News - 2005
SALES UPDATE - CHINA HOSPITAL ORDERS 3 USCOM MONITORS
December 20th, 2005
USCOM Ltd (ASX Code: UCM) today announced it had received commitments for the sale of 30 USCOM cardiac output monitors in the first half of the financial year commencing July 1, 2005, equalling the number of units sold for all of the 2004 financial year.
Among the most significant transactions is the purchase of 3 USCOM devices by a major hospital in China. USCOM distribution partner for the region, Hong Kong based Pacific Medical Systems, arranged the sale through the Intensive Care Department (ICU) of the Fourth Central Hospital in the northern city of Tianjin.
In Paediatrics, a priority sector for USCOM, the company is delighted to have recently secured sales to 2 strategically important paediatric sites, the Neonatal ICU at Mercy Hospital in Melbourne and the Duchess of Kent Children’s Hospital in Hong Kong, a major regional referral centre for paediatrics.
The adoption of USCOM at these prestigious sites follows the release of new data from the United States, confirming USCOM’s role in the management of sick children. A new study conducted by paediatric clinicians at the Vanderbilt Children’s Hospital in Nashville, Tennessee, one of the most prestigious children’s medical sites in the US concluded “the USCOM device proves to be a practical method of assessing cardiac status in a pediatric critical care setting.“
In the United States, USCOM’s recently appointed distribution partner for 7 States, Tri-anim Health Services Inc, has increased its order of 9 USCOM monitors to 10.
With commitments for 30 sales already in hand, the company today restated its projection of 100 + unit sales for the current financial year. The company also noted that further sales may be forthcoming prior to the close of the first half and that revenues for the first half would be running substantially ahead of the ’04 full year figure, with improvement in per-sale margins.
Commenting on the recent sales performance, the Chief Executive of USCOM, Mr Gary Davey said “We believe the company is making important progress on several fronts. Our 3 unit sale in China is significant, demonstrating the potential for multiple sales at a single clinical site. In the US, USCOM’s largest single market, the company is well positioned for substantial growth in 2006. And around the world, we are seeing extremely good results, in both science and sales, in the company’s priority field of children’s care. All of this points to an exciting year ahead.”
NEW CHILDREN’S STUDY IN U.S.
December 12th, 2005
USCOM Limited (ASX Code: UCM) ) today released significant new data, confirming USCOM’s role in the management of sick children.
A new study, titled “Clinical Utility of CW Doppler Ultrasound for Measuring Cardiac Output (USCOM)” was conducted by paediatric clinicians at the Vanderbilt Children’s Hospital in Nashville, Tennessee, one of the most prestigious children’s medical sites in the United States.
The purpose of the study was to investigate the clinical usefulness of USCOM for monitoring cardiac function in a paediatric critical care setting by evaluating intra-user variability and the time necessary to obtain measurements.
The study found a low level of intra-user variation. The study also showed the average time to acquire the first USCOM measurement on a patient was 6 minutes, while subsequent measurements took an average 1 minute 45 seconds to acquire.
The study concluded “The use of Continuous Wave Doppler ultrasound is a promising new technique for measuring cardiac output non-invasively. With low intra-user variability and an average measurement time of less than 2 minutes, the USCOM device proves to be a practical method of assessing cardiac status in a pediatric critical care setting.“
The Vanderbilt study was presented at the Pediatric Cardiac Intensive Care Society Symposium, which concluded last night in Miami, Florida.
Commenting today, the Chairman of USCOM, Mr Rob Phillips said, “Vanderbilt is one of the most respected paediatric sites in the world and we are delighted that they are achieving such outstanding results using USCOM. There is no doubt USCOM will play a critical role in the clinical management of haemodynamics in children and this data will advance the adoption of USCOM in the priority market of pediatrics.”
About Vanderbilt Children’s Hospital Vanderbilt Children‘s Hospital‘s story began in 1968 and culminated in the opening of the $172 million Monroe Carell Jr. Children’s Hospital in January 2004. With 206 inpatient beds, the hospital managed 220,000 patients in 2003. The hospital is also equipped with a 60-bed Neonatal Intensive Care Department and 12 operating rooms. Vanderbilt is a world-renowned academic medical research centre and serves as the paediatric teaching hospital for Vanderbilt University Medical School. USCOM announced in February 2005 it has signed a collaborative agreement with Vanderbilt as part of a network of paediatric sites across the United States. USCOM‘s lead collaborative partners at Vanderbilt are Dr. Kevin Churchwell, Associate Professor of Paediatrics and Anesthesiology, Vanderbilt University School of Medicine, Dr Mary Taylor, Clinical Director for Cardiac Critical Care and Dr William Heerman.
U.S. DISTRIBUTOR APPOINTED: NINE USCOM UNITS SOLD
November 24th, 2005
USCOM Limited (ASX Code: UCM) today announced the appointment of a new distribution partner for a significant part of the United States market.
The agreement, which goes into effect on December 1, includes the sale of nine USCOM non-invasive cardiac output systems.
The nation’s largest provider of specialty sales and distribution solutions for healthcare, Tri-anim Health Services, Inc. will represent USCOM in seven states for an initial period of seven months, with possible expansion of the distribution territory to the entire 50 United States. The agreement covers Michigan, Ohio, Western Pennsylvania, Kentucky, Maryland, West Virginia and the District of Columbia.
Tri-anim has a staff of over 200 sales and customer service personnel and a nationwide network of 13 distribution centres. As part of the USCOM agreement, Tri-anim is assigning nine specialty sales professionals, each to undergo custom applications training and to be equipped with an USCOM non-invasive cardiac output system for presentation to customers.
The Tri-anim partnership will be managed by USCOM’s Director of North American Operations, Mr Barry Zakar, who signed the agreement on behalf of USCOM in California today.
Commenting on the announcement, the Chief Executive of USCOM, Mr Gary Davey said, “This is an important milestone for USCOM. We are delighted that a national distribution organisation of the calibre of Tri-anim has seen the potential for USCOM in the U.S. medical system. It is significant that Tri-anim has backed that belief with a commitment of sales resources and an immediate order for nine USCOM systems. We are looking forward to an exciting launch period with Tri-anim and to deliver significant sales growth across the U.S. market.”
Tri-anim Vice President of Sales and Marketing, Mr Dale Clendon said, “This is the type of groundbreaking new technology our customers expect from Tri-anim. The USCOM 1A offers real-time beat-to-beat measurement of cardiac output non-invasively. Needless to say, we are extremely excited about the potential for this product to improve health care.”
2 NEW STUDIES IN EMERGENCY CARE
November 22nd, 2005
USCOM Limited (ASX Code: UCM) ) today released the findings of two new independent studies, demonstrating the reliability and utility of the USCOM non-invasive cardiac output monitor in emergency care.
The first study, conducted by emergency physicians in Hong Kong, found that emergency physicians can be trained to obtain reliable cardiac output measurements over the course of 15 patient assessments after just one hour of training. The study also tested for possible variations between measurements taken by different operators. With blinded measurements across 44 different patients, the study demonstrated excellent inter-assessor correlation.
The study was conducted at the Trauma & Emergency Centre of the Prince of Wales Hospital in Hong Kong in association with the Accident & Emergency Medicine Academic Unit at the Chinese University of Hong Kong.
The second study was conducted at the Department of Anaesthetics and Critical Care, Broken Hill Base Hospital where 250 volunteer patients were studied to establish normal haemodynamic variables and cardiac output.
The study states that the advent of a highly accurate yet entirely non-invasive monitor such as USCOM has allowed for the possibility of rapid (less than 10 minutes) determination of CO in emergency department patients. The derived data could then be used for optimising early goal directed therapy and normalising haemodynamics
The study also examined the role of Aortic Minute Distance (AMD) measurement as a tool for Early Goal Directed Therapy. The study states, “The ease and speed at which AMD can be measured using the USCOM, typically within 15 seconds, allows for the rapid evaluation of haemodynamics with a high degree of certainty.”
“Early goal directed therapy can then be initiated when indicated, and optimised by either repeated measurements of AMD at clinically appropriate intervals, or by formal cardiac output determination using the full features of the USCOM.”
The two studies were presented at the Scientific Session of the Hong Kong College of Emergency Medicine Conference.
