Mikebrissy interesting study and comments.   Was interested in how this EYE study compared to other glaucoma intervention. Results below using Gemini and the itrack study pdf:

OMNi appears to have an advantage in lowering pressure by around 1-2 mmg more and better drop free rates than Itrack. However Itrack is less than half the price and it is the surgeon or hospital that is directing the intervention, not the patient.

Some further AI questioning around OMNI which should be a vastly superior MIGS device because OMNI not only cleans out the Schlemms canal (Canaloplasty), but further has trabeculotomy functionality (cuts the trabecular meshwork). 

“OMNI is a mechanically rational device in a psychologically irrational market.

Surgeons reward:

• simplicity
• predictability
• low bleeding
• short learning curve
• clear reimbursement

OMNI delivers:

• complexity
• variability
• bleeding
• skill dependence
• reimbursement friction

So despite its elegant dual‑mechanism, it sits in a niche rather than dominating MIGS.”

Itrack is a similarly niche procedure, however it appears to be a simpler, cheaper and have more certainty of reimbursement than OMNI.

An AI comparison with OMNI/Itrack versus stents:

On why stents “win” commercially: Not because they crush OMNI/iTrack on IOP, but because they are:

• easier to implant
• cleaner (less bleeding)
• faster
• backed by clearer reimbursement and more RCTs

However the big selling point of Itract is the surgical work flow link between cataract surgery and canaloplasty (Itrack). This would appear to be a key Itrack sales driver.

Back on the yesterday’s study results, agree studies of this type have a bias as the surgeons reporting seem to be the ones whom have a favourable view of the device in any case and they appear to be given some level of assistance from EYE. Balancing this out, there is some skill needed to use it effectively so those surgeon that have developed the skill you would expect to be the ones who feel positive about it.

The safety profile is a big one and is positive.

In the EYE Webinair of the 2/2/26 CEO Mr Spurling said twice to sensitive questions: “trust me”. As unsatisfactory a response as that is, in many ways that is what shareholders are left with in a good many of these investments.  To date improving sales have been the most powerful indicator of the future company health. Will be interesting to see how it further plays out.   

OMNi appears to have an advantage in lowering pressure by around 1-2 mmg more and better drop free rates than Itrack. However Itrack is less than half the price and it is the surgeon or hospital that is directing the intervention, not the patient.

Great posts on here @Scoonie et al

One thing I'd add here is that this glaucoma treatment is high workflow short time. My understanding is that in that environment iTrack can service more patients and hour that can make it more profitable for the surgeon per hour. I think I saw 1-2 minutes v 5-7 minutes for OMNI.

Always got to know who the customer is and in this space the surgeon is absolutely the customer.

I got burnt on AXP (AirXpanders) years ago because I didn't fully appreciate that point!

I am always attracted to a biotech where there is a lot of hate. And I would imagine if you were in EYE any time in the last decade there would be plenty to hate. The only substantial appears to be Australian Ethical at 17%. Maybe a hangover from the glory days of Ellex Medical Lasers.

An ugly business that appears as Wini has described to be changing to a much better one and have bought a few.  

Highly niche product, though it would seem Itrack has an edge on the competition as well as a very capable sales team in the US.  Leads to speculation (mine) there may be two paths to realising value in EYE - growth to profitability and/or being taken out. Particularly by a surgical competitor who is adjacent to canalplasty.  

@Scoonie that's a very good point.

$EYE would look attractive to other players in the ophthalmic surgery market who could fold the existing product into their sales team, wipe out the overheads etc. etc. creating quite a lot of value.

I've definitely seen enough to look again!

@Wini @mikebrisy @Scoonie Unfortunately my wife and one of my good friends have glaucoma and this non invasive technology is of personal interest to my wife and I. The procedure looks interesting https://youtu.be/TzAM7VbdSxU?si=OjrKDoDbNfJ1Dl-h

Non invasive technology has some real advantages over traditional treatments due to a much lower risk of failure.

My wife was diagnosed with glaucoma 25 years ago. She started on, and is still using twice daily eye drops. These take up to 20 mins twice each day to administer (3 different drops with 5 minute intervals between drops). The drops alone are not enough to lower the pressures adequately.

Next was laser treatment which is only a temporary measure. This was followed by a trabeculectomy in her right eye. The trabeculectomy failed because it was too aggressive, releasing too much fluid from the eye and resulting in unnecessary additional vision loss. Low eye pressure is just as damaging as high eye pressure. The trabeculectomy was successfully repaired by a top QLD glaucoma surgeon.

My wife then had 2 micro stents inserted in the other eye. In combination with eye drops these are working well.

The iTrack technology has not been suggested or mentioned by my wife’s specialist to date. Specialists generally like to watch and wait before adopting new technologies, so adoption can be slow. Even as new stent technologies emerged he said “you don’t want to be the first one to try these things!”

Understandably my wife is in no hurry to have a second trabeculectomy. We are both waiting and hoping a new technology emerges to avoid this risk. Perhaps iTrack might be it? I like that it’s non invasive and restores the eye’s natural fluid drainage system.

Not held

Hi Rick, sorry to hear about your wife's medical travails. I am not an expert in this area however whilst Itrack is TGA approved it does not attract Medicare reimbursement. Plus there is a deal of specialised training needed to use it. Hence there are few specialists in Australia using the device. This maybe why it did not come up as a treatment method for your wife.

The specialist is effectively pushing a tiny catheter with a light at the end around the eyeball (called the Schlemms canal) and so improving eye drainage and reduce internal pressure on the optic nerve. Interesting technology.

@Rick thank you for sharing your personal experience with this, and I wish your wife well in the ongoing treatment. This condition is also quite close to home for me, with an older sibling who is at the eye drops treatment stage, and there is a genetic linkage. So, it is a condition for which I have some personal motivation to study up on (and keep up to date with my regular optician eyechecks ... next one due this Friday!).

@Scoonie 's point about local treatment availability is such a good one. Pricing, regulation, and market size/structure make the US the place where medical devices and pharma most often go first. And in many cases, treatments that are readily accessible in the US take years to become available elsewhere, and even longer to be reimbursed, if ever it happens.

