News - 2015
New SpiroSonic Series of Asthma Products
November 30th, 2015
On the 25th of November, Uscom announced to the market the release of a new series of medical devices for improving diagnosis and treatment of asthma and chronic obstructive lung disease (COPD). The devices were acquired in the Thor transaction and have undergone renaming, rebranding, relabelling and repricing and are being prepared for sale in global markets over the next twelve months.
The SpiroSonic range of spirometers utilises advanced and novel ultrasound technology to accurately measure the direction, velocity and volume of airflow during inspiration and expiration. The patterns of this airflow can be used to diagnose diseases of the lungs including asthma and COPD, disease which effect 500 million patients worldwide. The devices can also be used to measure the effectiveness of asthma and COPD therapies. SpriosSonic has been trademarked by Uscom worldwide.
Disordered breathing is at the centre of sleep medicine, and these new high fidelity ultrasound devices have important potential applications in sleep medicine.
The SpiroSonic range includes 7 premium quality products; the SpiroSonic Flo, SpiroSonic Mobile, SpiroSonic Smart, SpiroSonic Pro, SpiroSonic HD, SpiroSonic Reader and Spirosonic Reporter. There are also a further 3 research products currently under clinical testing for release over the next 12 to 18 months.
The Uscom SpiroSonic digital spirometers have been designed to take research quality respirometry measurements into clinical and home care applications. The devices are FDA cleared and covered by US CPT and Australian MBS Codes for between $50 and $87 AUD, and will retail for approximately $2,000 to 3,000 AUD.
Executive Chairman of Uscom, Associate Professor Rob Phillips said, “The release of the SpiroSonic suite of digital ultrasonic spirometers has caught the attention of the spirometry market, and we have had a lot of interest in our new products at Medica in Dusseldorf last week. Our strategy has been to build a practice leading product portfolio across the vital applications of cardiac, vascular and pulmonary medicine and this is a next step. The release of the SpiroSonic range will spearhead our entry into the UK and US spirometer market, and we are currently negotiating with specialist distributors in these jurisdictions. The objective is to be generating substantial revenue from these devices within the next 12 months.”
Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom Thor 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.
USCOM can Replace Cardiac Catheters in Children
November 9th, 2015
Uscom is pleased to announce the publication of a double blinded, prospective, observational study confirming the accuracy of the USCOM 1A compared to invasive catheter measurements; the current gold standard technology. The study was performed by medical researchers from the prestigious Children’s Hospital, Los Angeles and the Keck School of Medicine, University of Southern California.
The study of 31 children aged 9 months to 19 years, is the first to validate the non-invasive USCOM 1A as a replacement technology for the invasive pulmonary artery catheter (PAC) in children. The mean measures by each method differed by less than 5% while the mean error was 11%, well inside the acceptable error which was determined a priori to be 30%.
The PAC procedure requires anaesthesia, cardiac catheterisation, can take up to 2 hours to perform, and is associated with a significant risk of infection and death. USCOM is entirely non-invasive and causes less distress to children than a simple blood pressure reading, takes 5 to 10minutes per measure and is entirely safe.
The USCOM 1A technology is a recommended standard of care in the Pediatric Sepsis Guidelines for measurement of cardiovascular function and implementation of advanced haemodynamics.
Executive Chairman of Uscom, Associate Professor Rob Phillips said, “USCOM is already routine management in leading pediatric intensive care units worldwide, and is being used to save children’s lives. This study provides the evidence necessary for widespread adoption of the USCOM 1A in pediatric critical care medicine and cardiology, and supports its replacement of the PAC, and other less accurate methods more generally.
Uscom is a Company based on innovative, practice leading science, and improving the care of children has always been a core objective for us. This study is another measure of our scientific success, and is further evidence of the fundamental and long term social and commercial value of our technologies.”
Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom Thor 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 clinical and home care.
Uscom Establishes UK Subsidiary
November 4th, 2015
We are pleased to announce the establishment of a wholly owned UK subsidiary based in London. The entity is registered as Uscom Medical Limited (Uscom Medical).
The establishment of the UK entity is the next decisive step in the global expansion of Uscom and extends its strategic reach into the European and US markets in response to increased global demand. This expansion also follows the acquisition of Thor Laboratories in Budapest (Uscom Budapest) by Uscom in September. Uscom Medical will function as a regional hub for Uscom Budapest manufactured goods and ensure delivery of Uscom products and service to the regional US and European markets.