The Chief Executive of USCOM, Mr Gary Davey said, “These two studies provide strong support for the reliability and usefulness of the USCOM system in emergency care. We are delighted to have further evidence to reinforce USCOM’s role as an important tool for haemodynamic management and the application of Early Goal Directed Therapy.”
USCOM PROVEN IN BABIES STUDY
October 24th, 2005
USCOM Limited (ASX Code: UCM) today released new scientific evidence, supporting USCOM’s role in the management of sick children.
A new study, conducted at the Royal Prince Alfred Hospital in Sydney, was presented today at the Australia & New Zealand Intensive Care Society Conference in Adelaide.
The study was designed to test the accuracy of the USCOM method of measuring blood flow through the hearts of pre-term neonates, ranging in size from 3.1 kilograms down to just 390 grams, with cardiac outputs from 0.12 to 1.61 Litres Per Minute.
Using the established Echocardiographic method (2D imaging and Doppler) for comparison, the study found no significant difference between the Echo and USCOM measurements, with a mean error between measurements of -3.7%. Importantly, the study also concluded that the USCOM method may be more sensitive to haemodynamic changes in neonates than traditional Echocardiography and so be more useful for haemodynamic management.
The results, combined with previous validation studies (Knobloch K, et al. Annals of Thoracic Surgery 2005;80:1479-84), confirm that USCOM is now validated in patients from the age of 81 years down to 26 week gestational age neonates and in outputs ranging from 17 down to 0.121 Litres Per Minute. This wide range of validation is unique among haemodynamic monitoring methods, and is important because USCOM is totally non-invasive.
Commenting on the study today, the Chief Executive of USCOM Limited, Mr Gary Davey said, “We are excited by the findings of the RPA study. This now proves USCOM’s accuracy in even the tiniest of babies through to the most elderly in our community and confirms that our non-invasive and accurate technology will have a significant role in improving clinical management, particularly in children. Being simpler to use, significantly less expensive and possibly more sensitive for haemodynamic management than traditional Echo, USCOM anticipates widespread adoption in the neonatal and paediatric fields.”
NEW USCOM EVIDENCE: MEASURES CHANGE BETTER THAN PAC
October 21st, 2005
USCOM Limited (ASX Code: UCM) today announced the release of an important new study, demonstrating the accuracy of the USCOM system in measuring haemodynamics in comparison to the current clinical and research “gold standards”.
The new study, conducted at the Howard Florey Institute in Melbourne, was presented today at the Australia & New Zealand Intensive Care Society conference in Adelaide.
The study conducted a direct 3-way comparison between USCOM, surgically implanted Flow Probes and the clinical “gold standard” method of the Pulmonary Artery Catheter (PAC). More than 800 measurements were taken from a series of sheep subjects at the Howard Florey medical research centre
The study found extremely close agreement between USCOM and the highly sensitive Flow Probe method with a mean error of 5.5%. However, the mean error between Flow Probe and the Catheter was a clinically significant 20.4%.
In addition, the study assessed the ability of the 3 methods to measure changes in haemodynamics, altered by the induction of dobutamine, commonly used in the treatment of heart failure, to increase cardiac function. USCOM and the Flow Probe showed extremely close agreement, measuring changes of 22% for USCOM and 21% for the Flow Probe. PAC, on the other hand, measured change of just 9%. The study concluded that the findings have significant ramifications for future clinical practice and medical research.
These findings support recent papers published in the Journal of the American Medical Association (JAMA) which concluded there was no evidence to support the routine use of PAC to adjust therapy in heart failure (Report on the ESCAPE Trial, JAMA 2005;294:1625). USCOM’s case as a potential replacement for PAC was supported in the conclusion to the report which stated, “future trials should test non-invasive assessments…” to improve patient management.
USCOM is unique in the field of cardiac output monitoring by being completely non-invasive, well validated across a wide range of cardiac outputs and by being soundly patent protected.
Commenting on the study today, the Chief Executive of USCOM, Mr Gary Davey said, “This is compelling evidence that USCOM is more accurate than the PAC, not just in measuring cardiac output levels, but more importantly in tracking changes brought about by therapy. This is an extremely significant finding, given last week’s publication of important new evidence in the United States challenging the safety and usefulness of the PAC and advocating the exploration of non-invasive methods. Also in October, a study published in the prestigious Annals of Thoracic Surgery concluded that USCOM was an accurate and viable alternative to the PAC. We are delighted to be in the non-invasive sector of medical practice and look forward to seeing this research guide the changes in medical practice required to advance the adoption of USCOM and improve patient management.”
SALES UPDATE AT AGM: 20 units by end October
October 20th, 2005
USCOM Limited (ASX Code: UCM) today provided investors with a progress report on sales, with a cumulative 20 unit orders expected by the end of October, for this financial year to date.
The update was provided at USCOM’s Annual General Meeting, held this morning at the offices of USCOM’s Audit firm, PKF.
In his Chief Executive’s report to shareholders, CEO, Gary Davey said the company had received 11 unit orders during the first quarter, a cumulative 14 unit orders had been advised up to today, and a further 6 are anticipated by the end of the month.
Mr Davey said, “The company is pleased with progress to date, having taken orders from each of our priority markets. USCOM’s customer pipeline continues to build and we anticipate steady growth in sales through the rest of the year. With 20 unit sales by the end of October, we will reach two-thirds of last year’s full-year unit sales figure. This keeps the company firmly on track to meet its full year objective of 100+ unit orders. We are reconfirming this target today.”
In his presentation to the meeting, the Chairman of USCOM Mr Rob Phillips summarised the company’s position by saying, “USCOM is meeting its milestones and has made enormous progress in science and technology in the past year. We have a great product, with a long selling cycle. The challenge and frustration is the time it takes to convert product enthusiasm into sales and revenue. As a result, we believe time is our only enemy. We are committed to delivering 100+ unit sales for this financial year. We can assure our investors that the company has adequate cash and other resources. And as a management team, we remain more convinced than ever that USCOM has an important role to play in global medical practice and we look forward to the opportunities of the year ahead.”
At the AGM, shareholders voted to adopt all resolutions as presented. This included the re-adoption of the Financial Report and the Remuneration Report, as well as the re-election of two USCOM directors, Mr Roman Zwolenski and Dr Fred Berry.
NEW EVIDENCE AGAINST INVASIVE METHOD
October 13th, 2005
Significant new studies have been released in the United States, further challenging the current “gold standard” for the measurement of Cardiac Output.
The October edition of the prestigious Journal of the American Medical Association has presented 2 substantial new studies questioning the usefulness of the Pulmonary Artery Catheter (PAC) and in an editorial, calls for a review of practice associated with its use.
USCOM Limited (ASX Code: UCM) manufactures and distributes a completely non-invasive alternative to the PAC.
The first of the two US studies, The ESCAPE trial, was prematurely halted when the National Heart, Lung, and Blood Institute data safety monitoring board cited concerns about excess adverse events. The authors of the study stated, “Based on ESCAPE, there is no indication for routine use of pulmonary artery catheterization to adjust therapy during hospitalization for decompensation of long-term heart failure.”
The study found that the use of PAC significantly increased in-hospital adverse events; 47 versus 25 (P=0.04), and did not increase survival, improve exercise tolerance, or improve quality of life. The study concluded that the PAC does more harm than good when used in patients who are hospitalized for severe congestive heart failure. Additionally the Authors felt that “Future trials should test non-invasive assessments with specific treatment strategies. To better tailor therapy for both survival time and survival quality”
In an editorial accompanying the two new studies, Dr Jesse B. Hall, M.D. of the University of Chicago wrote that the data “collected to date certainly do not support the routine use of the catheter in any patient group, and the currently available information could be viewed as justifying ‘pulling the pulmonary artery catheter’ from routine use, a suggestion made almost 10 years ago.”
This publication comes in the same month that an USCOM trial was published in another important US journal, the Annals of Thoracic Surgery, concluding that “Using USCOM, it is possible to determine non-invasive CO in post cardiac surgical patients without the possible complications of PAC.”
In the second JAMA study, a meta-analysis of 13 randomised clinical trials using the PAC, found that routine use “neither improves outcomes in critically ill patients nor increases mortality or days in the hospital.” The take home point, according to Dr. Shah and colleagues, is that pulmonary artery catheterization “should not be used for the routine treatment of patients in the ICU, patients with decompensated heart failure, or patients undergoing surgery.”