This is particularly the case when you get to alternative treatments for a condition, with an established standard of care. In small markets the bar for a follow-on treatment to get approved appears to be so much higher unless there is a compelling safety, efficacy or economic case.

That's one reason I am so interestined in $OCC and Remplir (for nerve repair). ANZ was the first market to be cracked a few years ago, with FDA approval only coming last year. The question there is the inverse of what we normally see - can an "improved me too" product that appears to be getting traction in ANZ, make it in the US? The jury for that one is still out. But I have a bet on "Yes".

As another example, consider $TLX: Illuccix has been selling in the US for 4 years, yet is only now winding its way through the EU/UK approval and reimbursement process, and into sales.

Or consider $NEU with DAYBUE - we are into the 3rd year of sales in the US, still awaiting approval in the UK/EU, and with a "Do Not Reimburse" recommenddation tabled in Canada, after the "approval" earlier last year.

Medical devices can be even trickier, because there can be specific skills training required to be able to use the device, and that usually requires a local KOL or champion to get the ball rolling in a particular country for a host of reasons. Perhaps they first gained the knowledge through involvement in a clinical trial, or maybe they got trained up travelling first to another country.

That's part of what makes the whole pharma /biotech/ medtech sector so fascinating to me. The pace of process at times appears glacial, but the cumulative progress when observed over the timeframe of decades is staggering. And the future remains very exciting, when you consider all the ongoing innovation. But to invest and have a reasonable hope of success, you've got to get into the granularity of the individual markets.

Thanks all for the great posting and personal experiences. Great to see some of the best of strawman circling around EYE! I am a long suffering holder of EYE (even ELX) and appreciate all the great points and analysis. I can’t add to that, but thought I could add my perspective of management (and remember I am jaded and long-suffering!).

I don’t think this is the type of management that is going to “walk the tightrope” on liquidity. Their raisings have often come early and at what I thought are fairly steep discounts, 20-30%. The last 3 years there has been a raising in the first quarter, or there abouts, so my expectation is for another raising based on current elevated price and recent announcements at something like 15c. Hopefully not, hopefully they hold out for a good price and hopefully they let shareholders in on the action…..but hope is not a strategy (well it is for me sometimes, but I wouldn’t recommend it!). Shareholders have been left out of 2 of the recent 3 raisings from memory.

It would be interesting to see Tom Spurling on strawman, or if any of you have any personal experience. I heard him years ago at a half year analyst call and thought he was uninspiring, he then left the company (or at least the top job), before making a comeback. In my very limited and humble view he lacked cutting edge for a CEO in charge of this type of opportunity. I remember an instance where he couldn’t recall why the company had strong sales in one region, and it was almost like he didn’t care. My impression was, and I’m jaded remember, that the company was more about research papers and medical prestige than generating value for shareholders.

I continue to put all of that aside and tell myself that this year its different. The device and the growth are strong, the market cap is so low, they have the 2RT product in the background, it has obvious re-rate potential. So I would say I have a strong belief in the product and value proposition, but low trust in management. Its been enough for me to hold a small (and getting smaller - although I topped up in the 20-25c range a few years ago) parcel for a number of years, but a good lesson for me (that I refuse to accept by continuing to hold :)) on multiple fronts:, med-tech can take a long time and be bumpy, poor management is to be avoided, thesis creep, endowment effect and the list goes on.

@Longpar5 interesting perspectives, thanks. Given their cash position at the last 4C, ongoing albeit reducing burn, the quarterly revenue report, and the company preso, … looks like they are limbering up for the next raise at the next 4C … so a halt and capital raise any day now? Or, given that they are getting close to CF break even, might they bridge the gap with debt?

Given your point about share issue price discounts and my observation that SP pulls back a little after raises, then the next raise could offer an entry point if we see SP pull back to around $0.15-$0.16. That said, if the cashflow trend and half year results are strong, we could see a SP take a leg up.

It all sounds like a case to pull forward on my deep dive, as I am getting way ahead of myself taking about timing of purchases, having not even really started to assess if this is an attractive investment! As you say ( and many of us here can attest to) medical devices can be a long drawn-out and unrewarding grind, particularly if you choose the wrong entry!

That said, I have one early impression regarding their 2026 US market focus:

My first impression is that US Annual Revenue per Sales Rep looks pretty decent given that it’s early days (almost A$2m, up from just over $1m at 1Q25) from 9-10 Reps. I think there is headroom to scale, with early positive contribution per rep, and a decent productivity ramp. A good benchmark in this category is $US3-4m per rep, or A$4-6m. It’s conceivable they can get there over another 2-3 years as accounts mature and geographical density per rep increases. I am also encouraged to see management focusing on this metric and giving investors this level of transparency.

If we guesstimate that in the US there around 1,500 ophthalmic surgeons who could adopt the technology (out of 18,000 licensed ophthalmologists), then at a benchmark ratio of 1 rep per 30 surgeons, that indicates a peak sales force of up to 50 sales reps to adequately cover the market. … help obviously provided in the background here by my BA, so not fact-checked by me yet.

So, both from a TAM perspective, sales coverage, and early sales momentum, it appears totally rational to me that $EYE should start to scale their US sales force, to sustain the c. 40% momentum.

@Strawman did you see @Longpar5’s suggestion we might get the CEO in for a SM meeting? I’m just listening to a recording of the quarterly sales report conference call and they sounded happy that 90 people were attending. The Strawman community might be of interest to him.

A lot more to do on this one, but it seems worth the effort.

Disc: Not held

Great thread, and thanks for putting this one on the radar @Wini. Looks interesting.

I've just emailed the MD to see if he's available for a meeting.

