EXPERIENCE

MAGIC IN
ITS TOUCH
 SCOPE OF DEB WHY SIROLIMUS ?

• DES – restenosis + COMPARISON OF DRUG

• Very Late Thrombosis
Attribute Limus Paclitaxel
• Long DAPT Therapy
• Small Vessels Mode of Action Cytostatic Cytotoxic
• Bifurcation Lesions
• Acute Myocardial Infarction Margin of Safety 10,000 fold 100 fold
• Diabetes
Anti-restenosis Optimal Good

+ ADVANTAGES OF DEB
Tissue Absorption Easier
More Difficult
• Local drug delivery over a very short period of time and & Elution
retention of drug in vessel.
• Avoids chronic inflammation due to absence of polymers Level of Competition Low Very High
• Better re-endothelialisation : reduced DAPT
Cardiologist Perception Positive Controversial
• No distortion of original vessel anatomy in bifurcation
• No double / triple metal layers in the case of ISR

NANOLUTETM TECHNOLOGY
Concept Medical has developed the world's first • Nano carrier based drug elution technology
Sirolimus drug coated balloon, MagicTouch. It utilises the • Encapsulation technology using bio-compatible excipients
safe and effective Sirolimus drug on the balloon for
• Reduction in particle size creates larger surface area to volume ratio
treatment. Product design involved developing a highly
effective coating which could transfer the drug in the
shortest time frame.
The NANOLUTE T M 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 Drug Carrier Nano
Particle Creation Particle Creation

+ NANOLUTETM TECHNOLOGY PROVIDES

DRUG

• Lower in-transit loss,

• Acute drug transfer, Drug (inside)
Nano Carrier Formulation with Nano sized Drug Particles Excipient (outside)
• Better drug retention, Dedicated Spray Coating System

• Targeted drug delivery,

• Reduction of drug rejection ratio,
• Controlled drug degradation
• Alteration of its pharmaco-kinetics.
Drug Coated Balloon
 PK STUDY OCT STUDY
9.32 140.6 Median NIH Obstruction Median NIH Obstruction
By OCT (%) By Histology (%)
37.9
P=0.03 42.3
7.08 32.2

ng/mg of Arterial Tissue

28.1 28.6 35.1
33.4
ng/ml of Blood

30.2

4.09 20.9
17.3

15.5
5.5
0.81

• • • • • • • • • •
• • • • • • • 0.25:1 0.5:1 1:1 1:0 POBA 0.25:1 0.5:1 1:1 1:0 POBA
0.5 1 3 24 1 8 14
Hour Hour Hours Hours Day Days Days
The evaluation was done with OCT as well as by Histology. The Ratio of 1:1, 0.5:1, 0.25:1,
OCT and Histology Study showed Excipient to Sirolimus Excipient only and POBA were
Sirolimus Blood Concentration Tissue Concentration ratio of 1:1 provides the best reduction NIH. evaluated in the study.

+ PI: DR RENU VIRMANI, + PI: DR PEDRO LEMOS,

CV Path Institute, USA InCOR Institute, Brazil
This study showed Sirolimus drug concentrations of a good quantity with The evaluation was done with OCT as well as by Histology. The OCT
transient balloon inflations at the target site. Concentrations achieved and histology study showed an Excipient:Sirolimus ratio of 1:1
were compared with studies of Sirolimus stents in published literature provides the best reduction of NIH.
COATING
showing longerFORMULATION DEVELOPMENT
drug retention in the target site. II The Ratios of 1:1, 0.5:1, 0.25:1, Excipient only and POBA were also
evaluated in the study.

DTF LABELLED 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.
 CLINICAL STUDY - NANOLUTE: ISR CLINICAL STUDY - NANOLUTE: SMALL VESSEL
BASELINE CHARACTERISTICS BASELINE CHARACTERISTICS

CHARACTERISTICS PATIENTS (N= 156) CHARACTERISTICS PATIENTS (N= 145)

Age, years ± SD 59.61 ± 10.36 Age, years ± SD 58.40 ± 11.35
Male, (%) 80.13 Male, (%) 82.76

CARDIOVASCULAR RISK FACTORS, (%) CARDIOVASCULAR RISK FACTORS, (%)

Diabetes 52.56 Diabetes 42.07
Hypertension 46.79 Hypertension 44.14
Hyperlipidemia 14.74 Hyperlipidemia 04.14
Family history of CAD 05.77 Family history of CAD 09.66

PREVIOUS CV HISTORY, (%) PREVIOUS CV HISTORY, (%)

MI 60.26 MI 15.17
PCI 97.44 PCI 04.83
CABG 07.05 CABG 02.76

CLINICAL PRESENTATION, (%) CLINICAL PRESENTATION, (%)

Stable angina 53.21 Stable angina 46.90
ACS 46.79 ACS 24.83
Non-ST elevation MI 03.85 Non-ST elevation MI 08.28
ST-elevation MI 05.13 ST-elevation MI 18.62
Unstable angina 37.82 Unstable angina 46.90

LESION AND PROCEDURAL CHARACTERISTICS LESION AND PROCEDURAL CHARACTERISTICS

NO. OF LESIONS = 168, NO. OF DEVICES= 191 NO. OF LESIONS = 156, NO. OF DEVICES = 170
TARGET VESSEL, (%) TARGET VESSEL, (%)
Left anterior descending 48.21 Left anterior descending 48.08
Circumflex 22.02 Circumflex 24.36
Ramus 00.60 Ramus 05.77
Right Coronary Artery 27.98 Right Coronary Artery 21.79
Graft 01.19 Graft 00.00

