admin Epilepsy, a neurological disorder characterized by recurrent seizures, affects approximately 50 million people worldwide, according to the World Health Organization (WHO). Traditional anti-epileptic drugs aim to prevent seizures but often fall short, especially for the one-third of patients who do not respond to medication. These patients continue to endure seizures despite various drug treatments, leading to significant lifestyle limitations and mental health challenges.
Enter Precisis GmbH, a trailblazing company dedicated to revolutionizing epilepsy treatment through bioelectronic methods. Precisis has developed device-controlled therapies that offer a groundbreaking alternative to traditional medication, providing new hope for patients with drug-resistant epilepsy.
The Inception of EASEE®
Precisis’ journey began with Dr. Angela Liedler, a medical doctor and CEO of the company. Inspired by her observations of deep brain stimulation (DBS) procedures, Dr. Liedler questioned why seizures couldn’t be suppressed at their origin using electrical impulses. This curiosity led to the development of EASEE® (Epicranial Application of Stimulation Electrodes for Epilepsy), a minimally invasive, precise bioelectronic solution for epilepsy.
In 2015, Precisis was established as a start-up focused on bringing this visionary project to life. EASEE® represents a significant advancement in epilepsy treatment, offering a novel approach that directly targets the brain’s seizure onset zones with electrical impulses, thereby providing patients with a sense of security and the ability to live their lives with greater freedom.
Core Values and Operations
Precisis is driven by a mission to enhance the lives of patients suffering from functional brain disorders through innovative neurostimulation technologies. The company’s team comprises 24 members, with a remarkable 41% being women. This diverse group includes physicists, physicians, psychologists, and mathematicians, all united by a shared goal of delivering next-generation neuromodulation solutions to patients.
The team’s diversity fosters a collaborative environment where different perspectives are valued, and innovative ideas are nurtured. This synergy enables Precisis to push the boundaries of medical technology and develop effective treatments for epilepsy and other neurological disorders.
EASEE®: A Revolutionary Bioelectronic Product
EASEE® stands out among epilepsy treatments due to its unique design and functionality. Unlike traditional devices, EASEE® is implanted just beneath the skin, directly above the epileptic focus. This minimally invasive procedure involves two small incisions: one on the head for the electrode placement and another in the chest area for the implantable pulse generator (IPG). Importantly, the procedure does not involve touching sensitive tissues like nerves or the brain itself.
EASEE® combines two clinically proven stimulation paradigms. High-frequency alternating current is delivered in short bursts throughout the day to disrupt impending seizures, while direct current-like stimulation is applied once daily for long-term brain stabilization. Both stimulation intensities are set below sensory thresholds, ensuring that patients do not feel the stimulation.
Clinical studies in Europe have demonstrated EASEE®’s efficacy, with 84% of severely ill patients benefiting from the device after six months of stimulation. Remarkably, 53% of patients experienced a significant reduction in seizure frequency, and 17% became completely seizure-free. Moreover, no device-related serious adverse events have been reported, underscoring the safety and effectiveness of EASEE®.
Ensuring Safety and Efficacy
Precisis is committed to expanding the potential applications of EASEE®. After receiving the CE mark for adult use, the company is now focusing on extending the treatment to children and teenagers aged 12-17, who have even fewer treatment options. A clinical study scheduled for early 2023 aims to demonstrate the safety and efficacy of EASEE® in this younger patient group.
The technology behind EASEE® has broader implications beyond epilepsy. By developing a robust technological foundation, Precisis aims to address other conditions such as aphasia after stroke and neuropathic pain. The ability to switch the polarity of stimulation allows for targeted treatment of various cortical dysfunctions, making EASEE® a versatile tool in neurological therapy.
Scaling Operations and Future Goals
To achieve successful scale-up, Precisis recognizes the need to bolster its sales and marketing efforts. Increasing awareness of EASEE® within the medical community is crucial for its widespread adoption. The company also plans to enhance its production capacity to meet the growing demand for this innovative device.
Precisis values its strong network within the medical community, working closely with key opinion leaders (KOLs) in epilepsy research. This collaboration has been instrumental in conducting clinical studies and advancing the development of EASEE®.
Attaining Recognition of Excellence
Precisis’ efforts have garnered praise from experts in the field. Christian Elger, MD, Medical Director and Managing Partner of Beta Neurologie Bonn, highlights the importance of EASEE® in expanding treatment options for drug-refractory epilepsy patients. Dr. Schulze-Bonhage, MD, Head of the Department of the Epilepsy Center at the University Hospital Freiburg, commends the device’s efficacy and low-risk implantation procedure, envisioning it as a future therapeutic option for focal epilepsies.
CEO’s Vision for Bioelectronic Medical Innovation
Angela Liedler emphasizes the importance of a diverse team and a robust quality management system in bringing innovative bioelectronic medical devices to market. She believes that diverse backgrounds enrich discussions and generate novel ideas, driving the development of cutting-edge solutions like EASEE®.
Dr. Liedler also underscores the challenges posed by the new Medical Device Regulation (MDR) system, which demands extensive technical documentation and reports. To navigate these regulatory hurdles, Precisis has established a comprehensive regulatory and quality management system early in the development process.
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