Profound Medical’s PRO-Talk Live! Event Features the Present and Future of TULSA
16 September 2024 - 10:00PM
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, was pleased to host its second ‘PRO-Talk Live!’
event in Las Vegas this past Saturday, September 14, 2024.
With 70 physicians participating, 31 of whom
being existing TULSA-PRO® users and the other 39 being potential
users, the program featured presentations on TULSA-PRO® and its
unrivalled flexibility to treat a wide variety of prostate disease
patients from key opinion leaders who have gained first-hand
experience with the technology. In addition, members of Profound’s
management team provided clinical, technology and commercial
updates, with a focus on the future of TULSA-PRO®. Finally,
participants heard from representatives of two leading global
medical technology companies, Siemens Healthineers and Cook
Medical, who discussed their shared common vision with Profound of
creating a total magnetic resonance (“MR”) solution to support the
Modern Treatment Pathway that allows for more accurate and precise
prostate disease diagnosis, the TULSA Procedure, and follow-up.
The PRO-Talk Live! physician speakers
included:
- Joseph
J. Busch, Jr., M.D., a board-certified Radiologist
specializing in Interventional and Diagnostic Radiology at the
Busch Center in Alpharetta, Georgia. With over 40 years of
experience, Dr. Busch leads the charge in diagnostic and
interventional treatment options for prostate issues, particularly
Benign Prostatic Hyperplasia (BPH) and Prostate Cancer.
- Y. Mark
Hong, M.D., F.A.C.S., a distinguished urologist and one of
the world’s first board-certified specialists to complete a
fellowship in Integrative Medicine. An expert in minimally invasive
surgery, Dr. Hong has been published in nearly every major
international urological journal, having authored publications
ranging from prostate cancer detection to healthcare policy.
-
Laurence Klotz, M.D., FRCSC, an esteemed urologist
and professor of surgery at the University of Toronto and the
Sunnybrook Chair of Prostate Cancer Research. As a pioneering
figure in the field of urology, with over 550 peer-reviewed
publications and numerous prestigious awards along the way, Dr.
Klotz has made a significant impact on the advancement of prostate
cancer treatment throughout his career.
-
Xiaosong Meng, M.D., Ph.D., an Assistant Professor
in the Department of Urology at UT Southwestern Medical Center. Dr.
Meng’s clinical interests include prostate cancer and focal therapy
for prostate cancer, kidney cancer, testicular cancer, and bladder
cancer.
- Ram A.
Pathak, M.D., an Assistant Professor in the Department of
Urology at Mayo Clinic Florida. Dr. Pathak specializes in Urologic
Oncology and has special interests in the diagnosis and management
of prostate cancer.
- Peter
A. Pinto, M.D., a board certified urologic surgeon and
Tenure Track Principal Investigator, Senior Surgeon, Head of the
Prostate Cancer Section, and Fellowship Director in the Urologic
Oncology Branch, National Cancer Institute, National Institutes of
Health, Bethesda, MD. Dr. Pinto is nationally and internationally
recognized as an expert in the minimally invasive treatment of
urologic cancers, specializing in laparoscopic and robotic surgery
for prostate, kidney, bladder, and testicular cancer. His research
goals focus on developing novel diagnostic and treatment modalities
for localized and locally advanced prostate cancer.
- Preston
C. Sprenkle, M.D., an Assistant Professor of Urology at
Yale University, specializing in the treatment of urologic cancers,
primarily prostate cancer, as well as kidney cancer, bladder
cancer, and testicular cancer. Dr. Sprenkle has dedicated his
career to using the latest technologies to improve prostate cancer
diagnosis and treatment that minimizes the impact on a man's
quality of life.
- Steven
Sukin, M.D., a board-certified urologist at Texas Urology
Specialists. With over 15 years of experience, Dr. Sukin has
performed over 1,200 robotic cases, including radical
prostatectomies, nephrectomies, partial nephrectomies,
pyeloplasties, and adrenal procedures.
Highlighting the advancement of an integrated,
MR-centric approach for prostate cancer patients:
- Siemens
Healthineers presented on its game-changing MAGNETOM Free.Max MR
scanner. As previously announced, Profound and Siemens Healthineers
have entered into a non-exclusive collaboration aimed at laying the
groundwork for the marketing of a complete therapeutics solution,
combining the TULSA-PRO® system with the MAGNETOM Free.Max.
- Pete
Polverini, Vice President of Cook Medical’s Interventional
MRI division, sat down for a conversation with Profound’s Chief
Commercial Officer, Abbey Goodman, to discuss Cook’s development of
a turnkey interventional MRI (iMRI) suite.
“This past weekend’s PRO-Talk Live! event
brought together both experienced and potential physician users for
a day of face-to-face presentations and discussions, many of which
highlighted TULSA’s clinical use across the entire prostate disease
spectrum,” said Arun Menawat, Profound’s CEO and Chairman. “Quite
frankly, education by existing users is a great way to market to
future users, and TULSA is an ideal product for that strategy.”
“Importantly, as awareness and adoption of TULSA
continues to grow, and we make final preparations for the permanent
CPT® Category 1 codes for the procedure going into effect at the
beginning of 2025, expanding physician and patient access will be a
very important driver of our success,” added Dr. Menawat. “To that
end, we were thrilled that two global leaders like Siemens
Healthineers and Cook Medical were able to share their respective
visions for incorporating TULSA-PRO® and their own products and
technologies into 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 prostate disease patients.”
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 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. 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
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