Infertility affects 1 in 6 people globally, leading more patients to turn to assisted reproductive technologies (ARTs) such as IVF, ICSI, and IUI. Despite advances across many areas of reproductive medicine, success rates have stagnated at approximately 33% live births per cycle, and sperm selection remains an under-innovated step in the ART workflow. Conventional methods such as swim-up and density gradient centrifugation are labour-intensive, operator-dependent, and can compromise sperm quality while limiting throughput and recovery. Further, current methods often force a trade-off between selecting the highest-quality sperm and recovering sufficient volume for clinical use. There is therefore a need for a simple, rapid, and scalable platform capable of delivering sufficient numbers of high-quality sperm for clinical use.

To address this unmet need, we have developed *Sperm Syringe*, a patented biomimetic microfluidic sperm selection platform that mimics the natural, highly parallelised selection environment of the female reproductive tract. Unlike conventional methods, Sperm Syringe selects sperm based on their natural ability to actively navigate confined microfluidic pathways, without centrifugation, electrical fields, membranes, or complex manual handling. Whilst many existing microfluidic sperm selection technologies are limited by low sample volume, low recovery, slow operation, or poor integration into clinical workflows, Sperm Syringe combines biological relevance, high throughput, simple operation, and manufacturability within a syringe-like user interface. Our published 3D-printed alpha prototype contains over 500 microchannels and processes ~0.5 mL of raw semen in only 15 minutes, recovering around 1.85 million sperm. Proof-of-concept testing demonstrated over 90% improvements in key sperm quality measures, including DNA integrity and morphology, while also improving throughput and collection volume compared with conventional and emerging sperm selection approaches.

The project is now progressing from a 3D-printed research prototype toward scalable manufacturing through injection moulding using IVF-grade polymers. The next-generation design incorporates improved usability, manufacturing suitability, and a 16-fold increase in channel throughput. Development is being undertaken with Forme Technologies - an ISO 13485-certified manufacturer - supporting design-for-manufacture, material selection, tooling strategy, and scalable production. Candidate materials have been assessed using mouse embryo assay to confirm embryo safety and support regulatory readiness. These activities provide a clear pathway from a published research prototype to a scalable, reproducible, and commercially viable product.

Sperm Syringe has applications across livestock and human assisted reproductive technologies. Our translation strategy is to first enter the livestock IVF market, where lower regulatory barriers enable faster market entry and earlier commercial adoption. Initial customers include livestock IVF laboratories, animal breeding companies, semen processing providers, and commercial embryo production groups seeking improved fertilisation consistency, embryo production efficiency, and reduced waste of valuable reproductive material. This provides a defined first market where Sperm Syringe can generate early revenue and demonstrate value in high-volume workflows before expansion into human fertility clinics.

In parallel, the technology will progress toward human ART applications through safety, performance, and regulatory studies, including FDA 510(k) and TGA pathways.

Through this pathway, Sperm Syringe has the potential to improve fertility treatment outcomes, increase consistency in livestock embryo production, and create a globally scalable commercialisation opportunity.