Belluscura Regulatory News (BELL)

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Belluscura plc

("Belluscura" or the "Company" or "Group")

Orders for over 6,500 DISCOV-R™ received

Pre-commercial launch orders by leading online retailers and medical equipment providers demonstrate the scale of the demand for this transformational product

LONDON, U.K. AND PLANO, TX, U.S. (16 August 2023). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that it has received purchase orders for over 6,500 of its next-generation DISCOV-R portable oxygen concentrator. This represents approximately $15 million of potential revenue to the Company, with initial production of the DISCOV-R expected to begin by the end of this quarter.

Following the pre-market launch of DISCOV-R and a patient usability study in June 2023, the Company plans a controlled roll out of the DISCOV-R this autumn and into 2024 to meet growing demand for the device amid substantial interest from medical device distributors, retailers, patients and durable medical equipment (DME) providers, among others.

The DISCOV-R is expected to be the world's first ambulatory two litre continuous flow, eight level pulse dose portable oxygen concentrator when it is released. With the ability to produce two litres of continuous flow and maximum single pulse dose volumes exceeding 110ml, the Company believes that the DISCOV-R will be covered by both CMS E1390 (stationary) and E1392 (portable) reimbursement codes, making the DISCOV-R a better financial option for the thousands of homecare oxygen providers. It will also produce nearly three times as much oxygen by weight than its dual flow competitors.

The recent purchase orders follow the signing of several distribution agreements with medical device distributors and other home healthcare providers, including a distribution agreement with a division of McKesson, one of the largest distributors of pharmaceuticals and medical devices in North America, earlier this month and a marketing agreement with GoodRx®, a leading digital healthcare platform, in February 2023. The Company has received multiple additional requests from leading oxygen homecare providers in the US to distribute the DISCOV-R. 

The Company will update the market later this year as it plans its controlled roll out of the DISCOV-R this autumn and into 2024.

Substantial progress on X-PLOR® and proprietary NOMAD biometric app

At the same time, the Company continues to progress its CE and UKCA registration mark application for its X-PLOR® portable oxygen concentrator. Since resources in the US were redirected to completing the development and launch of the DISCOV-R, production of X-PLOR by our Chinese partner, Innomax Medical Technology Ltd (Innomax), has now progressed, with 1,500 units recently being manufactured and shipped to the US for distribution. 

The Company recently established a subsidiary and hired its first employees in Shenzhen, China as it prepares for the anticipated registration of the X-PLOR for sale and distribution in China and Hong Kong later this year. The Company and Innomax believe there is a significant market opportunity in China with approximately 100 million people suffering from COPD.

Additionally, the Company continues to drive innovation in telemedicine and artificial intelligence with its proprietary NOMAD biometric app. The NOMAD app will allow users of the DISCOV-R to track performance data on their concentrator and connected devices such as an Apple® or Samsung® Watch, FitBit® device or Nonin® and Masimo® pulse oximeters. The collective information can then be provided to a patient's healthcare provider in person or remotely.

The Company is already working on the next-generation NOMAD app that will alert patients when their blood oxygen saturation level has varied beyond parameters set by their doctor, which is expected to help patients better monitor their conditions, but also improve the efficiency of the device by delivering supplemental oxygen as needed.

Bob Fary. Sr Vice President of Global Sales, Belluscura plc, commented:

"We are very excited about the overwhelming interest in the DISCOV-R by online retail sellers and other medical equipment providers. Following the pre-market launch of the product and the patient usability study in June, initial feedback suggests we will receive the same or greater level of interest from leading home healthcare providers once it is launched commercially."

Bob Rauker, Chief Executive Officer, Belluscura plc, commented:

"We believe the DISCOV-R, combined with our proprietary NOMAD app, will be transformational to the portable oxygen industry and patient outcomes. This is reflected by early demand for the product prior to its full commercial launch, which is expected to take place later this year. The significant number of orders received demonstrates the substantial appetite for this product and we anticipate adding several more of these providers to our distribution network as we balance the high demand with production expectations over the next twelve months.

"This marks another exciting development for the Company, delivering on our strategy to design and manufacture highly differentiated, high quality and high margin products. Amid growing sales and continued progress with our X-PLOR device and NOMAD app, we continue to seek further opportunities to improve the quality of life for our end users".

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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.