Full Press Release Details
Medical Announces Preliminary Unaudited 2022 Year-End Financial Results & Recent Operational Highlights
| Significant regulatory and reimbursement milestones achieved | ||
| Positive interim clinical results for ProSense in the treatment of kidney tumors and breast cancer | ||
| Fortified balance sheet with $23.6 million in cash and cash equivalents including short-term deposits as of December 31, 2022 | ||
| ProSense System and disposable cryoprobe sales continue to increase in the U.S. |
Israel, February 9, 2023 -- 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 as an
alternative to surgical tumor removal ("ProSense"), today announced preliminary unaudited year-end financial results for
the twelve months ended December 31, 2022.
decreased to $3.1 million in 2022, compared to $4.1 million in 2021.This is due to decreased revenue recognition of approximately $0.6
million from the distribution agreement with Terumo Corporation and a decrease of sales in most territories by 25%, which was partially
offset by a 28% increase in U.S sales, and higher sales of disposable probes, as previously sold and installed systems were increasingly
utilized for procedures in clinical settings. IceCure expects revenues may continue to fluctuate in the near future while the Company
awaits a response from the U.S. Food and Drug Administration ("FDA") on regulatory clearance for ProSense in early-stage breast
of December 31, 2022, the Company's cash and cash equivalents, including short-term deposits, totaled $23.6 million, compared to $25.6
million on December 31, 2021. In December 2022, IceCure raised $14.5 million in an equity financing funding priced at-the-market under
Nasdaq rules with no warrants.
2022 we delivered across the board on our goals from regulatory achievements and making progress with respect to obtaining the CPT Category
III code for insurance reimbursements, to interim clinical results, to traction in the medical and scientific communities, and commercialization.
Our team has worked extremely hard, and we thank the patients who have enrolled in our trials, as well as the increasing number of doctors
using ProSense across the world," stated Eyal Shamir, IceCure's Chief Executive Officer. "We are well funded to continue
to execute on an enormous opportunity to expand the use of cryoablation, delivering better treatment of numerous indications. We believe
our recent fund raise, which was completed on very favorable terms given current market conditions, is a testament to IceCure's
technology and our ability to deliver."
the regulatory front, we filed a De Novo classification request with the FDA for Marketing Authorization of our ProSense System with
Breakthrough Indication for early-stage, low-risk, breast cancer patients at high risk to surgery. Elsewhere, we filed for approvals
in Canada and Vietnam and received approval in Brazil for our cryoprobes."
we await a response from the FDA on our regulatory filing, reimbursement and affordability for patients is critical. We were very pleased
to receive the assignment of a $3,400 CPT Category III code from the Centers for Medicare & Medicaid Services ("CMS") for
breast cancer cryoablation procedure facility fees. Concurrent with potential regulatory clearance, we will continue working with CMS
to refine reimbursement codes to include payment for the physician, thereby enabling greater availability and affordability of the ProSense
System for breast cancer."
body of clinical data on ProSense continues to grow. Interim results from ICESECRET were recently presented at the Urological Association
Conference in Israel which demonstrated ProSense is safe and effective in treating kidney tumors with an 89.5% recurrence-free rate.
When filing our De Novo application with the FDA, we submitted the most recent interim ICE3 trial results, which showed there were six
cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or 3.09%. Our commercial and scientific team, including
principal investigators of our trials, have been very active presenting, training, and demonstrating ProSense at medical conferences.
The high level of interest in ProSense from patients and the medical community is highly encouraging."
is committed to leading cryoablation technology. We've recently received patent allowances for technologies that enable our next
generation of systems. We expect our commercial momentum will continue to build in 2023."
plans to report full 2022 audited financial results upon filing its annual report on Form 20-F with the U.S. Securities and Exchange
above information reflects preliminary, unaudited estimates with respect to certain results of IceCure for the full year ended December
31, 2022, based on currently available information. Because the audit for 2022 is not yet complete, IceCure's final results may vary
from the preliminary estimates.
Medical (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 FDA and approved in Europe with
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: its expected financial results and continued growth; the
expectation that revenues may fluctuate in the near future; the belief that the Company is well funded to continue to execute on expending
the use of cryoablation and delivering better treatment; the Company will continue working with CMS to refine reimbursement codes to
include payment for physicians, enabling greater availability and affordability of ProSense; expecting commercial momentum to continue
to build in 2023; and awaiting the FDA's response to the Company's regulatory requests for clearance for ProSense in early-stage
breast cancer; . 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 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.