Executive Chairman of Uscom, Associate Professor Rob Phillips said, “Uscom is proudly Australian and expanding rapidly into export markets, and the establishment of Uscom UK is the next step in the globalization of our operations. This expansion establishes a European platform for our next generation of global growth.”
Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom Thor digital ultrasonic spirometry technologies. These premium digital devices 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 clinical and home care.
Uscom Completes Thor Acquisition
September 1st, 2015
Uscom is pleased to announce it has completed its acquisition of 100% of Thor Laboratories following successful diligence and capital raising. Thor is a revenue stage, medical device manufacturer specialising in high fidelity digital Doppler technology for measurement of respiratory function. Thor has partnered with Cohero Health in New York or the development and marketing of world leading personal asthma monitoring products.
Thor Acquisition Summary:
- Cash flow positive medical technology company with high quality digital Doppler respirometry devices.
- Internationally accredited manufacturing, R&D and engineering facilities.
- Established distribution network, primarily in Europe.
- Multiple CE/TGA/FDA approved products, each with re-imbursement.
- Partnership with Cohero (New York) for marketing of Thor developed home care, cloud based, asthma and COPD monitoring technologies.
- George Ferenczi and team to join Uscom providing international footprint.
- Complementary technologies with synergies of science, technology and operations.
The acquisition will expand the Uscom footprint internationally and include the addition of of approximately 16 engineers, and 10 administrative staff based in Hungary. George Ferenczi, the Thor founder and a world leader in respiratory devices, also joins the Uscom team and will lead new product development. The Thor manufacturing facilities in Budapest will provide expanded manufacturing capacity to meet the increased demand for USCOM 1A, and the US marketing of Uscom BP+, and the expansion of Thor products into the US following FDA approval in June 2015.
Uscom CEO, Associate Professor Rob Phillips said, “This acquisition is another great step for shareholders adding value at many levels: revenue, scale, manufacturing, distribution, products and international market partnerships. The devices are Doppler ultrasound based, like USCOM 1A, and relate to the cardiopulmonary clinical market. Thor will provide a high quality, approved and manufacturing base close to international markets. Hungary is a European manufacturing secret, providing highly cost-effective manufacturing for the medical device companies of Germany and Switzerland. The Thor products are innovative with an expanding market recognition and will be managed under under Stephen Wilson’s guidance in the US now they have FDA approval. We are looking forward to working closely on development of both the current Uscom products and the Thor products with our new expanded team. We have grown our staff from 12 to 38 overnight with all the development, distribution and management efficiencies that brings, at a time when our rapid growth requires it most. This is a very fortuitous partnership at exactly the right time.”
Stephen Wilson, Uscom’s US VP of Business Development said, “George and I displayed some of the Thor devices at the FIME medical device conference in Florida last month and there was considerable excitement. I think these products have a great future in the US asthma and COPD market, and particularly for home care and cloud based monitoring, and I am looking forward to developing the distribution partnerships to make that happen.”
The new suite of Thor spirometric devices will slipstream Uscom’s flagship USCOM 1A and Uscom BP+ products and expand Uscom technology into practice leading positions in cardiac, vascular and pulmonary applications.
To view an Investor Update Presentation Click Here
USA FDA Clearance for Thor Ultrasonic Spirometers
July 29th, 2015
Uscom is pleased to confirm the USA Food and Drug Administration (FDA) recognised the SpiroThor digital ultrasonic spirometers as equivalent to predicated class II diagnostic spirometers and therefore approved the devices for marketing into the USA.
Uscom has entered into an agreement to purchase 100% of Thor operations and intellectual property, subject to completion of satisfactory due diligence.
Thor Laboratories manufacture a range of high accuracy digital ultrasonic spirometers for the specialized for measurement and monitoring of lung function and lung therapy, with particular application in asthma and chronic obstructive pulmonary disease (COPD), and emerging applications in sleep medicine.
Thor is a cash flow positive medical device manufacturer with current annual revenues of approximately $500k AUD. Its devices already have CE and TGA approvals. Uscom management considers the Thor acquisition to be a key strategic growth opportunity, providing additional revenue, internationally accredited manufacturing and R&D capabilities, distribution and a product suite of ultrasonic spirometers for Uscom to feed into its growing global distribution network.