I work with an ophthalmic surgeon who specialises in glaucoma surgery. He mostly puts in iStents which are made by Glaukos and are the MIGS market leader. The iStent devices are popular because there is a good evidence base for them and they are relatively easy to put in. They tend to be more forgiving if they are mal-placed or non-functioning. Even non-glaucoma eye surgeons will put them in which increase the user base. But there is a lot of competition in this area and the biggest problem holding the iTrack stent back is a lack of good evidence base. Medicine and especially new device technology is strongly directed by the supporting evidence. The iTrack stent has a relatively poor evidence base with mostly retrospective studies and Nova Eye need to invest into a meaningful randomised control trial before they will get the glaucoma body behind it. The other problem with the iTrack stent in Australia is there is no item number so patients have to self-fund if they want that device. There are some US trained surgeons with experience using them in Australia - but not many and it is mostly being pushed by incentivised industry proponents in this country. The three main MIGS devices in use in Australia are the iStent, the Hydrus stent and the Minijet. It is worth remembering that the customer here really is the surgeon. They are the ones who decide which MIGS device to use even if they are not paying for them! Obviously that is why the company reps spend so much time buttering up the surgeons. But as I said before MIGS device selection is a strongly evidence based decision.

I have looked at Nova because of their pitch into the US market... but the above commentary and their glaucoma focus have me hesitant.

Based on where the 'eye problems' are, I would suggest focusing on the Asian marketplace.

Check out their massive myopia problem among children, which is only going to get worse because of close work on iPads and IPhones etc.

Bottom line: There are plenty of spectacles to be made just north of us!

In contrast, the Australian figure is around 40% (from memory).

e

Thanks for the great interaction and feedback guys, really highlights the value of the Strawman community.

@mikebrisy I’ve read through a few Sight Sciences quarterly reports and best I have seen is they blame their mediocre revenue growth on changes to Medicare reimbursement and increased competition. I take “increased competition” to refer to EYE, given if you add EYE’s incremental growth to Sight Sciences you pretty closely replicate the industry growth rate.

@Rick Sorry to hear about your wife, unfortunately her story seems like a common one for glaucoma sufferers. The eye drop treatments sound very onerous and lots of people are left with irritated eyes because of them. It’s not a surprise you haven’t been recommended iTrack though, as @Scoonie correctly pointed out despite TGA approval the reimbursement in Australia is not as favourable as the US meaning not as much uptake. There are some ophthalmologists who can do the procedure but they are few and far between.

@Longpar5I agree that looking at the past management have been quick to pull the trigger to raise capital to the detriment of long suffering shareholders. That said the path to breakeven has never been clearer so maybe it could be avoided but no doubt short term it is a key risk and I expect it to overhang the stock. Also if the share price continues to strengthen on the back of good trading updates I suspect they would lock in some funding to de-risk.

I agree on your view of Mr. Spurling, seeing him present I don’t come away thinking he is a commercially driven executive that will stop at nothing for EYE to succeed, but he handles himself well enough. Doing some LinkedIn stalking though I think the key executive is Joe Bankovich, President of Global Sales based over in the US and sits on the American Glaucoma Society Foundation’s Advisory Board. Keeping Mr. Bankovich employed and happy is key to the near future I would think!

@ShapeshifterGreat context and I think you summed up why it is so difficult for new products to get traction and commercialisation. I often pour cold water on bio/medtechs when they come up on The Call on ausbiz for that very reason. EYE is seeing some good commercial traction in the US right now but it is a moving beast and some adverse treatment outcomes can send things off the rails very quickly.

@PortfolioPlus EYE recently got Chinese approval for iTrack Advance, I’m not factoring in any massive growth but given the recent success in the US came from the upgraded Advance product you could be hopeful China could follow in time.

@Shapeshifter it is always great to get direct observations from customers!

You are right to say that a randomised, controlled, trial (RCT) against the existing treatments is the gold standard, and is key to moving surgeons to change their practice.

However, particularly in medical devices where there are multiple, approved, competing treatments, real world evidence (RWE) from independent, prospective case databases (like iTrack's Registry) can influence treatment guidelines and reimbursement decisions. As such, they can be important in helping the device to gain market share.

In the case of iTrack, it seems to me from an initial look, that this product is gaining share in canaloplasty in the US, so clearly, many surgeons have been convinced to try it and payers to pay for it, and that cohort is growing. While growth appears quite strong in the US, it is not so convincing in Germany and China (from what I can see).

Health Technology Assessment (HTA) bodies around the world increasingly hold the position that "Observational data is acceptable if it is prospective, transparent, and appropriately analysed." For example, I know first hand that NICE in the UK has for many years had a clear framework for how to use such evidence.

I don't know the extent to which the iTrack Registry meets the best-practice requirements for "independence" and "propsectivity"

First, "propsective": the case has to be entered into the database before the treatment outcome is known, and with clear criteria for inclusion, and clear upfront definition of end point measures and timeframe. This sets it apart from the plethora of datasets assembled retrospectively, and which are therefore prone to "cherry-picking" - whether on case inclusion or the endpoints chosen or both! Second, "independent": the management and analysis of the real world data must be independent from the company that makes or markets the device - and I think "independent" means both organisationally and with respect to any incentives (needed to double check the second point, but I'm pretty sure that's the case).

I don't know to what extent the iTrack Registry is considered to meet best practice for generating RWE. But I am doing some digging to find out as part of my deep dive.

In conclusion, clearly a RCT trial for iTrack against one or more other MIGS would be great, however, I'm not sure the absence of one will prevent me forming an investment thesis.

As an aside, while I was digging into this I found that there is an RCT open for iTrack against OMNI - but I haven't heard anything about it.

https://clinicaltrials.gov/study/NCT05786196#study-overview

This trial, known as MAGIC, appears to be ongoing. However, I have been unable to find any references to it. Which seems strange. Even more suspicious is that historical conference presentations/papers have made reference to MAGIC, however, the more recent conference proceedings - including from 2025 - have fallen silent. Hmmmmm. Not sure what to make of that.....

I must admit that my previous post about 'eye problems' and my quest for opportunities in Asia were predicated on myopia and Japan in particular. which has a massive problem and one with some opportunity - for example, Japan Eyewear (5889JP), which has a ROE of 27%, EV/S of 3.07x, EV/EBIT of 9.4x, and a 4.7% dividend. Plus a reasonable MC of $309m USD

I had stupidly dismissed glaucoma as a very small problem. How wrong I was. So, I did some digging into glaucoma in Japan. REASON: not only must an area have the problem, but also the financial means of rectification.

