Cambridge, UK – 28 July 2020 – Directed Systems Ltd today announced that it had received a COVID-19 Continuity Grant from Innovate UK to ensure the continuity and completion of its Innovate UK project so its vitally needed clinical decision support technology, Hypotension Decision Assist (HDA)™ can be brought to operating theatres in hospitals as soon as possible.
Hypotension Decision Assist (HDA)™, is a uniquely designed clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer that supports anaesthetists by providing intuitive visualisation on a single display of at-a-glance time critical information about emerging critical cardiovascular situations to help better manage hypotension during surgery in the operating theatre.
The operating theatre is a high pressurised environment for anaesthetists whose constant vigilance and speedy reactions are needed to perform their job well with appropriate interventions used to keep patients stable and avoid inter-operative hypotension (IOH). IOH can cause poor outcomes, even death – especially in high-risk patients undergoing surgery. Currently operating room multi-parameter patient monitors monitor blood pressure and associated trends but do not provide the clinical decision support information to the anaesthetist that HDA provides. Even short periods of IOH during surgery, where it falls below certain patient specific critical thresholds, may increase the risks of organ injury and other adverse outcomes for the patient.¹ A 2014 study of almost 17,000 anaesthetic records revealed that 26% of the surgical patients involved had a peri-operative systolic blood pressure of < 80 mmHg for > 5 minutes². The threshold for myocardial injury is an operative Mean Arterial Pressure (MAP) < 65mmHg. The threshold for renal injury may be higher, possibly nearer 75 mmHg. A few minutes of a MAP < 55mmHg is associated with Acute Kidney Injury and Myocardial Injury and has been demonstrated to increase markedly with prolonged intra-operative hypotension¹.
HDA is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their invasive arterial pressure is being continuously monitored by a multi-parameter operating room patient monitor . It is indicated for use to assist anesthesia healthcare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery. The U.S. Food and Drug Administration (FDA) 510(k) clearance of a US version of Hypotension Decision Assist (HDA)™ was received in November 2019. Preparations for a US launch are well underway.
About Innovate UK and its COVID-19 grant
Innovate UK is part of UK Research and Innovation, a non-departmental public body funded by a grant-in-aid from the UK government. Innovate UK has made £90 million available as additional COVID-19 Continuity Grants to currently funded project participants to ensure their continuity in and completion of those existing projects.
The funding has been made available to enable SMEs or third sector organisations already supported by Innovate UK to continue and where necessary, complete their projects during the disruption caused by COVID-19. Grants have been made available between £25,000 and £250,000. Any cumulative state aid awarded under the temporary framework cannot exceed €800,000.
To date, the company has been discussing its HDA technology with more than 20 US based hospitals over the last 18 months. The first US hospitals are now beginning to implement the use of HDA within their operating rooms, post the COVID-19 delays. As some hospitals are getting back to normal services, that includes the more routine use of elective surgery.
“We at Directed Systems Limited are delighted that Innovate UK, supported by the UK government, has awarded us with a COVID-19 continuity grant for the launch of our Hypotension Decision Assist (HDA)™” explained Mark Leaning PhD, CEO and Founder of Directed Systems Limited. “The grant underscores the value of our HDA technology and recognises the impact that the COVID-19 pandemic has had in frustrating our Innovate UK project and the knock-on effect on our launch plans in the US, especially given that access to hospitals has been severely restricted until now. Thankfully, routine elective surgery is now beginning to return. This grant now gives us a shot in the arm to continue to support our project and business plans in a more realistic timeframe in this interpandemic period.”
The company has already been recognised with significant grants made available by Innovate UK. Total funding to date is £1.5 million (including equity and grants) and it has been operating as a very capital efficient business to date. It is now looking to raise further capital to support its expansion plans into the USA and to underpin the work to secure a CE Mark, the regulatory requirement, enabling access to the European market.
1. Walsh M. Kurz A. Turan A. et al. Relationship between Interoperative Mean Arterial Pressure and Clinical Outcomes after Noncardiac Surgery. Anesthesiology 2013; 119 (3);507-505. Doi:10.1097/ALN.0b013e3182a10e26.
2. Nair et al. “Anesthesia information management system-based near real-time decision support to manage intraoperative hypotension and hypertension.” Anesth Analg 2014; 118: 206–214