Commenting on the JAMA publications, the Chairman of USCOM Limited, Mr Rob Phillips said, “This is a very important global health issue and these publications certainly endorse the USCOM position that non-invasive CO assessment is the goal. We have always believed in non-invasive care. Our current collaborative research is exciting with preliminary results confirming that USCOM is a more accurate and sensitive measure of haemodynamics than the PAC and is non-invasive. In combination with the JAMA publications, this has important ramifications for future clinical practice and supports the adoption of USCOM as a global standard of care.”
NEW USCOM STUDY PUBLISHED IN SURGERY JOURNAL
October 4th, 2005
USCOM Limited (ASX Code: UCM) announced today the publication of significant new research in one of the world’s most prestigious medical journals.
The new study, comparing the noninvasive USCOM cardiac output monitor with the current invasive method among heart surgery patients, was published this week in the US-based Annals of Thoracic Surgery.
The study, conducted among 36 open heart surgery patients, proved the accuracy and reliability of the USCOM system in measuring Cardiac Output (CO) non-invasively, without the risk of invasive catheters.
In the case of 6 patients, measurements were taken with the USCOM transducer placed directly on the pulmonary artery during open heart surgery. The CO measurements were identical to those measured by the Pulmonary Artery Catheter (PAC) method.
The study concluded, “Using the USCOM system it is feasible to determine beat-to-beat CO in critically ill patients in the cardiac intensive care unit, non-invasively. These measurements demonstrate a high correlation to invasively determined CO, CVS percentage, and SV by a Swan-Ganz PAC, without the possible complications associated with invasive right heart catheterization. The device provides instantaneous results and is portable, with applications in the intensive care unit, emergency department, and operating room preoperatively and perioperatively.”
In an invited commentary to the paper by 2 senior clinicians from the Cleveland Clinic Foundation, it was stated, “This study does suggest the potential value of this innovative technology to assist in the perioperative management of the cardiac surgery patient.”
The paper, titled “Non-Invasivre Cardiac Output Determination by Two-Dimensional Independent Doppler During and After Cardiac Surgery” was authored by Dr Karsten Knobloch from the Department of Trauma Surgery at the Hannover University Medical School, in Hannover Germany.
Dr Knobloch stated, “These findings confirm the reliability of the USCOM device and suggest that it may have multiple clinical applications in which the immediate and non-invasive assessment of CO is important. Clinical adoption of this method may reduce the need for invasive procedures such as PAC and left ventricular angiography, and may improve care by providing hemodynamic data on patients not suitable for invasive monitoring.”
“Applications for this novel device may include the intensive care unit as well as intermediate or regular care units to immediately assess the hemodynamic status of a critically ill, unstable patient. Furthermore, the USCOM system may be of special value in the operating room preoperatively, perioperatively and postoperatively in the hands of anaesthesiologists in which hemodynamic management may be critical. Additional use may be applicable in the transplantation ambulance to assess transthoracic CO non-invasively, allowing early hemodynamic optimization.”
“Non-invasive Doppler determination of CO using the USCOM device is easy to achieve by both medical and nursing staff, and it provides real-time assessment of CO.”
“Results correlate highly with invasive methods of CO determination, as this study demonstrates. In addition, the USCOM system is lightweight and portable, so it can be used in serial hemodynamic determinations in the emergency department, the intensive care unit, and even in the operating room prior to and during procedures. As a non-invasive method that does not require calibration, additional measurements for optimizing hemodynamic interventions can be acquired at no patient risk cost. These repeated measurements also result in significant improvements in measurement sensitivity.”
“The USCOM device can measure hemodynamics from both the right and left heart, and a number of acoustic accesses, allowing for versatility in the surgical environment where access may be restricted by dressings and leads. The device is simple to understand and operate, so reliable results should be attainable in general clinical practice, and these may improve with increased use, such as with other ultrasound modalities.”
USCOM PROVEN IN U.S. EMERGENCY STUDY
September 28th, 2005
USCOM Limited (ASX Code: UCM) today announced the presentation of significant new research demonstrating the application of USCOM in emergency medicine.
The study, conducted at the Loma Linda University Medical Centre in California, was presented yesterday at the Scientific Assembly of the American College of Emergency Physicians in Washington DC, the world’s largest and most prestigious emergency medicine conference.
The study was designed to test the reliability and reproducibility of the USCOM cardiac output monitor in a busy ER setting, among a wide range of operators, including nurses, students, physicians and paramedics.
The abstract objectives stated, “The ultrasound cardiac output monitor (USCOM Ltd, Australia) has been shown to be a potential non-invasive alternative to the pulmonary artery catheter as a hemodynamic monitoring tool.”
Blinded measurements of Cardiac Index and Stroke Volume Index were taken from 104 emergency department patients by 44 different operators, achieving good agreement between pairs of operators.
The paper concludes by saying, “The USCOM is a feasible non-invasive hemodynamic monitoring device in the ED with acceptable inter-rater agreement when utilized by ED personnel involved in patient care.”
One of the co-authors of the paper is Dr Bryant Nguyen, a leading authority in emergency care management and the second co-author of the influential “Rivers” paper, a ground breaking study demonstrating the advantages of Early Goal Directed Therapy in the management of emergency patients.
The Chief Executive of USCOM, Mr Gary Davey said, “This is a significant result for USCOM. It shows that every staff member of an emergency department can reliably use the USCOM machine to non-invasively measure vital heart function information. We are especially excited to see such outstanding results from a prestigious site such as Loma Linda.”
NORTH AMERICA LAUNCH FOR USCOM
September 27th, 2005
The Australian medical devices maker, USCOM Limited (ASX code: UCM), today announced the North American launch of its non-invasive cardiac output monitor.
USCOM staged its product launch for the new device at the American College of Emergency Physicians (ACEP) Scientific Assembly being held in Washington DC September 26 to 29.
The Chief Executive of USCOM, Mr Gary Davey said, “After many years of fine-tuning the USCOM technology and applications, we are very excited to reach the commercial release of the product in the United States market. The ACEP Assembly is the biggest and most prestigious gathering of emergency medicine professionals in the world, the perfect time and place to unveil this important new product. Having secured FDA regulatory clearance in February, and our first customer sale in July, the company’s US plan is off to a promising start.”
As part of its launch program, USCOM is a sponsor and exhibitor at the ACEP conference, presenting live demonstrations of its cardiac output technology.
USCOM was the subject of an ACEP Satellite Symposium last night (Sunday, September 25), presented by the Temple University School of Medicine.
Titled, “Hemodynamic Assessment in the Emergency Department. Tools and Information for Clinical Decision Making”, the symposium is to be opened by Dr Robert Bilkovski MD, Senior Staff Physician at the Emergency Department, Henry Ford Hospital, Detroit. Henry Ford is the home of the ground-breaking Rivers study which showed a 30% improvement in mortality rates through the implementation of Early Goal Directed Therapy in Emergency Care.
Other speakers at the Satellite Symposium were:
H. Bryant Nguyen, MD, MS, Assistant Professor, Department of Emergency Medicine, Loma Linda University, Loma Linda, CA. Nathan Shapiro, MD, MPH, Research Director, Department of Emergency Medicine Staff Physician, Department of Emergency Medicine, Beth Israel Deaconess Hospital, Boston, MA. Wayne Satz, MD, Clinical Associate Professor Clinical Director of Emergency Medicine, Temple University School of Medicine, Philadelphia, PA.
The Overview to the Symposium stated: “The need for hemodynamic assessment of patients in the Emergency Department is well acknowledged especially with the increased interest in Early Goal Directed Therapy (EGDT) for sepsis patients. However, widespread use of existing technologies and integration of the hemodynamic information gained from their use remains elusive in everyday practice. This program will provide an update to emergency physicians on currently available tools for hemodynamic monitoring and use of this information for decision making in Emergency Departments and transport patients.”
The symposium has been supported by an unrestricted educational grant from USCOM.
USCOM Releases Annual Report
September 19th, 2005
USCOM Limited (ASX Code: UCM) today released its annual report for the year ending June 30, 2005.
Printed copies of the annual report and a formal notice of the Annual General Meeting are being delivered by mail to all shareholders during the week commencing Monday, September 19. Interested parties are invited to download these documents from this website.
