Tekcapital’s Belluscura granted US FDA clearance for X-PLO2R™
(TEK ) announced that its portfolio company Belluscura has now been granted 510(k) clearance from the US FDA for its Portable Oxygen Concentrator (“POC”), X-PLO2R™.
A 510(k) is a premarket submission made to demonstrate that the stated device to be marketed is safe and effective and substantially equivalent to a legally marketed device.
Belluscura has been granted 510(k) clearance and marketing authorisation for its POC product X-PLO2R™, which it developed with its research partner Separation Design Group, an award-winning oxygen enrichment research laboratory.
X-PLO2R™, which is expected to be commercially launched in 2021, has patented technology which delivers up to 95% pure oxygen to patients 24 hours a day, 7 days a week.
The device weighs less than 3.25 lbs. (1.5 kg) and is designed to replace larger, metal oxygen tanks and heavier portable oxygen concentrator devices to help improve the quality of life for millions of people worldwide who suffer from chronic lung diseases, such as the Chronic Obstructive Pulmonary Disease (COPD) and respiratory distress caused by COVID-19.
Tekcapital, the UK intellectual property investment firm which holds c.17.8% interest in Belluscura, has described the US FDA clearance as ‘a transformative development’.
To date, Belluscura, which operates as a UK-based medical device company focused on developing oxygen enrichment technology, has exclusively licensed, acquired or jointly invented 18 patents and applications in the field of concentrated oxygen generation.
According to data collected from Global Market Insights, the medical portable O2 market is expected to grow from $1.6bn in 2018 to US $2.4bn by 2025 with a CAGR of 8%.
Meanwhile, Belluscura has confirmed that it is considering the feasibility and timing of an initial public offering, and the potential admission to trading on the AIM Market of the LSE.
"We are excited to see that the FDA has cleared the X-PLO2R device for sale, as Tekcapital and Belluscura believe it could be helpful to patients during the COVID-19 pandemic, and for many of the 250 million people worldwide suffering from chronic obstructive pulmonary disease (COPD),” commented Clifford M. Gross Ph.D., Executive Chairman of Tekcapital.
Shares in Tekcapital have increased by over 12% in value since the beginning of 2021. Today’s FDA clearance, which is said to mark a “transformative development for Belluscura”, offers both vote of confidence from the US FDA ahead of the Group’s commercial launch of X-PLO2R™ and enables Belluscura to attack the significant and growing portable O2 market this year. TEK stock was trading 24.14% higher this morning at 18p with investors keen to watch the progress of Belluscura towards an IPO as another validation point for the TEK business model.
Reasons to TEK
Tekcapital’s mission is to create value from university Intellectual property that is ready for mass markets:
- TEK has the World’s largest network of University IP
- TEK enables rapid value creation with market ready technology selection
- Multi-Year track record of significant revenue and net-asset growth
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