Polarean Imaging Share Discussion Threads

[74tom] 12/10/2020 11:58

Seller at 50p has been taken to the cleaners here, that’s a very decisive breakout to all time highs :)

[acuere] 12/10/2020 11:41

From last years HY results :-

“ The number of systems installed or on order is currently 25*.”

Today’s order is number 24. So there is at least one other system installation still to come which I seem to recall they expect to complete before year end.

Clearly FDA approval will be catalyst to enable ramp up of sales.

Renx on my watchlist.

[nobbygnome] 12/10/2020 11:32

LOL. POLX is yet another appalling buywell call. He thinks he is the messiah but strangely the reality is slightly different from that narrative......

[loglorry1] 12/10/2020 11:28

Anything under 100p is very cheap for this in the run up to approval. No reason this can't be a $1bn market cap company on approval. There are many similar companies with US listings with this sort of market cap.

[markstevenkirby80] 12/10/2020 11:00

Was in here at 18 p, silly me did sell on a profit though, I couldn't be bothered waiting all this time, but ,, now worth the wait time is coming soon

[mr roper] 12/10/2020 10:56

Same, hold both Renx and polx. Think both have potential to double in the next 6mths.

[74tom] 12/10/2020 10:55

Same @Faz, that podcast really flagged the huge potential here - both fantastic companies with gigantic addressable markets, on the cusp of take off.

[faz] 12/10/2020 10:09

RENX also mentioned in that Amiti podcast Acuere. Only posting because I have held RENX for a while and it is another company awaiting FDA clearance before take off.

[loglorry1] 12/10/2020 10:09

Great to see another machine sold for research purposes but probably what's more important is to see who is buying it.

MD Anderson Cancer Center is a massive tier 1 hospital full of key opinion leaders. This is a real vote of confidence for POLX tech which is far more important than the actual sale value.

When the FDA approval lands the flood gates will open here I think.

[mr roper] 12/10/2020 10:06

Yup. Glad to see momentum continuing. Transformational tech.

[richardjohn10] 12/10/2020 07:24

Sleeping giant this share. Will carry on accumulating.

[acuere] 09/10/2020 10:04

Patient investors should be amply rewarded here.
On the money week podcast of 1st Oct, an Amati Fund Manager was asked if they were only allowed to hold one stock out of all the ones they are invested in for 10 years which would he chose. He picked Polx.

[gregb] 09/10/2020 09:34

Good to see Tyndall topping up their holding.

[pentacosttempleton] 08/10/2020 15:57

lithological heterogeneities even after the small run up here this is still very cheap. I've seen stuff on Nasdaq with phase III approval with a tenth of the potential trading with a market cap way over $1bn.


I think on approval we'll see way over £1.50 and a steady run up until then.

[acuere] 08/10/2020 15:45

Was that a serious question? I guess if 8 months is too long then best wait. However I’ve no idea what the share price will be 3 months but you could be paying a fair bit more.

[lithological heterogeneities] 08/10/2020 15:37

Just listened to Vox Markets interview.

A very exciting company.
However, CEO says FDA answer expected in 8 months instead of 12 months so will save about 4 months.

Too soon to get in ?

[loglorry1] 07/10/2020 21:44

Because of HW it is up to 8 months for accellerated approval and up to 12 months otherwise. It's possible that approval could come in 5 months since it is "up to" but these are back stop timescales.

I see no reason why after approva this can't be a £500m company which would be 6x current share price.

The two criteria for approval are safety and efficacy. Clearly efficacy is nailed on as it passed Phase III trials and its comparitor product is so inferior. Safety is down to Xe gas which is innert and used in many medical products already.

My guestimate is 90% they'll get approval.

Can anyone else show me a 90% chance of 6x in the market right now?

[hedgehog 100] 07/10/2020 18:56

Supernumerary,

The Blue Earth Diagnostics FDA approval only took 6 months under a priority review, and that was without the increased imperative that COVID-19 has created for POLX's technology.

So when you look at the way some things have been rushed through for COVID-19, I think that approval here in as little as a few months could be on the cards.