The company’s Annual General Meeting will be held at :
PKF Chartered Accountants & Business Advisers
Level 10, 1 Margaret Street , Sydney NSW 2000
Thursday, 20 October 2005
5 UNIT SALES IN CHINA
August 24th, 2005
New distributor for Beijing
USCOM Limited (ASX Code: UCM) reported today the sale of a further 5 USCOM cardiac output monitors, with the appointment of a new distributor for an important region of Northern China.
Two of the 5 USCOM units have already been sold to major hospital sites in the city of Tianjin.
The new distributor, Far-East Deer Medical Instruments, based in Beijing, was appointed by Pacific Medical Systems, USCOM’s Hong Kong based distribution partner for North Asia.
Commenting on the sales today, the Chief Executive of USCOM, Mr Gary Davey said, “We are delighted to have a high quality and experienced partner representing our company in Northern China. It is particularly exciting that our new partner in Beijing has already on-sold two USCOM machines to hospitals in the region. China will be an exciting market for USCOM in this financial year.”
FY’05 Year End Result
August 18th, 2005
Revenue up 25% – Targeting 100+ unit sales for FY’06
USCOM Ltd (ASX Code: UCM) today presented the preliminary financial report for the financial year ending 30 June 2005.
It has been another year of tremendous progress in the company’s mission to confirm the USCOM non-invasive cardiac monitor as a standard tool of medical practice. The company has grown significantly during FY ‘05. Our staff numbers increased from 14 to 23, with 8 of the new personnel dedicated to sales and marketing in Australia, Europe and North America. With almost 60 units sold worldwide since inception, we know there is demand for our product. However, USCOM represents a significant change to current medical practice. Although this brings challenges and frustrations in the selling process, it also highlights the true scale of our opportunity.
Financial Performance The company ended the financial year with $606,548 in cash receipts from customers. Having secured the sale of 30 USCOM units, revenues were up 25% on last year. With net operating cash outflow for the year of $2.6 million, USCOM Ltd had $10.5 million cash in hand at the end of June. The company has continued to carefully manage its cash resources, while at the same time, accelerating sales and marketing activity in all our priority territories.
Revenue from sales – $480,107
Grants – $150,000
Interest – $637,411
Other – $1,568
Total Revenue – $1,269,086
Total Costs = $3,815,004
Profit / (Loss) ($2,545,918)
Cash receipts from customers – $606,548
Net operating cash outflow – $2,588,370
Cash in hand at 30 June – $10,545,218
Key Milestones The company has achieved many important milestones for the year ending 30 June 2005. Among the highlights of the year was the delivery of regulatory clearance allowing sales to commence in the United States. The company received its regulatory clearance (510K) from the Food & Drug Administration in February 2005 and we are delighted to report that our first US customer sale was secured in July 2005.
Outlook for FY 06 We are off to an encouraging start having already secured end user sales in the US and Europe this financial year and we are pleased to state a clear objective for the year of achieving in excess of 100 sales.
NEW PRODUCT FOR 2006
August 12th, 2005
USCOM Ltd (ASX Code: UCM) today unveiled its second major product, for commercial release in 2006.
The new product, the OXYCOM™ monitor, will add oximetry to USCOM’s proven method of non-invasive cardiac output, providing clinicians with a real-time measure of oxygen delivery. This is a strategically important milestone for USCOM. The OXYCOM™ monitor is in addition to the existing USCOM 1A cardiac output monitor, as the second release from USCOM’s product development pipeline.
The patent supporting this ground-breaking new device was published today in Washington by the U.S. Patent Attorney’s Office.
OXYCOM™ is the novel combination of high resolution cardiac output flow measurements, using the patented USCOM method, and non-invasive oximetry. This combination provides real time non-invasive beat to beat measures of the volume of blood delivered by the heart and the oxygen concentration carried by the blood, and effectively measures tissue perfusion or oxygen delivery.
The OXYCOM™ patent will provide the platform for a new generation of USCOM devices designed to take haemodynamic management to an exciting new level by allowing management to be guided by real time oxygen delivery. The OXYCOM™ device will establish USCOM Ltd firmly as the global leader in innovation and development of practice changing haemodynamic devices.
Commenting on the announcement today, the Chairman of USCOM, Mr Rob Phillips said “Accurate measurement of CO is a very powerful clinical tool; combining this with oxygen saturation in an entirely non-invasive device will dramatically influence the way patients can be managed. This is an incredibly exciting development for USCOM and creates enormous opportunity in the cardiovascular market place.”
The OXYCOM™ patent was lodged in May 2003, and the company anticipates the patent will be granted within 6 to 12 months from today’s publication date. Publication of the patent will be used as the impetus to accelerate the current R&D plan and deliver the OXYCOM™ product to market.
NEW E.R. SALE IN EUROPE
August 5th, 2005
USCOM Limited (ASX Code: UCM) today announced another strategically important sale of its non-invasive cardiac output monitor, to a leading Emergency Care site in Europe.
The latest sale, confirmed today, is to the University Hospital of Basel, Switzerland. The USCOM monitor will be primarily used in the hospital Emergency Department, but will also be deployed in the Intensive Care Unit and general wards.
This is the second sale of an USCOM device to a major Swiss teaching hospital. In April 2005, the company announced a sale to the Department of Neonatology at the University Hospital of Zurich, an important European centre for Paediatric and Neonatal medicine.
Commenting on the sale today, the Chief Executive of USCOM, Mr Gary Davey said, “Emergency Care is USCOM’s highest priority sector and we are delighted to be gaining traction among leading European emergency care centres of excellence. In addition, the University Hospital of Basel has identified a role for USCOM outside the Emergency department, with application in both the ICU and general wards. This will be an important European showcase for USCOM.”
As an accurate and non-invasive method of measuring cardiac output, USCOM fills an important role in the ER, especially in the implementation of Early Goal Directed Therapy. USCOM is a reliable method for haemodynamic optimisation, accurately guiding clinicians in customising therapy, including fluid levels and drug dosage.
TRAINING & EDUCATION PLAN
August 4th, 2005
USCOM Limited (ASX Code: UCM) ) today announced details of its coordinated programme for user training and education.
USCOM has completed a custom training curriculum, supported by education materials in printed and digital form to efficiently assist users achieve high levels of operational competence with all the sophisticated features of the USCOM device. As part of the programme, the company has also established a relationship with the Australian Institute of Ultrasound (AIU) for external education and accreditation of USCOM users. This provides for independent recognition of USCOM operational competence and is an important development for adoption and effective use of the USCOM device in clinical practice.
In addition, USCOM is working with the AIU to develop an on-line version of the training programme, so that people in remote locations can receive expert tuition in USCOM via the internet.
Although the USCOM device has been designed for simple and intuitive operation by clinicians, optimal use and the pace of global adoption will be impacted by clear and efficient delivery of an understanding of the science and advanced applications of the USCOM. These education materials and the relationship with the AIU create the infrastructure to deliver this support worldwide.
Commenting on the sales programme, the Chairman of USCOM, Mr Rob Phillips said, “Teaching people to become expert USCOM users is a key part of our sales mission. We are very proud of our science and are committed to continuing education, and these developments are tangible evidence of this commitment. We are delighted to be partnering with the Australian Institute of Ultrasound with its recognised credentials as a quality provider of ultrasound education. With any novel product, education is a critical part of the pathway to universal adoption, and as the USCOM product platform expands this will become even more important to the company.”
NEW HEART MEASURE FOR USCOM
July 28th, 2005
USCOM Ltd (ASX Code: UCM) today announced the release of an important new advancement to its non-invasive cardiac output monitor.
The latest version of USCOM operating system software includes an innovative method for real-time calculation of beat-to-beat Systemic Vascular Resistance (SVR), a cardiovascular measure relating to cardiac output and blood pressure.
SVR is now available as a standard parameter of the USCOM system.
The new SVR function was demonstrated for the first time at the USCOMTWO company conference in Coffs Harbour where visiting collaborative luminaries from around the world, including The Henry Ford Hospital in Detroit, the Great Ormond Street Hospital in London and Hannover University Hospital in Germany were gathered to discuss recent research and clinical experiences with the USCOM device.
Commenting on the new system, the Chairman of USCOM, Mr Rob Phillips said, “This is the first non-invasive device to provide real time instantaneous SVR readouts from a true ventriculo-arterial output, and represents a significant leap in the technology available for haemodynamic management. We are very proud of what our engineers have created and look forward to the device impacting on clinical practice, particularly in the field of emergency medicine.”
