TORONTO, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, will announce its fourth quarter and full year 2023 financial results after market close on Thursday, March 7, 2024.

Reminds me of the old Remingtoncommercial where the guy says he was so impressed with their electric razor he bought the company. Looks like DSKE was just bought out in December which may have freed up a lot of cash for him. Anyway nice vote of confidence. We have the best mousetrap, now we just need insurance coverage to kick in next year and demand to go way up.

I thought this was interesting:
Satisfied TULSA prostate cancer procedure patient discloses 5.2% stake in Profound Medical
January 12, 2024
Profound Medical
In a 13G filed with the SEC today, accomplished businessman and founder of namesake transportation company Daseke (NADAQ:DSKE), Don Daseke, disclosed he has taken a 5.2% ownership stake in Profound Medical (NASDAQ:PROF).

yeah it's working, just no news here for a while. I'm not expecting sales to ramp up until 2025 . Sometime between now and then the stock should start moving in anticipation.

Test

The payment ratio has not been determined. Obviously, this information will be soon and more specific because of the January start. Arun, in the question he fielded during the Investor's Day, alluded to it as the same percentage as any other established Medicare procedure.

Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, announced today that, pursuant to the 2024 Final Rule published yesterday by the U.S. Centers for Medicare and Medicaid Services (“CMS”), use of HCPCS C code, C9734, previously established for the Hospital Outpatient Prospective Payment System (OPPS), has been extended for use in the Ambulatory Surgical Center (“ASC”) setting, and that MRI-Monitored Transurethral Ultrasound Ablation (“TULSA”) of prostate tissue, performed using Profound’s TULSA-PRO® system, has been assigned device-intensive status. The ASC extension will go into effect on January 1, 2024.

I don't understand it either. Poorly written PR. Why not just say what percent of procedures now get covered and how much CMS pays?

So they finally got this approval. But I've never quite understood how it can be used. Aren't the ASC's more for small surgeries? tulsa needs an mri machine.

Profound Medical Announces CMS Extension of Temporary ‘Code’ for TULSA to ASC Setting

I agree on the Cleveland Clinic deal. However I am growing impatient with the slow growth. No mention of the C code and no analyst even asked about it. Only 3 installations for the qtr so up to 41. They need to do 3 a month this qtr to meet their goal of 50 by year end.

Looks like the initial reaction is the stock is up anyway. I'm not selling any. Being patient is hard but I know we have the better mousetrap.

Nothing was mentioned about the temporary C-code. However, the Master Agreement with Cleveland Clinic and their 20 sites is impressive.

I hope they address the C code issue that there has been no decision on.

Profound Medical to Release Third Quarter 2023 Financial Results on November 2 – Conference Call to Follow

Profound just posted the event on their website: Investors/Webcasts/Profound Medical 2023.......

Thanks James. I believe Arun also described it as, "a work in progress."

To be clear Arun previously suggested final decision could go either way…

The CMS was to publish their proposed remarks this summer and finalize them by October. I don’t know what was published but Arun suggested final decision could go either way. New c-code would be effective Jan 2024 which would help bridge the gap until CPT in Jan 2025.

I have not yet listened to Friday’s event.

Profound Medical 2023 Virtual Analyst & Investor Day-This event was held this last Friday. The agenda showed a Q&A session at the end of their presentation. I was not able to find a transcript for that moment. Did anyone experience this event, and if so, was there any hint of the C-Code?

Gov funding to Nov 15 is helpful because otherwise C code decision would have been delayed

Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO® Thermal Boost
The first of the TULSA AI modules, Thermal Boost enables predictable, customized ablation at the prostate capsule

TORONTO, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA) for the Company’s Thermal Boost module for use in conjunction with TULSA-PRO®.

TULSA-PRO® enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low-, intermediate-, or high-risk prostate cancer; with benign prostatic hyperplasia (“BPH”); as well as those prostate cancer patients on active surveillance seeking treatment of their cancer and relief from their symptoms of BPH. Profound’s data indicates that, in a commercial setting, approximately 60% of the patients being treated with TULSA require whole gland ablation, whereas the remaining 40% receive partial gland ablation. In addition, TULSA surgeons are treating prostates of various shapes and sizes, ranging from prostate volumes of less than 20cc to greater than 250cc, confirming TULSA-PRO® as one of the most versatile technologies currently available for the treatment of prostate disease.

Recognizing that the TULSA patient population consists of a wide variety of prostate disease states, as well as prostate shapes and sizes, the Company is developing a novel set of software modules that will work in conjunction with TULSA-PRO® to further enable treating such variety with further customizability, ease of use, and higher confidence in clinical outcomes. Profound plans to market these new clinically relevant modules under the name brand ‘TULSA AI’.

