Regulatory approval in China – Supplement reply submitted
VibroSense Chinese distributor UMCARE has submitted a supplementary response to the Chinese regulatory authority NMPA. Provided that the NMPA approves the company's application, the regulatory approval is expected to be completed in April 2025.
“I am very hopeful that UMCARE's response to the NMPA will take us all the way to regulatory approval in China. It has required an extensive effort from both UMCARE and VibroSense and now I hope that we will soon reap the fruits of this work. Once the certificate is in place, the next phase of launching Diabetic Foot Screening in China will begin," says Toni Speidel, CTO VibroSense Dynamics AB.
About UMCARE and Diabetes in China
UMCARE is a subsidiary of China General Technology Group (Genertec). The company is China's 42nd largest state-owned company. In February 2022, VibroSense signed a distributor agreement with UMCARE that gives UMCARE an exclusive time-limited exclusive right to sell the VibroSense Meter II throughout China for three years. The distributor agreement also includes a binding order of EUR 3.8 million with fixed minimum calls during three years. UMCARE also holds VibroSense's application for regulatory approval in China. UMCARE plans to begin sales in China immediately once regulatory approval is in place.
According to a 2020 estimate by the American Diabetes Association (ADA), there are approximately 130 million patients with diabetes in China, making the country the largest market for diabetes care in the world. There are about 36,000 hospitals, of which 24,000 are private and 12,000 are public. The cost of diabetes care is estimated at the equivalent of 70 billion EUR per year.
Contact
Toni Speidel, CTO VibroSense Dynamics AB
Tel: +46 40 88 026
Email: [email protected]
www.vibrosense.se
"The new Gold Standard for reliable
detection of nerve damage"
About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (publ) develops and sells medical technology products to facilitate diagnosis of peripheral nerve damage in the hands and feet. The method involves measuring and quantifying the ability to perceive vibrations at several frequencies. The company's customers are diabetes clinics, occupational health care, hospitals, point of care centers and researchers.
Our vision is for the company's products to be a standard instrument in all neurological examinations to detect early signs of changes in sensation so that patients and their caregivers can implement preventive measures that prevent, reduce or delay the onset of nerve damage in the hands and feet.