1 The EIC Accelerator Project

EIC Accelerator Program Overview

The EIC Accelerator, part of the European Innovation Council, is a funding initiative designed to support innovative small and medium-sized enterprises (SMEs) and startups within the European Union. This program aims to foster the growth and scalability of deep-tech innovations by providing financial support and strategic guidance. The EIC Accelerator is particularly focused on projects that demonstrate significant technological innovation and have the potential to create substantial societal impact.

Funding Structure

The EIC Accelerator offers two main types of funding: grants and equity investments.

Purpose in the European DeepTech Ecosystem

The EIC Accelerator plays a critical role in the European deep-tech and startup ecosystem by addressing the funding gap often faced by innovative companies. Many startups struggle to secure sufficient funding from private investors, particularly during the early stages of development when risks are high, and proof of concept is still pending. The program not only provides financial support but also connects companies with a network of investors, mentors, and experts who can guide them through the scaling process.

The EIC Accelerator serves as a catalyst for innovation, encouraging the development of groundbreaking technologies that can lead to economic growth and job creation across Europe. By targeting high-impact projects, the program aims to position Europe as a leader in technological advancement and innovation.

Case Study: PRECISIS GMBH and the BFORE Project

Company Overview

PRECISIS GMBH, a German-based company, emerged as a winner of the EIC Accelerator with its innovative project titled BFORE, which stands for Breakthrough Brain Stimulation Device for Epilepsy. The company specializes in developing cutting-edge medical technologies aimed at enhancing patient outcomes and improving the quality of life for individuals suffering from neurological disorders.

Project Description: BFORE

The BFORE project focuses on the creation of a groundbreaking brain stimulation device designed specifically for epilepsy management. Epilepsy is a prevalent neurological condition characterized by recurrent seizures, which can significantly impact the lives of affected individuals. Traditional treatment methods, including medication and surgery, do not work for everyone and can lead to substantial side effects.

The BFORE device employs advanced neurostimulation technology to regulate abnormal electrical activity in the brain, potentially reducing the frequency and severity of seizures. The device is designed to be minimally invasive, providing a more patient-friendly alternative to existing therapies. By targeting specific brain regions, the BFORE device aims to restore normal brain function, offering hope to patients who have not responded to conventional treatments.

Technological Background

The underlying technology of the BFORE device is based on neuromodulation principles, which involve altering nerve activity through targeted electrical stimulation. This approach has shown promise in various neurological applications, including pain management and movement disorders. The BFORE project utilizes sophisticated algorithms and real-time feedback mechanisms to optimize stimulation parameters, ensuring a personalized treatment experience for each patient.

The device is equipped with sensors that monitor brain activity and adjust stimulation levels accordingly. This adaptive functionality is crucial for maximizing therapeutic effects while minimizing risks and side effects. The technology not only represents a significant advancement in epilepsy treatment but also holds potential for addressing other neurological conditions in the future.

Conclusion

The EIC Accelerator program serves as a vital engine for innovation and growth in the European deep-tech ecosystem. Through a combination of grant and equity funding, it empowers startups like PRECISIS GMBH to bring transformative technologies to market. The BFORE project exemplifies the type of impactful innovation the EIC Accelerator seeks to promote, promising to enhance the quality of life for individuals living with epilepsy. As the program continues to support groundbreaking projects, it plays an essential role in shaping the future of healthcare and technology in Europe.

2 The Funding Rounds

# PRECISIS GMBH: Funding Journey and Growth Since EIC Accelerator Funding

PRECISIS GMBH, based in Heidelberg, Germany, has established itself as an innovative medical device company specializing in bioelectronic brain stimulation systems. The company has secured significant funding to develop its groundbreaking EASEE® system, a minimally invasive treatment for epilepsy that has received FDA Breakthrough Device designation.

Funding History

PRECISIS has successfully secured multiple rounds of funding to support its development of innovative medical devices:

Financial Round A (2015)

In 2015, PRECISIS received approximately €20 million from private investors in its Financial Round A. During this same period, the company also secured significant funding from the German Federal Ministry of Research and Education.

€20 Million Funding Round (October 2021)

In October 2021, PRECISIS closed another €20 million financing round with Cochlear Limited, the global leader in implantable hearing solutions. This strategic partnership allowed PRECISIS to benefit not only from Cochlear's financial investment but also from their scientific expertise.

