anterior segment company showcase - z lens
TRANSCRIPT
Zonular Capture Haptic
Accommodating-Disaccommodating IOL with Zonular Capture HapticsOIS, Chicago, October 13th 2016
Eppur si muovePaul Beer MDZ Lens LLC Founder & CEO
1
ManagementDr. Paul Beer (inventor)28 years as retinal surgeonProfessor of Ophthalmology at Albany Medical Center Founder, former President of the Retina Research FoundationMerit and Senior Honor Awards from the American Society of Retinal Specialists & AAOPI in >25 multicenter clinical trials in vitroretinal therapiesPI in multiple ISTs
Edward EvelethMultiple start-upsFounded Cyclics CorporationPurchased patents to unique plastic from GERaised over $40M in equityBuilt plant in GermanyMBA, Cornell University
The Teams:Rob Stupplebeen9+ years experience IOL and contact lens engineering 6 yrs at Bausch + LombConsulted for 5 IOL CosMEng, Cornell University
Wisconsin Primate CenterDept. of Ophthalmol, UW-Madison
Paul Kaufman MD Mary Ann Croft MAGreg Heatley MDJarred McDonald
Learner Research Institute-Biomedical Engineering
Animal ExperimentsDesignPrototypingAdvisors
Tom DunlapTom McNicholas
Overview
Validation:Rhesus monkey animal studies (9 eyes, > 1 yr.) show results beating competitionProduct:Accommodating Intraocular LensProtection:2 foundational patentsSize:$500MM+ current market - $1B anticipatedFinancing:NSF Phase I, Phase IB and Phase II SBIR; NIH Phase I STTR, NEI high program relevanceApplication:Cataract patients
Our goal:To replicate the movement of the natural lens
Our achievement:We did it!We made the best single rigid optic accommodating IOL-preclinical-
AD-IOL with ZCH Concept
Manufactured primate size AD-IOL (Rhesus monkey 9mm )
Optics certified by Photon gear Inc., 245 david parkway, Ontario, NY 14514
Successfully captures & responds to zonular forces
YAG laser activation & radial capsular sectioning
Titration of radial capsular sectioning
7
Results:Eppur si mouve!
And yet it moves and moves and moves
8
Physiologic level of accommodation via stimulation of EW electrode
9
Physiologic level of accommodation via stimulation of EW electrode
10
Physiologic level of accommodation via stimulation of EW electrode1 year post implantation
11
Crystalline Lens vs. AD-IOL
Anterior Lens face shifts: 0.48mmAnterior Optic face shifts: 0.47mmPhysiologic level of accommodation via stimulation of EW electrode
Physiologic level of accommodation via stimulation of EW electrodeAxial shift Ant. Lens face: 0.59mm
Axial shift Ant. Optic face: 0.80mm
Crystalline Lens vs. AD-IOL
13
Results in briefAxial shift Optic: 0.8mm Flexion haptics: ~ 20 degrees
Biometricly Predicted Accommodation: 1D/1mm of axial shift
Observed accommodation: ~2D/0.5-8mm (1-3D EW, 4D Carb)-objective=Hartinger Refractor-meets FDA label requirements*
14
Movement amplitude and dynamics match movement of natural young lens
15
Zonular Capture Haptics =Enabling technologyMovement captured=Movement transformedShape shifting optic provides more accommodation
Driven by a haptic structure that works
Dual Mode AD-IOL= shape & axial shifting
Small, simple, easy to make optic vesicle
Small & simple fluid filled optic vesicle gets thicker during accommodationDual Mode AD-IOLpatent pending
Dual Mode AD-IOLpatent pending
Current prototype will be ready for animal testing Q1 2017
Dual Mode AD-IOLpatent pendingFEA: lens in cross section
IP Protection
Accommodation methodU.S. Patent No. 9,220,590 "ACCOMMODATIVE INTRAOCULAR LENS AND METHOD OF IMPROVING ACCOMMODATION"
Dissaccommodation MethodU.S. Patent No. 9,364,318 B2"ACCOMMODATIVE-DISACCOMODATIVE INTRAOCULAR LENS
Devices:Divisional applications covering all device concepts and device in useProvisional Application covering Dual Mode IOL
Finacial Strategy1. Finish development of prototypes
2. Round A -2 MM to take Dual Mode AD-IOL to human trial
3. Explore Industry Partnership
Axial Shift AD-IOLDual Mode AD-IOLHuman trials of best designBuild and test prototype
SummaryNovel, powerful IOL conceptsMajor Milestones achievedExpert team with proven successPatent protectionMassive opportunity 500MM marketDr. Paul M. BeerZ Lens [email protected] captured the movement!
Eppur si muove