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

An important milestone was the commencement of the pediatric study in May 2023, which will provide insights over the coming years into the extent to which the innovative EASEE® device can expand the treatment options for children and adolescents. The study is open to 12 to 17-year-olds who suffer from medication-resistant epilepsy. The study is currently underway at the following centers:

  • UK Freiburg
  • UK Heidelberg
  • Epilepsie-Zentrum Kehl Kork
  • Schön Klinik Vogtareuth
  • UK Frankfurt
  • Epilepsie-Zentrum Bethel, Bielefeld
  • Kepler UK Linz (AU)

At the same time, the Precisis team is working diligently to introduce EASEE® into additional European markets. Based on the positive feedback from the NHS in October 2023, EASEE® is expected to be available for epilepsy treatment in the United Kingdom from Q2 2024.

Since the EASEE® System is built on a platform technology, the device can potentially be adapted for use in other medical conditions in parallel to epilepsy. In the summer of 2023, the Precisis team decided to explore depression as another application area. Collaborations with various clinics are currently underway to plan potential scientific study protocols and project timelines. We anticipate receiving approval for a clinical study in the spring of 2024 to evaluate the therapeutic potential of EASEE® in the treatment of patients with severe medication-resistant depression.

Management

Dr. Angela Liedler - CEO
Dr. Angela LiedlerCEO

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

Pedro Marques - Chief Commercial Officer
Pedro MarquesChief Commercial Officer

Experiences:

  • Vice President Global Access and Clinical Development Medtronic
  • Vice President International Sales HeartWare Inc.

Education:

Perfusionist at the Academy for Cardiotechnology in Berlin

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®
20162018201920212023EASEEAnimalEASEEIIEASEElbPre-clinical phaseClinical phaseLine extensionPIMIDES IEASEE4YOUAssessment of interictal activityAssessment of biocompatibilityAssessment of performance and safetyAssessment of responsive neurostimulationAssessment of clinical outcome in kids 12-17y

The EASEE4YOU study assesses the performance of the EASEE® System in children and adolescents with therapy-resistant epilepsy aged 12 to 17 years.

Therapy options for patients in this age group are even more limited than those for adults. Precisis GmbH aims to provide these individuals with an option for a better quality of life in the future.

Therefore, we are pleased that the German and Austrian centers listed here are participating in the EASEE4YOU study to achieve this goal:

  • UK Freiburg
  • UK Heidelberg
  • Epilepsie-Zentrum Kehl Kork
  • Schön Klinik Vogtareuth
  • UK Frankfurt
  • Epilepsie-Zentrum Bethel, Bielefeld
  • Kepler UK Linz (AU)
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.

We take pride in the fact that our product is already presenting a promising alternative for individuals with severe epilepsy conditions. Following market approval in September 2022, several successful implantations have been carried out in specialized epilepsy centers in Germany, Austria, and Switzerland.

When making the decision regarding bioelectronic therapy with EASEE®, a team of specialists and experts is always being consulted. Consequently, we are expanding our in-house team to include a diverse range of professionals. This includes the addition of Field Clinical Engineers, who assist with the system implantation in the operating room. We are also deploying reimbursement specialists to meet the various international requirements. Additionally, we are creating more capacity in the service and communication sectors. Finally, we aim to gather and effectively implement the desires and expectations of patients and their families, and to achieve this, we are currently expanding our social media activities.

Overall, the commercial team, led by CCO Pedro Marques, is undergoing strategic expansion.

Advisory Board

Dr. Felix Baader - null
Dr. Felix Baader

Chairman

Highly accomplished MedTech executive with over 30 years of experience in key positions at Roche Diagnostics, Biotronik Vascular Intervention, Philips Patient Monitoring.

Serves as board member at:

  • BIBUS Group AG
  • Valtronic Holding AG
  • Berlin Heals Holding AG
  • Congenius AG
  • Medtor Inc (exit completed)
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
Dr. Hermann Sommer - null
Dr. Hermann Sommer

More than 30 years’ experience in restructuring, financing and managing small and middle size companies.

Last position as CEO in a market leader healthcare company including billing of prescriptions (30 billion Euro money transfer per year)

Today

  • advisor in various companies
  • member of executive board (STRIVE AG, founder and shareholder of PRECISIS)
  • M&A and restructuring companies, investor and strategy advisor
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
Thorben Katzer - null
Thorben Katzer

Broad experience in the areas Mergers & Acquisitions, Private Equity (Buyout and Venture Capital), Corporate Strategy, Business Development, Corporate Finance and Investment Management.

  • Head of Corporate Investments (Alternative Investments), Münster Stegmaier Rombach Family Office GmbH
  • Managing Director FO Administration GmbH
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
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