Bioelectronics Corp (BIEL)

[DewmBoom]

Read here my earlier post . This is separate:


FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder

Developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain, may also apply. Applicants selected for the Challenge will work directly with the FDA to accelerate the development of and eventual review of marketing applications for innovative products, similar to what occurs under the Breakthrough Devices Program. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application. Proposals submitted will be evaluated based on the feasibility, potential public health impact, and novelty of the concept. The number of proposals selected into the Challenge will be determined by the quality of applications received and available FDA resources. The FDA intends to announce applications selected for the Challenge in November 2018.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm609082.htm

BIEL is a great candidate to show how the Actipatch minimized the use the drugs and opioids in pain management, thus reducing the likelihood of opioids addiction. They already demonstrated this in several studies for the UK NHS.

Quote:
The ActiPatch is a drug-free, wearable medical device that regulates peripheral nerve activity to provide pain relief. The NHS based its decision considering strong clinical evidence and a health economics study, which found that ActiPatch significantly decreased pain and improved quality of life, while reducing overall healthcare costs by 42% (58.5% reduction in physician appointment costs, 35% reduction in prescription medication costs).


http://www.bielcorp.com/bioelectronics-actipatch-drug-free-pain-therapy-receives-united-kingdom-national-health-system-payment-coverage/



Replies:
BIEL has applies to the FDA Innovative Challenge
DewmBoom on 6/2/2018 4:09:19 PM



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