AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems.
The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of CO2 up to three times a day.
This study was the first of its kind to report on a novel breast expansion technology combined with a newer reconstructive technique, according to the company. The retrospective analysis evaluated 115 patients with 185 breast reconstructions in a single institution. Of these reconstructions, 74 (40%) used the AeroForm tissue expander, and 111 (60%) used traditional saline expanders. Key findings in the paper, published in the journal Plastic and Reconstructive Surgery included:
- More adverse events in the saline group as compared to AeroForm (45.9% versus 32.4%).
- No post-operative wound infections or full-thickness skin necrosis in the AeroForm cohort, compared with 5.4% of each in the saline group.
- The AeroForm cohort showed reduced time to expand versus saline (an average of 45 days versus 87 days) and reduced time to reconstruction (an average of 94 days versus 143).
“The clinical benefits we have noted include the ability to expand gradually in less time, elimination of the risk of iatrogenic introduction of bacteria into the implant pocket, elimination of the chance for iatrogenic rupture during needlesticks, and the ability of the patient to expand at their own rate depending on the patient’s level of comfort,” the paper’s authors wrote. “The benefits from a patient care perspective include less burden on the patient for clinic visitation and decreased utilization of healthcare resources during the fill process. Moreover, this expands the ability for breast centers to care for more patients since the time scheduled for expansions is eliminated and patients who live farther away require fewer visits for expansion.”
The principal author, Dr. Karan Chopra, is chief resident in the Department of Plastic & Reconstructive Surgery at Johns Hopkins University in Baltimore. Co-authors included Dr. Devinder Singh, chief of plastic surgery at Anne Arundel Medical Center in Annapolis and Dr. Luther Holton III, also from Anne Arundel Medical Center’s plastic surgery division.
“The data suggest that reducing multiple needle sticks may be a contributing factor in reducing rates of infection and the consistent weight of the gas-filled AeroForm Expander may explain the reduced necrosis rates,” said AirXpanders president & CEO Frank Grillo in a prepared statement. “This is significant for both the hospital and patient in terms of readmission costs and quality of care.”
In August, AirXpanders said that it had closed funding rounds worth approximately $15 million in total, including an approximately $11.2 million (AUD $15.7 million) rights offering and US-based private placement with approximately $3.4 million (AUD $4.6 million). In 2017, the company said that it raised $15 million in debt financing from Oxford Finance.