- ProSense® system and disposables sales continue upward
trend compared to the equivalent prior year period
- Expanded regulatory footprint, growing body of
evidenced-based data, and distribution agreements demonstrate an
increasing acceptance of minimally invasive alternatives to
standard of care cancer treatment
- ICE3 trial remains on track and expected to be completed
in the first quarter of 2024
- Conference call scheduled for today at 10 am EST
CAESAREA, Israel, Nov. 15,
2023 /PRNewswire/ -- IceCure Medical Ltd.
(Nasdaq: ICCM) ("IceCure" 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 reported financial results as of and for the nine
months ended September 30, 2023, as
well as operational and recent corporate developments.
"First, I must make it clear that although Israel is engaged in a war with Hamas, IceCure
remains more focused than ever on bringing our life-preserving
technology to people around the world for improved healthcare
outcomes. While our team and everyone in Israel is personally impacted by the war,
IceCure continues to push ahead. We achieved several key objectives
during the third quarter, including significant approvals in
Brazil and Canada," stated Eyal
Shamir, Chief Executive Officer.
"Furthermore, we believe the positive interim data from our ICE3
trial and the expanding body of independently conducted trials and
published scientific data is an overwhelmingly strong testament to
ProSense®'s path to widescale adoption across numerous indications,
globally. While we have received clearance from the U.S. Food and
Drug Administration ("FDA") for general minimally invasive
cryoablation applications, including kidney, liver, and benign
breast tumors, our primary objective is to gain marketing clearance
for breast cancer, so that women will have an alternative treatment
to the current standard of care, lumpectomy."
"With this aim, and with the U.S. representing the largest
opportunity for ProSense®, we are continuing with the ICE3 trial,
and we expect that it will be completed in the first quarter of
2024, when the final patient will have her five-year follow-up
examination. In the interim, we have filed an appeal with the FDA
regarding its decision on our De Novo filing for breast cancer and
look forward to productive communications regarding the comparator
and discussing the requested indication with the agency."
Filed Appeal with U.S. FDA Regarding Decision on the
Company's Marketing Clearance Application of ProSense® in the
Treatment of Early-stage Breast Cancer
- In October 2022, IceCure filed a De Novo Classification
request with the FDA for regulatory approval of ProSense® for the
indication of early-stage (Luminal A T1 invasive) low-risk breast
cancer patients, who are at high risk for surgery (not suitable for
surgical alternatives) based on interim data from its ICE3 breast
cancer study. Based on the strength of the interim data, the
Company believed there was a rare and unique opportunity to submit
a De Novo Classification request and make its minimally-invasive
ProSense® cryoablation procedure available to women sooner for this
important and underserved indication. In September 2023, the FDA denied the Company's De
Novo request. The FDA's decision has no bearing on patients in the
U.S. for indications already cleared by the FDA, as these patients
still have access to ProSense® for treatments on these indications.
On November 14, 2023, the Company
filed an appeal with the FDA focused on the FDA's choice of the
comparator group for the Company's ICE3 study data. Through its
appeal, IceCure seeks to come to an understanding with the FDA on
an appropriate comparator group and subsequent analysis of the data
that may lead to marketing clearance for ProSense for this
indication.
- ICE3 Study Expected to be Completed in Q1
2024: With fewer than 20 patients left to undergo their
five-year follow-up examinations, the Company anticipates the last
patient will return for her final follow-up examination in the
first quarter of 2024.
Independent, Non-sponsored
Studies Initiated by ProSense®
Users Reporting Efficacy
and Safety Data Add to
the Growing Body of
Evidence in Peer Reviewed
Journals and Conferences
- Women Deemed Inoperable for Breast Cancer Treated
with ProSense® Had Tumor Reduction Rate of 93.43% to
96.81%: Findings from an independent breast cancer study,
performed by a leading radiologist in Italy, were presented in a poster titled
"Assessing the outcome of cryoablation treatment on different
molecular subtype of low-grade breast cancer" at the European
Society of Breast Imaging Annual ("EUSOBI") Scientific Meeting that
was recently held in Valencia,
Spain in September. At six months after treatment, women
with the molecular subtype Luminal-A had the best outcomes, with a
tumor reduction rate of 96.81% as compared to women with Luminal-B,
who had a tumor reduction rate of 93.43%. Therefore, the
disappearance of lesions and absence of residual malignant cells in
Luminal-A group is considered to be predictive for the complete
effectiveness of the treatment.
