Leading the way to better fertility outcomes. By Helen Henderson and Bethan Halliwell
The femtech market is thriving with more investment and attention than ever before as it ushers in a new wave of health solutions for women, including advancements to infertility treatments. Recent examples of breakthroughs include the first birth achieved through mitochondrial donation treatment (MDT) and successful conception through the utilisation of a sperm-injecting robot.
Whilst advances are being made, there is still much work to be done, particularly in the area of assisted reproductive technologies (ART), which are typically only successful for one in three women. With demand for new technology driving the pace of development, femtech innovators are exploring ways to improve outcomes for families.
IVF and automation
The automation of IVF treatments is being driven by the need for greater efficiency and accuracy. Where previously human involvement and oversight could lead to errors, automation mitigates this risk, for example by freezing egg cells in a process known as oocyte cryopreservation. This automated process involves maintaining the fertilised eggs under controlled conditions, increasing the likelihood that an embryo will develop.
Early-stage hormone treatments are also becoming automated to reduce the risk of human error and facilitate better outcomes. For example, an algorithm has been developed in Japan that is able to precisely measure dosages of recombinant follicle-stimulating hormone (rFSH) – the hormone required to stimulate egg production in IVF patients. In doing so, it reduces the risk of ovarian hyperstimulation syndrome (OHSS).
In addition to advances in automation, AI and machine learning are increasingly playing a role in areas such as embryo selection. Israel-based company, Fairtility, has developed an AI-based decision support system capable of predicting embryo viability, with a patent application pending at the World Intellectual Property Office (WO 2022/259028).
This technology is able to analyse time-lapsed images of key visual indicators such as the size, proportion, area, shape and symmetry of a developing embryo using artificial neural networks to give a reliable prediction of its viability. Time-lapsed images make it easier to identify the differences between states over a given time frame (for example from fertilisation to blastulation). As the system is also able to analyse minute features that might get missed by a clinician viewing a static image, the risk of human error is reduced further, leading to improved results.
IVF progress in the home
It’s not just clinical or laboratory settings that are seeing advances in FemTech. This fast-growing market which is expected to reach US$20.59 billion by 2030, has seen a boom in apps and other digital platforms designed to give patients greater insight and a sense of control over their fertility and IVF journey, from the comfort of their homes. By using such tools to gather patient data and combine it with other third-party data, scientists are gaining knowledge about infertility which could help to speed the way to new solutions.
The benefits of alternative technologies for treatment outcomes
The recent surge in the use of apps has coincided with growing interest in the benefits that can be achieved by practising IVF in space. For example, experiments in a low-gravity environment have led to the development of MDT – an innovative treatment to tackle mitochondrial disease which is a genetic mutation affecting over 14,000 people in the UK. In this treatment, nuclear DNA from the mother’s fertilised egg is replaced by that of a donor’s fertilised egg.
SpaceBorn United, an innovator based in the Netherlands, is planning to launch a series of unmanned bio-satellites over the next five years to further this research. The company is intending to undertake the first human IVF procedure whilst in orbit, as part of the Assisted Reproductive Technology in Space (ARTIS) research programme. This programme involves a series of missions up to 2028, at which point the conception and development of a human embryo in a partial gravity environment will be attempted.
Protecting innovations within IVF technology
With so much innovation activity in the femtech space, some of which is related to advancing IVF treatments, it is increasingly important for research teams to protect their innovations.
There are some particular challenges to be aware of when seeking patent protection for innovations in this field, not least the fact that some may not meet the stringent patent eligibility criteria. This is further complicated as different patent laws apply in different countries. For example, the European Patent Office (EPO) will not permit patents for methods that involve embryo destruction, the use of embryos for either industrial or commercial purposes, or any processes designed to modify the germline genetic identity of human beings. The United States Patent and Trademark Office (USPTO) will not patent anything that can be considered as relating to natural phenomena, such as processes that involve the visual monitoring of embryo development.
In a rapidly developing area of life science, innovators must remain focused on the ultimate goal – discovering new ways to treat infertility and improving patient outcomes.
Helen Henderson and Bethan Halliwell are both patent attorneys at European intellectual property firm, Withers & Rogers, specialising in the life sciences and medtech sectors