Tego Science said that Kaloderm, a homologous cell-based drug, will receive reimbursement in treating diabetic foot ulcer treatment from next month.
|Kaloderm, a wound dressing for diabetic foot ulcer, by Tego Science|
Kaloderm will receive reimbursement for all skin defects that have a smooth blood supply and no infectious symptoms for four weeks of once-weekly administration and extend up to six weeks if the treatment reduced the size of the ulcer by 40 percent. Patients that have an ulcer size of up to 150 sq. centimeters will receive the benefit.
Kaloderm is the only cell-based remedy for wound healing with indications for burns and diabetic foot ulcers. After receiving approval for treating burns in 2005, Tego Science managed to expand indications to diabetic foot ulcer by proving its efficacy through a phase 3 clinical trial in 2010.
Tego Science managed to get reimbursement after phase 3 trials and post-marketing data showed diabetic foot ulcers patients treated with Kaloderm had their symptoms cured within 12 weeks of treatment with no relapse.
The cure period lasted an average of five weeks, reducing the treatment period by 40 percent compared to the control group.
The treatment was especially effective in patients with Wagner grade Ⅱ, which expose tendons and bones. According to the International Wound Journal in 2019, the procedure was also effective even when the ulcer size exceeded 50 cm².
“Considering that diabetic foot ulcer is a diabetes complication that frequently occurs in financially struggling people, the insurance benefits for Kaloderm will become a turning point for those patients,” a company official said.