Company

Precisis Steril

Precisis GmbH is headquartered in Heidelberg and specialises in the development of innovative medical devices. Precisis GmbH stands for outstanding success in the realm of device-controlled therapies for the brain.

Our plans for the future

The next crossroads for the company is CE-certification for the innovative brain stimulation device EASEE® for the treatment of severe epilepsy. This will be followed by the launch of studies in paediatric and adolescent epilepsy patients in the autumn of 2022.

Management

Dr. Angela Liedler - Manager
Dr. Angela LiedlerManager

Experiences:

  • Group President EU Operations for InVentiv Health Inc., Columbus, Ohio
  • Clinical Research Organisation Liedler GmbH, München
  • Medical Marketing, Pfizer, Freiburg/Karlsruhe
  • Senior House Officer Liverpool, Ärztin, Freiburg

Education:

Medical studies and doctorate, RWTH Aachen

Founding member Healthcare Frauen e.V

Michael Tittelbach - Chief Technical Officer
Michael TittelbachChief Technical Officer

Experiences:

  • Senior Direktor Forschung & Entwicklung Kombinationsprodukte für die interventionelle Kardiologie bei der Biotronik AG
  • Entwicklungsingenieur und Projektmanager bei der Biotronik SE

Education:

Physikstudium an der Friedrich-Alexander-Universität, Erlangen-Nürnberg

Joachim Schneider - Quality Management
Joachim SchneiderQuality Management

Experiences:

  • Manager Regulatory Affairs, SIGNUS Medizintechnik GmbH
  • Lead Auditor and Technical Expert for In-vitro Diagnostic and Active Medical Devices, TÜV Rheinland Product Safety GmbH
  • Technical Support Specialist, Siemens Healthcare Diagnostics Products

Education:

Diploma Engineering Degree (Dipl.-Ing. FH) Biotechnology, University of Applied Sciences Giessen-Friedberg

Anja Resler - Clinical Affairs
Anja ReslerClinical Affairs

Experiences:

  • Senior Field Clinical Specialist Europe (Neuromodulation), Autonomic Technologies Inc.
  • Regional Manager Clinical Operations EMEA, Abbott Vascular International
  • Senior Clinical Research Associate, Guidant Europe S.A., Belgium
  • Cardiac Cath Lab Assistant, Frankfurt, Germany

Education:

Medical Laboratory Technician

The Precisis team has succeeded in negotiating the jungle of regulatory norms and hurdles faster and more effectively than most comparable start-ups.

Pre-clinical and clinical studies with EASEE®
20162018201920212022EASEEAnimalEASEEIIEASEElbPre-clinical phaseClinical phaseLine extensionPIMIDES IEASEE4YOUAssessment of interictal activityAssessment of biocompatibilityAssessment of performance and safetyAssessment of responsive neurostimulationAssessment of clinical outcome in kids 12-17y
EU MDR
Patient safety

Before a medical technology product becomes available on the open market, it must undergo many laborious technological development steps, and extensive testing and validation procedures. These include both animal studies and studies on sick people.Precisis conducted the first implantation of its system in 2019 – the ‘first-in-human’ clinical study. Since then, we have developed the perspective of several hundred therapy months and can proudly claim that our initial creative idea has gone on to become a safe and highly effective therapeutic method. The step-by-step, careful and laborious licensing procedure (Medical Device regulation, MDR) is intended primarily to serve patient safety: however, the data evaluation also serves to answer the question whether what may be an expensive innovative therapy should take its place in our health insurance system and be regarded as worthy of reimbursement. We consider ourselves fortunate in that our brain stimulation product is already achieving significant success in people with severe brain disorders, currently in the framework of clinical studies but soon also on the open market.

Advisory Board

Jens-Martin Schwärzler - null
Jens-Martin Schwärzler

More than 28 years experience in the Consumer Goods Industry for a leading global Dax 40 company.

Last position as Executive Vice President / Member of the Management Board

Serves today besides others as

  • Senior Advisor to McKinsey
  • Supervisory Board Predimo
  • Start-up coach and investor
Richard Brook - null
Richard Brook

Spent more than 20 years in the implantable industry for cardiac and hearing loss products

  • President – Europe, Middle East & Africa, Cochlear Ltd.
  • Director - Distributor Operations: EMEA
  • Divisional Vice President Alaris Medical Inc.
André Burch - null
André Burch

More than 28 years experience in global leading medical device companies

  • Board of Directors, VP Finance & Administration at BIOTRONIK Vascular Intervention (VI)
  • VP Clinical/Regulatory Affairs, VP New Businesses, Director R&D at BIOTRONIK VI
  • Director R&D, Boston Scientific and Pfizer/Schneider Worldwide
  • MSc ETH Zurich / Executive MBA IMD Lausanne, Switzerland
Pedro Eerdmans - null
Pedro Eerdmans

Broad experience in the Neurology, Cardiology, Urology, Hepatology and Orthopedics field.

  • Hospital, service (Clinical Research Organization) and medical industry environment
  • Director Clinical, VP Medical Affairs and CMO positions managing global clinical and regulatory departments in start-up and large medical device companies
  • Interaction with most governmental agencies, including the FDA and PMDA, and Notified bodies.
Peter Weiland - null
Peter Weiland

Spent 30 years in the medical device industry with 20 years of management experience

  • CEO and founder of NGMedical GmbH
  • Previously CEO and founder of AMT Advanced Medical Technologies AG
Berth Hausmann - null
Berth Hausmann

15 Years experience as CFO in global technology companies

  • Deputy Chairman of the Supervisory Board, GBC
  • Supervisory Board Hymer Leichtmetallbau GmbH
  • Deputy Chairman CAPCAD Systems AG
Investments for innovations

To date, Precisis has benefited from two BMBF (German Federal Ministry of Education and Research) grant programmes that financially support medical technology innovations. With these grant programmes, the Federal Ministry of Education and Research has indicated its conviction that the medical technology sector represents a highly innovative and fast-growing branch of the health care industry and that technological innovations can not only improve the care of sick individuals but also represent the best economic opportunities for companies. However, the bulk of financing during the high-risk start-up phase of development was carried through private investments.

bmbf.de
Cooperation with Cochlear

In 2021, Precisis and the Australian firm Cochlear Ltd concluded a partnership agreement. The new relationship with Cochlear offers financial benefits for Precisis along with access to Cochlear’s scientific expertise.Cochlear is the world’s leading provider of implantable solutions for people who are hearing- impaired. The firm employs over 4,000 people worldwide and invests more than AUD 180 million annually in research and development. Its products include hearing systems for cochlear implants, bone conduction implants and acoustic implants, which were developed for the treatment of moderate to severe hearing loss. Since 1981, the company has manufactured more than 650,000 implantable devices, which are helping people of all ages to hear in around 180 countries.

cochlear.com