- Physician Interest and Adoption of ProSense in the U.S.
Builds Momentum as ProSense is Featured at Medical Conferences and
Educational Courses
- ProSense was the only Cryoablation System Used in a
First-of-its-Kind Cryotherapy Continuing Medical Education (CME)
course at the American Society of Breast Surgeons (ASBrS) 2023
Annual Meeting Where a Plan was Presented for a Proposed ASBrS
Cryoablation Trial
- Regulatory Approval Received in China for Commercial Use of Disposable
Cryoprobes
- Independently Conducted Endometriosis Study Shows 92.8%
Efficacy in Avoiding Secondary Surgery
- Conference Call to be Held Today at 10:00 am Eastern Time
CAESAREA, Israel, May 22, 2023
/PRNewswire/-- IceCure Medical Ltd. (the "Company" or "IceCure")
(Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense® System, a
minimally-invasive cryoablation technology that destroys tumors by
freezing as an alternative to surgical tumor removal, today
reported financial results as of and for the three months ended
March 31, 2023 as well as operational
and recent corporate developments.
"ProSense is gaining heightened interest among breast surgeons,
breast radiologists, and interventional oncologists globally and
particularly in the U.S. where we are focusing our
commercialization and marketing efforts. We believe this momentum
in the market is bolstered by a broader trend toward minimally
invasive procedures," stated IceCure CEO Eyal Shamir.
"We continue to engage with the U.S. Food and Drug
Administration ("FDA") following the October
2022 filing for marketing authorization for ProSense for
early-stage low risk breast cancer in patients who are at high
risk for surgery. These ongoing discussions are part of the
regulatory submission process. Concurrently, we are highly
encouraged by the American Society of Breast Surgeons' ("ASBrS")
expressed plans for a cryoablation trial. We believe that such a
planned trial could potentially establish a new minimally invasive
standard for the treatment of low risk, early-stage breast cancer.
We further believe it will support our commercialization plans, and
raise awareness among ASBrS members, which include 3,000 of the
most influential physicians in breast surgery.
"Globally, we continue to build momentum through regulatory
submissions and approvals including in China where our IceSense3 system and
cryoprobes are now fully approved for commercial use. In addition,
we were pleased to learn of the favorable results from an
independent study in France where
ProSense and another cryoablation technology were used to treat
endometriosis. We expect the continued adoption of ProSense through
the rest of 2023.
"Our cash position at the end of the quarter remains strong at
over $20 million, and we believe our
continued prudent management of our financial resources gives us
the confidence to invest in our U.S. commercialization activities
as we await the FDA's response."
First Quarter of 2023 and Recent Operating Highlights
- ProSense and Cryoablation Received High Levels of Interest
at ASBrS Meeting—Plans for Cryoablation Study Unveiled:
Surgeons attending the ASBrS 24th Annual Meeting
enrolled in the Society's first-ever continuing medical education
("CME") course on cryoablation, which used the ProSense system.
During the course led by cryoablation thought leaders, surgeons got
first-hand experience using ProSense. They were also presented with
interim results from IceCure's ICE3 clinical trial and the proposed
plan for a future ASBrS trial that would evaluate cryoablation as a
treatment for low risk early-stage breast cancer for women between
the ages of 55 to 85. Breast cryoablation was favorably mentioned
several times over the course of the 5-day conference including
during a keynote speech by ASBrS leadership. Breast surgeons who
visited IceCure's booth and participated in other hands-on
demonstrations expressed a high level of interest in adopting the
system and incorporating it into their practice. A hands-on
training for ProSense also took place during the ASBrS Breast
Fellows Course in January.
- ProSense Featured in Breast Session at Society of
Interventional Oncology's Annual Scientific Meeting:
Demonstrations on ProSense took place throughout the duration
of the conference at IceCure's booth where interventional
radiologists engaged with the system and expressed interest.
ProSense was also featured in a panel discussion led by doctors
currently using the system.
- ProSense Featured in Workshop "Chest Ablation: Inside and
Outside" at the Society of Interventional Radiology Annual
Conference: ProSense was featured as part of a
well-attended panel discussion led by ICE3 Trial Co-Primary
Investigator, Dr. Kenneth
Tomkovich.
- Received Regulatory Approval in China for Commercial Use of IceSense3
Cryoprobes: The National Medical Products Administration
("NMPA") of China approved the
IceSense3 (ProSense's brand name in China) disposable cryoprobes for
commercial use, to be used in combination with the Company's
IceSense3 system console, which was previously approved by
the NMPA. Commercialization in China is driven by IceCure's exclusive
distribution agreement with Shanghai Medtronic Zhikang Medical
Devices Co. Ltd., an affiliate of Medtronic, which includes minimum
purchase targets.
