|By PR Newswire||
|April 15, 2014 07:00 AM EDT||
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."
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.
Lazar Partners LTD.
E-mail: [email protected]
SOURCE AirXpanders Inc.
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
Jan. 24, 2015 11:00 PM EST Reads: 2,615
SYS-CON Media announced today that PagerDuty has launched a popular blog feed on DevOps Journal. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done.
Jan. 24, 2015 11:00 PM EST Reads: 1,229
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, addressed the big issues involving these technologies and, more important, the results they will achieve. Rodney Rogers, chairman and CEO of Virtustream; Brendan O'Brien, co-founder of Aria Systems, Bart Copeland, president and CEO of ActiveState Software; Jim Cowie, chief scientist at Dyn; Dave Wagstaff, VP ...
Jan. 24, 2015 11:00 PM EST Reads: 2,293
SYS-CON Events announced today that CodeFutures, a leading supplier of database performance tools, has been named a “Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. CodeFutures is an independent software vendor focused on providing tools that deliver database performance tools that increase productivity during database development and increase database performance and scalability during production.
Jan. 24, 2015 11:00 PM EST Reads: 1,408
SYS-CON Events announced today that ActiveState, the leading independent Cloud Foundry and Docker-based PaaS provider, has been named “Silver Sponsor” of SYS-CON's DevOps Summit New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. ActiveState believes that enterprises gain a competitive advantage when they are able to quickly create, deploy and efficiently manage software solutions that immediately create business value, but they face many challenges that ...
Jan. 24, 2015 09:00 PM EST Reads: 1,668
Companies today struggle to manage the types and volume of data their customers and employees generate and use every day. With billions of requests daily, operational consistency can be elusive. In his session at Big Data Expo, Dave McCrory, CTO at Basho Technologies, will explore how a distributed systems solution, such as NoSQL, can give organizations the consistency and availability necessary to succeed with on-demand data, offering high availability at massive scale.
Jan. 24, 2015 07:00 PM EST Reads: 1,322
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile ...
Jan. 24, 2015 06:45 PM EST Reads: 2,280
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what th...
Jan. 24, 2015 06:15 PM EST Reads: 3,679
Security can create serious friction for DevOps processes. We've come up with an approach to alleviate the friction and provide security value to DevOps teams. In her session at DevOps Summit, Shannon Lietz, Senior Manager of DevSecOps at Intuit, will discuss how DevSecOps got started and how it has evolved. Shannon Lietz has over two decades of experience pursuing next generation security solutions. She is currently the DevSecOps Leader for Intuit where she is responsible for setting and driv...
Jan. 24, 2015 06:00 PM EST Reads: 1,282
Dale Kim is the Director of Industry Solutions at MapR. His background includes a variety of technical and management roles at information technology companies. While his experience includes work with relational databases, much of his career pertains to non-relational data in the areas of search, content management, and NoSQL, and includes senior roles in technical marketing, sales engineering, and support engineering. Dale holds an MBA from Santa Clara University, and a BA in Computer Science f...
Jan. 24, 2015 06:00 PM EST Reads: 2,842
SYS-CON Media announced that Cisco, a worldwide leader in IT that helps companies seize the opportunities of tomorrow, has launched a new ad campaign in Cloud Computing Journal. The ad campaign, a webcast titled 'Is Your Data Center Ready for the Application Economy?', focuses on the latest data center networking technologies, including SDN or ACI, and how customers are using SDN and ACI in their organizations to achieve business agility. The Cisco webcast is available on-demand.
Jan. 24, 2015 05:00 PM EST Reads: 1,049
Thanks to Docker, it becomes very easy to leverage containers to build, ship, and run any Linux application on any kind of infrastructure. Docker is particularly helpful for microservice architectures because their successful implementation relies on a fast, efficient deployment mechanism – which is precisely one of the features of Docker. Microservice architectures are therefore becoming more popular, and are increasingly seen as an interesting option even for smaller projects, instead of bein...
Jan. 24, 2015 05:00 PM EST Reads: 1,581
Datapipe has acquired GoGrid, a provider of multi-cloud solutions for Big Data deployments. GoGrid’s proprietary orchestration and automation technologies provide 1-Button deployment for Big Data solutions that speed creation and results of new cloud projects. “GoGrid has made it easy for companies to stand up Big Data solutions quickly,” said Robb Allen, CEO, Datapipe. “Datapipe customers will achieve significant value from the speed at which we can now create new Big Data projects in the clou...
Jan. 24, 2015 03:15 PM EST Reads: 1,449
The Internet of Things (IoT) promises to evolve the way the world does business; however, understanding how to apply it to your company can be a mystery. Most people struggle with understanding the potential business uses or tend to get caught up in the technology, resulting in solutions that fail to meet even minimum business goals. In his session at @ThingsExpo, Jesse Shiah, CEO / President / Co-Founder of AgilePoint Inc., showed what is needed to leverage the IoT to transform your business. ...
Jan. 24, 2015 03:15 PM EST Reads: 2,898
Cloud Technology Partners on Wednesday announced it has been recognized by the Modern Infrastructure Impact Awards as one of the Best Amazon Web Services (AWS) Consulting Partners. Selected by the editors of TechTarget's SearchDataCenter.com, and by votes from customers and strategic channel partners, the companies acknowledged by the Modern Infrastructure Impact Awards represent the top providers of cloud consulting services for AWS including application migration, application development, inf...
Jan. 24, 2015 03:00 PM EST Reads: 1,089