- Data confirm previous results showing that
ProSense® cryoablation is highly effective for kidney
tumors < 3 cm and a safe procedure for kidney tumors < 5 cm
in people ineligible for surgery
- Interim results presented at the Israeli Urological
Association Conference in Eilat, Israel
- ProSense® is approved for benign and malignant
kidney tumors in the U.S., Europe
and numerous other countries
CAESAREA, Israel, Dec. 5, 2024
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ('IceCure',
'IceCure Medical' or the 'Company'), developer of
minimally-invasive cryoablation technology that destroys tumors by
freezing as an alternative to surgical tumor removal, today
announced interim results from the Company's ICESECRET study of
cryoablation for patients with small renal masses ('SRM') who
cannot be offered kidney preserving surgery. Data were presented on
December 5, 2024 at the Israeli
Urological Association Conference in Eilat, Israel. The presentation titled 'Renal Mass
Cryoablation - Interim Analysis of ICESECRET Study' was delivered
by Dr. Keren Boguslavsky of Bnai
Zion Medical Center.
Results were reported at a mean follow-up period of 36 months
for 111 patients with 117 lesions. A summary of the key results
were:
- In 91 patients (approximately 82%), no tumor recurrence was
observed.
- Following an additional cryoablation procedure for the same
tumor in 13 patients, the success rate for the overall population
was 83.8%, with a mean follow-up time of 39.6 months. In patients
without a history of kidney cancer with one tumor < 3 cm,
the success rate was 88.7%.
- Freezing of the renal tumor, including safety margins of 0.5
cm, was achieved in 95.6% of the procedures demonstrating high
efficacy in cases without anatomic limitation for ice ball
creation.
- Four procedure-related serious adverse events were reported,
three of which were mild and treated conservatively. One severe
complication was observed seven months after the cryoablation
procedure.
- Renal function was preserved, on an average basis across the
patient cohort, with no significant change in creatinine and
hemoglobin levels compared to baseline.
- The procedure time, relative to the standard of care as
supported by and documented in medical literature, was short at
approximately 25 minutes.
"The ability to offer cryoablation for kidney cancer is a large
unmet need, particularly in patients who are ineligible for kidney
preserving surgery. We are very pleased that ICESECRET's latest
interim results present ProSense® as a safe and
effective option for these patients. These results are particularly
important since ProSense® is already approved for the as
a cryosurgical tool in the destruction of malignant and benign
tumors of the kidney in key markets including the U.S. and
Europe," stated IceCure's Chief
Executive Officer, Eyal Shamir.
According to the American Journal of Roentgenology, small renal
masses, which may be malignant or benign tumors in the
kidney, have been increasing in incidence over the past
two decades. According to the American Cancer Society, in 2024, in
the United States, an
estimated 81,610 new cases of kidney cancer will have been
diagnosed, with approximately 14,390 dying from the
disease. Globally, there were more than 434,000 new cases of
kidney cancer in 2022 and about 156,000 deaths according to World
Cancer Research Fund International.
About ICESECRET
ICESECRET, a prospective, multicenter, single-arm clinical trial
is being performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical Center in
Zerifin, Israel and is being led
by Principal Investigator Prof. Halahmi Sarel. The trial includes
114 patients (138 lesions) with localized SRM of ≤5 cm that were
ablated with ProSense® cryoablation under CT guidance.
Follow-up visits are performed six weeks, six months, one year, and
then annually up to five 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 ProSense®
The ProSense® Cryoablation System is a
minimally invasive cryosurgical tool that provides the option to
destroy tumors by freezing them. The system uniquely harnesses the
power of liquid nitrogen to create large lethal zones for maximum
efficacy in tumor destruction in benign and cancerous lesions,
including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by
accelerating recovery, reducing pain, surgical risks, and
complications. With its easy, transportable design and liquid
nitrogen utilization, ProSense® opens that door to fast
and convenient office-based procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced
liquid-nitrogen-based cryoablation therapy systems for the
destruction 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 Company's flagship
ProSense® system is marketed and sold worldwide for the
indications cleared and approved to date including in the U.S.,
Europe and China.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
Logo:
https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/icecures-prosense-cryoablation-safe-and-effective-in-destruction-of-kidney-tumors-with-88-7-recurrence-free-rate-based-on-interim-icesecret-study-results-302323599.html
SOURCE IceCure Medical