Periodic Reporting for period 1 - VENOCLOSE (World’s first absorbable percutaneous closure device for large venotomies)
Reporting period: 2020-05-01 to 2021-04-30
Our solution: Vivasure has developed PerQseal®Venous, the world’s first absorbable patch-based closure product for large venotomy closure (over 8 mm). Vivasure’s innovation, derived from its patented PerQseal® technology, is to deliver an intra-venous patch without additonal surgery, sealing the vessel from the inside while providing a matrix to support wound healing. The PerQseal®Venous product is largely based on Vivasure’s already existing and clinically-validated PerQseal®Arterial product, which is used to close arterial vessels and already in clinical use. Vivasure’s PerQseal® technology is world-wide patent protected. The PerQseal®Venous will be able to make transcatheter heart valve interventions and LAAOs simpler to perform. This will result in a significant cost reduction by:
Reduction in the vascular surgery team involvement;
Reduction of total procedure time;
Reduction of hospitalisation time;
Reduction of anaesthesia and post-operative opioid (pain medication) use.
In addition to the cost savings, PerQseal®Venous will improve patient outcomes by reducing the infection rates and other complications such as blood loss and thrombosis.
The overall objective of the project to to design, develop and manufacture and Venous closure device for a First in Human study to demonstrate the clinical feasibility of such a device.
In conjunction with the design and development work the company has developed an IP strategy along with Market and Product specification. The company currently engaging in an Arterial US clinical study and has been able to leverage it's engagement with the US FDA to help guide the development of the Venous protocol, clinical operator and site selection, IRB interactions, CRO management and hospital contracting which will prove very helpful when we are ready to propose a venous closure device EFS study. The Company is also engaging in a EU Arterial clinical study and will be similarly be able to leveraging this experience.