BIOELECTRONICS CORPORATION PUBLISHED FACTS
BioElectronics Corporation was organized in Maryland in April 2000. It develops, manufactures, and markets drug free, disposable, topical pain medical devices. Its products comprise ActiPatch therapy for over-the-counter treatment of back pain and other musculoskeletal complaints; Allay menstrual cycle pain therapy; RecoveryRx for chronic and post-operative wound care; and HealFast therapy, a drug-free therapy for healing of muscle and tendon injuries, sores, and incision in horses, cats, and dogs. The company markets and sells its products under the ActiPatch, Allay, and RecoveryRx brand names through distributors in over 50 countries.
ActiPatch does fit into new Class II
BioElectronics Corporation has United States Patent and Trademark Office patent protection until at least 2030.
Best selling pain item on Amazon UK, Europe and Canada.
Are shareholders and public entitled to know Bioelectronics business tactics? No, not a good business practice.
Is the 90 days just an estimate for Approval by the FDA? Yes
Does the 90 days just include FDA Days? Yes.
Does elapsed time include FDA Days and FDA Hold Days? Yes
Can a 510(k) assessment clear a device in a week or two? Yes it can.
Does that happen often? Not very often.
Is the main reason for hiring experts to do a 510(k), to get it right and avoid Additional Information requests. Yes
Are Additional Information requests pretty common? Yes, FDA issues many requests every day for more data or clarifications as required.
DO YOUR OWN DUE DILIGENCE WHEN INVESTING. GO BIEL!!!
BIOELECTRONICS CORPORATION ACCOMPLISHMENTS:
Nov. 9, 2015 - Leading UK Retailer, Superdrug to market and sell ActiPatch® Pain Therapy. Superdrug is a subsidiary of the A.S. Watson Group, the world’s largest international health and beauty retailer with 12,000 stores.
Oct. 20, 2015 - BioElectronics Corporation announced that it has received initial orders for its ActiPatch® Musculoskeletal Pain Relief products for 1,077 Lloyd's pharmacies, the second largest chain in the UK and Gordons Chemists which has over 60 pharmacies in shopping centers across Scotland and Northern Ireland. ActiPatch will be on promotion in stores and online beginning November 1.
October 13, 2015 - The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device “nonthermal shortwave therapy” (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices.
August 6, 2015 – BioElectronics Corporation submitted new 510(k) application at the recommendation and invitation of FDA.
June 30, 2015 - 8,000,000,000 shares authorized and 7,999,028,602 shares issued and outstanding at June 30, 2015.
June 30, 2015 - Sales were up 164% for the first 6 months. June 30, 2015 sales: $1,178,796 June 30, 2014 sales: $446,280
May 15, 2015 - the Therapeutic Products Directorate, Medical Devices Bureau of Health Canada has issued a Class II License for the RecoveryRx™ Post-Surgical and Wound Care Recovery product. The license means that the product can be sold Over-the-Counter (OTC) in Canada. RecoveryRx uses pulsed electromagnetic field therapy to reduce pain and inflammation and promote healing of injured tissue.
February 9, 2015 - B. Braun Medical Ltd announced as exclusive distributors for RecoveryRx in the UK and Ireland. B. Braun has over $6 billion in annual sales and is the 12th largest device companies in World.
December 9, 2013 - BioElectronics Corporation announced that Boots, the UK‘s premiere health and beauty retailer is selling its ActiPatch® Pain Therapy products in 585 select stores in the UK and Ireland for back, knee and musculoskeletal ailments.
2010 - Allay™ Menstrual Pain Therapy product has been approved for over the counter sale by Health Canada for the treatment of menstrual pain symptoms, including cramps and abdominal pain.
2005 - Health Canada approves ActiPatch Therapy for relief of pain in musculoskeletal
complaints.
2004 - US Medicare and Medicaid agree to reimburse for electromagnetic treatment of chronic Stage III and IV wounds.
2004 - The Company received ISO and CE (European Common Market)
certification. For low dose ActiPatch Therapy as a Class II medical device.
2002 - U.S. FDA approves low dose, extended duration ActiPatch Therapy for the treatment of edema following blepharoplasty.
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