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.
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:
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.
Experiences:
Education:
Experiences:
Education:
Physikstudium an der Friedrich-Alexander-Universität, Erlangen-Nürnberg
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:
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.
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:
Spent more than 20 years in the implantable industry for cardiac and hearing loss products
More than 28 years experience in global leading medical device companies
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
Spent 30 years in the medical device industry with 20 years of management experience
Extensive experience in Mergers & Acquisitions, Private Equity (Buyout and Venture Capital), corporate strategy, development, financing, as well as investment management.
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.deIn 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
