Infertility is the most common healthcare condition for adults in their 30s-40s, affecting 3.5m people in the UK alone, and 15% of all couples worldwide. It has been declared a Global Public Health Issue by WHO, and global fertility rates are expected to decline further to 2.4% by 2030(UN). Around 50% of fertility issues are male-related and of these 90% are due to sperm number, mobility or motility and have been shown to reduce chance of pregnancy, reduce quality of embryo and are negatively correlated with miscarriages. Intracytoplasmic Sperm Injection(ICSI) is a clinical procedure whereby a sperm is injected into an egg to assist fertilisation. Despite ICSI having been around for more than 25 years and importance of high-quality sperm for successful ICSI, 'best' sperm is **manually** selected by an embryologist based on sperm morphology and motility. The operation is dependent on the skills and experience of the embryologist. This project will see the University of Birmingham collaborate with Myma Medical Ltd. and a leading IVF clinic, Cambridge-IVF to develop autoICSI-Sperm; an advanced AI-based microfluidics system to automate sperm selection, isolation, quality evaluation, and immobilisation processes all in a single, integrated lab-on-a-chip device. Based on WHO guidelines, autoICSI-Sperm will automatically select a healthy sperm from a whole semen sample for subsequent injection into an egg. By enabling full automated sperm selection our technology can overcome the challenges of the current manual approach, helping improve success rates for couples, profitability for clinics, and cost-effectiveness for NHS Integrated Care Systems (ICSs). As a stand-alone product, autoICSI-Sperm will address critical points of failure within the current process by automatically trapping and isolation of individual healthy sperm, vision recognition to digitally tag the healthiest sperm, and an AI-assisted, real-time data-driven quality assessment for motility and morphology using WHO guidelines. Automatic sperm immobilisation will then take place prior to injection. However, we will also focus on developing autoICSI-Sperm as an AI-based innovation for integration into our in-development autoICSI-Egg system, which offers automated egg manipulation and fully-automated precision sperm injection, to form the world's first complete automatic ICSI system. The main project output will be an automatic sperm-selection system ready for pre-clinical trials, taking us closer to commercial launch. A completely new offering, vastly improving current IVF processes worldwide and an opportunity for Myma Medical and the UK to become world leaders in the $23.4b Artificial Reproductive Technology market.

Highly accurate vision camera system with enhanced AI algorithm to assist in automated ICSI process for IVF treatment. Infertility affects 3.5m people in the UK, 186m worldwide and is the most common healthcare condition for 30-40-year-olds, with 106 IVF clinics in the UK and over 5000 worldwide. It is estimated that approximately 10% of women globally are affected, with ~14% of couples in their reproductive age facing challenges. This is expected to rise due to individuals delaying having children and low sperm counts in men becoming more common. Individuals with fertility issues are also at a higher risk of anxiety and depression. Despite the huge problem, the most common and effective type of assisted reproductive technology (ART); in-vitro fertilisation (IVF) has seen no significant improvements in 25+ years. During the current process embryologists select the best sperm available and fertilise eggs by manual injection via microscope-mounted electromechanical micromanipulator using joysticks. This process depends on individual skill, and can result in poor control/accuracy during injection, procedural inconsistency, egg damage and inevitable human error. This leads to low success rates (~30%) and patients requiring several cycles/procedures before conception@£10k-12K per-cycle. This issue is worsened by a lack of highly-skilled embryologists resulting in long waiting lists and poor pregnancy rates. New technologies are essential to increase fertilisation success rates, increase profitability for clinics and cost-effectiveness for the NHS. In collaboration with University of Birmingham and £600k grant funding (IUK, EPSRC, MRC), Myma Medical has designed AutoICSI; a first-of-its-kind automated ICSI system. AutoICSI is currently at TRL4, proof of concept has demonstrated a reduction in egg damage (upto 10%), human error and improved inconsistencies between embryologists, leading to a 10% increase in fertilisation success rate compared with current IVF. The high accuracy vision camera system with enhanced AI algorithm will significantly improve performance of AutoICSI system by making it easier for the micro-pipette to track, immobilise and pick up the most conforming sperm for injection into the egg.

Myma Medical will collaborate with the University of Birmingham and Cambridge IVF fertility clinic to develop a first-of-its-kind automated Intracytoplasmic Sperm Injection (ICSI) system to improve fertility treatments. "autoICSI" will use robotics, vision recognition and AI to minimise the risks of inconsistencies and damage potential of manual egg manipulation and sperm injection, helping improve success rates and accessibility for couples, profitability for clinics and cost-effectiveness for NHS Clinical Commissioning Groups(CCGs).