Russ Trenary President & CEO.

Transcription

1 Russ Trenary President & CEO

2 The InnFocus Winning Combination in Glaucoma Lowest IOP in studies IOP data below 14 mmhg with 3 year follow up. FDA requires 2 years max. SIBS material is revolutionary 13 years in cardio, 7 years in the eye Utilizes 50 year proven aqueous drainage pathway The one and only randomized trial against trabeculectomy A unique FDA label will emerge No requirement for cataract removal like most others Larger market than other devices currently being studied We don t need meds to lower IOP and no scleral flap increases safety. Deep R&D pipeline Business model being proven in the market place with more niched products Next round requires only approximately $17-$22MM Insiders poised. 2

3 Building Value / Preserving Cash Potential for an exit exists without excess amounts of new cash; A) Large strategic is already an investor (Hoya Corp, over $10B mkt cap). B) Possible InnFocus will be sold prior to commercialization costs being incurred. C) Modest amount of capital historically consumed enhancing investor returns. D) InnFocus MicroShunt obsoletes Trabs and Alcon ExPress Who will benefit? Regulatory and reimbursement favorable to InnFocus studies. A) Codes already in existence in the US B) May be only company to comply with EU reimbursement requirements. C) Remaining risk is FDA. Trial design plays to FDA desires for randomization to trabs 3

4 InnFocus Goals Provide a safe, effective and easy treatment for early-stage to latestage POAG patients First randomized controlled study against trabeculectomy, the gold standard Implant over 150 patients by over 20 doctors in 7 countries, followed for up to 3 years, by early Leverage the technology to treat Normal Tension and Closed Angle Glaucoma. Encompasses all major glaucoma types in all geographies Conclude C Round in 2015 B round led by a $10 billion value ophthalmic company 4

5 Glaucoma Chronically high intraocular pressure (IOP) > 21 mmhg No significant warning signs Loss of peripheral vision initially Loss of central visual field over time Non-reversible End result is blindness #2 Cause world wide 78MM patients Worldwide 5

6 Global Glaucoma Market: 2 nd leading cause of blindness affecting 78.5 MM patients worldwide Other Glaucomas (WW) 8 MM (10%) Patients with Open-Angle Glaucoma 51.7 MM WW (66%) 3.5 MM in the U.S. Angle-Closure Glaucoma (WW) MM (24%) CAGR for glaucoma surgical devices estimated at 41% for the next 5- years, representing one of the largest growth opportunities in medical devices! Market Scope 2014: Comprehensive Report on the Global Glaucoma Surgical Device Market 6

7 How is glaucoma currently treated? Prescribe 1 st eye drop until it fails Prescribe 2 nd eye drop until it fails Prescribe 3 rd eye drop until it fails Perform 1 st laser procedure until it fails Perform 2 nd laser procedure until it fails Implant a tube shunt or do a trabeculectomy InnFocus MicroShunt can be substituted everywhere above 7

8 InnFocus MicroShunt Benefits; Results, Material, Market Size, and Study Format and Labeling Proven in OUS trials; achieving mean post op IOP below 14 mm Hg, and 80% med reduction. Durable surgical results uniquely not temporary. IOP reduction at 3 months is similar to 3 year results. Revolutionary SIBS material is ultra-stable, won t degrade, has a 13-year proven history on drug eluting coronary stents (TAXUS ); the eye doesn t know this material is in the eye, Dr. Paul Palmberg, MD, PhD. We address the largest patient segment by far - in a large and growing market. Glaucoma is the second leading cause of blindness affecting well over 100 MM eyes worldwide. Our US FDA trial is the only randomization against the gold standard trabeculectomy procedure. 8

9 InnFocus MicroShunt ; Procedural Benefits Short and simple procedure. Uses the time-tested gold standard drainage pathway to achieve low IOP and no scleral flap Successful with or without cataract surgery Safe, with little required follow-up Repeatable in all quadrants 9

10 InnFocus MicroShunt Shape conforms to ocular tissue curvature Does not require a cadaver patch Soft, flexible, compliant, no erosion Atraumatic fins prevent Migration Peri-annular leakage Design prevents chronic hypotony Outer diameter = 350 µm Lumen diameter = 70 µm Length = 8.5 mm 100% SIBS 10

11 Implanting the InnFocus MicroShunt Conjunctiva Tenons

12 Implanting the InnFocus MicroShunt

13 Implanting the InnFocus MicroShunt

14 Implanting the InnFocus MicroShunt

15 Multinational Study Baseline Characteristics (France, Spain, Switzerland, Dominican Republic) Characteristics Both Groups Patients (n=) 79 Age -Years (mean ± sd) 63.1 ± 13.6 (Range 27-83) Mean Visual Field MD ± 11.8 db Phakic/Pseudophakic/Cataract 26/35/18 Baseline IOP (mmhg) (mean ± sd) 23.0 ± 5.6 (Range 15 38) Mean Visual Acuity (Snellen) 20/50 (LP-20/20) Glaucoma Diagnosis 77 POAG, 2 NTG Glaucoma Meds/patient (mean ± sd) 2.8 ± 1.2 (1-5) 15

16 Multinational Study: Change in Intraocular pressure with time (France, Spain, Switzerland, Dominican Republic) 30.0 Intraocular Pressure (mmhg) Pre-Op IOP = 23.0 ± 5.6 mmhg on full meds n= mmhg 11.8 mmhg n=47 n=34 n=23 AGIS zone of no progression of vision loss* n= mmhg Courtesy Juan Batlle, Isabelle Riss, et al. * AGIS. Am J Ophthalmol 2000;130(4): Months Post-Op 16

17 Qualified Success Rate, Change in IOP, and Percent of Patients 18 and 14 mmhg over the 3 Years Studied *Qualified success = (< 21mm Hg result, > 20% decline in IOP, and reduced meds usage) Time N Qualified Success (%)* IOP mmhg Mean Drop in IOP (%) % Patients w/iop 18 mmhg % patients w/iop 14 mmhg Pre-Op 79 N/A 23.0±5.6 N/A N/A N/A Yr % 11.4±3.1 51% 100% 85% Yr % 11.8±3.6 49% 91% 82% Yr % 10.9±3.5 54% 100% 82% 17

18 Change in Glaucoma Medication; Patients off Glaucoma Medication with Time Time N Glaucoma Meds/Patient Reduction in Med use from baseline (%) Patients off Meds (%) Pre-Op ± 1.2 N/A 0% Yr ± % 82% Yr ± % 86% Yr ± % 73% 18

19 Conclusions from Multi-national Studies (France, Spain, Switzerland, Dominican Republic) IOP reduction over 50% from baseline (on full meds) to under 14 mmhg More than 80% of eyes with IOP 14 mmhg 84% reduction in glaucoma meds to 0.5 med/patient Over 70% of patients entirely off eye drops at 3 years No long-term sight-threatening adverse events 19

20 The US IDE Study Design THE ONLY prospective, randomized controlled clinical study MicroShunt with MMC versus Trabeculectomy with MMC Major Inclusion Criteria: Trabeculectomy-stage patients uncontrolled by medication Phakic and pseudophakic (no combined cataract cases) Two Phases with two year follow-up Phase 1 (safety) 75 patients, in progress Phase II Final (safety and effectiveness) Begin in 2015, 439 patients. 20

21 Think Low. The next small thing in glaucoma surgery