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PALO ALTO, Calif. (November 24, 2014) – AirXpanders, Inc., a company developing novel technology for women undergoing tissue expansion for breast reconstruction following a mastectomy, today announced that Australian Therapeutic Goods Administration (TGA) has officially approved the AeroForm® needle-free, patient-controlled tissue expansion system for reimbursement. AeroForm will appear on the Australian Prosthesis List in late-November.

 

The TGA’s decision follows the agency’s approval of the technology in November 2013, which resulted from positive safety and efficacy outcomes from three prospective clinical trials—the Patient Activated Controlled Expansion (PACE) I and II studies and ASPIRE study—led by Australian plastic surgeon Tony Connell, FRACS.

 

Dr. Connell's final PACE II data, which reported that patients who received the AeroForm expanders were able to complete their expansion in 17 days on average, was recently published online in the October 2014 issue of Plastic and Reconstructive Surgery, the journal of the American Society of Plastic Surgeons (ASPS). Dr. Connell is one of five plastic surgeons in Australia who are participating in a limited market release of the AeroForm technology. A full market release is planned for mid-year 2015.

 

“I look forward to breast cancer patients having access to a breast tissue expansion option with improved aesthetic outcomes and a less painful, faster expansion process,” Dr. Connell said. “With the AeroForm device, patients can complete expansion in the comfort of their own homes without the need for weekly office visits to receive bolus saline injections that are required with traditional expanders. This approval for reimbursement can provide cost savings for patients who want greater control over their expansion and a more comfortable experience."

 

The Australian Government Prostheses List Arrangements allow for a defined benefit to be paid for implantable medical devices. Under the Private Health Insurance Act 2007, private health insurers are required to pay mandatory benefits for a range of prostheses that are provided as part of an episode of hospital treatment (or hospital substitute treatment) where a Medicare benefit is payable for the associated professional service (surgery).

 

“The TGA’s reimbursement approval of the AeroForm expander is a tremendous milestone which will significantly improve the reconstruction process for Australian patients,” said Scott Dodson, president and chief executive officer of AirXpanders. “We look forward to providing more physicians with our innovative technology and improving care for post-mastectomy patients who desire a faster expansion and less pain prior to breast reconstruction.”

 

The most common 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 chest 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 2010, breast cancer was the most common cancer in Australian women (excluding non-melanoma skin cancer), accounting for 28 percent of all new cancers in women, according to the Australian government.^1,2 The incidence of breast cancer in Australia is increasing: in 2010, the number of new cases of breast cancer diagnosed in women increased to 14,181 from 5,303 in 1982.¹ In 2014, about 15,270 Australian women are expected to be diagnosed with breast cancer.³ In 2020, it is estimated that there will be 17,210 new cases of breast cancer diagnosed in women.³

 

About AirXpanders

 

AirXpanders, Inc., is a medical device company focused on the area of tissue expansion. The AeroForm device is specifically designed for breast reconstruction and is the first product developed by AirXpanders. 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 be improved 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 current standard-of-care. AirXpanders plans to develop tissue expanders that can be used in other therapeutic areas, such as burns and pediatrics. At this time, AirXpanders’ products are not cleared or approved for sale in the U.S. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Correlation Ventures and Shalon Ventures. For more information, please visit: http://www.airxpanders.com/.

 

¹ Australian Cancer Incidence and Mortality (ACIM) Books - Breast cancer for Australia (ICD10 C50). http://www.aihw.gov.au/acim-books/  [Accessed March 2014].

 

² Australian Cancer Incidence and Mortality (ACIM) Books – All Cancers combined for Australia (ICD10 C00-C97, D45-46, D47.1, D47.3).

 

³ Australian Institute of Health and Welfare 2012. Cancer incidence projections: Australia, 2011 to 2020. Cancer Series no. 66. Cat. No. CAN 62. Canberra: AIHW.

 

 

 

Media Contact

Caitlin Nolan

MSLGROUP

AirXpanders@mslgroup.com

415-512-0770

 

 

Company Contact

Scott Dodson

President & CEO

sdodson@airxpanders.com

650-390-9008

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