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  • VibroSense Dynamics AB
    VibroSense Dynamics AB Medeon Science Park, Per Albins väg 41, 205 12, MALMÖ
    +46 40 88 026
    http://www.vibrosense.com
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    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,"

    LifeMed Oy – New Distributor in Finland

    VibroSense Dynamics AB has signed an agreement with LifeMed OY in Finland. The agreement allows LifeMed OY to market and sell VibroSense Meter II in Finland within the product's application areas.“We are excited to have started this cooperation with LifeMed in the Finnish market. VibroSense Meter II has a wide range of applications and we look forward to offering our solutions in Finland together with LifeMed”, says Tarik Cengiz, CEO of VibroSense Dynamics AB. ContactTarik Cengiz, CEO VibroSense Dynamics ABTel: +46 40 88 026E-mail: info@vibrosense.comwww.vibrosense.com"The new

    New CEO takes office today

    Tarik Cengiz takes office today as the new CEO of VibroSense Dynamics, which is part of strengthening the organization with a focus on distributors and OEM customers.Tarik Cengiz will work on developing existing partnerships in the company's current markets. He will also put a lot of focus on driving a geographic expansion and increased sales by addressing potential international partners such as distributors, agents or OEM partners. "I would like to warmly welcome Tarik to VibroSense, both I and the board look forward to working together with him when VibroSense now clearly focuses on

    Receives a new patent in the EU

    VibroSense Dynamics AB has received a so-called "Intention To Grant" on its patent application in the EU, which strengthens the protection for the product VibroSense Meter® II. The patent describes a principle for measuring skin temperature wirelessly before and during an examination, which ensures measurement quality.The patent was approved in Sweden in November 2020 and in April in China, and after an international application, the company has now been informed that the patent will be approved in the EU. After that, a process for national applications begins throughout the EU. The company

    Strengthens the organization with a new CEO

    VibroSense Dynamics strengthens the organization by recruiting Tarik Cengiz as new CEO. Tarik will start his position as CEO on September 16, 2024 after he leaves his previous position as Global Sales Director at Arcoma AB.Tarik Cengiz will work with developing existing partnerships in the company's current markets. He will also put a lot of focus on driving a geographic expansion and increased sales by addressing potential international partners such as distributors, agents or OEM partners.Tarik has deep knowledge of how healthcare works, both in Sweden and internationally. He also has

    Regulatory approval in China is delayed 4 months

    The last and final step in obtaining regulatory approval of the VibroSense Meter ® II in China is delayed approximately four months. The delay is due to that VibroSense's Chinese distributor UMCARE has received many questions on its application, from the Chinese regulatory authority NMPA. According to UMCARE, the NMPA requires an extra careful review because there is no similar instrument in China, which is considered to be an advantage when the product is ready for launch in China. The regulatory approval is now estimated by UMCARE to be obtained at the end of April 2025 compared to their

    Investment after the completion of the new share issue

    VibroSense gains new momentum after the completion of the new share issue and increases investment in existing markets. At the same time, the company plans to gear up with more activities to reach out to new countries and thereby accelerate the company's sales.VibroSense will mainly focus the use of the issue proceeds in the areas of sales and marketing, which is completely in line with what was communicated before the recently concluded new share issue.OrganizationThe company will strengthen its own organization in the area of sales, but also take new approaches with foreign partners

    Receives new patent in China

    VibroSense Dynamics AB (VibroSense) has got a patent approval in China. The patent describes a principle for measuring skin temperature wirelessly before and during an examination, which ensures measurement quality.Obtaining the patent in China is part of a long-term strategy to protect VibroSense intellectual property rights. The patent protection will be further strengthened by several patent applications currently pending in various countries around the world. The current patent for wireless measurement of skin temperature was approved in Sweden in 2019.VibroSense strategy to protect

