AirXpanders Data Shows Radiation Therapy After Mastectomy Does Not Affect Mechanism in AeroForm™ Expander
PALO ALTO, Calif. (October 28, 2013) – AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced new data published in The Journal of Radiation Oncology that demonstrates the AeroForm™ Tissue Expander can withstand radiation levels well above the maximum dose level typically used in post-mastectomy radiation therapy. “Once a woman undergoes a mastectomy, she may still have to undergo radiation therapy. AeroForm offers women a more gradual, patient-controlled option for expansion, and I’m pleased to see that the device is unaffected even by extremely high levels of radiation,” said James L. Rembert, M.D., a radiation oncologist at Alta Bates Summit Comprehensive Cancer Center, Berkeley, Calif. “It is further proof that women who require additional radiation can feel confident that the AeroForm will not be impacted, so that they can continue to make progress towards regaining their shape even while continuing to receive treatment.” The study determined that the electronics inside the AeroForm expander continued to function properly after exposure to radiation levels up to 75 Gy – well above the maximum dose level (usually 50-60 Gy). Following radiation exposure, thirty-two tissue expanders were functionally tested, and each was successfully able to establish communication with the dosage controller and deliver three CO2 doses according to product specifications. A second, separate poster presented at the American Society for Radiation Oncology (ASTRO) by Jeffrey Kuo, M.D., at the University of California at Irvine demonstrated that the AeroForm expander did not significantly impede the delivery of radiation doses compared to dosing in breast cancer patients who have intact breasts. Results showed that measured skin doses varied only from -12 to +12%, and suggested that CT scans can help optimize dose variation. The annual ASTRO meeting took place September 22-25, 2013 in Atlanta. “We are committed to providing clinical evidence that illustrates the benefits of a patient-controlled, gas filled expansion system. This data confirms that AeroForm is not adversely affected by radiation therapy, and there is minimal interference in the delivery of radiotherapy with an AeroForm implant in place,” said Scott Dodson, AirXpanders President and Chief Executive Officer. “As with all tissue expanders, the decision to use radiotherapy in conjunction with a tissue expander is at the discretion of the radiation oncologist and plastic surgeon. We are diligently working towards regulatory approval in Australia, and expect to complete U.S. trial enrollment by the end of the year.” About AirXpanders 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 reclaiming one’s body after cancer can potentially be eased with this needle-free technology. This technology is easy to use and may enable the patient to proceed to a permanent implant much faster than the current standard-of-care. 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, Shalon Ventures, Correlation Ventures and Western Technology Investments.
Media Contact: Erich Sandoval
Lazar Partners LTD.