5 May 2017

Ellex iTrack MIGS Technology to Feature at 2017 American Society of Cataract and Refractive Surgery

Adelaide, Australia, 5 May 2017 – Ellex Medical Lasers Limited (ASX:ELX), a global leader in medical devices for the diagnosis and treatment of eye disease, today announced that its proprietary iTrack™ minimally invasive glaucoma surgery (MIGS) technology will figure in the official scientific program of the annual American Society of Cataract and Refractive Surgery (ASCRS), Los Angeles, 5-9 May 2017. This will also coincide with the release of positive, interim 24-month ABiC™ case series data by Dr. Mark J. Gallardo (El Paso Eye Surgeons, Texas, USA).

ASCRS 2017
The annual ASCRS meeting is the preeminent scientific and industry event for cataract and refractive surgeons and medical personnel in the ophthalmic industry. Key physician presentations and courses featuring Ellex iTrack™ and ABiC™ at ASCRS 2017 are listed below.

1. ASCRS MIGS Skills Transfer Wetlab Session
Monday, 8 May 2017

ABiC™ with iTrack™ will figure alongside other leading MIGS procedures, such as iStent (Glaukos Corporation) and XEN (Allergan, Plc), at a MIGS Skills Transfer Wetlab session. During this CME-accredited event key faculty members, including Dr. Gallardo, will teach the key steps of the ABiC™ procedure.

According to Ellex CEO, Tom Spurling, the inclusion of Ellex iTrack™ in the ASCRS Skills Transfer program signals its acceptance as a major player in the MIGS space.

“This is a significant milestone for Ellex iTrack. It is the first time we have been chosen to feature in the ASCRS teaching program. Not only will delegates have an opportunity to undertake didactic and wetlab training on the ins and outs of the procedure, but they will do so at the same time as learning about other MIGS procedures, such as iStent.”

2. ASCRS Paper Session (Category: Glaucoma)
Saturday, 6 May 2017

Clinical outcomes with Ellex iTrack™ will be presented during three paper sessions. Dr. Gallardo will share the interim 24-month results from his case series involving mild-tomoderate glaucoma patients, and Dr. Mahmoud A. Khaimi (Dean McGee Eye Institute, University of Oklahoma, USA) will highlight the interim 18-month outcomes for ABiC™ as both a standalone treatment and as an adjunct to cataract surgery.

1:42 – 1:47pm, Mahmoud A. Khaimi, MD
“Ab-Interno Canaloplasty As a Standalone Treatment and in Adjunct to Cataract Surgery for the Treatment of Open-Angle Glaucoma”

1:47pm –1:52pm, Mark J. Gallardo, MD
“Twelve-Month Outcomes of Ab-Interno Canaloplasty for Mild-to-Moderate Controlled and Uncontrolled Glaucoma

1:52 – 1:57pm
“Three-Year Outcomes of Canaloplasty Without Suture Placement for the Treatment of Open-Angle Glaucoma”

All educational content of the ASCRS•ASOA Annual Symposium & Congress is planned by its program committee and ASCRS•ASOA does not endorse, promote, approve or recommend the use of any products, devices or services.

3. EyeWorld Corporate Education Event
“A New MIGS on the Block?”
Saturday, 6 May 2017

The breakfast symposium, moderated by glaucoma specialist Steven Vold MD (Vold Vision, USA), will feature guest speakers Dr. Gallardo and Dr. Khaimi.

An avid user of MIGS and one of the highest volume iStent users in the USA, Dr. Gallardo will address his use of ABiC™ with iTrack™ as both an adjunct to, and in conjunction with, other MIGS procedures.

“Not only does it provide a therapeutic benefit, but it can also provide a diagnostic tool for evaluating the patency of the distal system. With this, we may be able to couple other MIGS procedures to ABiC for maximum benefit,” commented Dr. Gallardo.

Dr. Gallardo will also address the favourable benefit-to-risk ratio of ABiC™ with iTrack™.

“By lowering IOP without alteration of the trabecular meshwork, ABiC appears to have a much safer profile than most other MIGS procedures. It also has the added benefit of not hindering a patient’s suitability for additional ocular surgery in the future, if needed, including iStent implantation and supraciliary/suprachoroidal shunt implantation,” added Dr. Gallardo.

