AirXpanders Secures $7 million Senior Secured Credit Facility from GE Capital
Credit facility to support completion of AeroForm™ U.S. pivotal trial and pre-commercialization activities
BETHESDA, Md. and PALO ALTO, Calif. (April 2, 2014) – AirXpanders Inc., a company developing an alternative technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced that it has secured a $7 million senior secured credit facility from GE Capital, Healthcare Financial Services, of which $3.5 million has been funded. GE Capital is acting as administrative agent and sole lender for the credit facility.
AirXpanders’ AeroForm is an injection-free, patient-controlled tissue expansion system under investigation in the United States. The credit facility will be used primarily to fund the completion of the U.S. clinical trial and implement semi-automation into the AeroForm manufacturing process to increase throughput as the company seeks to file for 510(k) clearance in the U.S. Outside of the U.S., the company will initiate a limited market release in Australia, following Australian Therapeutic Goods Administration (TGA) approval in November 2013, in addition to conducting a key opinion leader assessment in Europe. The credit facility from GE Capital provides additional flexibility for AirXpanders’ product development needs.
“We thank GE Capital for supporting the company as we work towards our goal of offering women who undergo a mastectomy a new, more convenient, needle-free option to expand tissue during breast reconstruction surgery,” said Scott Dodson, AirXpanders’ President and Chief Executive Officer. “As we conclude our U.S. trial and await regulatory approval, we are confident that our device will prove to be a significant advancement in breast reconstruction allowing patients greater control, convenience and a faster method of recovering their shape than the current technology provides.”
Results from clinical studies of AeroForm in Australia demonstrate that women are able to complete their expansion within an average of 17 days, while traditional saline expansion requires women to visit their physician for frequent injections until they complete the process, which can take several months.
“We’re pleased to provide financing to AirXpanders given their novel approach to tissue expansion for those who seek breast reconstruction,” said Neil Bonnano, segment leader, GE Capital, Healthcare Financial Services, Life Sciences. “We are excited to support such a promising company through its development phase.”
According to the American Cancer Society about 232,670 new cases of invasive breast cancer will be diagnosed in women in 2014.[i] Roughly 250,000 women undergo a mastectomy in the U.S. each year.
About GE Capital, Healthcare Financial Services
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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 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 in the United States. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital and Shalon Ventures.
GE Capital Contact
GE Capital, Healthcare Financial Services
Maria C. Moreno
GE Capital, Americas
Lazar Partners Ltd.
President & CEO
[i] American Cancer Society: 2014 Breast Cancer Statistics