A GAME CHANGER IN ENDOSCOPIC ULTRASOUND GUIDED BIOPSY BETTER BIOPSIES TO ADVANCE PRECISION MEDICINE AUTUMN 2020 ASSAF KLEIN, CEO
DISCLAIMER IMPORTANT NOTICE This presentation includes certain statements and of an offer to buy, the C ompany’s securities in any This presentation has been prepared by Limaca estimates provided by the company with respect to jurisdiction. Neither this presentation nor anything Medical Ltd. (the “ C ompany”) solely for the projected future performance of the Company. in it shall form the basis of any contract or informational purposes. The information contained such statements, estimates and projections reflect commitment. Prospective investors should not herein has been prepared to assist prospective various assumptions by management concerning construe the contents of this presentation as investors in making their own evaluation of the possible anticipated results, which assumptions may business, legal, tax, investment or other advice. Company and does not purport to be complete or or may not be correct. No representations are made Each prospective investor should make his, her or to contain all of the information a prospective or as to the accuracy of such statements, estimates or its own inquiries and consult his, her or its own existing investor may desire. in all cases, interested projections. This presentation may contain advisors as to the appropriateness and desirability parties should conduct their own investigation and statements that are not historical facts, referred to of an investment in the Company and as to analysis of the company and the data set forth in as “forward looking statements.” The C ompany’s business, legal, tax and related matters concerning this information. The Company has prepared this actual future results may differ materially from an investment in the company. presentation based on information available to it, those suggested by such statements. No assurance including information derived from public sources can be given that future events will occur or that An investment in the Company shall be allowed that have not been independently verified. The projections will be achieved. Past performance is only to such number and category of investors in Company makes no representation or warranty as not a reliable indication of future performance. This accordance with applicable laws and regulations to the accuracy or completeness of this information presentation is not, and nothing in it should be and pursuant to a predetermined process. and shall not have any liability for any construed as, an offer, invitation or Accordingly, detailed information in connection representations (expressed or implied) regarding recommendation in respect of the C ompany’s with the investment shall be revealed and delivered information contained in, or for any errors securities, or an offer to sell, or a solicitation only to a limited number of qualifying investors as omissions in, this presentation. provided by law.
LIMACA ’ S PRECISION ™: EUS BIOPSY GAME CHANGER IMPROVES DIAGNOSIS AND PROGNOSIS WHILE ADVANCING MORE PRECISION PATIENT-SPECIFIC TREATMENTS Automated, Improves Obtains larger Enables procedure electro-mechanical diagnostic accuracy samples with higher with 1/10 number quality core tissue of typical stabs revolving needle
PRECISI ON™: A LEAP CHANGE IN EUS BiOPSY Manual 2-4 Passes with Time Poor Echo Imprecise User Dependent 30-50 Stabs Consuming Visualization Poor Quality Standard Frequently Insufficient ofCare Samples Excellent Quality Precision Meets All Diagnostic by Limaca Testing Requirements Automated One Pass and Shorter Excellent Echo Precise Not User 2-3 Stabs only Procedure Visualization Dependent
Over $1 BILLION MARKET OPPORTUNITY FOR LIMACA ’ S PRECISION EUS BIOPSY PLATFORM # OF RELEVANT MARKET PROCEDURES 850,000 Pancreatic 225,000 Liver 200,000 Lung TOTAL 1.275 million Source: EUS Needles Market - Global Industry Analysis and Forecast, 2017 to 2025 by Transparency Market Research (TMR) Global Liver Biopsy System Market 2020 to 2026 by 2020 Global Info Research (GIR)
CANCER TREATMENT MOVING TOWARDS PRECISION MEDICINE Precision Treatment: Matches patient with the best available treatment Genetic Profiling: Analyzing each cancer DNA to define the genomic defect Genetic Profiling requires high quality tissue sample EVOLVING REQUIREMENTS OF PRECISION MEDICINE REQUIRES SIGNIFICANT IMPROVEMENTS IN ENDOSCOPIC ULTRASOUND GUIDED BIOPSY
1,000,000 biopsies performed annually 10% 9% Genetic Testing CAGR 5-years Every tumor is different, requiring survival rate genetic profiling diagnosis 1 ST INDICATION: PANCREATIC 25% CANCER Recent studies suggests that 460,000 1 of every 4 pancreatic cancer new cases patients will benefit significantly of pancreatic cancer from precision treatment. have been reported Many more bio-markers and globally in 2018 personalized therapies in pipeline PANCREATIC CANCER SAMPLES ARE INADEQUATE FOR GENETIC PROFILING WITH ABOUT 50% SUCCESS RATE ONLY
FIRST-IN-HUMAN CLINICAL STUDY Enrolling in To date: Next stage: 10 patients enrolled validate superiority two leading centers for genetic profiling in israel out of 32 Safety & usability is excellent with 10X fewer stabs. Comparing Precision Precision acquired large intact white cores to existing manual EUS biopsy device in comparison to mainly diced bloody biopsy samples with existing manual EUS biopsy devices IYAD KHAMAYSI MD Using L imaca’s Precision in first-in-human trial at RAMBAM Medical Centre, Haifa
HISTOPATHOLOGY QUALITY RESULTS SharkCore Precision Sample acquired 10X more stabs with only three stabs Non- structural, diced tissue Contiguous and intact sample Adequate for cytology at the cellular level only Adequate for cytology and histopathology
REGULATORY AND IP IP REGULATORY Endoscopic Biopsy Device: National Phase FDA Class II, CE Class IIa, Reimbursement 510(k) pathway, submission will codes in place no clinical follow clinical study Tissue Penetrator: study required Provisional application (confirmed by FDA)
EXPERIENCED TEAM Precision’s impact on endoscopic biopsy will play out similarly to what was seen in the past decade with breast biopsy IYAD KHAMAYSI MD ASSAF KLEIN CARL RICKENBAUGH procedures shifting FOUNDER & MED. DIRECTOR CEO CHAIRMAN OF THE BOARD from basic manual 20 years’ experience in medical Director, Invasive Endoscopy President, First Keel Consulting; cutting tools toward device companies; managerial Unit, Department of current Board Member of electromechanical and R&D positions in the fields Gastroenterology and Paragonix Technologies; former devices specifically of gastroenterology spine and Hepatology, Rambam Health executive M&A Head of Bard cardiovascular; projects include Care, Israel; Clinical Assistant Peripheral Vascular & Biopsy (13 tailored to optimize implantable devices and Professor, Faculty of Medicine, years), and M&A Head at EQT biopsy delivery systems; Technion Institute of Technology; Private Equity Company Clinical former CEO, MediValve; MBA, research expertise in clinical and Innovations (successfully exited Bar-Ilan University; B.Sc., experimental endoscopy, to Patricia AB company Laborie mechanical engineering, pancreatic cancer, experimental Medical in 2020); leadership in Technion Institute of models of pancreatitis and sales, marketing and product Technology, Israel. rheology of pancreatic cysts. development at Abbott Laboratories (13 years).
FUNDRAISING $ Round A Round B SAFE EQUITY 1 2 3 Precision Clinical Validation Commercialization Post Marketing Clinical Studies V&V Production scale-up FDA 510(k) Clearance ISO and CE Approvals Lung Version Design Freeze
THE NEXT GENERATION IN ENDOSCOPIC ULTRASOUND GUIDED BIOPSY BETTER BIOPSIES TO ADVANCE PRECISION MEDICINE ASSAF@LIMACA-MEDICAL.COM
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