Imagin Medical Inc. (IMEXF)

[Golden Cross]

News Out: Imagin Medical Announces Meeting Regarding i/Blue’s Regulatory Pathway
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September 26, 2019 08:13 ET | Source: Imagin Medical Inc.
VANCOUVER, British Columbia and BOSTON, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Imagin Medical (CSE: IME) (OTCQB: IMEXF) (Frankfurt & Stuttgart Symbol: DPD2) (“Imagin” or the “Company”) today announced it recently met with the U.S. Food and Drug Administration (“FDA” or the “Agency”) to discuss its premarket approval regulatory pathway for marketing authorization.

Based on the Company’s continued collaborative discussions with the Agency, Imagin anticipates pursing approval for the i/BlueTM Imaging System through a regulatory pathway that demonstrates safety and effectiveness but that is also the least burdensome approach for the Company. The initial i/Blue functional products, along with the necessary documentation to support them, are on schedule to be verified late this year.

“We are pleased with the feedback we received from the FDA during our second meeting to discuss i/Blue’s regulatory path,” said Jim Hutchens, Imagin’s President and CEO. “We will continue to collaborate with the Agency as we move closer to our submission package.”

About Imagin Medical

Imagin Medical is a surgical imaging company focused on establishing a new standard of care in visualizing cancer during minimally invasive surgeries (MIS). The Company’s first product, the i/Blue Imaging™ System, is based on advanced optics and light sensors and employs patented ultrasensitive imaging technology. The Company’s initial focus is bladder cancer. Learn more at www.imaginmedical.com.

Forward-Looking Statements

Information set forth in this news release contains forward-looking statements. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Specifically, there is no assurance the Company’s imaging system will work in the manner expected. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. The CSE has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.

Contacts:

Jim Hutchens
President & CEO
Telephone: [phone]
Email: [e-mail]

[Neverending]

$1.2 loss per Q and 3.4 left and they are OUT! Good luck raising money at even the 1-2c range! 1 BILLION shares outstanding soon in my opinion to keep this junk bus afloat until the 2 years (plus in my opinion) when they will actually have product to sell. Better to sell now my fiends. Most peeps into the scam stocks invest in the pot crypto or miners. You should do likewise. There is money to be made there.

[Neverending]

Rochester.study.results.were.just made public August 19! Wow wait til this gets widely known. Even if the company is telling the truth that the study was a success the study itself as published on a US govt website says it completely failed to achieve its hoped for results. This should kill the stock completely. Hard not to see it going into the sub pennies. In my opinion.

[Neverending]

Imagin tech.did.not work in the Univ.of Rochester study!!! So says the results (my bolding) https://www.clinicaltrials.gov/ct2/show/results/NCT03058705?term=Imagin&rank=4

Title Minimal Dwell Time
Hide Description The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Dwell time was not collected on any participant due to failure to visual fluorescence in the subjects.


Provided this is the same University of Rochester study that the company was saying in a PR:

July 17, 2018 16:30 ET | Source: Imagin Medical Inc.
VANCOUVER, British Columbia and BOSTON, July 17, 2018 (GLOBE NEWSWIRE) -- Imagin Medical (CSE:IME) (OTCQB:IMEXF) (Frankfurt:DPD2) (Stuttgart:DPD2) (“Imagin” or the “Company”) announced today favorable results in the 10-subject investigator-sponsored research study being conducted at the University of Rochester Medical Center using the i/Blue Imaging System (the “URMC Research Study”), an important step in the development of a commercially-viable product.

In the URMC Research Study, fluorescence was successfully demonstrated in 15 minutes, confirming that the i/Blue Imaging System will potentially allow physicians to “see” bladder cancer significantly faster than the full hour or more required by currently available imaging technology

SO the study results say Imagin tech failed completely and the company says it succeeded. Big difference. Sum ting wong! In my opinion.

[Sux2BU]

Swing and a miss, HaHa!!

[Neverending]

.0328C! Headed to??? Sub pennies soon in my opinion. Best sell now whilst U can still buy a (small) cup a joe.

[Neverending]

3c-2c-1c DONE! Garbage! Soon gone in my opinion!

[Neverending]

Stock is dead. total garbage in my opinion. Sell while it is still worth anything! In my opinion.

