Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the
“Company”), a commercial-stage medical device company that develops
and markets customizable, incision-free therapies for the ablation
of diseased tissue, is pleased to announce the unveiling of its
third TULSA-AI® software module, UA Alignment Assistant, in
addition to six presentations featuring the Transurethral
Ultrasound Ablation (“TULSA”) procedure, at the upcoming 110th
Scientific Assembly and Annual Meeting of the Radiological
Society of North America (“RSNA 2024”) being held in
Chicago, IL, December 1-4, 2024, and the 25th Annual Meeting of the
Society of Urologic Oncology (“SUO 2024”) taking place in Dallas,
TX, December 4 - 6, 2024.
The TULSA procedure, performed using Profound’s
TULSA-PRO® system, has the potential of becoming a mainstream
treatment modality across the entire prostate disease spectrum;
ranging from low-, intermediate-, or high-risk prostate cancer; to
hybrid patients suffering from both prostate cancer and benign
prostatic hyperplasia (“BPH”); to men with BPH only; and also, to
patients requiring salvage therapy for radio-recurrent localized
prostate cancer. TULSA employs real-time MR guidance for precision
to preserve patients’ urinary continence and sexual function, while
killing the targeted prostate tissue via precise sound absorption
technology that gently heats it to 55-57°C. TULSA is an incision-
and radiation-free “one-and-done” procedure performed in a single
session that takes a few hours. Virtually all prostate shapes and
sizes can be safely, effectively, and efficiently treated with
TULSA. There is no bleeding associated with the procedure; no
hospital stay is required; and most TULSA patients report quick
recovery to their normal routine.
Recognizing TULSA is being used by urologists to
treat an unrivalled variety of prostate cancer and/or BPH patients,
Profound is developing a novel set of software modules under the
TULSA-AI® brand to work in conjunction with TULSA-PRO® to provide
further customizability, ease of use, speed of treatment and higher
confidence in clinical outcomes.
As the name implies, UA Alignment Assistant
streamlines the alignment of the ultrasound applicator (“UA”)
catheter that resides in the center of the prostate during the
TULSA procedure. The primary benefit of the software is improvement
in workflow consistency, as instead of aligning it manually, it
will now be done the same way every time via the module.
Previously, the manual TULSA-PRO® UA alignment meant that users had
to spend time scrolling through MR images and clicking through to
align them to the UA. Via the new software, MR images will be
automatically imported and then immediately displayed to the user
in an aligned way.
“One of the focusses of RSNA 2024 – which is
expected to attract more than 40,000 physicians, researchers and
industry participants – will be on the increasingly important role
that AI can play in improving the efficiency and quality of care,”
said Arun Menawat, Profound’s CEO and Chairman. “Accordingly, it is
the ideal forum for us to unveil for the first time our third
TULSA-AI® module, UA Alignment Assistant. Effectively, the module
removes a whole procedural step from TULSA, resulting in less
mental charge, fewer steps to remember, and overall procedural
simplification for users. We are also excited to see that the RSNA
and SOU 2024 meetings will feature presentations on the TULSA
procedure by esteemed physicians and researchers from the Busch
Center, UT Southwestern Medical Center and the Mayo Clinic.”
Presentation details:
RSNA 2024
- Customized Whole-Gland
MR-Guided Transurethral Ultrasound Ablation (TULSA) for the
Treatment of Localized Prostate Cancer: A Single Centre
Retrospective of 73 PatientsJoseph J. Busch, MDBusch
Center (Alpharetta, GA)December 4, 2024; 9:00-9:30 p.m. CST
- Real-World Efficacy of
MRI-Guided Transurethral Ultrasound Ablation of the Prostate:
Initial Report from the Customized Ablation Registry
(CARE)Daniel N. Costa, MDUT Southwestern Medical Center
(Dallas, TX)December 4, 2024; 12:45-1:15 p.m. CST
SOU 2024
- Real-World Efficacy of MRI-Guided Transurethral
Ultrasound Ablation of the Prostate: Initial Report from the
Customized Ablation Registry (CARE)Chandler Dora, MDMayo
Clinic (Jacksonville, FL)December 5, 2024; 4:15-5:15 p.m. CST
- Post-Operative Sentiment in Patients After MRI-Guided
Transurethral Ablation (TULSA) of Localized Prostate Cancer:
Quantifiying Regret and Correlating Patient-Reported Regret with
Functional OutcomesAndrew MurphyUT Southwestern Medical
Center (Dallas, TX)December 6, 2024; 9:00-10:00 a.m. CST
- MRI-Guided Transurethral
Ultrasound Ablation (TULSA) of Localized Prostate Cancer: Single
Institution Experience of Treatment EfficacyEmily Bochner,
MDUT Southwestern Medical Center (Dallas, TX)December 6, 2024;
9:00-10:00 a.m. CST
- CAPTAIN Randomized
Controlled Trial of TULSA Against Radical Prostatectomy for
Intermediate-Risk Prostate Cancer: Design and Recruitment
UpdateXiaosong Meng, MD, PhDUT Southwestern Medical Center
(Dallas, TX)December 6, 2024; 9:00-10:00 a.m. CST
About Profound Medical Corp.
