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Profound Medical Corp. develops and markets interventional MRI medical devices for incision-free tissue ablation. Its recurring news centers on TULSA-PRO® and the TULSA Procedure™, which use real-time MRI guidance, robotically controlled transurethral ultrasound and temperature feedback to ablate prostate tissue in prostate cancer and benign prostatic hyperplasia.
Company updates also cover Sonalleve®, an MRI-guided therapy used for pain palliation of bone metastases, desmoid tumors and osteoid osteoma, as well as gynecologic conditions including uterine fibroids and adenomyosis. Recurring developments include financial results, revenue guidance, payer coverage, CAPTAIN post-market clinical data, scientific-meeting presentations, treatment-site adoption milestones and investor conference updates.
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN), a company specializing in incision-free medical device therapies, announced its participation in the Lake Street Capital Markets 8th Annual Best Ideas Growth Conference. The conference will be held on September 12, 2024, in New York City and will feature one-on-one investor meetings. Management from Profound Medical will be present to discuss the company's advancements and future plans. No webcast will be available due to the event's format.
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) reported its Q2 2024 financial results. Key highlights include:
- TULSA-PRO® systems installed base grew from 53 to 57
- Revenue increased 39% to $2.23 million
- Net loss decreased to $6.9 million ($0.28 per share)
- Cash position of $34.1 million as of June 30, 2024
The company received FDA clearance for its Contouring Assistant AI module and expects CMS reimbursement for TULSA procedure to be effective January 1, 2025. Profound anticipates full-year 2024 revenue between $11.0-$12.0 million, representing 53-67% year-over-year growth.
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN), a commercial-stage medical device company specializing in incision-free therapies for diseased tissue ablation, has announced its plans to release second quarter 2024 financial results on Thursday, August 8, 2024, after market close. The company will host a conference call at 4:30 p.m. ET on the same day to discuss the financial results and recent business developments.
Investors and interested parties can register for the live call through a provided link. Additionally, the call will be broadcast live and archived on Profound Medical's website under the 'Webcasts' section in the Investors area.
Profound Medical announced the U.S. Centers for Medicare and Medicaid Services (CMS) proposed a Category 1 CPT code for Transurethral Ultrasound Ablation (TULSA), effective January 1, 2025. This includes three physician codes for different procedural scenarios, introducing greater billing flexibility for pre and post-procedure visits.
TULSA will be recognized across Hospital Outpatient, Ambulatory Surgical Centers, and Private Offices. The proposed payments for the complete TULSA procedure are $9,208.50 for Hospital Outpatient and $7,195.00 for Ambulatory Surgical Centers.
Physician fee schedules vary based on whether one or two physicians are involved, with RVUs assigned accordingly. This move is expected to enhance the accessibility and affordability of TULSA for treating prostate diseases.
Profound Medical Corp. announced the voting results from its Annual General Meeting of Shareholders held on May 15, 2024. A total of 15,336,388 common shares, representing 62.78% of the outstanding shares, were represented. All proposals were approved by the majority vote. Six board nominees were elected: Arun Menawat (97.776% for), Brian Ellacott (98.269% for), Cynthia Lavoie (98.9% for), Murielle Lortie (97.623% for), Arthur Rosenthal (98.264% for), and Kris Shah (98.269% for). PricewaterhouseCoopers LLP was reappointed as the auditor for the next fiscal year.
Profound Medical has received FDA 510(k) clearance for its 'Contouring Assistant' AI module, designed to assist in creating automated TULSA treatment plans for prostate disease. This module utilizes deep learning with over 24 million parameters derived from 7,466 images and was validated in clinical studies by leading experts. The studies showed that urologists using the module improved segmentation accuracy and were 32% faster. TULSA is a non-invasive, one-session procedure using real-time MR guidance to treat prostate conditions while preserving urinary and sexual functions. CEO Arun Menawat emphasized the milestone's significance in improving treatment efficiency and confidence.
Profound Medical Corp. announced its first quarter 2024 financial results and issued full-year 2024 revenue guidance. The Company reported revenue of $1.91 million for Q1 2024, with 3% growth from the same period last year. Operating expenses increased by 9% to $8.8 million. Net loss for Q1 2024 was $6.2 million. The Company expects full-year 2024 revenue to range from $11.0 million to $12.0 million, representing significant growth. Profound had cash of $41.2 million and 24,428,899 common shares outstanding as of March 31, 2024.
Profound Medical Corp.'s TULSA procedure is gaining recognition as a mainstream treatment for prostate diseases, with 25 scientific research presentations this year alone. The clinical evidence showcases TULSA's efficacy in treating a diverse range of patients with localized prostate cancer and/or BPH. The company's CEO, Arun Menawat, highlights the positive outcomes from top medical centers worldwide, positioning TULSA as a leading treatment modality.
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