[Dosdos]

https://imaginmedical.com/wp-content/uploads/2019/07/Press-Release-7-15-19-Imagin-Progress-Update-FINAL.pdf

[Dosdos]

https://imaginmedical.com/wp-content/uploads/2019/07/Press-Release-7-15-19-Imagin-Progress-Update-FINAL.pdf

[Dosdos]

https://imaginmedical.com/wp-content/uploads/2019/07/Press-Release-7-15-19-Imagin-Progress-Update-FINAL.pdf

[Neverending]

ANOTHER company.with an.ALREADY FDA approved system>>>>

Both Olympus and Storz, WELL established players, already have flat bladder cancer detection solutions and they are FDA APPROVED now! You are late to the game with a non FDA approved solution and no established market presence. You canucks need to stick to your scam mining, crypto stocks or the pot stocks. At least they have potential! In my opinion.

https://medical.olympusamerica.com/articles/fda-clears-olympus%E2%80%99-narrow-band-imaging%C2%AE-nbi-effective-targeting-bladder-cancer-biopsies

[Neverending]

WELL established players.ALREADY HAVE.a PRODUCT! FDA APPROVED!

https://www.karlstorz.com/cps/rde/xbcr/karlstorz_assets/ASSETS/3557592.pdf

IMO this thing is likely well done.

[Neverending]

Set a time-line...miss it.Set another...miss it.Its what.they do!!! If they say product for sale by 2020 count on it by 2023! In my opinion.

[Neverending]

Per PR YESTERDAY-NO EARNINGS! Still.just "talking"to the FDA not even an approved clinical trial application! Burning through cash! Maybve if a trial is ever approved and it is finished in 1-2 years you can have a product to sell in 2023! That is if another company does not beat you out! If this company is even around it will have like a billion shares outstanding! They will need to raise case soon. In my opinion.

[Neverending]

Once again the idiot.get.rich quick penny pumpers.get hosed!

[Neverending]

Expect MASSIVE.share dilution! They.need.to.raise money! In my opinion

[Neverending]

Not even.a.FDA.trial approved yet!=YEARS AWAY from.commercialization. When...IF a trial is ever approved then they have to recruit for a trial then a years long trial then review by the FDA then maybe approval to make certain claims. We are talking maybe 2022 for commercialization. They will either go bankrupt by then or there will be a billion shares outstanding they needed to sell for almost nothing to raise money. My opinion: a lotto ticket is a better bet!

[Neverending]

This junk.stock.should bite the dust soon! IMO! Total garbage.

[Neverending]

Sadly.ignorant"mon'N'pop" investors.R.gett'N snookered here! Sell.UR.shares.and shuffle.along.my friends. They are not good people in my opinion. The get rich quick folks always fall for these penny junk stocks. Stick with the mining, crypto and pot scams. They have much more potential!

[MSU]

Wake up people this needs to be sold!

[Neverending]

I hear the crypto scam stocks.R.the way.to go my friends! Check it out! OR the pot stocks. U got hosed here! Sell UR shares and shuffle along.

[Neverending]

How can.U.peeps.be so STUPID! This is pure.garbage! A.flim.flam.operation in my opinion!

[Neverending]

No.FDA.application even approved yet! Not to mention a study that will likely take well lover 1 year. An FDA study is required before the company can make any claims about their product in marketing. They said they will need to raise more money before this is even finished! Maybe they can sell a boatload of shares at 3c! This thing is toast. It is worth much less than the current trading price. In my opinion.

[Rihlefeld]

Is that it? Just "Stay Away"??

[MSU]

Stay away

[Rihlefeld]

I know small stocks can be erratic but this one goes up 10%-15% one day, down just as much the next day, then back up again soon after.
Any thoughts on what's going on with this one????????

[Sux2BU]

time to move higher, FDA news out this week? IME will close higher tomorrow that’s for sure,

[Neverending]

Stick to the.pot.miner.or crypto scams.my friends! Much.better.opps.than this junk! Jus say'N!

[Neverending]

TRIED 2 warn.U but U would.not listen! Stock.is.garbage.

[Sux2BU]

FDA news on the way finally in a week or 2? See if it closes above 10 cents today

[Money $hot]

+1 unfortunately you were/are right.

Not releasing the Messing Report is nuts! The reason given is nuts!

No insiders are willing to buy the stock @ 52 week low or lower.

HUGE RED FLAGS EVERYWHERE!

Jim Hutchens now says he's going to pitch the company to industry insiders.

Meaning, zero accountability for what he is doing.

Jim Hutchens is an old man (maybe conman) clinging to a dream of hitting it big.

