PowerPoint Presentation One Person Out of Ten Will Suffer from CARPAL TUNNEL SYNDROME They will need a surgery, Usually on both sides 25% UNSATISFACTORY OUTCOME 31 DAYS AVERAGE SICK LEAVE JOB CHANGE...

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PowerPoint Presentation One Person Out of Ten Will Suffer from CARPAL TUNNEL SYNDROME They will need a surgery, Usually on both sides 25% UNSATISFACTORY OUTCOME 31 DAYS AVERAGE SICK LEAVE JOB CHANGE 10-15% (USA) ENDOSCOPY : STILL AN INCISION, MORE DANGEROUS SPIRECUT’S BREAKTHROUGH SAFE SURGERY, NO SURGICAL INCISION, NO DRESSING NO SCAR, IMMEDIATE RETURN TO DAILY ACTIVITIES USP : SINGLE-USE STERILE SURGICAL INSTRUMENT IN KIT, PROPOSED MARKET ENTRY PRICE 300 CHF (GM 81%) CLASS II-A MEDICAL DEVICE IN EUROPE, I IN USA No single case of tendon, nerve nor vessel injury Bilateral surgery when indicated Very satisfied patients Average duration 14 min (half) 600 PERCUTANEOUS OPERATIONS USING MVP Proof of Concept OTHER INDICATIONS Competitors 8,4M 446M 328M ≈ 1.7 M 1’402 M POPULATION NR/YEAR Market Size Users : surgeons, radiologists, rheumatologists Total available market (excluding China) : 877 MCHF Customers : hospitals and clinics 25 000 ≈ 1.9 M ? Trop d’éléments 10 Roadmap Intellectual Property European patent in 2018 Patent for instruments and surgical technique (USA) Freedom to operate report Additional features : ongoing new patent and protection of design and trademark Achievements Technical Certification Notified body pre-audit (2K) - done Adaptation of QMS based on remarks of auditor (5K), European representation (8K), – May 2021 Verification of prototypes (10K) –End 2021 Industrialization, sterilization and validation (450K) – End 2021, begin 2022 Finalization of technical documentation and risk analysis (20K) – Begin 2022 Audit of critical suppliers (10K) – End 2021 Clinical investigation (400K) – Dec 2021-March 2022 Clinical investigation report – April 2022 Notified body audit (25K) – June 2022 CE-marking – June 2022 Adaptation of QMS to FDA (10K) – May-Nov 2021 FDA listing (10K) – End 2021 Achievements Reimbursement policies Publications Identification of KOL’s Preparation of market launch, first in Switzerland COUNTRYREIMBURSEMENT POLICIES (CAPAL TUNNEL OPERATION) SwitzerlandTARMED system, different in each Canton, rate for carpal tunnel and sonography. Sono-Instrument in the hospitalization fee (1395 CHF) or possibly charged to the patient with the material. BelgiumReimbursement needs authorization of CRIDMI of the INAMI/RIZIV, if not has to be covered by the hospital in the flat rate for day hospitalization. FranceNUB quick reimbursement pathway for new technologies, if not case-based fee system (G-DRG) with individual negotiations with each hospital. GermanyLPP list, if nor: to be covered by the hospital or clinic, if over, PLV charged to the patient. United KingdomTotal reimbursement: £2.590 (hospital costs including medical devices and fees.) Specific reimbursement possible through Healthcare Groups of NHS United StatesMedicare reimbursement if FDA approval, defined benefit category and code. If not, Sono-instruments to be charged to the facility fee ($796/operation) Finances BREAKEVEN IN 2025, THEN PROFITABLE IN 2021 : 1,024MCHF IN EQUITY FROM PRIVATE INVESTORS FRÉDÉRIC SCHUIND Founder and CEO, Professor of Surgery & Orthopaedics, Brussels FABIAN MOUNGONDO Inventor, Professor of Orthopaedics, Brussels LOÏC VOILLAT Head of Software Development CLÉMENCE HERMANN Business Development Manager EDMOND SULA R&D & Quality Assurance Direction, Team & Advisors BOARD OF DIRECTORS Five members including two independent directors ADVISORY BOARD Experienced representatives of shareholders SCIENTIFIC COMMITTEE Inventor + KOL’s 16
Nov 25, 2021
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