iTrack™ Advance Real-World Registry Data and CATALYST Study Data to be Presented at the 2023 ESCRS Annual Congress, Vienna

FREMONT, Calif.–(BUSINESS WIRE)–Nova Eye Medical Limited, a medical technology company committed to advanced ophthalmic treatment technologies and devices, is pleased to announce that the Company’s proprietary canaloplasty technology platform (iTrack^™and iTrack^™ Advance) will be featured in numerous presentations and posters during the official scientific program of the European Society of Cataract and Refractive Surgeons (ESCRS) 41^st Congress on September 8-12, 2023 in Vienna, Austria.

Europe’s largest annual meeting for anterior segment surgeons and comprising both a scientific program and a technical exhibition, the ESCRS Annual Congress provides an important opportunity for the Company to share clinical research and collaborate with existing and future customers.

“ESCRS is a key event in our global calendar, particularly at this important juncture in our growth strategy as we ramp up launch efforts for iTrack^™ Advance,” said Kate Hunt, Chief Commercial Officer of Nova Eye Medical. “This year’s official ESCRS scientific program will spotlight a number of papers and posters featuring our new iTrack^™ Advance, including the interim 12-month results from the iTrack^™ Global Data Registry. The Registry has been adopted by surgeons across the globe to collect real-world data for our iTrack^™ and iTrack^™ Advance canaloplasty devices and we have been buoyed by the enthusiasm of the surgeons involved.”

Established in May 2022, the iTrack^™ Global Data Registry is collecting prospective, multicenter, longitudinal data for canaloplasty in the treatment of glaucoma and currently counts 367 canaloplasty procedures from surgeons in the United States, Canada, Europe and Australia. More than 500 canaloplasty procedures are expected to be independently documented by surgeons via the iTrack^™ Global Data Registry, providing a real-world assessment of the clinical utility of the Company’s iTrack^™ and iTrack^™ Advance canaloplasty devices.

The iTrack^™ Global Data Registry is incorporated in the global International Glaucoma Surgery Registry (IGSR), an observational, non-interventional study of patients undergoing laser or surgical treatment for glaucoma. Established five years ago, the IGSR already counts more 7000 procedures in 63 countries and is the official registry partner of the European Glaucoma Society (EGS).

World-renowned glaucoma surgeon and one of the IGSR founders, Prof. Keith Barton, MD FRCP FRCS (United Kingdom) will present the interim 12-month data from the iTrack^™ Global Data Registry, “Multicenter Canaloplasty Data Registry – Outcomes of Ab-Interno Canaloplasty Across Different Glaucoma Types and Severity,” in the official MIGS session at the ESCRS. Refer to session details below.

“The IGSR was developed to provide surgeons with an opportunity to contribute directly to better understanding the clinical effectiveness of the various glaucoma procedures and thus enable evidence-based decision making. We are pleased to collaborate with Nova Eye Medical in facilitating the collection of real-world evidence of the effectiveness and safety of canaloplasty to treat glaucoma,” commented Prof. Barton.

Also to be presented in the ESCRS scientific program are the interim results of the Cataract Surgery in Conjunction with Ab-interno Canaloplasty using the iTrack Advance device Compared to Cataract Surgery Only (“CATALYST”) Study. The multicenter, randomized control study was initiated in 2022 by the Company across four sites in Germany to assess the effectiveness, safety and quality of life (QoL) outcomes of canaloplasty using the Company’s iTrack^™ Advance device, as compared to a cataract surgery-only control arm. Key assessment outcomes include reduction in mean intraocular pressure (IOP) and mean number of glaucoma medications, surgical and postoperative complications, endothelial cell count and QoL utilizing a patient reported outcome measure. Karl Mercieca, MD, FEBO will present the interim data update for the CATALYST Study at the 2023 ESCRS Annual Congress. Refer to poster details below.

A summary of the ESCRS 2023 presentations and posters featuring iTrack^™and the newly launched iTrack^™ Advance is included below.

Podium Presentation

Keith Barton, MD (UK); Shamil Patel, MD (USA), Nathan Kerr, MD (Australia); David Lubeck, MD (USA); Iqbal Ike K. Ahmed, MD (Canada)

“Multicenter Canaloplasty Data Registry – Outcomes of Ab-Interno Canaloplasty Across Different Glaucoma Types and Severity”

Session: Minimally Invasive Glaucoma Surgery (MIGS)

Date: Monday, September 11, 2023

Time: 8:48-8:54am

Location: Lehar 1-2-3 Free paper podium 4

Presented Posters

James Murphy, MD (USA)

“Efficacy of Ab-Interno Canaloplasty Performed With and Without GATT Following Previous Glaucoma Laser Treatment – 24-Month Outcomes”

