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Latest News

Uscom BP+ Distributor for SE Asia

July 17th, 2017

Appointment of established partner to distribute BP+ and BP+ Reporter in South East Asia

Uscom has announced a distribution agreement for the Uscom BP+ and BP+ Reporter with Pacific Medical Systems Limited (PMS) of Hong Kong. The three year agreement covers distribution into Thailand, Hong Kong and Macau, Singapore, Taiwan, Malaysia and Indonesia

Key Points

  • The Uscom BP+ is practice changing suprasystolic oscillometric technology for central blood pressure monitoring and central pulse pressure wave analysis
  • The BP+ Reporter is the proprietary stand-alone software solution that provides a digital platform to archive patient examinations and images, display trend measures over time, analyse blood pressure waveforms and values, and generate patient reports.
  • PMS are master medical device distributors with many years regional expertise in China and SE Asia with specific skills in bringing new medical technologies to market
  • PMS are long term Uscom partners, having introduced USCOM 1A on its release, and currently distribute USCOM 1A through China, Taiwan, Korea and SE Asia
  • The BP+ agreement covers countries with a combined population of 393M (Aprox 5% of world pop)
  • Best intentions BP+ and BP+ Reporter targets are for approximately AU$1.5M sales revenue over 3 years following regulatory approval
  • BP+ and BP+ Reporter are currently in process for global regulatory approvals with new distributors currently being appointed worldwide

Executive Chairman of Uscom, Associate Professor Rob Phillips said, “This is another major territory covered by new distributors preparing to deliver the innovative Uscom BP+ and BP+ Reporter to market. PMS are experienced master distributors in China and SE Asia and are keen to get sales under way as soon as regional regulations allows. Worldwide we are appointing new distribution to ensure that immediately our regulatory approvals are received we can begin to sell these revolutionary technologies in the market. The patent protected BP+ devices have major application for assessment of hypertension and vascular health, rapidly increasing disease with high social and cost burdens.”

Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies. These premium digital devices are changing the way we diagnose and treat cardiovascular and pulmonary diseases, including hypertension, heart failure, asthma, COPD and sleep disorders. The products are integral for optimising management of sepsis and guidance of fluid, inotropes and vasoactive therapies in critical care monitoring, and in clinical and home care delivered asthma and COPD medications and in sleep medicine.

TGA for Uscom SpiroSonic Digital Spirometers

July 13th, 2017

Uscom advanced digital ultrasonic SpiroSonic lung function devices receive regulatory listing for sale in Australia

Uscom announced that the Uscom SpiroSonic product range of lung function monitors have been listed on the Australian Regulator of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA). This listing allows sale of the Uscom high fidelity, digital ultrasonic SpiroSonic pulmonary function monitors as a class IIA device.

Key Points

  • TGA is Australian regulatory authority for therapeutic goods including medical device and listing is required before sale in Australia
  • Chronic respiratory diseases (asthma, COPD and sleep apnoea) are common and increasing worldwide
  • Uscom SpiroSonic devices are high fidelity pulmonary function testing devices used in home care, clinics and advanced pulmonary testing laboratories to diagnose and manage asthma, COPD and sleep apnoea
  • SpiroSonic devices have recently received CE (European) approval and are currently in process for CFDA (China) and FDA (US) approvals
  • Uscom BP+ and BP+ Reporter are also in process for global regulatory approvals

Regulatory approvals are essential for permission to sell in almost all global jurisdictions and are evaluated in terms of safety and efficacy. The SpiroSonic devices are listed by the ARTG with the identifier 291176. The SpiroSonic devices already have CE (Europe) and now TGA approval, and are in process for CFDA (China) and FDA (USA). The Uscom BP+ and BP+ Reporter are also undergoing the same processes, but because of precedent approvals the timeline may be shorter. However the duration of the regulatory processes vary with jurisdiction and product, and are therefore uncertain. Uscom has already appointed an Australian distributor to begin sales, and multiple new European distributors, and is looking to appoint new US and SE Asian distributors.

Executive Chairman of Uscom, Associate Professor Rob Phillips said, “Regulatory approval is the path to sales and revenue for our new products, and each new approval represents another regional revenue stream. Our strategic objective is to bring the SpiroSonic devices and the BP+ central blood pressure devices to global markets and anticipate receiving regulatory approvals for all products in all jurisdictions intermittently over the next 12mths. Our current growth has been predominantly attributable to USCOM 1A sales, and so the approval for sale of additional devices in additional jurisdictions represents incremental future revenue opportunities and growth drivers. We are building a real company aiming to combine blue sky, practice changing science with hard measures of sales, revenue, profitability and shareholder distributions. Regulatory approvals are vital steps in this process and a key focus of our operations.”