The new feature is the product of over 12 months of research and development by the USCOM engineering team and confirms the innovative USCOM culture and commitment to continuing development of practice leading technology.
The new SVR function is now being distributed to existing customers at no additional charge, as part of software upgrade 1.5.
The addition of SVR to the USCOM system dramatically improves the clinicians ability to understand the haemodynemic triad of preload, cardiac output and afterload, allowing for beat-to-beat assessment of patient condition and response to therapy. Real time readouts of the numbers physicians need to optimise haemodynamics will help to improve management and outcomes.
The new USCOM system is the platform for a worldwide marketing campaign to accelerate the adoption of the USCOM device and will feature at the USCOM satellite symposium of the American Society of Emergency Physicians in Washington on September the 25th, being moderated by Dr Emanuel Rivers of the Henry Ford Hospital in Detroit, a world leader in the practice of haemodynamic optimisation. USCOM announced its first US sale on July 27, with the receipt of an order from the Regional Heathcare System for Orlando Florida.
USCOM REPORTS FIRST U.S. SALE
July 27th, 2005
USCOM Ltd (ASX Code: UCM) today reported the first sale of its non-invasive cardiac output monitor to a clinical site in the United States.
The order was placed by Dr Edgar Jimenez, MD, Director of the Medical Intensive Care Unit at the Orlando Regional Medical Centre, a part of the Regional Health System of Orlando, Florida.
The Orlando Regional Healthcare System is a network of 8 hospitals, serving the central Florida region, and providing almost 1,600 hospital beds.
Commenting on the sale today, the Chief Executive of USCOM, Mr Gary Davey said, “This is an extremely important milestone for USCOM. The United States is USCOM’s single biggest market. This sale marks the beginning of what we believe will be an extremely active year ahead for us across the US. It demonstrates there is a real clinical demand for the USCOM method.”
USCOM secured the necessary regulatory clearance for the US market in Febuary this year, with the receipt of a 510K notification from the US Food and Drug Administration (FDA).
As part of its campaign to accelerate the adoption of the USCOM device, the company is hosting a satellite symposium at the American Society of Emergency Physicians in Washington on September the 25th. The special seminar will include presentations from 5 luminary US clinicians and will be moderated by Dr Emanuel Rivers of the Henry Ford Hospital in Detroit, a world leader in the practice of haemodynamic optimisation.
YEAR END: REVENUES UP 25%
July 1st, 2005
USCOM Ltd (ASX Code: UCM) today released preliminary results for the financial year ending June 30, 2005, showing a 25% year-on-year increase in revenue from product sales.
The company recorded 30 sales of its non-invasive cardiac output monitor, generating revenue of $479,847.
Notably, average per unit revenue increased by 50% in the second half of the year, reflecting an increased proportion of sales to end users against sales to dealers and distributors.
Commenting on the result, the Chief Executive of USCOM, Mr Gary Davey said, “The past financial year has been an incredibly busy one for USCOM and this revenue result is only part of the picture. Accomplishments include regulatory approval in the USA and Japan, a significant product software release, the setting up of luminary research agreements with key clinicians and the recruitment of key staff in the USA, Europe and Australia. We now have the structure in place to move into this new financial year and leverage off the solid gains that have been made to date.“
USCOM is encouraged by the results that we are seeing in our distribution network. These distributors have invested a lot in USCOM and believe that they are now well positioned to see a return on that investment.
Mr Davey added, “We have been pleasantly surprised by the early traction obtained by our direct sales force in Australia, having secured 3 new Australia sales in the last quarter alone. With some early conversions and real progress on several opportunities we have high expectations for the team over the coming period.”
NOTE: The above is a preliminary statement only and is yet to be audited.
ANNOUNCEMENTS SCHEDULE: July 20: Quarterly Cash Statement (Appendix 4C)
August 18: FY 04 Audited results
September 20: Release of Annual Report
October 20: Annual General Meeting
USCOM WELCOMES UK SURGERY STUDY
June 30th, 2005
USCOM Ltd (ASX Code: UCM) today welcomed the release of an important new study in London recommending a new approach to the management of patients under-going surgery.
The report, titled “Modernising Care For Patients Undergoing Major Surgery” has been published by the Improving Surgical Outcomes Group (ISOG), a pre-eminent group of U.K. surgeons, anaesthetists and intensivists.
In welcoming the release of the report today, USCOM Limited believes this study, although based in the UK, has implications for the evolution of patient management worldwide. The study clearly supports the core proposition that non-invasive technologies such as USCOM have an important and critical role to play in the improved management of patients in the pre-surgical, intra-operative and post-operative clinical environments. Commenting on the report today, the Chairman of USCOM, Mr Rob Phillips, said “This paper provides important support for the adoption of USCOM in UK health, and supports USCOM’s belief that we will become an essential and widespread tool for haemodynamic management.” The Group identified haemodynamic optimisation as a means of decreasing the rate and severity of post-operative complications and recommended increased spending on technology to improve patient outcomes and save money. This proposition is supported by an abundance of recent U.K and international publications suggesting haemodynamic optimisation in a variety of clinical applications significantly improves patient outcomes and decreases hospital costs.While these studies all used invasive methods for optimisation, USCOM is unique in providing this information non-invasively and allowing for application of haemodynamic optimisation beyond the operating room.
USCOM has spent nearly three years in validation, proving its accuracy for non-invasive and reliable assessment of haemodynamics, while other methods remain either invasive or of uncertain reliability. USCOM, already validated in adults, has just completed studies validating the device in neonates of weights down to 380gms.
The principal recommendation of ISOG was to implement new standards of care that incorporate improved pre-operative assessment, preparation and triage, intra-operative care, and improved use of post-operative resources. As a validated non invasive haemodynamic measurement method, USCOM is ideally suited to contribute to this drive to improve UK patient outcomes.
Sales Update: 3 NEW ORDERS FOR AUSTRALIA
June 23rd, 2005
USCOM Ltd (ASX Code: UCM) today announced three new Australian orders for its non-invasive cardiac output monitor, further demonstrating the role of USCOM in regional health care.
USCOM system orders have been received from the Toowoomba Base Hospital in Southern Queensland, a general practice in Coffs Harbour, New South Wales and a private anaesthetics practice in Ballarat, Victoria.
The three sales were concluded by USCOM’s recently appointed direct sales force in Australia.
Commenting on the sales today, the Chief Executive of USCOM, Mr Gary Davey said, “We are excited about the potential for USCOM in regional health care, where facilities and personnel are in limited supply. We expect significant growth in sales across regional Australia, as well as in the capital city hospitals. We are also delighted that our direct sales force, appointed in mid May, has been able to achieve such early traction.”
USCOM has also made significant progress in sales activity across all its priority markets and is scheduled to release a full year summary of sales results in the first week of July.
NEW DISTRIBUTORS FOR USCOM
May 20th, 2005
USCOM Limited (ASX Code: UCM) today announced the appointment of new distribution representatives for the markets of Israel, the Netherlands and South Africa.
In Israel, USCOM has appointed Amos Gazit Ltd, one of Israel’s leading distributors of medical equipment. The Tel Aviv based company was founded in 1958 and represents a wide range of capital equipment items for emergency, intensive care and anaesthesia.
In the Netherlands, USCOM has signed a distribution agreement with Innomed, an Amsterdam based distributor with extensive experience in selling to the emergency care and paediatrics sectors.
In South Africa, USCOM has appointed BEM Medical, focused on the marketing of medical products into South Africa’s private and provincial hospitals. Mr Bheki Gumede, the Managing Director of BEM Medical, is an executive committee member and vice chair-person of the South African Medical Device Industry Association.
Commenting on the appointments today, the Chief Executive of USCOM, Mr Gary Davey said, “Each of these markets represent real sales potential for USCOM and we are excited to be working with our new partners, each with special skills and experience in precisely our target markets.”
SENIOR SALES & MARKETING APPOINTMENTS
May 19th, 2005
USCOM Limited (ASX Code: UCM) today announced a number of senior appointments in sales and marketing, including a head of sales operations for the UK and European markets.
The company has appointed Ms Ali Hughes-Jones to lead the company’s selling effort across Europe, including the supervision of USCOM’s European network of distribution partners.
Ms Hughes-Jones, a qualified radiographer, has 13 years experience in the marketing of medical devices to the critical care market in Europe. Most recently, Ms Hughes-Jones was a senior executive with Deltex Medical, a UK-based company which specialises in Doppler ultrasound methods for the measurement of cardiac output. At Deltex, Ms Hughes-Jones held the positions of UK Sales Manager and Director of Clinical Development.
