On October 6, 2022, the annual general meeting of VibroSense Dynamics AB (publ) ("VibroSense" or the "Company") decided on an incentive program consisting of warrants of series TO2022/2025:S for board members and an incentive program consisting of warrants of series TO2022/2025:N to employees in the Company. The subscription period for participation in the respective incentive program has now ended and the warrants have been assigned. Board members and employees subscribed a total of 130,000 warrants at the subscription price of SEK 1.03 per warrant, of which 75,000 warrants were subscribed by board members and 55,000 warrants were subscribed by employees.
Press Releases and News
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A clinical study in oncology has shown that cannabis oil provides a significant reduction in nerve damage during the initial part of the treatment. The study was carried out at the Department of Clinical Oncology at Zealand's University Hospital in Roskilde, where the VibroSense Meter® II was used to investigate how the vibration sensibility is affected throughout the treatment.
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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.
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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.
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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.
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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).
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After attending DIABETES KONGRESS 2022 in Berlin 25-28 May and visiting first potential KOL clinics, VibroSense can conclude several immediate positive opportunities.
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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.
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VibroSense Dynamics AB (VibroSense) has today signed an exclusive distributor agreement with the Chinese state-owned company Genertec Universal Medical Group (UMCARE).
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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.
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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.
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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.
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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.
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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.
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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.
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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.