The world’s first Ultrasound AI software for blood clots obtains EU Approval
EU Regulatory Approval
ThinkSono has been developing ThinkSono Guidance for the past 7 years. After running multi-centred, doubled blinded clinical trials in multiple countries in the EU, we’re extremely proud to announce that we have obtained a CE Class IIb approval under EU MDR.
For those not familiar with the healthcare space, any medical device (including software) in Europe must obtain the approval prior to selling into the EU. It is also currently accepted in the UK and multiple other countries around the world.
The regulation is extremely comprehensive covering everything from clinical trial design, clinical claims, cyber security, marketing, quality management and pretty much every other aspect of a medical product that you can imagine.
To get this approval not only means that the technology is safe and effective, but it also shows that ThinkSono’s technical development process meets both national and international standards of rigour.
What does ThinkSono Guidance do?
In simple terms, ThinkSono Guidance uses AI to guide non-ultrasound trained healthcare staff (e.g nurses) to perform an ultrasound scan with a handheld ultrasound machine, on patients who have a suspicion of deep vein thrombosis (DVT). The data is then sent to a remote clinician (e.g radiologist) who can make a clinical assessment*
Prior to our software, only ultrasound trained staff (e.g sonographers) were able to perform this type of scan and due to resource limitations, many patients would have to wait many hours to be seen. With ThinkSono guidence, even non-ultrasound trained staff can perform the same scan guided by the AI.
To understand why ThinkSono Guidance is a paradigm shift in both ultrasound and medicine. It is important to have the clinical context of DVT.
Venous thromboembolism — A major global burden of disease
VTE, deep vein thrombosis (DVT) and pulmonary embolus (PE) are the leading cause of hospital-related disability-adjusted life years lost. At least 7.7 million people will require investigation for VTE every year. An ageing population across many countries will lead to a greater health burden, particularly in middle- and low-income countries where early death from infection is decreasing.
Mortality from VTE is common, a European study estimated 534,000 deaths per year and a similar study in the US reported 60,000–300,000 deaths per year. As many as 900,000 people are affected by VTE in the US alone.
DVT has a high level of morbidity. 30–50% of the surviving patients develop long-term symptoms in their affected leg (post-thrombotic syndrome).
In high-income countries, the routine practice to diagnose patients after a positive D-dimer blood test and an indicative evaluation using the Wells score (a risk assessment) is to confirm or rule out a suspected DVT with a two- or three-point ultrasound scan.
Ultrasound scans are most commonly performed in a radiology or cardiovascular department of a hospital by a highly trained radiographer/radiologist.
The Inefficient DVT patient pathway
Up to 90% of patients presenting to their GP in high-income countries with a suspected DVT will be investigated only to find no evidence of a thrombus.
Many patients will receive unnecessary anticoagulants with numerous potential side-effects through an often-painful subcutaneous injection whilst waiting more than the recommended four hours for their scan.
Safely negating this wait would improve patient satisfaction, reduce the burden of high-risk treatment (anticoagulants confer haemorrhagic complication risks) and discount healthcare costs.**
The clinical pathway may also be very long, taking in some cases 24 hours, which can be mitigated using ThinkSono Guidence in the hands of non-ultrasound trained staff (e.g nurses or doctors).
ThinkSono Guidance Improves the Clinical Pathway
The potential to improve patient care and the clinical pathway with ThinkSono Guidance is hugely significant as shown in the example image below. This will of course vary from hospital to hospital, but overall the potential improvements are significant.
$2.7Mn Funding round and U.S Expansion
In order to obtain EU regulatory approval and commercialise the technology in Europe, we’ve raised £2.1Mn (~$2.7Mn).
This oversubscribed round was led by id4 Ventures, with participation from Brandenburg Kapital, Calm Storm Ventures, Dubai Angel Investors, CrowdCube, Cur8 Capital as well as multiple prominent angel investors and clinicians in vascular surgery.
We’re hugely grateful to the consistent support from all our investors, who decided to back our team and allowed us to work on one of the most pressing problems in medicine. It truly takes conviction to back a startup that not only works on impactful clinical problems but building cutting edge AI at the same time.
We’ve also been lucky to be working with the leading U.S institutions such as NYU Langone Health and Temple Health in running our clinical studies, in preparation for our full U.S expansion post FDA approval.
Contact us:
For any hospital administrators or clinicians wishing to work with us and use ThinkSono Guidance, please contact us at: hello@thinksono.com
For more information visit: www.thinksono.com.
For published clinical evidence see here. Note that some clinical studies are not yet available yet, but will be published in due course.
*For those interested in the formal clinical claims, including the intended purpose, please see the ThinkSono Guidance instructions for use here.
* *Source here.
