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Selio


Colm McGarvey.gif

Colm McGarvey
Selio

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A novel medical device that will transform lung biopsy procedures by eliminating pneumothorax: a common, costly and dangerous complication.

Lung cancer is the most common cancer worldwide with over 1.8 million new cases diagnosed annually. It was responsible for 1.6 million cancer deaths worldwide in 2012. Lung cancer has a 5 year survival rate of only 10%, in part due to late diagnosis. Early detection and diagnosis of lung cancer is vital as it reduces morbidity and saves lives. CT-guided transthoracic needle biopsy (TTNB) is the gold standard for lung cancer diagnosis and histological evaluation.

Although it is generally regarded as a safe procedure, complications exist, the most common being pneumothorax. Pneumothorax, or a collapsed lung, is caused by the needle puncturing the lung during a TTNB. Air then leaks through the hole created by the needle into the pleural cavity and leads to uncoupling of the lung and chest wall. The air pushes on the outside of the lung and causes it to collapse. This leads to an oxygen shortage, impaired ventilation and significant morbidity for the patient.

The clinically reported rate of pneumothorax ranges from 15-42%.  Treatment of pneumothorax via intercostal chest tube placement is required in up to 20% of all cases. This substantially increases the cost of care by converting an outpatient procedure to one mandating hospitalization.  SELIO will prevent a pneumothorax during TTNB and thereby reduce patient morbidity, eliminate further clinical intervention and significantly reduce health provider and insurer costs.

The SELIO System is a first-in-class medical device designed specifically to address the complication of lung biopsy related pneumothorax.

Pneumothorax, or collapsed lung, is the most common, costly and dangerous complication associated with percutaneous lung biopsy. As a result of puncturing the lung, air leaks into the pleural cavity and pushes the lung away from the chest wall, causing it to collapse.

All previous attempts to tackle this problem have focused on plugging the needle tract in the lung post-biopsy and have proven ineffective. SELIO is revolutionary as it forms a temporary pleural seal pre-biopsy. The biopsy is carried out through this air tight seal and in doing so a pneumothorax is prevented during and after the biopsy procedure.

I co-founded Selio with Dr Garrett Ryan. Together we form a formidable and dynamic team with over 50 year’s combined medical device, research and commercial experience.

We are supported by a very experienced multi-disciplinary clinical, business and academic advisory team. The clinical team includes internationally renowned Interventional Radiologists from Ireland and the UK.

Garrett and I met during our BioInnovate fellowship in the National University of Ireland, Galway in 2014 (http://www.bioinnovate.ie/).

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. On validating this need and analysing the market opportunity we realised that we could develop a novel solution which would create significant benefits for clinicians, patients and payers.

The team has been formed for the express purpose of commercialising this device. We are passionate about solving this unmet need and driven to achieve success.

Healthcare Economics

There are over 1.1 million Transthoracic needle biopsy (TTNB) procedures carried out globally per annum. On average 33% of patients suffer from a pneumothorax and 11% of patients require invasive treatment, leading to 121,000 extra hospital admissions per annum for a preventable complication.

A pneumothorax substantially increases the cost of care by converting an outpatient procedure to one mandating hospitalization.

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 approx 11% of TTNB cases at an average cost of $11,000 per patient.

Interventional Radiologists worldwide have confirmed that pneumothorax is a significant problem worth solving and that there is currently no effective method of prevention. As well as preventing patient pain, resolving this problem will also positively impact on clinical workload and stress.  Clinicians across the world have confirmed that many patients who require a lung biopsy do not currently receive one due to the risk of a pneumothorax and that they would carry out significantly more lung biopsy procedures if there was a method of avoiding this complication.

This market is rapidly increasing with a rising global incidence of lung cancer and the adoption of government implemented lung cancer screening programs in many countries. The recent advancements in new lung cancer therapies with 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% increase in the number of TTNB procedures in the last three years. This large unmet market need has been confirmed through research and review of the scientific literature and validated through follow-up with key opinion leaders, both in a clinical and corporate setting.

Big Ideas represents a fantastic opportunity to promote Selio and to create market interest in our technology.
We will 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, bring it to first in man clinical trials and on to commercialisation.
Big Ideas will allow us to introduce the technology to potential investors, mentors, strategic partners, suppliers and key stakeholders.

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