- ProSense® had a 96.8% Success Rate in Another Independent
Breast Cancer Study That Validated its Safety & Efficacy as an
Outpatient Procedure: Women with early-stage breast cancer
who declined surgery at the University Hospital Lucus Augusti in
Lugo, Spain, were treated with
ProSense®. The median follow-up was 10 months, with a range of 0 to
40 months. Cancer progression was observed in 1 patient (1/31,
3.2%). No major complications were seen and the procedure was well
tolerated by all patients. The success rate was 96.8% as reported
in a poster presentation titled "Cryoablation for the treatment of
early-stage breast cancer in patients who decline surgery" by Dr.
Graña-López at EUSOBI.
- Independent Scientific Paper by Doctors Using ProSense® was
Published in Journal of Breast Imaging: A scientific
paper titled "Cryoablation Therapy for Early-Stage Breast Cancer:
Evidence and Rationale" presented the advantages of cryoablation
over surgery in early-stage breast cancer patients. The paper was
co-authored by ProSense® users Dr. Robert
C. Ward and Dr. Alexander B. Sevrukov, who both cited ICE3
interim results as evidence of the safety and efficacy of
cryoablation in early-stage breast cancer.
- Substantial Additional Data Currently Being Generated by 19
Ongoing Studies: In addition to IceCure's own studies,
ICE3 for early-stage breast cancer and ICESECRET for kidney cancer,
17 independent studies of ProSense® in various indications are
ongoing, with many more expected to commence. Twelve studies have
already been published and there are 13 studies in breast cancer
that are published and are ongoing.
Regulatory Approvals in Key Growth Markets, Appointment of VP
Sales North America, and Participation at Prestigious Conferences
Continue to Expand Global Footprint and Utilization of
ProSense
- Regulatory Approvals Received in Canada and Brazil: Health Canada, the Canadian
government's regulatory agency, has approved the ProSense® System,
introducers, and disposable cryoprobes as cryosurgical tools for
numerous indications. The ProSense® System also received regulatory
approval as a Class III device from the Brazilian Health Regulatory
Agency ("ANVISA") for indications for oncology, which includes the
ablation of benign and malignant tissues in the breast, prostate,
kidney, lung, liver, musculoskeletal, and skin tissue, for
palliative intervention and other indications. ProSense®'s
disposable cryoprobes and introducers were previously registered as
Class II devices by ANVISA.
- Appointed VP of Sales, North
America to Accelerate Commercialization in the U.S. and
Canada: IceCure appointed
Shad Good, a seasoned healthcare
executive, as Vice President of Sales for North America. His primary responsibility is
to build out the Company's sales infrastructure in anticipation of
the broader commercialization of ProSense® in the U.S. He most
recently worked with a market leader in minimally invasive breast
diagnostic and therapeutic devices, which are sold in 45
countries.
- Expanded Distribution of ProSense® in Portugal with Upfront Sales of Systems and
Probes: IceCure entered into a non-exclusive distribution
agreement with Medicinália Cormédica – MC Medical, Lda. ("MC
Medical"), the largest distributor of third-party medical devices
in Portugal. MC Medical made an initial purchase of two
ProSense® systems, along with disposable cryoprobes and
introducers.
- India's First Breast
Cancer Cryoablation Performed with ProSense® & ICE3
Results Presented at BISICON 2023: IceCure participated the
10th Annual Conference of the Breast Imaging Society of
India (BISICON 2023) in
conjunction with its in-country distributor, Novomed, in
October 2023. ProSense® was featured
at Novomed's booth, where doctors had the opportunity to get
hands-on experience with the cryoablation system. Results from
IceCure's ICE3 study were presented by the study's Co-Primary
Investigator, Dr. Kenneth R.
