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Tuesday, September 21, 2021 3:58:33 PM
<<<<<<<<< Sales tanked in 2006 >>>>>>>>>>>
Sales actually rose in 2006 eclipsing 2005's $303k by close to 30%.
By 2008 BIEL had $716k in Sales.
In 2009 BIEL had its first $1 million year.
As far as Authorized Shares there was a slow climb every year as BIEL was using the Shares to pay off Loans that were financing the company.
The last increase was in 2018 to the current cap of 25 billion.
BIEL has invested $38 million in obtaining 5 FDA 510k Indications.
With this achievement in Research and Regulatory Clearance completed BIEL is now monetizing its products with the help of KT Health, DJO Global, CVS, Target, Walgreens and others.
The average cost to bring a Medical Device to Market through the 510k process is $31 million.
BIEL has FDA Indications for:
Eye Surgery
Post-Op Surgery
Plantar Fasciitis
Knee OA
Musculoskeletal Pain (every muscle, bone and joint in the body)
All for $38 million.
"How much does it cost to get a medical device approved?
Approximately 4,000 510(k) applications are submitted to the FDA each year compared to less than 100 PMA applications. The average cost to bring a medical device to market through the 510(k) pathway is $31 million compared to the PMA pathway with average costs of $94 million. Sep 12, 2019"
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