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Kitazato’s Cryotop Method, the future of embryo cryopreservation

Article - February 20, 2023

Since its foundation in 1998, Kitazato Corporation has played a major role in the area of assisted reproductive equipment and technologies, with the revolutionary Cryotop Method among its latest contributions to the field.

CRYOTOP VITRIFICATION

“We believe that reducing the cost of fertility treatment will make it more accessible, which in turn will improve the birthrate and lead to the growth of the next generation on a global scale.”
Futoshi Inoue,
MBA, PhD. , President, Kitazato Corporation

Infertility is a global health issue that affects some 48 million couples and 186 million individuals worldwide according to the World Health Organization. In line with these numbers, it is understood then that infertility affects 15% of couples across the globe, and due to environmental and lifestyle factors, many experts believe that infertility rates will continue to rise in many countries.

As such, demand for assisted reproductive technologies  – such as in vitro fertilization (IVF), intracytoplasmic sperm injection, cryopreservation of gametes or embryos, sperm or egg donation and the use of fertility medication – will continue to grow. For many couples however, the price of treatments like IVF can be too expensive, particularly considering the often low success rate. But thanks to companies like Japan’s Kitazato Corporation leading advancements in the field of assisted reproductive technologies, the success rate of fertility treatments will continue to improve as the costs also come down.

Since its establishment in 1998, Kitazato has been at the forefront of developments in reproductive technologies. The company performs extensive research to develop, manufacture and market medical devices and media to support a wide range of fertility treatments, from IUI to PGD – with its aim to provide the best quality products and services in order to help physicians and embryologists maximize IVF clinic success and contribute to the happiness of patients.

Over its 24-year history, Kitazato has managed to significantly expand its global business operations, and key to the company’s success has been the ability to offer the highest quality products while keeping costs down, as highlighted by president Futoshi Inoue. “Kitazato products are relatively inexpensive, and it could be one of the reasons for their widespread use, but we also take customers' opinions into account and continuously make small improvements to increase their reliability,” he explains. “I believe that this attitude is the reason why our products continue to be supported by our customers and why we have increased our market share. In addition, we offer not only inexpensive products, but also value-added products which are relatively high-end.

The reason why Kitazato does not raise prices and continues to offer low-price products is because it wants to lower the price of fertility treatment”, Mr. Inoue stresses. “We believe that reducing the cost of fertility treatment will make it more accessible, which in turn will improve the birthrate and lead to the growth of the next generation on a global scale.”

Kitazato offers a broad selection of quality products that maximize success at every step of the IVF cycle, including needles, catheters, pipettes, media and cryopreservation equipment. With over 3,000 clinics worldwide trusting in its products, the Japanese firm continues to cement its reputation as a world leader in vitrification.

“At Kitazato, the three main product groups are needles, catheters, and cryopreservation of vitrification. Next are media, pipettes, and equipment, in that order. In fertility treatment, needles to collect eggs, media to fertilize eggs and culture subsequently, and catheters to return fertilized eggs into the uterus are universally indispensable products,” the company president explains, adding that continuous improvement of its products is Kitazato’s utmost priority. “We need to keep on focusing on these areas and develop them into even better products. We also continue our efforts with new research and collaborative developments in vitrification, pipettes, and equipment as well, so that fertility treatment increases the chances of pregnancy by even 1%. This may result in a new seventh category.”

Such intensive R&D has seen the company develop groundbreaking technology, with the best example being the Cryotop Method, a technique of vitrification of oocytes and embryos that is arguably Kitazato’s greatest contribution to the field of assisted reproductive technologies. During the last decade, thousands of professionals have placed their trust in the fantastic results offered by the Cryotop Method, making it the undisputed market leader in cryopreservation of human gametes. It has been applied in more than 2,500,000 clinical cases annually in over 115 countries and 3,000 assisted reproduction centers, with hundreds of scientific publications having certified the excellent results achieved.

“It is recognized as a great blessing that the cryopreservation of eggs and fertilized embryos has significantly changed the conventional fertility treatment program by making it easier and safer for anyone to achieve high viability results. The viability of cryopreserved eggs and fertilized eggs used to be low, but cryopreservation using Cryotop has resulted in an almost 100% survival rate,” explains Mr. Inoue.

“In the past, patients had to undergo treatment several times and experience multiple needle punctures to have eggs retrieved. Now, there is no need for patients to have needle punctures repeatedly because multiple oocytes can be cryopreserved from a single retrieval. We believe that this has contributed to the reduction of medical accidents and the emotional and financial cost to the patient.”



