VibroSense Dynamics AB (VibroSense) has signed an agreement with Genertec Universal Medical Group (UMCARE), to apply for registration of VibroSense Meter® II in the Chinese market. UMCARE estimate that there is a good possibility to obtain a regulatory approval and product registration in China within 12-18 months.
The signed registration agreement is part of a recently started collaboration between VibroSense and UMCARE, to market and sell VibroSense Meter® II (VSM II) in China. After approved registration by the Chinese National Medical Products Administration (NMPA), VibroSense will hold full rights and certificates to market and sell VSM II in China.
According to a preliminary review, VSM II will be classified as a Medical Device Class II in China. In parallel with the registration agreement, VibroSense and UMCARE are negotiating a distributor agreement, with the aim that UMCARE will receive the exclusive right to sell VSM II in China. The distributor agreement is planned to be signed no later than Q1 2022.
“I am very hopeful about this prodigious opportunity for VibroSense. Negotiations with UMCARE have so far gone beyond our expectations and I look forward to working with UMCARE to reach out with our products in the Chinese market. UMCARE is a very strong partner that owns hospitals and has an established infrastructure for distribution, marketing and sales throughout China”, says Hans Wallin, CEO at VibroSense Dynamics.
“We are very happy and optimistic about our collaboration with VibroSense Dynamics. Diabetes is a large and growing problem in China, where we see that VibroSense Meter II has an important role to play to improve the diagnosis of diabetic peripheral neuropathy ", says Leo Mengran Li, Product Sourcing Manager at Genertec Universal Medical Group.
About diabetes in China
According to an estimate from the American Diabetes Association (ADA) from 2020, there are about 130 million patients with diabetes in China, making China the largest market for diabetes care in the world. There are about 36,000 hospitals in China, of which 24,000 are private and 12,000 are public. The cost of diabetes care in China is estimated at the equivalent of SEK 800 billion per year
Hans Wallin, CEO VibroSense Dynamics AB,
Phone: +46 40 88 026
About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (public) sells and develops efficient systems to support early detection and diagnosis of sensory neuropathy, i.e. disease of large nerve fibres and nerve trunks in e.g. legs and arms. Our vision is that the VibroSense Meter® shall be the golden standard instrument for neurological examinations to assess sensory neuropathy and help to improve life conditions for patients having a risk of getting nerve injuries.