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MEMPHASYS LIMITED. Capital/Financing Update 2019

Jan 10, 2019

65314_rns_2019-01-10_396d49f2-7170-4117-a371-055ab8b02c21.pdf

Capital/Financing Update

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ASX Release

11 January 2019

TWO MORE KEY OPINION LEADERS APPOINTED TO UNDERTAKE FELIX ASSESSMENT AHEAD OF COMMERCIALISATION

Highlights

  • Memphasys signs MoUs with two additional Key Opinion Leaders (KOLs) to separately take part in in-vitro assessments of the Felix device.

  • The independent studies will be led by much publicised and international leaders in reproductive medicine and andrology.

Australian-based bio-separations company Memphasys Limited (ASX: MEM) (“Memphasys” or “the Company”) is pleased to announce it has signed two further Memorandums of Understanding (“MoUs”) with globally significant research and clinical service facilities, the University of Florence (Italy) and the Isfahan Fertility & Infertility Clinic (Iran), to take part in in-vitro assessments of the Felix device.

Memphasys has now signed and announced a total of five KOLs to participate in its commercial Felix assessment program, ensuring its commercial plans remain on track in 2019.

The two new KOLs are as follows:

University of Florence (Italy) – Assoc Prof Elisabetta Baldi and Dr Monica Muratori

The Laboratory of Sperm Biology at the University of Florence and Azienda OspedalieraUniversitaria Careggi is a long-standing leader in Italy and internationally in male infertility.

Associate Professor Baldi and Dr Muratoris’ focus is on sperm biology, sperm function and sperm DNA damage. Both are much published in peer-reviewed publications in these fields.

The Isfahan Fertility & Infertility Clinic (Iran) - Dr Mohammad Hossein Nasr-Esfahani

The Isfahan Fertility & Infertility Clinic is headed by Dr. Mohammad Hossein Nasr-Esfahani.

Dr. Mohammad Hossein Nasr-Esfahani has an international reputation in embryology and andrology. He is Chief Embryologist at the Isfahan Fertility and Infertility Center and is Professor of Embryology at the Royan Institute in Isfahan, Iran.

He obtained his PhD in embryology in the University of Cambridge under the co-supervision of professors John Aitken, now at University of Newcastle, and Martin Johnson and he has published widely in international journals.

Under the terms of the three independent MoUs signed, Assoc Prof Elisabetta Baldi, Dr Monica Muratori and separately Dr. Mohammad Hossein Nasr-Esfahani will participate with worldrenowned fertility expert and co-inventor of the Felix technology, Prof John Aitken, and Memphasys in the clinical validation of the Felix device in a clinical setting.

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They will independently work collaboratively with Prof Aitken to validate the Felix system and confirm its application and efficacy in separating spermatozoa under clinical conditions from a range of clinical samples of human semen.

Commenting on the signing of two additional KOLs, Memphasys Executive Chairman Ms Alison Coutts said:

“With the signing of these additional KOLs, Memphasys has proven that globally significant and world-renowned fertility experts, IVF clinics and andrology reference centres want to be actively involved in clinical validation of the Felix device in a clinical setting, as a precursor to commercialisation of the Felix Device.

“The recruitment of these leading IVF clinics and andrology reference centres in the United States, Europe, Middle East and Australia who have initiated their willingness to take part in the Felix assessment is testament to the interest in the device. Recruitment of other leading centres is proceeding well and will continue to be announced as they are finalised.”

Recently, the Company signed an MoU with USA-based fertility specialists, Colorado Center of Reproductive Medicine, CCRM (see ASX announcement dated 20 December 2018) and two European centres: Stockholm-based leading male infertility clinic and andrology centre, ANOVA (see ASX announcement dated 22 October 2018) and with UCA/GReD, France (see ASX announcement dated 22 November 2018).

As previously outlined, the KOL clinical assessment studies will assess and confirm Felix’s performance for IVF clinics in preparing sperm from diverse semen types when compared with the current lab-based methods, (“density gradient centrifuge” and “swim up”), which are labour intensive, costly and DNA-damaging.

The outcomes of the Felix clinical assessments will provide further evidence as to the technical capabilities and broaden the clinical benefits of the Felix device, provide significant user examples of its range of use and further refine the commercialisation strategy of the Company.

Assessment Protocols

Prof Aitken will develop assessment protocols with each IVF clinic and andrology centre. The Felix assessment program is expected to have two protocols at each site – one general protocol for all IVF clinics and andrology centres, comparing the Felix-selected sperm against the quality of sperm selected by current lab methods (Swim Up/ DGC) with routine clinical semen samples; and a second assessing Felix performance for particular types of male infertility of particular interest to each individual IVF clinic or andrology centre.

ENDS

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For further information please contact:

Alison Coutts Executive Chairman Memphasys Limited +61 2 8415 7300 [email protected]

David Tasker Managing Director Chapter One Advisors +0433 112 936 [email protected]

About Memphasys:

Memphasys Limited (ASX: MEM) specialises in biological separations for high value commercial applications. The Company’s patented membrane processes in combination with electrophoresis, the application of an electrical potential difference across a fluid, enable the separation of high value substances or contaminants from the fluid in which they are contained.

The main application of the technology is the separation of the most viable sperm cells for artificial reproduction, most particularly for human IVF.

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