    Regulatory application in China receives "Notice of Acceptance" status

    VibroSense Chinese distributor UMCARE, announces that it has received a so-called "Notice of Acceptance" from the Chinese authority NMPA, regarding the company's application for regulatory approval in China for VibroSense Meter ® II and Diabetic Foot Screening.In a next step, a "Supplementary Notice" is expected to be received from the NMPA during June 2024. Thereafter, the application enters the final stage which includes final supplements before a certificate can be issued by the NMPA, which is expected to be ready in December 2024. The new timetable, which was communicated on March 12,

    Steno Diabetes Center Odense, Denmark, evaluates Diabetic Foot Screening for clinical use

    The Diabetes Clinic at Steno Diabetes Center Odense, Denmark, has begun an evaluation of the VibroSense Meter® II with Diabetic Foot Screening as part of testing a new process to optimize patient flow.Steno Diabetes Center, Odense has started a project to optimize patient flow as part of implementing a "One Stop Shop" concept, with the aim of minimizing the number of hospital visits for regular health checks of people living with diabetes. If the outcome of the evaluation is approved, the new concept can be implemented in the regions' other hospitals, which in that case entails

    Diabetic Foot Screening is introduced at Skåne University Hospital, Lund

    The Diabetes Clinic, Skåne University Hospital in Lund has decided to introduce Diabetic Foot Screening as standard in the clinical operations, for regular control of nerve damage in the feet of people living with diabetes.The diabetes clinic at Skåne University Hospital in Lund uses the VibroSense Meter® II and introduces the Diabetic Foot Screening examination as standard in its clinical operations. At the clinic, the methodology will be used in foot examinations of people living with diabetes. "The method adds an increased opportunity for earlier diagnosis and treatment, which we hope

    New publication demonstrates strong correlation between Multi Frequency Vibrometry and Nerve Conduction Studies for diagnosis of nerve damage caused by diabetes.

    In a publication on Plos One,  the results of a clinical study were reported in which the company's technology Multi Frequency Vibrometry (MFV) was compared with Nerve Conduction Studies (NCS), which is generally regarded as the Gold Standard in the diagnosis of nerve damage caused by diabetes. The publication shows that there is a strong connection between MFV and NCS. For diabetes clinics, this means that they can provide Diabetic Foot Screening as an equivalent specialist examination (NCS), which is normally only

    Receives provisional patent protection for prediction of nerve damage caused by chemotherapy

    The company's patent application "CIPN Prediction ", to assess the risk of developing permanent nerve damage when treating cancer with chemotherapy, is published by the European Patent Office EPO on January 3, 2024. With the publication of the application, the company has a "provisional protection" for patent infringement.The patent application "CIPN Prediction” describes a method and a Biomarker to assess the risk, in different treatment options, to develop permanent nerve damage after completion of treatment. With the patent as a basis, the company's preliminary algorithm can provide

    Submits application for regulatory approval in China

    After extensive testing in China and compilation of the required documentation, VibroSense has submitted an application for regulatory approval for the Company's product VibroSense Meter® II, to the Chinese authority National Medical Products Administration (NMPA).In February 2022, VibroSense signed an exclusive distributor agreement with the state-owned Chinese company Genertec Universal Medical Group (UMCARE ). The agreement includes a commitment that UMCARE will assist VibroSense with the application for regulatory approval at NMPA. An approval

    Starts a collaboration in research on diabetes-related nerve damage with a prominent university clinic in Great Britain.

    VibroSense has signed a collaboration agreement regarding research on diabetes-related nerve damage with Professor Mitra Tavalkoli at the University of Exeter, Center of Excellence for Diabetes Research in the UKProfessor Tavakoli intends to introduce and evaluate the VibroSense Meter® II in ongoing clinical studies on people with diabetes. The aim is to investigate whether the VibroSense instrument can be a tool for early and reliable detection of nerve damage caused by diabetes (Diabetic Peripheral Neuropathy). For VibroSense, the collaboration is expected to provide the company with

    VibroSense Dynamics AB (publ) – VibroSense Meter ® II registered in Great Britain