Tomkovich, during a session titled "Pushing the
boundaries—minimally invasive cancer therapies".
- ProSense® Featured at Hands-On Cryoablation Session &
Symposium at CIRSE 2023 Annual Congress: IceCure participated
in the Cardiovascular and Interventional Radiology Society of
Europe (CIRSE) 2023 Annual
Congress in Copenhagen, Denmark in
September, where a tumor ablation hands-on device training with
ProSense® was conducted. Additionally, a symposium titled
"Cryoablation using a liquid nitrogen, single probe system: from
simple to complex cases" was conducted by two leading
interventional radiologists who used ProSense®, one of whom
conducted a cryoablation endometriosis study. Outcomes of the
published endometriosis study demonstrated cryoablation's efficacy
rate of 92.8% per patient and 93.6% per nodule in avoiding
secondary surgery. In addition, the system's capabilities and
advantages were presented for several case studies.
- Professor Eisuke Fukuma, who
has Performed 600+ ProSense® Breast Cancer Procedures, Led a
Symposium with ProSense® at 16th Thai Breast
Symposium: A cryoablation symposium titled, "Cryoablation
Emerging as Effective Treatment for Breast Cancer" was led by
Professor Fukuma, Director of the Breast Center at Kameda Medical
Center in Japan, at the
16th Thai Breast Symposium in Bangkok, Thailand in August. IceCure
participated at the conference in conjunction with the Terumo
Corporation, the Company's exclusive distributor in Japan and Thailand.
Financial and Operating Results as of and for the Nine Months
Ended September 30, 2023
For the nine months ended September 30, 2023, the Company
reported an 11% increase in ProSense® systems and disposable probes
sales to $1.7 million, compared to
$1.5 million for the nine months
ended September 30, 2022, driven by
higher sales in the U.S. and China. Revenues for the nine months ended
September 30, 2023, were $1.97 million compared to $2.15 million for the nine months ended
September 30, 2022, due to the end of
revenue recognition from the exclusive distribution rights
agreement with Terumo Corporation in Japan, which was partially offset by an
increase in ProSense® systems and disposables sales.
Gross profit was $0.73 million for the nine months
ended September 30, 2023, compared to
$0.98 million for the nine
months ended September 30, 2022.
Gross margin was 37% for the nine months ended September 30, 2023, compared to 46% for the nine
months ended September 30, 2022. The
decrease in gross profit and gross margin was primarily
attributable to the decrease in revenue recognition from the Terumo
distribution agreement.
Research and development expenses for the nine months ended
September 30, 2023, were $6.39
million compared to $6.89 million for the nine
months ended September 30, 2022. The decrease was primarily
due to a reduction in development expenses of IceCure's
next-generation single-probe system and a decrease in clinical and
regulatory costs.
In support of ongoing global commercial adoption and in
anticipation of increasing U.S. commercial efforts, sales and
marketing expenses for the nine months ended September 30, 2023, were $3.23 million,
compared to $2.24 million for the nine months ended
September 30, 2022. General and
administrative expenses for the nine months ended September 30, 2023, narrowed by 30% to $3.27
million, compared to $4.67 million for the nine months
ended September 30, 2022. A portion
of the decrease was also due to a decrease in director and officer
insurance costs.
Total operating expenses for the nine months ended September 30, 2023, were $12.89 million,
compared to $13.79 million for the nine months ended
September 30, 2022. The decrease in
operating expenses was primarily attributable to reductions in
general and administrative expenses, which were partially offset by
the increase in sales and marketing expenses.
Net loss reported for the nine months ended September 30, 2023, decreased by 11%
to $11.66 million, or $0.26 per share, compared with
a net loss of $13.03 million, or $0.35 per share, for the
same period last year.
