MEM (ASX) MEM Discussion

Originally posted by Quest09: ↑

(Link to previous post : https://hotcopper.com.au/posts/78889423/single )

(Link to previous post : https://hotcopper.com.au/posts/78890458/single )

Update on the weekly MEM chart (see above links for previous analysis/opinion).

The double bottom formation continues to build quite nicely.

Volume has seen a relatively massive increase in trading. As the below table shows, 725 million units have been traded at about this level..........that is almost 1 billion units in 5 months of trading.

IMO, the signs are good for upwards momentum after a massive accumulation of shares at these current levels.

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Originally posted by Quest09: ↑

An IVF company in Brazil called Overture Life has just had an automated cryogenic freezing device for IVF cleared for use in Brazil by the Brazilian National Health Surveillance Agency (ANVISA). The device has been cleared for commercial sale and use (as per below screenshot).

As we know MEM has just started commercial discussions with a company called Androscience in brazil to introduce the Felix System into the Brazilian market, as per following link (Link to post about Brazil Androscience deal: https://hotcopper.com.au/posts/78693773/single ).

The interesting thing about this is that apparently, the Overture Life device was classified as a Class 1 medical device for the regulatory clearance process.....and here is the really interesting part...............registration for commercial sales of class 1 and class 2 devices in Brazil are described below, alongside the average timeframe to achieve registration (apparently it only takes 1 to 3 months for the process):

Key Differences and Timeframe for Registration :
Class I devices are non-invasive and pose minimal risk, requiring a simpler and faster approval process.

Class II devices may have some level of invasiveness or require additional documentation for safety compliance, making the approval process slightly longer than Class I devices.
Both classifications allow for a notification-based registration, avoiding the lengthy full registration process required for higher-risk devices like Class III and IV.

If my research is accurate, then MEM device could potentially be classified as a Class 1 or Class 2 device and therefore could potentially receive clearance for sale in as little as 3 months through a notification process provided by the Brazilian regulator.

Felix sales and a commercial deal for Felix sales in Brazil could be much closer than we think.

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Originally posted by Quest09: ↑

IMO, this below announcement regarding the MEM expansion into Brazil takes on a whole new and important meaning given the above attached information about the Brazil medical device government approval process (potentially, approval for commercial sales can be achieved in 1 to 3 months).

Also, the clinical trial being conducted by Lab Androscience was estimated to take 3 months. That was just on 3 months ago now.....so we could be due news on this at anytime.

From the announcement in February:
"sophisticated investors associated with Laboratorio Androscience have expressed an interest in supporting Memphasys’ activities in the country............... they are likely to invest to facilitate market entry via a licensing arrangement...........the Company (MEM) will keep the market fully informed should a proposal be received that warrants disclosure."

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This last line in the announcement seems like a little teaser of what is to come.

Moving from local auditors (Pitcher Partners) to international auditors (BDO) could mean more than meets the eye, especially with that last line added into the announcement.

Originally posted by Quest09: ↑

Updated article on Trump's USA policy on IVF, with reference to the above attached posts.

Some quotes from the article:

"This is a key priority for President Trump, and the Domestic Policy Council has completed its recommendations"

" 'As a fertility doctor who's been practicing for the last 13 years, I don't think I've ever had this level of excitement for what the government is going to do,' he said. 'For the first time in my career, IVF is a priority at the highest levels of the government. It signals to patients that finally our advocacy is being heard. Both sides of the aisle are recognizing the problem we have in this country with access to IVF care'."

"IVF costs vary but range from about $12,000 to $25,000 per cycle, and people often need more than one cycle."

"During his campaign,Trump vowed to make the fertility treatment free for women but didn't give details about how he would fund his plan or precisely how it would work."

USA looking very positive in relation to potential IVF activity and potential IVF investment.

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Originally posted by Quest09: ↑

EU fertility rates are in decline.
2.1 births per woman is the threshold for maintaining population size, let alone increasing population size. Below image shows that pretty much all of Europe is far below the threshold for maintaining population size. This trend does not only occur in Europe, but is a global problem faced in many countries and continents, like America, China, Japan, etc. etc.

The policy and procedures surrounding IVF is becoming a strong focus for many countries around the globe (see below attached posts).

MEM is in the process of applying for CE Mark certification to sell the Felix system into Europe.

As per above attached post, a snapshot of how MEM's Felix System compares to the conventional methods of IVF sperm separation shows that the Felix System is "best in class" with "clear advantages in performance, quality and operating costs."

IMO, it is easy to see how the Felix System can quickly achieve the required certifications to supply and sell its "best in class" IVF device into IVF clinics within Europe and around the world.

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