IceCure Medical Ltd. · NASDAQ:ICCM
IceCure Medical — Investor Presentation (April 2023)
28 slides from IceCure Medical's investor presentation, April 2023
Slide 1: Freezing cancer in its tracks
Freezing cancer in its tracks IceCure Medical enabling non‐surgical, treatment of cancerous tumors Corporate Presentation | April 2023 (NASDAQ & TASE: ICCM) icecure-medical.com Nasdaq & TASE: ICCM
Slide 2: Forward Looking Statement
Forward Looking Statement Disclaimer: IMPORTANT: The following applies to this document, the oral presentation of the information in this document by IceCure Medical Ltd. (the “Company”, “we” or “us”) and any question-and- answer session that will follow the oral presentation (collectively, the “Pre
Slide 3: Introducing ProSense Non-surgical Next-Generation Cryoablation Technology
Introducing ProSense® Non-surgical Next-Generation Cryoablation Technology Cryoablation is a minimally invasive image guided (US or CT) treatment that uses extreme cold to freeze and accurately destroy diseased tissue within the tumor zone IceCure’s flagship product ProSense® cryoablates tumors quic
Slide 4: Company Highlights
Company Highlights Regulatory approval in 15* Wide market applications ICE3 Breast Cancer Trial countries including EU, Growing number of $2.4 B tumor ablation market in US for FDA approval in treating China & US FDA Clearance; global distribution by 2028 † early-stage breast tumors Filed FDA De Nov
Slide 5: Market Opportunities
Market Opportunities Tumor Ablation US Cryoablation Tumor Ablation Market Expected To Reach Breast Tumors $2.4 Billion in 2028† • Targeting ~288K new invasive breast cancer patients estimated in 2022* • 10% of female pop. est. to have fibroadenomas** $2.4B (CAGR) Potential driven by non/minimal Brea
Slide 6: Regulatory approvals worldwide
Regulatory approvals worldwide FDA Approval for general CE Approval for benign or Rest of World Approvals: minimally-invasive cryoablation malignant tissue of: Israel, Singapore, Hong Kong, India, Breast, Lung, Musculoskeletal Thailand, Australia, South Africa for applications, specific indications
Slide 7: ProSense is Superior to Competing Thermal Ablation Technologies
ProSense® is Superior to Competing Thermal Ablation Technologies Cryoablation Thermal Ablation IceCure ProSense® (Radiofrequency & Microwave) Pain Minimal to no pain* Very painful Anesthesia Local High amount to general Excellent contour under Visualization Limited visualization Ultrasound & CT Accu
Slide 8: ProSense - Advanced Cryoablation Technology
ProSense® - Advanced Cryoablation Technology Superior Liquid Nitrogen (LN2) technology for optimal tumor destruction* 40 Rapid cooling Temperature (ºc) 20 IceCure system 0 Argon system Lower and more -20 Other LN2 systems stable temperatures -40 -60 Larger lethal zone -80 -100 LN2 less expensive -12
Slide 9: Breast Tumor Market Activities
Breast Tumor Market Activities Nasdaq & TASE: ICCM 9
Slide 10: Challenges in Breast Cancer Surgery (Lumpectomy)
Challenges in Breast Cancer Surgery (Lumpectomy) • Cost • Cosmetic outcome • 14% - 20% of patients undergo re-excision after lumpectomy due to unclear margins* • Recovery time • Use of operating rooms places an additional strain on hospital resources * https://link.springer.com/article/10.1245/s1043
Slide 11: ProSense - Value for All
ProSense® - Value for All Patient Physician Insurer Healthcare Provider LN2* - Maximum Efficacy Easy to Use, In-office Lower Reimbursement Patient Demand Drives Procedure Expense Vs. Surgery Reimbursement Non-surgical Low Risk, Safe Procedure In-Office Procedure Faster, In-Office Pro
Slide 12: Unique Value Proposition ICE3: Landmark U.S. Breast Cancer Trial
Unique Value Proposition ICE3: Landmark U.S. Breast Cancer Trial Largest USA controlled multicenter clinical trial ever performed for LN2 based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative to surgery “Cryoablation potentially represents a dramatic improvemen
Slide 13: ICE3: U.S. Breast Cancer Trial Interim Analysis
ICE3: U.S. Breast Cancer Trial Interim Analysis Submitted to FDA 194 19 82 Patients Eligible Hospitals Patients Followed For 5 Years Patients (Incl. Columbia University Medical Center and Mount Sinai Beth Israel) 96.91% 100% 100% 100% Results Recurrence free Safe procedure Doctor satisfaction Patien
Slide 14: U.S. Clinical Market Analysis of Invasive Breast Cancer
