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Duo: A minimally invasive device to treat all patients with tricuspid valve disease

Periodic Reporting for period 1 - Duo (Duo: A minimally invasive device to treat all patients with tricuspid valve disease)

Reporting period: 2020-06-01 to 2021-05-31

BACKGROUND: Heart failure is the leading cause of death for both men and women affecting 15 million patients across Europe and the US. In patients with heart failure, the right heart expands, resulting in the tricuspid valve not closing properly and blood leaking backwards. This is called tricuspid valve regurgitation. The past decade has witnessed a revolution in the treatment of heart valve disease. For the aortic valve, patients no longer need to have their chest cut open and their heart stopped in order to have their valve replaced. While the same revolution is already on its way for the mitral valve, the tricuspid valve has remained largely forgotten due to unique functional and anatomical challenges. Although there are 550,000 new tricuspid valve disease cases diagnosed every year in the US and EU, less than 1% of these patients are treated. This is due to the fact that open-heart surgery is still the only treatment option, which is very risky. Without suitable treatment options, all that doctors can do is to manage their patients’ symptoms with diuretics. These patients face worsening quality of life and eventually die. The prognosis is bleak with 3 of every 5 patients dying within 3 years.

DUO SOLUTION: DUO is a minimally invasive device uniquely tailored to the anatomical challenges of the tricuspid valve. Designed by a leading interventional cardiologist, DUO is the only minimally invasive tricuspid valve that works in tandem with the native valve. An innovative adjustable anchor holds the device in position between the tricuspid valve leaflets, anchored against the venous wall, where it does not touch the fragile cardiac tissue or the native tricuspid valve leaflets. The DUO-TF (Duo-transfemoral) device is a next generation device, designed to support delivery through a vein in the leg is the focus of the FTI project. Patients have restrictions that prevent transjugular delivery due to the size of the vein or the presence of a previously implanted devices. Additionally, it changes the procedure from one requiring general aesthetic to one where only local sedation is needed, minimising impact to the patient and increasing adoption.

FTI PROJECT: This FTI project will progress and finalise the development of the Duo-TF device and enhance Duo’s profile by developing clinical evidence with the next generation device, demonstrating the clinical benefits to the patient. This consortium is a group of innovative and complementary SME’s that are uniquely positioned to undertake the activities necessary to accelerate the device to market and maximise penetration. The main goal of the project is to strengthen the position of Duo as the Gold Standard treatment for Tricuspid Regurgitation, thus saving the lives of thousands of patients suffering with this condition and reducing the high healthcare burden associated with their care.
The first reporting period is 01/06/2020 to 31/05/2021, and during which the consortium completed extensive technology development and testing, as well as a full analysis of the competitor landscape, clinical approach and route to market for the DUO System.

Device Development: The anatomy, specifically the angles between the inferior vena cava and right atrium, pose significant technical challenges for the Duo-TF device. Highlights during this reporting period are:
- Establishing a Technical Advisory Board to ensure input from global thought leaders
- Optimization of the coaptation valve body for durability
- Optimization of design for manufacturability
- Definition of the patient anatomy and optimization of the anchor system

Device Testing: Design verification is a critical activity and a significant investment of time and budget. Highlights of this are:
- Animal study design.
- Definition of the suite of testing required for Biocompatibility
- Developing an appropriate catheter fatigue test method
- Developing an appropriate valve fatigue test method
- Update to the coaptation valve packaging test method and equipment

Regulatory: Two pre-submission reviews with the FDA were completed which fully aligned on the requirements for initiating an Early Feasibility Study for the Duo device (EFS), this included pre-clinical testing and clinical protocol design.

Clinical: Detailed planning has been completed to ensure initial clinical cases will be successful, this planning has included:
- Imaging and core lab assessments
- Protocol design
- Site assessment

Market Development: During this reporting period, the focus has been on developing marketing material, engaging Key Opinion Leaders to ensure the device is designed in line with their user needs and planning the route to market. Highlights of this are:
- Early adopter engagement
- Promotional activities

Business Development: During this period, the focus has been on understanding the optimal clinical strategy to ensure efficient market approvals in Europe and the US. Highlights of this are:
- Patient population definition
- Clinical Strategy determination through to EU and US market approvals.
- Investor networking
As the demographics of our population in Europe and the Western world continues to age, Tricuspid Regurgitation will become more prevalent. In 2020, there are approximately 56 million US citizens and 140 million EU citizen over the age of 65. Tricuspid valve disease is a disease of old age, occurring in 3.5% of patients over 70 years of age. Currently only 1% of these patients receive surgical treatment due to the poor outcomes of open-heart surgery. This results in patients being turned down for surgery, suffering low Quality of Life and needing multiple hospitalisations. Including a transfemoral device, along with the transjugular device will expand the patient population, ensuring patients with smaller jugular veins and pacemaker implants can be treated with a minimally invasive procedure.

Health economic studies demonstrate that reducing hospitalizations have significant cost benefits for the healthcare system. Delgado et al. found that, in Spain, one year health care costs for Heart Failure patients with no hospital admissions (EUR 1,857) is less than 1/4 the cost of patients with one admission (EUR 8,475) and less than 1/10 the cost of patients with multiple admissions (EUR 21,022). Other health economic studies in the US, Europe and Australia indicate similar short term cost benefits of improving the rate of hospitalization. The Duo device will offer gold standard treatment that is safe and easy to use. It can reduce re-hospitalisation at 1 year by >70% and reduce pressure on the European healthcare costs.

Minimally invasive devices are the future of heart valve disease. There are two other minimally invasive approaches to fix the tricuspid valve: Repair and Replacement
- Repair: Reducing the size of the expanded/dilated valve back closer its healthy size or clamping the leaflets together to help leaflet coaptation and sealing
- Replacement: Fully replacing the tricuspid valve with a prosthetic valve
However, repair & replacement don’t address key clinical requirements and so will see limited market penetration. The DUO system is a disruptive approach combining the advantages of both repair and replacement, without their complications: implanting a valved spacer to work in tandem with the native valve.