Project summary
The Arterial Access System (AVAS®) is an implantable medical device that enables clinicians to access the arterial circulation and provides an ability to isolate and independently target a tumour within a specific organ in the body.
What is the issue?
Solid organ cancers, in general are expected to be ongoing issues in healthcare for the foreseeable future, with incidence rates generally expected to increase into the future.
Isolation of cancerous organs in the body allow clinicians to treat the organ with high concentrations of anti-cancer agents, reducing side effects from the chemotherapy including reduced nausea and neuropathies. This approach enables patients to be treated more frequently and aggressively.
What does the research aim to do and how?
The Arterial Access System (AVAS®) is an implantable medical device that enables clinicians to access the arterial circulation and provides an ability to isolate and independently target a tumour within a specific organ in the body.
The device is currently being used in the treatment of unresectable colorectal liver metastases (CRC-LM), with the AVAS® enabling the delivery of high concentrations of an effective but toxic chemotherapy called oxaliplatin directly into the liver with reduced side effects.
This targeted and isolated method of delivering therapeutics has many advantages over the current intravenous (IV) route which circulates throughout the whole body, these being:
- isolation of the liver results in a significant reduction in side effects, including reduced fatigue, nausea and neuropathies. This enables patients to be treated more frequently and aggressively
- a reduction in overall treatment time leading to improved quality of life. The standard IV treatment regimen is compressed from six months to two-three months through the increased infusion frequency
- isolation of the liver and targeted delivery enhances the tumour perfusion ensuring improved uptake of the anti-cancer agent.
A 10 patient clinical trial for patients with unresectable CRC-LM and who had a limited life expectancy was completed at Macquarie University Hospital in late 2016.
Whilst these patients had a poor survival prognosis, three patients responded to treatment, one of which was resectable with two of these patients surviving for >5.5years – well beyond expectations. A further three patients were stabilised.
The AVAS® has regulatory approval for sale in Australia and Europe and is now being used to enable patients to complete the CRC-LM chemotherapy regime with reduced side effects.
The Medical Devices Fund grant will be invested to develop commercial revenue for the AVAS® device from ANZ and assist with an initial development of commercial sales into targeted European countries. It will scale-up device sales and fund the commencement of a further clinical trial that will be used in support of the Company’s FDA application. The trial is investigating patients with CRC-LM at an earlier stage of diagnoses and will commence in late October 2020, with the establishment of NSW based Centres of Excellence at Liverpool Hospital, and North Shore Public Hospital.
Company contacts
David Radford
davidradford@allvascular.com
www.allvascular.com
0407 218 922