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I thought we were going to .0004 RZ
In the US there are around 1 million hip/knee replacements per year. I don't know the number of spinal surgeries, but you can assume it's significant and more than joint replacements. Now imagine you have FDA clearance for post-surgical use and you have a "gizmo" that will decrease hospital stays, Physical therapy tx, drug use and lead to better outcomes. Hell, it will decrease productivity loss because you can get back to work more quickly. I Dare say it's your patriotic duty to use Actipatch for the good of the country.
The ever insolvent Medicare should look at my personal example below:
I used to go to the doctor for lateral epicondylitis and shoulder bursitis/tendonitis. I would have a GP Dr visit resulting in an xray and NSAID prescription and then a second visit to get a referal to an Ortho doc. The ortho doc does an xray also plus an aircast (for elbow) and a script for 4 weeks of phyical therapy. In some cases an MRI is ordered. Then a painful injection into the elbow or shoulder. These were both chronic issues, look at the cost of those visits. I have NEVER had another doctor visit for shoulder or elbow issues in the many years that I have used the ActiPatch. That is some serious cost savings right there. I wonder how many other visits for knee, wrist and back that I have preempted with the sweet little gizmo called Actipatch. This is how you combat the opioid problem and spiraling healthcare costs.
FREDERICK, MD, May 29, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com reports that it has cancelled today’s scheduled US Food and Drug Administration meeting. “The FDA’s response to our questions, suggestions, and instructions are more than adequate for us to proceed with filing of the formal 510(k) Market Clearance Application”, stated Ian Rawe, Ph.D. BioElectronics’ Director of Research. The FDA’s Pre-Submission Program is designed to provide guidance and feedback on clinical data and the correct regulatory pathway to expedite market clearance.
While RecoveryRx is already US FDA cleared and available for treatment following eyelid surgery, the expanded market clearance would allow use by millions of Americans annually, who undergo a surgical procedure including hip and knee joint replacements and general surgery. RecoveryRx provides an adjunctive or alternative treatment to analgesics for postoperative pain and can reduce the need for opiate analgesics during postoperative recovery. Upon its review of the submitted information the FDA has provided written feedback and guidance for a 510(k) application to obtain expanded market clearance for treatment of postoperative pain.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit www.bielcorp.com
If we get cleared for Post surgical use, BIEL needs to market to high volume surgeons. Hell, insurance companies should be clamoring for the prescribing of ActiPatch to lower healthcare utilization. As an example, I used to go to the doctor for lateral epicondylitis and shoulder bursitis/tendonitis. I would have a GP Dr visit resulting in an xray and NSAID prescription and then a second visit to get a referal to an Ortho doc. The ortho doc does an xray also plus an aircast (for elbow) and a script for 4 weeks of phyical therapy. In some cases an MRI is ordered. Then a painful injection into the elbow or shoulder. These were both chronic issues, look at the cost of those visits. I have NEVER had another doctor visit for shoulder or elbow issues in the many years that I have used the ActiPatch. That is some serious cost savings right there. I wonder how many other visits for knee, wrist and back that I have preempted with the sweet little gizmo called Actipatch. This is how you combat the opioid problem and spiraling healthcare costs.
I agree with BD that opiate abuse is fueled by opiates feeling great when you take them. The way that BIEL can thwart that is by never letting people get to the point they are hooked. Actipatch will prevent many from ever needing opiates or only taking them in the 3-5 day time frame the way they are intended. Heroin comes in to play when people are hooked and can't afford or are no longer prescribed opiates. It is very cheap in comparison. ActiPatch NOW!
I hope the Dr. Scholls deal has a little up front cash and is in the near term. I think a big company like that with some actual skin in the game would open some investor eyeballs and get some people off the fence. Now I want to know when the presubmission meetings are gonna be for Allay and migraine :)