Press Releases and News

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.

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.

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.

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.

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.

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.

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.

Organization

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 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.

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.

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.

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.

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.

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).

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 UK.

Professor 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).

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 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 2 000 EUR.

VibroSense Dynamics AB (VibroSense) - Several positive signs from the market as the Company continues to implement its business plan.

The business plan is continuously implemented with several actions in parallel. VibroSense has carried out various market activities and supported its customers as well as partners in multiple research studies. VibroSense has also identified that there is a pronounced interest in Sweden among people living with diabetes, to pay themselves for a reliable foot examination outside the public health care system.