Uscom CEO, Associate Professor Rob Phillips said, “Products are profit, and the FDA approval of the Thor ultrasonic spirometers provides great commercial opportunity for Uscom to expand into the US market. One person dies from COPD every 4 minutes in the US and asthma continues to increase world wide as air quality deteriorates. There are a number of different technologies applied to spirometry, but digital Doppler ultrasound is considered the most accurate, and the Thor products are class leading. These spirometers are complimentary to the USCOM 1A cardiac output and Uscom BP+ central blood pressure monitors, which already have FDA approval. Our philosophy has been to develop and market the best quality non-invasive technologies in vital clinical applications. This acquisition and FDA approval, now allows us to deliver practice leading devices into the lucrative US cardiac, vascular and pulmonary markets.
Our newly appointed US VP of Business Development, Stephen Wilson, spent 10 years marketing blood pressure technologies and spirometers for Welch Allyn, and is well qualified to ensure the Thor devices are effectively delivered into the substantial US markets.”
Uscom recently raised $1.55m via a placement of shares to new and established institutional and sophisticated investors, with a further $0.4m underwritten for sale to existing shareholders via an SPP in the coming weeks. These funds will be used for the Thor acquisition and for working capital.
Uscom Quarterly Report - June 30 2015
July 27th, 2015
- Year on year sales growth of 59%
- Net operating quarterly cash flow of -$0.045m
- International acquisition to boost manufacturing, revenue and products
- New US VP Business Development appointed
Uscom Limited has released its Appendix 4C – Quarterly Cashflow report for the quarter ended 30 June 2015 (the Quarter). The results disclosed in the Appendix 4C are in Australian dollars.
During the Quarter, we note the following:
• Annual receipts from customers for 2015 up 59%
• Net quarterly operating cash flows of -$0.045m
• International ultrasound acquisition to boost manufacturing, revenue and products
• Former Welch Allyn executive appointed Uscom US VP Business Development
Significant events after the reporting period
Uscom completed a successful capital raise of $1.55m on 23 July 2015, and has announced an SPP for current shareholders underwritten for a further $0.4m. The Company also announced the acquisition of Thor Laboratories, a Hungarian ultrasound respiratory device manufacturer, for $700,000 in cash and additional earn outs of $200,000 in cash and 500,000 shares over a three year period. The Company considers the Thor acquisition to be a key strategic growth opportunity, providing additional revenue, internationally accredited manufacturing and R&D capabilities, distribution and a suite of ultrasonic spirometry products to Uscom.
Quarterly results demonstrate a 59% annual growth in customer receipts and a 32% diminished quarterly year on year cash consumption, despite increased staff and R&D costs. Net operating cash flows for the quarter were -$0.045m.
The sales growth was almost entirely from USCOM 1A and reflects an increasing clinical take up of the flagship Uscom cardiac output monitor. This take up was driven by new scientific publications demonstrating the effectiveness of the USCOM 1A across a range of clinical applications. The most important publication was in the use of USCOM 1A for detection of pre-eclampsia (i.e. hypertension in pregnancy) where its use was associated with earlier detection, more rapid treatment, and better outcomes for mothers and children. The author recommended USCOM 1A be uses as a screening device for pregnancy.
The Company appointed Stephen Wilson as US VP Business Development to head the marketing, reimbursement and distribution activities of Uscom products in the US. Stephen has 20 years experience in the field of blood pressure monitoring having developed patent protected blood pressure technology and led the marketing of new blood pressure devices in his position as VP Corporate Development for Welch Allyn, USA. His appointment to Uscom will accelerate the adoption of the Uscom BP+ central blood pressure monitor in the US market once the USA CPT Code 1 approval for central blood pressure measurement is introduced (expected to be early in 2016).
The Company maintains its strategy of increasing distribution to drive sales and revenue, and recently announced the appointment of an additional 8 distributors throughout India, the Middle East, Europe and Australia, taking to 38 the total number of distributor agreements for Uscom products worldwide.
Development continues on the Uscom BP+ in preparation for global volume marketing. The China regulatory approval is under way for the BP+ which will lead to initiation of the China Pioneer distribution deal, which is contracted to deliver an average $1.4m US revenue per annum over each of the next 5 years to Uscom.
Executive Chairman of Uscom, Associate Professor Rob Phillips said “The Company continues to meet its financial milestones and is now at an operational inflection point; reporting year on year revenue and sales growth averaging in the order of 60% for the last two consecutive years with a 20% decreased annual cash consumption despite increasing personnel and R&D costs. Uscom has also acquired two international medical device companies in the last 3 years, both of which bring sector leading products to Uscom with significant distribution synergies and sales opportunities.