Session: Glaucoma for Cataract Surgeons

Date: Saturday, September 9, 2023

Time: 2:15-3:45pm

Location: Podium 3

David Lubeck, MD (USA); Keith Barton, MD (UK); Iqbal Ike K. Ahmed, MD (Canada); Nathan Kerr, MD (Australia); Shamil Patel, MD (USA)

“Ab-Interno Canaloplasty Effectiveness Categorized Based on Viscoelastic Volume”

Session: Glaucoma for Cataract Surgeons II

Date: Sunday, September 10, 2023

Time: 5:00-6:00pm

Location: Podium 3

E-posters

Norbert Körber, FEBO (Germany); Simon Ondrejka, FEBO (Germany)

“6-Year Clinical Effectiveness of Ab-Interno Canaloplasty using the iTrack In Reducing The Medication Burden in Glaucoma Patients”

Simon Ondrejka, FEBO (Germany); Norbert Körber, FEBO (Germany)

“6-Year Efficacy and Safety of iTrack Ab-interno Canaloplasty as a Standalone Procedure and Combined with Cataract Surgery in Primary Open-Angle Glaucoma”

Karl Mercieca, FEBO (Germany); Simon Ondrejka, FEBO (Germany); Markus Kohlhaas, MD (Germany); Norbert Körber, FEBO (Germany)

“Cataract Surgery in Conjunction with Ab-interno Canaloplasty using the iTrack Advance device Compared to Cataract Surgery Only (CATALYST Study)”

David Lubeck, MD (USA); Keith Barton MD (UK); Iqbal Ike K. Ahmed, MD (Canada); Nathan Kerr, MD (Australia)

“iTrack™ Global Data Registry to Support the Role of Canaloplasty for Treatment of Glaucoma”

David Lubeck, MD (USA); Robert Noecker, MD (USA)

“Endothelial Cell Density And Loss Following Ab-Interno Canaloplasty In Patients With Mild-Moderate Glaucoma As Compared To Severe Glaucoma”

James Murphy, MD (USA)

“Efficacy and Safety Profile of Ab-Interno Canaloplasty Performed With and Without GATT – 24-Month Outcome”

Full session details can be accessed via the ESCRS program:

https://escrs-apps.m-anage.com/escrs2023/en-GB/pag

All educational content of the ESCRS Annual Meeting is planned by its Program Committee. The ESCRS do not endorse, promote, approve, or recommend the use of any products, devices, or services.

Nova Eye Medical will also provide additional peer-to-peer educational opportunities by hosting a series of interactive panel discussions during the ESCRS 2023. Surgeons from the USA, Canada and Germany will discuss their unique insights and experiences using the iTrack™ Advance as a minimally invasive glaucoma surgery (MIGS) treatment. All registered delegates of the ESCRS 2023 Annual Congress are invited to attend the Speaker Forum at the Nova Eye Medical Exhibit, #114 (Hall C). See full session details here: https://nova-eye.com/escrs

ABOUT NOVA EYE MEDICAL

Nova Eye Medical Limited is a medical technology company that develops, manufactures and sells a portfolio of proprietary ophthalmic treatment technologies and devices. Used by eye surgeons in more than 100 countries globally, these technologies include the iTrack^™portfolio of canaloplasty devicesfor the treatment of glaucoma. The Company also manufactures and sells the proprietary Molteno3^® glaucoma drainage device for the treatment of severe or complex glaucoma. With its sales headquarters based in Fremont, California, Nova Eye Medical is supported by sales offices in Adelaide, Australia and Berlin, Germany, and a global network of more than 50 distribution partners. Manufacturing facilities are located in Fremont, California and Dunedin, New Zealand.

ABOUT CANALOPLASTY

First introduced in 2008, canaloplasty is a surgical treatment for glaucoma that targets the main sites of outflow resistance in the conventional outflow pathway: the trabecular meshwork, Schlemm’s canal, and the distal collector channels. Based on the same principles as angioplasty, a flexible microcatheter is cannulated 360 degrees around Schlemm’s canal during the procedure to manually break and remove blockages. Next, viscoelastic fluid is injected into Schlemm’s canal as the microcatheter is withdrawn to dilate the distal outflow system and to improve the function of the trabecular meshwork.

The iTrack^™ Advance canaloplasty device has a US Food and Drug Administration (FDA) 510(k) and CE Mark (Conformité Européenne) for the treatment of open-angle glaucoma.

The iTrack^™ Advance canaloplasty device has been cleared for the indication of fluid infusion and aspiration during surgery, and for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.

For additional information about the iTrack^™ Advance, including safety information, please visit: https://itrack-advance.com

Contacts

For media enquiries, please contact:

Kate Hunt: Nova Eye Chief Commercial Officer – khunt@nova-eye.com
Giorgio Pirazzini: GP Communications – giorgio@gpcommunications.eu