VitalWear integrates optical fiber sensing technology into textiles to create sensor solutions for non-invasive medical monitoring, with the detection of the early onset of pressure ulcers as its first application focus.
https://www.vitalwear.nl
High Tech Campus 27, 5656AE Eindhoven
Aantal werknemers:
7
Healthcare
B2B
Idea Stage
Pressure ulcers represent a significant, world-wide healthcare challenge, which in the United States every year leads to the death of 60,000 of the 2.5 million affected patients and to additional healthcare costs of more than $ 26b, as well as to 17,000 legal cases against healthcare institutions, which are settled for an average of more than $ 200k. By detecting pressure ulcers at an early stage, so that their full formation can still be prevented, and by indicating which patients currently do not need attention, VitalWear helps to reduce the number of pressure ulcer cases while also lowering the amount of time that the nurses need to spend on pressure ulcer prevention.
VitalWear’s unique monitoring and decision support solution monitors pressure and temperature distributions on the patient's skin, continuously and autonomously. The solution informs nurses about which patients need immediate attention to prevent a developing pressure ulcer from fully forming and about which patients currently do not need to be disturbed (repositioned). Via timely interventions, pressure ulcer incidences are lowered. By enabling the move from time-based care intervals to data-driven care, the VitalWear solution helps the nurses to reduce, without higher risks for their patients, the amount of time that they need to allocate to pressure ulcer care. The VitalWear solution consists of sensor sheets that are installed in hospital or nursing home beds, a readout device, data processing and interpretation algorithms, and a user interface for the nurses. The monitoring focuses on the body areas where pressure ulcers typically occur, such as the sacrum and heels.
Eric Thelen, CEO, https://www.linkedin.com/in/ethelen/ - Previously: CTO Philips Home Monitoring, Sector Head and Vice President Philips Research, Director EIT Digital Silicon Valley Hub Kostas Voutyras, CTO, https://www.linkedin.com/in/konstantinosvoutyras/ - Previously: ASML (Metrology Design Engineer) and Smart Photonics (Test and Measurement Engineer) Jettie Hoonhout, Medical Strategy Officer and Quality Manager, https://www.linkedin.com/in/jettiehoonhout/ - Previously: Senior Scientist Philips Research - Human Factors and Usability Specialist, Experience with Clinical Studies and Regulatory Compliance Jonathan Palero, Senior R&D Engineer, https://www.linkedin.com/in/jonathanpalero/ - Previously: Senior Scientist Philips Research, PhD Biophysics (Utrecht University), Intellectual Property Specialist Leon Hermans, Senior R&D Engineer, https://www.linkedin.com/in/leon-hermans/ - PhD Biomedical Engineering (TU Eindhoven) Pablo de Anta Dardagan, R&D Engineer, https://www.linkedin.com/in/pablo-de-anta/ - Master of Science Biomedical Engineering (TU Delft) Artur Orlov, Data Engineer, https://www.linkedin.com/in/artur-orlov/ - Master of Science Mechatronics, Robotics and Automation Engineering (St. Petersburg Polytecnic University)
VitalWear will initially fully focus on optimized pressure ulcer prevention and address the hospital market first, as this is where patients often develop pressure ulcers and where the nurses with the best training are available to successfully adopt new technology. VitalWear then plans to market its solution towards nursing homes and rehabilitation centres and, ultimately, also towards home care. Wheelchair users, who cannot sense developing wounds e.g. due to spinal cord injury, represent an additional market opportunity for pressure ulcer prevention. With respect to geographical roll-out, VitalWear intends to start in 2027 with its home market in the Netherlands, before expanding into Germany and the United Status in 2028. In the future, VitalWear will offer fully mobile and wearable solutions and explore, in collaboration with clinical experts, a variety of additional applications for non-invasive medical monitoring based on optical fiber sensing integrated in textiles. Truly continuous and unobtrusive monitoring of vital signs as well as patient movements will improve care for conditions such as Parkinson’s disease and epilepsy as well as facilitate innovations for fields such as orthopaedics and sleep management.