Current growth is being driven by growth of USCOM 1A sales, which will continue, while we anticipate increasing revenue from BP+ sales associated with the Pioneer contract and China approval, and from the USA CPT Code 1 introduction early in 2016. Thor, the most recent Uscom acquisition, had more than A$500k annual revenue in 2014, with outstanding growth opportunities in the US and China, and, on completion, will ensure continued Uscom revenue growth.
The appointment of USA blood pressure and marketing specialist Stephen Wilson will be instrumental in the growth of US sales for all Uscom products, but he will be particularly focused on applying his 10 year Welch Allyn experience to the revenue opportunities of the Uscom BP+ device in the US.Following the completion of the due diligence on, and the acquisition of, Thor, we intend to grow distribution of the Thor digital ultrasound spirometry products as each has CE and TGA approval. We will also look to rationalise manufacturing and operational efficiencies for all Uscom products which we anticipate will deliver incremental revenue and profit growth.
Uscom management is focused on becoming a multi-technology, fast growth international medical device company selling a sophisticated and profitable suite of noninvasive, sector leading technologies into world medical markets. Uscom management continues to focus on active growth strategies and optimising shareholder value, with a view to wider global expansion.”
Read full announcement here
Uscom announces $1.95m capital raise and acquisition
July 21st, 2015
- Completion of Private Placement to raise $1.55m
- Acquisition of Thor Laboratories KFT
- Share Purchase Plan to be underwritten for an additional $0.4m
Uscom is pleased to announce the completion of a $1.55m Placement to professional and sophisticated investors (Placement). The company is also pleased to announce a Share Purchase Plan (SPP) to be underwritten up to $400k by Patersons Securities Limited (Patersons). The proceeds from the capital raise will be used to fund the acquisition of Thor Laboratories KFT (Thor), integration of Thor’s operations into Uscom’s existing operations, and for working capital.
The Placement was led by Patersons and was completed at an issue price of 15 cents per share. This represents a discount of 18.0% to the VWAP of 18.3 cents over the previous five days on which UCM shares traded and a 16.7% discount to the last traded price of 18 cents. The Placement also includes one free attaching unlisted option for every three shares subscribed for under the Placement, exercisable at 25 cents on or before 31st July, 2017. The securities in the Placement are expected to be issued on or around 22 July 2015, and the shares will rank equally in all respect with existing ordinary shares currently on issue.
Uscom has entered into an agreement to purchase 100% of Thor operations and intellectual property, subject to the completion of satisfactory due diligence. Thor is a cash flow positive medical device manufacturer with current annual revenues of approximately A$500k and specialises in high fidelity digital Doppler technology for measurement of respiratory function. Thor is based in Budapest, Hungary, a key centre for European medical device manufacture. Thor manufactures a number of devices with specific application in the assessment of asthma, COPD, and other respiratory disorders, with new potential applications in sleep medicine.
The Thor devices have a range of approvals in various jurisdictions including CE certification and TGA approval, with some devices under FDA submission. Thor founder, Mr George Ferenczi, will become a full time employee of Uscom as part of the transaction, continuing to manage the Thor operations and contribute to an expanded product development programme for Uscom.
The Company considers the Thor acquisition to be a key strategic growth opportunity, providing additional revenue, internationally accredited manufacturing and R&D capabilities, distribution and a respirometric product suite to Uscom.
Consideration for the acquisition of Thor and its assets is a total of AUD$1 million, comprising $700k in upfront cash, and $200k in cash earn-outs and $100k in equity earn-outs over a three year period from the date of acquisition. The total assets of the company were valued at $361k at 31st December 2014, and an additional $100k of cash will be left in the company as working capital.
The IP, the operations and global certificates and approvals were not included in the valuation. The acquisition was led by K&L Gates, Sydney, Australia.
Share Purchase Plan
The Company is pleased to offer eligible shareholders the opportunity to apply for new shares under a Share Purchase Plan. The SPP will be open to shareholders with registered addresses in Australia or New Zealand who were holders of UCM Shares at 5.00pm AEST on 17 July 2015 and (Eligible Shareholders). Eligible Shareholders will be able to apply for up to $15,000 worth of new Uscom Shares at the Placement issue price of 15 cents per share.
The SPP is to be underwritten by Patersons. Patersons will underwrite the subscription of the first 2,666,667 New Shares under the SPP Offer, limited to a total underwriting commitment of no more than $400,000.05. For every three shares Patersons underwrites under the underwriting agreement, it will receive one free option on the same terms and conditions as the options issued under the Placement. Subject to the ASX Listing Rules, the Directors reserve the right to accept applications in excess of the underwritten amount.