EIC Accelerator Funding (2022)

PRECISIS submitted a Step 2 proposal to the European Innovation Council (EIC) Accelerator program on October 5, 2022, and subsequently won in the Step 3 interview. This funding has further supported the company's development and clinical validation of its innovative medical technologies.

Investor Information

PRECISIS has attracted a diverse range of investors throughout its funding journey:

• Private Investors: Contributed significantly to the company's Financial Round A in 2015.
• German Federal Ministry of Research and Education: Provided substantial funding support alongside the private investment in 2015.
• Cochlear Limited: A strategic investor that contributed €20 million in October 2021. As the global leader in implantable hearing solutions, this partnership provides both financial resources and valuable scientific knowledge.

Product Development and Clinical Progress

The funding secured by PRECISIS has been primarily directed toward the development and clinical validation of EASEE®, their innovative bioelectric brain stimulation system designed for treating epilepsy:

• The EASEE® system offers a minimally invasive approach to epilepsy treatment, allowing for customized treatment based on each patient's specific disease history.
• Several clinical studies have already demonstrated the high efficacy of EASEE® in inhibiting epileptic seizures.
• The FDA has designated EASEE® as a "Breakthrough Device," which allows for an expedited review process for clinical studies and commercial clearance.
• Clinical studies in the U.S. were planned to begin in 2023, with the goal of introducing the therapy to the market as soon as possible.

Company Information

PRECISIS GMBH is headquartered in Heidelberg, Germany, at Hans-Bunte-Straße 8-10. The company specializes in developing innovative medical devices, with a particular focus on device-guided therapies for the brain. Under the leadership of Dr. Angela Liedler, Managing Director, PRECISIS has established itself as a pioneer in bioelectronic methods to direct therapeutic currents at defined target areas of the brain.

The company's strategic relationship with Cochlear Limited represents a significant milestone, providing both financial support and scientific expertise to advance their innovative technologies.

Market Position and Future Outlook

With the FDA Breakthrough Device designation for EASEE®, PRECISIS is positioned for accelerated market entry in the United States. The company continues to focus on clinical validation and regulatory approval processes to bring its innovative epilepsy treatment to patients worldwide.

The ongoing development of EASEE® addresses a significant unmet need in epilepsy treatment, as approximately one in three epilepsy patients does not respond to available drug therapy options. This positions PRECISIS's technology as a potentially transformative solution in the field of neurological disorders.

Sources: - Precisis company information, funding & investors

• Precisis Concludes Funding Round of €20 Million For Its Bioelectric Brain Stimulation System
• Minimally Invasive Epilepsy Treatment EASEE® Receives FDA Breakthrough Device Designation

3 The Press Releases

PRECISIS GmbH: Post-EIC Accelerator Innovation Trajectory Since securing EIC Accelerator funding in October 2022, PRECISIS GmbH has accelerated its development of the EASEE® system, a minimally invasive brain pacemaker for drug-resistant epilepsy. Below are key advancements, recognitions, and operational updates from their press releases and official communications:

Awards and Recognitions

• Innovation Award of Baden-Württemberg 2023: Won in November 2023 for their neurostimulation device, emphasizing its potential to improve quality of life for epilepsy patients.
• TOP 100 Seal 2023: Awarded in February 2023 for systematic innovation processes and leadership.
• HEALTH-i Award 2024: Secured second place for advancements in epilepsy treatment technology.

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Technology Advancements

• CE Certification: Achieved for EASEE®, enabling commercialization in Germany, Switzerland, Austria, and later the UK (May 2024).
• Breakthrough Device Designation: Granted by the U.S. FDA, highlighting its therapeutic potential.
• Clinical Results: Demonstrated a 53% responder rate at six months post-implantation (JAMA Neurology), with sustained improvements during long-term follow-ups.

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Market Expansion

• UK Launch (May 2024): EASEE® became available on the NHS for adults with drug-resistant focal epilepsy. The implant’s minimally invasive design positions it as an alternative to resective surgery, which is viable for only ~1% of patients.
• Global Growth Strategy: Highlighted in Medtech Outlook (October 2023), outlining plans to expand into international markets beyond Europe.