Uscom SpiroSonic Devices for Spanish Health Project

June 1st, 2017

Spanish eHealth monitoring of patients with chronic disease using digital Uscom SpiroSonic spirometers and software platform

Uscom subsidiary Uscom Europe announced a partnership with Sonmedica S.A., the Public Health Agency of Catalonia and the Health Campus of the University of Barcelona to deliver telemetric pulmonary care via the Nextcare Digital Health Care Project to patients in Catalonia. The project, the first of its kind worldwide, aims to deliver personalised home care to patients with chronic disease via a public digital health care framework.

The pulmonary arm of the Nextcare project is being led by Professor Josep Roca, MD, PhD, the Director of The Lung Function Unit at the Barcelona Hospital Clinic, Professor of Medicine at The University of Barcelona, and the former president of the European Respiratory Society credited with over 470 peer reviewed publications.

The pulmonary arm of the Nextcare project uses the new Uscom SpiroSonic tSpiro telemetric ultrasonic spirometers for the home care monitoring of patients with chronic pulmonary disease. The Uscom SpiroSonic devices utilise multi-path ultrasonic technology and are wirelessly connected to the central hospital record keeping systems with Uscom SpiroReporter proprietary digital phone and cloud based software applications. Specialist pulmonologists then evaluate the measurements and direct management via mobile phone, thus by-passing expensive hospital treatment.

Key Points

  • The Nextcare digital health care project is designed to provide digital home care monitoring for patients with chronic diseases, including asthma and COPD
  • Pulmonary diseases such as asthma and COPD are increasing worldwide as air quality deteriorates
  • Uscom tSpiro multi-path ultrasonic spirometers provide practice leading pulmonary function measurements
  • Uscom proprietary software and digital connectivity with SpiroSonic devices provides for high acuity home care monitoring of pulmonary function
  • As part of the Nextcare program approximately 50 Uscom tSpiro devices have been deployed and connected to regional hospital medical recording systems as part of the pilot study, while the system is expected to be rolled out state wide over the next few years as its clinical value is established.
  • The pulmonary arm of the Nextcare project is the first worldwide to implement telemetric pulmonary care into the eHealth home care model
  • The Uscom tSpiro platform of devices are currently being adopted by a number of eHealth providers around the world and are approved for European sales, and are currently being reviewed for US FDA and Chinese CFDA approval.
  • The Nextcare Digital Health Care Project is supported by European Union funding

Uscom’s Global Head of Product Innovation and Digital Pulmonary Devices, George Ferenczi said: “Our engineering team have spent a lot of time working with Sonmedica and the scientists in the Nextcare program at the University of Barcelona matching the digital interfaces of our SpiroSonic devices with the Catalonian Hospital medical records systems and ensuring ease of digital communication and simplification of signal analysis.”

Executive Chairman of Uscom, Associate Professor Rob Phillips said: “Our digital health work with the Barcelona University and Public Health Agency of Catalonia is the first of its kind worldwide, and will become the template for digital health care worldwide; this project is setting the standards for eHealth excellence for the future. It’s a great credit to our Uscom engineers that this innovative model has been so seamlessly implemented for the benefit of the people of this highly developed region of Spain, and we look forward to the adoption of our digital technologies in similar models worldwide.”

Digital cloud based pulmonary monitoring is an emerging global trend in clinical care, and provides for early detection of changes in pulmonary function and improved guidance of therapy. This collaboration between the Public Health Agency of Catalonia, the Health Campus of the University of Barcelona, and Sonmedica with Uscom Europe is supported by European Union funding, and is further recognition of the superior quality of the SpiroSonic digital spirometers and our connectivity solutions. While many current spirometers use mechanical turbines, Uscom’s patented multi-path ultrasonic spirometers provide higher accuracy, lower maintenance, are simpler to use, and are more hygienic.

Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies. These premium digital devices are changing the way we diagnose and treat cardiovascular and pulmonary diseases, including hypertension, heart failure, asthma, COPD and sleep disorders. The products are integral for optimising management of sepsis and guidance of fluid, inotropes and vasoactive therapies in critical care monitoring, and in clinical and home care delivered asthma and COPD medications.

References:

http://blog.aquas.cat/wp-content/uploads/2016/12/Catalunya-2016-Reference-Sites.pdf