The complete terms and conditions of the SPP will be mailed to all eligible shareholders shortly. Shareholders are encouraged to read the SPP terms and conditions in their entirety before deciding whether to participate in the SPP.
Uscom CEO, Associate Professor Rob Phillips said, “This acquisition is transformational, growing Uscom’s revenue and providing international manufacturing, distribution, additional skilled personnel, and a new suite of products ready for sale with CE and TGA regulatory approvals and some regional reimbursement. The Thor products complement the current USCOM 1A and BP+ devices and can be sold side by side into hospitals, clinics and ultimately the lucrative and rapidly growing home care markets of the US and China.
The Thor acquisition is revenue positive and value accretive for Uscom shareholders, and
advances Uscom’s strategy to build a company of world leading non-invasive technologies for accurate measurement of heart, lung and vascular function, and improved management of cardiovascular and pulmonary care. The transaction has operational, technologic and clinical synergies and so provides ideal incremental growth for Uscom.
We are delighted with the capital support from established and new shareholders for the Thor acquisition, and the timing of the acquisition is excellent. Just as Uscom is transitioning to profitability off USCOM 1A sales, and the Uscom BP+ is set for market release, we have acquired an expanded distributor workforce and enhanced manufacturing capability.”
George Ferenczi is a world leading Bio-engineer and will ensure the seamless integration of the acquisition and contribute to the ongoing success of the business. George plans to feed the USCOM 1A, Uscom BP+ and the Thor suite of products into the combined Uscom/Thor distribution network, ensuring full revenue value is extracted from the growing distributor channels.”
George Ferenczi said “It has taken me 12 years to develop Thor and its products, and bringing Thor together with Uscom creates scale and commercial opportunity that the two companies alone could not achieve. I’m looking forward to joining the Uscom team and accelerating the growth of the combined business.”
Uscom technologies will now hold practice leading positions in cardiac, vascular and pulmonary applications with new investor funding applied to advance new marketing initiatives for the flagship USCOM 1A, and the Uscom BP+, and the new Thor devices.
USCOM Signs Eight New Distribution Agreements
July 7th, 2015
Uscom is pleased to confirm the execution of eight new distribution agreements across its USCOM 1A cardiac output monitor and the Uscom BP+ central blood pressure monitor products.
The eight new distribution arrangements are made up of five for USCOM 1A and 3 for Uscom BP+, with agreements covering India, the Middle East, Europe and Australia. This continues Uscom’s global strategy of expanding global reach into new and under penetrated markets.
Uscom CEO, Associate Professor Rob Phillips said, “These appointments are in line with our stated management strategy to grow distribution to increase sales and achieve our milestone revenue goals. As we grow the number and quality of distributors carrying Uscom products increases, so the revenue knock on will be enhanced. The appointment of Steve Haken in the UK and Denise Pater in Australia, to develop appointment and management of distributors, has increased significantly the number and quality of global Uscom distribution. The appointment of ex Welch Allyn Director of Corporate Development, Stephen Wilson, as Uscom VP of USA Business Development, will rapidly accelerate our US operations and provide an even greater platform for revenue growth.”
Uscom is continuing to focus on increasing distribution, sales and revenue as it transitions to its revenue phase. The appointment of additional global distributors will help Uscom to achieve its aggressive growth goals over the coming period.
Former Welch Allyn Executive appointed to Uscom USA; New US VP of Business Development
July 6th, 2015
Uscom is pleased to announce the appointment of Stephen Wilson as Vice President of Business Development in the United States. Stephen was formerly the US based Director of Corporate Development for Welch Allyn, and will now focus on driving Uscom growth in the US in the key areas of reimbursement, distribution, sales and marketing.
Stephen has 10 years experience as a medical device executive for Welch Allyn in the US and Singapore. Welch Allyn is a US medical device company with annual revenues of US$700m and 2,500 employees globally. Stephen is an electrical engineer by training with a master’s degree in computer engineering and an MBA from the University of Chicago Booth School of Business. Stephen has extensive experience in the regulation, reimbursement and distribution of medical devices and specialises in bringing new blood pressure and other technologies to the US market. Stephen has previously negotiated agreements for the licensing and sale of IP as well as executed strategic partnership agreements for Welch Allyn.
