DGAP-News: VisionHealth receives EU Medical Device Regulation certification

VisionHealth receives EU Medical Device Regulation certification

• VisionHealth is among the first app manufacturers to receive EU Medical Device Regulations (MDR) certification
• MDR certification prerequisite to enhance, further develop and release future Kata^(R) versions
• Next Kata^(R) app version will be a CE marked class IIa medical device (MDR)

Munich (Germany), December 20, 2021 - VisionHealth GmbH, a pioneer in digital therapeutics (DTx) for the inhaled treatment of chronic lung diseases, today announced the successful certification of its quality management system according to the new EU Medical Device Regulation (MDR 2017/745) and EN ISO 13485. This certification enables VisionHealth to confirm compliance of their Kata^(R) app, as well as subsequent versions, with the MDR standards based on the Company's audited quality management system.

With the regulatory change from the Medical Device Directive (MDD) to MDR, requirements for both manufacturers and notified bodies have changed significantly. The new MDR extends the needs and details for technical documentation and introduces requirements for state-of-the-art IT security.

"I would like to thank the whole team for the intensive work and tremendous effort to complete the certification in such a short time. We have worked hard to fulfill the standards for a MDR certification of our quality management. This certification allows us to advance our platform to further strengthen the benefits patients and medical professionals can take from Kata^(R). Certification also proves that VisionHealth is a reliable partner and represents an important milestone on our path towards DiGA application," said Dr. Sabine Häußermann, CEO and founder of VisionHealth GmbH.

VisionHealth's DTx App Kata^(R) is CE marked and a medical device class I (MDD). From the next version on, it will be classified as class IIa medical device (MDR) due to its intended use to monitor and improve inhalation therapy: The Kata^(R) app guides patients suffering from chronic respiratory disease like asthma and Chronic Obstructive Pulmonary Disease (COPD) to improve their inhalation technique, leading to a better medication deposition in the lung. The execution of the inhalation process is prone to errors: studies have shown error rates between 32 and 100 %.^{[1],[2],[3],[4],[5]} Incorrect inhalation and the resulting underdosing of drugs cause a high unmet medical need and higher rates of complications and exacerbations in the most prevalent chronic lung diseases, Asthma and COPD.^[6] Especially in COPD, every exacerbation is known to cause an irreversible loss of lung function.^[7] Better disease control with fewer exacerbations and consequently lower hospitalization rates could lead to massive cost savings for public health systems.⁶ The Kata^(R) app controls the therapeutic inhalation and trains the patient by providing immediate feedback through its proprietary AI-based algorithm, thus delivering the support that is needed to regularly deposit the intended dose of the drug in the lung. Worldwide, Kata^(R) could support the therapy of approximately 250 million patients suffering from chronic respiratory diseases, with an estimated 8.9 million cases alone in Germany.^[8],[9]

About VisionHealth

VisionHealth GmbH is a pioneer of digital therapy support for respiratory diseases. In cooperation with research institutions and selected industry partners, medical experts and IT experts, VisionHealth develops innovative and unique digital health solutions enabling sustainable improvements to existing standard therapies for patients with chronic lung diseases like asthma and COPD. The Munich-based private company was founded in 2017 by inhalation therapy specialists. Investors include business angels and private investors with many years of industry expertise, particularly in inhalation therapies. www.visionhealth.gmbh

About Kata^(R)

Kata^(R) is a VisionHealth proprietary platform based on artificial intelligence to support inhalation therapy. The aim of the Kata^(R) app for patients is to optimize the drug inhalation therapy of chronic lung diseases through digital support by help of augmented reality using the smartphone camera for immediate feedback and correction. Clinical evidence shows that patients frequently fail to correctly perform their necessary and regular inhalation due to a lack of therapy adherence or knowledge. As a result, the prescribed medications are not adequately delivered to the respiratory airways. A multitude of different devices for drug inhalation increases the training effort for physicians and patients and makes therapy monitoring almost impossible. This issue affects around 250 million people worldwide suffering from chronic lung diseases to whom Kata^(R) could bring urgently needed relief. Kata^(R) is a proprietary platform application providing a completely novel and unique combination of artificial intelligence (AI) and computer animation. Kata^(R) is among the first digital applications to have received medical device certification.

A modified Kata^(R) app for clinical trials (Kata^(R) Clinical) combines data and patient management to enhance the participants' experience and improve study outcomes at the same time. Based on the customized adaptation to the specific needs of a study, data collection and management can be conducted more efficiently and are less error-prone due to automation.
www.kata-inhalation.com

Contact

Dr. Sabine Häußermann | CEO | +49 151 701 865 89 | [email protected]

VisionHealth GmbH | Landsberger Str. 72 | 80339 München

Media Contact

MC Services AG

Katja Arnold / Dr. Brigitte Keller

+49 89 210228 0
[email protected]

References
^[1] Press VG et al. J Gen Intern Med. 2011; 26:635-42. https://doi.org/10.1007/s11606-010-1624-2
^[2] The Inhaler Error Steering Committee. Respir Med. 2013; 107:37-46. https://doi.org/10.1016/j.rmed.2012.09.017
^[3] Price DB et al. J Allergy Clin Immunol Pract. 2017; 5:1071-1081.e9. https://doi.org/10.1016/j.jaip.2017.01.004
^[4] Molimard M et al. Eur Resp J. 2017; 49:1601794; https://doi.org/10.1183/13993003.01794-2016
^[5] Lindh A et al. Nursing Open 2019; 6:1519-1527; https://doi.org/10.1002/nop2.357
^[6] Usmani OS et al. Respiratory Research 2018; 19:10. https://doi.org/10.1186/s12931-017-0710-y
^[7] Anzueto A. European Respiratory Review 2010; 19: 113; https://doi.org/10.1183/09059180.00002610
^[8] Steppuhn H et al. Journal of Health Monitoring 2017; 2: 37-45; https://doi.org/10.17886/RKI-GBE-2017-052
^[9] Steppuhn H et al. Journal of Health Monitoring 2017; 2: 46-54; https://doi.org/10.17886/RKI-GBE-2017-053