CANALOPLASTY. RESTORATIVE GLAUCOMA SURGERY. ABiC™ is a new ab-interno MIGS procedure that can comprehensively restore the natural outflow pathways for your glaucoma patients.

Minimally Invasive & Maximally Effective.ABiC™ may finally be the answer we have

been waiting for – a MIGS procedure that

flushes out the natural outflow channels,

without damaging tissue, and without

leaving behind a stent or shunt. A truly

comprehensive MIGS, ABiC™ accesses,

catheterizes, and viscodilates the

trabecular meshwork, Schlemm’s canal,

and the distal outflow system, beginning

with the collector channels.

RESTORING THE NATURAL OUTFLOW PATHWAYS

Canaloplasty works by restoring the natural outflow pathways for aqueous humor in glaucoma patients, using a technique similar to angioplasty. Performed with our proprietary iTrack™ microcatheter, Canaloplasty comprehensively addresses all aspects of potential outflow resistance, including Schlemm’s canal, the trabecular meshwork and, importantly, the distal outflow system, beginning with the collector channels.

With more than 60,000 procedures performed to date, clinical studies have shown that Canaloplasty, performed alone or in conjunction with phacoemulsification, can significantly and durably reduce IOP in many patients.1,2 It can also reduce or eliminate the medication burden.1,2

Importantly, Canaloplasty addresses the full spectrum of the glaucoma disease process: it can be performed via both ab externo and ab interno approaches in order to meet all glaucoma criteria.

During the procedure, 360-degree viscodilation of Schlemm’s canal opens up the ostia of the collector channels, re-establishing outflow. Specifically, the precisely controlled delivery of Healon/Healon GV during withdrawal of the iTrack™ microcatheter separates the compressed tissue planes of the trabecular meshwork, and also triggers the withdrawal of any herniated inner wall tissue from the collector channels. To provide further reduction in IOP, the ab externo Canaloplasty procedure also entails performing a deep sclerectomy, creating a Descemet’s window and deploying a tensioning suture in Schlemm’s canal.

Canaloplasty has been clinically proven

to provide long-term reduction in IOP and

reduced dependance on medications.1,2

Unlike other glaucoma treatments, which

only address one or two aspects of

ocular outflow, Canaloplasty works by

comprehensively opening up all components

of the eye’s natural outflow system.

Canaloplasty does not result in a bleb or

bleb-related complications, offering an

unprecedented level of safety and quality of

life for glaucoma patients.3

Canaloplasty can be used in conjunction with

existing drug based glaucoma treatments,

after laser or after other types of incisional

surgery and does not preclude or affect the

outcome of future surgery.

WIth the recent addition of ab interno

Canaloplasty, dubbed ABiC™, Canaloplasty

can address the full spectrum of the

glaucoma disease process.

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THE IMPORTANCE OF THE COLLECTOR CHANNELS

Canaloplasty is the only currently available glaucoma procedure to address blockages in the collector channels. Studies undertaken in human POAG eyes by Haiyan Gong, MD, PhD (University of Boston) have shown that many of the collector channels may be partially or totally blocked with herniated trabecular meshwork tissue.4 Cannulating the whole of Schlemm’s canal with Canaloplasty, via a process of 360-degree viscodilation, may “pop” open these herniations and enable full access to collector channel ostia for the egressing aqueous. In the case of other glaucoma treatments, where only a segment of Schlemm’s canal is addressed, or where the trabecular meshwork is targeted in isolation, any herniated tissue would most likely prevent improved outflow.

Highly effective as a stand-alone procedure or as an adjunct to cataract surgery, ABiC™ is a new, comprehensive MIGS procedure that flushes out the natural outflow channels, without touching the sclera, and without leaving behind a stent or shunt.

Performed via a self-sealing, clear corneal incision, ABiC™ offers the clinically proven benefits of 360° viscodilation of Schlemm’s canal provided by traditional Canaloplasty but via a simplified and much faster ab interno approach. On average, the procedure can be performed within 5 minutes.

