Russ Trenary President & CEO

Slides:



Advertisements
Similar presentations
Confidential The Device Development Industry December 4, 2010 North American Neuromodulation Society 14 th Annual Meeting Frank Fischer President and CEO.
Advertisements

Trabeculectomy + MMC Audit Mark Chiang, Clinical Research Fellow Mr. Peter Shah, Consultant Ophthalmic Surgeon Good Hope Hospital.
Company: Aeon Astron Europe B.V. Date: Apr Management of Glaucoma Surgery: Indian Perspective.
Martha J. Morrell MD NeuroPace, Inc.
EX-PRESS® Device in Clinical Practice New York September, 2011 Marlene R. Moster MD Professor of Ophthalmology Thomas Jefferson School of Medicine Wills.
Successful Treatment of Low Back Pain with a Novel Neuromodulation Device Iris Smet, MD 1 Jean-Pierre Van Buyten, MD 1 Adnan Al-Kaisy MB ChB FRCA 2 1 AZ.
Ablation for Paroxysmal Atrial Fibrillation (APAF) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Carlo.
Clinical Trials The Way We Make Progress Against Disease.
Angioplasty’s Fight against Restenosis: Drug Eluting Stents & Bare Metal Stents.
OPEN ANGLE GLAUCOMA Frank J. Weinstock, MD, FACS Professor of Ophthalmology- NEOUCOM Canton, Ohio USA.
9/5/20151 Surgical Therapy in Glaucoma 2014 J. James Thimons, O.D.,FAAO Ophthalmic Consultants of Connecticut Fairfield, CT.
“Paying for clinical trials with an SBIR grant” Our experience obtaining millions of dollars through the NIH's Phase II Competing Renewal program Adapted.
Will my Glaucoma patient lose vision ?
Safe Eye Care James C. Orcutt, MD, PhD National Program Director Ophthalmology.
Clinical Experience With the EX-PRESS ® Glaucoma Filtration Device Thomas W. Samuelson, M.D. Minnesota Eye Consultants Minneapolis EXP11748SK.
RANDOMIZED CLINICAL TRIALS IN GLAUCOMA- WHAT DO THEY TELL US? Dr Jyoti Shetty B.W.Lions superspeciality eye hospital.
TARIQ ALASBALI WHICH PATIENTS ARE AT RISK FOR THE PROGRESSION?
1 Bi o medical Designs Provides Smart Catheter Solutions January 2012.
South Hills Eye Associates
A TOUR OF THE WORLD OF GLAUCOMA SURGERY Dr. Jennifer Fan Gaskin Glaucoma Specialist.
Laser-Ranibizumab-Triamcinolone for DME Study DRCR.net Protocol I
>>0 >>1 >> 2 >> 3 >> 4 >> FULL PANRETINAL PHOTOCOAGULATION IMPROVES THE OUTCOME OF TRABECULECTOMY IN NEOVASCULAR GLAUCOMA Saleh alobeidan MD Essam osman.
The REALITY Study Results. REALITY Study Design The REALITY Study : Prospective randomized clinical trial to evaluate the safety and efficacy of CYPHER®
Enrollment and Outcomes Fan Fan Hou, et al. N Engl J Med 2006;354:
Combined Phacoemulsification and Ahmed Glaucoma Drainage Implant Surgery Leonidas Traipe, M.D. Felipe Valenzuela, M.D. Carlos Nieme, M.D Juan Stoppel,
A Randomized Trial of Peribulbar Triamcinolone Acetonide with and without Focal Photocoagulation for Mild Diabetic Macular Edema: A Pilot Study.
DRUG ELUTION FOR ALL? THE CASE AGAINST Jim McLenachan Yorkshire Heart Centre, Leeds.
Randomized Trial of Dermatome Technique vs
V Dilraj Grewal MD SPS Grewal MD Rajeev Jain, MD G S Brar MD Evaluation of Sub-Conjunctival Bevacizumab as an antiproliferative agent in Glaucoma Filtering.
Combined cataract surgery and endoscopic cyclophotocoagulation in patients with glaucoma without prior incisional glaucoma surgery Matthew P. Traynor,
Alexander J. Brucker, M.D. Protocol Chair
A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients TReated with Endothelial Progenitor Cell CapTuring Stents for De Novo.
1 Slides Shown at FDA Advisory Committee Eyetech Pharmaceuticals Pfizer, Inc. Dermatologic and Ophthalmic Drugs Advisory Committee Meeting 27 August 2004.
Advanced Glaucoma and Cataract: Management Options Regenbogen Michael – Ichilov Amer Radgonde – Hadassah Ron Yonina – Beilinson Reyvitch Svetlana – Barsilai.
Ki-Cheol Chang, MD Department of Ophthalmology, Dankook University Hospital, South Korea Financial disclosure : Author has no commercial associations.
Sponsored by the National Eye Institute,
