Dr. Brendan Boland CEO Co-founder CONTACT:

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Judith Davidson
6 years ago
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1 Dr. Brendan Boland CEO Co-founder CONTACT:

CLINICAL PROBLEM Thumb base arthritis SOME FACTS: Unmet clinical need

the body affected by arthritis Pain on daily activities Approx.

Americas, and Australasia WHO IS AFFECTED: Most common in those aged

3 CLINICAL PROBLEM Thumb base arthritis SOME FACTS: Unmet clinical need identified through BioInnovate Fellowship Third most common joint in the body affected by arthritis Pain on daily activities Approx. 20 million affected - in the US alone 117 million across Europe, Americas, and Australasia WHO IS AFFECTED: Most common in those aged over 65 Up to 30% prevalence in women over 55 5% of general population have severe symptoms

4 MARKET OPPORTUNITY Thumb base arthritis SOME FIGURES: Up to 230,000 surgical procedures per year in the US and EU combined $600 million per year addressable surgical market US and EU combined Target market population growing: Those over 65 will make up 19% of the US population in next 15 years Thumb base arthritis more prevalent than hip arthritis Under-penetrated market

5 CURRENT TREATMENT SOLUTIONS Thumb base arthritis NON-SURGICAL OPTIONS Physio, splinting, activity modification SURGICAL OPTIONS Removal of trapezium bone hand strength loss Ligament rebalancing with removal of trapezium bone 12% persistent pain Joint fusion decreased function and persistent pain in up to 25% Joint implant current implants associated with failure rates up to 40% ALL CURRENTLY SUB-OPTIMAL FOR BOTH PATIENTS AND CLINICIANS

mimicking the motions of the native joint This avoids all failure

6 OUR SOLUTION FROM The device is the only device to provide two points of motion, that can act independently and concurrently, thereby exactly mimicking the motions of the native joint This avoids all failure mechanisms of any previous device and a better functional outcome than any other surgery.

7 OUR EVIDENCE-BASED SOLUTION

enable visualisation of both points of articulation VOICE OF Prof.

8 OUR SOLUTION FROM 8 consecutive successful pre-clinical Implantations Optimal test model used human Note a radiolucent stem is used here to enable visualisation of both points of articulation VOICE OF Prof. FILIP STOCKMANS PROFESSOR OF ORTHOPAEDIC HAND SURGERY KU LEUVEN UNIVERSITY BELGIUM

9 US COMPETITOR IMPLANTS ALL 510(k) NUGRIP PYROCARBON from STABLYX DEVICE from MODULAR THUMB IMPLANT from MINI TIGHTROPE CMC from UP TO 40% FAILURE RATE NO CLINICAL DATA THE TECHNIQUE MAY NOT BE MASTERED EASILY NO BETTER THAN TRAPEZIECTOMY ALONE

10 SOLUTION ADOPTION FACTORS Maintains trapezium bone Fully mimics natural motions of the joint Simple fast procedure Short recovery time Options to bail-out not a treatment cul-de-sac High reimbursement value Podium speaking KOLs design and use

11 TEAM CO FOUNDERS Dr. BRENDAN BOLAND CEO BMEDSC MB BCH BAO MRCPI MICGP BIOINNOVATION Mr. GERRY CLARK CTO BSC MBA MSC BIOINNOVATION Dr. ANTON CLIFFORD BUSINESS DEVELOPMENT ADVISOR INTERNATIONAL KOL CLINICAL ADVISORY PANEL Dr. AMY LADD CHIEF OF HAND SURGERY STANFORD UNIVERSITY, US Dr. PETER WEISS PROF. OF HAND SURGERY BROWN UNIVERSITY, US Dr. FILIP STOCKMANS PROF. OF HAND SURGERY KU LEUVEN, BELGIUM

12 INTELLECTUAL PROPERTY Our patent has now been filed. PCT and US patents filed Core IP for platform of applications

13 REIMBURSEMENT AND SALES Thumb base arthroplasty is a fully reimbursed procedure with no need for any new codes Code Arthroplasty with prosthetic replacement; trapezium 2016 Medicare Base Payment Rate Hospital outpatient - $ Medicare Payment Rate Ambulatory Surgical Centre - $

14 REGULATORY STRATEGY Our patent has now been filed. US 510(k) with the FDA Two separate independent regulatory strategy opinions concur. EU Class IIb my opinion that the NUIG InDx device will be regulated by the US FDA as a Class II medical device HASTINGS CONSULTING

15 Validated unmet clinical need Clear regulatory pathway 510(k) Existing reimbursement pathway Unique biomechanical solution Underpenetrated market with positive market drivers Endorsement & design support of highest level KOLs Rapidly growing market Outstanding commercial opportunity IP filed with clear landscape $600 million addressable market

16 CONTACT:

Integra. Thumb Joint Replacement PATIENT INFORMATION. with PyroCarbon implants

Integra. Thumb Joint Replacement PATIENT INFORMATION. with PyroCarbon implants Integra Thumb Joint Replacement with PyroCarbon implants PATIENT INFORMATION Anatomy of the Hand The hand is composed of many different bones, muscles and ligaments that allow for a large amount of movement