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Reproductive technology developed by Memphasys (ASX:MEM) is proving to be a gamechanger in addressing the men’s side of infertility – which is now understood to cause at least half of all conception issues.
The company’s Felix™ System has successfully completed its Phase III clinical trial, proving it works faster than traditional methods, without adverse effects, and with scientists preferring it over the most widely used traditional IVF technologies.
Memphasys reached its primary endpoint comparing its Embryo Utilisation Rate against existing Density Gradient Centrifugation (DGC) and Swim-Up IVF techniques.
The trial has proven Felix is as good as the Swim-Up technique and “superior” to the world’s most used DGC method. And, Felix has other benefits in relation to both existing methods, which I’ll run through shortly.
Enormous demand
To say Memphasys is working to address an unmet need is an understatement – the demand for solutions to fertility issues is enormous.
Most of us know of someone who’s been through the IVF process. It’s stressful, expensive, and utterly devastating if it doesn’t work. Memphasys’ technology could be the answer for would-be parents who’ve seen other IVF options and multiple rounds of IVF fail.
Can Felix make a difference to the outcomes for IVF patients?
“Yes” and “Absolutely,” Memphasys MD and CEO Dr David Ali told HotCopper.
“The trial was extremely rigorous, and we chose an endpoint of embryo utilisation because that’s the benchmark of Assisted Reproductive Technology (ART) cycle success. We now have data that meets this benchmark.
“We’ve really met the acid test in proving that our device works effectively.”
Memphasys partnered with Monash IVF Group (ASX: MVF), another Australian reproductive and fertility services company, for the trials.
Guys: You matter too
IVF has long focussed on female fertility, but andrology – the science of male reproduction – suggests 50% of the onus of creating a baby actually lies with men. That’s right, male infertility is just as likely to be the problem in failed conception!
The forgotten half: One in 20 men infertile
Memphasys’ work was based on the male side of fertility being the ‘forgotten half’.
Male infertility can be caused by issues including low sperm count, poor sperm quality, hormonal imbalances, genetic disorders, and more.
Global authority on reproductive biology, Emiritus Professor Dr John Aitken, leads a team studying fertility at The University of Newcastle’s Centre for Reproductive Science. He wrote the book The Infertility Trap and is the Scientific Director of Memphasys.
“Our understanding of the male reproductive system is approximately 20 years behind our understanding of the female system,” he said.
“One in 20 men is infertile, yet we do not have a medical specialty in male reproduction.”
(You can read more about Professor Aitken’s work in the area here.)
It’s in this male reproduction side where Memphasys is positioned – and is set to make a real difference for patients and its shareholders.
Much faster, cheaper to run and less risk of contamination
Memphasys’ Felix™ system “works with sperm in a way other devices can’t,” Dr David Ali said.
Dr Ali is also an expert in the field; he holds a PhD in Pharmacokinetics and is a published researcher. He’s presented at international conferences and worked in drug discovery, clinical project management, clinical pathology, business development, and operations at senior levels – so there are no novices here.
“Our trial results reinforce the ability of Felix to effectively separate high-quality sperm and improve embryo utilisation rates.
“While other methods are focussed on sorting sperm according to the motility, size and quality, the process takes 45 minutes to an hour.
“The whole Memphasys Felix process can take six minutes!”
It’s not hard to see this will eventually reduce staffing costs – labs will need fewer people and fewer qualified people as you can have a technician run the Felix device rather than an andrologist or embryologist.
Perhaps even more importantly, the risk of damage and contamination is reduced due to the single cartridge design. The risk of sperm getting mixed up and confused is much lower, need we say more!
“The clinical trial reported no adverse events related to the FelixTM System,” Dr Ali said.
“And 100% of scientists preferred the FelixTM System over DGC; while more than half of the scientists preferred the FelixTM Systemover Swim-Up.”
What’s next?
“As of now, we have a product that’s clinically validated,” he said.
“Memphasys is preparing data to enter the CE Mark regulatory process”.
“Once registration is achieved this will provide the company with the opportunity to market the Felix™ System in Europe, Australia and India, as well as in markets where mutual recognition of conformity assessment is already recognised.
“This includes countries like Japan, Canada, U.S., and Switzerland, where Felix is already being sold.”
But that’s only the start.
“We already have distribution agreements in Japan, Canada, and New Zealand through Vitrolife, a Letter of Intent (LOI) with Heranova in China, and R&D sales through Panacea Medizintech LLC in the United Arab Emirates (UAE),” Dr Ali said.
“We are having conversations with external parties who wish to engage us in distribution arrangements or licensing deals. If a particular entity is interested in buying the device, I’m interested in looking at a deal around that.
“The message to our shareholders will be commercialisation, commercialisation, commercialisation in 2025, getting this product registered, trying to expedite that time, and to get it sold in market, and do commercial deals – that will be the focus.”
What is the commercial potential?
The commercial opportunity is substantial. On that, Dr Ali has told HotCopper: “China is 33% of the global market, one of their clinics could do up to the same number of cycles as Australia would do in one year.”
“It’s a huge market; there’s huge opportunity there.”
Next on the hit list would be Japan as well as India, the latter of which has seen 11 couples deemed sterile birth healthy children in the wake of a 2023 trial of Felix.
“When you think that both China and India have mandates given by the Government to increase the population, there’s no reason why Felix won’t fit into the reproductive paradigm in those countries,” he said.
Recurring revenue
“Really importantly, our revenue model is extremely exciting as well,” Dr Ali explained.
“It’s based off the printer and ink revenue model. Nowadays you purchase a printer unit which is relatively cheap – as is our console.
“The revenue and return sales are generated by the consumable… which is the cartridge. Each cartridge is a single-use cartridge, so if you’re doing 20,000 cycles a year, you will be using 20,000 cartridges, for example, and you must use new cartridges each time. It’s a really good way to generate revenue.”
How it works
MEM’s Felix™ System is an automated sperm separation device, utilising electrophoresis and a proprietary membrane technology to gently separate sperm for Assisted Reproductive Technology (ART) procedures.
The Felix™ device consists of two main components: a console, which supplies electrical power, and a sterile disposable cartridge for sperm isolation and selection.
And it works for animal infertility too
Memphasys has identified a need in the equine industry.
“We’ve found the device can actually be used off the shelf to separate sperm for horses or horse breeding,” he said.
“No more R&D has to go into changing Felix or altering Felix from its current state, which is a huge advantage.
“We are currently talking to people in the equine market that are interested in the device and applying it to horses.
“There are applications across many other animals – we’ll be happy to explore those.”
The next Rockstar – well let’s call it RoXsta
There’s a new RoXsta (rapid in-vitro antioxidant assessment) in the wings too.
Memphasys’s RoXsta device will quickly measure oxidative stress which can affect fertility in both humans and animals because oxidation can affect sperm quality.
“It’s a very high-value area to look at,” Dr Ali said.
“We expect to be the first in market as a point of care rapid clinical diagnostic and we see clinicians in the IVF space could use this device within their clinic rooms.
“They’ll be able to get readings on oxidative stress levels for their patients and then be able to prescribe the right medication or antioxidants to them almost immediately.
“This will transform oxidative stress diagnostics.
“It will help to resolve and manage many key factors in: Male fertility; cardiovascular disease; livestock health; food technology; and the cosmetics industry – it can be used in multiple industries globally and for multiple applications within those industries.
“We are hopeful for another huge success.”
The bottom line
Given all of this, you’d have to think that big pharma and device companies could be watching, or even circling.
Time will tell.
Memphasys last traded at 0.7c.
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