Another reason we decided to focus on Australia as a key market was data receptivity, which is incredibly high for submissions that are going into the FDA or other regulatory bodies around the world. Therefore, we took this as an opportunity to complete our clinical trials and take a look at our early-stage commercial marketing.

DOTmed News: What kind of regulatory hurdles, if any, have you faced with international expansion?

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SD: Every market has its own regulatory hurdles. We’ve found that the best approach is to partner with very strong local sponsors to help navigate the regulatory pathway. We have also been able to partner with excellent key opinion leaders whom we have worked closely with to make continuous improvements to our device and assist in publishing their clinical experiences in peer-reviewed journals.

DOTmed News: How has AirXpanders’ expansion in Australia helped position it for success in the U.S.?

SD: Expanding into Australia has set us up nicely as we aim to go to market in the U.S. In April, we completed patient enrollment in our U.S.-based, multi-center, prospective, randomized, controlled, open-label pivotal study of 150 patients using AeroForm.

The study was designed to directly compare outcomes in two-stage breast reconstruction, including successful expansion to implant exchange, average number of days to achieve the desired expansion, total reconstruction time, pain and patient satisfaction with AeroForm versus traditional saline expanders.

We have also been able to fine tune our sales model so that we can predict the uptake within a given hospital based on surgeon support. This experience is scalable and portable into other markets that we will move into as we gain regulatory approvals.

DOTmed News: What international markets are you going after next?

SD: We have targeted several Asian countries, including Japan, South Korea and China. Since there are greater regulatory hurdles in these countries, we plan to use our anticipated FDA approval to serve as a basis for regulatory submissions in Asia.

DOTmed News: What is your advice to companies looking to develop an international marketing strategy?

SD: It’s critical to understand each market and why you want to go into it because that impacts everything. Focus not only on the individual country, but also on what you are trying to achieve.

There are four main things to keep in mind when expanding into international markets:

1. Enlist either a local agent or a direct representative to serve as your key point of contact in that market. Trying to do international business remotely from the U.S. is difficult and doesn’t always work.

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