HUGE RED FLAGS EVERYWHERE!

If Imagin Medical had the tech of the ages, it would not be a heavy lift/challenge to move the company along.

It's all BS while he collects a woefully undeserved salary/expenses.

The folks left now are simply big-time bagholders.

HUGE RED FLAGS EVERYWHERE!

/////AMG

[Neverending]

Told.ya.hosers! No Product.4.sale.until.LATE 2020 (2021-22 MAYBE in my opinion these guys can never make a timeline even one they establish!). They said they will need more money red flag! They seemed to say their Rochester study results would not be published to protect their secrets! RED FLAG! Nothing in the public sphere to support even the current valuation. In my opinion this thing has all the BS trappings of your typical penny stock piece of junk. Dump it now! In my opinion.

[Money $hot]

...and Pigs Fly. Goodbye. EOM


/////AMG

[IMeasy]

More detail and an honest question. There was a lot to like in the conference call, such as management's openness to talk details. Though some might not like all the answers, I appreciated CEO Hutchins' willingness to be specific. Ex: Dr. Messing's report will not be publicly published (tips our hand), not promoting the 15 minute process advantage (complicates FDA review), management tried to keep expenses under control last quarter, legal fees to prep for FDA are a lot and are $ 180,000 in accounts payable already, we have firm ownership of our patents, units proposed for market ready configuration will be ready for FDA mandated human tests by the end of September, we do not know yet if the FDA will require a lot of human tests-fewer human tests- or no human tests, we do not yet know precisely what these tests will cost or how long they will take, we DO know that we will have to raise more money before FDA mandated testing, once approved by FDA we could be filling the first orders relatively quickly, the potential per unit profit margin is on the high side of the medical device range, the CEO has not purchased any shares this past year and has no stated plans to buy any, stock price promotion will take the form of marketing to doctors and finance industry players in the near term and not to the independent investor community, the company is for sale if a good match can be made and our management has a very positive view of Stryker (one of our potential buyers). And here is my question: why is it going to take until the end of September to have FDA test ready units (given that we have been working on miniaturizing and perfecting a working model for a year)? My impression is that we can go into any required human testing as soon as the units are ready. So we need to expidite this. It appears the next promotable news event will be when we have units ready and the FDA indicates what degree of testing they will require. So I am seeing that as our next stock inflection point, and that could be eight months away. So until then management will try to increase stock value by promoting the current pitch package to industry insiders. Note how demand has soared since that same presentation package was pitched at Noblecon. And sometime near the end of September we will have to raise more money. I am in for the long haul and I am holding my shares, but investors may need to understand that there may not be a catalyst for share value growth for some months. Those wishing to add shares may have quite a while yet to value shop. But there appears to be an increasing likelihood that the patient investor will be well rewarded. Dilution may be on the menu before then though, but a buyout could occur at any time as well.

[Money $hot]

I chimed in late on the call yesterday. However, the takeaway for me was Jim Hutchens had no credible explanation for why insiders barely hold shares at the same time he wants others to buy in. It's my firm belief this stock and Jim Hutchens rhetoric is overcooked toast.

Common shareholders simply got burned!

/////AMG

[IMeasy]

Our first conference call. I was satisfied with CEO Hutchins' explaination for why the 15 minute process turn around claim has gone off the active duty list (do not want to add more hoops to the FDA approval gymnastics). But, his reason why he has not bought a single share of a stock this past year that sells for under a dime is leaving me flat:....because he can not afford to buy them. If you are a smart buyer you can buy one million shares for under $100,000 US. His home equity line probably could cover that. And it appears that FDA trials will not start till Fall 2019. And by that time we will need more money, which may mean more shares at whatever this is at then. I am not counting on seeing many 38 cent warrents redeemed, especially given how many expired worthless in the last batch. In general though, I thought the conference call was a great success. I know I am feeling more in-tune with managements hopes and dreams, and I am holding my shares for now. If others feel that way maybe we have established a fire break and can start to push back now.

[SO75]

Was hoping for a bit more excitement. Hopefully it ticks up a bit more before close and pops huge tomorrow. BOL


2.61 M 
Total volume

 

1.56 M 
CSE vol

 

1.05 M 
ATS vol

[SO75]

Imagin management will host a conference call at 5:00 p.m. ET to review the financial results
and discuss business developments in the period

[Money $hot]

Nice work!