Uscom CEO, Associate Professor Rob Phillips, said, “Stephen’s appointment is a key step in the execution of Uscom’s growth strategy and provides a significant boost in the world’s largest medical device market. Stephen will drive the practice leading USCOM 1A and BP+ technologies toward wide spread clinical adoption by drawing on his strong links in US distribution and his deep knowledge of the blood pressure market.”
Stephen said, “I’m delighted to join the Uscom team to drive the US market, and I look forward to applying the skills I acquired during my years with Welch Allyn to growing US distribution, sales and revenue for Uscom. Historically this focused approach to high value markets yields excellent growth. We are looking forward to the implementation of the CPT 1 Code for central blood pressure monitoring which we anticipate will provide a great kick start to our drive for widespread BP+ adoption in the US.”
Uscom is continuing its focus on increasing distribution, sales and business development as it transitions to its revenue phase. The appointment of Stephen Wilson will help Uscom to achieve its aggressive growth goals over the coming period.
USCOM Recognised by China National ICU Society
May 20th, 2015
Uscom is pleased to announce the China National Intensive Care Unit (ICU) Society have included USCOM 1A in their national survey of clinical member current practices and that it was the only non-invasive haemodynamic monitor included.
Only four monitoring methods in total were named; three based on invasive catheter measurements and the non-invasive USCOM 1A. The shift from less accurate invasive monitoring to accurate non-invasive cardiovascular monitoring is a worldwide trend and has been an objective of Uscom since conception. A reduction in use of expensive catheters is also seen as a means to reduce the incidence of catheter associated infections.
In China, the USCOM 1A is recognized as the emerging technology for advanced haemodynamic practice, and while global adoption of the USCOM 1A is increasing, China is advanced in adoption of noninvasive technologies and is looking to the USCOM 1A.
There are approximately 200 USCOM 1As currently installed in China. There are 10,000 ICUs in China and each ICU potentially requires 3 to 5 USCOM units. This National Survey by the China National ICU Society will provide a marketing springboard for USCOM sales into China.
The USCOM 1A received a 5 year CFDA approval in February 2015.
Uscom CEO, Associate Professor Rob Phillips said, “Uscom has been in China for a number of years and have established deep clinical, academic and distribution relationships. China is keen to lead the world in clinical medicine and healthcare delivery, and is very focused on adopting the best technology and developing best clinical practices, and Uscom is pleased to be a part of this growth. The ICU is the missionary market for USCOM 1A, and this recognition shows the impact we are having at the top levels of ICU practice in China. We expect that, with this recognition by the China National ICU Society this early adoption will accelerate into general and widespread practice, a shift that bodes well for future sales.”
Uscom Receives Research and Development Tax Incentive Payment
April 30th, 2015
Uscom is pleased to confirm the receipt of $313,050 as reimbursement in respect of eligible research and development (R&D) activities for the 2014 tax year.
The R&D Tax Incentive is targeted to support R&D programs which benefit Australians and is administered jointly by Aus Industry (on behalf of Innovation Australia) and the Australian Taxation Office.
Uscom CEO, Associate Professor Rob Phillips said, “This is a really important and effective Australian Federal Government policy run to support Australian R&D activities which contribute to the welfare of all Australians. R&D is a vital part of the Uscom business and ensures that our products remain at the cutting edge of global medical technology. The R&D tax incentive program also ensures that the benefits of Australian innovation and entrepreneurship are both directly delivered to Australians, and indirectly through the generation of high value add, highly technical, skilled and clean employment. The program is a well administered and vital part of Government policy supporting Australian innovation, manufacturing and employment.”
On going Uscom R&D programs are focused on development and improvements to the current range of Uscom products and as background for new products.
New Research - USCOM for Hypertension Screening in Pregnancy (Pre-eclampsia)
April 21st, 2015
Uscom has reported a publication of a peer reviewed study in the Journal of Pregnancy Hypertension demonstrating that the USCOM 1A can detect pre-eclampsia in otherwise normal pregnant women as early as 5 weeks into pregnancy, and that USCOM 1A screening in early pregnancy may allow more appropriate and earlier interventions and improve outcomes.
- Pre-eclampsia, or high blood pressure in pregnancy, is a common complication which increases mortality and morbidity for pregnant mothers and their unborn babies
- An estimated 10million pregnant women develop pre-eclampsia every year, and early detection and treatment improves outcomes for mothers and babies
- Pre-eclampsia is responsible for approximately 76,000 maternal and 500,000 fetal and neonatal deaths each year (more than 200 and 1300 per day respectively) – (World Health Organization)
- The study found the USCOM 1A detects pre-eclampsia as early as 5 weeks into pregnancy, while conventional blood pressure measures detect it after 20 weeks
- The study concluded that USCOM 1A screening for pre-eclampsia early in pregnancy may allow earlier intervention and improved outcomes.
