CAESAREA, Israel, Sept. 20,
2023 /PRNewswire/ -- IceCure Medical Ltd.
(Nasdaq: ICCM), 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 U.S. Food and Drug Administration ("FDA") has at
this time denied the Company's De Novo Classification request for
breast cancer which was submitted based on interim analysis from
its ICE3 study. The FDA's position on the De Novo Classification
request for breast cancer has no effect on ProSense's FDA cleared
authorization for other indications in the U.S. and patients in the
U.S. continue to have access to ProSense for those treatments. The
Company is pursuing all avenues to address the FDA's response as
global adoption of ProSense outside of the United States continues to build. IceCure
filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3
breast cancer study for the Breakthrough Indication of early-stage
(Luminal A T1 invasive) low-risk breast cancer patients who are at
high risk to surgery (not suitable for surgical alternatives).
IceCure continues its ICE3 clinical study, the largest clinical
trial of its kind, which is expected to complete during the first
quarter of 2024.
"The positive expected five-year results based on the interim
analysis of the ICE3 trial, which demonstrated a survival-based
estimate for the 5-year ipsilateral breast tumor recurrence (IBTR)
of 4.3%*, allowed us a rare and unique opportunity to submit a De
Novo Classification request and make our minimally-invasive
ProSense cryoablation procedure available to women sooner for this
important and underserved indication," commented Eyal Shamir, Chief Executive Officer. "We, along
with our regulatory consultants, believe the FDA's response to the
De Novo Classification request is largely due to the FDA's need for
additional scientific literature as a comparator rate of recurrence
in patients treated with lumpectomy. We are committed to working
with the FDA to address its comments by using the broadly available
published scientific literature on recurrence outcomes in patients
treated with lumpectomy. ProSense remains available in the U.S.
under prior FDA clearances and we will continue to execute our plan
and progress towards achieving our primary objective of completing
the 5-year follow ups with our last patients in the ICE3 study by
the first quarter of 2024, while we simultaneously evaluate all
strategies to efficiently and effectively address the FDA's
comments."
The Company's ProSense system was given a Breakthrough Device
Designation by the FDA in March 2021,
and previously received clearance in the U.S. for general minimally
invasive cryoablation applications, including kidney, liver and
benign breast tumors. ProSense is approved for the treatment of
malignant breast tumors in other jurisdictions, including
Europe, China, and Brazil.
ICE3 is the largest controlled multi-location clinical trial
ever performed for liquid nitrogen (LN2)–based cryoablation of
small, low-risk, early-stage malignant breast tumors without
subsequently removing them. The trial began in 2014 and has 194
eligible patients) in 19 hospitals and medical centers across the
U.S., including Columbia University
Medical Center and Mount Sinai Beth Israel. The expected
survival-based estimate for the 5-year IBTR was 4.3%* for patients
who received ProSense system cryoablation treatment are free of
recurrence, with one-third of patients reaching 5 years post
treatment. Additionally, to date, there have been no significant
device-related adverse events reported with no scarring or change
in shape and size of the breasts, while 100% of doctors and 100% of
patients reported satisfaction with the cosmetic results.
*Based on the last interim results release on October 19, 2022, there have been 6 cases of
ipsilateral breast tumor recurrence ("IBTR") out of 194 patients,
or 3.09%. The survival-based estimate for the 5-year IBTR is 4.3%
with a one-sided 95% confidence level, upper bound of 8.4% for the
entire study.
About ProSense
ProSense cryoablation is a minimally invasive, non-surgical,
outpatient 40-minute procedure that only requires a local 1%
lidocaine injection (similar to its use by dentists when performing
certain dental procedures) enabling the patient to remain alert
during the procedure and then walk out of the doctor's office to
resume their day. Cryoablation costs less than the current standard
of care breast cancer surgery of lumpectomy or partial mastectomy
which requires general anesthesia and has cosmetic
consequences.
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
expected plan and progress towards completion of the follow-up on
the ICE3 clinical study in February
2024; evaluating all strategies to efficiently and
effectively address the FDA's comments; and the expected 5-year
results passed on the interim analysis of the ICE3 trial. Historic
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. 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.
Logo -
https://mma.prnewswire.com/media/1941429/IceCure_Logo.jpg
IR contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
View original
content:https://www.prnewswire.com/news-releases/icecure-medical-receives-fda-response-to-de-novo-classification-request-for-breast-cancer-301933082.html
SOURCE IceCure Medical