EXPERIENCE MAGIC IN ITS TOUCH

Transcription

1 EXPERIENCE MAGIC IN ITS TOUCH

2 SCOPE OF DEB WHY SIROLIMUS? DES restenosis + COMPARISON OF Very Late Thrombosis Long DAPT Therapy Attribute Limus Paclitaxel Small Vessels Bifurcation Lesions Acute Myocardial Infarction Mode of Action Margin of Safety Cytostatic 10,000 fold Cytotoxic 100 fold Diabetes Anti-restenosis Optimal Good + ADVANTAGES OF DEB Local drug delivery over a very short period of time and retention of drug in vessel. Tissue Absorption & Elution More Difficult Easier Avoids chronic inflammation due to absence of polymers Better re-endothelialisation : reduced DAPT No distortion of original vessel anatomy in bifurcation Level of Competition Cardiologist Perception Low Positive Very High Controversial No double / triple metal layers in the case of ISR TM NANOLUTE TECHNOLOGY Concept Medical has developed the world's first Sirolimus drug coated balloon, MagicTouch. It utilises the safe and effective Sirolimus drug on the balloon for treatment. Product design involved developing a highly effective coating which could transfer the drug in the shortest time frame. Nano carrier based drug elution technology Encapsulation technology using bio-compatible excipients Reduction in particle size creates larger surface area to volume ratio T M The NANOLUTE coating design is used on the MagicTouch drug coated balloon. Studies conducted confirm satisfactory transfer of the drug and a suitable 14 day retention within the arterial tissue. Drug Nano Particle Creation Drug Carrier Nano Particle Creation TM + NANOLUTE TECHNOLOGY PROVIDES Lower in-transit loss, Acute drug transfer, Better drug retention, Targeted drug delivery, Reduction of drug rejection ratio, Controlled drug degradation Alteration of its pharmaco-kinetics. Nano Carrier Formulation with Nano sized Drug Particles Dedicated Spray Coating System Drug Coated Balloon Drug (inside) Excipient (outside)

3 PK STUDY OCT STUDY Median NIH Obstruction By OCT (%) Median NIH Obstruction By Histology (%) 37.9 ng/ml of Blood ng/mg of Arterial Tissue P= Hour 1 Hour 3 Hours 24 Hours Sirolimus Blood Concentration 1 Day 8 Days 14 Days Tissue Concentration 0.25:1 0.5:1 1:1 1:0 POBA The evaluation was done with OCT as well as by Histology. OCT and Histology Study showed Excipient to Sirolimus ratio of 1:1 provides the best reduction NIH. 0.25:1 0.5:1 1:1 1:0 The Ratio of 1:1, 0.5:1, 0.25:1, Excipient only and POBA were evaluated in the study. POBA + PI: DR RENU VIRMANI, CV Path Institute, USA This study showed Sirolimus drug concentrations of a good quantity with transient balloon inflations at the target site. Concentrations achieved were compared with studies of Sirolimus stents in published literature showing COATING longer FORMULATION drug retention in the target DEVELOPMENT site. II DTF LABELLED STUDY + PI: DR PEDRO LEMOS, InCOR Institute, Brazil The evaluation was done with OCT as well as by Histology. The OCT and histology study showed an Excipient:Sirolimus ratio of 1:1 provides the best reduction of NIH. The Ratios of 1:1, 0.5:1, 0.25:1, Excipient only and POBA were also evaluated in the study. Day 1 Day 3 Day 7 + PI: DR RENU VIRMANI, CV Path Institute, USA Study with DTF labelled Sirolimus drug was done to study the drug distribution following DCB treatment. The study showed good drug presence at 1, 3 and 7 days. The drug retention and travel was demonstrated with medium to low concentrations observed up to the adventitial layer at 7 days indicating in tissue travel of the drug.

4 CLINICAL STUDY - NANOLUTE: ISR BASELINE CHARACTERISTICS CHARACTERISTICS PATIENTS (N= 156) Age, years ± SD ± Male, (%) CARDIOVASCULAR RISK FACTORS, (%) Diabetes Hypertension Hyperlipidemia Family history of CAD PREVIOUS CV HISTORY, (%) MI PCI CABG CLINICAL PRESENTATION, (%) Stable angina ACS Non-ST elevation MI ST-elevation MI Unstable angina LESION AND PROCEDURAL CHARACTERISTICS NO. OF LESIONS = 168, NO. OF DEVICES= 191 TARGET VESSEL, (%) Left anterior descending Circumflex Ramus Right Coronary Artery Graft PCI APPROACH Pre-Dilation, % DEB alone therapy,% DEB and bare metal stenting, % Mean number of DEB per patient Mean diameter of DEB, mm ± 0.44 Total length of DEB (average), mm ± 6.71 CLINICAL STUDY - NANOLUTE: SMALL VESSEL BASELINE CHARACTERISTICS CHARACTERISTICS PATIENTS (N= 145) Age, years ± SD ± Male, (%) CARDIOVASCULAR RISK FACTORS, (%) Diabetes Hypertension Hyperlipidemia Family history of CAD PREVIOUS CV HISTORY, (%) MI PCI CABG CLINICAL PRESENTATION, (%) Stable angina ACS Non-ST elevation MI ST-elevation MI Unstable angina LESION AND PROCEDURAL CHARACTERISTICS NO. OF LESIONS = 156, NO. OF DEVICES = 170 TARGET VESSEL, (%) Left anterior descending Circumflex Ramus Right Coronary Artery Graft PCI APPROACH Pre-Dilation, % DEB alone therapy, % DEB and bare metal stenting, % Mean number of DEB per patient Mean diameter of DEB, mm ± 0.46 Total length of DEB (average), mm ± 6.80 CLASSIFICATION OF IN-STENT RESTENOSIS, (%) I (FOCAL) II (DIFFUSE- INTRA-STENT) III (DIFFUSE- PROLIFERATIVE) IV (DIFFUSE- TOTAL OCCLUSION) CLINICAL FOLLOW UP CLINICAL FOLLOW UP MACE Event (%) 6.87 MACE Event (%) 3.64 TLR/TVR 6.11 TLR/TVR 2.73 MI 0.76 MI 0.91 DEATH % patients completed 1 year follow up DEATH % patients completed 1 year follow up

