Memphasys WKN: A2ANGR ISIN: AU000000MEM5 Kürzel: IG7 Forum: Aktien User: Mef36
0,0035 EUR
±0,00 %±0,0000
22. Nov, 21:34:01 Uhr,
Lang & Schwarz
Kommentare 51
Icondor,
26.11.2021 15:09 Uhr
0
Ich viel passiert nach der HV
Icondor,
25.11.2021 18:33 Uhr
0
Bin auch wider eingestiegen mal schaun was geht😁
D
Doorsjim,
25.11.2021 6:06 Uhr
0
1 gerät verkauft heute is Versammlung
Icondor,
08.11.2021 19:55 Uhr
0
Bin am überlegen wider einzusteigen, das Volumen ist aber sehr niedrig, mal schaun ich überlege noch
D
Doorsjim,
07.11.2021 11:01 Uhr
0
Jepp Verifizierung abgeschlossen Ende November ist Hauptversammlung ich werde meine Aktien noch paar Jahre halten
Icondor,
04.11.2021 2:07 Uhr
0
Gibt es neues von Felix? Ich bin vor einiger Zeit ausgestiegen, Beobachte aber die Aktie weiter
D
Doorsjim,
03.11.2021 21:22 Uhr
0
Jetzt geht's wieder nach ob Ende November sind wir wieder auf min 10 Cent
D
Doorsjim,
17.06.2021 20:16 Uhr
0
Kapitalerhöhung abgeschlossen somit ist wieder genug Geld für die Weiterentwicklung des kann wieder aufwärts gehn
D
Doorsjim,
14.03.2021 15:17 Uhr
0
Ich glaube immer noch an einen möglichen Erfolg aber ich glaube auch das die Finanzmittel knapp werden ohne corona würde es hier ganz anders aussehen
Icondor,
09.03.2021 8:25 Uhr
0
Ich bin ausgestiegen bei 0,071, keine News, keine Zahlen, kein Volumen nicht los mit der Aktie
D
Doorsjim,
08.03.2021 20:21 Uhr
0
So langsam werd ich nervös bin bald wieder beim kauf Wert angekommen
D
Doorsjim,
06.02.2021 0:15 Uhr
0
Hast du ne Ahnung wie viele Cash Reserven noch vorhanden sind ich hab angst das denen das geld aus geht
M
Mef36,
28.01.2021 19:32 Uhr
0
Werde aufjedenfall bis April einfach liegen lassen eventuell sogar nachkaufen.
M
Mef36,
28.01.2021 19:31 Uhr
0
Angesichts der negativen aktuellen Auswirkungen von Covid-19, einschließlich der Abschaltung vieler unserer KOL-Kliniken und der KOLS
in frühen Märkten, in denen neue optimierte Protokolle für ihre Praktiken getestet werden sollen
Produktionsgeräte) rechnet das Unternehmen nun mit ersten kommerziellen KOL-Verkäufen in „frühen Märkten“
im März / April 2021.
M
Mef36,
27.01.2021 17:58 Uhr
0
technique improvements. This has led MEM to amend the protocol for using the Felix device, with KOL
partners requested to use the amended protocol assessment, and improved technique, moving forward.
Preliminary sales discussions have commenced with some early market KOL partners; however they have
requested to conduct further Felix testing with production devicesfrom the initial production run and with
the new optimised operating protocols, to ensure consistency with earlier results, before resuming
commercial discussions. These devices and cartridges have been sent to these KOL partners, with
optimised assessment to occur using these devices in January/ February 2021.
Given the adverse current impact of Covid-19 including shutdown of many of our KOL clinics, and the KOLS
in early markets seeking to undertake testing of new optimised protocols for their practices using
production devices), the Company now anticipates first KOL commercial sales in ‘early markets’ to occur
in Mar/Apr 2021.
Potential Research Sales and Collaboration with Prestigious Chinese Universities
Following a well-attended Felix ‘wet lab’ demonstration at the Chinese IVF Congress in November 2020
the Company has been approached and is in advanced negotiations with several leading Chinese medical
research institutes which are seeking to use the Felix systems for male infertility research projects in
conjunction with Prof John Aitken.
Memphasys is working to get Fast Track regulatory clearance in China, which could potentially enable
National Medical Products Administration (NMPA)1 clearance in 2nd Half 2022. China is the single largest
IVF market in the world. It is estimated that in 2012 there were approximately 40 million infertile orsterile
individuals in China, with changing lifestyle patterns delaying pregnancies, which has led to declining rates
of fertility2
.
In 2017, the number of IVF cycles performed in China was 302,190 and it is expected to reach 842,890
cycles in 2025. In terms of value, the China IVF services market accounted for $957.04 million in 2018 and
it expected to reach $2.68 billion by 20263
.
This announcement has been approved for release by the board of Memphasys Limited.
M
Mef36,
27.01.2021 17:58 Uhr
0
Highlights
• Preliminary sales discussions underway with some Key Opinion Leaders(KOLs) in ‘early markets’
with low regulatory requirements.
• Initial Felix KOL testing results have been positive, with recent testing with Monash IVF and
University of Newcastle identifying further technique improvements which KOL partners will
now incorporate into Felix assessments.
• Key Opinion Leaders (KOLs) in early markets now wanting to test final Felix production
cartridges which are now available, to ensure consistency with earlier results, before resuming
sales discussions.
• MEM continues with production of final production cartridges, positioning the Company to fill
Felix commercial sales orders in early low regulatory markets from early 2021.
• Initial production capability is 26,000 Felix cartridges per annum, with capacity to increase as
required.
• Initial sales of Felix production devices are being negotiated with prestigious Chinese medical
research institutions seeking to collaborate with Professor John Aitken and his research group
at University of Newcastle to expand Felix clinical utility.
Australian-based bio-separations company Memphasys Limited (ASX: MEM) (“Memphasys” or “the
Company”) is pleased to provide an update on the commercialisation activities for its Felix device, a novel
automated device for quickly and gently separating high quality sperm from a semen sample for use in
human IVF procedures.
Cleanroom & Verification and Validation
Memphasys has completed its initial run of the production cartridges in its cleanroom facility, located at
the Sydney headquarters of manufacturer W&S Plastics. W&S has the capacity to produce approximately
100 cartridges per day (26,000 cartridges annually) within the cleanroom, with the ability to scale up
substantially, depending on demand. Validation and verification testing for early markets, with cartridges
from the initial production, will be completed in early January (after which time customers from early
markets can receive product).
Commercial KOL Sales Update
Memphasys remains in regular contact with its KOL partners and in particular the KOLs in early access
markets, which provide an opportunity to accelerate commercialisation of the Felix device.
The Felix device has been operating as expected and initial assessment results from KOL partners has been
positive, however, recent testing with Monash IVF and University of Newcastle has identified further
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