Commenting on the appointment today, the Chief Executive of USCOM, Mr Gary Davey said, “The appointment of Ali Hughes-Jones is an important strategic step for USCOM, demonstrating our determination to aggressively pursue business in the UK and European markets. Ali has unique experience in the field of Doppler cardiac output and we are delighted that she is joining USCOM to advance our sales efforts in Europe.”
In addition, USCOM announced today that Michelle Meurs, one of the company’s most senior Marketing Executives is to relocate to the UK for a period of 4 months to provide support to the USCOM distribution network across Europe.
In Australia, USCOM also announced today the appointment of four new sales executives, as part of the company’s transition to a direct sales model for the Australian market.
- In Melbourne, the company has appointed Mr Peter Halaseh MBA, BSc, a 17-year veteran of hospital products sales, with responsibilities for Victoria.
- In Brisbane, Mr Chris Aitken, a qualified intensive care nurse and highly experienced in medical equipment sales, joins the company with responsibility for Queensland.
- In Sydney, Mr Mark Thomas, highly successful in sales across multiple hospital departments, takes responsibility for the New South Wales region.
- And the company has engaged Adelaide-based Ms Jayne Graves BSc, with 15 years experience in cardiac ultrasound, to provide applications support for the company’s sales effort in South Australia
The Australian appointments follow USCOM’s April 14 announcement of a reorganisation of the company’s sales and marketing structure for the Australasian market, with a focus on direct selling.
The new personnel report to the Chief Executive, Mr Gary Davey, with support from the company’s consultant Sales Coordinator, Mr Das Menon.
Mr Davey said, “We are delighted with the calibre of new people we have attracted to the company. Each brings valuable experience in the marketing of medical devices to the Australian hospital market. This is the beginning of an exciting new era for the company.”
RESPONSE TO ASX PRICE QUERY
May 18th, 2005
USCOM Limited (ASX Code: UCM) today issued a statement to the Australian Stock Exchange in response to a Price Query from the ASX dated May 17.
In the company’s response, USCOM stated the company was not aware of any information concerning it that has not been announced which, if known, could be an explanation for the recent trading in the securities of the company. A copy of USCOM’s written response to the ASX is attached.
PROGRESS IN PAEDIATRICS SECTOR
April 14th, 2005
USCOM Limited (ASX Code: UCM) announced today a significant sale of an USCOM cardiac output monitor, confirming the company’s progress in the priority sector of Paediatrics and Neonatology
USCOM’s most recent sale was confirmed this week at one of Europe’s most respected sites for the management of sick children. The USCOM monitor was purchased by the Department of Neonatology at the University Hospital of Zurich, an important European centre for Paediatric and Neonatal medicine.
The company is seeing very positive response from Paediatric and Neonatal clinicians in Asia, Europe and the United States. The company expects this sector to be an important part of our business going forward.
USCOM secured its first international paediatrics sale in September 2004, with the installation of an USCOM monitor at the world renowned Great Ormond Street Hospital in London. In the United States, USCOM has signed collaborative agreements with 2 of the top US paediatrics centres of excellence.
AUSTRALIA SALES REORGANISATION
April 14th, 2005
USCOM Limited (ASX Code: UCM) announced today a reorganisation of its sales and marketing structure for the Australasian market.
The company is appointing 4 full time sales executives in Sydney, Brisbane and Melbourne as well as part-time representation in Adelaide and Perth, with the first of the new recruits commencing work in May. The new sales executives will report to the Chief Executive of USCOM, Mr Gary Davey.
USCOM has also engaged Mr Das Menon, a 25-year veteran of the medical equipment industry, as a consultant Sales Coordinator to assist in the establishment of USCOM’s direct sales force. The addition of a direct sales team is to supplement the activities of USCOM’s Australasian distribution agent, Coefficient Systems.
Commenting on the announcement today, Mr Davey said, “We have carefully timed the addition of our direct sales force. We are beginning to see real traction in the Australian medical market, especially in regional health care and we are now ready to step up the selling process. . The scale of the Australian market, taking into account both the capital city and rural hospitals, certainly justifies the allocation of direct sales resources. Coefficient Systems, having assisted us in the early stages of development, will continue as a sales and marketing partner under the terms of our existing agreement.”
NEW ACCURACY STUDY RELEASED
March 29th, 2005
USCOM Ltd (ASX Code: UCM) today released the findings of an important new study further demonstrating the accuracy of the USCOM non-invasive cardiac output monitor.
The study was conducted at the University of Arizona Medical Centre, where measurements were made in patients with an implanted CardioWest Total Artificial Heart device. The CardioWest consists of a pneumatic blood pump delivering measured pulsatile flow to an implanted artificial heart. As it is not feasible to place Flow probes chronically in humans, the CardioWest patients were chosen because the circulation could be mechanically controlled and accurately measured.
In an IRB approved protocol, 461 paired measurements were analysed from 11 examinations of 4 adults, in whom the CardioWest pump was mechanically varied to create a range of Cardiac Outputs.
There was good correlation of Cardiac Output, Stroke Volume and Heat Rate measures by both methods without significant difference. The study concludes, “This study confirms both the accuracy of flow measurements using the USCOM device, and the feasibility of obtaining reliable non-invasive cardiac output and other parameters on patients in a clinical setting.”
A co-author of the paper is Dr. Jack Copeland, Chief of Cardiovascular and Thoracic Surgery at the University of Arizona Medical Centre and one of the world‘s leading heart surgeons. The Tucson facility is an internationally recognised centre of excellence in both clinical care and research. The hospital is among the best hospitals in the U.S. across nine areas of specialty medical care.
The CardioWest device has been used as a bridge to transplant in more than 175 patients worldwide since its first use in 1983. The device was approved by the US Food and Drug Administration (FDA) in October 2004.
The study, released today, is the first collaborative research project with the University of Arizona Medical Centre, under a collaborative agreement with USCOM, announced in January 25. The results were presented at the International Symposium on Intensive Care in Brussels, Belgium.
Commenting on the study today, the Chairman of USCOM, Mr Rob Phillips said, “This is compelling evidence for the accuracy of USCOM. With the CardioWest device we knew exactly how the patient’s circulatory system was functioning in both rate and volume. This was an important test for the USCOM monitor because we had a precise and reliable check against the USCOM measurements. We are delighted with the results and we look forward to advancing our work with the Arizona team.”
Presentation to Brokers and Analysts
March 15th, 2005
USCOM STUDY PUBLISHED IN INTERNATIONAL JOURNAL - “Our data supports the use of the USCOM system as a non-invasive clinical monitor of cardiac output.”
March 15th, 2005
USCOM Ltd (ASX Code: UCM) today announced the publication of a major study, proving the accuracy of its non-invasive cardiac monitor, in one of the world’s most prestigious international medical journals.
The paper, entitled: “Testing the Reliability of a New Ultrasonic Cardiac Output Monitor, the USCOM, by Using Aortic Flowprobes in Anesthetized Dogs” was published in the March 2005 edition of the UK-based Anesthesia & Analgesia.
The lead author of the study is Dr Lester Critchley, Associate Professor at the Department of Anesthesia and Intensive Care at the Chinese University of Hong Kong. Dr Critchley is a world authority on methods of measuring cardiac output and has been conducting research into the USCOM method since early 2003.
Dr Critchley states: “In conclusion, our data shows that the USCOM provides reliable cardiac output measurements over a wide range of values. Thus, the device has the potential to fill a much needed gap in current clinical monitoring.”
Commenting on the release today, the Chief Executive of USCOM, Mr Gary Davey said “The publication of scientific work in peer reviewed journals is an essential step in USCOM’s journey to global clinical adoption. This study is a critical milestone, delivering clear and positive scientific support for the USCOM solution from an internationally recognised expert in the field.”
USCOM LAUNCHES NEW SYSTEM BREAKTHROUGH
March 14th, 2005
USCOM Limited (ASX Code: UCM) today announced the most important technical advancement to its non-invasive cardiac output monitor.
At an international conference in Europe, the company unveiled for the first time its new “FlowTracer” ™ fully automated measurement system, an innovative method to dramatically advance the speed, simplicity and efficiency of the USCOM system. The “FlowTracer”™ technology made its debut in Berne Switzerland, where the Chairman of USCOM, Mr Rob Phillips, conducted a live demonstration of the system to an audience of experts from the field of Paediatric and Neonatal Intensive Care.
