|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.
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and ...
Dec. 5, 2016 09:29 AM EST Reads: 102
"Venafi has a platform that allows you to manage, centralize and automate the complete life cycle of keys and certificates within the organization," explained Gina Osmond, Sr. Field Marketing Manager at Venafi, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 09:15 AM EST Reads: 874
Application transformation and DevOps practices are two sides of the same coin. Enterprises that want to capture value faster, need to deliver value faster – time value of money principle. To do that enterprises need to build cloud-native apps as microservices by empowering teams to build, ship, and run in production. In his session at @DevOpsSummit at 19th Cloud Expo, Neil Gehani, senior product manager at HPE, discussed what every business should plan for how to structure their teams to delive...
Dec. 5, 2016 09:15 AM EST Reads: 1,408
"We are a modern development application platform and we have a suite of products that allow you to application release automation, we do version control, and we do application life cycle management," explained Flint Brenton, CEO of CollabNet, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 08:45 AM EST Reads: 795
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Dec. 5, 2016 07:30 AM EST Reads: 7,040
We are always online. We access our data, our finances, work, and various services on the Internet. But we live in a congested world of information in which the roads were built two decades ago. The quest for better, faster Internet routing has been around for a decade, but nobody solved this problem. We’ve seen band-aid approaches like CDNs that attack a niche's slice of static content part of the Internet, but that’s it. It does not address the dynamic services-based Internet of today. It does...
Dec. 5, 2016 07:30 AM EST Reads: 978
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web ...
Dec. 5, 2016 07:15 AM EST Reads: 1,253
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 5, 2016 06:45 AM EST Reads: 1,793
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Dec. 5, 2016 06:45 AM EST Reads: 1,594
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Phil Hombledal, Solution Architect at CollabNet, discussed how customers are able to achieve a level of transparency that e...
Dec. 5, 2016 06:45 AM EST Reads: 980
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 06:30 AM EST Reads: 731
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
Dec. 5, 2016 06:15 AM EST Reads: 895
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Dec. 5, 2016 06:00 AM EST Reads: 1,679
Kubernetes is a new and revolutionary open-sourced system for managing containers across multiple hosts in a cluster. Ansible is a simple IT automation tool for just about any requirement for reproducible environments. In his session at @DevOpsSummit at 18th Cloud Expo, Patrick Galbraith, a principal engineer at HPE, discussed how to build a fully functional Kubernetes cluster on a number of virtual machines or bare-metal hosts. Also included will be a brief demonstration of running a Galera MyS...
Dec. 5, 2016 04:30 AM EST Reads: 5,225
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...
Dec. 5, 2016 04:15 AM EST Reads: 1,617