Publicly listed IVF technology innovator Memphasys (ASX: MEM) has started its much-anticipated Key Opinion Leader (KOL) assessment program, with key IVF sites around the world poised to asses the technical capabilities and commercial opportunities of the Felix device in commercial IVF centres.
KOL sites are expected to be some of the first to purchase the Felix system cartridges and consoles.
Local IVF player and KOL Monash IVF and the University of Newcastle will be the first KOL participants to test the new production devices ahead of wider international KOL assessments.
The Felix device has been developed to improve IVF rates by separating high quality sperm from semen. It is expected the assessments at leading andrology centres globally will provide widespread validation of the device prior to the commercial sales, which are anticipated to launch by mid to late 2020.
Monash IVF which is Australia’s most established IVF pioneer has been strongly supportive of the device development, participating in pilot cartridge and device testing, and will be an important source of data for the upcoming KOL trials.
To date Memphasys has produced 300 cartridges, with a further 200 to be delivered by mid-November and 2,000 in early December.
Three consoles which operate the single-use cartridges have also been produced, with a further 15 to be supplied in early December and in early 2020.
The rigorous assessment being undertaking by Monash IVF and University of Newcastle will not only confirm the clinical results assess the performance of the device, but will also review the packaging, labelling and instructions for use, to ensure the wider KOL roll-out occurs successfully.
The KOL assessments are anticipated to occur in a staggered release, reaching at least 13 clinics in the USA, Europe and the Middle East, amongst others.
Commenting on the commencement of assessments, Memphasys Executive Chairman Ms Alison Coutts said:
It is exciting to finally see the consoles and cartridges produced and that the KOL evaluation program is underway.
“With respect to market strategy, the company, together with our regulatory advisors, has been proactive in analysing a range of sizable early strategic test markets with lower lead times than CE Mark in Europe and the US FDA and we have come up with a number of new, highly attractive markets which we are verifying.”
In tandem with the trial launch, Memphasys has also signed-on another clinic, with India-based Nova Pulse IVF Group agreeing to participate in the KOL program.
Nova Pulse, which is a leading clinic across the sub-continent, will trial the Felix device at a western India-based clinic, which is one of Nova Pulse’s 19 clinics across the country.
Memphasys has also identified and met with three other potential and strategically important additional KOLs.
The KOL trials will generate important clinical data to accelerate regulatory clearance across the different international markets, with Memphasys looking at locations to launch commercial sales.
While Australia, Europe and the USA present higher regulatory hurdles, the IVF innovator remains on track to file a request for a pre-submission meeting with Australia’s TGA in Q4 CY2019.
Australian data from Monash IVF and the University of Newcastle will feed into the submission and to be deemed a commercial device, the Felix devices must also pass a verification and validation process.
According to Memphasys, verification is commencing now and is expected to be complete by year end, while the subsequent validation process is expected to be completed by mid-2020.