Coronary heart disease. S. Sundar Manoharan, Department of Chemistry Indian Inst of Technology Kanpur

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1 Applying Nanotechnology to Coronary heart disease S. Sundar Manoharan, Department of Chemistry Indian Inst of Technology Kanpur

2 Crisis : Ischemic heart disease Manifestations : Angina, Heart attack and Heart failure Existing remedy: Angioplasty

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4 STENT ANGIOPLASTY

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9 900,000 stent procedures done per year in USA alone against 20,000 in India

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11 Drug Paclitaxel Multi- functional Interrupts Restenotic cascade

12 Schematic representation of biodegradable (bioerodible) drug delivery device

13 There are three major components to a drugeluting stent:

14 Type of stent that carries the drug coating Method by which the drug is delivered (eluted) by the coating to the arterial wall (polymeric or other) The drug itself how does it act in the body to prevent restenosis?

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17 THROMBOSIS

18 TWO FOLD Challenges : In-stent Restenosis and Thrombosis Problem addressed by the Industry: Use Drug Eluting Stents(800 USD) instead of Bare Metal Stents(2200 USD), However DES leads to thrombosis and BMS leads to Restenosis.

19 (A) (B) (C) (D)

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21 Image courtesy: JACC 50, S 55(2010)

22 Technology Description Technology is to employ a Nano polymer coating which would avoid the post stenting crisis such as catastrophic complication of acute thrombosis, andinstent restenosis By means of.. State of the art deposition technique for nanocoating Inexpensive, biocompatible and chemically inert material Totally feasible for large scale production & clinical trials

23 The Developed Technology (c) Novelty of this coating (a.u.) I N TE N S I T Y (100) (110 0) (20 00) (2 204) (b) (a) Stent inert Reduce platelet adhesion Prevent acute thrombosis (clotting ) PED Deposited film Novelty of this innovation: Transmittan nce (%) Bulk The material coated is new The process to coat in nm is new The time scale needed for deposition < 2 hours Wavenumber (cm -1 ) Low cost production

24 SEM IMAGE OF UNCOATED SURFACE SEM IMAGE OF COATED SURFACE

25 Coated Co Milling

26 Biocompatibility Nano coated vs bare stent In vitro exposure to human blood

27 Coated stent surface Nanocoated and baremetal stent exposed to platelets Uncoated stent surface

28 Excellent biocompatibility established for Nano coated stents

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30 Stent Market Analysis Global Stent device market is $ 6 Billion 30 (USA 43%) 20 Competition is for bare 10 0 metal stents($ 800) and drug coated stents ($2300) FDA (USA) or CE 2000 (Europe) approval 1500 dictates the clinical trials 60 Global % USA % 0 bare stents drug coated Stent market in $ cost of stents in $ 900,000 stent proceedures done per year in USA alone

31 J & J Medtronics Abbott Boston CeloNova BioSciences, Atlanta

32 Solution and differentiators Important pointers from this Innovation: Prospects for a Third generation Stent involving Nanotechnology Biocompatibility Nano coated vs bare stent were In vitro exposed to human blood Excellent biocompatibility and anti platelet adhesion properties were seen on Nano coated stent surface. Large platelet adhesion seen on Bare metal stents showing high risk for thrombosis. Novelty of this invention Value Proposition Stent inert Global Stent device market is $ 4.2 Billion Reduce platelet adhesion (USA 43%)/per year Competition is for Prevent acute thrombosis clotting bare metal stents($ 800) and drug coated The material coated is new stents ($2300) The process to coat in nm is new Our innovation will provide stents at 800 The time scale needed for deposition USD with anti < 2 hours restentosis and anti thrombosis effect. Low cost production This is the first of its kind from India where a Nano coated stent is developed

33 mont ths FDA & CE Time line for future activities

34 Current Status Currently the company is incubated at the SIDBI center at IIT Kanpur (since Feb 2010) Capital seed fund from MSME IITK. TePP Phase II grant DSIR (committed), Liasoning through FICCI) TDB grant committed by DST( This innovation won the Gold medal for the DST LOCKHEED MARTIN INDIA GROWTH INNOVATION PROGRAM 2009 and was specifically identified for funding by the DST). NDA signed sg with American Cardiovascular ascu a Imaging g company to initiate tate clinical trials at USA laboratories and to raise VC funding for animal studies NDA signed with Opto Circuits for providing Stent platform and for Animal studies to be carried out at Vienna Austria INDIAN PATENT AND PCT FILED i J d J INDIAN PATENT AND PCT FILED in June 2009 and June 2010 respectively

35 Risks IPR issues. International competition (cf: Catania stents reported by Dr Corrado Tamburino (Ferrarotto Hospital, Catania, Italy, April 2009). The next months is crucial in taking the product level l to Clinical i l stage.

36 Out of Intense complexities Intense simplicities emerge. Winston Churchill

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39 After 90 days With Drug Paclitaxel After 90 days Without Drug

40 MOTIVATION: Coronary stent has emerged over the years to be the established platform strategy for interventional procedures performed in all modern day cardiac catheterization laboratories. Unfortunately many of these patients(20 to 40%) develop an exaggerated vascular neointimal proliferation after stenting namely, in stent restenosis. On the other hand, Drug Eluting Stents bring in late stent thrombosis. New generation stents are needed to abolish restenosis and thrombosis without compromising safety.

41 Coated stent surface Nanocoated and baremetal stent exposed to platelets Uncoated stent surface

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