Thermal Boost, Profound’s first FDA-cleared TULSA AI module, enables surgeons to temporarily increase the ablation target temperature in prostate regions where advanced stage cancer might reside, further increasing their confidence that aggressive cancer cells have been ablated. The Thermal Boost module is already CE-Marked and is being used in up to 50% of the TULSA patients being treated in Europe. Based on a recent TULSA-PRO® survey, European surgeons indicated that Thermal Boost resulted in improved treatment outcomes in 88% of their prostate cancer cases.

“The Thermal Boost feature is a significant development of the TULSA technology,” said Dr. Mikael Anttinen, Urologic Oncologist at Turku University Hospital in Finland. “It opens an important degree of freedom for the surgeon, allowing for controlled increased thermal dose to be delivered to selected regions of the treatment plan. Achieving complete thermal coverage is critical to successful prostate disease treatment, so being able to customize ablation temperature in real time has improved treatment efficacy as well as workflow efficiency. The Thermal Boost feature has allowed us to expand our confidence in patient selection, for example to include patients with MRI-visible lesions bulging the prostate capsule, and other higher risk features.”

Arun Menawat, PhD, Profound’s CEO and Chairman, commented, “We believe that the TULSA technology can be used to treat up to 600,000 patients per year in the United States, and based on the utilization data from Europe, Thermal Boost may have an application in the majority of late-stage disease cases. In addition, the feedback from European surgeons using the module indicates that Thermal Boost could significantly increase both the ease and speed of treatment in a certain subset of the patient population.”

Profound is continuing to develop additional TULSA AI modules, including one that will enable the creation of an AI-driven automated treatment plan, which will be based on a database of successful physician-created treatment designs. The Company is working with the FDA on a pathway to achieve the Agency’s clearance for this module.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® has the potential to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (“BPH”). TULSA-PRO® is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Seeking Alpha article

Profound Medical (NASDAQ:PROF) soared on Monday as investment bank Raymond James raised its rating on the medical device company to Strong Buy from Outperform and maintained a price target of $20.00.

PROF traded 18.63% higher at $9.49 in afternoon trading.

Drawing parallels with PROCEPT BioRobotics (PRCT), Raymond James said that PRCT's Current Procedural Terminology (CPT)-driven revenue trajectory portends a revenue inflection for PROF in 2025 once its new CPT reimbursement codes come into force.

"We expect this revenue inflection to begin pricing-in to the stock in 1H24, so are raising our rating to Strong Buy," said analysts at Raymond James.

PROCEPT Biorobotics, which quadrupled its revenue with CPT-1 reimbursement commencing ~Jan. 2021, was noted by Raymond James to have its reimbursement and sales path highly predictive of Profound Medical.

The investment bank also expected CPT -1 reimbursement to drive Profound Medical's 2025 revenue to about $40 million.

Profound Medical has fallen 14.12% since the start of the year but has gained about 80.76% on a 12-month reading. PROF is rated Buy by SA analysts and Wall Street but is marked Hold by the Seeking Alpha Quant rating system.

More on Profound Medical
Seeking Alpha’s Quant Rating on Profound Medical
Historical earnings data for Profound Medical
Financial information for Profound Medical
Profound Medical Corp. (PROF) Q2 2023 Earnings Call Transcript
Profound Medical: TULSA-PRO Now Selling, Recurring Revenues Up 43%
Profound Medical announces $30M equity offering

Small float and thinly traded can make this one move big on any news. Up 1.39 a minute ago.

Wow it’s really taking off now…

Raymond James upgraded to strong buy. Still looking for the report

Agreed. Just one day but still good to see…

Price action pretty good today after the ATM announced last night. Right now the stock is up for the day after a gap down. Looks to me like the drift lower was in anticipation of a dilution and hopefully now that it's in the past we can move up again.

Profound Medical Announces At-the-Market Offering of up to US$30,000,000

TORONTO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX: PRN; NASDAQ: PROF) (“Profound” or the “Company”) announces that it has established an at-the-market equity program (the “ATM Program”) that allows the Company, through certain securities dealers acting as agents (together, the “Agents“), to issue and sell from time to time up to US$30,000,000 of common shares in the capital of the Company (the “Common Shares”).

Any Common Shares sold under the ATM Program will be made through “at-the-market distributions” as defined in the Canadian Securities Administrators’ National Instrument 44-102 - Shelf Distributions, including sales made through the Toronto Stock Exchange (the “TSX”) or the Nasdaq Stock Market LLC (the “Nasdaq”) or on any other trading market for the Common Shares. The TSX has conditionally approved the listing of the Common Shares that may be issued under the ATM Program and listing will be subject to the Company fulfilling all of the listing requirements of the TSX. Distributions of the Common Shares under the ATM Program will be made pursuant to the terms of an equity distribution agreement dated September 6, 2023 (the “Distribution Agreement”) between the Company and the Agents.

