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, today announced that it has received 510(k)
clearance from the U.S. Food and Drug Administration (“FDA”) for
the Company’s second TULSA-AI module, Contouring Assistant, for use
in conjunction with its TULSA-PRO® system.
The Transurethral Ultrasound Ablation (“TULSA”)
procedure 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 pixel-by-pixel
precision to preserve prostate disease patients’ urinary continence
and sexual function while killing the targeted prostate tissue via
a precise sound absorption technology that gently heats it to kill
temperature (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.
Contouring Assistant, Profound’s second
FDA-cleared TULSA-AI module, is a machine learning-based prostate
segmentation tool designed to assist in efficiently delineating the
prostate and target ablation volume. This module uses a large
database of successful physician-created TULSA treatment designs
and recommends a design in a new procedure based upon that
knowledge. Moving forward, as the TULSA treatment and outcomes
database continues to grow via real-world adoption, and as AI
technology evolves, the proposed treatment designs are expected to
continue to improve.
In support of the FDA 510(k) application,
Contouring Assistant went through rigorous clinical analysis.
First, a Reference Standard was created by
combining contours from three expert prostate radiologists: Edward
Steiner, MD (WellSpan York Hospital); Steven Raman, MD (UCLA
Health); and Robert Princenthal, MD (Rolling Oaks
Radiology/RadNet).
Then, Contouring Assistant was validated in two
clinical studies:
- A standalone
study in 100 prostate cancer cases, comparing Contouring Assistant
to the Reference Standard. This study demonstrated:
- Contouring
Assistant was non-inferior to the Reference Standard, similar to
expert radiologist inter-reader variability; and
- Contouring
Assistant contoured the 100 prostate cases with an average
Sørensen–Dice coefficient of 0.910 +/- 0.031.
- A multi-reader,
multi-case (“MRMC”) study was conducted by five prominent
radiologists: Pejman Ghanouni, MD, PhD (Stanford Medicine); Aytekin
Oto, MD (University of Chicago); Adnaan Moin, MD (WellSpan York
Hospital), Sandeep Arora, MBBS (Yale School of Medicine); and Ara
Karamanian, MD (HALO Precision Diagnostics). In addition, the same
study design was used to assess performance by three renowned
urologists: Laurence Klotz, MD (Sunnybrook Health Sciences Centre);
Christian Pavlovich, MD (Johns Hopkins University); and Preston
Sprenkle, MD (Yale School of Medicine). This MRMC study
demonstrated that:
- The MRMC
readers using Contouring Assistant were non-inferior in terms of
contouring accuracy, but also 29% faster on average; and
- The three
urologists who tested this feature showed statistically significant
improvement in their segmentation accuracy using Contouring
Assistant, and were 32% faster on average.
“Profound is to be commended for supporting this
rigorous clinical analysis of the Contouring Assistant feature,
which was on par with that normally associated with testing
diagnostic-level AI software,” said Dr. Sprenkle. “Importantly,
Contour Assistant not only allowed my esteemed urologist colleagues
and I to approach the accuracy of an expert radiologist reader in
our TULSA treatment designs, but also enabled us to reduce overall
procedure times by one-third.”
Arun Menawat, PhD, Profound’s CEO and Chairman,
commented, “The addition of a second, FDA-cleared TULSA-AI module
is an important milestone as we continue to deliver on our promise
to continuously improve the TULSA treatment experience for
urologists and their patients. To that end, we believe that
Contouring Assistant should not only increase urologists’
confidence in their treatment designs, but also significantly
increase their procedural efficiency.”
Profound is continuing development work on the
next planned TULSA-AI module, TULSA BPH, and expects to provide
more details on that later in 2024.
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. TULSA-PRO® is designed to provide customizable and
predictable radiation-free ablation of a surgeon-defined prostate
volume while actively protecting the urethra and rectum to help
preserve the patient’s natural functional abilities. TULSA-PRO® has
the potential to be a flexible technology in customizable prostate
ablation, including intermediate stage cancer, localized
radio-recurrent cancer, retention and hematuria palliation in
locally advanced prostate cancer, and the transition zone in large
volume benign prostatic hyperplasia (“BPH”). 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. 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. In addition, there is uncertainty
about the spread of the COVID-19 virus and the impact it will have
on Profound’s operations, the demand for its products, global
supply chains and economic activity in general. 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 Relations
sthomas@profoundmedical.comT: 619.540.9195
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