The most defining aspect of ABiC™ is its comprehensive approach. Whereas other MIGS procedures treat only one aspect of aqueous outflow5, ABiC™ comprehensively accesses, catheterizes, and viscodilates the trabecular meshwork, Schlemm’s canal, and the collector channels. Another hallmark of ABiC™ is that it preserves tissue. And because it does not require permanent placement of an implant or stent, it does not preclude or compromise future

surgery if it should become necessary.

Based on a 12-month case series review of 228 eyes by Mark J. Gallardo (El Paso Eye Surgeons, PA) and Mahmoud A. Khaimi, MD (Dean McGee Eye Institute, University of Oklahoma, OK), the preliminary results for ABiC™ are very encouraging – at this point similar to traditional Canaloplasty.6 (See Table 1.)

Of the 130 patients who underwent ABiC™ in combination with cataract surgery, mean preoperative IOP was reduced from 17.1 mm Hg to 13.1 mm Hg at 12 months. The mean number of medications was also reduced by 50% from 2.0 to 1.0. Importantly, ABiC™ was shown to be highly effective outside of cataract surgery. Of the 98 patients who underwent ABiC™ as a stand-alone procedure mean IOP was reduced by 36.74% to 13.6 mm Hg at 12 months. The mean number of medications was also reduced by 66.66% to 1.0.

AB-INTERNO CANALOPLASTY

TABLE 1: ABiC CASE SERIES - 12 MONTH RESULTS6

ABiC with Phacoemulsification ABiC without Phacoemulsification

Exam n Mean IOP (mm Hg) ± SD

Mean Medications (n) ± SD n Mean IOP

(mm Hg) ± SDMean Medications

(n) ± SD Baseline 130 17.1 ± 5.0 2.0 ± 1.0 98 21.5 ± 7.4 3.0 ± 1.0 3 Months 92 13.5 ± 3.1 0.0 ± 1.0 65 16.4 ± 4.3 1.0 ± 1.0

6 Months 83 14.0 ± 3.6 0.0 ± 1.0 51 15.5 ± 3.9 1.0 ± 1.0

12 Months 34 13.1 ± 2.1 1.0 ± 1.0 14 13.6 ± 1.9 1.0 ± 1.0

BENEFITS AT A GLANCE

Comprehensive: treats trabecular meshwork, Schlemm’s canal and collector channels.

No permanent implant or stent.

Effective outside of cataract surgery.

Patient selection criteria similar to current MIGS procedures.

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MINIMALLY INVASIVE

Gonioscopic view of nasal angle one month postoperative. Note the normal appearance of the drainage angle despite previous surgical manipulation.

Image courtesy of Mark J. Gallardo, MD

Traditional Canaloplasty, performed via an ab-externo approach to Schlemm’s canal, is ideally suited for patients with advanced glaucoma. By addressing all of the possible sites of resistance, including potentially occluded collector channels, and with the addition of the scleral lake, Descemet’s window and tensioning suture, Canaloplasty enables surgeons to obtain post-operative pressures in the range of 12-14 mm Hg, similar to that achieved with trabeculectomy7 - but with a reduced risk of complications.1,8 (See Table 2.)

TABLE 3: CANALOPLASTY MULTI-CENTER TRIAL - THREE YEAR RESULTS1

Canaloplasty Phaco-Canaloplasty

Exam n Mean IOP (mm Hg) ± SD

Mean Medications (n) ± SD n Mean IOP

(mm Hg) ± SDMean Medications

(n) ± SD

Baseline 103 23.5 ± 4.5 1.9 ± 0.8 30 23.5 ± 5.2 1.5 ± 1.0

6 Months 86 16.1 ± 3.4 0.4 ± 0.7 25 12.8 ± 2.9 0.1 ± 0.3

12 Months 91 16.1 ± 3.9 0.6 ± 0.8 27 13.6 ± 4.1 0.1 ± 0.4

24 Months 89 16.1 ± 4.0 0.6 ± 0.8 25 13.4 ± 3.2 0.2 ± 0.4 36 Months 89 15.5 ± 3.5 0.0 ± 0.9 27 13.6 ± 3.6 0.3 ± 0.5

In a three-year multi-center trial by Lewis et al, Canaloplasty was found to significantly lower IOP and dependence on medications.1 (See Table 3.) Specifically, in patients that underwent Canaloplasty outside of cataract surgery, mean IOP was reduced by 35% from 23.5 mm Hg to 15.5 mm Hg at 36 months.1 When performed in conjunction with cataract surgery, Canaloplasty resulted in a 42% reduction in mean IOP from 23.5 mm Hg to 13.6 mm Hg, combined with an 80% reduction in medications.1