Professor Valensise and his team from the Department of Obstetrics and Gynaecology at the University of Rome Tor Vergata have been working on this USCOM 1A project for over 3 years. They conducted a prospective observational trial of normal healthy pregnant women with normal blood pressure and found that USCOM 1A detected the circulatory changes of pre-eclampsia as early as 5 weeks, while the current standard of care, conventional blood pressure monitoring, detects pre-eclampsia after 20 weeks, thus significantly delaying diagnosis and treatment.
Uscom Limited CEO, Associate Professor Rob Phillips said, “This new study provides evidence supporting USCOM 1A screening in early pregnancy. The study suggests USCOM 1A screening will significantly improve pregnancy outcomes and contribute to the saving of lives of mothers and babies world wide. We are proud that our device is improving care in such an important group. This is the first study to prove that USCOM 1A measurements detect changes in cardiovascular function long before they are detected by simple blood pressure monitors. This potentially revolutionises the way we approach hypertension and all cardiovascular disease, and opens the door to markets worth hundreds of millions of dollars annually to Uscom.”
Maternal health is an emerging USCOM 1A application with a number of leading centres globally researching pre-eclampsia using the USCOM 1A. This publication will accelerate this field of research and support the appointment of new specialised distributors into worldwide maternal health centres thus creating a new revenue stream for Uscom.
1. Tiralongo GM, Presti DL, Pisani I, Gagliardi G, Scala RL, Novelli GP, Vasapollo B, Andreoli A, Valensise H. Assessment of total vascular resistance and total body water in normotensive women during the first trimester of pregnancy. A key for the prevention of preeclampsia. J Preg Hypertension: An International Journal of Women’s Cardiovascular Health 2015;5(2): doi.org/10.1016/j.preghy.2015.02.001
AMA Accepts Recommendation for CPT Code for Central Arterial Pressure Waveform Analysis
March 31st, 2015
Uscom notes that the American Medical Association (AMA) has posted its Current Procedural Terminology (CPT) Editorial Panel actions from its February 2015 meeting.
- AMA accepted recommendation for a new Category I CPT code (9300X1) to cover the “non-invasive calculation and analysis of central arterial pressure waveforms with interpretation and report”
- CPT code is a critical step to gain reimbursement coverage in the United States
- Uscom BP+ noninvasively measures the central arterial pulse pressure waveforms and blood pressures and has US FDA clearance
- AMA does not include proprietary references nor recommend a specific medical device
Uscom notes that the AMA CPT Editorial Panel has recommended accepting the Renal Physicians Association application for addition of a new Category I CPT code (9300X1) for the “non-invasive calculation and analysis of central arterial pressure waveforms with interpretation and report”. This Code is intended to replace the existing temporary Category III CPT code (0311T). Uscom also notes that the exact wording of the Code is yet to be finalized and may change prior to publication.
Uscom CEO Assoc. Prof. Rob Phillips said “This AMA Editorial Panel decision is an important step in the process of U.S. reimbursement for clinicians measuring and analysing central arterial pressure waveforms, and is highly important for the U.S. adoption of the Uscom BP+. The BP+ is U.S. patent protected with an innovative approach to the measurement of pulse pressure waveforms and central blood pressure, and has been reported as the device with the greatest clinical applicability in this field by researchers from the University of Cambridge, Weill Cornell Medical College, the University of California and the Wales Heart Research Institute.
While a number of medical devices may potentially offer similar central blood pressure measurements sought to be reimbursed under the preliminary Category 1 CPT code, we believe this AMA Editorial Panel decision is a key step to broader adoption of our technology in the world’s largest healthcare market.”
CPT codes are reserved for those procedures that are performed by many physicians and other qualified health care professionals across the United States and have US FDA clearance.