The Sales of Common Shares, if any, will be made at the market prices prevailing at the time of each sale and, as a result, prices may vary as between purchasers and during the period of the ATM Program. The volume and timing of distributions under the ATM Program will be determined at the Company’s discretion. The ATM Program will be effective until the earlier of the issuance and sale of all of the Common Shares issuable pursuant to the ATM Program and April 23, 2024, unless terminated prior to such date in accordance with the terms of the Distribution Agreement.

The offering of the Common Shares under the ATM Program will be made pursuant to a prospectus supplement dated September 6, 2023 (the “Prospectus Supplement”) to the Company’s short form base shelf prospectus dated March 23, 2022 (the “Base Shelf Prospectus”), which were each filed with the applicable securities regulatory authorities in each of the provinces and territories of Canada, and in the United States pursuant to a prospectus supplement dated September 6, 2023 (the “U.S. Prospectus Supplement”) to the Company’s U.S. base shelf prospectus (the ”U.S. Base Shelf Prospectus“) included in its registration statement on Form F-10, as amended (File No. 333-263248) (the “Registration Statement”), filed with the U.S. Securities and Exchange Commission under the U.S. Securities Act of 1933, as amended.

The timing and extent of the use of the ATM Program will be at the discretion of the Company. Accordingly, total gross proceeds from equity offerings under the ATM Program could be significantly less than US$30,000,000.

The Company intends to use the net proceeds of the Offering, if any: (i) to fund the continued commercialization of the TULSA-PRO® system in the United States, (ii) to fund the continued development and commercialization of the TULSA-PRO® system and the Sonalleve® system globally, and (iii) for working capital and general corporate purposes.

Copies of the Distribution Agreement, the Prospectus Supplement and the Base Shelf Prospectus are available on SEDAR+ at www.sedarplus.ca and the Distribution Agreement, the U.S. Prospectus Supplement, the U.S. Base Prospectus and the Registration Statement are available on EDGAR at www.sec.gov.

Copies of the Distribution Agreement, the Prospectus Supplement, the Base Shelf Prospectus, the U.S. Prospectus Supplement, the U.S. Base Shelf Prospectus and the Registration Statement may also be obtained directly from the Company at 2400 Skymark Avenue, Unit 6, Mississauga, Ontario, L4W 5K5, Telephone: (647) 476-1350.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® has the potential to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (BPH). TULSA-PRO® is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but are not limited to, statements with respect to the ATM Program, including the use of proceeds thereof, the expected ATM Program jurisdictions, and the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the ATM Program (including that the Company may be unsuccessful in selling Common Shares under the ATM Program or that the Company’s use of proceeds of the ATM Program may differ from those indicated), the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition, and the other risks described in the Prospectus Supplement, the Base Shelf Prospectus, the U.S. Prospectus Supplement, the U.S. Base Shelf Prospectus and the Registration Statement, and the documents incorporated by reference therein. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. All forward-looking information in this news release is as of the date of this news release. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849

I'm hoping it holds 9.50. Unfortunately there is probably no news for a while. C code now delayed until October and does not sound like a sure thing. On the bear side there could be a dilution at any time. The last time they sold stock the stock price went up but we can't count on that happening again.

I don't want to see it drop below $9.00, but if it does I will add to my position.

Thank you James, I appreciate the update.

Thank you Hayfarmer, maybe that's why RJ downgraded the stock because he doesn't expect the C code until October or not at all.

I listened to the call. No talk of raise. Generally a positive call although it’s a tough market right now so I would not be surprised if stock goes down tomorrow. But in the grand scheme that does not matter at all. The stock is so thinly traded.

Arun will not rush things and he is very cautious to not over promise. We need to just wait here. There will be further volatility, certainly.

I had to go after the first analyst from RJ. It came out that the C code news may not come until October now. They are in continuing discussions with medicare. They think they have a good case to get it and it an easy change for medicare but medicare could decide since they will have CPT codes in 2025 it's not worth the effort.

They have 38 installations now and still expect 50 by year end and 75 by end of 2024. They expect revenue growth to continue to accelerate and felt they are meeting all the goals they have set. They said there would be some capital sales in EU in 2nd half, or maybe it was in Japan.

When I got off there was no discussion of a raise but it could have happened later.

Overall a very positive call for the part I heard.

