah, Burylad, once again gracing us with the comedic stylings of a bloke who peaked during Year 9 banter. I get it—reading actual analysis is hard work, much easier to lob in a tired "get a room" gag and call it a day. But here’s a thought: instead of hovering around like the bitter ex who wasn’t invited to the party, why not try contributing something worthwhile? Or is the extent of your market insight limited to playground-level quips? Either way, keep ‘em coming—this thread could always use more comic relief.

Hey Unhooked,

Really enjoyed your take on POLX—your ability to zoom out and assess the bigger picture is always valuable, and I find myself nodding along with most of your points. The Taiwan expansion is a significant step, and I like how you framed it—not just as a new market entry but as a strategic move that diversifies their exposure beyond the U.S. It’s easy to get caught up in the short-term implications of deals like this, but you highlight the long-term positioning well. Sumtage’s experience in the region should help, though as you say, “interest” from academic medical centers is promising but still a step away from actual commercial traction. That said, if those institutions start integrating the tech into their research and workflows, it could be a real tipping point for adoption.

Your financial breakdown really resonated with me, too. So many AIM stocks operate on fumes, constantly raising just enough to keep the lights on, so seeing Polarean with a 2.4-year cash runway gives them a fighting chance to execute without an immediate funding overhang. Of course, we both know that no matter how well-structured a company is, the market doesn’t always reward logic—execution is everything. If they can start converting their partnerships and interest into revenue, then we’re looking at a very different valuation conversation down the line.

The recent 12% price move is interesting as well. Like you, I’m cautious about reading too much into short-term fluctuations, but it does show that the market is at least paying attention to these developments. And unlike some of the usual AIM pump-and-dump cycles, this move feels more grounded in actual progress rather than speculative hype.

Appreciate your level-headed approach as always. Too many discussions around these stocks swing between blind faith and outright cynicism, but you always manage to keep it balanced and thoughtful. Looking forward to seeing how this one plays out—plenty of potential here if they can keep delivering.

Cheers,

ST

I get you Unhooked. Sorry to hear of your loss, but we chose to step into the rain. I have a great feeling about this company. We aren't far away for it to fly upwards in due course. I joined for the long term. The day I see TR1s selling big here is when I would worry, but so far they are sitting tight. They know something we do too, so no day trading for me, regardless of doomsayers in boiler rooms (all in the filtered sauna cubicle for me) shpill here. Good luck and I hope you too will have fun times herst

Unhooked, selling is always an option for you. You seem stressed about this. Un-hook yourself and maybe get some more Boohoo shares?

Morning chaps,

I am not going to be posting here all the time, as I am very busy out there. :0) but, having said that, I am super comfortable to wait, just like the big boys who invested here are, for this baby to mature into something way past 10p. The doors are opening for POLX and nothing can stop it, not even the posters that I can even remember who they are now as I filtered the trash. Day traders who want my money like some dodgy Nigerian cyber crooks! Ha, ha, ha! I love filtering them.

Good luck all.. now, where'are my sandals?

ST