    VibroSense Meter® II is now registered in Great Britain, which opens up a new market for the company's product. The VibroSense Meter® II facilitates reliable detection and diagnosis of peripheral nerve damage in hands and feet caused by, for example, diabetes, chemotherapy and hand-held vibrating tools.All medical devices sold in the UK must be registered with the government agency “Medicines and Healthcare products Regulatory Agency” (MHRA). VibroSense Meter® II is now registered and shortly the product will be listed in the MHRA Public database https://pard.m  h

    Status report from VibroSense Dynamics AB (VibroSense)

    Good start to the new financial year and a promising first quarter.The first quarter of the fiscal year 2023/2024 has been good for VibroSense and the company continues the positive development with Diabetes Foot Screening . The company has delivered instruments to new customers and the positive sales trend continues for the fifth quarter in a row! Marketing and sales activitiesDuring the most recent period, VibroSense activities have continued to focus on Sweden, China and Germany. As previously announced, the company will participate in a number of international congresses during the

    Diabetic Foot Screening is now available at the Insurance Clinic at Sophiahemmet in Stockholm

    Diabetic Foot Screening is introduced at the Insurance Clinic at Sophiahemmet as standard procedure in the clinical operations, for regular control of nerve damage in the feet of people living with diabetes. They are the first private healthcare provider in Sweden to use the method.The Insurance Clinic Sophiahemmet uses the instrument VibroSense Meter® II and introduces the Diabetic Foot Screening examination as standard procedure in its clinical operations. Existing diagnostics tools, Tuning Fork and Monofilament are thus replaced with Diabetic Foot Screening for conducting foot

    VibroSense Dynamics delivers VibroSense Meter ® II with Diabetic Foot Screening to new customer in Germany

    VibroSense Dynamics has delivered an instrument to the Chemnitz University of Technology, which is a new customer in Germany. The deal is designed as a rental agreement, which is estimated to provide a total income of at least EUR 18,000 over three years. The delivery of VibroSense Meter® II and Diabetic Foot Screening is the second in a short time to Germany and the company's launch in this new market.Dr. Falk Zaumseil is a Professor of Movement Science and researcher in Biomechanics at Chemnitz University of Technology. He, together with two colleagues, will use the VibroSense Meter® II

    Breakthrough for Diabetic Foot Screening in Germany – Top-Ranked Diabetes Clinic Purchases VibroSense Meter ® II

    The Diabetes Clinic Herz und Diabetescentrum Nordrhein-Westfalen (HDZ NRW) has purchased VibroSense Meter® II and Diabetic Foot Screening after completed evaluation.The clinic has been evaluating VibroSense Meter® II and the application Diabetic Foot Screening with a stated goal of purchasing the instrument after the evaluation is completed, provided that the instrument meets defined requirements. The order value is 16 500 EUR including an annual recurring software license fee of 2000 EUR. The diabetes clinic at HDZ NRW is a highly ranked clinic at the university hospital in Bochum in

    Promising progress in Germany and positive response for Diabetic Foot Screening

    VibroSense Dynamics' (VibroSense) increased activities in Germany and the Nordics have been well received by the market. In Germany, VibroSense has identified a new strategy with existing reimbursement codes that is deemed to significantly facilitate the company's expansion in Germany. VibroSense has received positive response from its marketing activities towards both customers and investors.VibroSense current main focus is on two business areas, Diabetes and Occupational Health Care. In Germany, where the focus is on Diabetic Foot Screening, this has resulted in collaboration with a

    Groundbreaking results with VibroSense Meter® II in research with cannabis oil and chemotherapy

    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.The current study is part of a research-collaboration between VibroSense Dynamics and Zealand's University Hospital in Roskilde, with the aim of improving treatment of cancer with chemotherapy. The results from the

    VibroSense Dynamics takes the first order from Finland

    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.The total order value is divided into two parts: SEK 184,000 for the purchase and start-up of the instrument, and approximately SEK 240,000 for the license and service agreement calculated over 10 years. Oulu University Hospital (OYS) is the northernmost of five university central hospitals in Finland. The area

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