EXPERIENCE MAGIC IN ITS TOUCH MAGIC TOUCH

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1 EXPERIENCE MAGIC IN ITS TOUCH MAGIC TOUCH THE WORLD S FIRST SIROLIMUS COATED BALLOON

2 NANOLUTE TM COATING FORMULATION Nanolute Technology - a Nanocarrier based Drug Delivery Technology specifically designed for Drug Coated Balloons (DCB). MECHANISMS OF ACTION + WHAT ARE THE ADVANTAGES? Drug Nano Particle Creation Drug Carrier Nano Particle Creation Effective diffusion into the tissue Avoids non-specific drug distribution is within the body Highly effective means of transfer Can overcome difficult to penetrate barriers and easy penetration into submucosal layer leading to high vessel uptake Nano Carrier Formulation with Nano Sized Drug Particles Dedicated Spray Coating System Increased saturation solubility and increased bioavailability Increased dissolution velocity due to large surface area to volume ratio 1000x 500x E X C I P I E N T O N Helps in decreasing applied dosages Targeted delivery of drug High resolution scanning electron microscopy with Sirolimus Nanocarrier on balloon surface Drug (inside) Excipienton (outside) Drug Coated Balloon 1

3 DEVICE SPECFICATIONS RELEASE MECHANISM Nanolute is a nanocarrier based drug delivery technology developed for medical devices. The Sirolimus nano particles are encapsulated in an excipient and are transferred into the arterial tissue within short duration 60 seconds inflation time. DOSE CARRIER Sirolimus 180ug on 3.00x15 mm 2 (1.27 ug/mm 2 ) Phospholipid Based Excipient PTCA BALLOON % RELEASE FROM BALLOON LOST IN TRANSIT 10 % PRIMARY INFLATION 56% TIME (IN SECONDS) SECONDARY INFLATION 20% RESIDUAL ON BALLOON 14% Magic Touch SCB SIROLIMUS NANO CARRIER

4 PHARMACOKINETIC STUDY OF A NANOCARRIER BASED SIROLIMUS COATED BALLOON (SCB) IN THE RABBIT ILIOFEMORAL ARTERY - CV Path Institute Washington DC, USA CONCEPT MEDICAL INC. A TEMPORAL ASSESSMENT OF DTF LABELED STUDY PERFORMED TO E-EVALUATE NANO CARRIER DISTRIBUTION IN ARTERIAL TISSUE WITH CONFOCAL MICROSCOPY - CV Path Institute Washington DC, USA DAY DAY DAY 7 BLOOD CONCENTRATION TISSUE CONCENTRATION Eurointervention;9(1), , J. Am. Coll. Cardio., 58/20B6 (2011).

5 EFFICACY EVALUATION OF SIROLUMIS COATED BALLOON (SCB) WITH DIFFERENT DOSE COMBINATION OF EXCIPIENT V/S. SIROLIMUS - InCor Institute, São Paulo, Brazil NANOLUTE ISR PATIENT CHARACTERISTICS N=120 VARIABLES n(%) BALLOON CHARACTERISTICS Avg. Balloon/Patient 1.20 Smoking/Tobacco Use 2 (1.67%) Mean Diameter (mm) 2.88±0.40 MEDIAN NIH OBSTRUCTION BY OCT (%) MEDIAN NIH OBSTRUCTION BY HISTOLOGY (%) Diabetes 64 (53.33%) Hypertension 59 (49.17%) Mean Length (mm) 22.44±6.53 LESIONS TREATED N= P= Previous MI 119 (99.17%) Previous PTCA 83 (69.17%) Previous CABG 4 (3.33%) Family History of CAD 8 (7.50%) Stable Angina 9 (7.50%) Unstable Angina 47 (39.17%) LAD 51% RCA 29% LCX 11% OM 6% RAMUS 1% DIAGONAL 1% RENAL ARTERY 1% *MACE - Major Adverse Cardiac Events 10 FOLLOW UP (MONTHS) 1M (N=119) 3M (N=112) 6M (N=64) 12M (N=64) 5 0 MACE (D/TLR/TVR/MI) 1 (0.83%) 2 (1.66%) Death (D) 0.25:1 0.5:1 1:1 1:0 POBA OCT Study showed Sirolimus to excipient ratio of 1:1 provides the best NIH. The evaluation was done with OCT as well as by light microscopy of histology images. 0.25:1 0.5:1 1:1 1:0 POBA 1.RevistaBrasileira de CardiologiaInvasiva, 20(2), , (2012). Target Lesion Revascularization (TLR) Target Vessel Revascularization (TVR) Myocaridal Infarction (MI) 1 (0.83%) 1 (0.83%) 2 (1.66%) 2 (1.66%)

