Profound(PROF)
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Profound Medical Receives U.S. FDA 510(k) Clearance for 'Contouring Assistant' AI Module that Enables Creation of an Automated TULSA Treatment Plan
Newsfilter· 2024-05-14 11:30
– Prostate segmentation using a deep learning convolutional neural network – First, a Reference Standard was created by combining contours from three expert prostate radiologists: Edward Steiner, MD (WellSpan York Hospital); Steven Raman, MD (UCLA Health); and Robert Princenthal, MD (Rolling Oaks Radiology/RadNet). Then, Contouring Assistant was validated in two clinical studies: – Urologists testing this TULSA-AI module improved their segmentation accuracy and were 32% faster in their contours – TORONTO, M ...
Profound(PROF) - 2024 Q1 - Earnings Call Transcript
2024-05-11 17:47
Thank you, everyone, for your participation in today's conference call. This does now conclude the program. You may now disconnect. Yes. I think that is certainly the principle that we're using. And I think as you heard from Mathieu comments, also, we think that TULSA a very efficient procedure, and that efficiency will continue to grow. And so we think that on use per unit time basis, we will continue to show productivity and that could over time be a reason to maintain our prices and maybe improve upon th ...
Profound(PROF) - 2023 Q4 - Earnings Call Transcript
2024-03-08 04:35
Financial Data and Key Metrics Changes - Total operating expenses in Q4 2023 were $9.8 million, a 5% increase from $9.4 million in Q4 2022 [51] - R&D expenditures increased by 28% year-over-year to $4 million, G&A expenses rose by 41% to $3 million, and selling and distribution expenses surged by 74% to $3 million [52] - Revenue for Q4 2023 was $2 million, a 60% increase from $1.3 million in the same period in 2022 [54] - The net loss for Q4 2023 was $8.9 million or $0.42 per share, compared to a net loss of $9.5 million or $0.46 per share in Q4 2022 [55] - Cash as of December 31, 2023, was $26.2 million, which increased to $45.4 million by January 31, 2024, after recent financings [56] Business Line Data and Key Metrics Changes - The company reported that TULSA is increasingly being used for a variety of prostate disease patients, with 67% treated for primary prostate cancer, 23% for hybrid patients, 7% for salvage treatments, and 3% for BPH only [32] - The installed base of TULSA-PRO systems reached 50, with expectations to grow to 75 by the end of 2024 [17][18] Market Data and Key Metrics Changes - TULSA usage is currently primarily cash pay, with a transition to a payer pay model expected to start in 2025 [18] - The American Medical Association established three new CPT Category 1 codes for TULSA in mid-2023, which is expected to facilitate reimbursement [18][37] Company Strategy and Development Direction - The company aims to position TULSA as one of the three mainstream treatments for prostate cancer, alongside radical prostatectomy and radiation therapy [15] - A collaboration with Siemens Healthineers aims to create a total diagnostic and interventional MR solution to streamline workflow and optimize costs [22][41] - The company is focused on building a high-quality installed base and executing a U.S. reimbursement strategy for TULSA [18][37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing adoption of TULSA, despite the current reliance on cash pay patients [61] - The company is confident in the upcoming reimbursement decisions from CMS, which are expected to positively impact utilization rates [89][102] - Management noted that the number of patients educated about TULSA is significant, indicating strong interest despite current treatment costs [25] Other Important Information - The CAPTAIN post-market study is ongoing, comparing TULSA to radical prostatectomy, with recruitment rates increasing [44] - The TULSA AI brand is being aggressively built, with the first AI module already in use for about 50% of patients treated [38] Q&A Session Summary Question: Can you talk about your pipeline and how it’s looking? - Management acknowledged the positive trajectory of the pipeline and the successful installations at various sites [10][12] Question: What is the status of the reimbursement strategy? - Management confirmed ongoing communication with CMS and expressed confidence in securing appropriate reimbursement amounts [89][102] Question: What are the expectations for revenue in 2024? - Management indicated a potential revenue range around $12 million, driven by an increasing installed base and service utilization [75] Question: Are hospitals concerned about transitioning to the payer model? - Management noted that hospitals might slow down in the second half of the year as they await clarity on reimbursement codes [90] Question: What is the expected impact of the Siemens collaboration? - Management highlighted that the collaboration could streamline the sales cycle and enhance the economic model for ASCs and hospitals [96][99] Question: How many systems are expected to be sold under the revised capital sales model? - Management estimated that at least half of the new systems could come from existing contracts, with the remainder from the pipeline [140][141]
Profound(PROF) - 2024 Q1 - Quarterly Report
2024-03-07 21:10
Summary Fourth Quarter 2023 Results For the quarter ended December 31, 2023, the Company recorded revenue of approximately $2.0 million, with the full amount coming from recurring revenue, which consists of the sale of TULSA-PRO consumables, lease of medical devices, procedures and services associated with extended warranties. Fourth quarter 2023 revenue increased 60% from approximately $1.3 million in the same three-month period a year ago. Q4-2023 recurring revenue growth of 60% over Q4-2022. TULSA-PRO sy ...
Profound(PROF) - 2023 Q3 - Earnings Call Transcript
2023-11-04 15:45
Stephen Kilmer For the benefit of those, who are new to the Profound story, I would also like to take a moment to summarize our business. Profound develops and markets customizable incision-free therapies for the ablation of diseased tissue. We are currently commercializing TULSA-PRO, a technology that combines real-time MRI roboticallydriven transurethral ultrasound and closed-loop temperature feedback control. The technology is designed to provide customizable and predictable radiation-free ablation of a ...