I was not able to listen to the conference call. What was the Q&A like?

recurring sales of consumables is pretty good, I think it was 38% rise and they expect that to continue or accelerate from here. Bad news is only 5 quarters of cash left so a raise or debts likely in the next 6 months. No mention of the C code

Back to back good days before the ER. I hope this bodes well for the rest of the week. By the way I picked up some CRMD last week.

They sure did. BTW we are back above 200 day simple moving avg

I didn't think it was you, someone made a bad mistake.

Wasn't me.Yesterday much of gain lost but the volume was on the buy side.

Who bought 304 shares pre-market at $11.54?

Thank you. This will be an interesting week…

Welcome to the board James! It's nice to have another person to get their insight on what's happening with the company. I agree with a lot of what you said in your post. I hope we get some good news this week!

Thanks. I agree with everything you just posted. We can indeed go higher than 4-5 times - but timing is uncertain. Arun is getting older and he’s sold in the past so he may just want out at some point. Not sure about succession planning at co.

I do hope they get c code for 2024 and Gagnon asked about that in previous quarterly calls. The key is the CPT 1 approval and we have that know.

I understand selling as price went down. It turned out to be the right move to buy back at lower level. For stocks like this I just buy and hold (adding sometimes). There is certainly an opportunity cost and it has been frustrating but I do believe it will be worth the wait. A core holding makes sense for sure.

James, thanks for posting. I agree with everything you said and I'm also expecting a raise at some point. I think the potential gain here is even more than 4 or 5 times where we are now but when we will get there is anybody's guess. That is my disappointment....how long it's taking for this to catch on. Insurance coverage is definitely a huge reason why so not likely until 2025 or later. Not everyone can shell out 30k for the treatment out of pocket.

What are your thoughts on the C code being approved for 2024? That will help although I still agree a raise at some point is likely. I just hope it can wait until later 2024 or early 2025 when insurance kicks in and this starts getting on investor's radar.

The fact that no one knows about this one and the float is so small could really lead to an explosive move at some point!

I admit I was unable to ignore the price as it dropped from 28 to 3. I sold 75% on the way down, mostly at profits and managed to lower my avg cost. I'm fully back in at this point but that could change. I have have a core position I will never sell until we are much much higher.

Hi. I’ve been reading the posts from you and Hayfarmer over the past few months. You’ve both made some insightful comments.

I’ve held this stock for a long time like you. Arun knows what he’s doing. He is patient and not promotional. He’s experienced and he’s built companies up and sold them before. The pandemic set PROF back and it was unfortunate to only recently get CPT 1 approval effective 2025 rather than a year earlier in 2024 if the application had been approved in 2022 rather than being withdrawn. In any event TULSA has huge potential to disrupt and become the standard of care. However, the company will almost certainly need to raise equity again as sales will not really pick up until 2025 even with c-code approval outside of hospitals. More debt as a bridge is an option but I think they will dilute again.

The stock is so thinly traded. I don’t pay much attention to the daily stock prices. If things work out - and I think there’s a good chance they do - the stock will be much much higher in a few years. The market opportunity is significant and if the company can even capture a small portion of that with a modest multiple the stock will be 4-5 times higher than it is today.

The best thing is very few people have even heard about PROF. So like all small caps there are risks but the risk reward for this one is very interesting imo.

I don't know what he mentioned in his downgrade, i was only able to see the headline. I just search for Raymond James new reports for Profound Medical.

Yes they have 3 days. I agree it's strange to downgrade it now unless you're hoping to cause selling you can take advantage of and buy cheaper. Did the RJ downgrade mention the insurance C code? I don't have access to what RJ said in it's downgrade.

I hope I'm also wrong about having inside information. I believe a public company has 3 business days to release information that is material to the price of the stock. One of the catalysts he was writing about was the insurance code and was expecting the news to come out in July or early August. i believe we would have a substantial move to the upside if it was approved. Why come out with a downgrade before we find out if it's approved. PROF's numbers may be off but that's looking in a rear view mirrow if they get the approval. I still own a nice amount of stock and some options. I'm not sure you know this but RF sold a bunch of PROF stock in the 1st quarter. I will never forget about this stock, i've been in it for years.

Totally guessing but I'm thinking volume is low because very few retail investors are in this stock and RJ has already sold what they want to sell. After done selling they downgraded and probably hope to buy back cheaper. If that is the plan today's action didn't really go their way. The downgrade didn't result in many sellers.s In fact I saw a lot of buying late in the day. I am also very frustrated with the ultra slow sales progress.

I hope you'/re not right on them knowing about the insurance. That would be insider information but I know it happens. Government often makes no sense but it seems like medicare would want this procedure since it keeps people out of the hospital. It must be cheaper for medicare vs some of the alternatives.

I don't know your plans but I suggest keeping a few shares so it's on your quote list in case things change so you don't forget about it.