| Developers: | Koek Biotechnology |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
Main article: IVF (In vitro fertilization)
2023: Obtaining a Marketing Authorization
The R-Pharm Group of Companies received a marketing authorization (RZN 2023/21148 from 22.09.2023) for FERTILE, FERTILE PLUS and FERTILE ULTIMATE microfluidic chips. These are sterile products for single use, the principle of which is to separate sperm by their motility in the microenvironment. The project is being implemented under an agreement with the Turkish biotechnology company Koek Biotechnology. R-Pharm announced this on October 30, 2023.
The competencies of the future embryo are potentially influenced by the quality of germ cells - gametes. Therefore, in an embryological laboratory, gamete selection is a key task. FERTILE, FERTILE PLUS, FERTILE ULTIMATE microfluidic chips allow you to select the best sperm in terms of physiological characteristics in conditions as close as possible to natural ones. When using microfluidic chips, sperm preparation steps that can damage a living cell, such as centrifugation, are excluded. This has a positive effect on the competencies of future embryos and allows to increase the effectiveness of the cycle of assisted reproductive technologies (ART).
 | Male infertility is a medical problem, no less than female. Regularly published statistics indicate that the number of cases of male infertility is steadily increasing. As of October 2023, the male factor is the cause of infertility in a couple already in 50% of cases. Registration of microfluidic chips in Russia will enable specialists to use an innovative technique to help couples with male infertility factor get a long-awaited pregnancy, - said Elena Opanasyuk, Director of the Women's Health Department of the R-Pharm Group of Companies. |  |
| | These chips have been successfully used in Turkey since 2013 for intrauterine insemination, their effectiveness is confirmed by improved clinical indicators, pregnancy indicators and an increase in the frequency of successful birth outcome. The use of microfluidic chips for sperm sorting opens up new reproductive health opportunities contributing to positive fertility treatment outcomes, "said KOEK Biotechnology CEO Selchuk Kilinu. | |
FERTILE, FERTILE PLUS, FERTILE ULTIMATE microfluidic chips are an innovation in the ART market that has no analogues. They allow you to prepare sperm in a shorter time in a simple and convenient way, requiring much less laboratory procedures in comparison with other methods of preparing sperm, reduce the level of DNA fragmentation.
FERTILE, FERTILE PLUS, FERTILE ULTIMATE microfluidic chips are made of biocompatible materials and are designed to ensure maximum ergonomics, work safety and usability.
FERTILE PLUS and FERTILE ULTIMATE microfluidic chips can be used not only to prepare semen for ART procedures in the embryological laboratory of the IVF clinic, but also in the clinical and diagnostic laboratory to prepare semen for intrauterine insemination. The FERTILE ULTIMATE 3 ml microfluidic chip will be useful in cases where the patient's sperm concentration is low and more biomaterial is required.
2021: Entry of microfluidic chips for sperm selection in Fertile IVF procedures into the Russian market
On March 19, 2021, the R-Pharm group announced the conclusion with the Turkish biotechnology company Koek Biotechnology of an agreement on the supply of Fertile microfluidic chips for in vitro fertilization (IVF) to the Russian market. The deal involves the registration and distribution of Fertile, Fertile Plus and Fertile Ultimate devices.
They are designed to sort sperm that have better morphology and physiological characteristics from other dead or immature sperm without using damaging techniques such as centrifugation or Swim-Up. The technology is used in all assisted reproductive technologies, andrological or embryological laboratories. The chip has an input port for sample insertion and an output port for collecting sorted semen.
Fertile is a sterile disposable device for use in an embryology laboratory that mimics natural sperm selection when passing through the female vagina, uterus and fallopian tubes.
The method avoids damage to sperm due to oxidative stress, which has a positive effect on the quality of the embryo and increases the efficiency of the cycle. According to the developers, this technology reduces the time for preparing sperm for IVF by sorting sperm, reduces oxidative damage to cells during the procedure and is convenient for the embryologist to work in the laboratory.
Anastasia Batrak, Vice President of Strategic Marketing at R-Farm, said the company expects that the Fertile microfluidic chip sperm selection method will be recommended for inclusion in ART clinical guidelines and will soon become available to patients under the compulsory medical insurance program. By April 2021, about half of IVF cycles are funded under the compulsory health insurance program, which also includes a program to support assisted reproductive technologies, she noted.[1]
Notes
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