Investor Presentaiton

10 Clinical Validation Over 150,000 procedures performed in 60 countries since 2015 Launch ORIGINAL STUDY dent Outcomes Following Micropulse Transscle Cyclophotocoagulation: Intermediate-term Results Aleksandr Yelenskiy, MD Thomas B. Gillette, MD,* Analisa Arosemena, MD† Augustus G. Stern, MD Winston J. Garris MD.§ Curt T. Young MD|| Michelle Hoyt OD† Nancy Worley, BS* David Zurakowski MS PhD and Ramesh S. Ayyala, MD, FRCS# ment outcomes of micropulse transscleral ophotocoagulation in advanced glaucoma arah Kuchar Marlene R. Moster Courtney B. Reamer Michael Waixbourd' ORIGINAL STUDY icropulse Cyclophotocoagulation: Initial Resu in Refractory Glaucoma Matthew E. Emanuel, MD Davinder S. Grover, MD, MPH* Ronald L. Fellman, MD, David G. Godfrey, MD,* Oluwatosin Smith, MD,* Michelle R. Butler, MD Hal Kornmann, MD, PhD.* William J. Few val, MBBS Clinical & Experimental nalmology Toyos and Toyo DO OMI al Outcomes of Micropulsed Transcleral Cyclophotocoagulation in erate to Severe Glaucoma aM Toyos' and Rolando Toyos C, 2204 Cremor Road USA following blindne TSCPC) prove aque either to inc hun bort, multicenter (10 who underwent 2017 Terent les Purpose: To report the safety and efficacy o micropile transcleral cyclophotocoagulation dure in patients with uncontrolled glaucoma. Materials and Methods: Longitudinal retrospective study. Patients with different types of glaucon MPTSCPC with P3 probe between Aly 2015 and were treated by different glucoma specialists from (Tulane Study Group). Data on preoperative cha procedures) performed, and postoperative outcomes analyzed. Statistical analysis using logistic regression a analysis was performed with Stata software. Intraoper operative complications, incedar pressure, visual acum incisional glaucoma surgery, need for repeat micropals, and topical medications were studied isties, s one of the leading causes of irreversible orldwide. Glaucoma therapies are designed the outflow or decrease the inflow of in order to decrease intraocular pressure nde residual optic nerve function. Cyclo- coagula (CPC) is a form of glaucoma treatment infrared wavelength of 810 mm to target the melanin in themented ciliary body epithelium and thereby g a laser destruct the production photoco collected an plan-Meier and post od for POM Results Ox hundred ninety-seven eyes from 161 patients were included. Median follow-up was 12 months interquartile range (IQR), 6 to 14 Glama diagnosis included 141 primary open-angle glaucoma. OAG) 8 neovaser goms, and 12 others. The total success rate 71% Two percent (4 patients) developed postoperative cystoid lar edema. Preoperative mean intraocular pressure (SD) was 19 6mm Hg at last followup (P001) Median preoperative visual acuity (IQR) was 84 (0.2 1.0) and 0.3 (02 to 1.0 up ( 0.65, Wilson signed-rank test). Median number cal medications was 341 to 4) preoperative and 2 (1 to 3pat Fc000 Kaplan-Meier analysis indicated 90% of repeat MPTSCPC at 12 months Multivariable ntified 3 significant independent predictors of total OLD) (POAGI pevious glaucoma surgery rent procedures (P-0013 al cohort study has provided evi rally effective option in the ary body; this results in decreased aqueous hence IOP Traditional transscleral cyclo- on using continuous wave diode has been refractory glaucoma cases with poor visual due to the risk of phthisis, hypotony, visual deteri n, and unpredictability. The increased risk is ought to be largely from the nonselective nature of the traditional continuous wave diode laser.3,10 A new method of TCP has been described that uses a micropulse diode laser [micropulse transscleral cyclo photocoagulation (MPTSCPC)) and trans pars plana tre ment with a contact probe, which is thought to be more and at least equally effective as traditional diode laser more selective targeting of tissues. The micropul has been previously used for retinal procedures starting to be used in CPC. This methot delivery is advantageous because it deliver repetitive and brief pulses of laser energy periods, in contrast to traditional cont that deliver continuous intense body, 19 This method of laser produce more selective targ and less collateral dam allow energy Roccisod: 21 July 2015/Accepted: 11 Decembe 5/Published en Deco Springer-Verlag London 2015 Abstract Glaucoma is the leading cat ness worldwide. The goal of this st experience with the novel micropulse coagulation (MP-TSCPC; IRIDEX CA) in patients with advanced glauco vanced glaucoma who underwent MP-T of imeve e blind- was to cribe of sclerallophoto $10 Lasc in our study. Laser settings were 2000 mW ystems, Patients PC were inc diode laser set on micropulse delivery mod 10mm infrared delivered over 360° for 100-240 s. The duty Jaser was 31.3 %, which translated to 0.5 ms of "on time" and of "off time." Surgical success was defined as an intraocular ressure (IOP) of 6-21 mmHg, or a reduction of IOP by 20% he last follow-up visit. Failure was defined as an inability to the criteria for success or a need for incisional glaucoma Nineteen patients underwent MP-TSCPC with mean of 603 days. Mean IOP dropped from 37.9 mmHg ly to 22.7 mmHg at last follow-up, representing a c. The success rate for initial treatment was ree patients underwent a second treatment, necess rate to 89.5 % (n-17k Four ision, and four patients lost one Claser had a high rate of in patients with woods Trans cral cyclophotocoagulation Glaucoma Micro se diode er MP3 laser surgery duction, Glaucoma, world leading cause of irreversible blindness in the Glaucoma therapies are designed to either in- outflow or decrease the production of aqueous hu- mor in