AirXpanders

AirXpanders, Inc., which now operates under the name DMK Pharmaceuticals, was a medical device company established in 2005. The company was founded by Daniel Jacobs, a plastic and reconstructive surgeon from California, who also served as the company's chief medical officer. Dr. Jacobs' background in plastic surgery directly informed the company's core product, the AeroForm Tissue Expander System. This system was developed to offer a less burdensome alternative to traditional saline-based tissue expansion for women undergoing breast reconstruction after a mastectomy.

The AeroForm system is a patient-controlled, needle-free device. It consists of a self-contained tissue expander made of silicone, which is placed under the skin and pectoral muscle. A handheld wireless controller allows the patient to administer small, 10cc doses of carbon dioxide from an internal reservoir to gradually inflate the expander. This process is designed to be completed over a period of 10 to 17 days, a significantly shorter timeframe than the several months often required for saline injections. The primary benefit for patients is the convenience of managing the expansion process from home, eliminating the need for frequent and often painful visits to a surgeon's office for saline injections.

AirXpanders targeted the breast reconstruction market, serving post-mastectomy patients. The company's business model revolved around the sale of its AeroForm device to hospitals and surgical centers. The company achieved several significant milestones, including receiving CE Mark approval in Europe in 2012 and De Novo clearance from the U.S. Food and Drug Administration (FDA) in December 2016, allowing for its commercialization in the United States. However, the company faced substantial financial difficulties, leading to its voluntary delisting from the Australian Securities Exchange (ASX) and the appointment of voluntary administrators in June 2019 to restructure its operations. Subsequently, the company underwent a recapitalization and transitioned its focus, re-emerging as DMK Pharmaceuticals.

Keywords: medical device, breast reconstruction, tissue expander, post-mastectomy, patient-controlled, carbon dioxide, surgical devices, reconstructive surgery, FDA clearance, MedTech