News & Insights

At MedTech World 2025 in Malta, Ascend CRO's Joseph Panetta sat down with Nick from MedTech World to discuss why Australia has become the go-to destination for medical device clinical trials and how Ascend CRO's boutique approach is helping MedTech companies achieve their regulatory milestones.

The Australian Advantage: 43.5% Tax Rebate for Clinical Research

When it comes to conducting medical device clinical trials, location matters. Joseph Panetta explains why Australia stands out among global clinical research destinations:

Financial Incentive: The Australian government offers a 43.5% tax rebate on research and development. In practical terms, a $300,000 clinical trial effectively costs just $175,000—a significant cost reduction that makes Australia highly competitive for early-stage and pivotal trials.

World-Class Clinical Infrastructure: Australia boasts world-renowned physicians, cutting-edge clinical sites, and medical professionals eager to work with emerging technologies.

FDA-Aligned Regulatory Pathway: The Therapeutic Goods Administration (TGA) maintains regulatory standards closely aligned with the FDA, making Australia a recognized center of excellence for producing tier-one quality clinical data that the FDA accepts for regulatory submissions.

Ascend CRO: A Boutique Approach to Clinical Trial Management

Unlike large global CROs, Ascend CRO has deliberately maintained a boutique structure with approximately 20 team members. This "Goldilocks approach"—not too big, not too small, just right—allows for personalized service throughout the entire clinical trial journey.

Impressive Track Record

In the last year alone, Ascend CRO has:

• Served 14 sponsors across 25 clinical trials

• Worked across 9 therapeutic categories

• Achieved a 95% success rate in helping sponsors reach their next milestone (additional funding rounds, new indications, or progression to further research)

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Therapeutic Expertise

Ascend CRO specializes in medical device trials across multiple therapeutic areas:

• Orthopedics

• Cardiology

• Women's intimate health

• Men's intimate health

• Respiratory and pulmonary

• Robotics and AI-powered devices

• Software as a Medical Device (SaMD)

The team brings nearly 50 years of collective experience in medical device clinical research, with a deliberate focus on MedTech rather than pharmaceutical trials.

Comprehensive Clinical Trial Support Across Australasia

For MedTech companies navigating the complexities of clinical research, Ascend CRO offers end-to-end support:

• Protocol design and development

• Regulatory submissions and TGA liaison

• Local sponsor services

• Clinical field specialists and on-site monitoring

• Data management and analysis

• FDA and CE Mark pathway guidance

As Joseph notes, "Australia is a long way away" for many international sponsors. Ascend CRO bridges that gap by providing boots-on-the-ground support throughout the trial lifecycle, ensuring sponsors can confidently conduct research in Australasia without the need for constant travel.

Emerging Technologies: Robotics, AI, and Software-Driven Medical Devices

At MedTech World 2025, the focus on emerging technologies was clear. Ascend CRO is actively involved in clinical trials for:

• Robotic surgical systems

• AI-powered diagnostic tools

• Software as a Medical Device (SaMD)

• Next-generation medical technologies

These innovative device categories require specialized regulatory knowledge and clinical expertise—areas where Ascend CRO's boutique approach and deep experience deliver significant value.

From First-in-Human to Pivotal Trials

Whether you're conducting first-in-human studies or pivotal trials for FDA submission, Australia offers a compelling combination of financial incentives, regulatory alignment, and clinical excellence. The TGA's recognition by the FDA means that data generated in Australian trials carries weight in US regulatory submissions, making it an ideal starting point for global medical device commercialization.

Why Choose a Boutique CRO?

The Ascend CRO philosophy is simple: maintain a tight-knit team that can deliver comprehensive, personalized service. From sponsors who are unclear about protocol design to those needing full regulatory and clinical support, the boutique model ensures attention to detail and responsive partnership throughout the trial process.

As Joseph Panetta describes it: "We're the Goldilocks CRO. We're just the right fit."

Full Interview Transcript

Hi, Nick here, MedTechWorld 2025. Joseph Panada sitting here with me. Ascend CRO doing big things in Australia and working with a range of partners for a score of years.

Indeed, all of Australasia. Thank you so much. It's wonderful to be here in Malta at MedTechWorld.

Wonderful. It's great to have you. Why specifically that market? I'm understanding there's a system where there's a rebate in tax.

The data is exceptional. Do you need other reasons why? You know, a lot of MedTech sponsors and a lot of sponsors who are looking to do research have multiple opportunities. There are a lot of places in the world with animal labs, with physicians, with sites, with capabilities, but not all clinical destinations are created equal.

And what we find about Australasia and Australia in particular, the government incentivizes you to do your research there. So it is a 43.5% tax rebate on research. Meaningfully, that's a $300,000 trial costs you $175,000.

So that's a big difference. Then you've got world renowned physicians. You've got clinical sites eager to dig into technology.

And probably most important, the TGA, which is the regulatory body in Australia, is very aligned to the FDA. And so the FDA looks at Australia as a center of excellence, producing tier one quality data. So if you're doing first in human or pivotal, the FDA will actually regard tier one quality data coming out of Australia as part of your trial outcomes.

Can you give me a bit of a lowdown, a quick lowdown, A to B, start to finish, how your story began with the company Ascend and where you are now as regards to on the ground. Absolutely. Our partners got together quite some time ago.

I think collectively, we have something like nearly 50 years of experience in the company. And just in the last year alone, we've served 14 sponsors for 25 clinical trials, over nine therapeutic categories, and 95% of our sponsors achieve their next milestone, whether that is an additional round of funding or a new indication, or the ability to move on to more research. And you can handle more at the time.

That's a huge amount of individuals, it's a huge amount of data handling, and also this cross-sectoral. So which different nine key areas were you exploring? We are cross-therapy. So we do ortho, cardiology, women's intimate health, men's intimate health, respiratory and pulmonary.

We really run the gamut. There is not much we don't do. We don't do pharma.

We are med tech specific. We've done a lot in robotics lately. And it's interesting when we come to locations like this, where we see the emerging technologies.

And I mean, real technologies, things that are AI powered, software driven, and even robotics that are fascinating. And these are ones that you're interested in sponsoring? Well, we are doing some research currently in robotics and some with software, and software as a medical device. But what's really interesting is the fact that we are a boutique CRO.

We don't have designs on becoming this global behemoth, because we believe that when you keep it small and tight, we're 20-ish people, you can really serve your sponsors from soup to nuts. Everything from I don't know what a protocol looks like through the regulatory process, what do I want my data to deliver, all the way into I need a local sponsor, I need clinical field specialists, Australia is a long way away, and I can't be there to monitor my patients. We can do all of those things.

So I kind of refer to us as the Goldilocks CRO. We're just the right fit. Wonderful.

It's been amazing having you on the team. And thank you for being and with MedTechWorld. We couldn't thank you enough.

Thanks, Justin. Nicholas Jackman, signing off from MedTechWorld.

Ready to leverage Australia's clinical trial advantages? Contact Ascend CRO to discuss how our boutique approach can support your medical device development from first-in-human through FDA submission.