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Team and Operations

• Workforce Growth: Expanded from a core team of ~20 employees (early 2023) to over 34 by mid-2024, reflecting scaling operations.
• Leadership Statements: Emphasis on fostering an innovation-centric culture under CEO Dr. Angela Liedler and CTO Michael Tittelbach.

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Sources
[Listed chronologically by relevance]

4 The Technology Advancements

Overview of Precisis GmbH

Precisis GmbH is a German medical technology company based in Heidelberg, specializing in the development of innovative neurostimulation devices for treating brain disorders. Their focus is on improving the lives of patients with functional brain diseases through cutting-edge technology.

Capabilities and Advancements

Following the receipt of EIC Accelerator funding on October 5, 2022, Precisis GmbH has continued to advance its technology. The company is known for its EASEE system, a transcranial brain stimulation method designed to treat seizure disorders, epilepsy, cognitive dysfunction, and rehabilitation after stroke. This system involves subcutaneous electrodes for precise brain stimulation.

Technology Improvements

The EASEE system is notable for its individual-focused approach, using a minimally invasive procedure to implant electrodes. This method allows for deep and focused stimulation of the brain, adapting to varying resistances to achieve effective current flows. While specific details on new features or improvements since the funding are not readily available, the company's focus remains on enhancing neurostimulation technologies.

Market Demonstration

Precisis has demonstrated its technology through clinical trials. The EASEE system received the CE Mark for treating adults with therapy-refractory focal epilepsies in September 2022. Clinical results published in JAMA Neurology showed promising outcomes, with 53% of patients experiencing a significant reduction in seizure frequency and 84% showing some response.

Patents and Publications

There is limited publicly available information on new patents filed by Precisis GmbH since receiving the EIC funding. However, the company's work is supported by scientific research, as evidenced by publications and presentations related to its technology, such as those presented at the DGfE conference in Leipzig.

Clinical Trials

Precisis GmbH has been involved in clinical trials, notably those related to the EASEE system. These trials have contributed to its CE certification and have provided valuable insights into the efficacy of its neurostimulation technology.

Conclusion

Since receiving the EIC Accelerator funding, Precisis GmbH has continued to develop and demonstrate its innovative neurostimulation technology. While specific advancements or new features may not be extensively detailed, the company's progress in clinical trials and market readiness underscores its commitment to improving treatments for brain disorders.

Sources:

• Precisis – bioelectronics for the brain
• Precisis GmbH - Drug pipelines, Patents, Clinical trials
• Precisis GmbH - Product Pipeline Analysis, 2024 Update
• Precis Receives CE Mark for EASEE® System

5 The Partnerships and Customers

PRECISIS GMBH Partnerships and Market Positioning Since receiving EIC Accelerator funding in October 2022, PRECISIS has focused on advancing its EASEE® epilepsy treatment system, forging strategic collaborations to expand its clinical and technological footprint.

Key Collaborations and Customers

• Pagaimo Medical: Partnered for the introduction of EASEE® in Portugal, culminating in the first successful implantation at Coimbra University Hospital.
• Clinical Trial Networks: Actively engaged with medical institutions such as Coimbra University Hospital for registry studies (DRKS00032576) and pediatric trials (DRKS00031722) targeting patients aged 12–17.

Nature of New Relationships

The Pagaimo collaboration aims to establish EASEE® as a transcranial focal cortex stimulation solution for drug-resistant epilepsy, combining localized therapy with reduced surgical invasiveness. Clinical partnerships focus on generating long-term efficacy data across diverse patient cohorts.

Market Positioning Through Partnerships

These relationships solidify PRECISIS’s role as an innovator in neuromodulation, particularly within Europe’s growing deep brain stimulation market (projected CAGR of 10.40% post-2023). By addressing pediatric populations, they differentiate from competitors focused solely on adult care.

Technological Advancements and Scaling

Collaborations provide access to real-world EEG datasets, enabling optimization of ultra-low-power seizure detection algorithms critical for closed-loop neurostimulation systems. Pagaimo’s distribution network facilitates scaling into Southern European markets while adhering to regulatory frameworks like CE marking (implied by ongoing trials).