“FlowTracer”™ was formally released and made available for sale worldwide today.
The“FlowTracer”™ software eliminates the need for manual measurement. Until now, USCOM has used its unique semi-automated “TouchPoint”™ system for capturing precision flow data. The new system now provides for one hand operation. Detailed information across 9 parameters of cardiac function can be stored with the touch of a single button.
The “FlowTracer”™ system was developed in-house by USCOM engineers at the company’s Sydney head office, where filings for international patent and trademark protection have been lodged. The new system underwent rigorous testing at Beta test sites, prior to its formal release today.
Commenting on the release today, the Chief Executive of USCOM, Mr Gary Davey said “This represents a real breakthrough in the development of the USCOM system. We believe “FlowTracer”™ is the best automatic signal tracing method available and will significantly increase the appeal of the USCOM technology across the clinical market. The USCOM engineering team has done an outstanding job in its focus on customer feedback and the design of user-friendly advancements.”
Following the system’s debut in Berne, Switzerland, the “FlowTracer”™ technology will also be on display at the 25th International Symposium on Intensive Care and Emergency Medicine being held in Brussels, March 21 to 25.
USCOM FORMS U.S. PAEDIATRICS NETWORK
February 28th, 2005
USCOM Limited (ASX Code: UCM) announced today the formation of a collaborative hospital network across the United States in the critical field of paediatrics.
USCOM, the Australia-based developer of the USCOM non-invasive cardiac output system, has formally signed partnership agreements for clinical research and applications at two major paediatric centres of excellence with further announcements anticipated during the coming weeks. USCOM has initiated work with these internationally recognised university centres on important new research in the application of USCOM as a hemodynamics management tool for the care of children.
The children’s hospital network is an essential element of USCOM’s strategy for US market entry during calendar 2005.
The Chairman of USCOM, Mr. Rob Phillips said today, “We have been overwhelmed by the positive response of the leaders in paediatrics medicine in the United States. We had always known that children’s care would be at the core of the USCOM mission to change medical practice, but the active support and positive response from our new collaborative partners has exceeded even our own expectations.”
The Chief Executive of USCOM, Mr Gary Davey said “This is one of the world’s most prestigious sites in emergency care. Dr Rivers and his team have stimulated a groundbreaking change in emergency medical practice and we are proud to be working with them.”
The collaborative agreements enable USCOM to focus its validation and applications research at state-of-the-art facilities covering Intensive Care, Emergency Care, Cardiac Surgery and Trauma Retrieval.
The first two centres of excellence to partner in the USCOM hospital network are the Children’s Medical Centre, Dallas, Texas and Vanderbilt Children’s Hospital, Nashville, Tennessee.
Children‘s Medical Centre, Dallas, Texas Established for 90 years, the Children’s Medical Centre manages 103,000 patients per year. The centre is licensed for 406 beds, including a 52-bed paediatric intensive care unit. The hospital also has more than 50 outpatient clinics and a state-of-the-art emergency centre designed specifically for children. As a Class 1 Trauma Centre, the hospital is also the hub for the largest children’s medical retrieval service in the South West U.S., conducting annually more than 3,500 emergency retrievals. USCOM’s lead collaborative partner at Dallas is Dr. Thomas Abramo, Professor and Associate Medical Director, Division of Pediatric Emergency Medicine at the University of Texas SouthWestern. Dr Abramo is also medical director of the hospital’s paediatric transport program, equipped with a fleet of helicopters, planes and ambulances.
Vanderbilt Children’s Hospital Vanderbilt Children‘s Hospital‘s story began in 1968 and culminated in the opening of the $172 million Monroe Carell Jr. Children’s Hospital in January 2004. With 206 inpatient beds, the hospital managed 220,000 patients in 2003. The hospital is also equipped with a 60-bed Neonatal Intensive Care Department and 12 operating rooms. Vanderbilt is a world-renowned academic medical research centre and serves as the paediatric teaching hospital for Vanderbilt University Medical School. USCOM’s lead collaborative partners at Vanderbilt are Dr. Kevin Churchwell, Associate Professor of Paediatrics and Anesthesiology, Vanderbilt University School of Medicine and Dr Mary Taylor, Clinical Director for Cardiac Critical Care. Dr. Churchwell is also Associate Director of the hospital’s Pediatric Critical Care Services, Director of the Pediatric Critical Care Fellowship Program and Medical Director of Vanderbilt’s Paediatric Critical Care Unit.
USCOM TARGETS EMERGENCY CARE IN USA
February 21st, 2005
USCOM Limited (ASX Code: UCM) announced today it had concluded a collaborative research agreement with Henry Ford Hospital in Detroit.
This is an important milestone for USCOM and a key element of the company’s strategy for North America. The Detroit partnership will focus on proving clinical utility of the USCOM device across a wide range of medical illnesses, with a particular focus on emergency care.
The Emergency Medicine Department at Henry Ford, led by Dr Emanual Rivers, is the home of groundbreaking work in the resuscitation of critically ill patients, including the establishment of Early Goal Directed Therapy (EGDT) in the management of severe sepsis and septic shock. The work at Henry Ford Hospital, published in the New England Journal of Medicine, was a key contributor to the development of the global Surviving Sepsis Campaign, sponsored by numerous medical societies around the world.
Under the agreement with Henry Ford, USCOM will be working with Dr Rivers’ Emergency Department team, including Dr Bob Bilkovski and Dr Ronnie Otero on a wide range of research relating to USCOM’s role in emergency care practice. The USCOM device during the rigors of clinical study at Henry Ford Hospital will seek to prove validation with commonly used measures of hemodynamics which are invasive and expose each patient to an element of increased risk. The progression of clinical studies will evolve to include implementation of USCOM in the management of acute cardiovascular conditions (i.e. congestive heart failure), acute neurological conditions (i.e. stroke), trauma and children. The culmination of investigations is to dovetail the utilisation of the USCOM device with the proven benefits of EGDT in order to realise added outcome improvements in the management of patients with severe sepsis and septic shock.
The Chief Executive of USCOM, Mr Gary Davey said “This is one of the world’s most prestigious sites in emergency care. Dr Rivers and his team have stimulated a groundbreaking change in emergency medical practice and we are proud to be working with them.”
USCOM will commercially launch its non-invasive cardiac output system in the US during calendar 2005, following the receipt of the necessary 510K certification from the US Food and Drug Administration (FDA). USCOM announced on February 16 that it had received formal notification of its FDA clearance.
The partnership announced today is a cornerstone of USCOM’s North American market entry strategy. The company is establishing luminary partnerships across a wide range of applications, including emergency care, intensive care, paediatrics and cardiology. The first of these agreements was announced on January 25, a collaborative arrangement with the University of Arizona Medical Centre, with a focus on cardiology. Further announcements are expected in the coming weeks.
USCOM to tackle US market following FDA clearance
February 16th, 2005
USCOM Limited (ASX Code: UCM) today announced plans to target the significant US market having received formal notification of regulatory clearance for entry into the United States market earlier today.
The US Food & Drug Administration (FDA) issued the necessary 510K Pre-Market Notification in Washington today. USCOM had submitted its 510 application in November 2004.
Commenting on the announcement, the Chief Executive of USCOM, Mr Gary Davey said: “Securing FDA clearance is the most significant milestone in USCOM’s history paving the way for first commercial sales into the vast US market. It follows regulatory clearance and first sales in eleven other countries thus far. The FDA documentation allows the company to activate its sales and distribution strategy for the US market, taking the USCOM opportunity to a whole new level.”
The United States constitutes the world’s largest single market for medical devices, representing approximately 50% of global devices turnover.
USCOM has been presenting and exhibiting its technology at medical conferences in the US for approximately 2 years in anticipation of today’s announcement. The company has already signed high level collaborative agreements with some of America’s leading institutions in Emergency Care, Intensive Care, Paediatrics and Cardiology, acting as luminary research and reference sites.
The Chairman of USCOM, Mr Rob Phillips, said “This fundamentally changes the USCOM business opportunity. We are extremely proud of having reached this critical milestone. This is great news for our company, our staff and our investors. We have worked hard to establish our company at the highest levels of US clinical practice. Apart from the sheer scale of the US market, there is no doubt that our activities there will contribute to a global shift towards non-invasive cardiovascular assessment.”