/////AMG

[SO75]

I did not say it was FDA. It is a trial to collect data to present to the FDA. Which was updated on Feb 15 and the very next business day the company announced a conference call. Im liking our chances here. Lets see where its at about this time Thursday morning.

[Neverending]

That is not the FDA trial. Read the disclaimer>>

"The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government."

The FDA trial application is another matter and the FDA trial is what is required to be successfully completed before any claims can be made about the product in marketing material. This "trial" is just some stuff posted on a website. In my opinion.

[MSU]

Sad but true, take your beating, before the conference call IMO

[SO75]

https://clinicaltrials.gov/ct2/show/NCT03058705?cond=Bladder+Cancer&cntry=US&state=US%3ANY&city=Rochester&rank=2

Looks like the trial was updated a week ago. Hopefully that's Dr Messing putting his stamp on it and he's ready to publish results. Pretty nice coincidence with the update on the trial and a conference call coming.

[Neverending]

My guess is their FDA.trial.application.was denied. I am amazed that this garbage stock is still around! Snicker. What a stinker! I would sell them shares ASAP the 6c is a GIFT! These guys simply cannot fail to miss every single time! In my opinion.

[Money $hot]

I'm not expecting anything more than more BS coming out of Jim Hutchen's mouth. He will rehash the same shit and keep collecting his $1100 per day, everyday. 365 days a year salary. Kilmer Lucas will be praised for having done absolutely nothing to increase company awareness, i.e. positively impact share price for the $7500 USD per month fee. The questioners/calls will be screened, the answers will be drawn out, and we will come away with more speculation that before, if at all possible. Imagin Medical is a Cook Book...

To Serve Man

/////AMG

[IMeasy]

To finance a product roll-out. If management wanted to raise a modest $10 million USD to finance some startup expenses, the share dilution is staggering. At our current .067 share price about 149,000,000 new shares would have to be issued. That would nearly double our count. Plus all the new warrants required to grease the wheels of a new venture that enjoys no guarantee of success. Of course, there are other methods of financing a new venture: venture capital, a merger/partnership,..... But, more mouths to feed may mean fewer worms for those who have been patiently waiting since mother bird Hutchins built the nest. So I suggest to my fellow long suffering shareholders to not discount a buy-out, even if it seems less than ideal. As a disclaimer: I have no knowledge of any corporate proposal to purchase IMEXF.

[IMeasy]

A buy-out bargain. If we use 174,000,000 as the current outstanding share total with warrants, and attach some per share prices, IMEXF starts to look like a potentential bargain. I have stated before that I want to see this tech in use and saving lives as soon as possible. The fastest pathway to facilitating that goal may be incorporating IMEXF tech in another firm's platform. I am unconvinced at this time that management has command of the complex elements that would be required to launch a startup in this competitive market against well prepared and financed competitors. I do not even want to think about the dilution of shares required to finance a product roll out. Stryker has paid $ 800 million as a large down payment on what they hope will be the market standard system. So what would Stryker potentially pay us for our tech's unique features to complete their product? At $1.00 US per our share their initial combined out-of-pocket is still under a billion USD. That might be very affordable given the size of the global market. But, we can plug in any figure we are willing to consider: .88 USD , .78, .44? Pay me sooner than later and I am prepared to make a deal. I am now averaged at .14 USD, so I am down by half, but I can still see scenarios where this works out just fine. Individual satisfaction will vary by what each shareholder's expectations are.

[IMeasy]

Conference call Wednesday approximately 5:00 pm Eastern time. See company web site for details. I have a theory. Since the quarterly report will be rolled out first, and given how much management does not like interacting with share holders, and the rough treatment management should expect from shareholders, I suspect that management might try to "juice" the report with some little candy surprise to change the trajectory of the call-in portion. If they can get shareholders excited about some new information maybe they can distract callers from banging on about our long list of complaints. There has been a news drought for a long time, and this has contributed in part to the crappy stock price. So, we are overdue for a progress report. Frankly, I have no idea precisely what they are doing with my money right now. I have a foggy idea that there are scholarly reports being written, conversations about having conversations with the FDA occurring, and pitches to finance wonks being floated. But, I really need to have more detail, because we are in a competitive marketplace and milestones must be met in a timely manor or some other firm will meet them.

[Money $hot]

One of the 3 Amigos is now crying on yet another board today.

It must really be a butt hurt to stay broke as f*ck.

GL Amigos

/////AMG