AB-EXTERNO CANALOPLASTY

TABLE 2: COMPARISON - COMPLICATION RATES

CANALOPLASTY (Multi-Center Trial)1

TRABECULECTOMY (TvT)8

TUBE SHUNTS (TvT)8

Number of Patients 157 107 105 Reoperation for Complications 5 (3.2%) 9 (9%) 15 (14%)

Vision Loss of ≥ 2 Snellen Lines 0 (0%) 23 (22%) 17 (16%)

Serious Complications 1 (0.6%) 28 (27%) 24 (22%)

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© 2016, Ellex Medical Pty Ltd. Ellex, iTrack, iLumin, ViscoInjector and ABiC are trademarks of Ellex Medical Pty Ltd. E&OE. International patents pending and/or granted. PB00019D.

Specifications are subject to change without notice.

Ellex iScience, Inc. 41316 Christy St.,Fremont, CA 94538 USA. 0413

CANALOPLASTY MICROCATHETER

iTrack™ • lluminated, micron-scale microcatheter. • Illuminated tip for transscleral visualization during 360˚ cannulation, allowing surgeon to monitor location of catheter tip at all times. • Choice of intermittent “blinking” or “constant” illumination for patient safety. • Small-gauge support wire for greater control during advancement through Schlemm’s canal. • Infusion lumen for the controlled delivery of viscoelastic. • Round, bolus atraumatic tip and lubricious coating to minimize trauma to Schlemm’s canal during catheterization.

ViscoInjector™

(Note: included with iTrack™ microcatheter.)

• Viscoeslastic injector which attaches to iTrack™ microcatheter. • Manually operated for precise delivery of a specific volume of viscoelastic. • Tactile and audible knob: clicks every 1/8 turn (as per Canaloplasty protocol); alignment marks to guide priming/use. iLumin™ • Portable laser diode illumination source. • Proprietary connector for use with iTrack™ microcatheter.

Designed specifically for 360° viscodilation of Schlemm’s canal in open-angle glaucoma patients, the iTrack™ enables surgeons to: 1. Open a collapsed Schlemm’s canal; 2. Stretch the trabecular plates to allow aqueous into Schlemm’s canal; and, 3. Break adhesions and separate herniations to open the atrophied outflow collector channels.

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The iTrack™ system comprises the iTrack™ microcatheter, the ViscoInjector™ viscoelastic injector and the iLumin™ illumination source:

INDICATIONS FOR USE: The iTrack Canaloplasty microcatheter is indicated for fluid infusion and aspiration during surgery. The iTrack Canaloplasty microcatheter is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma. FDA Cleared. 510(k) # K080067.

REFERENCES:1. Lewis RA, von Wolff K, Tetz M, et al. Canaloplasty: three-year results of circumferential viscodilation and tensioning of Schlemm’s canal using a

microcatheter to treat open-angle glaucoma. J Cataract Refract. Surg. 2011(37):682-690.2. Bull H, von Wolff K, Korger N, Tetz M. Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results. Graefes Arch

Clin Exp Ophthalmol. 2011;249:1537-1545.3. Klink T, Panidou E, Kanzow-Terai B, et al. Are there filtering blebs after canaloplasty? J Glaucoma. 2012;21(2):89-94.4. Cha ED, Xu J, Gong H. Variations in active areas of aqueous humor outflow through the trabecular outflow pathway. Presented at ARVO 2015.

5. Brandão LM, Grieshaber MC. Update on minimally invasive glaucoma surgery (MIGS) and new implants. J Ophthalmol. 2013:7059156. Unpublished. Data on file.7. Brüggemann A, Despouy JT, Wegent A, Müller M. Intraindividual comparison of Canaloplasty versus trabeculectomy with mitomycin C in a

single-surgeon series. J Glaucoma. 2013;22(7):577-583.8. Gedde, SJ et al Review of the results from the Tube vs. Trabeculectomy Study Current Opinion in Ophthalmology 2010, 21:123-128