Surprise, surprise, Japan has the highest incidence of glaucoma per population at 2.31%, almost double that of the United States at 1.26% - according to Copilot.

In checking into the Japanese treatments for G, it became very apparent that the walls of 'evaluation, approval, and utilization' are fortress-thick. And there is no evidence of ITrack anywhere, but they are big on Minimally Invasive Glaucoma Surgery (MIGS) with IStent Inject, Hydrus Microstent, and PreserFlo MicroShunt, the go-to methods.

My conclusions are that it is going to be a hard slog to prove up the medical requirements, AND there will likely be a requirement for a different CEO in both the 'prove up the science' stage and the sales side, where you really need a gunslinger-style marketing person to run the show.

My investment's runway isn't as long as you whipper snippers, so I will watch from the sidelines, Best of.

.

(OK, just back at my desk from my own visit to the optician ... and as I am writing this post, Investor Relations has just gotten back to me with a response about the iTrack Register, so I will dump that verbatim at the end of this post)

@PortfolioPlus I have been digging further into the medical evidence and it brings me back to the point raised by @Shapeshifter. Without a comparison via an RCT or at least comparable real world evidence, it seems to me that $EYE cannot substantiate a claim of having a more effective product.

One barrier is that there are differences in the endpoints across trials, which makes even a less rigorous comparison (i.e., non head-to-head comparison across different trials), virtually impossible. For example, with respect to IOP reduction, a mix of measures including % reduction and reduction in mmHg are variously used across trials. So comparison is impossible, unless you actually get the pressure data. And even then you have the problem of different device/lab/operator/patient characteristics. etc.

Within the "error bars" iTrack cannot on my reading claim to be clinically superior, although the data could support a "not inferior' claim, and its IOP reduction achieved appears to be towards the higher end of the range for canaloplasty.

On safety, if the most recent data published from the Registry stands up, then iTrack could possibly claim to be safer with lower chance of side effects. Specifically, regarding hyphema (bleeding into the anterior chamber of the eye), iTrack does appear to have a lower incidence than OMNI. However, with OMNI, hyphema is described as "common but transient".

Both OMNI and iTrack might be favoured by some ophthalmologists because they avoid the need for permanent implants. And in that respect, there might be a patient preference, too.

Japan

So, coming back to Japan, I tend to agree with you. Given that the are multiple, established, approved MIGS treatments in the market, it seems likely that $EYE just don't have the data package including comparison data for market entry. Specifically, the PMDA/MHLW will want (1) a clear clinical positioning vs Japanese standard of care and (2) evidence the foreign data extrapolates to Japanese patients and practice.

More on this below!

US

Based on my investigations to date, I cannot find a clear clinical efficacy or safety reason to explain why iTtrack is gaining share over OMNI for canaloplasty.

So, now I'm going to speculate as to possible reasons:

1 ) Is iTrack being priced lower?

I'm having a hard time getting price data of sufficient quality to make a comparison. So, don't know. Maybe.

2) Surgeon Preference - is iTarget being positioned better with surgeons?

OMNI (name gives a hint) has been positioned for versaility within the Ophthalmic Surgeons tool kit, being used in both canaloplasty, trabeculotomy and hybrid procedures. iTrack is just used for canaloplasty. Therefore, is the workflow, the presentation to the patient, etc., for iTrack as a pure canaloplasty device giving the device an edge as simpler and/or less invasive (e.g. more simple to set up)?

3) Marketing Focus?

The Sight Sciences reps have mutliple products to promote, whereas Nova's are laser-focused on iTrack. Perhaps, by identifying surgeons who tend to specialise on Glaucoma, the $EYE Reps are able to provide more focus, and perhaps combined with 1) and 2) above, this is proving a winning formula? More air time to promote and reinforce key messages?

Something is going on and I know (from years studying several of the players in dermal repair) that there is more to selling more product than just the clincial data. There has to be a reason for the US sales chart shared by @Wini - and I wonder if a thesis is starting to form in the fog?

4) People

I don't have a gauge on management yet. But in medtech - as elsewhere - leadership makes a big difference.

For example, with $PNV the US business has done very well sustainably under a strong local VP Sales and Marketing. (By the way, dermal repair at $PNV does a lot less than US$2m per rep per year ... more like US$0.7m per rep per year by my count!)

For the $EYE team to have driven sales per Rep from US$1m per year to almost US$2m per year per Rep over 5 quarters, is very impressive. But what I cannot understand, is with that kind of market traction, why over the same period has the size of the salesforce actually GONE DOWN from about 11.5 average FTE to 9.5 FTE? The contribution per rep. (costing maybe US$150k all in) is very significant. With metric like that, I'd expect to see the workforce double in that time!!

There is somethere here that I am clearly missing. Possible explanations are: i) the existing sales forces has covered the entire market (which doesn't stack up for me) or ii) turnover is so high and training reps has a long runway, that they can't keep up.

Again, something in this picture doesn't make sense to me.

Conclusion

It appears that $EYE is on to something in US. And if that progress can be sustained, then - as plenty of companies have shown before - the US can be more than enough to build a successful medical devices business!

However, there are some things that just don't add up for me. I don't understand the clinical story, and I can't understand the marketing story. In writing this, I am not casting doubt on the device or the company, but being up front that I have only done very limited research over a couple of days. Also, this is a new therapy area for me, so I just don't have the body of knowledge I've built up in other areas like regenerative medicine, imaging, oncology etc.

I certainly don't have the confidence to invest yet, but it is early days, and this looks interesting enough to warrant further work.

I'll stop spamming the forum with posts, and will only update again when I have done some more conclusive work, and perhaps reached an investment decision.

====================================================================================

INFO From $EYE on the iTrack Registry (provide by $EYE Investor Relations)

Note the reference to the ongoing CATALYST Study, a prospective uncontrolled study using Registry data (EDIT: initially I erroneously said this was a RCT, it’s not). Maybe this is the kind of trial to support market entry to tough nuts like Japan? (Even though it is not being done head to head with another device).