- ProSense Used in Cryoablation Endometriosis Study That
Demonstrated 92.8% Efficacy in Avoiding Secondary Surgery: The
ProSense System was one of two types of cryoablation systems used
in a single-site study conducted at the Sorbonne University
Department of Interventional Radiology and Oncology, Tenon Hospital
in Paris, France and published in
the Journal of Vascular and Interventional Radiology. The
independent study and paper were not sponsored by IceCure. The
study concluded that percutaneous cryoablation is a safe and
effective procedure that significantly reduces pain and obtains
local control of extraperitoneal endometriosis. The efficacy rate
of cryoablation to avoid secondary surgery was 92.8% per patient
and 93.6% per nodule treated. The median pain-free survival rates
were 93.75% at 6 months and 82.72% after 36 months. ProSense has
regulatory approval in several countries, including FDA clearance
for use as a cryosurgical tool in gynecology.
- Patents Granted in U.S. and Japan: IceCure received patents in
the U.S. and Japan for its novel
cryogenic pump, potentially broadening the clinical indications
addressed by the Company's platform technology. This patent
potentially expands IceCure's portfolio of products with a broader
range of thinner cryoprobes and catheters designed for use in other
indications, multiple procedures or longer duration procedures
without the need to replenish liquid nitrogen.
- Company's Ordinary Shares to Trade Exclusively on
Nasdaq: IceCure announced its voluntary delisting from the Tel
Aviv Stock Exchange ("TASE"). The last day its Ordinary Shares will
trade on the TASE will be July 20,
2023, and the Ordinary Shares will be delisted from the TASE
on July 24, 2023.
Financial Results as of and for the Three Months Ended
March 31, 2023
For the three months ended March 31,
2023, the Company reported revenue of $0.71 million compared to revenue of $0.75 million for the three months ended
March 31, 2022. In the first quarter
of 2023, sales increased in the U.S. and Europe relative to the same quarter last
year.
Gross profit was $0.32 million for
the three months ended March 31,
2023, compared to approximately $0.43
million for the three months ended March 31, 2022. Gross margin was 45% for the
three months ended March 31, 2023,
compared to 58% for the three months ended March 31, 2022. The decrease in gross margin
compared to the same period last year resulted mostly from an
increase in manufacturing costs.
Research and development expenses for the three months ended
March 31, 2023, were $2.11 million compared to $2.39 million for the three months ended
March 31, 2022. The decrease was
primarily due to a reduction in development expenses of IceCure's
next-generation single-probe system, partially offset by an
increase in clinical and regulatory activities.
As a result of the Company's expanding commercialization
efforts, sales and marketing expenses for the three months ended
March 31, 2023, were $1.08 million, compared to $0.75 million for the three months ended
March 31, 2022.
General and administrative expenses for the three months ended
March 31, 2023, were $1.09 million, compared to $1.72 million for the three months ended
March 31, 2022. The decrease is
mainly due to a decrease in the cost of directors' and officers'
insurance.
Total operating expenses for the three months ended March 31, 2023, were $4.28
million, compared to $4.86
million for the three months ended March 31, 2022. The decrease in operating
expenses was primarily attributable to a reduction in research and
development expenses and cost of directors' and officers'
insurance. Net loss reported for the three months ended
March 31, 2023, decreased to
$3.77 million, or $0.08 per share, compared with a net loss of
$4.45 million, or $0.12 per share, for the same period last
year.
As of March 31, 2023, the Company
had cash and cash equivalents, including short-term deposits, of
approximately $20.46 million,
compared to $23.66 million as of
December 31, 2022.
Conference call & webcast info:
May 22, 2023, at 10:00 am ET
US: 1-888-642-5032
Israel/International:
+972-3-9180609
A live webcast will be available at:
https://veidan.activetrail.biz/IcecureQ1-2023
A recording of the webcast will be available at:
https://ir.icecure-medical.com/news-events/events-presentations
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 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
heightened interest and momentum in the market for its products,
its commercialization and marketing efforts, its regulatory
strategy, the ASBrS's plans for a cryoablation trial, its belief
that such a trial could establish a new minimally invasive standard
for the treatment of low risk, early-stage breast cancer and that
it will support its commercialization process and make physicians
aware of and participate in the trial being planned, the
expected continued adoption of ProSense through the rest of 2023,
