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#TEK Tekcapital PLC investee co #BELL Belluscura PLC – appoints Senior VP of Global Sales

Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that Robert (“Bob”) Fary has joined the Company as Senior Vice President of Global Sales.

 

Bob has thirty-years of experience in the respiratory industry where he has held leadership roles at major oxygen concentrator manufacturers and durable medical equipment companies. During the past two decades, Bob’s industry leading team was directly responsible or contributed to the sale of over 1 million portable oxygen concentrators (“POCs”), generating revenues in excess of $1 billion.

 

Commenting on the hire, Robert Rauker, Chief Executive Officer, Belluscura plc, said:

 

We are very excited that Bob has joined our team as we enter the next stage of growth at Belluscura. His deep knowledge of the portable oxygen concentrator sector and its channels to market will be invaluable as we build on our success to date to bring our latest generation of POCs to market.” 

 

Bob Fary, Senior Vice President of Global Sales, commented:

 

I am delighted to have joined Belluscura at this important juncture for the Company as it captures the demand in its markets for its best-in-class products. The planned launch of DISCOV-R will be another exciting step in meeting the needs of patients around the world. I look forward to working alongside the wider executive team to grow the Company’s sales in the US and beyond.”

For further information, please contact:

 

Belluscura plc

www.belluscura.com

Robert Rauker, Chief Executive Officer

via MHP

Anthony Dyer, Chief Financial Officer

SPARK Advisory Partners Limited (NOMAD)

Tel: +44 (0)20 3368 3550

Neil Baldwin

Dowgate Capital Limited (Broker)

Tel: +44 (0)20 3903 7715

James Serjeant / Nicholas Chambers

MHP (Financial PR and Investor Relations)

Tel: +44 (0)20 3128 8100

Katie Hunt / Pete Lambie / Matthew Taylor

Email: belluscura@mhpgroup.com

 

 

About Belluscura plc ( www.belluscura.com )

Belluscura is a UK medical device company focused on developing high performing, lightweight and portable oxygen enrichment technology used in a broad range of industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health, mobility and economic outcomes for patients, healthcare providers and insurance organisations.

#TEK TekCapital Plc investee co. #BELL Belluscura Plc – Year-end Trading Update

LONDON, U.K. AND PLANO, TX, U.S. (13 January 2023) Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen concentrator (“POC”) technology, provides a trading update for the year ended 31 December 2022.

The Group is pleased to announce that it has made considerable progress this year. Since the launch of the 1st generation X-PLOR in September 2021, the Group is now distributing throughout the US through multiple sales channels: Distributors and Durable Medical Equipment Providers both Online and Bricks and Mortar, Medical Supply Warehouses, Medical Device Intermediaries, Hospitals and Direct to Consumer.

In addition, the collaboration agreement with the VGM Group has already resulted in 17 new distribution agreements in the last 3 months, including the agreement with a leading durable medical equipment provider and distributor in the US, announced in September 2022, which serves nearly 2 million patients both online and through over 1,000 locations.

In December 2022 we also signed our first international distribution agreement, with MedHealth Supplies of South Africa, which sells to one of the world’s leading respiratory device suppliers. We have already received orders for over 1,000 units, with their first shipment sold out within 48 hours.

In December we produced a record 536 units in our in-house facility and with Innomax coming on-line in Q1 this will more than double production of X-PLOR. Of important note, even with the rapid increase in volume, the production quality of our in-house facility has been outstanding, with no units returned due to defects.

By 31 December 2022 the Company had shipped or received orders for 2,850 X-PLOR units with 1,226 units being shipped in 2022 (2021: 377). As at the year end, the Adjusted EBITDA1 loss is anticipated to be in line with market expectations and retained cash balances of $1.8 million, which together with inventory and inventory deposits, amounted to $11.9 million. 

The next generation X-PLOR, launched in September 2022, has been well received by the market based upon its performance and reliability. It provides more oxygen by weight than any portable oxygen concentrator in its class and is the first POC with a mobile app that connects to phones, tablets, pulse oximeters and wearables (the NOMAD Biometric App).

The first DISCOV-RTM POCs expect to be launched for pre-market evaluation in Q1 2023, with full commercialisation anticipated in Q2.  DISCOV-R is the first ambulatory pulse-dose and two-litre continuous flow POC in the world. Weighing c.40% less than any comparable dual flow oxygen concentrator on the market, the DISCOV-R produces nearly 3 times the oxygen by weight than its competition.  Distributors are very excited about DISCOV-R and it is already receiving pre-orders. The DISCOV-R will also include the transformational NOMAD Biometric App.

In March 2022, we signed a manufacturing Master Supply Agreement (“MSA”) with InnoMax Medical Technology, Ltd (“InnoMax”) to manufacture the X-PLOR portable POC in China, more than doubling our manufacturing capacity in 2023 and enabling us to accelerate our international expansion by opening up markets in Asia and beyond.  Innomax are anticipated to directly source most of their own components from the second half of 2023, which will also result in a significant margin improvement and reduction in the Company’s inventory levels.

Given the strong demand, the Group took the decision to transfer its US manufacturing in-house, to increase production output at high quality standards, and achieve a significant reduction in production costs. This was successfully completed at the end of July 2022, enabling the achievement of ISO:13485 accreditation.  The manufacturing facility is already demonstrating the required product quality to build a significant customer base and repeat orders, underpinning the building of a strong brand reputation for our best-in-class technology.

