A New Treatment Paradigm Outside-In
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- Suzan Watkins
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2 A New Treatment Paradigm Outside-In Mercator MedSystems OneMedForum Jan 8, 2013
3 Outside-In Response: Signal Amplification Signal convection Signal amplification Modified from Michel 2007, ATVB Mercator MedSystems OneMedForum Jan 8, 2013
4 Mercator s Proprietary Adventitial Delivery Platform Creates a natural drug-eluting reservoir with a single injection Observed diffusion volume and tissue dependent* 1.5 ml in cephalic vein (arm) - 4 cm 0.3 ml in coronary artery - 5 cm 1.5 ml in carotid artery -10 cm 3 ml in femoral artery -15 cm *Research Conducted by John Karanian PhD, USFDA Mercator MedSystems OneMedForum Jan 8, 2013
5 Microneedle: 130-micron diameter, 0.9 mm length Mercator MedSystems OneMedForum Jan 8, 2013
6 PAD: The Post-PTA Inflammatory Cascade Dexamethasone Knocks Out Restenosis Signals Balloon injury or vessel trauma Hours Adventitial inflammation Cytokine expression (CRP, MCP-1, TNFα, IL-10, etc) Endothelial damage DEX Targets Days Weeks Months Cellular recruitment (neutrophils, macrophages, etc.) Cellular proliferation (adventitial fibroblasts, smooth muscle cells, etc.) Cellular migration (neointima, restenosis, occlusion) CRP, MCP-1, TNFα Endothelial healing Further inflammation is prevented Mercator MedSystems OneMedForum Jan 8, 2013
7 Peripheral Artery Disease (PAD) Focusing on Effectiveness in Treatment Gaps 1 million PAD angioplasties per year in U.S. Mercator 12% restenosis at 6 months is better than paclitaxel coated balloon trials (17-28% reported rates) Popliteal and below Critical need - high rates of restenosis continue CLI incentivizes physician to rapidly adopt promising therapies Early data supports clinical expansion Mercator MedSystems OneMedForum Jan 8, 2013
8 DANCE Trial Results Comparison to Benchmarks Mercator MedSystems OneMedForum Jan 8, 2013
9 Global Registry Mercator MedSystems OneMedForum Jan 8, 2013
10 Adventitial Therapy Pipeline Renal Denervation Interventional Pulmonology Regenerative Medicine Mercator MedSystems OneMedForum Jan 8, 2013
11 Adventitial Renal Denervation for Resistant Hypertension Mercator nerve signal by 58% vs. Ardian 41% at 28 days in pigs Mercator has a pain-free, transradial approach Mercator addresses 28% of the market that cannot be treated with heat-based (RF or ultrasound) catheters Mercator MedSystems OneMedForum Jan 8, 2013
12 Broncho-Adventitial Chemotherapy for Malignant Airway Obstruction Direct Paclitaxel Delivery Non-small cell lung cancer (NSCLC) causing obstruction of a main bronchus Mercator MedSystems OneMedForum Jan 8, 2013
13 Interventional Pulmonology Markets Disease Prevalence # of U.S. Patients Malignant Airway Obstruction COPD (Emphysema and Chronic Bronchitis) Annual U.S. Healthcare Expenditure 0.017% >53,750 patients >$360 million 5.1% 16.0M patients $32 billion Asthma 8.2% 25.7M patients $18 billion Cystic Fibrosis % 30,000 patients $1.2 billion Tuberculosis % 11,182 patients $752 million Mercator MedSystems OneMedForum Jan 8, 2013
14 Regenerative Medicine AMI Regenerative Medicine: >$10B Worldwide Market Athersys AMI Preclinical: Stem cells delivered with Cricket home to ischemic region AMI Phase I Clinical Trial (19 pts): >25% in LVEF over baseline at 4 months 20% in LVEF over baseline at 12 months Phase 2 trial planned Autologous Stem Cells Adipose and bone marrow derived stem cells are predicted to have benefit with local delivery Mercator MedSystems OneMedForum Jan 8, 2013
15 Mercator s Adventitial Delivery System A Revolution in Therapeutic Applications Catheters 510(k) Clearance CE Mark Disease Specific Therapeutics Commercially available Clinical Investigations Provide Supporting Data to Drive Sales Drug Resistant Hypertension Therapy PAD occlusion Cardiac Cell Therapy Airway Disease Therapy Mercator MedSystems OneMedForum Jan 8, 2013
16 Patent Protection 15 Issued Patents (12 U.S., 3 foreign) Device (2027) Methods of use (2027) Methods to diagnose adventitial injection with contrast (2026) 2 Allowed Patents (U.S.) Broad methods for pharmaceutical renal denervation for hypertension treatment (2030) >20 Pending Patents (U.S. and foreign) Mercator MedSystems Confidential All Rights Reserved 1/18/13
17 Capitalization Summary Invested to-date: $11.9M NIH and other grants to-date: $2.0M Revenues to-date: $1.1M 2013 Series B: $4.4M Anticipated NIH grant: $2.1M Mercator MedSystems OneMedForum Jan 8, 2013
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