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 entered into a
non-exclusive collaboration with Siemens Healthineers, a global
leader in medical technology. The collaboration is aimed at laying
the groundwork for Profound to begin marketing a complete
therapeutics solution, combining its TULSA-PRO® system with the
MAGNETOM Free.Max magnetic resonance (“MR”) scanner from Siemens
Healthineers, via Profound’s own sales force. Profound will also
continue to market TULSA-PRO® as a stand-alone offering, providing
its customers with the flexibility to use the technology with the
MR hardware of their choice.
The Transurethral Ultrasound Ablation (“TULSA”)
procedure, performed using Profound’s TULSA-PRO® system, employs
real-time MR guidance for precision to save patients’ vital
functions while killing the targeted prostate tissue via a precise
sound absorption technology that gently heats it to kill
temperature (55°C). TULSA-PRO® enables surgeons to ablate whole- or
partial-gland prostate tissue in patients with low-, intermediate,
or high-risk prostate cancer; with benign prostatic hyperplasia
(“BPH”); as well as those prostate cancer patients on active
surveillance seeking treatment of their cancer and relief from
their symptoms of BPH. TULSA is a “one-and-done” procedure,
performed in a single session that takes a few hours, and no
hospital stay is required. Most TULSA patients report quick
recovery to their normal routine.
MAGNETOM Free.Max from Siemens Healthineers is
an innovative MRI scanner that combines a 0.55 Tesla field strength
with advanced hardware design and deep learning technologies. By
doing so, the scanner broadens the range of MR clinical
applications and provides customers with the inherent clinical
benefits of a mid-field MR scanner. The first and only 80 cm
wide-bore system available on the market, MAGNETOM Free.Max also
facilitates MR scanning for larger and/or claustrophobic patients,
enhancing the patient experience. At less than 7,700 Lbs and 80
inches high, MAGNETOM Free.Max is the most lightweight, compact
whole-body scanner ever offered by Siemens Healthineers. Its
reduced size permits installation with only minimal structural
modifications. Furthermore, where MR scanners typically require
several hundred liters of helium and a quench pipe for cooling
purposes, the new magnet of the MAGNETOM Free.Max uses less than 1
liter of liquid helium, reducing lifecycle and infrastructure
costs. For these reasons, MAGNETOM Free.Max has simplified MRI
integration in locations previously not suitable for MR
imaging.
Mark Emberton, MD, FRCS, FMedSci, Professor of
Interventional Oncology, Division of Surgery and Interventional
Science, University College London (UCL) commented, “The updated
guidelines from both the European Association of Urology and the
American Association of Urology support use of MR imaging to aid in
the diagnosis of prostate cancer. Beyond that, with the recent
introduction of TULSA-PRO®, MR imaging now not only has the power
to fundamentally change how prostate cancer is diagnosed, but also
how it is treated. I commend the teams at Siemens Healthineers and
Profound as they work to achieve the convergence of their
respective diagnostic and interventional MR technologies. Their
pioneering work has the potential to improve oncological and
functional outcomes for a very significant number of prostate
cancer patients.”
“We are thrilled to be collaborating with
Siemens Healthineers as we work toward offering a total diagnostic
and interventional MR solution that can streamline workflow;
optimize cost of care; and most importantly, improve the treatment
experience for urologists and their patients by ensuring TULSA can
be readily accessed in the most suitable settings,” said Arun
Menawat, Profound’s CEO and Chairman. “This partnership continues
to support the Modern Treatment Pathway that allows for more
accurate and precise diagnosis, treatment, and follow-up; and
brings us another step closer to realizing our long-term vision of
creating a total diagnostic and interventional MR solution that
will allow a prostate disease patient to be diagnosed in the
morning via a diagnostic MR procedure, treated in the afternoon,
perhaps even using the very same MR to guide TULSA, and then home
in time for dinner with his family.”
Donald Hardie, Vice President Global Marketing
& Sales Magnetic Resonance at Siemens Healthineers, commented,
“Our collaboration with Profound underscores our commitment to
leveraging cutting-edge technologies such as TULSA-PRO® to make a
difference in prostate cancer therapy. MAGNETOM Free.Max has
already brought MR to new places, varying from orthopedic centers
to rural hospitals, where patients need MR imaging most. We look
forward to collaborating with Profound to help expand access to
TULSA as well. Together, we are dedicated to advancing an
integrated, MRI-centric approach for prostate cancer patients
worldwide”.
Subject to the completion of TULSA-PRO® and
MAGNETOM Free.Max system integration, the companies currently
expect Profound to initiate sales of the combined solution in
2025.
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; Profound’s
preliminary unaudited fourth quarter and full year 2023 revenues;
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. 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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