VitalWear’s business model combines the sale of installations and sensor sheets with the sale of services. Customers pay a one-time purchase price plus monthly service fees, which can be balanced with each other based on customer preferences. Installations are initially expected to be sold at a price of € 12,000; sensor sheets are expected to be priced at € 1,000 each. Per installation, the targeted annual service fee is € 2,000.
In 2024, VitalWear has used the available financing to incorporate and operationalize the VitalWear company, to build the initial team, to analyze the patent landscape and to work towards VitalWear’s first patent application, to complete the development of its first-generation prototype and to make substantial progress towards the development of its second-generation prototype. The first-generation prototype has been used to demonstrate, in an important proof-of-concept experiment, that VitalWear is able to accurately monitor skin temperature changes. The second-generation prototype will be used for pre-clinical experiments, both internally at VitalWear (roughly during Q1 2025) as well as at the University of Southampton under the supervision of Professor Pete Worsley (roughly during Q2 and Q3 2025). Having been able to confirm the funding allocation for the EFRO OPZuid project “Vitale Vezels” represents an important step for the ongoing financing of VitalWear, as it provides a significant contribution to VitalWear’s salary costs until Q3 2026.
Minimaal gezocht:
1600000
Pre-money valuation:
3500000
Financieringsinstrument:
-
VitalWear
Pressure ulcers represent a significant, world-wide healthcare challenge, which in the United States every year leads to the death of 60,000 of the 2.5 million affected patients and to additional healthcare costs of more than $ 26b, as well as to 17,000 legal cases against healthcare institutions, which are settled for an average of more than $ 200k. By detecting pressure ulcers at an early stage, so that their full formation can still be prevented, and by indicating which patients currently do not need attention, VitalWear helps to reduce the number of pressure ulcer cases while also lowering the amount of time that the nurses need to spend on pressure ulcer prevention.
VitalWear’s unique monitoring and decision support solution monitors pressure and temperature distributions on the patient's skin, continuously and autonomously. The solution informs nurses about which patients need immediate attention to prevent a developing pressure ulcer from fully forming and about which patients currently do not need to be disturbed (repositioned). Via timely interventions, pressure ulcer incidences are lowered. By enabling the move from time-based care intervals to data-driven care, the VitalWear solution helps the nurses to reduce, without higher risks for their patients, the amount of time that they need to allocate to pressure ulcer care. The VitalWear solution consists of sensor sheets that are installed in hospital or nursing home beds, a readout device, data processing and interpretation algorithms, and a user interface for the nurses. The monitoring focuses on the body areas where pressure ulcers typically occur, such as the sacrum and heels.
VitalWear improves upon its competitors mainly in three ways: - The unique combination of pressure and temperature changes monitors the acute risk for pressure ulcer development. - The continuous and autonomous monitoring method does not require active support by the nurses and therefore addresses the still worsening nursing shortage. - The textile measurement surface fits into clinical practice and is fully comfortable for the patients. Compared to the status quo of frequently repositioning patients, as represented by the current clinical practice guidelines, VitalWear provides increased effectiveness and efficiency, without requiring compromises on patient comfort.