Registry design and scope

The iTrack Global Registry was established in 2022 as a prospective, real-world observational database. Participating surgeons submit consecutive iTrack cases under predefined inclusion criteria. Data collection is prospective and longitudinal, with structured follow-up intervals including 12-month endpoints.

 Governance and independence

The Registry is independently managed, with participating surgeons and sites contributing data. Nova Eye does not control case selection, clinical decision-making, or patient management. The framework is designed to reflect routine clinical practice rather than protocol-driven trial conditions.

 Data capture and quality controls

Data fields are standardised across sites and include baseline characteristics, intraocular pressure, medication burden, and adverse events. Participating sites follow defined data entry protocols. Ongoing cohort expansion is expected to further strengthen statistical power and subgroup analyses.

 Statistical analysis

Annual statistical reports are generated from prospectively collected data. Outcomes such as success rates, IOP reduction, medication reduction, and adverse events are analysed across the cohort. As the Registry matures, surgeons are preparing peer-reviewed journal publications based on extracted datasets.

 Relevance for reimbursement and HTA

Prospective real-world registry data is increasingly used to support reimbursement dossiers, clinical guideline development, and payer engagement. The iTrack Registry is intended to complement randomised controlled trials such as the CATALYST study, providing both controlled and real-world evidence.

@Wini I came across a recording of the latest quarterly sales webinar, ... just in case you didn't attend.

Audio Recording of Webinar

which was fortuitous, because $EYE is too small for my usual feeds to pick up the transcript.

Here is the corresponding slide pack: slides

I gained some insight into where @Longpar5's comment regarding management might be coming from. I mean just listen to the response to the question about that key slide 10 showing the sales force productivity from 14:30 onwards for a few minutes. Sheesh!

The deeper I get into this, the more I can see the potential for this business, focused on the US. But management, that's another question .......

Hi Mike, according to EYE's latest presentation the US Medicare rebate for the surgeon is $542 and hospital $2,231 for the canaloplasty procedure.

An AI search shows the more versatile OMNI device as costing around $2,500 while the Itrack is much cheaper at $1,000. Reimbursement is the same for either device for the same canaloplasty procedure.

So unless the surgeon is insisting on the OMNI device the incentive for the hospital is majorly to use Itrack.

I suspect the big orders are coming from hospitals which gels with the surprisingly high anualised sales per sales rep of close to $2m.   And when you are up against competitor OMNI at 2 – 3 times the price of Itrack then maybe sales are relatively easy to make - particularly to hospitals. 

Which is all fine as long as there is a non-eroding sustainable margin for EYE. The last company stated gross margin was in FY 23 when EYE advised a healthy GM of 73%.  

@Scoonie that’s starting to make sense, and it explains how a simpler more focused product can eat share from a more complex, versatile, and costly product. Once that gets traction, there’s a way to run!

On market structure I reckon there are about 1800 surgeons doing glaucoma surgery, but the high volume specialists are probably only 25% or 450 covering maybe 60% of the total volume of procedures.

That might explain why $EYE have had a static (actually declining) sales force of 9-12 FTE. Concentrated in major centres they could conceivably serve all 400-500 of the high volume surgeons, and it’s a process of attrition to grind them down on cost … one that seems to be working at the moment.

By my numbers % gross margin in FY24 was 72.2% in FY24 but fell to 68.6% in FY25, despite them using only 25,000 units of a 100,000 unit per annum facility. So I’d normally expect to see strong %GM leverage.

These are not stellar device gross margins, and with sales and marking / revenue at 62.3% in FY24 and 60.7% in FY25, you see that the business is not demonstrating strong economics.

On the next post I’ll share my cashflow analysis. Economically, it looks like a weak devices company, and I think for me it is one to avoid.

My main arguments to avoid at this stage are:

• Growth guidance for FY26 is weak (but may be lowballed)
• Operating economics and leverage do not appear compelling
• The US go-to-market strategy has not been well articulated … I’m playing guesswork.
• Im not sure about management

All that said, iTrack Advance seems like an amazing device, it is clearly stealing share in a competitive market, and the overall market is growing well.

If you’re an investor with a deeper insight, then the SP is undemanding and now would be a good time to pounce (down 15% today).

But to me, it looks like another device company that has a great device, but doesn’t necessarily look like a great business.

I’m going to watch and I will attend next weeks webinar.

If I am wrong and it can continue to steal US share based on price, performance (efficacy and safety) without materially expanding the US sales and marketing footprint, then I could definitely be very, very wrong and the next 2-3 years could be transformational.

The fact I’m not investing yet probably means it will!!

@Scoonie @Wini continuing the previous post.

Momentum might be turning the US, but the annual cashflow trend analysis over 4 years is not promising.

Source: Annual Accounts

I didn't go further back in time, because historically the numbers are dominated by the Ellex Lasers and Ultrasound business, which was divested in 2021.

Operating Cash Flow ticked up in 2025,... is this the start of something big? Maybe. But I don't have any basis to believe this.

Today the business is focused on iTrack, and guidance for FY26 is Revenue US$21-24m, so say A$30-34m (excl. China). If we throw in US$1.2m for China, then we get a range of A$32-36m, which is around 8% - 23% growth. With the kind of economic leverage implied in the cashflow chart, that does not look like a quality devices business to me.

In the last annual report, the business provided a functional (US GAAP-like) presentation of its numbers --- yay. Here's the picture it provides:

Normally, Quality, Regulatory and Site Operating Costs will be allocated to manufacturing costs (ending up in COGS) or in Overheads. So when benchmarking $EYE to other device companies I think the %GM is probably worse than it is.

In this picture, it does look like some operating leverage has appeared from 2024 to 2025, but because it seems to have come from tight control of the top 3 (smallest) buckets, its not clear how much "juice" there is left.

On this basis, how long does it take to breakeven? 3 years, 4 years, 5 years? How many capital raisings will that require?

As I said in my earlier post, you'd expect to see operating leverage at the % Gross Margin level (there wasn't any from 2024 to 2025) and also in Sales and Marking (there was a little).