Efficacy and Safety of the Ex-PRESS Glaucoma Mini-Shunt with Intraoperative 5-Fluorouracil ASCRS 2009 – San Francisco A. Balashanmugam, MD, L. Farrokh-Siar,
Effect of East Asian Race on Selective Laser Trabeculoplasty ASCRS 2011 Minerva Kim Johns Hopkins University Lawrence F. Jindra, MD Columbia University.
DSEK for the treatment of endothelial disease in India -Initial Experience in 80 eyes- Authors have no financial interest Dr Ashish Nagpal MD, FRCS Dr.
Boston Scientific Drug eluting stent program A Scientific Approach Identify therapeutic agent Identify appropriate polymer carrier Evaluate a broad range.
4/3/2016 U F G Universidade Federal de Goiás C B C O Centro Brasileiro de Cirurgia de Olhos A Prospective, Comparative Study Between Endoscopic Cyclophotocoagulation.
Evidence-Based Target Pressures Paul Palmberg, MD, PhD Bascom Palmer Eye Institute University of Miami School of Medicine How to Achieve Low Target Pressures.
The Royal Victorian Eye and Ear Hospital 24-hour eye pressure and glaucoma Dr Simon Skalicky FRANZCO, MPhil, MMed (Ophthal Sci), MBBS (Hons 1) Visiting.
InnFocus MicroShunt™ France & Dominican Republic 2 Year Follow-up Richard K. Parrish, MD 1 Juan Batlle, MD 2 Professor Isabelle Riss 3 Bascom Palmer Eye.
Effect of Previous Argon Laser Trabeculoplasty on Selective Laser Trabeculoplasty ASCRS 2011 Lawrence F. Jindra, MD Columbia University Winthrop University.
D.r Nishant Nawani, MS Dr. Surinder Singh Pandav, MD Dr. Amit Gupta, MD Dr. Sushmita Kaushik, MD Advanced Eye Centre PGIMER, Chandigarh The authors have.
CLASS™ by IOPtima Better & Safer Glaucoma Surgery Are you diagnosed with Glaucoma? Would you like to maintain your sight? Are you tired of applying medications?
(Relates to Chapter 22, “Nursing Management: Visual and Auditory Problems,” in the textbook) Copyright © 2011, 2007 by Mosby, Inc., an affiliate of Elsevier.
Simultaneous Cataract and ECP Glaucoma Surgery An opportunity to improve your vision while reducing or completely eliminating your dependence on Glaucoma.
V. Kumar 1,2, M. Frolov 1, I. Shepelova 1,2 Department of ophthalmology, People's friendship university of Russia, Moscow, Russian Federation 1 ; Ophthalmic.
EFFICACY OF SUBCONJUCTIVAL BEVACIZUMAB ASSOCIATED TO MITOMYCIN-C ON GLAUCOMA FILTERING SURGERY. Juan Carlos Mesa-Gutiérrez, MD, PhD, FEBOphth, FICOphth.
Surgical Outcomes In Children With Primary Childhood Glaucoma
iStent with phacoemulsification, n=50
A Santen company InnFocus mission
The Efficacy and Safety of the Low Intensity Ultrasound Treatment in Patients with Open Angle Glaucoma Hyoung Won Bae, Gong Je Seong, Chan Yun Kim Institute.
IOP control and corneal endothelial cell density changes
These slides highlight a presentation at the Late Breaking Trial Session of the American College of Cardiology 52nd Annual Scientific Sessions in Chicago,
New trends in glaucoma U Faridi 11th November 2016.
Selective laser trabeculoplasty in Korean eyes with medically uncontrolled pseudoexfoliation glaucoma Su Chan Lee1, Jung Hyun Lee1,
Spinal Cord Stimulation (SCS): A proven surgical option for chronic pain Jeffrey M. Epstein, M.D. Babylon, NY.
InnFocus MicroShunt®.
V. Kumar,1,2 M. Frolov,1 E. Bozhok,2 G. Dushina1
Glaucoma Drainage-Device Surgery
Trauma z Surgical treatment of extremely complicated forms of glaucoma
Preoperative Characteristics
Frolov Mikhail, Dushina Galina
Protocol U Short-Term Evaluation of Combination Dexamethasone + Ranibizumab vs. Ranibizumab Alone for Persistent Central-Involved DME Following Anti-VEGF.
Clinical study of open angle glaucoma surgery treatment trough deep slerectomy with T-Flux NV implant: three years follow-up Dr. Marco Rossi Dr Michele.
DW.Lee, NC Cho, MJ Kim, EY Kwen
Japanese Red Cross Society
Presentation transcript:

Russ Trenary President & CEO Caution: Investigational device in the U.S.  Limited by Federal Law to Investigational Use.

