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The Future Workshop - Medical Device Development

Offices in Tübingen, Germany, and in London, UK.

Clinical Trials For CE Certification And BfArM

Outsourcing Your DTx Development

Clinical research and development are at the heart of HPZenner. It is our philosophy to make contributions to the development of digital machines that preserve humanity.

Our background is excellence in science. Coming from medicine and neuroscience, the development experience of team members goes back from successful co-development of electronic neuroimplants to CE certification. Today, Digitineers is breaking new ground all the way to hybrid AI. We develop digital architectures along value chains. Digitineers combines product architecture and design with user knowledge and experience in the context of digital knowledge and thinking. And: we have built networks for valuable knowledge transfer. The result: an ecosystem with digital thought leaders, partners and customers with diverse inspirations for all involved.

Our R&D division is made up of graduates and scientists from the University of Munich (LMU) and the University of Tübingen, both in Germany. Our international education and professional experience spans both the EU and the US. Today, we work in an ecosystem with digital thought leaders, partners and customers with diverse inspirations for all stakeholders.

Vertidisan- The Vertigo DiGA

Digital health app: vertigo inhibition using therapeutic vertigo program.
Indications: Vertidisan is used for the symptomatic treatment of peripheral vertigo.
Mode of action: antivertiginous effect through neuronal learning of the central vestibular functional system.
Contents of an app: (1) ABEV: Adaptive Balance/Eye-Movement and Visual Stimulation. (2) KVT: Cognitive Behavioral Therapy. (3) MC: Medical Counseling. (4) PMR: Progressive Muscle Relaxation. (5) AG: autogenic training. (6) GE: health education. Supplemental: (7) RE: nonspecific relaxation.

The Galax Project - ESA funded space research: DTx development for prevention and treatment of space sickness before, during and after space flight.

Problem Statement. Space Motion Sickness (SMS) is observed in about 70% of astronauts in space and additionally after flight. More cases are expected in future space tourists. Medications are available, but they can have serious adverse effects. In addition, the drugs may lose their effectiveness during prolonged space missions.

Solution. A DTx (Digital Therapeutic) with the unique selling point of reducing or eliminating SMS at a higher rate than drugs or physical therapy, available anytime, anywhere, both on Earth for pre-flight prevention and post-flight treatment, and in space. Unlike medication, it does not lose efficacy or cause significant adverse events, and also covers stress and coping incapacity. Galax-Disan® is being developed as a digital therapeutic (DTx) to provide a stand-alone preventive and therapeutic solution.

The device is designed to be able to:
--Control a sensory conflict-free reorganization of the gravity-related relationship between different inputs provided by the eyes, skin, joints, muscles, and especially vestibular receptors in the inner ear.
-Stabilization of sensorimotor disorders.
--Stopping the illusion of self-motion associated with spatial disorientation.
--Induction of head movements in the pitch and roll planes. They cause stabilizing signals to be transmitted to the regions of the central nervous system responsible for the central integration of the arcades (angular acceleration) and the otolith organs (linear acceleration).
--The Coriolis cross-coupling stabilization is achieved by sudden accelerations and decelerations from constant-velocity rotation elicited by angular and linear movements, oculomotor and postural responses to optokinetic stimulation, and responses to caloric stimulation.

Efficacy and Safety. Upon approval by the appropriate nationally recognized ethics committee, prospective controlled clinical trials are legally and ethically feasible to investigate the feasibility, efficacy, and safety of the DTx for the prevention and treatment of vestibular disorders during and after flight. The studies could begin in 2023 and include parabolic flights and space flights. As a result, the DTx could be a stand-alone preventive and therapeutic solution for astronauts and space tourists to prevent and treat SMS during and after flight.