Public Funding for Deltex Medical Limited

Deltex Medical has been awarded an Innovate UK Smart Award to complete the development of SupraQ-PW. SupraQ-PW is an innovative hand-held non-invasive device for the assessment of cardiac function and fluid status for all hospitalised patients. Clinicians currently lack a simple, reliable, non-invasive haemodynamic monitor that rapidly and accurately assesses the circulatory status of sick non-ventilated patients, and then guides their treatment. SupraQ-PW will be used in A&E, pre-surgical screening, critical care, obstetrics and cardiology. Prompt diagnosis for Covid-19 patients, is critical before their circulatory problem becomes severe. Use to guide treatment would improve patient outcomes, reduce hospital stay, improve utilization of stretched resources and deliver economic benefits. SupraQ-PW will Pulse Wave ultrasound which has the advantage that it can echolocate the point of measurement. The system is non-invasive and can be used on non-ventilated awake patients across all hospital settings. This development is the result of over 10years research into the optimal design for a non-invasive Doppler ultrasound cardiac output device. The probe is placed in the suprasternal notch (V-shaped notch at top of the sternum at the base of the neck). From this position ultrasound can be directed down the patient's aorta without skeletal bone obscuring the beam. This innovative device is easy to use and provides accurate and reproducible measurements of cardiac function and fluid status without patient harm. SupraQ-PW is compatible with Deltex's latest portable TrueVue monitors such that no additional monitoring device is required. Medicine today faces increasingly complex cases as the population ages. Protecting patients from haemodynamic errors through improved monitoring would save thousands of lives, improve outcomes and reduce costs. Haemodynamic instability and low blood pressure are frequent, with consequences such as myocardial infarctions, stroke and kidney injury. Complications have serious clinical and financial consequences; unplanned intensive care admissions; longer hospital stay; increased readmissions; increased 30-day mortality; and shorter patient lifespan after discharge. The ability to quickly and simply screen in-patients at admission and throughout their care will be a significant contribution to patient safety, in-hospital care and post discharge outcomes. This development is a significant moment for Deltex in its mission to provide non-invasive measurements of cardiac output for all hospitalised patients. SupraQ-PW addresses a market need in Deltex's immediately accessible market of 4 direct territories and 23 distributors and potentially 16 million devices per annum. Deltex expects cumulative sales of £32 million by the end of the 5th year after launch.

SupraQ is a non-invasive Cardiac Output (CO) device using Continuous Wave ultrasound. Our technology utilises an ultrasound transducer presented to the suprasternal notch (V-shaped notch at base of neck) to measure blood flow in the ascending aorta. This need has enormous market potential helping over 16 million patients each year. Clinicians currently lack a low cost, simple, reliable, non-invasive haemodynamic monitor to assess the circulatory status of sick non-ventilated patients rapidly and accurately, and then guide their treatment. Protecting patients from haemodynamic errors through improved screening and monitoring would save thousands of lives, improve outcomes and reduce costs. Haemodynamic instability is frequent, resulting in myocardial infarctions, stroke and kidney injury. Complications have clinical and financial consequences; unplanned ICU admissions; longer hospital stay; increased readmissions; increased 30-day mortality; and shorter lifespan after discharge. Prompt diagnosis, particularly in Covid-19 patients, is critical before a circulatory problem becomes severe. Usage would improve patient outcomes, reduce hospital stay, improve utilization of stretched resources and deliver economic benefits. Deltex has vast experience in haemodynamics, its current ultrasound monitoring technology has been repeatedly demonstrated to improve patient outcomes (23 Randomised Controlled Trials and a NICE recommendation).

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Deltex Medical has been awarded an Innovate UK Smart Award to develop TrueVue - a disruptive technology for the diagnosis and management of the haemodynamics of surgical and critical care patients. It is designed for all patients from new-born to adult, anaesthetised or awake, across all hospital settings. Medicine today faces increasingly complex cases as the population ages. Protecting patients from haemodynamic errors through improved monitoring would save thousands of lives, improve outcomes and reduce costs. Diagnostic haemodynamic equipment needs to display the interaction of blood flow and pressure if it is to be truly effective. Haemodynamic instability and low blood pressure are frequent, with consequences such as myocardial infarctions, stroke and kidney injury. Complications have serious clinical and financial consequences; unplanned intensive care admissions; longer hospital stay; increased readmissions; increased 30-day mortality; and shorter patient lifespan after discharge. Monitors dependent on blood pressure measurement alone are failing to meet this need for all patients across all hospital settings. The novel TrueVue Velocity Pressure Loops system is the first monitor to display both aortic blood flow and aortic blood pressure simultaneously throughout the heartbeat. TrueVue will be a significant contribution to patient safety for surgical and critical care patients. TrueVue will operate by use of Doppler ultrasound and other non-invasive methods to measure blood flow velocity and combine this with standard measures of arterial blood pressure. The system can currently be used in all major surgical procedures and intensive care units; and with developments in non-invasive methods already foreseen by Deltex, could be applied across all surgical and after care procedures. The UK is a global clinical leader in haemodynamics and Enhanced Recovery Programmes. TrueVue is based on sound haemodynamic practices and is both a significant patient safety advance and a global business opportunity for the UK. TrueVue will address a market need in the UK alone of nearly 600,000 surgical patients, 90,000 intensive care admissions and a global market of nearly 40million in major/high-risk surgery and ICU. With expansion into all categories of surgery through non-invasive methods the technology has a potential market of 278million procedures annually. Deltex Medical expects to increase its market share, and revenues 5-fold to £35m in the first 6 years of sales.

