Dignitana announced that DigniCap Delta received market approval in Japan from the Ministry of Health, Labor and Welfare (MHLW). In Japan, Dignitana will provide DigniCap Delta to Konica Minolta as a medical device manufacturer, and Konica Minolta will proceed as a market authorization holder (MAH) to expand into the Japanese market. Regulatory approval for medical devices in Japan is similar to the FDA clearance process for medical devices in the United States, it is a pathway in which quality, efficacy, and safety are examined and approved according to the classifications established by law.

Based on Dignitana's distribution agreement with Konica Minolta, an initial order was placed in February and a second order for several devices will be placed in early spring 2024 to prepare for launch. With a primary market in the US, the FDA-cleared DigniCap Delta device uses industry-leading thermoelectric cooling to minimize hair loss that is a side effect of chemotherapy prescribed to treat solid tumors such as those from breast cancer, ovarian cancer and prostate cancer. Recognized internationally as a standard of care and quality of life advancement for cancer patients, scalp cooling is a treatment recommendation in the clinical practice guidelines published by National Comprehensive Cancer Network® (NCCN), European Society for Medical Oncology (ESMO), and Cancer Australia.

It is available in cancer centers around the globe.