Chronic cluster headache and chronic migraine pose a significant challenge for patients and neurologists worldwide. Approx. 48-64% of the patients experience only limited relief from drug-based treatments, they are drug-refractory. Salvia BioElectronics B.V. developed PRIMUS, an innovative peripheral nerve modulator to treat exactly these refractory chronic neurovascular headache patients. The ground-breaking dual-site stimulation targets both the front and back of the head. In ongoing first-in-human studies, PRIMUS has demonstrated a 98.5% effectiveness in reducing the frequency of the debilitating headache attacks (100% patient response rate). PRIMUS’ advanced design, with a lead of only 0.1 mm and no large implanted battery, significantly mitigates the risks of systemic side effects (0% device-related events reported). This in contrast to existing and competitive neuromodulation devices that are incompatible with the intricate anatomy of the head, placing a heavy and stigmatising burden on patients with severe device-related adverse events such as skin erosion and lead displacement. Using EIC support, Salvia will fund the clinical pivotal trial, regulatory approval and go-to-market for refractory chronic cluster headache. This strategic approach aims to prioritise the severe, yet comparatively rare, cluster headache indication while simultaneously maintaining a strong commitment to the much larger chronic migraine market worth €109B and heavily supported by our investors. By leveraging the positive outcomes for refractory chronic cluster headache, Salvia aims to convince the key partners, neurologists, to facilitate an expedited market access and penetration, in particular for the large refractory chronic migraine market segment. As such, reaching the full commercial potential of our product driven by its disruptive technology, we aim for market launch in Europe and the USA in 2026 and accelerated yet sustainable company growth followed by a an IPO in 2027.

The main goal of the proposal is to develop a new generation of bidirectional implantable electrodes connecting the human nervous system with external mechatronic aid devices such as exoskeletons and exoprostheses, thus helping people with arm amputations or leg paralysis regain their motor and sensorial functions. Electrodes will be the primary bidirectional interface to the nerves, followed by the implantable module, comprising an ASIC for signal processing, a microcontroller, an antenna for radio communication, a coil for wireless power charging and a supercapacitor for energy storage. To enable data communication to the mechatronic structures, as well as their power management and control (via AI modules) an embedded system will be designed, fabricated, and tested. This system will then be integrated into the mechatronic structures of exoprosthesis or exoskeletons. Due to the presence of bidirectional implantable electrodes a close loop between the user’s brain and the device’s control system will be created, with the AI module being used to learn and interpret the user’s synaptic signals. All the components and modules will be designed, fabricated, and tested with demonstration being assured by integrating the neural implantable systems with exoprostheses and exoskeletons into three demonstrators aimed at different categories of patients: with forearm amputation, with lower limbs paralysis and with single leg paralysis. A new generation of exoprostheses and exoskeletons controlled by the patient’s brain via the nervous system will change the paradigm of support for people with disabilities and will have an important social, economic, medical, and technological impact. The technology advances including miniaturization, wireless communication and power supply, progresses in medical microsurgery tools and methods, new biocompatible materials and technologies will considerably contribute to the project implementation.

The goal of the InForMed project is to establish an integrated pilot line for medical devices. The pilot line includes micro-fabrication, assembly and even the fabrication of smart catheters. The heart of this chain is the micro-fabrication and assembly facility of Philips Innovation Services, which will be qualified for small/medium-scale production of medical devices. The pilot facility will be open to other users for pilot production and product validation. It is the aim of the pilot line: to safeguard and consolidate Europe’s strong position in “traditional” medical diagnostic equipment, to enable emerging markets - especially in smart minimally invasive instruments and point-of-care diagnostic equipment - and to stimulate the development of entirely new markets, by providing an industrial micro-fabrication and assembly facility where new materials can be processed and assembled. The pilot line will be integrated in a complete innovation value chain from technology concept to high-volume production and system qualification. Protocols will be developed to ensure an efficient technology transfer between the different links in the value chain. Six challenging demonstrators products will be realized that address societal challenges in: “Hospital and Heuristic Care” and “Home care and well-being,” and demonstrate the trend towards “Smart Health” solutions.

The objective of POSITION-II is to bring innovation in the development and production of smart catheters by the introduction of open technology platforms for miniaturization, AD conversion at the tip, ultra-sound MEMS devices and encapsulation. Open technology platforms will generate the production volume that will enable sustainable innovation. The availability of open technology platforms will result in new instruments that have a better performance, new sensing and imaging capabilities, while the scale of volume will result in lower manufacturing costs. The production of the “brains” of these smart catheters will take place in Europe, with many European partners contributing essential technologies. The POSITION-II project will consolidate Europe’s premier position as manufacturer of cath lab infrastructure since these new smart catheters will be seamlessly integrated in the cath lab hardware and software platforms. By combining the different sensing and imaging data a more intuitive cath lab experience will be achieved. Looking forward, POSITION-II prepares the European electronics industry for the next revolution in healthcare, bioelectronics implants. Bioelectronics implants are expected to replace a considerable fraction of traditional medicine by direct stimulation of nerves. The miniaturization and soft encapsulation platforms developed in POSITION-II will be the ideal technology frame work for the manufacturing of these bioelectronics implants. The technology platforms developed in POSITION-II are demonstrated by five challenging product demonstrators covering FRR, IVUS, ICE, EP and cell therapy as well as a bioelectronics implant to treat cluster headache.

Compared to the pace of innovation in electronic consumer products, the pace of innovation for medical devices is lagging behind. It is the overarching objective of Moore4Medical to accelerate innovation in electronic medical devices. Moore4Medical emerging medical applications that offer significant new opportunities for the ECS industry including: active implantable devices (bioelectronic medicines), organ-on-chip, drug adherence monitoring, smart ultrasound, radiation free interventions and continuous monitoring. The new technologies will help fighting the increasing cost of healthcare by: reducing the need for hospitalization, helping the development of personalized therapies, and realizing intelligent point-of-care diagnostic tools. Moore4Medical will bring together 68 specialists from 12 countries who will develop open technology platforms for these emerging fields to help them bridge “the Valley of Death” in shorter time and at lower cost. Open technology platforms used by multiple users for multiple applications with the prospect of medium to high volume markets are an attractive proposition for the European ECS industry. The combination of typical MedTech applications with an ECS style platform approach will enhance the competitiveness for the emerging medical domains addressed in Moore4Medical. With value and IP moving from the technology level towards applications and solutions, defragmentation and open technology platforms will be key in acquiring and maintaining a premier position for Europe in the forefront of affordable healthcare