Eric Thelen, CEO, https://www.linkedin.com/in/ethelen/ - Previously: CTO Philips Home Monitoring, Sector Head and Vice President Philips Research, Director EIT Digital Silicon Valley Hub Kostas Voutyras, CTO, https://www.linkedin.com/in/konstantinosvoutyras/ - Previously: ASML (Metrology Design Engineer) and Smart Photonics (Test and Measurement Engineer) Jettie Hoonhout, Medical Strategy Officer and Quality Manager, https://www.linkedin.com/in/jettiehoonhout/ - Previously: Senior Scientist Philips Research - Human Factors and Usability Specialist, Experience with Clinical Studies and Regulatory Compliance Jonathan Palero, Senior R&D Engineer, https://www.linkedin.com/in/jonathanpalero/ - Previously: Senior Scientist Philips Research, PhD Biophysics (Utrecht University), Intellectual Property Specialist Leon Hermans, Senior R&D Engineer, https://www.linkedin.com/in/leon-hermans/ - PhD Biomedical Engineering (TU Eindhoven) Pablo de Anta Dardagan, R&D Engineer, https://www.linkedin.com/in/pablo-de-anta/ - Master of Science Biomedical Engineering (TU Delft) Artur Orlov, Data Engineer, https://www.linkedin.com/in/artur-orlov/ - Master of Science Mechatronics, Robotics and Automation Engineering (St. Petersburg Polytecnic University)
Healthcare
Medical technology, Wearables, Machine learning
VitalWear will initially fully focus on optimized pressure ulcer prevention and address the hospital market first, as this is where patients often develop pressure ulcers and where the nurses with the best training are available to successfully adopt new technology. VitalWear then plans to market its solution towards nursing homes and rehabilitation centres and, ultimately, also towards home care. Wheelchair users, who cannot sense developing wounds e.g. due to spinal cord injury, represent an additional market opportunity for pressure ulcer prevention. With respect to geographical roll-out, VitalWear intends to start in 2027 with its home market in the Netherlands, before expanding into Germany and the United Status in 2028. In the future, VitalWear will offer fully mobile and wearable solutions and explore, in collaboration with clinical experts, a variety of additional applications for non-invasive medical monitoring based on optical fiber sensing integrated in textiles. Truly continuous and unobtrusive monitoring of vital signs as well as patient movements will improve care for conditions such as Parkinson’s disease and epilepsy as well as facilitate innovations for fields such as orthopaedics and sleep management.
To be successfully adopted into clinical practice, a pressure ulcer monitoring solution needs to be reliable (nurses must trust the monitoring results), effective (utilization of the monitoring results must lead to a reduction in pressure ulcer cases), efficient (effort for the nurses compared to standard practice must be less and not more) and comfortable (an additional risk or burden for the patient is not acceptable). VitalWear has the potential to score high in all of these categories, while competitive solutions have one or more substantial weaknesses. While competitors are generally also able to provide reliable measurements, some of these measurements are only indirectly correlated with developing pressure ulcers and therefore less effective towards the reduction of pressure ulcer incidences. This is especially true for solutions such as the XSensor, which monitor only pressure, which can serve as a general risk indicator, but cannot determine whether a pressure ulcer is already developing. Solutions that require active interventions by the nurses, such as the sub-epidermal moisture (SEM) scanner by Bruin Biometrics or the PU Sensor that has been developed in Sweden, are less efficient compared to alternatives that monitor autonomously. Options for which a device is used to actively carry out measurements on a patient, such as the LEAF monitoring system that has been acquired by Smith+Nephew in 2019 with an estimated valuation of EUR 75m, are less comfortable compared to alternatives that collect data without the patient noticing this at all.
In 2024, VitalWear has used the available financing to incorporate and operationalize the VitalWear company, to build the initial team, to analyze the patent landscape and to work towards VitalWear’s first patent application, to complete the development of its first-generation prototype and to make substantial progress towards the development of its second-generation prototype. The first-generation prototype has been used to demonstrate, in an important proof-of-concept experiment, that VitalWear is able to accurately monitor skin temperature changes. The second-generation prototype will be used for pre-clinical experiments, both internally at VitalWear (roughly during Q1 2025) as well as at the University of Southampton under the supervision of Professor Pete Worsley (roughly during Q2 and Q3 2025). Having been able to confirm the funding allocation for the EFRO OPZuid project “Vitale Vezels” represents an important step for the ongoing financing of VitalWear, as it provides a significant contribution to VitalWear’s salary costs until Q3 2026.