USCOM’s United States management team is led by Mr Barry Zakar, the company’s Director of Operations for North America, based in California. Mr Zakar joined USCOM in August 2004, following a 25 year career in the US medical devices industry.
The first sales of the USCOM device in the North American market are anticipated during the current financial year.
To date, regulatory approvals have been secured for marketing of the device in: Australia; Japan; China and Europe. Commercial sales have already been made in each of those regions, totaling 11 different countries.
2005 SALES UNDERWAY
February 14th, 2005
USCOM Limited (ASX Code: UCM) reported today that marketing of its non-invasive cardiac monitor was off to a promising start for 2005, with sales already completed in both Australasia and Europe.
The most recent sale was recorded at a major public hospital in Wales. The order was taken by USCOM’s distribution partner for the UK and Ireland, Beaver Medical, based in Northhampton.
Commenting on progress, the Chief Executive of USCOM, Mr Gary Davey said, “December through February would normally be an extremely quiet time for sales activity. But we are pleased to have secured sales during this period in India, New Zealand and the UK. We have a healthy sales pipeline which we expect to convert to sales over the coming weeks. We are excited about the prospects for 2005.”
USCOM is currently involved in the final stages of sales of further units in Australia, the UK and Germany. Initial marketing has begun in Japan following regulatory approval in November 2004.
Importantly, the USCOM FDA application (USA regulatory approval) is progressing well and the company expects to be able to market the device in the United States in the coming months with initial sales in the North American market anticipated during the current financial year.
This week, the company is exhibiting at the Arab Health medical conference in Dubai for training of sales representatives and presentations to a number of potential Middle East customers. USCOM was on show at two important medical conferences in the US and one in Singapore through January and February. The company is also exhibiting and making presentations at a further two conferences in Europe during March.
The presentation of the science of USCOM, an essential element of the selling process, is also progressing well. The company announced today that an important study of USCOM in intensive care has now been published in a leading medical journal, the British Journal of Anaesthesia. The study, conducted at the Sir Charles Gairdner Hospital in Perth, concluded that the USCOM cardiac output monitor was “accurate, rapid, safe, well-tolerated, non-invasive and cost-effective.” The study was presented at the US Society of Critical Care Medicine (SCCM) Conference in Phoenix, Arizona, one of the US conferences where USCOM exhibited during January.
CARDIOLOGY PARTNER FOR U.S.
January 25th, 2005
USCOM Limited (ASX Code: UCM) today announced its principle North American partner in the field of cardiology.
The company has signed a collaborative agreement with the University of Arizona Medical Centre in Tucson for advanced research into the applications for USCOM in heart failure management, cardiac transplantation and post cardiac surgery.
Work has already begun on 4 separate studies, defining USCOM’s role in clinical practice.
The University of Arizona Medical Centre is an internationally recognised centre of excellence in both clinical care and research. The hospital is among the best hospitals in the U.S. across nine areas of specialty medical care.
Among the studies being conducted is the application of USCOM alongside the CardioWest Total Artificial Heart, developed by Dr. Jack Copeland, Chief of Cardiovascular and Thoracic Surgery at the University Medical Centre and one of the world‘s leading heart surgeons.
The CardioWest device has been used as a bridge to transplant in more than 175 patients worldwide since its first use in 1983. The device was approved by the US Food and Drug Administration (FDA) in October 2004.
The first collaborative research with USCOM and CardioWest will be presented in March at the International Symposium on Intensive Care in Brussels, Belgium.
The paper concludes, “This study confirms the accuracy of flow measurements using the USCOM device and the feasibility of non-invasive haemodynamic assessment of heart failure patients with artificial circulation.”
Commenting on the USCOM collaboration, Dr Copeland said, “Cardiac Output is the most important information for the management of the post cardiac surgical patient. To be able to acquire that non-invasively, at no patient risk is even more important.”
USCOM’s principle partner at Tucson is Dr Peter Lichtenthal, Associate Professor of Cardiothoracic Anaesthesia. Dr Lichtenthal said, “USCOM has the potential to be a very important monitoring device, which can add a new dimension to the care of the patient with heart failure. We are looking forward to its US launch during 2005.”
USCOM submitted its application for FDA clearance in November 2004.
Commenting on the Tucson partnership, the Chairman of USCOM, Mr Rob Phillips said, “We are honoured to have concluded a formal partnership with the University of Arizona team, who are world leaders in their field. The work we are doing in Tucson will form an important part of our US market entry. It will define the clinical utility of the USCOM device in the important clinical field of heart failure. Tucson will also serve as a centre of excellence reference site in cardiology.”
NEW ZEALAND DISTRIBUTION CONFIRMED
January 19th, 2005
USCOM Limited (ASX Code: UCM) announced today the appointment of Biolab Limited as its marketing and distribution partner for New Zealand.
As part of the agreement, Biolab has placed an immediate order for an USCOM cardiac output monitor, to demonstrate the USCOM technology to priority customers.
The Auckland-based Biolab is New Zealand’s largest provider of scientific instruments and consumables to the scientific and medical markets, handling up to 350 product shipments daily.
Commenting on the appointment today, the Chief executive of USCOM, Mr. Gary Davey said, “We have been delighted with the initial response from the New Zealand market. And with the experience, support and critical mass which Biolab can offer, we believe New Zealand will be a valuable market for USCOM.”
Biolab will represent USCOM in New Zealand in conjunction with Mr. Das Menon of Coefficient Systems, USCOM’s sales and marketing partner for Australasia.
USCOM has initiated important collaborative research in New Zealand, with clinical studies underway among infants and children at the Starship Children’s Hospital in Auckland.
USCOM PROVEN IN CARDIAC ICU STUDY
January 17th, 2005
USCOM Ltd (ASX Code: UCM) today released a study proving the accuracy of the USCOM device among intensive care patients who had just undergone cardiac surgery.
The study, titled “Clinical Evaluation of the USCOM Ultrasonic Cardiac Output Monitor in Cardiac Surgical Patients in the Intensive Care Unit” was conducted at the Sir Charles Gairdner Hospital in Perth, Western Australia.
Clinicians at the hospital’s Department of Intensive Care took 40 paired measurements from 22 patients immediately after cardiac surgery, demonstrating good agreement between the USCOM method and the standard thermodilution technique, using an invasive pulmonary artery catheter.
The study concludes, “The USCOM monitor has a place in intensive care monitoring. It is accurate, rapid, safe, well-tolerated, non-invasive and cost-effective. The learning curve for skill acquisition is very short.”
The study was presented today at the US Society of Critical Care Medicine (SCCM) Conference in Phoenix, Arizona by Dr Ling Tan from the Sir Charles Gairdner Intensive Care Department. The annual SCCM conference is the world’s largest convention specialising in critical care, attracting more than 5,000 medical professionals from over 50 countries.
Commenting on the study today, the Chairman of USCOM Limited, Mr Rob Phillips said, “The assessment of cardiac output immediately after cardiac surgery is critical information for the management of these patients. It is also information that is technically challenging for any technology to acquire, with the patient having just undergone open chest surgery. We are especially pleased with the outcome of this study because USCOM showed similar results to the thermodilution catheter, without the risks associated with the invasive method.”
New USCOM Study: Validated Against Invasive Method
January 12th, 2005
USCOM Limited (ASX Code: UCM) announced today the presentation of new research confirming the accuracy of the USCOM cardiac output monitor when compared to the established invasive method.
The study, titled, “Cardiac Output Measurement With the USCOM Ultrasonic Cardiac Output Monitor” was presented today at the 2nd Asian Pacific Congress of Heart Failure (APCHF) being held in Singapore.
The study was conducted at the Advanced Heart Failure and Cardiac Transplant Unit at Royal Perth Hospital, where the USCOM system was compared to the gold standard thermodilution catheter method, with 83 paired data sets from 15 patients.
The study concludes, “The USCOM is a non-invasive device that has good agreement with invasive measurements over a wide range of relevant cardiac outputs.”
The lead author of the study is Professor Gerry O’Driscoll, Head of Heart Failure and Cardiac Transplantation at Royal Perth Hospital.
The Royal Perth Cardiology Department is recognised for excellence in both clinical practice and important medical research. The department treats over 4,000 inpatients and approximately 4,500 outpatients annually.