Welcome!

News Feed Item

Interim Results of AirXpanders' Multi-Centered Randomized Controlled Trial Demonstrate Faster, Needle-Free Alternative to Saline Tissue Expanders

Highly statistically significant improvement in expansion and total implant times compared to saline

PALO ALTO, Calif., April 15, 2014 /PRNewswire/ -- AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today reported that interim data from its XPAND study show that the AeroForm™ device led to highly statistically significant reduction in the time it takes to expand a woman's breast tissue after a mastectomy and to undergo reconstruction with breast implants compared to patients who went through traditional saline expansion. This interim analysis was published in the April 2014 issue of Plastic and Reconstructive Surgery. The AeroForm device is an injection-free, patient-controlled tissue expansion system that is approved in Australia and under investigation in the United States. 

"Breast reconstruction following a mastectomy is long process, and tissue expansion is traditionally is one of the most tedious and painful aspects. For women to achieve expansion in 18.7 days on average and for the vast majority of the patients to report high satisfaction throughout the expansion process is extremely compelling, and further supports AeroForm as an exciting, much-needed innovation in breast reconstruction," said Kamakshi Zeidler, M.D., principal investigator of the trial. "Patient-controlled expansion, where women are able to expand at their own pace and level of comfort, offers mastectomy patients a needle-free, more convenient option for expansion – and a chance to regain control over their body during a time in which much is out of their control. It is my expectation that with 98% of the women in the early phase of the study reporting that the AeroForm is easy to use, CO2-based expanders have the potential to be adopted universally, and transform the process of tissue expansion."

As of the date of the publication, 115 patients had been enrolled into the XPAND study. The 87 patients in the study who have completed their expansion did so within an average of 18.7 days, consistent with all other published results of AeroForm studies to date. Traditional saline expansion requires women to visit their physician for frequent injections until they complete the process, which can take up to six months. For women in the control group who were implanted with traditional saline expanders, the expansion process took an average of 56.8 days to complete. The difference in expansion times was statistically significant (p-value was less than 0.001 with a 95% confidence interval).

Successful second-stage surgery, during which the tissue expander is exchanged for a permanent implant, has been completed in 78 patients with 53 in the investigational arm and 25 in the control arm. For patients who received AeroForm expanders, the full reconstruction process was complete in an average of 103.5 days, a statistically significant improvement over the average of 157.1 days for the control arm (p-value was less than 0.0005 with a 95% confidence interval).

"Enrollment in the ongoing XPAND study is nearly complete – only 31 patients remain – and we expect to announce the close of the trial by the end of the first half of 2014. We are working diligently towards U.S. Food and Drug Administration (FDA) regulatory approval," said Scott Dodson, AirXpanders President and Chief Executive Officer. "We are extremely pleased to see consistency in all of the trials that we have conducted. Results continue to show positive patient experiences, significantly faster expansion times and more patient control with the AeroForm expander compared to traditional saline expanders."

About AirXpanders
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 reclaiming one's body after cancer can potentially be eased with this needle-free technology. This technology 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, Shalon Ventures, Correlation Ventures and Western Technology Investments.

Media Contact:
Erich Sandoval
Lazar Partners LTD.
Tel. 917-497-2867
E-mail: [email protected] 

SOURCE AirXpanders Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Many banks and financial institutions are experimenting with containers in development environments, but when will they move into production? Containers are seen as the key to achieving the ultimate in information technology flexibility and agility. Containers work on both public and private clouds, and make it easy to build and deploy applications. The challenge for regulated industries is the cost and complexity of container security compliance. VM security compliance is already challenging, ...
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, will discuss the importance of WebRTC and how it enables companies to fo...
Designing IoT applications is complex, but deploying them in a scalable fashion is even more complex. A scalable, API first IaaS cloud is a good start, but in order to understand the various components specific to deploying IoT applications, one needs to understand the architecture of these applications and figure out how to scale these components independently. In his session at @ThingsExpo, Nara Rajagopalan is CEO of Accelerite, will discuss the fundamental architecture of IoT applications, ...
SYS-CON Events announced today TechTarget has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. TechTarget is the Web’s leading destination for serious technology buyers researching and making enterprise technology decisions. Its extensive global networ...
As cloud and storage projections continue to rise, the number of organizations moving to the cloud is escalating and it is clear cloud storage is here to stay. However, is it secure? Data is the lifeblood for government entities, countries, cloud service providers and enterprises alike and losing or exposing that data can have disastrous results. There are new concepts for data storage on the horizon that will deliver secure solutions for storing and moving sensitive data around the world. ...
Korean Broadcasting System (KBS) will feature the upcoming 18th Cloud Expo | @ThingsExpo in a New York news documentary about the "New IT for the Future." The documentary will cover how big companies are transmitting or adopting the new IT for the future and will be filmed on the expo floor between June 7-June 9, 2016, at the Javits Center in New York City, New York. KBS has long been a leader in the development of the broadcasting culture of Korea. As the key public service broadcaster of Korea...
In his session at 18th Cloud Expo, Bruce Swann, Senior Product Marketing Manager at Adobe, will discuss how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects). Bruce Swann has more than 15 years of experience working with digital marketing disciplines like web analytics, social med...
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
The essence of data analysis involves setting up data pipelines that consist of several operations that are chained together – starting from data collection, data quality checks, data integration, data analysis and data visualization (including the setting up of interaction paths in that visualization). In our opinion, the challenges stem from the technology diversity at each stage of the data pipeline as well as the lack of process around the analysis.
As machines are increasingly connected to the internet, it’s becoming easier to discover the numerous ways Industrial IoT (IIoT) is helping to shape the business world. This is exactly why we have decided to take a closer look at this pervasive movement and to examine the desire to connect more things! Now if you need a refresher on IIoT and how it is changing the world, take a moment and listen to Greg Gorbach with ARC Advisory Group. Gorbach believes, "IIoT will significantly change the worl...
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit y...
Cloud computing changed data analytics for good. It enabled companies to drastically decrease resources and architecture previously assigned with business intelligence departments. It also enabled laymen to run advanced business analytics. Cloud was also the architecture of choice for storing and processing big data. Data piling is a continuous process, which is going to explode with emerging Internet of Things concept. Answer to this issue developers found in new concept called fog computing. ...
There are several IoTs: the Industrial Internet, Consumer Wearables, Wearables and Healthcare, Supply Chains, and the movement toward Smart Grids, Cities, Regions, and Nations. There are competing communications standards every step of the way, a bewildering array of sensors and devices, and an entire world of competing data analytics platforms. To some this appears to be chaos. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will discuss the vast to...