- ProSense® is already marketed and sold in India based on previous regulatory
requirements and now has been re-classified due to new
regulations
- Breast cancer cryoablation is already performed in
India with ProSense®
CAESAREA, Israel, Nov. 29,
2023 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ:
ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of
the ProSense® System, a minimally-invasive cryoablation technology
that destroys tumors by freezing as an alternative to surgical
tumor removal, today announced that the Central Drugs Standard
Control Organization ("CDSCO") in India has granted approval for the ProSense®
system based on the CDSCO's updated regulatory requirements. This
is in addition to existing approvals, including disposables and
cryoprobes, already approved for indications covering general
surgery and oncology for tissues of the breast, lung, bone, kidney,
liver and more. ProSense® was previously marketed and sold in
India in accordance with prior
regulatory requirements. This latest approval, granted in
November 2023, confirms that
ProSense® meets all updated regulatory requirements in India.
ProSense® is marketed and sold in India through IceCure's distributor, Novomed.
The first breast cancer cryoablation procedure in India was conducted using ProSense® in June of
2023, at the Kovai Medical Center and Hospital in Coimbatore. Along
with Novomed, IceCure recently presented ProSense® at the 10th
Annual Conference of the Breast Imaging Society of India, where the cryoablation system was
enthusiastically received by doctors, who attended a presentation
of the ICE3 clinical study results and participated in hands-on
demonstrations.
"India is a very important
market for us because we see the potential for significant growth
with safe, effective, and cost-efficient technologies rapidly
adopted. We have a highly productive partnership with our
in-country distributor, Novomed, and anticipate increasing market
traction," stated IceCure's Chief Executive Officer, Eyal Shamir. "Obtaining and maintaining
regulatory approvals across the world supports our continued
commercial traction worldwide."
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 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 statement in this press release when it discusses: the
potential for significant growth and increasing market traction in
India; and that obtaining and
maintaining regulatory approvals supports the Company's continued
commercial traction worldwide. Historical results of scientific
research and clinical and preclinical trials do not guarantee that
the conclusions of future research or trials will suggest identical
or even similar conclusions. Important factors that could cause
actual results, developments and business decisions to differ
materially from those anticipated in these forward-looking
statements include, among others: the Company's planned level
of revenues and capital expenditures; the Company's available cash
and its ability to obtain additional funding; the Company's ability
to market and sell its products; legal and regulatory developments
in the United States and other countries; the Company's
ability to maintain its relationships with suppliers, distributors
and other partners; the Company's ability to maintain or protect
the validity of its patents and other intellectual property; the
Company's ability to expose and educate medical professionals about
its products; political, economic and military instability in
the Middle East, specifically in Israel; as well as those
factors 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