6 ISR CASE TECHNICAL SPECIFICATIONS AGE 58 years /EXCIPIENT Sirolimus BALLOON BALLOON MATERIAL Polyamide Blend SEX INDICATIONS STRATEGY MALE HTN, DM and prior CABG (2 Grafts LIMA-LAD (long arteriotomy CA reconstructed) and SVG to Distal RCA), Stenting in RCA, admitted with new acute inferior STEMI and complete heart block ISR segment treated with Magic Touch (2.50x30mm) DOSE CARRIER 180ug on 3.00 x 15 mm (1.27 ug/mm 2 ) Phospholipid Based Excipient CATHETER DESIGN Rapid Exchange (Rx) Design DELIVERY SYSTEM Shaft Diameter - Proximal 1.7 F Shaft Diameter - Distal 2.5 F Usable Catheter Length 140 cm Tip Profile Nominal Pressure 6 Bar Rated Burst Pressure Guiding Catheter Compatibility Guidewire Compatibility 16 bar (14 bar for 4.00/25 to 40 mm) 5F (inner lumen ) for all sizes max recommended ORDERING INFORMATION PRE - PROCEDURE POST - PROCEDURE 6 MONTH FOLLOW UP RESULTS At the 6 month angiographic follow-up angiography excellent patency of the RCA without any MACE or ST was observed. Dial/Length 1.50 mm 2.00 mm 2.25 mm 2.50 mm 2.75 mm 3.0 mm 3.50 mm 4.00 mm 10 mm CMT15015 CMT20010 CMT22510 CMT25010 CMT27510 CMT30010 CMT35010 CMT mm CMT15010 CMT20015 CMT22515 CMT25015 CMT27515 CMT30015 CMT35015 CMT mm CMT15020 CMT20020 CMT22520 CMT25020 CMT27520 CMT30020 CMT35020 CMT mm CMT15025 CMT20025 CMT22525 CMT25025 CMT27525 CMT30025 CMT35025 CMT mm CMT15030 CMT20030 CMT22530 CMT25030 CMT27530 CMT30030 CMT35030 CMT mm CMT15035 CMT20035 CMT22535 CMT25035 CMT27535 CMT30035 CMT35035 CMT mm CMT15040 CMT20040 CMT22540 CMT25040 CMT27540 CMT30040 CMT35040 CMT40040

7 CONCEPT MEDICAL INC NW 36th Street, Suite 204, Miami, FL USA Concept Medical Research Pvt. Ltd. (Wholly owned subsidiary of Concept medical. Inc) Division-B, 434/2, 1st Floor, Sorathia Compound, Near Navrang Dyeing, Khatodara, Surat (GUJ-INDIA) Tel: Fax: Web: The law permits devices to be sold by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Nanolute and Magic Touch are registered trademarks or trademarks of Concept Medical Inc. in India, USA and other countries. The product and its technology is protected by anyone of US B2, US B2, US B2, US , US South Africa 2011/09416, South Africa 2011/09415, WO , US , WO , WO , WO , Japan, China and other countries. NOT AVAILABLE FOR SALE IN THE UNITED STATES AND CERTAIN OTHER COUNTRIES. CE 1023