The annual release of the updated CPT codes is timed to coincide with the annual Medicare Physician Fee Schedule (MPFS). Following the creation of the new CPT Category I code, the Code is surveyed as part of the AMA/Specialty Society RVS Update Committee’s (RUC) review. The RUC makes recommendations to the Centers for Medicare and Medicaid Services (CMS) on which contribute to the calculation of the Medicare fee for the service, as well as for commercial insurance contracted rates. The new Category I CPT code is set to be released by the AMA Editorial Panel on August 31st 2015, and the final Medicare payment rates will be published by CMS in November 2015. A summary of the panel actions are located on the AMA website at https://download.ama-assn.org/resources/doc/cpt/x-pub/feb-2015-summary-of-panel-actions.pdf
Uscom Half-year Financial Results and Appendix 4D
February 24th, 2015
Uscom, a revenue stage, cardiovascular medical technology company, today released to market its interim financial report and financial results for the half-year ended 31 December 2014.
Financial Summary for Half-year
- Revenue for the half-year up 147% to $0.96m from $0.39m in the corresponding period.
- Sales revenue up 125% to $0.84m from $0.37m in the corresponding period.
- Operating expenses from ordinary activities increased to $1.31m.
- Net loss for the half year down 40% to $0.39m from $0.65m.
- At 31 December 2014, the Company had approximately $1.002m in cash.
- Johnson & Johnson Company of the Year award for 2014.
- Chinese FDA registration for the USCOM 1A.
- 6 new distribution agreements for BP+ and USCOM 1A in the United States and Europe.
- Sale of an USCOM unit into the Russian Federal Space Agency.
During the Half-year, sales and sales interest from current distributors continued to grow and the Company’s focus has been on ensuring timely manufacture and fulfilment of orders. In relation to manufacturing, international strategies are ongoing, ensure uninterrupted supply of both the BP+ and USCOM devices.
Operating expenses reflect working capital requirements to meet customer demand, and regulatory work associated with the Chinese FDA registration process. Wages and salaries slightly increased with the addition of Ms Denise Pater to the position of Sales & distribution manager. Ms Pater has over 20 years of experience including at GE Healthcare, Datex-Omeda, Medtel and Ramsay Healthcare.
The Company also expects to receive a refund of its R&D expenditure in the first quarter of 2015.
Executive Chairman of Uscom, Dr Rob Phillips said, “These results reflect our continued focus on distribution, marketing and sales with our first half revenue almost equal to total FY 2014 revenue. Last year we increased our distributors by 15 to 27 worldwide. These distributors are now starting to return early sales and we look forward to them increasing capacity over the next 12-18 months.
We are just beginning to see take up of the BP+, and expect this increase to continue over the next 12-18 months. We continue to appoint new distributors, seek incremental business opportunities and are committed to developing strategic partnerships with distributors of scale and reach.
The quality of Uscom products is being increasingly recognised by the market and we look forward to this uptrend in sales continuing as we target profitability in the first half of calendar 2015.”
A briefing call to discuss financial results and business update will be held at 12pm. AEDT on Thursday, 26th February, 2015.
Accessing the Briefing Call via Telephone:
Please dial in five minutes prior to the start of the call and provide the pin number 3175198. Regional dial-in numbers are as follows:
- Sydney: 02 9007 4041
- Melbourne: 03 9912 0327
- Brisbane: 07 3107 0200
- Australia: toll-free 1800 556264
- International: +61 2 9007 4041
The audiocast will be archived for 30 days following the call on the Uscom website at www.uscom.com.au.
USCOM 1A - New Regulatory Registration for China
January 27th, 2015
Uscom Limited, a revenue stage, cardiovascular medical technology company, today announced to market notification by the Chinese Food and Drug Administration (CFDA) of registration of the USCOM 1A device allowing sale into China.
The USCOM 1A examination and registration was conducted by the CFDA and comes after a rigorous review and permits the continued sale of the USCOM 1A into the Chinese market.
The USCOM 1A has previously had CFDA registration, however the new registration was attained under a process involving strict examination. This resulted in the USCOM 1A being reclassified as a Class II device and the new registration being for a 5 year period rather than the prior 3 years.
Executive Chairman of Uscom, Dr Rob Phillips said “China is an important market for USCOM 1A, and the Chinese have been early users of Uscom technology, leading the way in adoption of advanced haemodynamics practices. We conduct education, training and certification courses throughout China and Chinese sales contribute a significant and growing component of our global revenue. We are now undertaking the approval process for the BP+ and look forward to this being reviewed under the new accelerated registration pathway so that our partners, China Pioneer Pharma, can activate BP+ sales.”
Uscom manufactures and markets the USCOM 1A and the Uscom BP+, both premium cardiovascular devices changing the way cardiovascular diseases are diagnosed and treated. The devices have specific application in hypertension, heart failure and sepsis, and improve the use of fluid, inotropes and vasoactive therapies.