"Deltex is pleased to announce that it has gained Innovate UK funding through a successful bid to the Analysis for innovators round 4: mini projects phase 2 competition. This Innovate UK funding brings with it the opportunity to collaborate with world-class UK agencies to seek solutions to improve existing technologies. Deltex Medical is pleased to be partnering with the National Physics Laboratory (NPL) in a project to enhance the design of its haemodynamic monitoring probes. Deltex is the world leader in Doppler ultrasound for haemodynamic monitoring. Use of the company's TrueVue Doppler, is proven to reduce post-operative complications and is recommended by NICE. The system also saves hospitals the costs of treating complications that would otherwise result in increased lengths of stay. The minimally invasive TrueVue Doppler technology uses an ultrasound probe inserted into the patient's oesophagus (food pipe). The oesophagus lies close to the aorta in the patient's chest and so blood flow velocity can be measured much like a police speed camera checks a car's speed. In this case the moving objects are blood cells. The TrueVue system measures blood flow velocity and the timing of each heartbeat. TrueVue then calculates a range of parameters useful to clinicians in managing patient care to minimise or even prevent post-operative complications. Clinician's achieve focus of the probe by feel, navigating using their knowledge of cardiovascular anatomy and the ultrasound signal they view on the TrueVue monitor. They rotate and manipulate the depth of the probe to find the optimum aortic blood flow signal. Deltex will use the grant monies to collaborate with NPL in a study to develop ultrasound lenses to optimise the product's beam width and power output. The advantages of a wider beam are two-fold; firstly finding the aortic blood flow is quicker; and secondly any movement of the patient or equipment has less potential to move the beam out of focus. The result will be that users will be more confident with the device leading to increased use of a technology proven by NICE to reduce post-operative complications, hospital stay (-3 days) and healthcare costs (£1,100 per patient). The project will benefit clinicians and patients by leading to ease of use improvements. Deltex expects that the outcome will increase the range of uses of a medical device with already proven efficacy."

"Deltex are pleased to announce that it has gained Innovate UK funding through a successful bid to the Analysis for innovators round 3: mini projects phase 2 competition. This Innovate UK funding brings with it the opportunity to collaborate with world-class UK agencies to seek solutions to improve existing technologies. Deltex Medical is pleased to be partnering with the National Physics Laboratory (NPL) in a project to enhance the Quality Control of its haemodynamic monitoring probes. Deltex is the world leader in Doppler ultrasound for haemodynamic monitoring. Use of the company's TrueVue Doppler, is proven to reduce post-operative complications and is recommended by NICE. The system also saves hospitals the costs of treating complications that would otherwise result in increased lengths of stay. The minimally invasive TrueVue Doppler technology uses an ultrasound probe inserted into the patient's oesophagus (food pipe). The oesophagus lies close to the aorta in the patient's chest and so blood flow velocity can be measured much like a police speed camera checks a car's speed. In this case the moving objects are blood cells. The TrueVue system measures blood flow velocity and the timing of each heartbeat. TrueVue then calculates a range of parameters useful to clinicians in managing patient care to minimise or even prevent post-operative complications. Deltex will use the grant monies to collaborate with NPL in a study to further enhance the Quality Control measurements of the probe's ultrasound output. Partnering with NPL will bring considerable ultrasound expertise and access to specialised equipment. This will provide a better understanding of the energy map of the ultrasound crystals and deliver innovative methods to create a new generation of product test equipment. The system envisaged will also store all results digitally allowing rapid trend analyses. The result will be that the product's enhanced quality will provide increased use of a device already recommended by NICE to reduce post-operative complications, hospital stay (-3 days) and healthcare costs (£1,100 per patient). In conclusion a successful project will benefit clinicians and patients alike through enhanced quality management. Deltex expects that the outcome will increase the range of uses of a medical device with already proven efficacy."

