- ICESECRET study interim findings presented at the
Urological Association Conference in Eilat,
Israel
- ProSense was found to be a safe and effective treatment
method for renal lesions smaller than 5 cm in patients not suitable
for kidney-preserving surgery
- ProSense is approved for the treatment of benign and
malignant kidney tumors in the U.S., Europe, and numerous other
countries
CAESAREA, Israel, Dec. 19,
2022 /PRNewswire/ --- IceCure Medical
Ltd. (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the
"Company"), developer of minimally-invasive cryoablation
technology, the ProSense® System that
destroys tumors by freezing, today announced interim results from
the ICESECRET study for the treatment of patients with small renal
masses ("SRM") who cannot be offered kidney-preserving surgery.
Data were presented on December 14,
2022 at the Urological Association Conference in Eilat,
Israel. The presentation titled
"Renal Mass Cryoablation - Interim Analysis ICESECRET Study" was
delivered by Dr. Nasir Said of Bnai
Zion Medical Center.
According to the presentation, out of the 115 patients enrolled,
107 patients (112 lesions) returned for follow-up with a mean
duration of 22.8 months and a range 12-60 months.
- In a subgroup of patients with no previous history of kidney
cancer on the same kidney and a lesion ≤3 cm, an 89.5%
recurrence-free rate was observed at a mean follow-up time of 22.2
months when the procedure protocol was followed.
- The recurrence-free rate was 85.1% for the 107 patients (91
patients, including 13 patients who underwent a second
cryoablation), at a mean follow-up period of
16.5 months.
- 5 serious adverse events were reported, 4 of which were of mild
severity and were treated conservatively and resolved within 1-5
days, with one severe complication of a new onset of
ipsilateral hydronephrosis 7 months
after the cryoablation procedure that led
to nephrectomy.
- Cryoablation time and hospitalization time were
relatively short, up to approximately 25 minutes and 2 days,
respectively.
- The presentation concluded that, based on these interim
results, cryoablation is safe and effective for
treating renal masses under 5 cm.
According to the American Journal of Roentgenology, small renal
masses, which may be malignant or benign tumors in the kidney, have
been rising in incidence over the past two decades. According
to the American Cancer Society, in 2022, in the U.S., an estimated
79,000 new cases of kidney cancer will be diagnosed, with about
14,000 dying from the disease. Globally, there were more than
430,000 new cases of kidney cancer in 2020 and about 180,000 deaths
according to World Cancer Research Fund International.
"These impressive interim results demonstrate the value of
ProSense for urologists and interventional radiologists as a
therapeutic alternative when patients are not eligible for
surgery," stated IceCure's Chief Executive Officer, Eyal Shamir. "We believe the findings will
support further use of ProSense in the jurisdictions in which our
cryoablation system is approved for use with benign and malignant
tissues of the kidney. The growing body of data on ProSense's
efficacy and safety across a broad range of indications supports
commercialization momentum, particularly in facilities that benefit
from one device that can be used across multiple specialties."
ICESECRET, a prospective, multicenter, single-arm clinical trial
is being performed at Bnai-Zion Medical Center, Haifa, Israel, and Shamir Medical Center,
Zerifin, Israel, and led by
Principal Investigator Prof. Halahmi Sarel. The trial included 115
patients (138 lesions) with localized SRM of ≤5 cm who were treated
with ProSense cryoablation under CT guidance. Full engulfment of
the renal lesion, including a safety margin of 0.5 cm was achieved
in approximately 96% of the procedures where there was no
anatomical limitation. Follow-up visits are performed 6 weeks, 6
months, 1 year, and then annually up to 5 years after the
procedure. During the follow-up visits, data related to local
recurrence, based on CT imaging, is collected. Safety was
determined by monitoring procedure-related adverse events
throughout the study.
About IceCure Medical Ltd.
IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: 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 to-date by the U.S. Food and Drug Administration and
approved in Europe with the CE
Mark.
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
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
interim study results for ICESECRET; the value of ProSense for
urologists and interventional radiologists as a therapeutic
alternative when patients are not eligible for surgery; the
Company's belief that the interim results from ICESECRET will
support further use of ProSense in the jurisdictions in which the
Company's cryoablation system is approved for use with benign and
malignant tissues of the kidney; and the commercialization momentum
from a growing body of data on ProSense's efficacy and safety.
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,
2021 filed with the Securities Exchange Commission (the
"SEC") on April 1, 2022, as amended,
which is 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:
Ronen
Tsimerman
email: ronent@icecure-medical.com
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SOURCE IceCure Medical Ltd