And that's why, as a business investment, I'm not convinced this is for me.

@mikebrisy All fair points/criticisms. One thing to note on the gross margin weakness FY24 to FY25 is most of that was felt in 1H25 when margins fell to 66% due to some supply chain issues. GM recovered to 70% in the 2H, and to make the maths work on EBITDA breakeven on current revenue guidance you have to factor in gross margins recovering to ~75% historical levels. 1H statutory accounts will shed some light on that in a few weeks.

There does indeed seem to be a degree of varabaility in %GM.

Interestingly, in the FY25 results presentation there is a reference to "Gross margin improvement from 66% in H1FY25 to 70% in H2FY25 due to process improvements."

Looking at these numbers, and having looked superficially at the design of the iTrack, I wonder if the varaibility in %GM is a sign of manufacturability issues with the device. From what I can glean, the iTrack is close to the frontier of what can be manufactured at a medical grade of quality. At this limit, things like environmental control, machine vibration, die wear, polymer molecular chain length (mean and distribution - which can vary batch to batch), consistency/control of extrusion pull tension, etc. may well conspire to create significant yield losses and yield variations.

Basically, laser detectors of extruded product flag when tolerances are exceeded, and resulting material is rejected ... that would be a normal control for this technology.

(You might have guessed that this is triggering the engineer geek in me, as I started my career as a postdoc doing work to support the manufacturability of a global block buster drug delivery device with manufacturability issues, only then to go on a few years later to manage a pharma plant with a product with horrible process yield variations - as low as 40% and up to 70% yield on a good day. The process was so unrealiable that for any market order we almost has to make 2 batches for every batch ordered. I found it almost impossible to plan my plant's annual budgets for that product!)

Again, I know nothing about the inside of this particular process, but I would have %GM variability due to manufacuting yield as a potential risk to look out for.

If this is the case, and if management don't explain this carefully to investors (btw, they might choose not to because you don't want to bring the regulators attention to this!), then of course investors are going to attach meaning to half on half yield variations, which might be nothing more than noise.

Another thought I had was that it could be a ramp-up / learning curve issue. However, as far as I can tell iTrack Advance uses the same microcatheter as the original iTrack. So, one would expect several years down the track for the inevitable learning after launch (2023 for iTrack Advance) to have stablised.

Alternatively, perhaps, as production has scaled, they've add multiple exturders. So when they talk about producing 25,000 units in a factory scaled for 100,000, then as product ramps they simply add additional extruders and/or assembly workstations and workers into available oversized factory space. This is a common approach for this type of manufacturing operation.

Again, all this is pure speculation on my part. Apart from the observation that there is %GM variability over several periods, rather than a distinct improvement trend.

You could of course take management at their word. Perhaps the process has indeed been improved, so that %GM goes on an upwards path. That is entirely to be expected. And there are many reasons why they should invest in product process improvement.

Let's see what the 1H26 result reveals.

It’s great to see the discussion picking up on EYE, our first contender for our bi-monthly Stock Spotlight initiative. I can see why it has piqued member interest, even though the challenges of early-stage med-tech are well understood.

I’ve since received a reply from Tom, and we’re just trying to find a time to do an interview, but that should go a long way in helping us understand the opportunity.

I’ve done a bit of reading, and there’s not a lot I can add that hasn't already been highlighted. But at this stage, in an effort to condense my working thesis, I’ll summarise my thoughts as follows:

The fact EYE has an actual device, in-market, with strong sales momentum is what first captures your attention. No amount of TAM-based blue-sky aspiration can substitute for actual growing sales to end users. That is what demonstrates adoption.

What's especially encouraging is that sales growth exceeds that of the broader industry, all while a major competitor is exhibiting flat sales. Furthermore, it's nice to see clinical evidence emerge from their registry showing an 85% success rate. We’ll need to see more work done here, but hopefully the CATALYST and MAGIC trials will spur faster adoption.

The operational setup is also quite attractive since they have significant spare manufacturing capacity.. they appear to be using only about 25,000 units of a 100,000-unit annual facility limit. That means they can scale up without heavy capital expenditure, allowing operating margins to improve as they layer more sales over a relatively steady cost base.

A cap raise is definitely something to be mindful of. It’s a near certainty in my opinion. Even if they do hit EBITDA breakeven (this target has already been pushed back once), there are other investment cash flows that must be accounted for, and I suspect the company is still a year or two off from any free cash flow. Besides, never waste a share price spike, right? Even if things go really well, they’ll need cash to support growth. I suspect they will rely on their debt facility in the short term, hoping another quarter or two of good sales growth and hitting EBITDA positive will help lift the share price and give them a better opportunity to raise.

That's not a problem per se. If new capital can generate an attractive ROI, it'll likely more than make up for any dilutionary effects.

There’s some shareholder alignment, with the founder and exec chairman holding over 4% (roughly $2.2m worth). However, the CEO only holds about 0.35% (approx. $187k worth). It looks like he was granted these as part of incentive plans rather than purchasing them on-market. Still, he didnt qualify for any STI bonuses last year, and his base is far from exorbitant. And to get his LTIs (performance shares) we need a significant rise in the share price, and he must wait three years for them to vest.

Lastly, while China is obviously a huge opportunity, it's very early days, and it is a country that has crushed the hopes and dreams of many ASX hopefuls. Still, they are generating sales there, and it is good to see a local partner. It's definitely something to keep an eye on.

If shares were 10x sales, I’d probably not be interested, but at ~1.6x, it doesn't seem as though there's much optimism priced in at all. Again, as others have noted, there's good potential for a re-rate if they can sustain sales momentum without ratcheting up costs. Or, alternatively, the market is right to be sceptical...

I'll continue to dig..

If any questions for Tom come up during your research, please add them here

There was a Nova Eye Medical $EYE investor webinar this morning. The transcript appeared in my feed, and so I have posted a summary of the call at the bottom of this post.

