[Click eStock] "TegoScience's Rotator Cuff Treatment Nears US FDA Clinical Trial Application"

Hana Financial Investment Report,
Preparing for FDA Approval of Rotator Cuff Disease Treatment
Consistently Profitable Since 2014 Listing

[Asia Economy Reporter Minji Lee] Hana Financial Investment stated on the 25th that Tegosience, which possesses outstanding cell culture technology, is expected to experience high growth due to its global clinical trial application for a rotator cuff treatment.

Tecoscience Logo

Researcher Dohyun Kim of Hana Financial Investment explained, “Tegosience holds unparalleled cell culture technology domestically,” adding, “Based on this technological capability, 3 out of the 15 cell therapies approved in Korea belong to this company.”

The cell culture technology is an improved version of the Green culture method developed by Professor Howard Green, the pioneer of stem cells and regenerative medicine. Using the Green culture method, it is possible to culture over 10,000 cm2 of skin from 1 cm2 of skin tissue within 2 to 3 weeks.

Since its listing in 2014, Tegosience has recorded profits continuously. Most of its revenue comes from Kaloderm, an allogeneic cell therapy. Kaloderm has two indications: promoting re-epithelialization of deep second-degree burns and healing diabetic foot ulcers. Both indications are covered by national health insurance.

Additionally, sales of Holoderm, a third-degree burn treatment, Losmir, used for wrinkle improvement, and Neoderm, a skin model for basic research experiments, are steadily increasing.

Tegosience has TPA-114 and TPX-115 in its pipeline related to rotator cuff disease treatment, which was selected as a national project. TRX-114 uses autologous cells to treat full-thickness tears, while TRX-115 uses allogeneic cells to address partial-thickness tears.

Researcher Dohyun Kim stated, “Currently, TRX-114 is recruiting patients for a domestic phase 3 clinical trial, and TRX-115 has received IND approval for phase 1/2 clinical trials in Korea,” adding, “Since TRX-115 uses allogeneic cells, mass production of the finished product is possible, and an IND application for clinical trials with the U.S. Food and Drug Administration (FDA) is also being considered for early 2021.”

He continued, “With the aging population and increased leisure sports activities, the incidence of rotator cuff disease is expected to rise,” and forecasted, “This will benefit from the increased demand for cell therapies.”