CAESAREA, Israel, Jan. 4, 2023 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) (“IceCure” or the “Firm”), developer of minimally-invasive cryoablation know-how, the ProSense® System that destroys tumors by freezing, immediately launched the next letter to shareholders from its Chief Govt Officer, Eyal Shamir.
In 2022, we constructed a robust basis for the street forward. IceCure is creating the brand new customary in tumor remedy, freezing tumors of their tracks by means of a minimally invasive outpatient process that does not disrupt lives and goals to eradicate recurrence. We have reported strong information in breast and kidney most cancers this 12 months with investigator-initiated research in a number of different indications ongoing. All through 2022, we have delivered on said objectives by bolstering present buyer relationships, growing new partnerships, and innovating the subsequent era of our cryoablation know-how.
2022 Key Achievements
- Fortified Stability Sheet: Below very difficult market situations, we efficiently closed a $14.5 million fairness financing priced ‘on the market’ below Nasdaq guidelines and with out warrants. A number of of our long-term institutional shareholders participated within the transaction. We imagine that our capacity to execute this type of fundraise within the present market is a testomony to traders’ confidence in our know-how, market technique, and administration staff. With the online proceeds of this financing plus our money stability of $14.2 million as of the tip of the third quarter 2022, we imagine we’re properly funded to proceed to execute on the worldwide rollout of ProSense throughout a broad variety of indications.
- Submitted for Regulatory Approvals: We achieved a number of important milestones with submission for regulatory approvals in Canada, Vietnam, and our submitting of a De Novo classification request with the U.S. Meals and Drug Administration (“FDA”) for Advertising Authorization of our ProSense System with Breakthrough Indication for early-stage, low-risk, breast most cancers sufferers at excessive threat to surgical procedure representing an estimated $80 million annual addressable market within the U.S.
- Obtained Regulatory Approval: Our cryoprobes and introducers obtained regulatory approval in Brazil, a key step in the direction of opening the most important market in Latin America.
- Achieved Reimbursement Milestone within the U.S.: Our U.S. commercialization efforts made a significant transfer ahead with respect to insurance coverage reimbursement once we obtained the task of a $3,400 CPT Class III code from the Facilities for Medicare & Medicaid Providers (“CMS“) for breast most cancers cryoablation procedures for facility charges.
- Continued to Execute on International Industrial Rollout: In China, we entered into an unique distribution settlement with Shanghai Medtronic Zhikang Medical Gadgets Co. Ltd., an affiliate of Medtronic plc (NYSE:MDT) and Beijing Turing Medical Know-how Co. Ltd. ProSense has been put in at quite a few new websites in 2022, about half of which had been within the U.S., with others in Europe and Southeast Asia. We’re extremely inspired by the rising utilization throughout these websites and websites that had been put in beforehand.
- Medical Information Offered & Revealed: In probably the most up-to-date interim information out there from our ICE3 research, there have been six circumstances of ipsilateral breast tumor recurrence (“IBTR“) out of 194 sufferers, or 3.09%. Interim evaluation from our ICESECRET research discovered that ProSense was secure and efficient in treating kidney tumos with an 89.5% recurrence-free fee. Moreover, ProSense for breast most cancers was featured in a poster presentation on the Radiological Society of North America’s Annual Assembly. Two articles that includes ProSense had been revealed in medical journals; one article revealed in Cancers studied the feasibility and security of ProSense for kidney, bone, liver, lung, and comfortable tissue and the opposite article from Clinics in Oncology studied using liquid nitrogen based mostly cryoablation with ProSense within the remedy of metastatic lung most cancers.
- Raised ProSense’s Visibility Worldwide: We had been extraordinarily lively exhibiting and conducting dwell ProSense webinars and demos at medical conferences worldwide together with the Society of Interventional Radiology Annual Scientific Assembly and the European Convention on Interventional Oncology. We launched our breast most cancers cryoablation consciousness marketing campaign #FreezeCancerNotYourLife throughout Breast Most cancers Consciousness Month. Elevating consciousness among the many affected person inhabitants and educating clinicians will drive demand for our ProSense procedures.