InnFocus Update 1) Define the winning formula 2) Clinical results 3) Status of our US IDE

Our Goal Provide a safe, effective, easy to perform, cost effective, alternative for surgical treatment of Glaucoma. Primary Open Angle Glaucoma is our first area of investigation.

Requirements for success A proven drainage path that provides for IOP ≤ 14 mmHg A very inert biomaterial to minimize foreign body reaction A shunt design that will remain patent, prevent chronic hypotony, leakage, or migration An antiproliferative drug to minimize the initial surgical insult

The Winning Key is the SIBS Material There is one stretchy biomaterial that will not provoke scar tissue in the eye Poly(styrene-block-isobutylene-block-styrene) “SIBS” SIBS is ultra-stable and will not degrade in the body No degradation means no chronic inflammation and minimal scar SIBS is used on drug eluting coronary stents (TAXUS) Twelve-year history of use in the body Licensed from BSC for use in the eye

Excellent material but what about shunt design? Make the device thin and soft to conform to the curvature of the eye. Make the lumen sufficiently large to allow cells to pass yet small and long enough to prevent hypotony. Add a fin to prevent migration and leakage around the outside of the tube.

Implanting the InnFocus MicroShunt™ 2.8

Implanting the InnFocus MicroShunt™ 2.8

Implanting the InnFocus MicroShunt™ 2.8

Implanting the InnFocus MicroShunt™ 2.7

Clinical study Baseline Characteristics: Dominican Republic and France 35 POAG eyes All failed maximum tolerated medication Implanted 23 MicroShunts™ only, and 12 combined with cataract surgery Baseline IOP = 23.8 ± 5.3 mmHg Baseline meds per patient = 2.8 ± 1.2

Change in IOP with time for the InnFocus MicroShunt™ Combined data for Dominican Republic and France Baseline IOP = 23.8 ± 5.3 mmHg Average long-term IOP = 11.3 ± 3.2 mmHg AGIS zone for no progression of vision loss Courtesy Dr. Juan Batlle and Dr. Isabelle Riss

Conclusions from Studies in Dominican Republic and France; Data out to 2 Years IOP reduction of 55% from baseline to 11.3 ± 3.2 mmHg 82% of eyes with IOP ≤ 14 mmHg 89% reduction in glaucoma meds to 0.3 med/patient 89% of patients entirely off glaucoma meds Transient hypotony < 5 mmHg after Day 1 = 12% all resolved spontaneously No long-term sight-threatening adverse events No cases of endophthalmitis, chronic hypotony, choroidal hemorrhage Easy to perform and quick alternative to tube or trabeculectomy procedures

Meeting requirements for success in OUS studies? √ A proven drainage path that provides for IOP ≤ 14 mmHg √ A very inert biomaterial to minimize foreign body reaction √ A shunt design that will remain patent, prevent chronic hypotony, leakage, or migration √ An antiproliferative drug to minimize the initial surgical insult

US IDE Study Design Prospective, randomized, controlled, masked, multicenter study Phakic and pseudophakic stratified Two study groups test group is InnFocus MicroShunt™ with MMC control group is trabeculectomy with MMC Two phases with two year follow-up

The Business: Intellectual Property, Regulatory, Financing Issued US Patents 5,741,331 – SIBS for implant applications 7,431,709 – SIBS for use as a drainage tube 7,594,899 – Any tube from AC, w/wo MMC 7,837,644 – SIBS as drainage tube, w/wo MMC Others pending Regulatory CE Mark received January 2012 FDA clearance and initiation of phase I implants Q3, 2013 Financing $10 million from Boston Scientific Corporation, plus $22 million from Hoya, Saints Capital Everest and Angels 2.4

Board of Directors and Management Jean-Luc Boulnois, Ph.D. Scott Halsted Randy Lindholm Leonard Pinchuk, Ph.D. John Sheets, Ph.D. Russ Trenary Russ Trenary President & CEO Leonard Pinchuk, Ph.D. Founder, CSO Bruce A. Weber, MBA V.P., Reg., Clinical. and QA Yasushi P. Kato, Ph.D. V.P. R&D John B. Martin Jr. Chief Engineer, Co-founder

Thank you