Navigation Links
FDA Clears New Skin and Surface Treatment Applicator for Use With Xoft's Axxent(R) Electronic Brachytherapy (eBx) System
Date:3/4/2009

Most Recent Indication Expands Treatment Platform to Allow Axxent(R) System to Deliver Surface Brachytherapy, Including Intraoperative Radiation Therapy (IORT)

SUNNYVALE, Calif., March 4 /PRNewswire/ -- Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for a skin and surface treatment applicator for use with the Axxent(R) Electronic Brachytherapy (eBx) System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT). This latest FDA Clearance allows the applicator to be used on any external or internal surface of the body where radiation therapy is indicated.

Previously cleared for accelerated treatment of early stage breast cancer and endometrial and rectal cancers, the Axxent System is also cleared for use in the treatment of surface cancers or conditions where radiation therapy is indicated. The proprietary Electronic Brachytherapy treatment platform is designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings under the supervision of a radiation oncologist.

"As market and clinical adoption for Electronic Brachytherapy grows for our breast and endometrial applications, the FDA Clearance of skin and surface indications completely supports Xoft's mission of expanding the number of patients who can access radiation therapy and can dramatically benefit from it," said Michael Klein, president and CEO of Xoft. "Not only does it create access to a fast, convenient, non-isotope treatment option for millions of skin cancer patients, it continues to expand the clinical utility of the broad based Electronic Brachytherapy treatment platform that is being used at more than 50 radiation oncology centers across the United States."

Skin cancer is the most common cancer in the United States with more than 1 million cases diagnosed annually. If diagnosed and treated early, most cases of skin cancer can be cured; however the National Cancer Institute estimates that skin cancer results in more than 10,000 deaths each year. Radiation therapy is one of several primary treatment options used to treat skin cancers, including surgery and chemotherapy. Designed to kill cancer cells and reduce the spread and local recurrence of cancer, radiation therapy is used alone or in combination with surgery or chemotherapy, depending on the location and stage of the cancer tumor as well as the patient's general health.

In addition to skin indications, the FDA clearance also covers surface indications, which means that many intraoperative radiation therapy procedures can be performed with the Xoft source, while surgery is being performed. Intraoperative treatment potentially reduces the time required for radiation therapy by delivering it immediately during surgery before any remaining cancer cells have a chance to grow. IORT, utilizing the Axxent System's miniaturized X-ray source that can deliver localized and targeted radiation treatment, is designed to minimize radiation exposure to surrounding healthy tissue and enables physicians and treating professionals to remain in the operating room with the patient.

As a platform technology, the Axxent System addresses a variety of oncological and non-oncological indications. The Axxent System is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. Designed to deliver electronic, X-ray-based radiation treatment, the proprietary Axxent treatment platform can be used in many clinical settings. Treatment can be performed without the need for a shielded room, allowing the radiation oncologist and other medical personnel to be present during treatment delivery and minimizing patient anxiety. As a result, tens of thousands of patients annually will have greater access to therapy that is delivered more easily and conveniently.

About Xoft, Inc.

Xoft, founded in 1998, develops Electronic Brachytherapy (eBx) systems based upon miniaturized X-ray tube technology for the practice of radiation oncology in virtually any clinical setting, eliminating the need for heavily shielded environments. Xoft provides a "point of care model" that is patient centric and accessible to a broader spectrum of patients and their physicians. The Axxent treatment platform provides a therapeutic dose of radiation directly to the region at risk with minimal radiation exposure to surrounding healthy tissue and without the complex handling, resource logistics and costs associated with using radioactive isotopes. Xoft aligns with the Nuclear Regulatory Commission's (NRC) directive to seek alternatives for radioactive medical isotopes. Commercially available for treatment of early stage breast cancer and endometrial and rectal indications, the Axxent(R) Electronic Brachytherapy System is also cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated. For more information, visit www.xoftinc.com.

Axxent is a registered trademark of Xoft, Inc.


'/>"/>
SOURCE Xoft, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Global Gene Map Clears New Milestone
2. FDA Clears MDN-CGS(R) Intravenous Insulin Dosing Software
3. American Medical Association Clears Path for Adenoviral Conjunctivitis - Pink Eye - Detector
4. Congress Clears the Way for National CPR and AED Awareness Week
5. FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients
6. ClearScript Offers Innovative Medication Therapy Management Program to Employee Health Plans
7. Alzheimers vaccine clears plaque but has little effect on learning and memory impairment
8. Genetic Information Nondiscrimination Act clears Senate
9. Dutch Authorize Manufacture of Vaccinogens New Cancer Vaccine; License Clears Path to European Production, Final FDA Trial
10. FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression
11. FDA Clears the DPL (Deep Penetrating Light) Therapy System for Over-the-Counter - Home Use
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... ... 11, 2016 , ... Atlantic Information Services, Inc. (AIS) is ... Case Study for Plans and Purchasers.” Executives from Intel Corp. and Providence Health ... value-based health benefits program Connected Care, will discuss the challenges they faced (and ...
(Date:2/11/2016)... Australia (PRWEB) , ... February 11, 2016 , ... ... potential ?" motivational speaker, trainer and author Ray Clarke poses a question as ... personal fulfillment . In his book, "Being in the Being" (published by Partridge ...
(Date:2/11/2016)... ... February 11, 2016 , ... Greenfield ... charity program created to assist the people of their local community. The agency ... organizations and community leaders. Their hope is to bring awareness to important local ...
(Date:2/11/2016)... ... 2016 , ... Talix today announced that Clive Fields, MD, ... at the 2016 HIMSS Annual Conference & Exhibition, taking place February 29 – ... Coding for Care: Using Data Analytics for Risk Adjustment ,” Dr. Fields will ...
(Date:2/11/2016)... , ... February 11, 2016 , ... The annual list ... on evaluation of DataPoint’s team dedication and commitment to the SharePoint ecosystem. ... the annual list. The panel’s goal is to recognize and promote technology entrepreneurship. ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... Transformational M&A achieved through NPS and Dyax acquisitions ... Transformational M&A achieved through NPS and Dyax acquisitions and the ... M&A achieved through NPS and Dyax acquisitions and the announced ... with most robust pipeline in Shire , s ... most robust pipeline in Shire , s history ...
(Date:2/11/2016)... CHICAGO, Ill. , Feb. 11, 2016 /PRNewswire/ ... of the AbbVie Rheumatology Scholarship, designed to provide ... rheumatologic disease as they pursue higher education goals. ... each for the 2016-2017 school year. The AbbVie ... Tracie Haas , vice president, corporate social ...
(Date:2/11/2016)... , Feb. 11, 2016 Exactus Pharmacy ... providing high-quality specialty pharmacy care for those suffering ... it has achieved full Specialty Pharmacy Accreditation from ... dedicated to promoting health care quality through accreditation, ... --> The URAC accreditation process demonstrates ...
Breaking Medicine Technology: