Experts in biological Separation
NuSep Holdings Ltd (ASX: NSP) is an Australian publicly-listed bio-separations company with innovative separation techniques based on our proprietary membrane technology.
NuSep has approximately 55.1% shareholding in PrIME Biologics Pte Ltd, a Singapore based company commissioning a plasma fractionation facility in Singapore to address the Asian therapeutics plasma products market. For more information visit PrIME Biologics Pte Ltd.
NuSep Holdings Limited
Innovation in Biological Separation Processes
NuSep specialises in biological separations for commercial applications.
NuSep’s patented process enables the selection of high value substances from the fluid in which they are contained by applying an electrical field (electrophoresis) to the fluid. Proteins or cells can be extracted utilising NuSep’s proprietary polymer separation membranes to pick out specific components based on their size and charge.
NuSep’s business activities are currently focused on three main areas:
- SpermSep: NuSep’s Patented Process for Sperm Processing
- Bioseparations: Membrane and Electrophoresis Processes for Bioseparations
- Gels & Diagnostics: Electrophoresis Gels and Dagnostics
NuSep’s SpermSep business focusses on the selection of the most viable sperm from semen samples for use in fertility treatments including IVF for humans and various artificial reproductive techniques (ART) for animals.
There is currently a higher incidence of miscarriage, premature births and various genetically-based diseases such as cancers and neurological diseases in progeny created from IVF and certain other ART fertilization methods than from natural methods.
Increasingly, there is concern about the current human sperm preparation techniques of centrifuging and cell culturing as these introduce physical damage and oxidative stresses which lead to DNA damage to the sperm and subsequent possible impairment of the quality of the offspring.
The Separation Process: The CS10 utilises PRIME (Preparative Isolation by Membrane Electrophoresis), a patented technology that can purify most macromolecules from complex biological samples inside the containor.
Ongoing Clinical Assessment
Early clinical assessment has shown unique capability for human IVF using the SpermSep process. There have been three live births out of nine infertile couples while there were no live births out of the nine couples in the control arm of the trial. Publication of these results has generated considerable international interest.
THE SPERMSEP MARKET
The large and increasing use of Assisted Reproduction Technology (ART) in humans is driven by increasing incidence of both female and male infertility. Increasing numbers of couples are planning to have children relatively late in life, when natural fertility declines significantly. Male fertility is in long-term decline and is a factor in more than 45% of infertility cases.
The market for human assisted reproduction services is about 1.5 million cycles worldwide each year, producing approximately 350,000 babies.
There are approximately 3,000 human IVF clinics worldwide. Europe records the largest IVF activity, markedly exceeding the US due to the high reimbursement available for fertility treatments. Human IVF activity in Asia is also increasing rapidly.
The human IVF industry is estimated to be worth ‘around US$9.3 bn worldwide, growing to US$21.6bn in 2020’ (Allied Market Research, 2014), and A$470 million in Australia. In addition, ‘global human IVF disposables sales were estimated to have been US$370 million in 2013 (Vitrolife 2013 Annual Report), with 12% year-on-year growth driven by geographic expansion’ (Origio/Cooper, 2011).
Artificial Reproductive Techniques in Animals
Artificial Insemination (AI) is widespread in developed countries. In the USA over 90% of the nation’s dairy cows are bred by AI, and the use of AI by commercial swine producers is currently 70 – 75%. In the EU, almost 90% of pigs and dairy cows are produced by AI.
Artificial Reproductive Technology (ART) in veterinary applications such as IVF is a high cost business, and there is a continuing search for lower cost processes. Better sperm selection techniques are needed to increase the number of successful embryos generated per insemination.
IVF is an important growing niche in the animal ART market.
The veterinary ART consumables market is worth US$213m per annum globally.
NuSep will initially undertake IVF trials in high value animals using the SpermSep process.
Separation of Biological Material
In early 2014 NuSep spun out its previous major business in human plasma separation, Prime Biologics Pte Ltd in Singapore (refer www.Primebiologics.com). NuSep still has a majority of the shareholding in Prime, but management control is held by the new Asian investors.
NuSep has retained the key membrane technology scientists and is focusing on developing its own new separation membranes and capabilities for other bio-separation opportunities. The membrane separation technologies being developed will generate new patents which will be owned by NuSep.
Electrophoresis Gels & Diagnostics
NuSep currently make and distribute precast polyacrylamide gels and associated consumables internationally. In vitro diagnostic reagents are also distributed in Australia.
Two minute visualisation of Gel bands
Visualize Bands in 2 Minutes. All nUView precast gels incorporate a unique formulation allowing protein bands to be visualized in only 2 minutes in the presence of ultraviolet (UV) light. Simply place your gel over a 250-320 nm UV trans-illuminator and watch high-resolution bands appear in just 2 minutes. With nUView technology you no longer have to stain and de-stain your gels - increasing protein recovery and saving you significant time while receiving improved results.
NuSep has intellectual property relating to electrophoresis apparatus, consumables (e.g. separation cartridges and separation membranes) and other hardware relating to sperm separation.
NuSep holds patents specific to the SpermSep technology and a license agreement is being executed with our clinical research partner, the University of Newcastle, for IP they have developed in this field.
New membrane separation technologies being developed will generate new patents owned by NuSep.