Profound Medical Data Shows TULSA-PRO Superiority in Erectile Function Preservation

Key highlights

• CAPTAIN trial results demonstrated statistically superior preservation of erectile function versus robotic radical prostatectomy at six months
• Mayo Clinic Florida reported 100% pad-free continence and 87.5% erectile function preservation in patients beyond 12 months
• Mayo Clinic Rochester prospective study confirmed a sustained PSA reduction of 62% to 66% through one year of follow-up
• Technical validation was achieved on the Siemens 0.55T Free.Max MRI platform, reducing infrastructure barriers for future adoption
• Preliminary Q3 2026 revenue is projected at $9.8 million to $10.0 million, supporting full-year growth targets

What Happened

Profound Medical presented five abstracts at the 15th Interventional MRI Symposium in Boston, detailing the clinical performance and technical versatility of its TULSA-PRO system. The presentations featured real-world validation from the CARE Registry and high-volume centers like the Mayo Clinic, alongside comparative data from the CAPTAIN randomized controlled trial. A significant technical milestone was also reached through the validation of the TULSA procedure on the Siemens 0.55T Free.Max MRI platform. This achievement indicates that the procedure can be performed on lower-field-strength MRI systems, potentially expanding the available infrastructure options for healthcare providers and reducing capital equipment hurdles for new installations.

Significance

The clinical data from the CAPTAIN trial provides a clear competitive differentiator by demonstrating statistically superior preservation of erectile function and urinary continence compared to robotic radical prostatectomy. These functional outcomes are primary concerns for prostate cancer patients and represent a major hurdle for traditional surgical interventions. By proving that TULSA-PRO can achieve high oncological efficacy while better maintaining quality of life, Profound Medical is strengthening its position as a preferred alternative to surgery. Additionally, the compatibility with lower-field MRI systems significantly broadens the total addressable market, allowing the company to target a wider range of clinical settings beyond specialized high-field imaging centers.

Business Overview

Profound Medical is a commercial-stage medical technology company developing incision-free, MRI-guided thermal ultrasound therapies. Its primary platform, TULSA-PRO, uses a transurethral approach to ablate prostate tissue while sparing critical surrounding structures. The company also markets Sonalleve, a system for treating uterine fibroids and bone metastases. Profound operates in the interventional urology sector, focusing on transitioning prostate care from invasive surgery to precision, image-guided ablation. Recent leadership changes, including the appointment of Richard Fabian as President and Matthew Sobczyk as Interim CFO, signal a focus on scaling commercial operations and expanding the technology's clinical footprint globally.

Financial Context

The company is entering a high-growth phase, with preliminary third-quarter 2026 revenue expected to reach between $9.8 million and $10.0 million. This follows a reported qualified sales pipeline and order book of approximately $70.0 million as of mid-2026. Management has reiterated full-year 2026 revenue guidance of approximately $25.0 million, which would represent a 56% increase over the previous year. Profound maintains a robust gross margin target exceeding 70%, reflecting the scalable nature of its combined hardware and recurring procedural revenue model. Strategic moves, such as the co-education agreement with Telix Pharmaceuticals for PSMA-informed care, are intended to further drive adoption rates in the urology market.

Up 20.7% over the last month ($5.81 on 14 Sep → $7.01 on 13 Oct). Daily closing prices. Source: Yahoo Finance.

Show the prices

14 Sep	$5.81
15 Sep	$5.68
16 Sep	$5.83
17 Sep	$5.89
18 Sep	$5.86
21 Sep	$6.10
22 Sep	$5.89
23 Sep	$5.74
24 Sep	$5.60
25 Sep	$5.76
28 Sep	$5.92
29 Sep	$5.72
30 Sep	$5.80
1 Oct	$5.85
2 Oct	$5.84
5 Oct	$6.03
6 Oct	$6.08
7 Oct	$5.68
8 Oct	$6.91
9 Oct	$6.90
12 Oct	$7.25
13 Oct	$7.01

Executive Perspective

“These presentations illustrate how TULSA’s evidence base is evolving across the dimensions that matter most: meaningful functional outcomes for patients, reproducibility in routine clinical practice, and the potential to extend our technology to a broader range of iMRI platforms.”

Management commentary

“Together, they reinforce the differentiation of TULSA-PRO and its potential to support broader clinical adoption over time.”

Profound Medical Corp. · financial snapshot

Share price	$7.01
Market cap	$256M
Revenue (annual)	$16M
1-month price change	+17.42%
Sector	HealthcareMedical Devices

Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.