Periodic Reporting for period 1 - STstent (Short Term Stent - A composite removable sinus stent for functional endoscopic sinus surgery that improves patient outcomes and reduces revision surgeries)
Okres sprawozdawczy: 2018-08-01 do 2018-11-30
Chronic rhinosinusitis (CRS) is a common severe inflammation of the paranasal sinuses, the cavities that produce the mucus necessary for the nasal passages to work effectively. CRS affects around 10% of the EU population and is similarly prevalent worldwide. This causes nasal blocks, headaches, fatigue, facial pain and toothache, and in some cases severe fevers. CRS patients are typically first treated with medications such as nasal steroids, decongestants, antihistamines, saline solutions and antibiotics. When the symptoms persist for more than 12 weeks, patients can experience debilitating side effects. In approximately 20% of cases, breathing becomes sufficiently impaired to warrant functional endoscopy sinus surgery (FESS, 835,000 annual procedures in the EU); needed to improve airflow as the only form of alternative treatment. FESS procedures, however, suffer from severe post-operative complications (bleeding, scarring, inflammation, adhesions, polyposis among others) and high failure rates. It is reported that 23 – 47% of patients require revision surgery due to the return of CRS symptoms following a sub-optimal healing process. There is currently no truly effective medical device to ensure a successful healing process for the benefit of patients and healthcare providers. STS Medical have developed ArchSinus, a novel nasal stent which can be positioned in the nasal cavity following FESS to keep the sinus passages open and allow successful healing. It is anticipated that ArchSinus will overcome the post-operative complications suffered by millions of FESS patients worldwide and substantially reduce the cost burden on healthcare providers by removing the requirement for revision surgeries. The objectives of the feasibility study were to evaluate technical and regulatory requirements for introduction of the device into the European market, identify and finalise an optimised value chain, and design the clinical validation activities including securing sites for a clinical trial. STS Medical’s overall objectives are to become the foremost global supplier of stent technologies for treatment of prevalent nasal conditions, significantly increasing quality of life for sufferers of allergic conditions across the EU and globe.
STS Medical completed a full analysis of the technical and business potential of the ArchSinus device. The interest of 6 healthcare providers was secured, both in Europe and the US, enabling volume requirements to be established for full operations. STS Medical designed and secured a value chain which will be capable of efficiently delivering this volume of devices and identified the optimum sales channels. STS Medical also identified the optimisation work required in the manufacturing process to effect scale-up within the scope of a Phase 2 innovation project. From a regulatory perspective, STS Medical identified the clinical validation activities required to achieve the CE Mark in Europe, designed a suitable clinical trial, and secured the interest of 2 medical centres to act as recruitment and validation sites during the Phase 2 innovation project. Furthermore, STS Medical calculated detailed five year financial projections for commercialisation and analysed the financial and infrastructure requirements for achieving global sales.
The expected outcome is to optimise the manufacturing processes to enable the production to be scaled up, establish a manufacturing line to deliver sufficient quantities of product, and to complete clinical validation activities such that EU market readiness will be achieved by the end of the Phase 2 project. ArchSinus will have a significant impact on the lives of millions of FESS patients worldwide in terms of comfort and success of post-operative recovery, and provide substantial savings to healthcare providers.