PCI APPROACH PCI APPROACH

Pre-Dilation, % 97.44 Pre-Dilation, % 95.85
DEB alone therapy ,% 93.47 DEB alone therapy, % 93.47
DEB and bare metal stenting, % 06.53 DEB and bare metal stenting, % 06.53
Mean number of DEB per patient 01.19 Mean number of DEB per patient 01.19
Mean diameter of DEB, mm 02.86 ± 0.44 Mean diameter of DEB, mm 02.69 ± 0.46
Total length of DEB (average), mm 21.89 ± 6.71 Total length of DEB (average), mm 21.71 ± 6.80

CLASSIFICATION OF IN-STENT RESTENOSIS, (%)

I (FOCAL) 66.67
II (DIFFUSE- INTRA-STENT) 17.86
III (DIFFUSE- PROLIFERATIVE) 07.74
IV (DIFFUSE- TOTAL OCCLUSION) 07.74

CLINICAL FOLLOW UP CLINICAL FOLLOW UP

Event (%) Event (%)
MACE 6.87 3.64
MACE
TLR/TVR 6.11 TLR/TVR 2.73
MI 0.76 MI 0.91

DEATH 0.00 DEATH 0.00

83.97% patients completed 1 year follow up 75.86% patients completed 1 year follow up
 PRODUCT SPECIFICATIONS
COATING FORMULATION DEVELOPMENT: I
+ LIMUS DRUG DELIVERY
PTCA
BALLOON • 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.
+ BIOCOMPATIBLE CARRIER
• Biocompatible material without any adverse effects is essential.
• Properties required for the carrier are: a robust coating with low washout rates in
MAGICTOUCH
transit; and the avoidance of particulate matter issues.
SCB
+ HIGH IN-TISSUE UPTAKE - LONGER RETENTION
• Faster drug delivery requires a different method of uptake.
DRUG LIMUS
CARRIER DRUG • 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 + ENCAPSULATION

Utilisation of Nano Carrier technology for drug delivery by Encapsulating small sized drug particle to stabilise and assist in
creation of a Core/Shell Structure long term retention of drug in-tissue. Also provides protection to
drug during transit and transfer
+ BIO MIMIC CARRIER COMPONENT
For better compatibility and acceptance in tissue, reducing + BI PHASIC RELEASE
rejection of the drug by tissue Drug release is due to variation in pH of blood or mimicking of lipid
+ SIZE REDUCTION FOR INCREASED UPTAKE + PRO HEALING MATRIX
Reduction of carrier size enables faster transfer into arterial Excipient selected is such that it has pro-healing characteristics
tissue and increases uptake through Vasa Vasorum 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
 TECHNICAL SPECIFICATIONS
DRUG / EXCIPIENT BALLOON

DRUG Sirolimus BALLOON MATERIAL Polamide Blend

180µg on Rapid Exchange

3.00 x 15 mm CATHETER DESIGN
DRUG DOSE (Rx) Design
(1.27 µg/mm2)

Phospholipid
DRUG CARRIER
Based Excipient

DELIVERY SYSTEM

Shaft Diameter - Proximal 1.7 F Rated Burst 16 bar (14 bar for
Pressure 4.00 / 25 to 40 mm)
Shaft Diameter - Distal 2.5 F
Guiding
5F (inner lumen ≥
Usable Catheter Length 140 cm Catheter
0.058") for all sizes
Compatibility
Tip Profile 0.016”
Guidewire 0.014” maximum
Nominal Pressure 6 bar Compatibility 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 CMT15040
2.00 mm CMT20010 CMT20015 CMT20020 CMT20025 CMT20030 CMT20035 CMT20040
2.25 mm CMT22510 CMT22515 CMT22520 CMT22525 CMT22530 CMT22535 CMT22540
2.50 mm CMT25010 CMT25015 CMT25020 CMT25025 CMT25030 CMT25035 CMT25040
2.75 mm CMT27510 CMT27515 CMT27520 CMT27525 CMT27530 CMT27535 CMT27540
3.00 mm CMT30010 CMT30015 CMT30020 CMT30025 CMT30030 CMT30035 CMT30040
3.50 mm CMT35010 CMT35015 CMT35020 CMT35025 CMT35030 CMT35035 CMT35040
4.00 mm CMT40010 CMT40015 CMT40020 CMT40025 CMT40030 CMT40035 CMT40040

CONCEPT MEDICAL
USA OFFICE:
6555 NW 36TH Street, Suite 204 Miami, FL 33166 USA Nanolute and Magic Touch are registered trademarks or trademarks of Concept
INDIA OFFICE: Medical in India, USA and other countries.
Office No. 1-3, Silver Palm II, Opp. Sneh Milan Garden The product and its technology is protected by anyone of US9901662B2,
US8778013B2, US8178379B2, US8529983, US8585642 US20140107615,
Kadampalli, Nanpura, Surat-395001. Gujarat-INDIA WO2011089620, WO2011089618, WO2011086574, Japan, China and other
Email: [email protected] countries.
Web: www.conceptmedicals.com NOT AVAILABLE FOR SALE IN THE UNITED STATES AND CERTAIN OTHER COUNTRIES