Profound(PROF) - 2023 Q3 - Quarterly Report
2023-11-02 20:10
Exhibit 99.2 PROFOUND MEDICAL CORP. INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER 30, 2023 PRESENTED IN US DOLLARS (000s) Profound Medical Corp. | | | | | Accumulated | | | | --- | --- | --- | --- | --- | --- | --- | | | | | | other | | | | | | Share | Contributed | comprehensive | | | | | Number | capital | surplus | income | Deficit | Total | | | of shares | $ | $ | $ | $ | $ | | Balance – January 1, 2022 | 20,776,217 | 219,579 | 16,986 | 4,746 | (160,693) | 80,618 | | Net loss for the per ...
Profound(PROF) - 2023 Q2 - Earnings Call Transcript
2023-08-10 03:08
Financial Data and Key Metrics Changes - For the three-month period ended June 30, 2023, the company recorded revenue of $1.6 million, an increase of 38% from $1.2 million in the same period of 2022 [9] - Total operating expenses in Q2 2023 were $7.5 million, a decrease of 14% compared to $8.7 million in Q2 2022 [10] - The net loss for Q2 2023 was $7.4 million, or $0.35 per common share, compared to a net loss of $5.9 million, or $0.28 per common share for the same period in 2022 [25] Business Line Data and Key Metrics Changes - U.S. recurring revenue grew by 21% in Q2 2023 compared to Q1 2023, and by 63% when comparing the first half of 2022 to the first half of 2023 [27] - The installed base of TULSA systems increased from 34 to 38 in Q2 2023, with expectations to reach 50 by the end of the year [16][59] Market Data and Key Metrics Changes - Approximately 66% of patients treated were for prostate cancer, 25% for hybrid conditions of cancer and BPH, 7% for salvage, and 2% for BPH only [31] - The total addressable market for TULSA is estimated at about 600,000 patients, larger than any other technology for treating prostate cancer [45] Company Strategy and Development Direction - The company aims to drive adoption of the TULSA procedure in the U.S. and has achieved the approval of Category 1 CPT codes for the TULSA procedure, effective January 1, 2025 [13][50] - The focus remains on increasing the installed base in the U.S. while also expanding in international markets, particularly Japan [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving U.S. revenue growth of about 70% over the previous year, driven by a recurring revenue model [27] - The company is optimistic about the impact of the new CPT codes on adoption rates and is seeing positive feedback from hospitals and physicians [61] Other Important Information - The company has a net cash position of $39.3 million as of June 30, 2023 [25] - The TACT Pivotal Study results demonstrated the predictability and durability of the TULSA procedure, with promising five-year outcomes [46] Q&A Session Summary Question: Can you provide an update on the growth of installed devices? - Management noted the need to grow by an average of six more devices per quarter to meet the year-end goal of 50 installations, with positive momentum expected due to the new CPT codes [51][61] Question: What is the status of reimbursement discussions? - Management indicated ongoing dialogue with CMS regarding the expansion of existing codes to ambulatory centers, with updates expected in early October [62] Question: How is the macro environment affecting system installs? - Management reported that the macro environment is not presenting significant headwinds, and the pipeline for installations remains strong [80] Question: What are the expectations for the CAPTAIN clinical trial? - Preliminary results from the CAPTAIN trial are expected in early 2025, focusing on head-to-head comparisons with radical prostatectomy [78] Question: Can you discuss the potential for ASCs? - Management sees ASCs as a prime target for TULSA adoption, emphasizing the advantages of outpatient procedures without incisions [110]
Profound(PROF) - 2023 Q1 - Earnings Call Transcript
2023-05-11 03:08
Company Participants Conference Call Participants Operator I would now like to hand the conference over to your speaker today, Stephen Kilmer, Investor Relations. Please go ahead. Thank you. Good afternoon everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws of the United States and Canada. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, perform ...
Profound(PROF) - 2023 Q2 - Quarterly Report
2023-08-09 20:10
Exhibit 99.2 PROFOUND MEDICAL CORP. INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2023 PRESENTED IN US DOLLARS (000s) Profound Medical Corp. Interim Condensed Consolidated Balance Sheets In USD (000s) (Unaudited) | | March 31, | December 31, | | --- | --- | --- | | | 2023 | 2022 | | | $ | $ | | Assets | | | | Current assets | | | | Cash | 42,984 | 46,517 | | Trade and other receivables (note 3) | 6,995 | 6,344 | | Inventory (note 4) | 8,125 | 7,941 | | Prepaid expenses and deposits | 861 | 1 ...
Profound(PROF) - 2022 Q4 - Earnings Call Transcript
2023-03-08 02:22
Profound Medical Corp. (NASDAQ:PROF) Q4 2022 Earnings Conference Call March 7, 2023 4:30 PM ET Stephen Kilmer – Investor Relations Arun Menawat – Chief Executive Officer and Chairman Rashed Dewan – Chief Financial Officer Michael Sarcone – Jefferies Rahul Sarugaser – Raymond James Ben Haynor – Alliance Frank Takkinen – Lake Street Brian Gagnon – Gagnon Securities Scott McAuley – Paradigm Capital Good day and thank you for standing by. Welcome to the Profound Medical Fourth Quarter and Full Year 2022 Financi ...