PALO ALTO, Calif., June 2, 2014 /PRNewswire/ -- AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today reported published results that show that acceptable levels of radiation can be delivered to target tissue through the AeroForm patient-controlled breast tissue expander.
“By testing radiation delivery levels on a phantom model, we were able to confirm that it’s possible for breast cancer patients to receive adequate doses of radiation therapy while undergoing patient-controlled tissue expansion as part of the breast reconstruction process,” said Janaki Moni, M.D., lead author of the study that appeared online in the journal Practical Radiation Oncology on May 27. “These are important findings because many women start to undergo the first stages of breast reconstruction during their mastectomy surgery and radiation is often required afterwards to ensure that all of the cancer has been destroyed. Based on data from clinical trials published to date, the patient-controlled expander represents a significant improvement over standard saline expansion in terms of patient satisfaction, pain levels and expansion time, so we’re pleased to see that it could be possible for women undergoing breast reconstruction to have this as an option during various stages of their cancer treatment.”
The AeroForm device is an injection-free, patient-controlled tissue expansion system that is CE Marked, approved in Australia and under clinical investigation in the United States. Dr. Moni is a radiation oncologist at UMass Memorial Medical Center in Worcester, Mass.
According to the study results on the phantom model, clinically-acceptable amounts of radiation were delivered despite the presence of carbon-dioxide and a metallic reservoir. Radiation doses deviated from their normal path in the shadow of the metallic reservoir without any clinically-relevant dose decrements at the AeroForm -skin interface. Experiments for the current study were conducted using a 3-dimensional rendition of a 2-dimensional plan using standard tangent fields with 6-MV photons. These experiments are not designed to comment on the use of intensity modulated radiation therapy and only reflect results based on using the Varian Eclipse treatment planning system, AAA-8615 calculation algorithm.
“This new study adds to the growing body of clinical data showing that the AeroForm is a viable tissue expansion option for women at various stages of their cancer therapy,” said Scott Dodson, AirXpanders President and Chief Executive Officer. “We are actively working to enroll the final patients into the XPAND U.S. pivotal study, and remain on track to complete the study this summer, while we simultaneously roll out AeroForm to key plastic surgeons in the Australian market.”
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.
Tel. 917-497-2867
E-mail: esandoval@lazarpartners.com
SOURCE AirXpanders Inc.
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