"Deltex are pleased to announce that it has gained Innovate UK funding through a successful bid to the Design foundations round 1 2018 competition. Deltex is the world leader in Oesophageal Doppler ultrasound for haemodynamic monitoring. Use of the company's TrueVue Doppler, is proven to reduce the complications suffered by patients after surgery and is recommended by NICE. The system also saves hospitals the costs of treating complications that would otherwise result in increased lengths of stay. The minimally invasive TrueVue technology uses an ultrasound probe inserted into the patient's oesophagus (food pipe). The oesophagus lies close to the aorta in the patient's chest and so blood flow velocity can be measured much like a police speed camera checks a car's speed. In this case the moving objects are blood cells. The TrueVue system measures blood flow velocity and the timing of each heartbeat. TrueVue then calculates a range of parameters useful to clinicians in managing patient care and so minimising or even preventing post-operative complications. Clinician's achieve focus of the probe by feel, navigating using their knowledge of cardiovascular ultrasound signals. They have to find the optimum insertion depth and rotate the probe to find the correct signal quality. Deltex will use the grant monies to fund a study to understand how individual users insert and focus the ultrasound beam. The data obtained will help Deltex develop improvements in the probe's materials and packaging system to advance the probes handleability. The project will benefit clinicians and patients by leading to ease of use improvements. Deltex expects that the outcome will increase the range of uses of a medical device with already proven efficacy."

"Deltex are pleased to announce that it has gained Innovate UK funding through a successful bid to the Analysis for innovators round 3: mini projects phase 2 competition. This Innovate UK funding brings with it the opportunity to collaborate with world-class UK agencies to seek solutions to improve existing technologies. Deltex Medical is pleased to be partnering with the National Physics Laboratory (NPL) in a project to enhance the design of its haemodynamic monitoring probes. Deltex is the world leader in Doppler ultrasound for haemodynamic monitoring. Use of the company's TrueVue Doppler, is proven to reduce post-operative complications and is recommended by NICE. The system also saves hospitals the costs of treating complications that would otherwise result in increased lengths of stay. The minimally invasive TrueVue Doppler technology uses an ultrasound probe inserted into the patient's oesophagus (food pipe). The oesophagus lies close to the aorta in the patient's chest and so blood flow velocity can be measured much like a police speed camera checks a car's speed. In this case the moving objects are blood cells. The TrueVue system measures blood flow velocity and the timing of each heartbeat. TrueVue then calculates a range of parameters useful to clinicians in managing patient care to minimise or even prevent post-operative complications. Clinician's achieve focus of the probe by feel, navigating using their knowledge of cardiovascular anatomy and the ultrasound signal they view on the TrueVue monitor. They rotate and manipulate the depth of the probe to find the optimum aortic blood flow signal. Deltex will use the grant monies to collaborate with NPL in a study to optimise the beam's width and power output. The advantages of a wider beam is two-fold; firstly finding the aortic blood flow is quicker; and secondly any movement of the patient or equipment has less potential to move the beam out of focus. The result will be that users will be more confident with the device leading to increased use of a technology proven by NICE to reduce post-operative complications, hospital stay (-3 days) and healthcare costs (£1,100 per patient). The project will benefit clinicians and patients by leading to ease of use improvements. Deltex expects that the outcome will increase the range of uses of a medical device with already proven efficacy."

The accurate measurement of Cardiac Output (CO), the volume of blood pumped/min, is critical for clinicians to assess cardiovascular function & fluid status. Several invasive & non invasive techniques are currently available to determine CO; however these possess limitations with accuracy & suitability for use in all patient types. Deltex Medical (Deltex) currently manufactures a leading technology to assess CO using a 4MHz ultrasound Oesophageal Doppler Monitor (ODM). The technology is highly precise & has been widely demonstrated to improve patient outcome. However the probe is placed into the oesophagus which can initiate a ‘gag reflex’. The oesophageal probe is therefore not well tolerated in awake patients. To address this issue, Deltex aims to develop a non invasive CO measurement system based on Doppler ultrasound that can be applied non-invasively at the suprasternal notch. Such an approach has been adopted previously by both Deltex & a competitor (USCOM) using a reusable probe, resulting in issues with product sterility & high capital costs (see innovation question). Therefore, Deltex intends to develop the suprasternal ultrasound technique using a disposable 4 MHz probe. This has the major added advantage of being compatible with the company’s existing installed monitor base. The technology will initially be targeted towards the Enhanced Recovery Programme used in surgery, & in intensive care, where success will reduce the length of hospital stay & associated healthcare costs, & then extend CO measurement for use in new departments (e.g. cardiology, A&E, sports medicine, etc.). To date, Deltex has undertaken a pilot study to identify the optimal Doppler frequency, anatomical targets & begin verification of technical parameters such as head size & signal resolution. With the intended development of the pre-production prototype & a clinical trial, Deltex expects accumulated sales of at least £10M over 5yrs.