After attending DIABETES KONGRESS 2022 in Berlin 25-28 May and visiting first potential KOL clinics, VibroSense can conclude several immediate positive opportunities.
Press Releases and News
| Press releases
Following the completion of the survey of the German market, VibroSense will begin the next step in establishing sales in Germany. The plan includes introducing the company's product VibroSense Meter II at selected reference clinics.
| Regulatory press releases
VibroSense Dynamics AB (VibroSense) has received the company's largest order to date, with a value of at least 3.8 million EUR. It is the new Chinese customer and distributor Genertec Universal Medical Group (UMCARE), who placed a first order for VibroSense Meter® II in an agreement that initially extends over three years. The order is conditional on the product VibroSense Meter® II receiving a market approval in China.
| Press releases
VibroSense Dynamics AB (VibroSense) has today signed an exclusive distributor agreement with the Chinese state-owned company Genertec Universal Medical Group (UMCARE).
| Press releases
VibroSense Dynamics AB (VibroSense) instrument VibroSense Meter® II is used in an exploratory clinical study on Postural Orthostatic Tachycardia Syndrome (POTS). The purpose of the study is to investigate whether POTS also causes disorders in the peripheral nervous system.
| Press releases
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.
| Press releases
VibroSense Dynamics AB (VibroSense) has signed a Framework Agreement with Genertec Universal Medical Group (UMCARE), a subsidiary of China General Technology Group (Genertec), which is China's 42nd largest central State Owned Enterprise. The framework agreement concerns the distribution of VibroSense's product VibroSense Meter® II, with the application Diabetes Foot Screening in the Chinese market.
| Press releases
The Department of Oncology at Linköping University Hospital has started a multicentre study to identify biomarkers for advanced pancreatic cancer that are treated with chemotherapy. The study will be made in collaboration with VibroSense Dynamics which assists with advice and data extraction as well as analysis of data. The studies aim to investigate how nerves in the feet and hands are affected by chemotherapy.
| Press releases
The VibroSense Meter® II system (VSM II) is registered to comply with the new EU Medical Device Regulation (MDR) as a class 1 Medical device. A registration is made at the Swedish Medicines Agency where VibroSense Dynamics has received the EUDAMED registration number (SRN) SE-MF-000003787. Thus, the VibroSense Meter® II system has now a CE-mark which complies with the new MDR which became mandatory within the EU since May 26, 2021.
| Regulatory press releases
The result from a clinical pilot study, in collaboration with the clinic of Oncology at the university hospitals in Lund and Malmö as well as the hospital in Kristianstad, shows that VibroSense Meter® and its technology can be used to predict the risk of getting permanent nerve damage caused by treatment of cancer with chemotherapy. The discovery is an important step to pave the way for a new biomarker that can support physicians within cancer treatment with chemotherapy.
| Regulatory press releases
VibroSense Dynamics AB (VibroSense) clinical validation study for the new application Diabetes Foot Screening, shows that the company's product VibroSense Meter® II meets all essential criteria for approval according to the clinical validation plan. VibroSense thus keeps the schedule the company has previously communicated and is ready to launch the Diabetes Foot Screening application to both primary and specialist care.
| Regulatory press releases
At the scientific congress, Humanchwingungen in Würzburg Germany on October 1 2020, the results of a pilot study were presented in which the company's product VibroSense Meter® II was used. The aim of the study was to investigate short-term effects of exposure to hand-arm vibrations. The result showed a strong impact wherein a significant decrease of the sensitivity of fingers was detected with the VibroSense Meter® II. The data will become the basis for new recommendations for health controls of vibration-exposed personnel in Germany.
| Press releases
VibroSense Dynamics AB (VibroSense) has started a clinical validation of the new Diabetes Foot Screening application in the product VibroSense Meter® II. Clinical validation is the final step before the product is ready for launch within the diabetes foot care segment.
| News
VibroSense Dynamics AB (VibroSense) has received an "Intention to grant" from the Swedish Patent Office and a positive Written Opinion from an international PCT application. The patent covers an important part of VibroSense’s measurement technology to measure skin temperature continuously during an examination with VibroSense Meter® II.
| Press releases
VibroSense Dynamics AB (VibroSense) adds a new application to its product VibroSense Meter® II, which provides support for Diabetes Foot Screening. The new application is a result of 5 years of clinical studies involving adult patients with type 1 diabetes and is expected to be available for commercial launch in the fall 2020.
| Press releases
The Institute for Occupational and Environmental Medicine at Lübeck University Hospital (LIOH, Lübeck Institute of Occupational Health) has decided to purchase the VibroSense Meter II after completing a pilot study. The conducted study aimed at testing temporary impairments of sensitivity at fingers caused by short-term exposure to vibration. A larger study is now planned with the VibroSense Meter II to investigate whether the instrument can be used as a supervising tool to prevent vibration injuries caused by vibrating tools.
| Press releases
VibroSense Dynamics appoints Jan Kleijn Hesselink as Manager for the Benelux. This is a first step towards a planned geographic market expansion outside of Scandinavia for VibroSense Dynamics.
| Press releases
Doctor Eero Lindholm at Skåne University Hospital presented unique results from clinical study of Diabetic Peripheral Neuropathy (DPN) of feet in patients with type 1 diabetes. The results were presented at the world's second largest diabetes congress - EASD in Barcelona on September 17, 2019. The conclusion was that VibroSense technology and instruments can be used instead of Nerve Conduction Studies (NCS), for early diagnosis of nerve damage in feet caused by type 1 diabetes.
| Press releases
Avonova has decided to set up a nationwide organization in Sweden for health control of workers exposed for hand-arm vibrations. To perform these health controls, Avonova has signed a license agreement for 24 VibroSense Meter II, with option of additional instruments. The license agreement initially covers 36 months with the possibility of renewal. The agreement will have a positive impact on VibroSense Dynamics' results for current fiscal year.
| Press releases
A published study authored by researchers at the clinic of Occupational and Environmental Medicine at Sahlgrenska University Hospital provides strong support for VibroSense Dynamics' new method for screening of workers, exposed for hand- arm vibrations. The screening method, developed by VibroSense together with two companies in Occupational Health Care services in Sweden, means that an examination can be made in less than 10 minutes. The method will be important for VibroSense expansion in Germany, among others.