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I agree with you. If they don't know yet they should have just said it's under negotiation or something. They just left everyone hanging. I do think it will be SOC with TDAPA though. No matter what the pricing is it will still increase revenue for any provider while at the same time reduce infection rates. They are judged by CMS on infection rates and rewarded or punished accordingly so they will all want it.
Anyone here from IV? Wondering your thoughts on no reimbursement rate mentioned for TDAPA news
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.
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.
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?
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.
I hope they address the C code issue that there has been no decision on.
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.
Raymond James upgraded to strong buy. Still looking for the report
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 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.
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
They sure did. BTW we are back above 200 day simple moving avg
Wasn't me.Yesterday much of gain lost but the volume was on the buy side.
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.
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.
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.
It's already down a lot. If I sell any I'm waiting for the C code news.
I just saw Raymond James downgraded PROF this morning and lowered target to 23 from 28. I see now a week ago a story RJ had reduced it's holdings also in the 1st qtr by 37%. This explains the weakness
Breaking well below 200 day moving avg now. Not good but down so many days in a row on no known news is very odd.
It is down 9 out of the last 10 days so must be getting really oversold. I keep waiting for the C code news but it hasn't happened. I just checked and last year they reported Aug 4 so that is going to be late too. I'm guessing the company is waiting for C code news to report the quarter.
Maybe sales are not great? I don't know what else could be wrong.
I am also on Investorvillage.com where you can PM me if you ever want to. There is also a PROF board there but I was the only one posting so I stopped using it.
I've been in the CRMD I mentioned for years. They have a fantastic drug that will save many lives but so far the FDA has denied it twice for manufacturing reasons. They are on the third try now. Want to talk about frustrating?
I agree with you, this is an unknown stock. At one time when I first invested a few years ago I read 80% was privately held. IMO, the low float and unknown combination will be explosive some day once the growth is big enough for everyone to notice. They have the best solution imo for most patients so it's just a matter of time and patience.
The only problem I see is how long it's taking for the growth. The C code news could be any day and that should help; assuming it's good news as I expect. Holding 12 would be nice. There seems to be a lot of support there. I'm not selling any.
C code news coming soon. Maybe that will spark a rally
Another company I'm invested in is CRMD if you want to check it out. They have under FDA review a catheter lock solution that cuts catheter related infections by over 70%. They have gotten 2 CRL's for manufacturing issues so far so it's been frustrating but I think it has a lot of potential if they can ever get approval.
Over 42k shares traded in one block at 15. Appeared to be a sell order. I don't think it means much. It's had a decent run and no news expected until July now when a decision on the outpatient C code should be made.
I agree with you Dr's should recommend it however many don't know about it and the financial motive is for the doctor to recommend a service he can provide. An ad campaign to inform patients would help but that is expensive.
When I first invested I think I read only 20% of shares were in the float which is something a liked. Not sure if it is the same now. The coimpany is still an unknown which is our advantage right now.
One of my brokers is with UBS and he can't buy this because it is not covered by CFRA Marketscope Advisor. I emailed Investor relations to let them know and asked them to look into how to get coverred. UBS is a big brokerage. I wonder if other big brokers can't buy it. That could be holding down the price.
He said he can't buy it in any managed account.
Another target raise from 14 to 18
https://www.cantechletter.com/2023/06/profound-medical-wins-target-raise-with-leede-jones-gable/#
Thanks for posting. Do you have any links to reports?
My impression of this CEO is he may be interested in a buyout at some point. I read somewhere on this board or somewhere that is what he did with the last company he ran. But I think it's too early for him to sell it.
This stock is the real deal imo. I hope Lazerking still in and is ok. This company still mostly unknown. The broker who manages my IRA can't even buy it at UBS because not enough analyst coverage. I'm willing to wait 2 or 3 years when I think it could easily bring a buyout in 3 figures, meaning north of 100.
I may sell some shares on rips and try to buy back but I have a core position I won't be selling unless something fundamentally changes.
I seem to remember they payment going up this year to about 13,000 but I don't think PROF gets that. It goes to the provider. PROF gets roughly 8000 per procedure in rent and disposables. But where PROF will gain is in more procedures being done since it is not all cash now from the patient.
We also have the C code news coming and I would expect to get approval for that since it really makes no sense for it just to apply to hospitals. I think the government is seeing the ultimate savings of this outpatient procedure as compared to surgery requiring a hospital bed.
I wonder if your email spurred the PR? 1:40 pm is an odd time for this to come out. It's also strange nothing is in federal register that I could find.