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BioElectronics Expecting Near Term Decision From FDA on RecoveryRx(TM) Product
tweet2EmailPrint..Companies:BioElectronics Corporation.Related Quotes
Symbol Price Change
BIEL.PK 0.01 +0.01
{"s" : "biel.pk","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: BioElectronics Corporation On Wednesday August 3, 2011, 9:34 am EDT
FREDERICK, MD--(Marketwire -08/03/11)- BioElectronics Corp. (OTCQB: BIEL.PK - News) (Pinksheets: BIEL.PK - News), the maker of inexpensive, disposable drug-free anti-inflammatory devices, is pleased to announce it is currently awaiting a near term decision from the U.S. Food and Drug Administration relative to an additional indication of use for its RecoveryRx™ product. RecoveryRx is a disposable medical device that delivers continuous electromagnetic therapy that when applied to the site of a surgical incision quickly relieves post-operative pain and edema, providing patient comfort while accelerating healing. Management and its consultants have been responding to FDA's questions and have recently attended another meeting at the FDA's offices.
Currently, the Company's products' U.S. FDA clearance is limited to the treatment of edema following blepharoplasty (eye surgery). This additional clearance, a decision on which the Company expects over the coming weeks, will allow BioElectronics to significantly expand the addressable market opportunity.
"For the past few months we have been working with personnel at the FDA on questions they have posed on our application, the functionality of the device and on the efficacy," commented Andy Whelan, CEO of BioElectronics. "We have supplied FDA with an extensive amount of information, which we believe more than adequately addresses their questions. As a result we are expecting a positive result from the application process over the coming weeks."
The RecoveryRx™ device is flexible, comfortable, and easy to apply at the site of surgical incision. Once activated, RecoveryRx begins pulsing a continuous low level current to energize damaged cells in the surgical region, helping remove the effects of trauma so patients can feel better and look better faster than they would have ever thought possible. The low level current that is gently pulsed into the damaged tissue is undetectable, even though the device is continuously working to help the patient naturally heal faster. RecoveryRx™ is extremely safe when used as directed.
Mr. Whelan added, "It has been a long road toward additional clearances here in the United States, but it is a road to which we believe we now see the end. Our recent contacts with FDA have been very positive and as a result we believe significant progress has been made. This additional indication of use is not only important relative to potential sales in the United States, but should also positively impact worldwide sales due to the additional credibility we will gain in the marketplace."
About BioElectronics Corporation
BioElectronics Corporation is an award winning medical device developer and manufacturer of advanced medical devices. Its products are ActiPatch® Therapy, for over-the-counter treatment of back pain and other musculoskeletal complaints, the Allay™ menstrual cycle pain therapy, and RecoveryRx™ for surgical procedures and wound care. The unique therapy delivery system, using patented technology, provides a cost-effective home care to reduce soft tissue pain and swelling. For more information, please see www.bielcorp.com.
tweet2EmailPrint..Companies:BioElectronics Corporation.Related Quotes
Symbol Price Change
BIEL.PK 0.01 +0.01
{"s" : "biel.pk","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: BioElectronics Corporation On Wednesday August 3, 2011, 9:34 am EDT
FREDERICK, MD--(Marketwire -08/03/11)- BioElectronics Corp. (OTCQB: BIEL.PK - News) (Pinksheets: BIEL.PK - News), the maker of inexpensive, disposable drug-free anti-inflammatory devices, is pleased to announce it is currently awaiting a near term decision from the U.S. Food and Drug Administration relative to an additional indication of use for its RecoveryRx™ product. RecoveryRx is a disposable medical device that delivers continuous electromagnetic therapy that when applied to the site of a surgical incision quickly relieves post-operative pain and edema, providing patient comfort while accelerating healing. Management and its consultants have been responding to FDA's questions and have recently attended another meeting at the FDA's offices.
Currently, the Company's products' U.S. FDA clearance is limited to the treatment of edema following blepharoplasty (eye surgery). This additional clearance, a decision on which the Company expects over the coming weeks, will allow BioElectronics to significantly expand the addressable market opportunity.
"For the past few months we have been working with personnel at the FDA on questions they have posed on our application, the functionality of the device and on the efficacy," commented Andy Whelan, CEO of BioElectronics. "We have supplied FDA with an extensive amount of information, which we believe more than adequately addresses their questions. As a result we are expecting a positive result from the application process over the coming weeks."
The RecoveryRx™ device is flexible, comfortable, and easy to apply at the site of surgical incision. Once activated, RecoveryRx begins pulsing a continuous low level current to energize damaged cells in the surgical region, helping remove the effects of trauma so patients can feel better and look better faster than they would have ever thought possible. The low level current that is gently pulsed into the damaged tissue is undetectable, even though the device is continuously working to help the patient naturally heal faster. RecoveryRx™ is extremely safe when used as directed.
Mr. Whelan added, "It has been a long road toward additional clearances here in the United States, but it is a road to which we believe we now see the end. Our recent contacts with FDA have been very positive and as a result we believe significant progress has been made. This additional indication of use is not only important relative to potential sales in the United States, but should also positively impact worldwide sales due to the additional credibility we will gain in the marketplace."
About BioElectronics Corporation
BioElectronics Corporation is an award winning medical device developer and manufacturer of advanced medical devices. Its products are ActiPatch® Therapy, for over-the-counter treatment of back pain and other musculoskeletal complaints, the Allay™ menstrual cycle pain therapy, and RecoveryRx™ for surgical procedures and wound care. The unique therapy delivery system, using patented technology, provides a cost-effective home care to reduce soft tissue pain and swelling. For more information, please see www.bielcorp.com.
حصان طرواده
عضو نشط
- التسجيل
- 19 يوليو 2008
- المشاركات
- 1,228
اليوم بعد نزل خبر fda للمتابعه الهدف حول 10 سنت
دورة المؤشرنت للتحليل الفني
50 دينار كويتي