Section: Start-Ups Across Health Care
Emerging Company Profile: AirXpanders Inc.
Title: Compressed CO2 expands tissue for breast cancer
Women who undergo mastectomy for breast cancer may soon be empowered by playing an active role in their recovery. An implanted tissue expansion system from AirXpanders Inc. uses compressed carbon dioxide (CO2) to stretch existing tissue in preparation for a permanent breast implant. The patient is given an external, handheld dose controller that releases small amounts of CO2 into the tissue expander up to three times daily, per the recommendation of the patient’s physician, for around two weeks.
“This represents the first major breakthrough in breast construction surgery in over 30 years,” says company president and CEO Scott Dodson, referring to previously developed ADM (acellular dermal matrix) materials used in conjunction with conventional saline expanders to support devices and permanent implants. Two of the largest drawbacks of the i existing technology are patient pain from having to endure weekly bolus injections of saline and the lengthy treatment protocol (up to five months). “In our feasibility study, the physician received far fewer pain comments from patients presumably due to the incremental daily expansion vs. weekly bolus injections,” Dodson says.
Of the approximately 250,000 cases of breast cancer diagnosed yearly in the US, about 85,000 result in reconstruction, representing a monetary opportunity in the $300 million to $330 million range. Globally, the breast cancer reconstruction space is easily a $500 million dollar opportunity. “However, the number of reconstruction procedures should actually be about twice that number because patients are not particularly well informed about the options available to them,” Dodson notes.
AirXpanders expects the tissue expansion device to receive a CE Mark in 2011, followed by a 510(k) clearance.
Co-founder Dan Jacobs, MD, a plastic surgeon at Kaiser Permanante in San Jose, Calif. and Chief Medical Officer at the company, has believed for many years now that tissue expansion should occur more conveniently for the patient. CO2 was chosen because of its proven track record in medical applications, foremost in laparoscopic procedures. “CO2 is readily absorbed by the body and it is deemed safe,” Dodson says. The biggest challenge, though, was developing a system that would deliver precise doses of CO2 to the implant.
Dodson, who in September assumed the role of president and CEO at AirXpanders, most recently served as president and CEO of Avantis Medical Systems Inc. (imaging technology for colonoscopy) from 2008 to 2010. He has also held executive management positions at Boston Scientific Corp. (endoscopy), Orthofix Int. (orthopedics) and BarrX Medical Inc. (GI cancer).
AirXpanders has eight pending patents (none issued) and licenses some of its intellectual property from Shalon Ventures..
The tissue expansion system consists of two main components: the expander implant itself that contains a reservoir of compressed CO2 and an external dose controller that activates the implant. The implant is an anatomically shaped expander made of silicone whereas and the internal reservoir is made of stainless steel.
The technology is geared toward both an outpatient or inpatient procedure that takes about one hour under general anesthesia. After the plastic surgeon or breast surgeon makes an incision under the pectoral muscle, a breast pocket is created from dissection that holds the expander implant. Perioperatively, after the expander is placed and the wound is closed, the surgeon will activate the expander by pressing a button on the wireless, battery-operated controller, which transmits radiofrequency (RF) energy to an internal antenna on the implant that triggers the release of precise doses of CO2 to form a breast mound.
Typically, the patient is sent home for two weeks for wound healing. She then returns to the physician’s office for an assessment of her healing process and additional expansion with the dose controller. The patient is trained before the procedure and again when she returns post-operatively so that she can administer expansion by herself in the convenience of her own home.
At home, patients can dose up to three times a day, with each dose releasing 10 milliliters of CO2. However, for safety, there is a programmed three-hour lockout between doses and a programmed 24-hour lockout from the first to the fourth dose. “Much like pain pumps, the patient is unable to dose continually throughout the day,” Dodson explains.
It usually takes the patient a few days to observe a change in breast shape. The total at-home expansion cycle takes about two weeks. Permanent implant exchange surgery is then scheduled about two months later.
A human clinical trial of seven patients (10 implants) conducted in Australia in 2010 found successful expansion to the point of permanent implant exchange. There were also no reported device-related complications or significant adverse events with the tissue expansion system.
Traditional saline expanders from Allergan Inc. (CUI) and Mentor Corp. (Contour Profile) require weekly saline injections to inflate their device. “The bolus inflation process can be excruciatingly painful to patients,” Dodson states. Typically, injections occur weekly over a three to five month period, as opposed to normally just two follow-up office visits with the AirXpanders device. The pain associated with competing devices and the number of office visits required also lessens patient compliance. In fact, online blogs reveal that many women “would never have agreed to the expansion process if they knew in advance just how painful it was going to be,” Dodson says.
Additionally, the results with the AirXpanders system “are very consistent because our device has a predetermined anatomical shape,” Dodson says. “The CO2 seeks that shape, whereas traditional saline expanders act more like a standard balloon. The more medium you place in these saline expanders, the more the breast may appear misshapen.”
Sales of the AirXpanders system are expected to start in select European countries and Australia in 2011 through a network of distributors, followed shortly thereafter in the US, initially through a direct sales organization. “Like the US, reimbursement is federally mandated in many international markets,” Dodson says. “This is a tremendous advantage for this technology and for patients alike. Many new technologies are limited in their success due to very restrictive reimbursement guidelines and the establishment of new codes can result in years of slow growth or worse, non-coverage which makes market development much more difficult.”
The $12.1 million raised to date by the company constitutes a $5.6 million Series A round that closed in 2005 and was primarily funded by Heron Capital and Prolog Ventures, a $1.5 million Series B round in 2007 financed by inside participation, and a $5 million Series C round solely capitalized by GBS Venture Partners Ltd. which closed April 2010. An undisclosed dollar amount in Series D financing from a combination of VC firms and insiders will be initiated sometime in 2012 to carry the company to profitability.
Currently, AirXpanders has no strategic partnerships, but is seeking European and other international distribution partners. Besides breast cancer/breast tissue expansion, two other potential substantial markets are burn and pediatrics by offering skin grafting and creating skin through expansion. The two most likely exit strategies for the company are strategic acquisition and a public stock offering.
Meanwhile, AirXpanders expects a rapid adoption of its relatively painless technology for breast reconstruction. “I believe patients will undoubtedly play a big role,” Dodson says. “This is one of the most informed patient groups of any patient group in medical devices.” —Bob Kronemyer