its anticipation of the FDA's response to regulatory requests for
approvals, the potential of IceCure's product portfolio expansion
into thinner cryoprobes and catheters through its granted patents
in the U.S. and Japan, expansion
of clinical applications and potential market adoption of its
minimally-invasive cryoablation technology and the dates related to
the voluntary delisting of the Company's ordinary shares from the
TASE. . 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:
Michael
Polyviou
Email: mpolyviou@evcgroup.com
Todd Kehrli
Email: tkehrli@evcgroup.com
ICECURE MEDICAL
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
|
|
|
As of
March 31,
2023
|
|
|
As of
December 31,
2022
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
5,594
|
|
|
|
23,659
|
|
Deposits
|
|
|
14,870
|
|
|
|
-
|
|
Restricted
deposit
|
|
|
296
|
|
|
|
296
|
|
Trade accounts
receivables
|
|
|
143
|
|
|
|
78
|
|
Inventory
|
|
|
2,928
|
|
|
|
2,857
|
|
Prepaid expenses and
other receivables
|
|
|
866
|
|
|
|
1,240
|
|
Total current
assets
|
|
|
24,697
|
|
|
|
28,130
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS
|
|
|
|
|
|
|
|
|
Prepaid expenses and
other long-term assets
|
|
|
34
|
|
|
|
34
|
|
Right-of-use
assets
|
|
|
620
|
|
|
|
668
|
|
Property and equipment,
net
|
|
|
1,527
|
|
|
|
1,356
|
|
Total non-current
assets
|
|
|
2,181
|
|
|
|
2,058
|
|
TOTAL
ASSETS
|
|
|
26,878
|
|
|
|
30,188
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
|
Trade accounts
payable
|
|
|
685
|
|
|
|
714
|
|
Lease
liabilities
|
|
|
164
|
|
|
|
167
|
|
Other current
liabilities
|
|
|
3,643
|
|
|
|
3,455
|
|
Total current
liabilities
|
|
|
4,492
|
|
|
|
4,336
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
|
Long-term lease
liabilities
|
|
|
376
|
|
|
|
430
|
|
Total non-current
liabilities
|
|
|
376
|
|
|
|
430
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Ordinary shares, No par
value; Authorized 2,500,000,000 shares; Issued and outstanding:
45,623,434 shares as of March 31, 2023 and December 31, 2022,
respectively
|
|
|
|
|
|
|
|
|
Additional paid-in
capital
|
|
|
101,187
|
|
|
|
100,831
|
|
Accumulated
deficit
|
|
|
(79,177)
|
|
|
|
(75,409)
|
|
Total shareholders'
equity
|
|
|
22,010
|
|
|
|
25,422
|
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|
|
26,878
|
|
|
|
30,188
|
|
ICECURE MEDICAL
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
|
|
|
Three months
ended
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
|
|
U.S. dollars in
thousands
(except per share data)
|
|
Revenues
|
|
|
710
|
|
|
|
747
|
|
Cost of
revenues
|
|
|
390
|
|
|
|
313
|
|
Gross
profit
|
|
|
320
|
|
|
|
434
|
|
Research and
development expenses
|
|
|
2,111
|
|
|
|
2,394
|
|
Sales and marketing
expenses
|
|
|
1,075
|
|
|
|
747
|
|
General and
administrative expenses
|
|
|
1,091
|
|
|
|
1,718
|
|
Operating
loss
|
|
|
3,957
|
|
|
|
4,425
|
|
Financial expenses
(income), net
|
|
|
(189)
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
|
|
3,768
|
|
|
|
4,447
|
|
Basic and diluted
net loss per share
|
|
|
0.08
|
|
|
|
0.12
|
|
Weighted average
number of shares outstanding used in computing basic and diluted
loss
per share
|
|
|
45,623,434
|
|
|
|
36,814,335
|
|
ICECURE MEDICAL
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
|
|
|
|
Three months
ended
March
31,
|
|
|
2023
|
|
2022
|
|
|
U.S. dollars in
thousands
|
Cash flows from
operating activities
|
|
|
|
|
|
|
Net loss
|
|
|
(3,768)
|
|
|
(4,447)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
79
|
|
|
52
|
Share-based
compensation
|
|
|
356
|
|
|
450
|
Exchange rate changes
in cash and cash equivalents and short time deposits
|
|
|
8
|
|
|
62
|
Changes in assets
and liabilities:
|
|
|
|
|
|
|
|
|
Decrease (increase) in
trade accounts receivables
|
|
|
(65)
|
|
|
10
|
Decrease in prepaid
expenses and other receivables
|
|
|
374
|
|
|
728
|
Increase in
inventory
|
|
|
(71)
|
|
|
(369)
|
Decrease in right of
use assets
|
|
|
48
|
|
|
29
|
Decrease in trade
accounts payable
|
|
|
(29)
|
|
|
(211)
|
Decrease in lease
liabilities
|
|
|
(57)
|
|
|
(62)
|
Increase in other
current liabilities
|
|
|
188
|
|
|
1,131
|
Decrease in other
long-term liabilities
|
|
|
-
|
|
|
(433)
|
Net cash used in
operating activities
|
|
|
(2,937)
|
|
|
(3,060)
|
Cash flows from
investing activities
|
|
|
|
|
|
|
|
|
Investment in
short-term deposits
|
|
|
(14,870)
|
|
|
-
|
Purchase of property
and equipment
|
|
|
(250)
|
|
|
(144)
|
Net cash provided by
(used in) investing activities
|
|
|
(15,120)
|
|
|
(144)
|
Increase (decrease)
in cash and cash equivalents
|
|
|
(18,057)
|
|
|
(3,204)
|
Cash and cash
equivalents at beginning of the year
|
|
|
23,659
|
|
|
25,621
|
Effect of exchange
rate fluctuations on balances of cash and cash
equivalents
|
|
|
(8)
|
|
|
(62)
|
Cash and cash
equivalents at end of period
|
|
|
5,594
|
|
|
22,355
|
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SOURCE IceCure Medical