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FDA Grants AirXpanders, Inc. an Investigational Device Exemption to Begin Pivotal Study of an Investigational Tissue Expansion System for Women Undergoing Breast Reconstruction After Mastectomy


8/29/2011 9:00:17 AM

PALO ALTO, CA--(Marketwire - August 29, 2011) - AirXpanders Inc., a company developing technology to address current unmet needs for patients who require tissue expansion for reconstructive surgery, today announced the U.S. Food and Drug Administration (FDA) has granted the company an Investigational Device Exemption (IDE) to begin a clinical study of its AeroForm™ breast tissue expansion device in mastectomy patients undergoing breast reconstruction. The prospective, randomized, controlled, open-label pivotal study, XPAND (AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction), will be conducted at multiple centers across the U.S. and the results will be used as the basis for AirXpanders' AeroForm 510(k) filing with the FDA.

"Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and sometimes painful weekly bolus saline injections to create a pocket for a permanent implant following mastectomy," said V. Leroy Young, M.D., FACS, Principal Investigator of the XPAND study. "This investigational, remote-controlled system eliminates the need for saline injections by using compressed carbon-dioxide that is gradually released through a small internal valve to fill the expander. The patient will be able to inflate the expander at home using a small, hand-held wireless remote control on a daily basis, eliminating the need for weekly doctor visits."

Currently, surgeons implant a saline tissue expander under the skin and pectoral muscle at the site of the mastectomy. During subsequent weekly office visits, which can last for more than 22 weeks, the surgeon will insert a needle through the skin into the tissue expander's port and inject as much saline into the temporary implant as the woman can tolerate.

AirXpanders designed the AeroForm tissue expander to address the limitations of traditional saline expanders. The system consists of a technologically advanced self-contained tissue expander and a small hand-held wireless remote control. The AeroForm system uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander. Following a standard procedure to implant the expander, the patient can use the remote control at home to perform the expansion process as directed by the surgeon.

During the company's feasibility trial in Australia, the average expansion time associated with the AeroForm remote-controlled tissue expander was 15 days, a fraction of the time typically required using traditional saline expanders.

"We're pleased the FDA has granted us approval to start our pivotal study," said Scott Dodson, AirXpanders President and Chief Executive Officer. "We see an opportunity to help mastectomy patients restore their shape after the devastating effects of breast cancer and put some degree of control over recovery in their hands. We look forward to beginning study enrollment and collecting the data that will be submitted to the FDA in support of our 510(k) application. Given the positive momentum for the company at this time, we are initiating a new round of financing to support clinical and commercial activities for the near term and are soliciting new investors, who would participate side-by-side with our already strong lineup of existing investors."

"We are fortunate to have such committed investors and expect full insider participation," continued Dodson. "It's always good, however, to improve the capacity around the table, which is what we will seek to do with this round."

AirXpanders has previously raised $8 million through a $5 million Series C Financing led by GBS Ventures in April 2010 and an additional $3 million working capital line from Oxford Finance Corporation in February 2011.

The randomized, controlled clinical trial is designed to directly compare the outcomes of tissue expansion using the traditional saline expansion method to the investigational AeroForm, remote-controlled, needle-free tissue expander. Enrollment will continue until a total of 92 AeroForm devices have been implanted and 46 saline expanders have been implanted.

Participating sites include hospitals in Atlanta, Boston, New York, St. Louis, San Diego and other cities across the U.S.

For more information on the study, please visit clinicaltrials.gov and search "XPAND."

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 body 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 current standard-of-care allows. At this time, AirXpanders' products are not cleared or approved for sale. AirXpanders is backed by GBS Venture Partners, Prolog Ventures, Heron Capital and Shalon Ventures.


Media Contact
Hollister Hovey
Lazar Partners Ltd.
hhovey@lazarpartners.com
646-871-8482

Company Contact
Scott Dodson
President & CEO
sdodson@airxpanders.com
650-390-9008


Read at BioSpace.com

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