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Press Releases and News

| Press releases
The Clinic for Neurophysiology at Oulu University Hospital in Finland purchases the VibroSense Meter ® II instrument. The order includes a full license with access to all hand and foot examinations and has a total value of approximately SEK 420,000 including annual license revenue.
| Press releases
The diabetes clinic at the university hospital Klinikum Stuttgart evaluates the VibroSense Meter®II, starting on October 11, 2022. A Research collaboration between the clinic and VibroSense Dynamics focusing on nerve damage in the feet caused by diabetes is also discussed.
| Press releases
The first two VibroSense Meter® II instruments have now been delivered to China and received by VibroSense's new Chinese partner UMCARE. The instruments with its application "Diabetic Foot Screening" are part of UMCARE's effort to improve the care of the diabetic foot in China.
| Press releases

The diabetes clinic “Herz- und Diabeteszentrum Nordrhein-Westfalen” (HDZ NRW) evaluates the instrument VibroSense Meter ® II with a planned start on September 22, 2022.

The diabetes clinic at HDZ NRW is a top-ranked clinic at the university hospital in Bochum in Germany. For the past two years (2020 and 2022), the clinic has received the highly regarded award "5-Sterne-Auszeichnung" awarded by the institute "Bundesverband Klinischer Diabetes- Einrichtungen ” (BKvD).

| News
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
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.