Sensus gets Chinese regulatory approval for keloid device
US-based Sensus Healthcare has received approval from the China Food and Drug Administration (CFDA) to commercialise its keloid prevention and treatment device, SRT-100.
The tool is designed to deliver a precise and calibrated dose of superficial radiation therapy to ensure a skin deep and safe treatment for patients.
The low-dose radiation is intended to destroy keloid-causing non-malignant tumour cells, basal cell carcinoma and squamous cell carcinoma without the use of anaesthesia, risk of infection, scarring or the need for reconstructive plastic surgery.
Sensus intends to introduce SRT-100 into the country’s market in the fourth quarter of this year through its Chinese partner Chindex Medical, which is a division of Fosun Pharma International.
The device will focus on prevention and treatment of keloids associated with Cesarean sections (C-sections).
Sensus Healthcare CEO Joe Sardano said: "CFDA clearance of the SRT-100 for the treatment and prevention of keloids is an important milestone for Sensus, and a step forward for healthcare in China, especially women's health.
“With the relaxing of China's one-child policy in 2015, the prevention of keloids that form over the surgical scar following a first C-section will lessen complications of a second C-section.
“We believe the SRT-100 will be a major force in preventing these keloids from forming."
Since 2014, Sensus has been providing SRT-100 for the non-melanoma skin cancer treatment in the country via Chindex.
Chindex Medical CEO William Wang said: “This is another example of continued efforts by Chindex Medical to bring cost-effective solutions to our healthcare system.
“Our doctors now have a very important tool in a proven technology like SRT to remedy the keloids that impact millions of our citizens."