AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale, and distribution of the AeroForm® Tissue Expander System, today announced the publication of a study describing early clinical results of a treatment planning method for patients undergoing post-mastectomy radiation therapy (PMRT) with implanted AeroForm Tissue Expanders.
“The primary aim of this study was to examine the effects of radiation treatment on AeroForm Tissue Expanders and to describe the planning protocol for these patients. Our findings revealed that it is feasible to plan with a conventional 3D planning technique that is reproducible and the early outcomes of AeroForm patients treated with external beam radiation therapy are similar to patients without AeroForm Tissue Expanders,” said Dr. Yvonne Zissiadis, Genesiscare, Lead Investigator of the study.
President & CEO of AirXpanders Frank Grillo noted the study results showed AeroForm is compatible with radiation therapy and provides information to aid radiation oncologists who are unfamiliar with how to develop treatment plans for patients with the device in place.
“It is very encouraging to see such positive results which demonstrate that radiation therapy can be used with AeroForm patients. We very much appreciate the support of Dr. Zissiadis and Jennie Gilliman and thank them for sharing their findings at a notable event like the recent Melbourne International Joint Breast Congress, and discussing their experience of our breakthrough AeroForm technology with the surgeon community,” said Mr. Grillo.
The study reviewed eight patients with AeroForm who underwent external beam radiation therapy. Acute side effects were assessed at two, four and six weeks during radiation therapy and at six weeks after the final treatment.
The treatment planning method in the study used a 3D conventional planning technique with density overrides that were applied to account for factors such as the presence of air and position of the metallic reservoir within the expander. The authors concluded “it is feasible to plan radiation therapy in patients with air tissue expanders requiring chest wall (with or without nodal) irradiaton using appropriate planning technique and density overrides applied to critical structures.”
Findings from the study were presented by Dr. Zissiadis’ co-author, Jennie Gilliman, at the recent Melbourne International Joint Breast Congress (MIBC), a joint congress of the Australasian Society for Breast Disease (ASBD), 4th World Congress on Controversies in Breast Cancer (CoBrCa) and Breast Surgeons of Australia and New Zealand (BreastSurgANZ). The event covers issues in breast diseases and includes presentations, debates and discussions.
The study was also published in the Journal of International Radiology and Radiation Therapy.