Q2/Q3 2025: Pre-clinical validation experiments with healthy volunteers at University of Southampton Late Q2 / Early Q3 2025: Market Validation Report End of 2025: Minimum Viable Product with minimal regulatory certification to facilitate ethics approval for clinical validation testing with at-risk patients (most likely at UMC Utrecht, with the possibility to include other locations); textile integration strategy defined Q4 2025 / Q1 2026: Validation testing in nursing homes Q1 2026: First clinical validation results; preparation of outcome-oriented clinical study
Financing: VitalWear will spend its allocated budgets extra carefully while the longer-term financing has not been secured yet. Sensor accuracy: VitalWear has the necessary team in place to iteratively and consciously optimize sensor performance. Clinical: With Medical Strategy Officer Jettie Hoonhout, VitalWear has brought an experienced clinical study experts into the company. Plans for clinical experimentation will be carefully aligned with potential clinical partners. Regulatory: VitalWear is in the process of establishing a minimal Quality Management System, which will meet the regulatory requirements for VitalWear's current phase. At a later time, VitalWear will likely work with an external medical regulatory device expert to increase the likelihood for a timely and positive outcome. Market: VitalWear is currently carrying out a market validation initiative, which includes discussions with healthcare experts
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1600000
2000000
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3500000
Number of Shares: 10000 Shareholders - Percentage - Number of Shares Eric Thelen, Co-Founder & CEO - 44.00% - 4400 Kostas Voutyras, Co-Funder & CTO - 26.00% - 2600 High Tech XL (Venture Building Program in Eindhoven) - 20.00% - 2000 PhotonFirst (Optical Fiber Sensing Supplier in Alkmaar) - 10.00% - 1000
Brabant Startup Fund (Convertible Loan, EUR 240000); PhotonDelta (Loan, EUR 500000); EFRO OPZuid (Subsidy Project, ~EUR 500000)
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VitalWear’s main objective for the pre-seed financing is to develop a Minimum Viable Product that is able to collect measurement data for which a correlation between the data and the onset of a developing pressure ulcer can be demonstrated. The primary focus during this phase therefore is on research and prototype / product development. VitalWear will iteratively improve its solution with respect to measurement accuracy, robustness, usability and functionality. Next to pursuing this main objective, VitalWear will invests in further building the company and its operational robustness, to be ready to scale up further during its subsequent phase, which will then focus on generating clinical evidence (2026), initial market introductions (2027) and product industrialization and product scalability (2027 and beyond). VitalWear will also intensify its market validation efforts, to demonstrate, especially also towards investors, that a working VitalWear solution can be successfully introduced to the market and sold at a price that enables VitalWear to generate a profit margin. To reach the main objective for 2025, a dedicated focus on the necessary clinical validation steps is necessary. Starting with the first pre-clinical experiments with healthy volunteers, VitalWear prepares for obtaining the necessary ethical approvals for clinical validation tests with at-risk patients, which are expected to take place in late Q3 or in Q4. VitalWear needs to get ready to meet the regulatory requirements related to eventually introducing its products into the markets in Europe and the United States. On the path towards full regulatory compliance, the certification of VitalWear’s first Minimum Viable Product needs to be achieved. VitalWear has filed its first patent application in February 2025 and will proceed with further implementing its Intellectual Property strategy during the course of the year. In summary, VitalWear will emphasize in 2025 especially activities in the areas of technology development (second-generation prototype and Minimum Viable Product), clinical validation (with healthy volunteers and at-risk patients) and market validation (signals from potential customers).
Yes
VitalWear’s business model combines the sale of installations and sensor sheets with the sale of services. Customers pay a one-time purchase price plus monthly service fees, which can be balanced with each other based on customer preferences. Installations are initially expected to be sold at a price of € 12,000; sensor sheets are expected to be priced at € 1,000 each. Per installation, the targeted annual service fee is € 2,000.
During the current phase, VitalWear's main cost items are the salary costs for its initial team. Most of the effort is spent on the development of the prototypes and the Minimum Viable Product, which also requires investments into prototype materials and laboratory infrastructure. Fees for the involvement of clinical partners as well as for external services related to patent filings, regulatory compliance, legal support, etc., need to be budgeted as well. When VitalWear launches its first product, the Cost Of Goods Sold will be influenced by the components for the optical fiber sensing sub-system (interrogator devices and optical fibers with Fiber Bragg Grating sensors), by the scalable industrial manufacturing costs for the VitalWear sensor sheets, by fees for the backend data processing, data storage and data visualization elements and by costs for providing service to the VitalWear customers.
VitalWear expects to become profitable during the first year after market introduction in 2028 and to have recovered all investments (“break-even”) before 2030.
0
(0,0,0,0,0)
VitalWear expects to enter its first market in 2027; a small number of Minimum Viable Products may be sold to researchers already earlier
0
40000
5
199999
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