Tissue Expansion Device Approved in Australia

Australia’s Therapeutic Goods Administration (TGA) has greenlighted a needle-free, patient-controlled breast tissue expansion system made by AirXpanders Inc.

The approval of AeroForm stems from positive safety and efficacy outcomes from three prospective clinical trials–-the Patient Activated Controlled Expansion (PACE) I and II studies and ASPIRE–-led by Australian plastic surgeon Tony Connell, M.D., F.R.A.C.S.

“AeroForm represents a tremendous step forward in tissue expansion, and, in my opinion, is the single most important technological advance in breast reconstruction in 30 years,” said Connell, who has implanted more than 100 AeroForm devices. “Over the last four years that I have been implanting AeroForm tissue expansion devices as part of the Australian clinical trials, I’ve seen tremendous benefits for patients including better aesthetic outcomes, faster expansion and significantly less pain. My patients like the fact that AeroForm puts them in control of recovering their shape while offering them a needle-free and faster option for expansion compared to traditional saline devices. Many of my patients live far away and it is inconvenient for them to come into the office for multiple saline injections. With the AeroForm device , their visits are greatly reduced which is less disruptive to their daily lives.

Women in the Australian PACE trials who received the injection-free, patient-controlled AeroForm expansion systems completed their expansion in an average of 17 days with 100 percent treatment success and no device-related adverse events. Traditional saline expansion requires women to visit their physician for weekly injections until they complete the process, which can take up to six months. All PACE trial participants who received AeroForm had a successful expansion and completed their reconstruction with placement of traditional breast implants.

The company initially is launching AeroForm to a select number of surgeons in Sydney, Melbourne and Perth who gained experience with AeroForm under special permission by the TGA. The five surgeons, including Connell, will pool their results in a post-market registry called ASSIST.

“I’m excited that we have reached this regulatory milestone that allows us to commence the world’s first commercial rollout of AeroForm,” said Scott Dodson, AirXpanders president/CEO. “Approval in this market would not have been possible without the support of Dr. Connell and the feedback and input we’ve received from Australian physicians. Results from the three Australian trials will be leveraged in other markets so women around the world can have an expansion option that improves upon the current standard of care during their reconstruction process and gives them more effective results.”

The TGA approval comes more than 18 months after CE Mark certification in November 2012. Results from 138 U.S. patients enrolled in a prospective, randomized, controlled, open-label pivotal study (XPAND) will form the basis for the company’s 510(k) application with the U.S. Food and Drug Administration (FDA).

The most frequently used method of breast reconstruction involves tissue expansion followed by placement of a breast implant. In the traditional method for expansion, a surgeon places a saline tissue expander under the skin and pectoral muscle following the mastectomy. During subsequent office visits, the surgeon inserts a needle through the skin and muscle into a magnetic port to inject a bolus of saline into the expander to the level tolerated by the patient.

In 2009, breast cancer was the most common cancer in Australian women (excluding non-melanoma skin cancer), accounting for 27.4 percent of all new cancers in women, according to industry statistics. The incidence of breast cancer is expected to escalate over the next five years, with the number of new cases surpassing 17,000. Australians run a higher risk of contracting the disease (one in nine).

AirXpanders is a tissue-expansion company focused on the area of breast cancer reconstruction. The Melbourne-based firm is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital and Shalon Ventures.