Nova Eye Medical is confident its new user-friendly iTrack Advance canaloplasty device for glaucoma surgery will become a hit with a broader range of eye surgeons.

Following the US launch of iTrack Advance at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in May 2023, total US sales for Nova Eye Medical (ASX:EYE) for the three months to July 31, 2023 were ~US$2.2 million, up 32% on pcp.

For minimally invasive glaucoma surgery (MIGS), iTrack Advance is a consumable surgical device that restores the eye’s natural outflow pathway to lower pressure inside the eye and reduce patient reliance on anti-glaucoma medications for mild-moderate glaucoma.

EYE President of USA Sales, Joe Bankovich says the iTrack Advance, a surgical device for canaloplasty, takes its globally used legacy product and makes it much more user-friendly for surgeons.

“Not only are we going to be able to sell to more surgeons, but we are going to be able to sell to different types of surgeons,” Bankovich says.

EYE has, until now, been focussed on the specialised glaucoma surgeon market, but Bankovich says the real market growth is via comprehensive ophthalmologists and cataract surgeons, who are more likely to treat glaucoma in its early stages, which is where MIGS procedures are commonly deployed in clinical practice.

The medtech is committed to advancing ophthalmic treatment technologies and devices with a focus on two of the biggest diseases leading to blindness in the developed world – glaucoma and macular degeneration.

“If you look at the glaucoma specialist market in the US at the moment, there are probably about 1,000 doctors on the list – and we have been doing business with about 200 consistently,” Bankovich says.

“This group is very much embracing the new product but the other group we are targeting is the general front of the eye ophthalmologist which is 10,000 plus.”

The rise of MIGS

Surgeons across specialities are increasingly looking for technologies which will aid in minimally invasive surgeries – for example, keyhole surgery – and ophthalmology is no different.

“The buzz word is MIGS, meaning minimally invasive glaucoma surgery,” Bankovich explains.

He says typically, initial treatment for glaucoma involves eye drops or laser therapy. However, if these options become inadequate or unsuitable, glaucoma surgery may become necessary.

Although conventional glaucoma filtration surgery is effective, it comes with notable risk factors, many of which can be avoided through the use of recently-developed MIGS options for surgeons.

“Canaloplasty has always been considered a highly effective treatment option, but technical challenges associated with the Company’s legacy product limited its uptake by surgeons in the USA, with surgeons opting for more efficient MIGS procedures,” he says.

The original iTrack was launched in 2008.That iteration of the device was used in more than 120,000 canaloplasty surgeries with exceptional efficacy. However, the iTrack Advance now makes canaloplasty far more efficient and less cumbersome for the surgeon.

Bankovich says the original iTrack required the use of micro forceps in order to perform the canaloplasty procedure.

“You would go in with micro forceps and literally grab the tip of the catheter and feed it into the canal, one clock hour at a time,” he says.

“It would do a 360° around the canal and then when withdrawing the catheter viscoelastic is delivered to help dilate the canal.

“You had multiple incisions and were in and out of the eye several times and had to have the skill to feed this tiny little catheter through the canal.”

Bankovich says the catheter is ~200 microns so the equivalent of about two strands of hair, which feels like a wet slippery noodle. Feeding it through the canal was a tricky step for a surgeon to navigate.

He says with the iTrack Advance, surgeons can go in with a single small incision and push a slider to advance the catheter.

“It then does the full 360, before the surgeon slowly retracts the catheter – and that’s the efficiency we’re talking about,” he says.

“When you come down to tolerances and angles it was a challenging engineering exercise to enable the ease of use of an injector without compromising the performance of the catheter.” 

Proprietary devices give EYE market advantage

Bankovich says its canaloplasty procedure using the original iTrack was not going to penetrate the larger group of comprehensive ophthalmologists and cataract surgeons but the iTrack Advance is more likely to because of its improved ease of use.

The proprietary tech includes an illuminated catheter tip, which lets the surgeon know the location of the catheter in the canal.

“The canal is a circular like structure but sometimes surgeons encounter tears and obstructions, which can lead them into places they don’t want to go,” he says. “None of the other MIGS devices have that safety net of an illuminated catheter tip.”

Bankovich says the device also has a proprietary pressurised visco injector system, to deliver high volumes of viscoelastic at high pressure, and a proprietary guide wire with flexural rigidity, enabling it to intubate the full 360° of the eye’s natural drainage pathway, known as Schlemm’s canal.

That adds up to a three-pronged range of benefits that “no one else can do in the marketplace right now,” he says.

Scaling up US sales team

EYE has appointed additional sales personnel to enhance the reach and depth of its sales and clinical efforts across key territories in the US.

“We’ve added more reps around the country and what we are doing is adding as we grow,” Bankovich says..

Additionally, EYE is working to reactivate inactive customer accounts, before turning its focus to win new customer accounts in the remainder of CY23.

“We have a targeted growth plan which has been about conversion for the first few months,” he says.

“The next round will be the people who’ve never used this technology before, which is the most exciting part when you start to look at where that market takes you.”

The company has also expanded its production facility in Fremont, California, to materially increase production capacity to meet the anticipated rise in demand.

This article was developed in collaboration with Nova Eye Medical, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.