Belluscura FDA Clearance

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). With the publication of this announcement via a Regulatory Information Service ("RIS"), this inside information is now considered to be in the public domain.

8 March 2021

Tekcapital plc

 ("Tekcapital" or the "Company")

Portfolio Company Update

Belluscura plc announced the receipt of 510(k) Clearance from the US Food and Drug Administration (the "FDA") for its X-PLO₂R™, Portable Oxygen Concentrator

Tekcapital plc, (AIM: TEK), (OTCQB: TEKCF) the UK intellectual property investment group focused on creating valuable products from investing in university technology, announces that its portfolio company Belluscura plc has been granted 510(k) clearance and marketing authorisation by the U.S. Food and Drug Administration (FDA) for the X-PLO₂R POC portable oxygen concentrator (POC). Belluscura developed the X-PLO₂R POC with their research partner, Separation Design Group, an award-winning oxygen enrichment research laboratory. 

The X-PLO2R POC has patented technology that can deliver up to 95% pure oxygen to patients 24 hours a day, 7 days a week. Weighing less than 3.25 lbs. (1.5 kg), the lightweight X-PLO₂R POC 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. The X-PLO₂R is expected to be commercially launched in 2021.

This is a transformative development for Belluscura. Belluscura has exclusively licensed, acquired or jointly invented 18 patents and applications in the field of concentrated oxygen generation. According to 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%.¹ 

Belluscura also confirms that it is considering the feasibility and timing of an initial public offering (IPO), and the potential admission to trading on the AIM Market of the London Stock Exchange (or other recognised stock exchange) and expects investments should qualify for Enterprise Investment Scheme (EIS) relief.

Tekcapital owns approximately 17.8% (10.5m shares) of Belluscura.

From previous investments made by Tekcapital in Belluscura,  Tekcapital holds warrants to purchase 1,273,078 shares at 13p and 600,000 shares at 15p. Additionally, concomitant with Belluscura's receipt of FDA Clearance, Tekcapital has 30 days to exercise an option to purchase up to approximately 4.8m Belluscura shares between 21p - 23p depending upon amount invested. If all warrants and options are exercised, than Tekcapital would hold approximately 17.1m shares in Belluscura.

Clifford M. Gross Ph.D., Executive Chairman of Tekcapital plc commented:

"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)². Our congratulations to Robert Rauker and his capable team at Belluscura for a job well done! "

About Belluscura plc

Belluscura (www.belluscura.com) is a UK medical device company focused on developing oxygen enrichment technology spanning broad industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health and economic outcomes for the patients, healthcare providers and insurance organizations. 

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About Tekcapital plc

Tekcapital creates value from investing in new, university-developed discoveries that can enhance people's lives and provides a range of technology transfer services to help organisations evaluate and commercialise new technologies. Tekcapital is quoted on the AIM market of the London Stock Exchange (AIM: symbol TEK) and is headquartered in the UK. For more information, please visit www.tekcapital.com

LEI: 213800GOJTOV19FIFZ85

This press release is for informational purposes only. The information herein does not constitute investment advice nor an offer to invest and may contain statements related to our future business and financial performance and future events or developments involving Tekcapital that may constitute forward-looking statements. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, on social media, in material delivered to customers, stakeholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements may be based on the current expectations and certain assumptions of Tekcapital's management. Please note that these are subject to a number of risks, uncertainties and factors, including, but not limited to those described in various disclosures. Should one or more of these risks or uncertainties materialize, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Tekcapital may vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Forward-looking statements express, as at the date of this release, the Company's plans, estimates, valuations, forecasts, projections, opinions, expectations or beliefs as to future events, results or performance. Forward-looking statements involve a number of risks and uncertainties, many of which are beyond the Company's control, including those associated with COVID-19, and there can be no assurance that such statements will prove to be accurate. No assurance is given that such forward looking statements or views are correct or that the objectives of the Company will be achieved. Further, valuations of Company's portfolio investments and net asset value can and will fluctuate over time due to a variety of factors and this could have a material negative impact on the Company's financial performance. Tekcapital neither intends, nor assumes any obligation, to update or revise these forward-looking statements in light of developments which may differ from those anticipated.

References

1    https://www.gminsights.com/industry-analysis/medical-oxygen-concentrators-market-report

2    https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)