Forum Topics EYE EYE ASX Announcements FDA approval

Pinned straw:

Last edited 2 years ago

Nova Eye pioneered the fastest growing segment in the burgeoning ophthalmic market; canal surgery for glaucoma, and holds over 100 patents in this domain

Nova Eye has invested in developing a next generation product (iTrackTM Advance)

The iTrack advance gained FDA approval of Friday 31 Mar. Shares jumped around 25% initially then pulled back for a 5% gain.

FDA approval

I notice there was some activity on strawman a few years ago. Perhaps some strawfolks are able to comment on these new developments;) With the original device still in use the new design should gain widespread adoption fairly soon and it will be interesting to hear progress on the rollout and uptake

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Company presentation

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Held SM and IRL

Nnyck777
Added 2 years ago

I have been living at education conferences recently and thought I would share another series of discussions with eye surgeons regarding the Itrack and 2RT laser research that took place.

Investment thesis for Nova Eye is something along the lines of

1) Breakthrough new glaucoma stent Itrack by Nova Eye is changing the treatment of primary open angle glaucoma. Adoption curves will be huge and this is the stand out device so I will invest as the company is about to make knock out revenues.

2) The 2RT nano ophthalmic laser is the only treatment for intermediate AMD. The LEAD study will show outstanding phase 3 results, win FDA approval and everyone with this condition will be lining up as there is finally a treatment for this condition. I will invest the company is about to make huge revenues.

Bear Case

There are 31 glaucoma drainage devices currently on the market. 31!

The Itrack is one of the 31. The shear number of devices I think gives you a hint about the Itrack. No one device has solved the problem of guaranteed permanent IOP reduction with minimal complications and ease of application.

One of these surgeons had done many operations with this device and shrugged his shoulders. He uses Hydrus stents and Preserflo as his most reliable devices like most doctors I have spoken with. Hydrus and Preserflo certainly seem to be the standouts. He did say the blinking light was cool to watch going around but that was his highlight. He did not adopt this tech and also reported risks of IOP spikes after inserting the viscoelastic.

There is certainly no reported ease of use, post op advantage or IOP lowering advantage to this product. So the likely difference to any of the other 31 devices - MARKETING.

Summary: I doubt the adoption curve is going to be that great - hence revenues are unlikely to knock the lights out.

2) Photodynamic laser was the first treatment developed for wet AMD - in a nutshell cauterize the leaky blood vessels and we will prevent central vision loss. Problem you cauterize tissue you destroy it so people were left with blind spots throughout their vision. Fast forward to today and the nano ophthalmic laser is being used which should not cause as much tissue damage as you reduce the pulse time so the surrounding tissue should not heat up and be destroyed. The surgeons I spoke to stated there seems to be very limited success so far. The laser will be expensive and once again this is not a cure and doesn’t show profound improvement in vision for patients.

Summary: unlikely to be the breakthrough treatment people are hoping for. Thankfully we still have beneficial AMD anti-veg F injections which really are sight preserving.

Hope this helps.

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Nnyck777
Added 2 years ago

Nova Eye - Itrack device

I briefly looked at Nova Eye a few years ago and I recall I wrote a bear case for the company. 

I thought I would update following a recent conference I attended where I got to ask a few hard hitting questions to a couple of glaucoma surgeons who I respect. 

From first principles the I track sounds like a magical device – Feeding 360 degrees through Schlemm’s canal.  This helps to stop the canal from collapsing in glaucoma patients and helps facilitate aqueous fluid outflow from the anterior chamber, neatly across the trabecular meshwork, into Schlemm’s. The aqueous then flows through to the collector channels and drains away, leading to a intraocular pressure reduction in the eye. This lower pressure = less chance of damage to the optic nerve head.

But…. There is a but. Please read previous bear case for competition etc… My opinion is unchanged. The surgeons I chatted too still felt that the Itrack would be limited to moderate to advanced glaucoma. Other Migs surgeries e.g. Hydrus (I stent for the less skilled surgeons -don’t get me started on the evidence comparing these two devices) will still be the likely go to for the early mild to moderate cases. Hydrus is proving to be pretty effective in reducing the rate of glaucoma patient’s progressing. 

The itrack if limited (in these surgeons opinion’s to more moderate to advanced cases) means that they will compete in a much smaller pool with trabeculectomies and the / molteno’s / baerveldt’s / Preserflo devices. 

Some surgeon’s express discomfort at filling the entirety of Schlemm’s canal with a device as opposed to only a few clock hours. There apparently may be uncontrolled pressure rises which may potentially lead for removal of the device. One surgeon expressed to me that at this stage he would not consider inserting the device. He assured me the surgery is easy enough however he was not convinced of the benefit over current treatments. He is one of the more progressive surgeons but always does very due diligence prior to his surgeries. 

In my opinion it is unlikely that this device is going to be a major game changer in the glaucoma world – there is currently a lot of competition and no particular evidence I track offers anything above and beyond other devices pressure lowering capabilities. Of course do your own research. This is not financial advice and I have no financial incentives from any of these companies.

I will look into the AMD treatments further when I get a chance. 


Cheers

Nnyck 

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Rocket6
Added 2 years ago

Great post @Nnyck777, good to hear from those in the industry.

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