World’s First Needle-Free, Patient-Controlled Tissue Expansion Device for Women Undergoing Breast Reconstruction Following Mastectomy Approved in Australia.
Australian women will benefit from this new technology which aims to minimise some common barriers to breast reconstruction such distance to services and pain associated with expansion.
PALO ALTO, Calif. (November 4, 2013) – AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced that AeroForm®, the world’s first and only needle-free, patient-controlled tissue expansion system has been approved in Australia. The Therapeutic Goods Administration (TGA) approval comes as a result of 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, MD, FRACS.
Patient Controlled Tissue Expander
“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,” Dr. Connell said. “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 love 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 incredibly 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.”
Dr. Connell has implanted over 100 AeroForm devices to date, making him the most experienced plastic surgeon with this technology in the world.
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% 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 will initially launch 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 Dr. Connell, will pool their results in a post-market registry called ASSIST.
“I’m incredibly excited that we have reached this important regulatory milestone that allows us to commence the world’s first commercial rollout of AeroForm,” said Scott Dodson, AirXpanders President and Chief Executive Off icer. “Approval in this important market would not have been possible without the tremendous support of Dr. Tony Connell and the invaluable feedback and input we’ve received from Australian physicians. Results from the three Australian trials will be lever aged 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 occurs following a European CE Mark certification, which was secured in November 2012. Results from 138 patients enrolled in the U.S. in a prospective, randomized, controlled, open-label pivotal study (XPAND) will be 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 pec toral 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. The incidence of breast cancer in Australia is increasing: in 2009, the number of new cases of breast cancer diagnosed in women increased to 13,668, from 5,317 in 1982.1 In 2020, it is estimated that there will be 17,210 new cases of breast cancer diagnosed in women. While the US rate of developing breast cancer in women is 1 in 8, the risk in Australia is close behind at 1 in 9 women.
AirXpanders Inc. (www.airxpanders.com), is a tissue-expansion company focused on the area of breast cancer reconstruction. By employing a revolutionary patient-controlled expander, activated by a wireless remote control, the often painful process of recovering one’s feminine shape after cancer can potentially be eased with this needle-free technology that is easy to use and may enable the patient to proceed to a permanent implant much faster than the cur rent standard-ofcare. At this time, AirXpanders’ products are not cleared or approved for sale. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital and Shalon Ventures.