AirXpanders Inc., a company developing technology to address current unmet needs for patients who require tissue expansion for breast reconstruction surgery, today announced that it has secured $10 million in Series D financing. The round includes $7 million from new investor Vivo Ventures and $3 million from existing investors GBS Venture Partners, Prolog Ventures, Heron Capital and WTI.
Proceeds from this financing will be used to support the company’s efforts to complete its ongoing Investigational Device Exemption (IDE) study of the AeroForm(TM) Patient Controlled Tissue Expander System in the U.S., obtain a CE Mark and to execute market launches in the U.S., Europe and Australia following clearance. The results of the IDE study will be used to support the company’s 510(k) application in the U.S. later this year.
“We believe that AirXpander’s AeroForm tissue expansion system has the potential to provide hundreds of thousands of women who have a mastectomy a more patient-friendly and potentially faster expansion method than what is currently available in order to prepare them for their permanent breast implant,” said Albert Cha, MD, Managing Director, Vivo Ventures. “Given the strong initial clinical data, we believe that AeroForm represents the first major advance in breast reconstruction in decades.”
The AeroForm Patient-Controlled Tissue Expander System consists of a self-contained expander – which is implanted in the same manner as a traditional saline expander following mastectomy – and a small hand-held wireless remote control unit. A small lipstick-sized carbon dioxide reservoir in the expander gradually releases carbon-dioxide through a small internal valve, eliminating the need for invasive weekly saline injections typically associated with current on-market expanders. Following a standard implant procedure, the patient can fully regulate the expansion protocol directed by their surgeon at home.
Tissue expansion is required during breast reconstruction to adequately stretch the skin and underlying muscle in order to create a space to insert the permanent breast implant. Currently, the only commercially available option for patients is insertion of a saline tissue expander under the skin and pectoral muscle at the site of the mastectomy. During subsequent weekly office visits, the surgeon inserts a needle through the skin into the tissue expander’s port and injects as much saline into the temporary implant as the woman can tolerate, until full expansion is achieved. Today’s expansion process can take up to several months to complete.
Data from the company’s published feasibility trial in Australia, suggests that the average expansion time associated with the AeroForm remote-controlled tissue expander may be as short as 15 days. A more extensive pivotal study is currently underway in the United States.
The results of an earlier pre-clinical animal study appear in the January issue of the Aesthetic Surgery Journal, the peer-reviewed journal of the American Society for Aesthetic Plastic Surgery. Results showed that all 12 paired devices performed to specification and achieved successful expansion with no adverse events.
“We thank Vivo Ventures and our current investors for supporting the company to achieve a goal of offering the roughly 250,000 women who undergo a mastectomy in the U.S. each year a new, more convenient, needle-free option to expand tissue during breast reconstruction surgery,” said Scott Dodson, AirXpanders’ President and Chief Executive Officer. “We are confident that our device will prove to be a significant advancement in breast reconstruction allowing patients greater control, convenience and potentially less discomfort than the current technology provides.”
About Vivo Ventures Founded in 1996, Vivo Ventures is a healthcare investment firm focused on investing in and building high quality companies in the U.S. and China. With more than $1 billion under management, Vivo employs a unique multi-pronged strategy of identifying and working with companies with promising later development stage products in the U.S. and revenue stage companies in China. Vivo Ventures has offices in Palo Alto, California, Shanghai, China and Chengdu, China.
About AirXpanders AirXpanders Inc., 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 recovering one’s feminine shape after cancer can potentially be eased with this needle-free technology that 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 and Shalon Ventures.
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