Profound is a commercial-stage medical device
company that develops and markets customizable, incision-free
therapies for the ablation of diseased tissue.
Profound is commercializing TULSA-PRO®, a
technology that combines real-time MRI, robotically-driven
transurethral ultrasound and closed-loop temperature feedback
control. The TULSA procedure, performed using the TULSA-PRO®
system, has the potential of becoming a mainstream treatment
modality across the entire prostate disease spectrum; ranging from
low-, intermediate-, or high-risk prostate cancer; to hybrid
patients suffering from both prostate cancer and benign prostatic
hyperplasia (“BPH”); to men with BPH only; and also, to patients
requiring salvage therapy for radio-recurrent localized prostate
cancer. TULSA employs real-time MR guidance for precision to
preserve patients’ urinary continence and sexual function, while
killing the targeted prostate tissue via precise sound absorption
technology that gently heats it to 55-57°C. TULSA is an incision-
and radiation-free “one-and-done” procedure performed in a single
session that takes a few hours. Virtually all prostate shapes and
sizes can be safely, effectively, and efficiently treated with
TULSA. There is no bleeding associated with the procedure; no
hospital stay is required; and most TULSA patients report quick
recovery to their normal routine. TULSA-PRO® is CE marked, Health
Canada approved, and 510(k) cleared by the U.S. Food and Drug
Administration (“FDA”).
Profound is also commercializing Sonalleve®, an
innovative therapeutic platform that is CE marked for the treatment
of uterine fibroids and palliative pain treatment of bone
metastases. Sonalleve® has also been approved by the China National
Medical Products Administration for the non-invasive treatment of
uterine fibroids and has FDA approval under a Humanitarian Device
Exemption for the treatment of osteoid osteoma. The Company is in
the early stages of exploring additional potential treatment
markets for Sonalleve® where the technology has been shown to have
clinical application, such as non-invasive ablation of abdominal
cancers and hyperthermia for cancer therapy.
Forward-Looking Statements
This release includes forward-looking statements
regarding Profound and its business which may include, but is not
limited to, the expectations regarding the efficacy of Profound’s
technology in the treatment of prostate cancer, BPH, uterine
fibroids, palliative pain treatment and osteoid osteoma; and the
success of Profound’s U.S. commercialization strategy and
activities for TULSA-PRO®. Often, but not always, forward-looking
statements can be identified by the use of words such as "plans",
"is expected", "expects", "scheduled", "intends", "contemplates",
"anticipates", "believes", "proposes" or variations (including
negative variations) of such words and phrases, or state that
certain actions, events or results "may", "could", "would", "might"
or "will" be taken, occur or be achieved. Such statements are based
on the current expectations of the management of Profound. The
forward-looking events and circumstances discussed in this release,
may not occur by certain specified dates or at all and could differ
materially as a result of known and unknown risk factors and
uncertainties affecting the Company, including risks regarding the
medical device industry, regulatory approvals, reimbursement,
economic factors, the equity markets generally and risks associated
with growth and competition. Although Profound has attempted to
identify important factors that could cause actual actions, events
or results to differ materially from those described in
forward-looking statements, there may be other factors that cause
actions, events or results to differ from those anticipated,
estimated or intended. No forward-looking statement can be
guaranteed. Except as required by applicable securities laws,
forward-looking statements speak only as of the date on which they
are made and Profound undertakes no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events, or otherwise, other than as required by
law.
For further information, please contact:
Stephen KilmerInvestor Relationsskilmer@profoundmedical.com T:
647.872.4849
Susan ThomasPublic Relationssthomas@profoundmedical.com T:
619.540.9195
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