Following this transition and having achieved ISO13485 accreditation, we are confident in having both the quality of manufacturing facilities and the inventory levels to increase production commensurate with market demand, as we expand our sales channels and are able to apply to distribute products internationally.

Robert Rauker, CEO of Belluscura plc, commented: During the year we have made considerable progress. We have enhanced our production, quality accreditation and supply chain, positioning us well to deliver on the demand we are seeing for our devices, as we expand our distribution partners and geographical reach. Market reception for the next generation X-PLOR and Nomad App has been extremely positive, with an encouraging level of forward orders. We are very excited about the upcoming launch of the DISCOV-R, which we believe will be a transformational product, and we look to the future with confidence.”

Adjusted EBITDA is earnings before interest, tax, depreciation, amortisation, share-based payment expense, foreign exchange movements and non-recurring items. 

For further information please contact:

Belluscura plc

www.belluscura.com

Robert Rauker, Chief Executive Officer

via MHP

Anthony Dyer, Chief Financial Officer

SPARK Advisory Partners Limited (NOMAD)

Tel: +44 (0)20 3368 3550

Neil Baldwin

Dowgate Capital Limited (Broker)

Tel: +44 (0)20 3903 7715

James Serjeant / Nicholas Chambers

MHP (Financial PR and Investor Relations)

Tel: +44 (0)20 3128 8100

Katie Hunt / Pete Lambie / Matthew Taylor

Email: belluscura@mhpgroup.com

 

About Belluscura plc (www.belluscura.com)

Belluscura 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 organisations.

#ORPH Open Orphan PLC – CAP accreditation

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that its clinical laboratories in Queen Mary’s Bioenterprise Centre and Plumbers Row (hLab) have been awarded accreditation by the College of American Pathologists (“CAP”). The Company sought the accreditation as part of its ongoing commitment to maintaining best in class quality systems.

The CAP is the world’s largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes. The accreditation “supports laboratories performing testing on specimens from human, using methodologies and clinical application within the expertise of the program”. This further expands on the Company’s Good Clinical Practice for Laboratories (GCLP) accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA) and provides additional quality assurances of its laboratory services for its clients, especially within the United States, thus ensuring the accuracy of test results and conforming to the requirements from the US Food and Drug Administration (FDA).

hLab is a highly specialised virology and immunology laboratory, offering a suite of services to support both pre-clinical and clinical respiratory drug and vaccine discovery and development. This includes assay development, transfer and optimisation across immunology, molecular and cell-based assays, including extensive options in sample matrix and stability testing and analysis. hLab is well equipped with Biosafety Level 2 and 3 facilities to provide high quality data outputs to enable clients to achieve early proof of concept, or to make a breakthrough discovery in the pathology and possible treatment of diseases with unmet medical needs. hLAB now provides services beyond supporting the Company’s in-house human challenge trials, offering lab services as a standalone service to s upport vaccine and drug development from pre-clinical studies through Phases I – III clinical trials.

 

Brandon Londt, Development Operations Director, hLab Development at hVIVO, said : “We are proud to have received the CAP accreditation, which is recognition of the quality of our laboratory and further demonstrates our commitment to maintaining the highest standards of excellence and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide current and future clients a further degree of confidence in the quality of work performed in our laboratory and assurances of the results we produce.”

 

 

For further information please contact:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin Khan, Chief Executive Officer

Walbrook PR (Financial PR & IR)

Stephanie Cuthbert / Phillip Marriage /
Louis Ashe-Jepson

+44 (0)20 7933 8780 or  openorphan@walbrookpr.com

+44 (0) 7796 794 663 / +44 (0) 7867 984 082 /
+44 (0) 7747 515 393

Tim McCarthy , Non-Executive Chairman of ImmuPharma (AIM:IMM) Interviewed on ShareTalk

ImmuPharma focuses on developing pioneering and novel drugs in specialist therapeutic areas. We are an ethical organisation with the vision to develop novel drugs to treat serious medical conditions, delivering value to patients, medical professionals, healthcare payers and our shareholders.

We value innovation, creativity, integrity, fairness, competency, professionalism, and we have a passion for what we do.

Tim McCarthy, Chairman of ImmuPharma firmly committed to Lupuzor™ ahead of the start of the Managed Access Programme

ImmuPharma’s strategy and business model are different from many of its peers. We are a risk-averse company and our management team has extensive experience in senior positions in some of the world’s leading pharmaceutical companies. We focus on developing pioneering and novel drugs in specialist therapeutic areas where there is a distinct lack of existing treatments, avoiding primary care (diseases treated by GPs) where many treatments exist. This is consistent with the trends in the pharmaceutical industry. Since our foundation, our research strategy has been to work closely with the largest fundamental research organisation in Europe, the Centre National de la Recherche Scientifique, (CNRS) in France. This collaboration enables us to access innovative research with substantial embedded value and to work with many leading scientists and doctors. ImmuPharma has exclusive rights to all its intellectual property assets. Our market strategy is to license our assets to leading international corporations that are well-placed to further develop and/or commercialise our drugs. Our corporate deal with Cephalon Inc. in 2008, for the worldwide rights of our lead drug candidate for the treatment of Lupus, Lupuzor™ is one example of this strategy in action.

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