When it comes to embryo freezing, in general, only six out of eight eggs, or 75%, will survive the freezing and thawing process. However, Kitazato’s Cryotop method has over a 95% post-thaw survival rate. Pressed on how the company has been able to achieve such success rates, Mr. Inoue responds: “The answer is simple: we are blessed with researchers from all over the world who are willing to cooperate with us. We have received numerous comments and reports on the Cryotop method and have accumulated a great deal of experience. We are sincerely responding to each opinion we receive and that has led us to realize our products and methods giving a high survival rate. We will continue our efforts to further improve the survival rate with researchers around the world.”

Another important element behind Kitazato’s success has been monozukuri, the Japanese manufacturing philosophy dedicated to craftsmanship and the pursuit of perfection. Precision, high-quality manufacturing is absolutely crucial when it comes to medical devices and the reason why Japanese craftsmanship has excelled in the field thanks to companies like Kitazato.

"Our staff are trained to become professional and master craftsmen and their technique is passed on to the next generation to pursue even higher quality," says Mr. Inoue. "In Japan, there are many highly skilled small and medium-sized enterprises and elderly craftsmen, and we find it very meaningful to collaborate with them in the development of our products."

While digital transformation and the use of the latest technologies is indeed important, the Kitazato president insists that the skills of the human hand will always underpin the company's product development.

"In our case, automation and the use of IT to improve efficiency are outsourced to partner companies that excel in those areas or are partially incorporated into in-house manufacturing sites," he explains.

"What we should do at Kitazato's production sites is to continue to maintain high quality by valuing high technology that uses human hands ultimately without relying on AI or machines, although cost reduction is important. By clearly separating what can be done internally and what should be done externally, we believe it is our responsibility to support the development and research of fertility treatment, which is advancing rapidly, and working on that will lead to the next generation of fertility treatment. We are responsible for all products bearing the Kitazato name, so we manufacture all of our own products."

While the company strictly and solely bears responsibility for the manufacture of its products, room for collaboration does exist within the sphere of R&D, particularly as Kitazato branches out beyond assisted reproductive technologies.

“Of course, the market is global, so I direct product development and research with an eye to obtaining patents not only in Japan but also overseas. This may be done in conjunction with university institutions or large private fertility clinics and research institutes in various countries. But in the end, I will only bring to market products that I am convinced will work,” Mr. Inoue explains.

“Kitazato has an image of being outstanding in the field of fertility cryopreservation, but we are also contributing to various fields such as virus cryopreservation and gametogenesis of endangered species. I look forward to seeing new research projects that will be born as a result of the interest shown by readers of this article.”

As the company looks to expand internationally, it is paying particular focus on Asia, where in many countries, including Japan, fertility rates are among the lowest in the world. Kitazato has contributed to the development of fertility treatment in Asia by visiting hospitals in countries where fertility treatment is still developing and providing technical guidance.

“We have not simply sold products but have also worked with local distributors and doctors to improve fertility treatment techniques. As a result, we have gained the support of many doctors,” adds Mr. Inoue. “I was also blessed with a reliable partner, Mr. Ignacio Bermejo, CEO of Dibimed for our success in international business. We have key regions such as the U.S., E.U., Japan, and the U.A.E. in the Middle East, where we would like to establish local subsidiaries that can communicate directly with our customers. From there, we would like to expand into other areas. By providing tailored products with special features and specifications and easier-to-use products, we would like to provide beneficial solutions for fertility treatment that meet different local demands.”

Next year Kitazato will celebrate its 25th anniversary, a timely moment for the company to reflect on its contribution to assisted reproductive technologies, while also looking towards the future and setting the company’s direction for the decades to come. Mr. Inoue proudly highlights some of the influential Japanese researchers that have contributed to the field of fertility treatment, more of whom he hopes to work with in the future.

“In Japan, there are many world-renowned doctors in the field of fertility treatment. Dr. Atsushi Tanaka (St. Mother's Hospital, Fukuoka) has established a treatment method called ROSI, and is the only doctor in the world to have fertilized eggs from spermatocytes resulting in numerous pregnancies. He is doing a great job for male infertility patients.

“Dr. Yoshiharu Morimoto (Horac IVF Grand Front, Osaka) is the world leader in making in vitro maturation (IVM) clinically applicable and is now engaged in mitochondrial research. Dr. Keiichi Kato (Kato Ladies Clinic, Tokyo)  spreads the maternal-friendly natural cycle IVF technique around the world. Dr. Shokichi Teramoto (Natural ART, Tokyo) combines natural cycle IVM and IVF by maturing oocytes collected from small follicles. Prof. Nao Suzuki (St. Marianna University, Kanagawa) contributes to the worldwide acceptance of ovarian cryopreservation techniques for cancer patients, and has made a network of fertility preservation.

“I cherish the relationships with the people we have met and will meet in the future and want to spread Japan's wonderful fertility treatment technology throughout the world. I would like to continue my current business into the 22nd century while helping as many births as possible for the development of mankind.”

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