US Market Strategy:

I continue to fixate on the fact that over two years, the US has materially increased the revenue per sales reps, indicating strong volume growth. This while the number of resps has declined from c 11.5 FTE to 9.5 FTE over a two year period of growing revenue per rep of over $1 US million to just under US$ 2million. (Although in the earlier January call, Tom said that they have just recruited someone.) Having cranked te numbers, while OMNI's volume appears steady

I've now heard Tom requested to explain this multiple times, and he is constant in his answer. He was to maintain a high sales per rep sales force, to maximise the return and minimise the time to cash flow breakeven.

I've really tried to get my head around this strategy. Today, I got another insight. He made it clear that they are targeting the wider population of ophthalmic surgeons who do cataract surgeries, but find that 20% of their patients also have glaucoma, and so are offered a canaloplasty while they are in for the cataract surgery. This is important because it means that $EYE is targeting a wider US based than I first thought.

To recap, I concluded that the only way I could explain their saleforce strategy, was if the focus was the high volume, glaucoma specialists. I had estimated there to number about 1,800 but deeper research indicates a number of 1,200 - 1,500 is more likely.

This is important because in ophthalmology, having a sales force of, say, 10 reps, means each rep support 120-150 surgeons, which is a much higher number than typical bechmarks of 30-60.

Interestingly, investors pressed the CEO on this today, asking what he felt the maximum sales force would be at maturity (my words), but he would not be drawn. For clarity, here is the relevant extract from the transcipt.

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Mark Flynn   Investor Relations

Thanks, Tom. Lots of questions around the revenue per rep as per the sales rep. So whilst positive, obviously, to see that increase in the revenue per rep. So just some context around the chart around the headcount again, considering the sales team expansion would appear to be the principal driver of revenue growth?

Thomas Spurling   MD & Executive Director

Sales rep expansion in the United States does ultimately improve revenue. There's no doubt about it. We have regions in the United States that we feel are underpenetrated. And as we fill those regions, we will increase sales. We do this, as I've said a number of times, at a rate to ensure that our revenue per rep does not dramatically fall. Because we have such a reliance on the United States, if we spend too much on reps too quickly to try and grow too fast, we will ruin our bottom line. We -- as I've said a number of times, we are here to improve the bottom line and achieve growth. That balance involves a lot of above 20% growth seems to be what people want. But we are not exploiting the opportunity at the rate we could exploit in terms of sales if we chose to invest in reps harder and faster.

Mark Flynn   Investor Relations

What does that full U.S. coverage look like over time?

Thomas Spurling   MD & Executive Director

I think the best guidance on full U.S. coverage is that market share number I gave. 3.5%, 3.9% isn't very much. So I think -- imagine if it was, as I said, 7.8%, twice that. That means twice the revenue we had, which we're going to be happy with. So I don't have an answer to that beyond the fact that we are showing growth. We are tracking -- we continue to track up, and that shareholders should be learning to trust us that we can deliver on what we're saying we're going to deliver.

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Now, given that a sales rep costs all up maybe $150k p.a. and maybe $200k p.a. high end with all on costs, and given that they can get to $1million annual sales run rate in 4-6 months, from my perspective, scaling the salesforce has compelling economics. (For example, competitors in the space have a Glaucoma sales force of more like 50-70, without achieving anthing like the productivity that $EYE is achieveing.)

So What

I believe that thestrategy is to focus on the highest value accounts, and to prioritise postive EBITDA over value. But when the business turns to being cash generative, then I believe that $EYE will intensify its sales force investment in the US. Why am I confident that this is the case?

Well, consider the following facts about market structure.

Glaucoma Specialists:: 1,200-1,500 with >95% MIGS adoption performing stanard and complex glaucoma procedured

Comprehensive/Cataract Surgeons: 8,000 - 9,000 with 45% to 55% perfomring glaucoma procedures combined with cataract procedures = 3,800 to 5,000 surgeons

TOTAL MIGS Practitioners: 5,000 - 6,500 surgeons

At an extreme benchmark of 1 rep to support 100 surgeons, you get a mature glaucoma sales force of 50 - 65, up from around 10 today.

Now of course, you won't maintain US$2m revenue per rep at that level, but at the point at which the business becomes cash generative, then the investment in sale force will be the highest return opportunity available to the business.

Even at the low level of investment in sales force today, the market share for $EYE is increasing. If we look at the % revenue share of listed device companies operating in the Glaucoma space, the 2024 to 2025 share of revenue has progressed as follows:

• GKOX Stents - 68.8% to 63.9%, revenue = -18%
• SGHT (Sight Sciences) - 26.8% to 29.7%, revenue = -3%
• EYE 4.4% to 6.4%, revenue = +27%

So there is no question that:

1. Canaloplasty is taking share materially from more complex MIGS procedures (stents)

2. $EYE is capturing the lions share of the gains,..... without an aggressive sales force push.

So, my conclusion is that we will start to see some incremental sales rep additions this year, but once EBITDA positive is passed, then $EYE will (or should) ramp up the saleforce.

It also appears to me from having done a deep dive into the CMS HCPCS codes, that the system is incentivising surgeons to perform the simpler, cheaper canaloplasty than the more complex stent procedures. And it is also clear to me that $EYE are emphasising the better safety profile of iTrack over OMNI (less temporary eye bleeding).

So, the sales momentum is there without them really pushing. But will management push once they have operating cash generation?

My Overall Conclusion

I believe the set-up is there for $EYE to accelerate its US market penetration, but they may be waiting for the EBITDA breakeven before reinvesting operating cashflow into expanding the sales force. I get this clear impression from trying to decipher what the CEO is saying.

The sales momentum they are achieving in the US in the absence of driving rep count is, quite frankly, remarkable.

I still have questions over management, and I want to see what the 1H FY26 Gross Margin is. Has it stabilised or are we continuing to half on half volatility, which could point to underlying manufacturing issues? We'll have a further data point in a few weeks.

I continue to watch only for now, as I continue my research. but I agree that $EYE could be interesting.