order to reduce intraocular pressure (IOP) and preserve visual function. Traditional transscleral cyclophotocoagula- tion (TSCPC) is a cyclodestructive procedure that uses con tinuous diode laser to target the ciliary body in order to redu the production of aqueous humor. Traditional TSCPC m associated with serious complications including uveitis loss, chronic hypotony, and rarely phthisis bulbi an thetic ophthalmia [3-7]. Due to the risks of serice tions, TSCPC is typically reserved for the tre tory glaucoma or palliation of painful ey prognosis [8]. There has been debate direct correlation between the ar the rate of complication higher energy lend evaluate the ac of micropole transscleral cyclophotocoagon (MP-TSCPC), a new and increasingly popular treatment patients with uncon trolled glaucoma Purpose: The purpose of this study is Methods A retrospective chart revic was performed patients who underwent a MP-TSCPC of Texas. e Glaucoma, th MP T F ths. The were 27.7 mm as used was 33 e lowered to ImmHg. Results: A total of 84 eyes were treated study with a mean follow-up time of 43 treated patients was 74 years and 48 ( operatively, mean intraocular pressure (101 mean number of ocular antihypertensive med Mean postoperative IOP at months 1.3, 6. and 163mm Hg (41.2% reduction), 146, 13.0, an respectively. Postoperative ocular antihypertensive m was also lowered to 1.9, 20, 2.0, and 23 medications at mo.. 6, and 12. respectively. Five patients required further laser or ical intervention for adequate 1OP control. Complications ded hypotory, IOP spike, hyphema, serous choroidal ment, persistent inflammation, and vision loss. At 3 months, ation was still present in 46% of eyes and vision loss of at was present in 41% off eyes. MP-TSCPC is effective at lowering IOP and decreas racular antihypertensive medications Eyes with tential or at high risk for incisional glaucoma ly be treated with MP-TSCPC as a reason- ative to traditional CPC. These results both longer follow-up and further evelophotocoagulation, potenti and patients who are not good lidates, nsscleral cyclophotocoagulation ommon he continuous delivery of diode PC used to reduce IOP. TSCPC DP throu the cilia on. Studies effect t of TSCPC body, thereby decreasing aque- ve demonstrated that the IOP. correlated with number of laser ots applied. However his efficacy must be balanced ith the potential complions of TSCPC, as some studies Tave shown that the r of complications increases with higher energies. Co cations associated with TSCPC include prolonged ocular inflammation, pain, intra- ocular hemorrhay aypotony, phthisis bulbi, decreased vision, and rampathetic ophthalmia. The severity of these corations are felt to be secondary to the col ge surrounding tissues, including the ciliary stroma nonpigmented epithelium, and ciliary body Micropulse TSCPC (MP-TSCPC; IRIDEX, CYC G6 Glaucoma Laser System, Mountain View, CA) of variation of traditional TSCPC to treat glaucoma this system, short bursts of energy (on-cycle) delive to the targeted tissue, with the energy bursts building up to a photocoagulative state in th epithelium. At the same time, during " rounding tissue is allowed to cool and photocoagulative threshold, thereby, ing damage to surrounding tissu Previous studies, though follow-up, have demon effective and safe responding author: Mel Toys, TC, 2204 [email protected] Received date: Oder 24, 2016 Accepted date: Copyright: 2016 Tayon M, et al. This is an open sse, distribution, and reproduction in any medium, Abstract Purpose: The purpose continuous wave diode la glaucomatosevere. Methods: Twenty-six 37215, USA. TH 615-327-4015 Fax 615-327-4089; E-ma 06, 2016, Published date: December 12, artele debuted under the lens of the Creative mes Attribution License, which permits unrestricted ed the original author and source are credited. this study is in a clinicall of center Results were revie recommended treatment gues veness of a open angle Vents were treated by ingl прест w micropulsed transcleral coma, ranging from mild a single private practice epr MP3 setting according to Results: At baseline, patien ce on an average of 3.3 topicall glaucoma cations with an average IOP of 25.6 mmHg. At POD1 IOP was nedby 20%, by 3-4% at PO07, 8% at P and decreased 30% from baseline at the final postop visit 6-12 months the procedure. Average meuse decreased from 3.3 to 1.8 from baseline to final post op vist. There were sadverse event Conclusion: Micropulsed transceral diode laser is a safe and effective alterative for glaucoma therapy for patients with open angle glaucoma. Patients can expect significant IOP lowering along with reduction in number of topical glaucoma medications required for IOP controll Transcleral Glaucoma cyclophotocoagulation: de laser MP3 laser Sion people suffer from glaucoma globally. анке f blindness worldwide. Current edications, laser therapies, micro- glaucoma surgery. Most of aqueous humor while alloncing the heat to dissipate between pulses, pr efficacy while preventing umeanted inflammation, hypotony. The time between the pulses is called the time [3]. Pulsing or fractionating laser has also I treatments of CSCR. AMD and macular edeny in CO lasers used for cosmetic CCMEXTOLasering, USA, San Ramon Yon-cam, Israel)), SmartXxide, DF There are a few SAFE 70+ posters and presentations show low adverse event occurrence EFFECTIVE 19 peer-reviewed papers demonstrate sustained IOP reduction of 30-45% in 60-85% of patients DURABLE 500+ eyes in studies demonstrating durability greater than 12 months VERSATILE 2,500+ eyes studied in a wide spectrum of glaucomal types and stages IRIDEX