Humanity has a profound demographic problem and it’s not overpopulation.
On the contrary, men are becoming more infertile and the quality of their sperm is deteriorating, leading to health problems.
According to world leading male fertility expert Professor John Aitken, sperm counts have roughly halved over the last 50 years, with an estimated 20 per cent of men infertile.
Poor sperm quality means that 75 per cent of genetic mutations are passed on by the father, rather than the mother.
Another startling fact of life is that while males produce 1000 sperm a second, even in healthy males 96 per cent of them have deficiencies such as double heads, short tails or bent necks.
“An old lecturer of mine used to say that if men were bulls, they would be taken out the back and shot,” says Prof. Aitken.
While no-one’s sure of the reason for the reduced collective sperm count, vaunted factors include chemical pollutants and electromagnetic radiation.
Whatever the underlying cause, there’s an urgent imperative to improve the quality of the global sperm pool, or else ageing western countries with declining fertility rates will become even less productive.
A Distinguished Emeritus Laureate Professor who retired from the University of Newcastle in June 2021, Prof. Aitken has been intimately involved in an enhanced technique to select the very best sperm for in vitro fertilisation (IVF) and other artificial insemination (AI) procedures.
As he puts it: “the cells we choose are the best ones in a sea of mediocrity.”
The work is by way of collaboration between the University of Newcastle and the ASX-listed Memphasys, which is on the brink of commercialising its Felix sperm separation device.
A biochemist with a doctorate in wild animal reproduction,
Professor Aitken’s migration to Australia was serendipitous.
“I was at the University of Edinburgh and was offered a job at the University of Newcastle and I thought they meant the Newcastle University on Tyne, just up the road,” he says.
“It was quite a shock when they said they would fly me over to have a look.”
He had a look anyway, if only because the 1997 visit coincided with the Australia-West Indies Test match at the SCG.
He saw Australia win the match, but did not pull stumps and head home.
The Felix device evolved from Prof Aitken’s knowledge of the ASX-listed Gradipore, which was developing a device to separate molecules on the basis of size and electrical charge.
In a ‘light bulb’ moment, Prof. Aitken pondered whether the sperm could be separated using that technique; given healthy sperm have a strong negative charge.
The most common sperm separation technique – discontinuous density gradient centrifugation – risks accentuating such cell damage because of the powerful centrifugal forces involved.
Another method, swim-up can also be deleterious (as its name implies, swim-up selects the sperm most capable of busting out of the seminal plasma and making their long journey up the fallopian tube).
“Our process does not involve chemicals or shearing forces,”
Prof. Aitken says. “It’s also very quick.”
Gradipore morphed into NuSep and then into Memphasys.
The clinical testing of a predecessor prototype device centred on studies at Sydney’s Westmead Hospital. This prototype device proved at least as effective as conventional methods, as measured by pregnancy rates.
A small study sample meant the company could not claim the device was more effective. But it can safely assert that the Felix device method takes six minutes, compared with almost one hour for the centrifuge technique.
The commercialisation push had a setback in March, when an engineering flaw in the Felix device was identified.
This required further verification and validation testing to ensure the units would pass all quality control and assurance tests. The verification leg has been completed with the validation expected to be finished in the current quarter.
The company has also sought counsel from key opinion leaders (fertility experts) across 14 IVF centres in countries including Japan, USA, Germany, New Zealand, Canada and even populous India.
Then there’s potentially an even bigger market in the animal AI and diagnosis market, notably for horses and cattle.
On the testing side the idea is that after ‘covering’ a mare, a stallion will have his residual sperm assayed to test if it likely to result in a pregnancy.
Artificially inseminating thoroughbreds is illegal, but there’s strong demand for other equine sectors such as polo ponies and the harness racing industry, which is so short of runners it has resorted to importing them.
Work is also underway on developing semen transportation methods that don’t involve freezing and then thawing the samples, which reduces sperm fertility.
Research house GrandView Research expects the global animal AI market to be worth $US2.5 billion by 2026.
The animal potential is not lost on Perth horse breeder Bob Peters, the company’s biggest shareholder who last month contributed $1.65 million to a $3 million capital raising (by way of convertible notes).
Back on the human side, the company cites an addressable market of 1.2 million fresh IVF cycles by 2026, compared with 450,000 in 2018.
In Australia, 5 per cent of babies are conceived artificially while in Denmark the proportion is a world-leading 10 per cent.
“There are now eight million IVF babies globally, but the technology has remained the same since it was introduced in the late 1970s and early 1980s,” Prof. Aitken says.
“Now is a good time for us to revolutionise these technologies. And while we have had many twists and turns I think we are in the best place we could be.”