Case study
World’s first wearable ultrasound promises better care for critically ill patients
November 7, 2022
With support from EAHN™, Flosonics Medical conducted an accelerated clinical study at Health Sciences North to evaluate its wearable doppler ultrasound. The result are helping the company secure customers as it moves closer to market.
When caring for critically ill patients, clinicians work hard to avoid placing patients on a ventilator. Prolonged time on ventilation leads to poorer outcomes for patients, an issue made disturbingly clear during the COVID-19 pandemic.
Now, an Ontario company is tackling the problem with the world’s first wearable doppler ultrasound. Developed by Flosonics Medical, the FloPatch device promises better management of severely ill patients to help avoid the medical complications that lead to mechanical ventilation.
For critically ill patients, low blood pressure (hypotension) can lead to insufficient blood flow to the brain and other vital organs. Although intravenous fluids are routinely used to increase pressure, too much fluid can also create problems: If fluid builds up in the lungs, patients may require a ventilator to help them breathe. Managing fluids is critical and requires close monitoring of blood pressure and blood flow.
FloPatch is a small ultrasound sensor on an adhesive patch. Clinicians place the device over a major artery in a patient’s neck and blood flow monitoring data is transmitted via Bluetooth to an iPad or iPhone. Non-invasive and easy-to-use, the innovative, wireless device provides continuous measurement to aid clinical decision-making and can be used in emergency departments, operating rooms, ICUs and ambulances. It also eliminates the need for portable bedside ultrasound, which requires a trained operator and is a limited resource in most hospitals.
Bringing innovative technology to market—in a pandemic
Getting a new medical device to market is often a long process, but the COVID-19 pandemic added a new complication. By spring 2020, Flosonics Medical had completed its proof-of-concept research, received Health Canada validation for its manufacturing process and secured FDA approval. The company was ready to begin proof of clinical adoption—a key step in the journey to commercialization—when the pandemic began and access to clinical sites shut down.
The shutdown was especially frustrating because the technology had added potential in the context of COVID-19. Fluid management is particularly critical for patients with COVID-19, due to the infection in their lungs. In addition, FloPatch can reduce contact time with a COVID-19 patient; once the device is applied, clinicians can do blood flow assessments from outside a patient’s room.
” Imagine being a medical device company on the verge of commercialization and then COVID hits and everything locks down. You’re developing a technology which has the potential to help, but you’re still missing some key components to get the product to market and a mechanism to de-risk them.
Joe Eibl
CEO, Flosonics Medical.
EAHN™ facilitates accelerated study
OBIO’s Early Adopter Health Network (EAHN™) provided the solution. EAHN™ matches companies with innovative health technologies to receptive health organizations and helps them work together to develop, test, refine, adopt, promote and disseminate novel technologies. In May 2020, EAHN™ had announced a special initiative to advance new technologies with the potential to address COVID-19. As a successful applicant, Flosonics Medical was partnered with Health Sciences North in Sudbury to conduct an accelerated study to evaluate the use of FloPatch with patients.
For Health Sciences North Research Institute (HSNRI), the project was an opportunity to expand its clinical research portfolio and engage with the private sector on applied research. Flosonics Medical was also a known entity. Its founders were from Sudbury, and the company had previously used the hospital’s simulation lab to validate the technology.
EAHN™ provided a variety of supports. Flosonics Medical and HSNRI each received EAHN™ funding to support the study, which was matched by the company and hospital in cash and in kind. EAHN™ also provided a comprehensive project agreement and convened regular project meetings to troubleshoot issues and ensure the project remained on track. This formalized structure, clear communication and accountability mechanism ensured a smooth process for both the company and the hospital.
With the support of HSNRI, Flosonics Medical worked directly with clinical staff in the hospital’s operating rooms (OR). A brief training session and ongoing support was provided to staff by videoconference. The technology was tested with 10 critically ill patients in the OR over a two-week period, followed by a structured survey and follow-up interviews to gather feedback from clinicians.
Study insights lead to improved technology and marketability
The study provided the company with valuable clinical feedback on useability to further refine the technology. From a technical and engineering perspective, Flosonics Medical was able to gather insights on how the clinicians interacted with the data on their device, how intuitive the display was and whether the wireless range of the device was appropriate. On the clinical side, information from the study is helping the company to improve messaging and training for nurses and physicians using the technology.
The EAHN™ program also comes with an added benefit: A key end point for every study is the Determination of Value and Recommendation for Procurement. This document, completed by the hospital partner, details the outcomes of the evaluation, the value the technology offers to patients, clinicians and the system and whether the organization recommends the technology for procurement. The review for FloPatch was highly positive, providing the company with a valuable endorsement as it moves to develop its customer base.
Company leverages EAHN™ study to build customer base
Flosonics Medical plans to leverage the Determination of Value document when meeting with potential customers to demonstrate the technology’s potential to improve patient outcomes, reduce length of stay and improve workflow for clinicians. The company’s first priority is securing reference customers, with a particular focus on large academic centres in Canada and academic centres and community hospitals in the United States. And with a projected market of four to seven billion dollars, the company is confident about its prospects.
Investors seem to share this optimism. In early 2021, Flosonics Medical closed a $14 million USD funding round led by Arboretum Ventures with participation from existing investors IGan Partners and Genesys Capital. With this support, the company will continue clinical development and strengthen its focus on commercial development.
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