- We await the FDA’s response to our regulatory submitting, which included efficacy and security information, for early-stage, low-risk, breast most cancers sufferers at excessive threat to surgical procedure. Concurrent with potential regulatory clearance, we are going to proceed work with CMS to refine reimbursement codes to allow larger availability and affordability of the ProSense System for breast most cancers.
- Forward of potential FDA clearance, we’re rising commercialization efforts within the U.S. with a give attention to breast most cancers to deal with the preliminary indication market of 43,000 girls within the U.S. yearly.
- In Europe, we are also rising our give attention to breast most cancers and plan to conduct research in cooperation with our distributors and healthcare suppliers to gather scientific information and help commercialization. We imagine that the regulatory atmosphere in Europe presents our liquid nitrogen-based cryoablation system clear technological and market benefits and we are going to search to leverage these advantages within the coming 12 months.
- Globally, we count on continued business rollout, regulatory filings, and approvals. As we proceed discussions with potential distribution companions in new territories, we’re working intently with our present strategic companions Shanghai Medtronic Zhikang Medical Gadgets Co. Ltd. in Mainland China, Terumo Company in Japan and Thailand, and quite a few others all through Europe, Asia, and the Americas to make ProSense procedures extensively out there throughout quite a few indications.
- We’re additionally persevering with to discover cooperations with numerous strategic gamers within the trade to optimize the business improvement and rollout of our ProSense know-how.
With many accomplishments achieved this previous 12 months, IceCure seems ahead to a shiny and thrilling future in 2023. Keep tuned! We want you all a wholesome and affluent new 12 months.
Eyal Shamir, CEO
About IceCure Medical Ltd.
IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, a sophisticated liquid-nitrogen-based cryoablation remedy for the remedy of tumors (benign and cancerous) by freezing, with the first focus areas being breast, kidney, bone and lung most cancers. Its minimally invasive know-how is a secure and efficient various to hospital surgical tumor removing that’s simply carried out in a comparatively quick process. The system is marketed and offered worldwide for the indications cleared to-date by the FDA and authorised in Europe with the CE Mark.
Ahead Wanting Statements
This press launch comprises forward-looking statements throughout the which means of the “secure harbor” provisions of the Non-public Securities Litigation Reform Act of 1995 and different Federal securities legal guidelines and Israeli securitieis legal guidelines. Phrases akin to “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and related expressions or variations of such phrases are supposed to establish forward-looking statements. For instance, IceCure is utilizing ahead wanting statements on this press launch when it discusses its goals for 2023, together with: anticipating the FDA’s response to regulatory requests for approvals; additional research and cooperation efforts with distributors and healthcare suppliers to gather scientific information and commercialization; the continued business rollout; the assumption that the Firm is properly funded; regulatory filings and approvals for ProSense and different merchandise; its perception that elevating consciousness amongst sufferers and clinicians of the advantages of minimally invasive cryoablation will drive demand for its ProSense procedures; and its exploration of collaborations with strategic gamers within the trade. As a result of such statements take care of future occasions and are based mostly on IceCure’s present expectations, they’re topic to varied dangers and uncertainties and precise outcomes, efficiency, or achievements of IceCure might differ materially from these described in or implied by the statements on this press launch. The forward-looking statements contained or implied on this press launch are topic to different dangers and uncertainties, a lot of that are past the management of the Firm, together with these set forth within the Threat Elements part of the Firm’s Annual Report on Type 20-F for the 12 months ended December 31, 2021 filed with the Securities Change Fee (the “SEC”) on April 1, 2022, as amended, which is on the market on the SEC’s web site, www.sec.gov. The Firm undertakes no obligation to replace these statements for revisions or modifications after the date of this launch, besides as required by regulation.
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