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Summary of Today's Webinar Transcript

Nova Eye Medical – Investor Call Summary (Q2 FY26)

1. Market positioning & strategy

Nova Eye positions itself in interventional glaucoma, targeting patients earlier in the disease cycle to reduce reliance on eye drops. Management repeatedly emphasised the structural limitations of pharmaceutical therapy (poor compliance, quality-of-life burden) and framed surgical intervention as a superior long-term disease-management solution.

A key strategic advantage highlighted is the natural pairing of glaucoma treatment with cataract surgery:

• ~32m cataract surgeries globally per year
• ~20% of cataract patients also have glaucoma
• This creates a compelling “while-you’re-there” proposition for surgeons and patients.

Key message: Nova Eye is not competing head-on with drops, but reframing glaucoma management around earlier, device-based intervention.

2. Product & clinical differentiation (iTrack)

The iTrack catheter enables 360-degree canaloplasty (described as “angioplasty of the eye”), using a micro-catheter (~2 human hairs thick) to flush the canal of Schlemm and downstream collector channels with viscoelastic.

Differentiation repeatedly stressed:

• Implant-free
• Tissue-sparing
• FDA-approved for glaucoma
• No permanent foreign body left behind

Management contrasted this with MIGS competitors that either cut tissue or leave implants, positioning iTrack as the most physiologically conservative option.

3. Commercial traction & procedure volumes

• ~17,000 procedures in the last 12 months (run-rate)
• ~180,000 procedures performed cumulatively
• ~3.9% share of the MIGS market
• ~40% CAGR in U.S. revenues over the last six half-year periods

Management explicitly downplayed the current market share as “tiny,” reframing it instead as evidence of significant headroom in a large addressable market.

4. U.S. execution & sales infrastructure

Nova Eye places heavy emphasis on in-house U.S. sales infrastructure:

• Directly employed sales force
• Strong KOL support
• Investment in brand, clinical data, and reimbursement education

Management described this infrastructure as “boring but foundational,” arguing it underpins the sustainability of growth.

Operational capacity:

• FDA-approved manufacturing facility in Fremont
• Sufficient headroom to scale volumes

5. Financial performance & momentum

Key financial and operating highlights:

• Record December-quarter sales
• Growth driven primarily by the U.S.
• LTM revenue up ~24% (vs industry growth well below this)
• January U.S. sales momentum continuing (anecdotal, preliminary)

Cash flow commentary focused on underlying improvement, with management stressing that recent operating cash outflows were largely due to working capital investment (receivables) rather than structural losses.

6. Unit economics & pricing discipline

From Q&A – Pricing

• iTrack unit price has remained stable at ~US$1,000 (CEO note this isn't the price, but indicative number so investor can do calculations)
• Reimbursement levels have not increased
• Management explicitly ruled out price erosion
• Margin improvement is being driven by COGS reduction via scale, not pricing

This signals a volume-led operating leverage strategy, not a pricing-led one.

7. Sales efficiency & expansion strategy

Nova Eye highlighted sales per representative approaching US$2m per rep per quarter, described as industry-leading.

From Q&A – Sales force growth

• Revenue growth is driven by both:
• Adding new surgeons
• Increasing utilisation among existing surgeons
• Management is deliberately pace-controlling sales force expansion to avoid diluting revenue per rep and damaging near-term profitability.

Clear message: growth is being optimised for margin and cash flow discipline, not maximum top-line acceleration.

8. Clinical data & registry strategy

Management underscored the importance of its real-world registry, positioning it as:

• A continuous source of prospective data
• Critical for payer, regulator, and surgeon engagement
• A long-term competitive moat

A key near-term catalyst flagged:

• First peer-reviewed paper from the registry expected imminently

9. Cash flow outlook & credibility

From Q&A – Cash flow

• Management declined to comment on monthly cash flow volatility
• Reiterated focus on quarterly trends
• Emphasised delivery against guidance and improving predictability

Tone suggested a shift from “growth story” to execution and trust-building phase.

10. Management, geography & investor perception

From Q&A – Leadership

• CEO rejected the idea that a U.S.-based CEO is required
• Emphasised people and execution over geography
• U.S. sales leadership already locally based

From Q&A – Valuation & U.S. investors

• Acknowledged U.S. funds show interest but face ASX friction
• Management sees improving cash flow, scale, and liquidity as prerequisites for broader institutional uptake
• Standard response on valuation (“CEOs always think shares are undervalued”), but emphasis was on doing the work rather than promotion

Overall takeaways

• The call reinforced execution consistency, not strategic change
• U.S. growth, sales efficiency, and pricing discipline were the dominant themes
• Management is clearly prioritising predictability, operating leverage, and credibility
• Q&A responses were measured and conservative, with no promotional overreach

Investor signal: Nova Eye is positioning itself as a disciplined compounder in interventional glaucoma, rather than a high-risk, high-burn med-tech story.

One thing I'd want to understand better, is why isn't Sight Science's revenue growing?

I looked at this last year, the answer to this question boils down to basically surgeons were rorting Medicare in the US by stacking multiple procedures (OMNI has 3 available) into one procedure. In 2023 some Medicare providers reclassified these combo procedures as investigational which meant no reimbursment. This was subsequently overturned, but it knocked the wind out of SS sails and had surgeons reevaluate etc. There seems to be a belief now within Medicare/Medicaid that the OMNI product was created in part so that surgeons could juice reimbursements. That created the opening for iStent and iTrack which are single procedure devices to take market share as they are not considered "at risk" of losing reimbursement status.

From what I understand in the US, quite a bit of the opthamology industry has private equity interests in it. Hunting around for reimbursement "enhancements" would certainly fit that industry.

(a bit of this might be off because it was 6 or so months ago that I looked into it, but I think broadly I have got down the mechanics of what happened)

We managed to lock in Nova Eye CEO Tom Spurling for an interview. He'll be joining us at 11am AEDT on Monday the 16th of February.

With Nova Eye being our first stock in our Spotlight series, I'm keen to encourage members to take a look at the company when they can, and add any insights to the company page. Of course, sometimes digging into a company raises more questions than answers, so if that's the case it'd be great if you could list any questions on our slido page

Once the meeting is finished, we'll get together to discuss our findings and perspectives.