As of September 30, 2023, the Company had cash and
cash equivalents, including short-term deposits, of
approximately $13.2 million, compared to $23.66
million as of December 31, 2022. To ensure the Company is
in a position to achieve its near-term objectives, IceCure has
implemented an expense reduction plan that will reduce its
non-revenue generating and clinical efforts costs, lowering the
monthly cash utilization and ensuring it can meet its primary goals
in 2024.
Conference call & webcast info:
November 15, 2023, at 10:00 am EST
US: 1-888-642-5032
Israel/International:
+972-3-9180610
A live webcast will be available
at: veidan.activetrail.biz/IcecureQ3-2023
A recording of the webcast will be available for a limited time
at: ir.icecure-medical.com/
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:
that the interim positive data from its ICE3 trial and the
expanding body of independently conducted trials and published
scientific data is an overwhelmingly strong testament to
ProSense®'s path to widescale adoption across numerous indications,
globally; that its primary objective is to gain marketing
clearance for breast cancer so that women will have an alternative
treatment to the current standard of care; the expected plan
and progress towards completion of the follow-up on the ICE3
clinical study in the first quarter of 2024; that through its FDA
appeal, IceCure seeks to come to an understanding with the FDA on
an appropriate comparator group and subsequent analysis of the data
that may lead to marketing clearance for ProSense for this
indication; the expected five-year results passed on the interim
analysis of the ICE3 trial; that 17 independent studies of
ProSense® in various indications are ongoing, with many more
expected to commence; and when it discusses the implementation
of its expense reduction plan that will reduce its non-revenue
generating and clinical efforts costs, lowering the monthly cash
utilization and ensuring it can meet its primary goals in 2024.
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.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
|
|
|
|
|
|
|
ICECURE MEDICAL
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
|
|
|
|
|
|
|
|
|
As of
September 30,
2023
|
|
|
As of
December 31,
2022
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
3,826
|
|
|
|
23,659
|
|
Deposits
|
|
|
9,369
|
|
|
|
-
|
|
Restricted
deposit
|
|
|
296
|
|
|
|
296
|
|
Trade accounts
receivables
|
|
|
108
|
|
|
|
78
|
|
Inventory
|
|
|
2,646
|
|
|
|
2,857
|
|
Prepaid expenses and
other receivables
|
|
|
906
|
|
|
|
1,240
|
|
Total current
assets
|
|
|
17,151
|
|
|
|
28,130
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS
|
|
|
|
|
|
|
|
|
Prepaid expenses and
other long-term assets
|
|
|
33
|
|
|
|
34
|
|
Right-of-use
assets
|
|
|
722
|
|
|
|
668
|
|
Property and equipment,
net
|
|
|
1,515
|
|
|
|
1,356
|
|
Total non-current
assets
|
|
|
2,270
|
|
|
|
2,058
|
|
TOTAL
ASSETS
|
|
|
19,421
|
|
|
|
30,188
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
|
Trade accounts
payable
|
|
|
1,129
|
|
|
|
714
|
|
Lease
liabilities
|
|
|
221
|
|
|
|
167
|
|
Other current
liabilities
|
|
|
2,905
|
|
|
|
3,455
|
|
Total current
liabilities
|
|
|
4,255
|
|
|
|
4,336
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
|
Long-term lease
liabilities
|
|
|
379
|
|
|
|
430
|
|
Total non-current
liabilities
|
|
|
379
|
|
|
|
430
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Ordinary shares, No par
value; Authorized 2,500,000,000 shares; Issued and outstanding:
45,642,184 and 45,623,434 shares as of September 30, 2023 and
December 31, 2022, respectively
|
|
|
|
|
|
|
|
|
Additional paid-in
capital
|
|
|
101,853
|
|
|
|
100,831
|
|
Accumulated
deficit
|
|
|
(87,066)
|
|
|
|
(75,409)
|
|
Total shareholders'
equity
|
|
|
14,787
|
|
|
|
25,422
|
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|
|
19,421
|
|
|
|
30,188
|
|
|
|
ICECURE MEDICAL
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
|
|
|
|
|
|
|
Nine months
ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
|
U.S. dollars in
thousands
(except per share data)
|
|
Revenues
|
|
|
1,974
|
|
|
|
2,146
|
|
Cost of
revenues
|
|
|
1,243
|
|
|
|
1,162
|
|
Gross
profit
|
|
|
731
|
|
|
|
984
|
|
Research and
development expenses
|
|
|
6,390
|
|
|
|
6,886
|
|
Sales and marketing
expenses
|
|
|
3,234
|
|
|
|
2,238
|
|
General and
administrative expenses
|
|
|
3,268
|
|
|
|
4,667
|
|
Operating
loss
|
|
|
12,161
|
|
|
|
12,807
|
|
Financial expenses
(income), net
|
|
|
(504)
|
|
|
|
219
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
|
|
11,657
|
|
|
|
13,026
|
|
Basic and diluted
net loss per share
|
|
|
0.255
|
|
|
|
0.354
|
|
Weighted average
number of shares outstanding used in computing basic and diluted
loss per share
|
|
|
45,626,332
|
|
|
|
36,820,132
|
|
ICECURE MEDICAL
LTD.
