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HPZenner® - Driving Health Care Transformation

HPZenner. Health Care Transformation in Three Dimensions. (i) CRO. (ii) R&D. (iii) Venture Building.

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

(i) Clinical Research Organization (CRO)

As CRO we pave the way of your medical device to the EU market and to BfArM registration as DiGA.

(ii) Research & Development

Our R&D unit may perform the Clinical Development of your DTx up to the EU market. This may be followed by a DiGA registration with the BfArM. In a project funded by ESA a DTx is being developed for application in space.

(iii) Ensyme - The Digital Company Builder

HPZenner´s Ensyme company builder is highly specialized in the venture building of digital medical device start ups that wish to develop, produce and scale CE marked and BfArM/FDA registrated DTx/DiGAs.

HPZenner CRO - DiGA Market Access
Your access to the world´s largest digital therapeutics reimbursement market
London Office | HPZenner® Clinical Research Organization | +44 7981 859 404 | london-office@hpzenner.com

HPZenner helps your Health App´s jumpstart into the world´s largest digital therapeutics reimbursement market

Germany’s healthcare market, the world's largest per capita spending health care system with 72 million socially insured patients has been opened for digital therapeutics (DTx) in October 2020. The internationally unique feature: DTx listed with Germany’s Federal Institute for Drugs and Medical Devices (BfArM) can be prescribed to patients by their doctor free of charge. The manufacturer receives payment directly from the health insurer. Those DTx carry the "DiGA" designation.

HPZenner Clinical helps you enter this unique market by providing you with the full scientific evidence to obtain the “DiGa” designation for your health app via BfArM´s "Fast Track" approval process

Your DiGA success is our mission

As a manufacturer-independent institute within the meaning of § 139e Paragraph 4 SGB V, HPZenner Clinical has the experience and knowledge for your DiGA success: With its DiGA Clinical Study Program (DCSP) HPZenner Clinical already made a significant contribution to the successful inclusion of some of the first DiGAs in the BfArM DiGA directory since October 2020.

An evaluation concept and study protocol for the BfArM have already been drawn up for other manufacturers.

Do not hesitate to call +44 7981 859 404 or to mail to london-office@hpzenner.com.

DiGA

The CRO HPZenner®
is proud to have contributed significantly to the successful inclusion of some of the very first DiGAs in the BfArM directory. HPZenner is a Germany based CRO for the digital medical device industry. For manufacturers we offer full or partial service for clinical evaluations and clinical studies in Germany according to the German DiGAV as well as the EU MEDDEV 2.7/1 rev 4 / MDR.

Analytical. Clinical. Innovative.

Welcome to the London Office

"We are proud of our renowned partners in all clinical disciplines who are the basis of our ability to pave the way for your DiGA success in Germany."

Christian Zenner

Alliance Partner
London Office
253 Goldhurst Terrace
London NW6 3EP, United Kingdom
+44 7981 859 404
london-office@hpzenner.com
www.hpzenner.com

HPZenner® is a registered trademark.

HPZenner CRO - Clinical Evaluation

HPZenner CRO - Clinical Trials

HPZenner Ensyme - The Venture Builder

Ensyme is HPZenner´s digital medical device company builder lab. Beautyfully located in Tübingen, Germany, with its University of Excellence and situated in Germany´s Medical Device Valley Ensyme builds, invests and partners.

HPZenner´s Ensyme is a highly specialized venture building platform for founders or spin offs wishing to develop, produce and distribute CE marked DTx. HPZenner takes an active role in the cofinancing, development, marketing and scaling of the newly founded company.

Companies may be de novo start ups as well as spin offs.

To this end, HPZenner has established a central team that drives the development of the startup forward and supports the founding team. This includes software development, clinical contents development, TD according to MDR, ISO 13485 certification, EU market access including CE marking according to MDR, and BfArM registration including Clinical Trials according DVG and DiGAV.

Applications are welcome anytime.

Do not hesitate to contact HPZenner´s Germany office via office@hpzenner.com (phone: +49 7071 49645) or HPZenner´s UK office via london-office@hpzenner.com (phone +44 7981 859 404)

Our Ventures

Presently Ensyme manages the following start ups:

Digitineers

HPZenner R&D - Medical Device 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.


The Galax Project - 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.