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Sources

• Precisis News: EASEE® System Successfully Implanted at Coimbra University Hospital
• Precisis Company Leadership
• EASEE® News: Portugal Launch
• Deep Brain Stimulation Devices Market Analysis
• Precisis Clinical Trials and Pipeline
• Ultra-Low-Power Seizure Detection Study Collaboration

6 The Hiring and Company Growth

Precisis GmbH: Team Growth and Development Post EIC Accelerator Funding

Introduction

Precisis GmbH, a German medical technology company, has been a recipient of the EIC Accelerator funding, securing this prestigious award in October 2022. Since then, the company has continued to focus on developing innovative bioelectronic solutions for brain disorders, notably through its EASEE® system for epilepsy treatment. Here, we delve into aspects of their team growth, hiring processes, and strategic developments.

Hiring and Team Growth

Precisis emphasizes the diversity and talent of its team members, showcasing a blend of experienced and young professionals. While specific headcount details are not publicly available, the company's team is described as diverse and highly skilled, suggesting a strong hiring strategy focused on attracting the best talent for each role.

Current Hiring Status

Precisis is actively seeking to expand its team, as indicated by their invitation for applicants to join their diverse and skilled group. This indicates a growth phase where they are looking to onboard new members to support their innovative projects.

Growth and Scaling

Since receiving the EIC Accelerator funding, Precisis has made significant strides in its technological advancements, particularly with the successful implantation of its EASEE® system at Coimbra University Hospital. This achievement highlights their growth in clinical applications and their potential for further expansion into areas like depression therapy and stroke medicine.

Key Positions and Future Impact

While specific details on recent key hires are not available, Precisis's focus on AI-based bioelectronic solutions suggests that they are likely recruiting experts in AI, neuroscience, and engineering. New team members will play a crucial role in enhancing the company's technological capabilities, supporting the development of next-generation brain stimulators, and driving innovation in therapeutic areas.

Management and Founding Team Changes

Karl Stoklosa serves as the Managing Director and CEO, bringing extensive experience from the medical technology sector. There are no recent reports of major changes in the management or founding team. Stoklosa's background in neuromodulation and cardiac rhythm management underscores the company's commitment to leveraging experienced leadership to guide its growth.

Conclusion

Precisis GmbH is undergoing a phase of strategic growth and development, leveraging its EIC Accelerator funding to enhance its bioelectronic solutions and expand its team. The company's focus on innovative technologies and diverse talent positions it well for continued success in the medical technology sector.

Sources:

• Precisis – bioelectronics for the brain
• Company - Precisis AG
• News | Precisis
• The impact of EEG preprocessing parameters on ultra-low-power ...

7 The Media Features and Publications

PRECISIS GMBH: Post-EIC Accelerator Funding Activities and Visibility PRECISIS GMBH, a German medical technology company specializing in bioelectronic brain stimulation devices, was selected as an EIC Accelerator winner in October 2022. The company’s winning proposal centered on its EASEE® brain stimulation device, designed to suppress epileptic seizures through AI-driven therapeutic currents. Below is a synthesis of available information regarding media features, publications, and public engagements:

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Media Features & Publications

• EIC Accelerator Recognition: PRECISIS was prominently listed among EIC Accelerator winners in official European Commission documents and third-party analyses. These sources highlight its focus on epilepsy treatment and next-generation neurostimulation technologies.
• Company Website: Precisis.de details their mission to expand applications of cortical stimulation into depression therapy and stroke medicine. However, no peer-reviewed publications or independent media articles are explicitly cited on their site.

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Podcasts & Interviews

No publicly available podcasts or interviews with PRECISIS team members were identified through the provided sources. The company’s website does not list media appearances or audio content directly.

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Conferences & Event Participation

While specific conference participations are not detailed in the search results, the EIC Accelerator program typically facilitates networking through events like the EIC Summit. PRECISIS’ inclusion in EIC portfolios suggests potential involvement in such forums post-funding.

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Post-Funding Developments

PRECISIS emphasizes scaling its neurotechnology pipeline post-EIC funding. Key focus areas include:

• Miniaturizing brain pacemakers for improved patient tolerance.
• Expanding clinical applications for depression and stroke rehabilitation.

The €17.5 million maximum funding from the EIC likely supports these R&D efforts alongside market-entry strategies.

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Sources Referenced

• EIC Accelerator winners October 2022 - Strata
• European Innovation Council welcomes 78 high-potential start-ups