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
|
|
|
|
|
|
|
|
Nine months
ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
|
U.S. dollars in
thousands
|
|
Cash flows from
operating activities
|
|
|
|
|
|
|
Net loss
|
|
|
(11,657)
|
|
|
|
(13,026)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
240
|
|
|
|
174
|
|
Share-based
compensation
|
|
|
1,007
|
|
|
|
1,353
|
|
Exchange rate changes
in cash and cash equivalents and short-term deposits
|
|
|
203
|
|
|
|
477
|
|
Changes in assets
and liabilities:
|
|
|
|
|
|
|
|
|
Decrease (increase) in
trade accounts receivables
|
|
|
(30)
|
|
|
|
260
|
|
Decrease in prepaid
expenses and other receivables
|
|
|
334
|
|
|
|
1,693
|
|
Decrease (increase) in
inventory
|
|
|
211
|
|
|
|
(743)
|
|
Decrease in prepaid
expenses and other long-term assets
|
|
|
1
|
|
|
|
-
|
|
Decrease in right of
use assets
|
|
|
118
|
|
|
|
163
|
|
Increase (decrease) in
trade accounts payable
|
|
|
415
|
|
|
|
(279)
|
|
Decrease in lease
liabilities
|
|
|
(169)
|
|
|
|
(242)
|
|
Increase (decrease) in
other current liabilities
|
|
|
(550)
|
|
|
|
555
|
|
Decrease in other
long-term liabilities
|
|
|
-
|
|
|
|
(549)
|
|
Net cash used in
operating activities
|
|
|
(9,877)
|
|
|
|
(10,164)
|
|
Cash flows from
investing activities
|
|
|
|
|
|
|
|
|
Investment in
short-term deposits
|
|
|
(9,369)
|
|
|
|
(1,776)
|
|
Purchase of property
and equipment
|
|
|
(399)
|
|
|
|
(791)
|
|
Net cash used in
investing activities
|
|
|
(9,768)
|
|
|
|
(2,567)
|
|
Cash flows from
financing activities
|
|
|
|
|
|
|
|
|
Exercise of
options
|
|
|
15
|
|
|
|
-
|
|
Exercise of pre-funded
warrants
|
|
|
-
|
|
|
|
1
|
|
Net cash provided by
financing activities
|
|
|
15
|
|
|
|
1
|
|
Decrease in cash and
cash equivalents
|
|
|
(19,630)
|
|
|
|
(12,730)
|
|
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
|
|
|
(203)
|
|
|
|
(454)
|
|
Cash and cash
equivalents at end of period
|
|
|
3,826
|
|
|
|
12,437
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
activities
|
|
|
|
|
|
|
|
|
Obtaining a
right-of-use asset in exchange for a lease liability
|
|
|
172
|
|
|
|
|
-
|
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content:https://www.prnewswire.com/news-releases/icecure-medical-reports-financial-results-as-of-and-for-the-nine-months-ended-september-30-2023-and-provides-update-on-recent-operational-highlights-301989099.html
SOURCE IceCure Medical