This technology is urgently needed right now to help with the current pandemic, and there is a rich base of published research about it, so the case for swift approval is overwhelming.

[supernumerary] 07/10/2020 17:17

And a not so good recent example is Diurnal. At least not yet :¬)

The real questions now are whether they'll get accelerated approval, and if they do, how long it will take. I'm optimistic about the former, but have little idea on the latter. Any views, anyone?

[hedgehog 100] 07/10/2020 16:19

The closer we get to the FDA approval (effectively a licence to sell generally in the US), the more keenly will mass sales of POLX's technology be anticipated.

From a December 2018 Northland Capital broker note on POLX:
"“Polarean expects over US$500mln in system sales just to top-tier institutes,” said Alexandre in a note to clients."


That's why you tend to find that a share price will appreciate a lot during the FDA approval process, in anticipation of the approval.

A good relatively recent example is Shield Therapeutics (STX).

STX rose about six-fold in the first seven months of last year, from about 30p, until just after its FDA approval on 26th. July 2019.

And it more than trebled during this period ahead of the FDA approval, before enjoying a very strong rise at the FDA approval itself.


26/07/2019 07:00 UKREG Shield Therapeutics PLC FDA approves Feraccru® with a broad label

"London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product Feraccru(R) / Accrufer(R) for the treatment of iron deficiency in adults.

With this broad label approval Accrufer(R) (as the product will be marketed in the USA) has taken a big step towards exploiting the very large commercial opportunity in the USA, the world's largest and most attractively reimbursed pharmaceutical market. Market research suggests that the prescription market for iron replacement therapy in the USA is worth over $1.0bn annually. There are between 8 million and 9 million patients in the USA who suffer from iron deficiency anaemia and management estimate potentially two to three times this number require treatment for iron deficiency. ..."

[hedgehog 100] 07/10/2020 15:40

07/10/2020 07:00 UKREG Polarean Imaging PLC NDA Submission

NDA submission for Polarean's hyperpolarised (129) Xenon gas drug-device diagnostic for lung imaging

Polarean Imaging plc (AIM: POLX), the medical--imaging technology company, with an investigational drug--device combination product for magnetic resonance imaging (MRI), announces its submission of a New Drug Application ("NDA") and request for priority review to the US Food and Drug Administration ("FDA") for hyperpolarised (129) Xenon gas used to evaluate pulmonary function and to visualise the lung using MRI.

The submission of the NDA follows the Company's successful completion of two Phase III clinical trials (the "Clinical Trials") which demonstrated effective measurement of regional lung ventilation. In the Clinical Trials, Polarean's (129) Xenon gas MRI was used to measure regional pulmonary function in patients with a wide variety of underlying lung diseases who were being evaluated for possible lung resection or lung transplant surgery. As detailed in the Company's announcement of 29 January 2020, both Clinical Trials met their primary endpoints, showing pre-defined equivalence of hyperpolarised (129) Xenon Gas MRI to an approved comparator, (133) Xenon Scintigraphy, and displayed a benign safety profile.

(129) Xenon, when polarised in Polarean's proprietary drug-device system, permits functional, regional and quantitative imaging of the lungs using MRI, without the risk of exposing patients to ionising radiation. The polarised (129) Xenon is administered as an inhaled gas that is given to patients in a 10 second breath-hold MRI procedure.

Commenting on the submission, Richard Hullihen, CEO of Polarean, said: "The NDA submission of (129) Xenon gas MRI as a drug-device combination represents another key regulatory milestone for our Company. I am delighted with the performance of Polarean's team, who have worked tirelessly to achieve this important goal, and would also like to thank the institutions, clinicians and patients who took part in the studies that have formed part of this NDA.

"More than 30 million Americans suffer from a chronic lung disease and we see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnostic technology without exposing patients to ionising radiation. W e look forward to working with the FDA to address this unmet need."

[aberloon2] 07/10/2020 07:24

Bye bye 50p....hopefully :)

[gregb] 07/10/2020 07:14

Here we go...

[richardjohn10] 06/10/2020 20:08

What's with the two 27 trades earlier?