Profound Medical Receives FDA HDE Approval for Sonalleve®
November 30 2020 - 8:00AM
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the
“Company”) announced today that Sonalleve® has received U.S. Food
and Drug Administration (“FDA”) approval under a Humanitarian
Device Exemption (“HDE”) for the treatment of osteoid osteoma.
Osteoid osteoma is a non-cancerous bone tumor
that occurs most often in the long bones of the leg, such as the
femur and tibia, of young children and adolescents. An osteoid
osteoma causes a dull, aching pain that is moderate in intensity,
but can worsen and become severe, especially at night. Computed
tomography(CT)-guided radiofrequency ablation (RFA), the most
commonly used osteoid osteoma treatment, requires drilling through
muscle and soft tissue into bone, and also exposes the patient to
radiation from the imaging necessary to guide the probe that is
inserted to heat and destroy tumor tissue.
Sonalleve® is an innovative therapeutic platform
that combines real-time Magnetic Resonance imaging and thermometry
with thermal ultrasound to enable precise and incision-free
ablation of diseased tissue. Sonalleve® can offer patients
suffering with an osteoid osteoma a treatment that can be performed
safely with clinical improvement, but without any incisions,
needles, or ionizing radiation exposure.
“While we do not expect this FDA HDE approval
for Sonalleve® to have a material impact on revenues in the near-
term, it is nevertheless strategically very important,” said Arun
Menawat, Profound’s CEO and Chairman. “Obtaining the first
regulatory approval for Sonalleve® in the U.S. is a significant
milestone for the Company and we are making preparations for the
U.S. commercial launch in 2021. This positive FDA decision was
based on a rigorous safety review and is key to our global
expansion strategy for this groundbreaking therapeutic platform as
we conduct clinical trials to support additional marketing
approvals for the treatment of indications with larger patient
populations.”
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, uterine fibroids
and palliative pain treatment. 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 pharmaceutical 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
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