Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) has announced its financial results for the third quarter ended September 30, 2024, showcasing significant revenue growth and strategic advancements in its commercial operations. The company reported a 64% increase in revenue compared to the same period last year, primarily driven by the continued adoption of its TULSA-PRO® system.
TULSA-PRO Adoption and Clinical Utilization
The TULSA-PRO system is being utilized for a wide variety of prostate disease patients. According to the report, 64% of patients were treated for prostate cancer only, 28% were hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (BPH), 6% were salvage cases, and 2% were men with BPH only. In terms of cancer grade, 7% were GG1, 66% were GG2, 16% were GG3, and 11% were GG4 & GG5. Ablation types included 53% whole gland, 25% sub-total (more than half the gland), and 22% hemi-ablations or focal therapy. Prostate sizes varied, with 6% < 20cc, 40% between 20-40cc, 33% between 40-60cc, 15% between 60-100cc, and 6% over 100cc.
Reimbursement and Business Model Transition
A significant development highlighted in the report is the U.S. Centers for Medicare & Medicaid Services (CMS) final rule for the three new CPT® Category 1 codes covering the TULSA procedure, effective January 1, 2025. TULSA reimbursement was raised to Urology Level 7 Ambulatory Payment Classification (APC) from the Urology APC Level 6 proposed earlier.
"As excited as we were in July that TULSA was poised to start competing with other major prostate treatment modalities on a level playing field, now with the Final Rule, not only will TULSA be uniquely reimbursed at a higher Urology APC Level 7, but also feasible at an unrivaled number of locations compared to other prostate disease treatment modalities. We believe this will enable needed physician and patient access to innovative therapy that men deserve, and be an inflection point for our business," said Arun Menawat, Profound’s CEO and Chairman.
In light of this positive reimbursement news, Profound Medical is transitioning from a pure recurring revenue model in the U.S. to a more traditional medtech business model that includes both capital and consumable sales, as well as the sale of service/maintenance contracts.
Financial Performance
For the quarter ended September 30, 2024, Profound Medical recorded revenue of $2.83 million, with $2.65 million from recurring revenue and $179,000 from one-time capital equipment sales. Total operating expenses were $10.8 million, a 42% increase compared to the third quarter of 2023. The net loss for the quarter was $9.4 million, or $0.38 per common share, compared to $5.6 million, or $0.26 per common share, in the same period last year.
Ongoing Clinical Trial and Future Expectations
The ongoing Level 1 CAPTAIN trial, comparing the TULSA procedure to radical prostatectomy in men with localized prostate cancer, remains on track to complete patient enrollment by the end of this year. Profound Medical anticipates beginning to report interim data from this post-market study in the first half of 2025.
Profound Medical anticipates its total revenue for full-year 2024 to be in the range of $11.0 million to $12.0 million, representing total year-over-year revenue growth of 53% to 67%.