24-Month Data Update
The 2017 ASCRS will also mark the release of interim 24-month data for ABiC™ with iTrack™, based on the results of a 75-eye case series study by Dr. Gallardo at El Paso Eye Surgeons, Texas. The results show that ABiC™ can effectively reduce intraocular pressure (IOP) and medication dependence in glaucoma patients when used as both a standalone procedure, and as an adjunct to cataract surgery.

Interim data for the entire patient cohort show that at 24 months post-ABiC™ there was a total average decrease in IOP of 39% and a 70% reduction in medication budren. In 41 patients who underwent ABiC™ as a standalone procedure, there was a total average decrease in IOP of 34% and 43% at 12 months and 24 months respectively. Medication use was also reduced by 60% at 24 months.

There were no complications or safety issues reported.

Dr. Gallardo’s complete 24-month data is expected to be released in late 2017.

North American Investor Roadshow
To coincide with the 2017 ASCRS, Mr. Spurling will undertake a series of investor presentations with key members of US industry and the investment community prior to, and following, the congress period. Please refer to the presentation attached.

Download the North American Investor Presentation – May 2017 here

ABOUT ABiC

ABiC™ is a MIGS procedure that utilizes Ellex’s proprietary iTrack™ illuminated microcatheter to circumferentially viscodilate Schlemm’s canal, the collector channels and the trabecular meshwork. Unlike other MIGS procedures, it restores natural aqueous outflow without damaging ocular tissue or leaving behind a foreign body, such as a stent or shunt.

A key challenge faced by glaucoma surgeons using most MIGS procedures is the need to pinpoint the exact location of increased aqueous outflow resistance. However, it is not always possible to do so and there is no way for a surgeon to be sure that all sites of resistance have been located. Whereas other MIGS procedures treat only one aspect of aqueous outflow, ABiC™ comprehensively accesses, catheterizes, and viscodilates the trabecular meshwork, Schlemm’s canal, and importantly, the distal outflow system, beginning with the collector channels, this eliminating the guesswork inherent in stent-based MIGS.

ABiC™ with iTrack™ has also been shown to be effective as both a stand-alone procedure and as a combined procedure performed in conjunction with cataract surgery.

During the procedure, the Company’s patented iTrack™ illuminated microcathether is inserted through a small corneal incision and placed into Schlemm’s canal, a circular channel in the eye that collects aqueous humor and delivers it into the bloodstream. If aqueous humor cannot drain adequately through the trabecular meshwork and Schlemm’s canal, pressure within the eye (intraocular pressure, IOP) can become elevated. Through a process of 360-degree viscodilation, ABiC™ with iTrack™ is designed to restore the natural outflow pathways for aqueous humor and provide sustained IOP reduction.

For additional information on ABiC™ with iTrack™ please visit www.glaucoma-iTrack.com

ABOUT ELLEX

Ellex designs, develops, manufactures and sells innovative products that help eye surgeons around the world to effectively and efficiently treat eye disease. Ellex is a world leader in this field. Headquartered in Adelaide, Australia, Ellex has ophthalmic lasers and devices that treat glaucoma, retinal disease primarily caused by diabetes, secondary cataract and vitreous opacities, as well as age-related macular degeneration. Manufacturing is carried out in Adelaide, Australia and Fremont, California. Sales and service directly to eye surgeons is conducted via subsidiary offices in Minneapolis, Lyon, Berlin and Tokyo. A network of more than 50 distribution partners around the world services other markets.

For additional information about Ellex and its products, please visit www.ellex.com

For further information on Ellex please contact:

Tom Spurling, CEO
Ellex Medical Lasers Limited
2-3 Second Avenue
Mawson Lakes, SA, 5095
T +61 8 7074 5293 | M +61 417 818 658
tspurling@ellex.com

Andrew Angus
Investor Relations
Overland Advisors
M +61 402 823 757
andrewangus@overlandadvisers.com.au

Maria Maieli, CFO & Company Secretary
Ellex Medical Lasers Limited
2-3 Second Avenue
Mawson Lakes, SA, 5095
T +61 8 7074 5200
mmaieli@ellex.com