Disruptive Technology to Improve Palliative Care

An exciting new collaboration is underway in the West of Ireland, bringing disruptive technology into the palliative care space.

A consortium of four organisations have joined forces to bring to market innovative medical devices aimed at improving the treatment experience for people with late-stage cancers, half of whom develop malignant pleural effusions (MPE)¹ , also known as ‘fluid on the lung’, a condition that causes breathlessness, chest pain and a lot of patient distress.

With average life expectancy increasing, the market for palliative care is expected to double worldwide in the next decade². The total addressable market opportunity for MPE in the US and Europe is $1.2 billion. There has been no significant innovation in the MPE standard of care for over 20 years.

Now, a west of Ireland consortium will address this gap, having successfully secured €1.83m funding from the Disruptive Technologies Innovation Fund (DTIF) Call 3. The DTIF is a competitive fund implemented by the Department of Enterprise, Trade and Employment, for enterprise co-funded disruptive technology projects.

“We are delighted our consortium was selected by the DTIF Committee, knowing how highly competitive the selection process is and how difficult it is to secure funding”, says Tim Jones, Co-Founder and CEO of SymPhysis Medical. The three-year project commenced in October 2021 and will run until 2024, with the team targeting FDA clearance for the first-generation device in 2023.

The problem

Currently, patients receiving treatment for MPE have a drainage catheter inserted into their chest cavity which allows them to drain the fluid from their chest at home. The SymPhysis Medical founders identified a range of issues with the current catheters during their time on NUIG’s Biodesign Innovation Fellowship, including: the invasiveness of the catheter insertion procedure in the hospital; the patient’s heavy reliance on family and public health nurses to perform the drainage at home; and the occurrence of catheter complications such as infection due to the catheter being in place for several months.

A solution enabling independence and quality of life

A first-of-its-kind drainage device has been designed by SymPhysis Medical to improve the well-being of people receiving palliative care, enabling them to be more independent and stay mobile during treatment. The device empowers patients to drain at home independently without relying on family members or public health nurses, which is currently the case. The novel solution means the unsightly traditional external catheter tube is replaced with a neat port, giving patients greater freedom to continue with their day-to-day life. It will also be the least invasive solution on the market, requiring only one incision as opposed to two and negating the need for stitches.

Currently for patients with MPE, fluid continues to accumulate in the chest cavity; therefore ongoing drainage is required for months. The only solution designed to seal the chest cavity and break the cycle of fluid reaccumulation is invasive surgery. This new consortium aims to solve this problem by further developing an ‘active’ patent-pending technology, which aims to safely seal the chest cavity whilst the patient is at home. This will allow the catheter to be fully removed by a clinician after only a few weeks, as opposed to up to a year with the current catheters, and removes the need for invasive surgery.

The home drainage solution is designed for patient independence and ease of use

Making Palliative Care Smart

Work on a smart version of the device has been fast-tracked, thanks to the DTIF co-funding. The AI enabled system will incorporate sensors for automated recording of home drainage-related information such as drainage volumes. Gathering this key information digitally will facilitate remote patient monitoring, giving clinicians real-time data and reducing hospital visits.

Tim Jones, CEO of SymPhysis Medical, attending a Usability study in the National Innovation Centre of Ageing in the UK, where patient representatives gave feedback on the prototype design.

Who are the Consortium Partners?

The DTIF consortium leverages the expertise of four organisations to deliver on the goal of developing a state-of-the-art drainage catheter to be commercialised in the US and Europe from 2023.

SymPhysis Medical was co-founded by Dr. Michelle Tierney and Tim Jones after they identified MPE as an under-met clinical area during the NUIG BioInnovate Fellowship in 2017/2018. The company’s vision is to enhance the patient pathway to provide unrivalled patient independence and reduce hospitalisations. With two patents filed on the novel aspects of the technology, the team is using the data gathered from seven pre-clinical trials and feedback received from over 35 clinicians in Ireland, UK and the US, to further refine the product. The company closed its seed round funding in December 2021.

Gentian Services, The Innovator’s Partner, is a design and manufacturing company with expertise in medical device product development. Operating in an ISO 13485 certified and FDA compliant environment, the company has expertise working with medical device start-ups. It has invested in developing its technical and innovation development processes and competencies, along with the required regulatory knowledge and certification to enable it to operate within the medical device market.

The Smart Sensors Lab is a multidisciplinary research laboratory focused on innovative and translational research in medical sensing technologies. Combining expertise from electronic engineering, biomedical engineering, computer sciences and clinical research, their proficiency and experience will ensure the sensor technology in the smart drainage catheter enables the device to leverage AI and communicate data with a mobile phone app.

Galway University Hospitals (GUH) is a designated supra regional centre for cancer and cardiac services and is recognised for higher medical training in all specialities. The GUH team consortium lead is Dr. David Breen, a Respiratory Consultant and Lead Clinician in Lung Cancer Services in GUH, working in the Rapid Access Lung Clinic (part of the National Cancer Control Programme). Dr. Breen has been a key mentor to the SymPhysis Medical co-founders for over three years. The former lead of the Oxford NHS Trust Lung Cancer Services, he has more than 85 publications in the areas of respiratory, interventional pulmonology and bronchoscopy.

Watch this Space

2022 will be a busy year for the consortium team. Key milestones include detailed research, recruitment, design verification and validation, usability workshops, as well as pre-clinical and clinical studies.

Knowing the technology will bring a significant improvement compared to current treatment practices is a great motivation. “Developing the first ever smart, digital-enabled approach to MPE drainage is exciting,” says Michelle Tierney, Co-Founder and CSO of SymPhysis Medical. “We know our technology is disruptive and will improve the quality of life for people receiving palliative care.”

Further information on the consortium partners is available on the partner websites and through the following platforms:
SymPhysis Medical: www.symphysismedical.com. Follow us on LinkedIn and Twitter
Gentian Services: www.gentianservices.com/
Smart Sensors Lab: http://smartsensors.ie/
GUH: Galway University Hospitals - HSE.ie

[1] Boshuizen, R. C. (2017) Management of malignant pleural effusion. Thesis. University of Amsterdam.

[2] https://www.alliedmarketresearch.com/palliative-care-market.

[3] Cited papers in US and Europe, as well as research commissioned by SymPhysis Medical Market Research