5 PRODUCT SPECIFICATIONS COATING FORMULATION DEVELOPMENT: I PTCA BALLOON + LIMUS DELIVERY Less Lipophilic drug but preferred choice for CAD Very difficult to coat without a polymeric carrier Slow drug uptake and hence longer time required at site. CARRIER MAGICTOUCH SCB LIMUS + BIOCOMPATIBLE CARRIER Biocompatible material without any adverse effects is essential. Properties required for the carrier are: a robust coating with low washout rates in transit; and the avoidance of particulate matter issues. + HIGH IN-TISSUE UPTAKE - LONGER RETENTION Faster drug delivery requires a different method of uptake. Surface deposition does not work with Sirolimus formulations. Different methods of drug delivery with special characteristics are required for retention and residence of drug in tissue. COATING FORMULATION DEVELOPMENT: II + PRINICIPLES OF NANO TECHNOLOGY Utilisation of Nano Carrier technology for drug delivery by creation of a Core/Shell Structure + BIO MIMIC CARRIER COMPON ENT For better compatibility and acceptance in tissue, reducing rejection of the drug by tissue + SIZE REDUCTION FOR INCREASED UPTAKE Reduction of carrier size enables faster transfer into arterial tissue and increases uptake through Vasa Vasorum + ENCAPSULATION Encapsulating small sized drug particle to stabilise and assist in long term retention of drug in-tissue. Also provides protection to drug during transit and transfer + BI PHASIC RELEASE Drug release is due to variation in ph of blood or mimicking of lipid + PRO HEALING MATRIX Excipient selected is such that it has pro-healing characteristics and assists in the endothelialisation process. + ADVANTAGES Uniform coating surface Reduced in-transit loss of drug Increased bio-availability of drug Better bio-compatibility of drug Encapsulation enhances drug retention Faster uptake of drug in tissue on delivery Drug released on dissolution of nano carrier Programmable drug release from surface of device

6 TECHNICAL SPECIFICATIONS / EXCIPIENT BALLOON Sirolimus BALLOON MATERIAL Polamide Blend DOSE 180µg on 3.00 x 15 mm 2 (1.27 µg/mm ) CATHETER DESIGN Rapid Exchange (Rx) Design CARRIER Phospholipid Based Excipient DELIVERY SYSTEM Shaft Diameter - Proximal Shaft Diameter - Distal Usable Catheter Length Tip Profile Nominal Pressure 1.7 F 2.5 F 140 cm bar Rated Burst Pressure Guiding Catheter Compatibility Guidewire Compatibility 16 bar (14 bar for 4.00 / 25 to 40 mm) 5F (inner lumen 0.058") for all sizes maximum recommended ORDERING INFORMATION Dia/Length 10 mm 15 mm 20 mm 25 mm 30 mm 35 mm 40 mm 1.50 mm CMT15010 CMT15015 CMT15020 CMT15025 CMT15030 CMT15035 CMT mm CMT20010 CMT20015 CMT20020 CMT20025 CMT20030 CMT20035 CMT mm CMT22510 CMT22515 CMT22520 CMT22525 CMT22530 CMT22535 CMT mm CMT25010 CMT25015 CMT25020 CMT25025 CMT25030 CMT25035 CMT mm CMT27510 CMT27515 CMT27520 CMT27525 CMT27530 CMT27535 CMT mm CMT30010 CMT30015 CMT30020 CMT30025 CMT30030 CMT30035 CMT mm CMT35010 CMT35015 CMT35020 CMT35025 CMT35030 CMT35035 CMT mm CMT40010 CMT40015 CMT40020 CMT40025 CMT40030 CMT40035 CMT40040 CONCEPT MEDICAL USA OFFICE: TH 6555 NW 36 Street, Suite 204 Miami, FL USA INDIA OFFICE: Office No. 1-3, Silver Palm II, Opp. Sneh Milan Garden Kadampalli, Nanpura, Surat Gujarat-INDIA contact@conceptmedicals.com Web: Nanolute and Magic Touch are registered trademarks or trademarks of Concept Medical in India, USA and other countries. The product and its technology is protected by anyone of US B2, US B2, US B2, US , US US , WO , WO , WO , Japan, China and other countries. NOT AVAILABLE FOR SALE IN THE UNITED STATES AND CERTAIN OTHER COUNTRIES