- $6.6 million in sales
expected in Brazilian market over the next five years per
distribution agreement guarantees
- High level of early interest in ProSense in
South America's largest
market
CAESAREA, Israel, Sept. 5,
2023 /PRNewswire/ -- IceCure Medical Ltd.
(Nasdaq: ICCM) ("IceCure" or the "Company"), developer of
minimally-invasive cryoablation technology, the ProSense® System,
that destroys tumors by freezing as an alternative to surgical
tumor removal, today announced that its ProSense System has
received regulatory approval as a Class III device from the
Brazilian Health Regulatory Agency ("ANVISA"). ProSense's
disposable cryoprobes and introducers, were previously registered
as Class II devices by ANVISA. Applications for both the ProSense
System and its disposable cryoprobes and introducers were submitted
to ANVISA by IceCure's distributor in Brazil, Ktrfios Importação e
Exportação LTDA ("Ktrfios").
ProSense's indications approved by ANVISA are oncology, which
includes the ablation of benign and malignant tissues in the
breast, prostate, kidney, lung, liver, musculoskeletal, and skin
tissue, as well as for palliative intervention and other
indications.
Healthcare providers are cleared to conduct procedures with
ProSense, its introducers and disposable probes, and Ktrfios is
cleared to both market and sell ProSense's introducers and
disposable probes. ANVISA has assessed that the probes, which were
initially registered as a Class II device under ANVISA rules, are
to be transitioned to a Class III device and aligned with the
Brazilian regulatory system classification for the same class as
ProSense. Therefore, ANVISA has requested that the probes also be
submitted by Ktfrios for regulatory approval as a Class III device.
The introducers remain a Class II device and do not require an
additional regulatory submission. Class III device clearance for
the probes is expected to be finalized by the end of the first
quarter of 2024.
"We are very pleased that ProSense has received regulatory
approval in Brazil. We expect this
to translate into near-term revenues. Early indications of market
interest point to strong demand in the largest market in
South America where
cost-effective, minimally invasive, safe, and effective
cryoablation procedures can offer great benefits compared to
traditional surgical interventions," stated IceCure Chief Executive
Officer, Eyal Shamir.
With a total population of over 200 million people, more than
500,000 new cancer cases and more than 250,000 deaths attributed to
cancer each year according to the World Health Organization's
Cancer Tomorrow | IARC project, Brazil has an urgent need for minimally
invasive cancer treatments.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®,
an advanced liquid-nitrogen-based cryoablation therapy for the
treatment of tumors (benign and cancerous) by freezing, with the
primary focus areas being breast, kidney, bone and lung cancer. Its
minimally invasive technology is a safe and effective alternative
to hospital surgical tumor removal that is easily performed in a
relatively short procedure. The ProSense System is marketed and
sold worldwide for the indications cleared and approved to date
including in the U.S., Europe, and
China.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and other Federal and
Israeli securities laws. Words such as "expects," "anticipates,"
"intends," "plans," "believes," "seeks," "estimates" and similar
expressions or variations of such words are intended to identify
forward-looking statements. For example, IceCure is using forward
looking statements in this press release when it discusses: the
expected Class III device clearance for the probes by the end of
the first quarter of 2024; the expected near-term revenues as a
result of regulatory approval of ProSense in Brazil; and the potential of ProSense to offer
great benefits compared to traditional surgical interventions.
Because such statements deal with future events and are based on
IceCure's current expectations, they are subject to various risks
and uncertainties and actual results, performance, or achievements
of IceCure could differ materially from those described in or
implied by the statements in this press release. The
forward-looking statements contained or implied in this press
release are subject to other risks and uncertainties, many of which
are beyond the control of the Company, including those set forth in
the Risk Factors section of the Company's Annual Report on Form
20-F for the year ended December 31,
2022 filed with the SEC on March 29,
2023, and other documents filed with or furnished to the SEC
which are available on the SEC's website, www.sec.gov. The Company
undertakes no obligation to update these statements for revisions
or changes after the date of this release, except as required by
law.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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SOURCE IceCure Medical