Ventracor aiming for CE approval by next year

Ventracor's VentrAssist left ventricular assist device may see market approval as early as next year, according to company CEO, Michael Spooner.

Speaking at the American Chamber of Commerce today, Spooner said the company was poised to take advantage of a potential AUD$12 billion a year market with the device. Spooner said the market only featured four competitive products, which signalled a positive future for the company.

"If things go well we could be looking at CE (European) approval as soon as the end of next year," he asserted. "It will be longer than that for the US market, and we expect to start the FDA approvals process at a number of hospitals next year," he said.

The company is reticent to put dates on a US product launch, instead concentrating on what Spooner described as a "milestone approach".

"We are taking a rolling view of the future based on achieving our milestones. We are not set on hard launch dates; we will meet them when we reach them. It would be wrong to give dates," he commented.

Spooner said the company would nonetheless concentrate on adding value to its product through licensing deals and partnerships, but added it would not be tempted to stray outside the medical product market.

"We have had approaches to work with or supply product to builders, car makers and pump companies, but we are committed to staying in the high value market with our product," he said. "We will not go outside the medical device industry, although we have had plenty of requests," he noted.

Spooner was less definite about possible future funding options, admitting the possibility of sourcing overseas funding from what he said was now "an industry without borders". Although claiming that Ventracor was firmly rooted in Australia, he did not rule out the possibility of overseas funding options. "The markets we are in no longer have national boundaries," he noted.

Spooner finished by describing new avenues and links to hospitals and surgeons. These were being forged by the company to maintain what he described as "fundamental" relationships with doctors, other device companies and manufacturing capabilities.