U.S. Clinical Market Analysis of Invasive Breast Cancer – 2022 • According to the American Cancer Society, 287,850 new cases there are a total 340K* breast cancer patients of invasive breast cancer each year • 287,850 are invasive breast cancer* 143,875 Luminal A • Luminal-A is the most common subty
Slide 15: Breast Cancer & Benign Tumors - U.S. Strategy
Breast Cancer & Benign Tumors - U.S. Strategy Regulatory Strategy FDA clearance for general minimally-invasive cryoablation applications & for fibroadenoma (benign breast tumors) cryoablation FDA granted ProSense® Breakthrough Devices Designation* for proposed indications, including for use in t
Slide 16: Breast Cancer - US Healthcare Economics & Reimbursement
Breast Cancer – US Healthcare Economics & Reimbursement Healthcare Economics Reimbursement $ Cryoablation costs less than IceCure's application to Centers for Medicare & Medicaid Services (CMS) is the standard-of-care lumpectomy first and only Medicare coverage approval of cryoablation procedure
Slide 17: Breast Cancer - China Strategy
Breast Cancer - China Strategy Regulatory Approval Console and disposable probes approved by the National Medical Products Administration (NMPA) in China and in Hong Kong for Shanghai Medtronic benign or malignant tissue of the breast, lung, musculoskeletal Zhikang Medical Devices Co. Ltd (bone),
Slide 18: Breast Cancer - Japan Terumo Agreement
Breast Cancer - Japan Terumo Agreement Exclusive strategic distribution agreement with Terumo to accelerate commercialization of ProSense® in Japan and Thailand For >6 years ProSense® has been sold through a Private Import License—now leveraging agreement with Terumo to expand distribution and acqui
Slide 19: Fibroadenomas
FIBROADENOMAS Nasdaq & TASE: ICCM 19
Slide 20: ProSense: Becoming the Standard in Fibroadenoma Therapy
ProSense®: Becoming the Standard in Fibroadenoma Therapy Treating 60 patients fibroadenomas who underwent successfully office-based since treatment clinical trials reported: began in 2012 (ProSense® cryoablation treatment under ultrasound guidance) Minimally invasive, in-office Lesions tended to alt
Slide 21: Interventional Radiology
Interventional Radiology Kidney Lung Bone Liver Cancer Cancer Cancer Cancer Nasdaq Nasdaq & TASE: & TASE: ICCM ICCM 21
Slide 22: Interventional Radiology: Expanding Product Line
Interventional Radiology: Expanding Product Line Over 500,000 new people each year are diagnosed with kidney, lung, liver and prostate cancer in the U.S. alone >2.5M new cases of lung 488K new cases of kidney Pain care for bone cancer cancer globally by 2025* cancer globally by 2025* metastasis • Ja
Slide 23: Interventional Radiology - USA Strategy
Interventional Radiology - USA Strategy Regulatory Strategy FDA approval for general minimally-invasive cryoablation applications FDA approval for kidney and liver as of Dec 2019 FDA granted ProSense® Breakthrough Devices Designation for proposed indications, including for use in the treatment
Slide 24: Business Model – Revenue Generators
Business Model – Revenue Generators Console and consumable probe business model Direct sales and via distributors Direct sales to hospitals, clinics and doctor offices Reselling to distributors Used as a mobile device in different hospitals, clinics, doctor offices in Europe Console related re
Slide 25: Well-Financed to Advance Commercialization of ProSense
Well-Financed to Advance Commercialization of ProSense®® 2021: Raised $32M (gross) in private placement and Nasdaq offering led by three institutional investors as well as the Share Price (04/05/23) $1.11 controlling shareholder of IceCure. Market Cap (04/05/23) $51 M Shares Outstanding (12/31/22) 4
Slide 26: Global Presence of IceCure Technology
Global Presence of IceCure Technology NETHERLANDS POLAND HUNGARY GERMANY ROMANIA FRANCE SPAIN ITALY UNITED STATES JAPAN TURKEY CHINA ISRAEL INDIA TAIWAN HONG KONG COSTA RICA THAILAND SINGAPORE BRAZIL SOUTH AFRICA AUSTRALIA Nasdaq & TASE: ICCM 26
Slide 27: Proven Leadership Team
Proven Leadership Team Ron Mayron, Chairman of the Board Shay Levav, VP Clinical, Regulatory & QA Served for 20 years in several positions at Nearly 20 years’ experience in regulatory and quality Teva including as VP – Israel & Africa & assurance in the healthcare sector CEO of Teva Israel Eyal Sham
Slide 28: ProSense Freezing Cancer In Its Tracks
ProSense® Freezing Cancer In Its Tracks THANK YOU EYAL Shamir – CEO E: eyals@icecure-medical.com Ronen Tsimerman – CFO/COO E: ronent@icecure-medical.com T: +972-4-623-0333 Nasdaq & TASE: ICCM 28