Nuwa Life Submits IPO Prospectus: Pioneering PIMS Technology Revolutionizes Assisted Reproductive Industry with Epigenetic Screening

In June 2021, Guangzhou Nuwa Life Technology Co., Ltd. was established in Huangpu District, Guangzhou. True to its name, the company focuses on “creating life”—specifically, assisted reproductive services—and has introduced a new generation of embryo screening technology for IVF, known as “PIMS,” to the assisted reproductive testing industry.

PIMS, or Pre-implantation Methylation Screening, differs from traditional third-generation IVF technology (PGT) as a novel approach to pre-implantation embryo selection based on epigenetics. By assessing the genome-wide DNA methylation status of embryos, PIMS simultaneously evaluates embryonic developmental quality from two dimensions: methylation levels and chromosomal ploidy.

The PIMS technology is the culmination of nearly a decade of scientific research by Professor Liu Jiang’s team. Professor Liu is a doctoral supervisor at the Beijing Institute of Genomics, Chinese Academy of Sciences (CAS), Director of the CAS Key Laboratory of Genomic Science and Information, and Deputy Director of the Institute’s Academic Committee. He has published five articles in top-tier international journals, including Cell and Nature, with his 2013 paper in Cell beingThe First Cover Article Independently Published by a Chinese Team in This Journal。 

Prior to joining the Beijing Institute of Genomics, Chinese Academy of Sciences, Professor Liu Jiang conducted scientific research at the University of Michigan, Yale University, and the University of Chicago in the United States, engaging in in-depth research for six years in the fields of cell biology and genomics. In 2009, Professor Liu returned to China and established his laboratory team at the Beijing Institute of Genomics, Chinese Academy of Sciences, where he began exploring how genetic information is transmitted from parents to offspring based on genomics, with a particular focus on the inheritance patterns of DNA methylation in gametes.

The decision to focus on embryonic DNA methylation research was driven not only by Professor Liu Jiang’s strong interest in the field, but also by his recognition of the significant pain points in clinical assisted reproduction at that time.

Assisted reproductive technology has brought hope to a large number of infertile patients, but clinical data from the United States in 2019 showed that only 25.5% of embryo transfers resulted in live births. Even with preimplantation genetic testing (PGT), only about 40% of embryos led to live births. Professor Liu Jiang stated, “I wanted to find out whether abnormal DNA methylation was responsible for the high rate of embryo transfer failure. Therefore, our laboratory collaborated with Peking University Third Hospital, and our research indeed revealed that a significant number of human embryos exhibited abnormal DNA methylation.”

In light of this phenomenon, Professor Liu Jiang began to explore whether a novel embryo selection technique based on epigenetics could be developed to improve clinical live birth rates in assisted reproduction. Guided by this hypothesis, Professor Liu’s team initiated clinical trials in collaboration with Shandong University. The results validated his hypothesis, with extensive clinical data demonstrating that embryo screening via DNA methylation analysis can significantly increase the live birth rate of in vitro fertilization (IVF).

To further expand research and translate this public-benefit technology from scientific inquiry into clinical application, Professor Liu Jiang led his team in establishing Guangzhou Nuwa Life Technology Co., Ltd. (hereinafter referred to as “Nuwa Life”), thereby advancing the commercialization of Preimplantation Methylation Screening (PIMS) technology and benefiting a broader population undergoing assisted reproductive treatments. Meanwhile, leveraging PIMS technology, Nuwa Life has implemented a global intellectual property strategy; it has already secured patent grants in China, Japan, the European Community, and South Korea, while patent applications in the United States and Eurasia are currently under substantive examination.

Seven years ago, after Professor Liu Jiang’s team discovered a strong correlation between embryonic DNA methylation levels and embryo development, they began attempting to perform whole-genome DNA methylation analysis and library preparation using minimal amounts of embryonic cells. This represented the first major hurdle in the practical implementation of PIMS technology: how to achieve single-cell DNA methylation library preparation.

During the DNA methylation library preparation process, bisulfite treatment results in an 80%–90% loss of DNA. Through extensive research, Professor Liu Jiang’s team successfully overcame the technical barriers associated with “single-cell DNA methylation library preparation.” Building on this breakthrough, they have gradually established a whole-genome DNA methylation database comprising nearly 1,000 embryo samples, laying a solid foundation for the subsequent commercialization of PIMS technology.

Following the completion of the initial R&D of the PIMS technology, Nuwa Life commenced investigator-initiated trials (IITs),Conducted over 800 embryo tests, screened for healthy embryos for more than 180 families, and found that the live birth rate per single embryo transfer using DNA methylation-selected high-quality embryos reached 70%.。

It is reported that methylation-based detection technologies are widely used in the field of oncology, where clinical early cancer screening is performed by detecting specific methylation sites. The PIMS technology, however, differs not only in its application scenario but, more critically, in that Guangzhou Nuwa Life Technology Co., Ltd. has conducted comprehensive methylation analysis across approximately 28 million sites spanning the entire embryonic DNA methylome. This approach not only enables the identification of epigenetic disorders undetectable by conventional third-generation IVF techniques but also allows for the assessment of embryonic developmental quality by evaluating the overall methylation levels of the embryonic genome.

It is worth noting that while the PIMS technology detects genome-wide DNA methylation levels in embryos, it can also screen for aneuploidy in the embryonic chromosomes, thereby covering the scope of traditional PGT-A testing. This means that if PIMS screening is used clinically, there is no longer a need for PGT-A screening. Correspondingly,The single-embryo transfer success rate based on PIMS testing has also increased from the traditional 30–40% to over 70%., effectively addressing key pain points such as the low overall efficiency of current assisted reproductive technologies and the high incidence of birth defects.

Furthermore, unlike PGT-A screening, which targets a specific demographic of IVF patients—namely, women of advanced maternal age (over 35) and those with recurrent miscarriages—PIMS screening encompasses the entire spectrum of individuals preparing for pregnancy, from younger to older patients. It is applicable to all individuals undergoing IVF, thereby improving success rates across the board. In comparison, the advantages of PIMS technology are disruptive. With Guangzhou Nuwa Life Technology Co., Ltd. promoting its application, the assisted reproductive technology industry is poised for a new landscape, holding significant implications for population health in China.

Currently, Nuwa Life is actively advancing the clinical research of its PIMS technology and submitting applications for Class III medical device registration in accordance with national regulatory requirements. Meanwhile, Nuwa Life has launched its Series A financing round, with the funds raised primarily designated to accelerate the registration application process for Class III medical devices based on PIMS technology, as well as to support the research, development, and commercial translation of new products.