Profound Medical NASDAQ: PROF highlighted what it described as growing clinical evidence, expanding software capabilities, and improving reimbursement dynamics for its MRI-guided “incision-free” ultrasound platform during a conference presentation led by Arun, a company executive who said he has been with the company for about 10 years.
The company’s primary commercial focus is TULSA, a prostate-focused system that uses MRI guidance and real-time temperature monitoring to ablate tissue via controlled heating. Profound also discussed a second product, Sonalleve, but emphasized it is spending “99%” of its energy on TULSA for now.
Incision-free prostate therapy and positioning versus alternatives
Arun contrasted TULSA with robotic prostatectomy, which he described as the current standard of care with “pretty significant and life altering” side effects for patients. He said TULSA uses MRI imaging and an AI-based planning approach that allows physicians to delineate anatomy such as nerve bundles and sphincter muscles, then deliver treatment without incisions. “You are literally not cutting the patient,” Arun said, adding that patients typically go home “within an hour after the procedure.”
He also discussed competition from “focal therapy” approaches that aim to treat only cancerous portions of the prostate. While calling the idea of focal therapy “very sound,” Arun argued that prostate cancer is multifocal and said cancer can return “about 50% of the time” if stem cells are not addressed. Profound’s goal, he said, is to occupy a middle category offering both whole-gland and partial-gland treatment through image-guided precision therapy.
On energy sources, Arun said TULSA heats tissue to about 57 degrees Celsius while monitoring temperature in real time, describing this as a “soft kill” that results in tissue being reabsorbed over time. He said the energy used is “0.02 kcal/cc,” which he compared to HIFU and other energy modalities that he said can require “10-100 times higher” energy.
Software updates and AI tools
Profound described multiple software features intended to expand use cases and streamline workflows:
- Thermal Boost: Intended to deliver additional energy in situations where disease may be at the prostate edge or slightly outside it, allowing treatment “a couple of millimeters beyond the prostate,” Arun said.
- Contouring Assistant: Introduced about 90 days prior, Arun said it is a “one click” planning tool. He said the company presented data to the FDA showing its AI was “equivalent to the best radiologists in the country,” and “better than most urologists” in statistical comparisons.
- Volume Reduction: Described as a tool to automatically delineate areas that should not be treated, with a goal of shortening procedure time and supporting benign prostatic hyperplasia (BPH) use cases.
Interventional MRI partnerships and workflow strategy
Addressing concerns about reliance on diagnostic MRI suites, Arun said Profound has a relationship with Siemens, which he said has produced a 0.55 Tesla interventional MRI system that is “about a third the weight and half the size and half the cost.” He also said it is designed so users “don’t even need an MR tech,” and that Siemens and Cook have taken steps to support interventional MRI adoption, including Cook creating an iMRI division.
Arun characterized interventional MRI as an emerging platform opportunity, calling it “the iPhone,” and said Profound aims to be “the king app” driving utilization.
On commercialization, Arun said the company is focused on making physician workflow more consistent—similar to how robotic surgery is often scheduled in set blocks—by offering a broader mix of treatable cases, including cancer and BPH, to support predictable scheduling.
CAPTAIN early data and reimbursement discussion
Arun said Profound recently announced early data from CAPTAIN, which he described as the first “level one head-to-head study against robotic surgery.” He said the trial recruited over 210 patients (originally designed for 201).
On safety and recovery, Arun cited return-to-work timing of “10 days versus 19 days” for TULSA compared with robotic surgery, and emphasized less variability in outcomes. He also reported that “over 6%” of robotic surgery patients required additional hospitalization, including ICU in some cases, versus “zero” for TULSA.
Regarding the trial’s primary endpoint—combining erectile dysfunction and incontinence—Arun said the study is “already showing we’re going to meet the endpoint,” with p-values “well below 0.05 already.” He added that incontinence had already reached statistical significance, while erectile dysfunction had not at six months, noting ED is typically measured out to three years.
On reimbursement, Arun cited January rates showing hospital payment for TULSA of “$13,479 or $13,500 approximately,” compared with robotic-assisted radical prostatectomy at about “$10,800-something.” He said TULSA involves no hospital stay and argued the economics can be compelling for hospitals, particularly for Medicare prostate cancer patients.
Financial model, growth, and utilization commentary
Arun described Profound’s model as a “razor and razor blade” approach. In Q&A, the company said gross margins are “70%+” on both capital systems and consumables, attributing this to software-driven intellectual property and “relatively straightforward” hardware.
He also discussed utilization variability across sites, citing locations doing “more than 100 cases per year,” some at a “150 patient run rate,” while other sites perform about “once a month.” Arun said the company believes “at least 50 cases per year is very reasonable, per site, over time,” and noted some sites are doing “four cases per day.” He said the company expects “major insurance company coverages by end of this year,” which he believes could lift utilization at underperforming sites.
On market sizing, Arun said that out of about 300,000 diagnosed prostate cancer patients, the company believes it can treat about 200,000. For BPH, he cited about 12 million patients, but said the company is focusing on the segment where the alternative is surgery, which he pegged at about 400,000 patients. Combined, he described a roughly 600,000-patient opportunity. He outlined a model of about “$500,000 capital upfront and $5,500 per patient in the disposables,” adding that amortizing capital suggests roughly “$8,000 per patient.”
Arun said the company generated about CAD 10 million in revenue in 2024 and about CAD 16 million in 2025, and that it is “on track to grow again in high double-digit numbers” this year. He said costs are “burning maybe about CAD 20 million - CAD 25 million” and suggested profitability could be reached at roughly 200 sites doing about 50 cases per year, which he said could equate to about a CAD 80 million revenue run rate.
Profound also briefly discussed Sonalleve, which Arun said is installed at “over 10 sites outside of the United States” with “over 4,000 patients treated,” but reiterated the company’s near-term focus remains on TULSA.
About Profound Medical NASDAQ: PROF
Profound Medical Corp is a medical technology company headquartered in Toronto, Canada, that specializes in the development and commercialization of minimally invasive therapeutic solutions using magnetic resonance–guided ultrasound ablation. The company's proprietary platform delivers focused ultrasound energy to targeted tissue under real-time MR imaging, offering a non-incisional alternative to traditional surgical approaches.
The company's lead product, the TULSA-PRO system, is designed for the treatment of prostate conditions, including localized prostate cancer and benign prostatic hyperplasia.
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