A reader worn on the skin and working in conjunction with an injected hydrogel sensor for real-time oxygen monitoring in tissue is has been unveiled by integrated biosensor maker Profusa and NextFlex, America's Flexible Hybrid Electronics (FHE) Manufacturing Institute. For more information see the IDTechEx report on Electronic Skin Patches 2018-2028.
The Lumee™ Oxygen Platform is intended for use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from continuous monitoring. The injectable hydrogel sensor is currently CE Marked in Europe and it is not yet commercially available elsewhere.
"Ten years ago, you couldn't build a reader that could sense multiple signals and filter out the 'noise' of the body's other signals, all while being small and skin-worn," said Ben Hwang, CEO of Profusa. "With the latest advancements in flexible hybrid electronics technology, it's just mature enough to work the way we want — primarily because we selected the right domain expertise partner to work with, namely NextFlex. Rather than managing development across multiple R&D and manufacturing facilities, we found a single place at NextFlex's Technology Hub, where we could develop our solution in very short time and have the right conversations to move our reader design toward production at scale."
The skin-worn reader was developed in record time, just in four months, at NextFlex's research center and fab in San Jose, Calif., since the facility and the team combine expertise in flexible hybrid electronics, engineering, materials science and optics all reside under one roof. NextFlex has taken Profusa's design work and criteria, and pushed them toward a smaller, flexible reality that works in harmony with Profusa's tissue sensors. With this stage completed and other medical devices in the pipeline, NextFlex is engaged in the application for FDA approval for medical device manufacturing.
"We've been able to take technology that could previously only be deployed in a hospital setting and move toward having a device with clinical-grade information in a wearable and flexible form that's attractive to consumers, like Profusa's skin-worn reader for tissue oxygen monitoring," said Wilfried Bair, NextFlex Vice President of Engineering. "This reflects the accelerated adoption of wireless and flexible hybrid electronics technologies in the digital health era, with wearable devices that generate data that medical doctors and consumers can get the most out of."
NextFlex®, America's Flexible Hybrid Electronics Manufacturing Institute, is a leading force in the Manufacturing USA network of Institutes. Formed through a cooperative agreement between the U.S. Department of Defense (DoD) and FlexTech Alliance, NextFlex is a consortium of companies, academic institutions, non-profits and state, local and federal governments with a shared goal of advancing U.S. manufacturing of FHE. Since its formation in 2015, NextFlex's elite team of thought leaders, educators, problem solvers, and manufacturers has come together to collectively facilitate innovation, narrow the manufacturing workforce gap, and promote sustainable manufacturing ecosystems. For more information, visit www.nextflex.us and follow NextFlex on LinkedIn, Facebook and Twitter.
Profusa is leading the development of bioengineered sensors that become one with the body to detect and continuously transmit actionable, medical-grade data of body chemistry for personal and medical use. Overcoming the foreign-body response to in-body monitoring for long-term use, its tissue-integrated biosensors open the door to accessing, connecting and applying body chemistry in unprecedented ways, transforming the management of personal health and disease. Please visit profusa.com for more information.
Karen Savala, 408-797-2219
The Hoffman Agency
Christine Li, 408-975-3058