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The other day, someone asked me, “What is the reason why your company succeeded in regenerative medicine using the patient’s own cells?” I immediately answered, “We haven’t really succeeded yet, because we are not making enough of a profit as a corporation.” But it seems that what was of interest to that person was the fact that we have already stably provided regenerative medical products to over 2,000 patients.

What is difficult about regenerative medicine that uses the patient’s own cells?

I’d like to try reconsidering regenerative medicine and our involvement in it along the lines of the question above. The products that we handle have been approved as regenerative medical products by the Ministry of Health, Labour and Welfare. This means having the necessary documentation and records in order in accordance with the rules stipulated in the Act on Pharmaceuticals and Medical Devices. And unlike ordinary drugs and medical devices, these products are based on the patient’s own cells. Because they are completely made to order, they contain the variations inherent to the patient’s own cells. Considerable experience and know-how are necessary in order to make nonuniform cells into products that satisfy set standards. Moreover, our products are something that is suddenly ordered by doctors at medical institutions when the need arises, such as when a patient sustains major burns. But while it is difficult to predict when we will receive orders (and to plan for them), we must nevertheless prepare a certain number of items in advance. The culture solution and Petri dishes used in culturing cells must be set up to go, because without this preparation we will be unable to accommodate sudden orders. Furthermore, cells vary from patient to patient, and some do not multiply the way we would wish. We have to have a Plan B in readiness if cells do not increase the way we expected. Providing our products to over 2,000 patients has meant that our various departments have needed to work together to carry out a series of operations that must be tailored to each case. From the Sales Department that serves as the liaison with doctors, to the department that establishes a production plan for each order, the department that actually cultures the cells and manufactures the product, the department that performs quality testing, the department that delivers the product to the medical institution, and the department that supervises this series of activities, all must collaborate to realize a stable supply of made-to-order products.

All under our own steam

From the very start of our business, we decided to go it alone. Because we started out as a small-scale venture business, we could have stuck to the path of an R&D-oriented venture. However, there were no precedents for the system needed to provide such complicated and original products. The difficulty of delivering regenerative medical products that use the patient’s own cells lies in independently creating a business model of a kind that has not previously existed. In order to realize this, our company has done everything independently. I think that ultimately this has given rise to our strengths. If we do succeed in this field in the future in the way the question at the opening suggested, it may very well be because we have gone it alone and created the system for providing these regenerative medical products that are neither drugs nor medical devices through solely independent efforts, without being influenced by the products of the past.
At present, we are gradually beginning to mechanize and automate the systems that we have created in order to improve their performance and give them higher functions. We are steadily introducing IT. This accounts for some of our development costs. With steady determination, we are rationally creating new systems based on our experience in doing things that only we can. The fact that we have the ability to take on challenges like this may also be one of our strengths.

September 26, 2022