Selio lung biopsy device exemplifies medtech growth and scale

The Irish medtech sector consistently punches above its weight. It helps that 19 of the top 25 global companies covering the field of medical devices, diagnostics and software development are based in Ireland. It has been a crucial factor in fostering a vibrant start-up community that has broadened the manufacturing mix, while 50 per cent of the 450 medtech companies in the Republic are now homegrown.

Selio, based in Trinity College Dublin, is an example of what is emerging as a consequence of an ecosystem that is nurturing innovation. Backed by the right supports, it is set on a path towards commercialisation.

It has developed a novel medical device that will transform lung biopsy procedures by eliminating a complication in the form of a collapsed lung (pneumothorax), which is common, costly and dangerous. This new treatment could prevent approximately 121,000 extra hospital admissions yearly; saving healthcare costs of over €1 billion globally.

Selio may still be made up by just two people, Colm McGarvey and Dr Garrett Ryan, but it has cleared big hurdles within a short period and early endorsement has come with a series of innovation awards.

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A collapsed lung occurs when the lung biopsy needle pierces the lung and air escapes into the chest cavity. This substantially increases the cost of care by converting an outpatient procedure to one requiring hospitalisation, explains McGarvey – its frequency is stark; arising in some 33 per cent of cases.

He outlines the significance of their product in the context of lung cancer; the most common cancer worldwide – with over 1.8 million cases diagnosed globally, including about 2,300 Irish cases every year. Lung biopsies are the most common method for diagnosis – by way of transthoracic needle biopsy (TTNB) but they can be hazardous because of collapsed lung risk.

Patient morbidity

“We have developed a world-first medical device to eliminate this dangerous and costly complication which will reduce patient morbidity, eliminate unnecessary clinical intervention and significantly reduce healthcare costs,” he says.

Selio’s smart needle technology has been tested in pre-clinical models to prove its efficacy. The innovation is in the formation of a temporary pleural seal at pre-biopsy stage. The biopsy is then carried out through this airtight seal, preventing pneumothorax, both during and after the procedure. “All previous interventions to prevent a pneumothorax have focused on deploying an adhesive or plug in the needle path post-biopsy, and have poor effectiveness,” McGarvey notes.

With over one million lung biopsy procedures carried out globally per annum, this new device could prevent over 350,000 cases of lung collapse annually. Treatment of a pneumothorax involves placing a hollow plastic tube between the ribs and into the chest to drain the air from around the lungs. It is required in approximately 11 per cent of TTNB cases, at an average cost of €10,000 per patient.

Chest radiologists acknowledge pneumothorax as a significant complication of "percutaneous lung biopsy" for which there are few effective methods of prevention, according to UCC professor of radiology Michael Maher, a consultant radiologist at Cork University Hospital.

Pneumothorax complicates 10 -50 per cent of percutaneous lung biopsies, being more common in patients with underlying emphysema. It may result in chest pain and severe breathlessness and frequently results in prolonged hospital stay post-biopsy, he adds.

As well as preventing considerable pain for patients, reducing pneumothorax incidence will increase the safety of lung biopsy and reduce costs associated with treating this potentially dangerous complication. Some patients with suspected lung cancer who require a lung biopsy are considered unfit for the procedure due to pneumothorax risk. Reducing its incidence would likely result in more lung biopsies being performed in high-risk patients, thus expediting definitive diagnosis, he says. “The prospect of a device to reduce pneumothorax after lung biopsy is a really welcome development.”

Commercialisation support

McGarvey and Ryan conceived their idea in 2014 while pursuing the BioInnovate Fellowship, an innovation programme affiliated with Stanford BioDesign programme, at NUI Galway. They were soon successful in attaining Enterprise Ireland (EI) commercialisation fund support valued at €500,000.

McGarvey, who is from Tyrone and is a Queen's University Belfast pharmacy graduate, has over 20 years' commercial experience in healthcare and business development. Ryan is a biomedical engineer from Tipperary with over 12 years' experience in medical device development. He completed his PhD with Amber (the Science Foundation Ireland-funded materials research centre in TCD) investigator Prof Bruce Murphy, who acts as technical adviser for the company.

“We discovered this large ‘unmet clinical need’ during the clinical immersion phase of the BioInnovate programme and selected it from over 450 documented unmet needs,” McGarvey notes.

This market is increasing due to the rising global incidence of lung cancer and screening programmes in many countries. Recent advancements in lung cancer therapies with the use of personalised medicines is driving demand for molecular profiling, which can only be carried out through a tissue biopsy. A recent survey of US clinicians has reported a 25 per cent increase in the number of TTNB procedures in the past three years.

Selio is backed by an experienced clinical, business and academic advisory team in addition to Amber. It was among the first group of Irish researchers funded through the SFI/National Science Foundation Innovation-Corps Entrepreneurial Training Programme in Georgia Tech, US. It supports SFI-funded researchers in developing entrepreneurial skills. They attended an intensive bootcamp in Atlanta, followed by a six-week period meeting potential investors and key stakeholders.

Strategic partners

They recently won the MedTech Innovator award, the medical technology industry's non-profit global competition. As a follow-on, they will be in San Jose, California, in September competing with 49 American finalists for a $500,000 prize.

This summer they were singled out by EI as one of the top 10 investor-ready start-ups in their “Big Ideas” 2017 showcase, which allowed them introduce the technology to potential investors, mentors, strategic partners, suppliers and key stakeholders. They also won the 2017 EIT Health Headstart Award in Oxford University, receiving a €50,000 prize.

They plan to spin this technology out of TCD at the end of the year to form an Irish high-potential start-up medical device company. “We require investment in this company and relationships with partners to further develop the technology,” he explains. The likely sequence includes “in-man” clinical trials, validation, approval by regulatory authorities and then on to commercialisation.

Heartened by the progress within a short period, Selio hopes its technology will be available within another three years through a manufacturing base in Ireland – thereby further adding to the 27,000 people employed in a thriving Irish medtech sector.