TGA certification | Basecare Full line Assisted Reproductive Culture Solution Gems is approved in Australia

Recently, the third generation of full-line assisted reproductive culture fluid Gems developed by BMX (Genea Biomedx), a subsidiary company of Basecare, passed the Australian TGA standard certification. This means that the culture solution has met the quality requirements of the Australian TGA and is eligible for legal sale in Australia. Previously, Gems culture solution (a total of 12) has all obtained the EU CE certification, of which 6 have also been approved in the United States FDA.

Australian TGA Certified production standard "Tip of the pyramid"

The TGA, or Australian Medical Supplies Authority, is the regulatory body for medical supplies (including drugs, medical devices, health products, etc.) in Australia. TGA certification is known as the "top of the pyramid" production standard in the international community, which sets strict testing standards for the raw materials, production facilities, production process and efficacy claims of the audited products, and is recognized as one of the world's most stringent management and market access difficult product audit systems.

The TGA certification also means that Gems is also recognized by other member countries of the PIC/S (International Pharmaceutical Certification Partnership), including the UK, France, Germany, Canada and more than 20 other countries."

The whole line assisted reproductive culture medium, to achieve the whole cycle of uninterrupted culture

The culture solution can simulate the human environment and provide nutrients for the gametes and embryos to survive. Its use runs through the complete chain of assisted reproductive operations and has a direct impact on the success rate of eventual implantation of the embryo back to the mother. Different stages have different requirements for the formulation of culture medium, and it is necessary to use multiple culture medium in the laboratory to complete all in vitro culture operations, and the research and development of culture medium has high technical barriers and difficult clinical verification challenges.

第三代全品系辅助生殖培养液Gems

12 customized culture fluids covering the whole process of assisted reproduction

Gems has 12 different formulations, including: fertilization medium, cleavage embryo medium, blastocyst medium, whole course medium, follicle flush medium, sperm gradient separation medium, sperm culture medium, sperm buffer, Gavi freezer, vitrification freezer, glass dissolve jelly and gamete buffer.

Gems is involved in the whole process of assisted reproduction, covering sperm extraction, egg and sperm evaluation selection, fertilization, cleavage embryo culture, blastocyst culture, embryo continuous culture, freezing, transfer steps, which can provide a safe and stable medium and the best nutrients required for embryo development.

The development quality of blastocyst was significantly improved by continuous culture

A clinical study of more than 40,000 embryos showed that compared with the combination of "desktop incubator + sequential culture Medium", the combination of "wet time difference incubator Geri+ full culture medium Geri" can achieve uninterrupted continuous culture, effectively improve the quality and utilization of blastocyst development, and bring about an increase in the success rate of embryo transfer.

Clinical data showed that as of the 5th day of in vitro culture, the blastocyst rate under continuous continuous culture was 33.6% (non-continuous culture was only 23.6%), the blastocyst utilization rate was 52.5% (non-continuous culture was only 41.5%), and the fetal heart pregnancy rate after transplantation was 37.3% (non-continuous culture was only 30.1%).

Research and development iteration for more than 30 years, the product reputation is widely recognized

In June 2023, Basecare completed the acquisition of BMX Singapore and its seven subsidiaries. BMX, a Singapore company that is a global leader in assisted reproduction culture solution and incubator technology, began to engage in the development of culture solution in 1991, and its first generation of culture solution technology was licensed to Cook Medical (Cook Medical) and approved by the National Medical Products Administration (NMPA).

After years of formula iteration and innovation, the third-generation full-line assisted reproductive culture solution Gems was officially put into clinical use in 2013, and obtained EU CE and US FDA certification in 2016 and 2017, respectively, and product safety and high quality are widely recognized worldwide。

夯实胚胎实验室场景，全产业链布局再提速

除了本次获批的Gems培养液，收购还为贝康医疗带来了全球唯一可加湿的时差胚胎培养箱Geri、全球首款全自动玻璃化冷冻仪Gavi和全流程电子管理系统Gidget。这些产品在全球20多个国家取得了超过70张注册证，为600多家辅助生殖机构所使用。

Basecare has built five assisted reproductive laboratory scenarios including PGT, embryo, andrology, freezing and whole fertility cycle software management system around the assisted reproductive diagnosis and treatment process, with products covering intelligent equipment, testing reagents, high-end consumables, management software and technical services. The acquisition of BMX Singapore strengthens Bekon Medical's strength in the embryo laboratory and further accelerates Basecare full industrial chain layout in the field of assisted reproductive medical devices.

Previously, the time difference embryo incubator Geri has been approved in China. In the future, Basecare will accelerate the commercialization process of Geri in China and gradually introduce the full line of BMX products, including Gems culture solution, to China. By building a production base covering an area of about 70,000 square meters, we will gradually promote the localized production of overseas high-end assisted reproductive medical devices, and bring more accessible quality options to Chinese assisted reproductive institutions and patients.

In addition, Basecare has also entered into a strategic cooperation with Genea, a world-renowned fertility group with 13 reproductive facilities worldwide. In the future, with Genea Group's rich clinical resources and Singapore BMX company's deep overseas sales channels, Basecare will thus open the road of internationalization of medical innovation products, and continue to promote China's assisted reproductive innovation products to the world.