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:5/24/2016)... ... ... Controlling and maintaining the home’s water heater just got infinitely easier, more ... Controller , a first-of-its-kind system that enables remote and convenient control of a water ... for HVAC systems, Aquanta gives users a much more efficient, versatile way to use ...
(Date:5/24/2016)... Forest Lake, Minnesota (PRWEB) , ... May 24, ... ... his 13th mission trip to the Dominican Republic on September 21, 2016. Dr. ... Biology from Northwestern, serves with ChiroMission, a not-for-profit organization promoting health and wellness ...
(Date:5/24/2016)... , ... May 24, 2016 , ... ... , Out patient Services To Begin In June , Aloria Health, specializing in ... announce the opening of Aloria Milwaukee, its first treatment facility for outpatient, day ...
(Date:5/24/2016)... ... 2016 , ... "ProText Layouts Vol. 3 is a plugin that will keep ... Studios. , ProText Layouts Vol. 3 is a set of 30 self-animating kinetic text ... Layouts, video editors can create an lively typography video with incredible ease. Utilize intuitive ...
(Date:5/24/2016)... ... May 24, 2016 , ... The old expression “a ... problem. A common injury that’s often misunderstood, whiplash should be swiftly diagnosed and treated ... orthopedic spine surgeon at Atlantic Spine Center . , So named because ...
Breaking Medicine News(10 mins):
(Date:5/23/2016)... , May 23, 2016 ... for detection of multiple diseases; ,Technology to be presented ... Yissum Research Development Company of the Hebrew ... into a research agreement with Aurum Ventures MKI, the technology ... development of a new diagnostic approach for early detection ...
(Date:5/23/2016)... , May 23, 2016   Purdue Pharma ... into an agreement with Egalet Corporation and Acura ... As part of the agreement the companies will ... enable all three companies to develop and sell ... "This agreement reflects the commitment of Purdue ...
(Date:5/20/2016)... -- - Revenue Forecasts And R&D ... Recombinant Coagulation Factors and Regenerative Medicine ... Reveals Selling Opportunities and Revenue Prospects to Help ... the future of biologics, especially new drug classes? ... Staying ahead in data and knowledge, you benefit ...
Breaking Medicine Technology: