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Posted On: 06/18/2019 10:11:04 AM
Post# of 8403
The 'Letter to Share holders' is emailed to those who are on BIEL's mailing list.
Takeaways from letter:
* There is a dialogue going on between BIEL and the FDA regarding the postoperative pain 510k. The last FDA request was answered in 3 days. A decision should happen this month.
* There are 22 million surgeries each year in the US. B Braun, who BIEL works with in the UK market, has a strong presence in the US and can provide distribution. The Opioid Crisis has changed the guidelines for postoperative pain management to include non drug solutions.
* The Full Body ActiPatch 510k with the new cervical osteoarthritis (neck pain) study is on schedule to be submitted by the end of June.
This change in clinical data for the 510k, changing it from Female only to both sexes, was done with guidance from the FDA.
* BIEL is one of 30 companies selected by Walmart to present their new Pain Relief products for consideration. Keith Nalepka – VP of Sales and Marketing is making the presentation this week, 6/17/2019.
* BIEL is in talks with Mundipharma, a global multi billion dollar distributor, to add 13 Countries/Territories to the 7 that they have current distribution rights to.
* BIEL is developing a line of Active(ActiPatch)/Passive(Compression) Products. These new products will be marketed to both pharmacies and medical professionals.
* The Journal 'Pain Management' is publishing the research of Dr.Sree Koneru/Dr.Richard Staelin/Dr. Ian Rawe, 'Chronic pain intervention using pulsed shortwave therapy: the relationship between pain demographics and central sensitization inventory'
https://www.futuremedicine.com/doi/abs/10.2217/pmt-2018-0032
Takeaways from letter:
* There is a dialogue going on between BIEL and the FDA regarding the postoperative pain 510k. The last FDA request was answered in 3 days. A decision should happen this month.
* There are 22 million surgeries each year in the US. B Braun, who BIEL works with in the UK market, has a strong presence in the US and can provide distribution. The Opioid Crisis has changed the guidelines for postoperative pain management to include non drug solutions.
* The Full Body ActiPatch 510k with the new cervical osteoarthritis (neck pain) study is on schedule to be submitted by the end of June.
This change in clinical data for the 510k, changing it from Female only to both sexes, was done with guidance from the FDA.
* BIEL is one of 30 companies selected by Walmart to present their new Pain Relief products for consideration. Keith Nalepka – VP of Sales and Marketing is making the presentation this week, 6/17/2019.
* BIEL is in talks with Mundipharma, a global multi billion dollar distributor, to add 13 Countries/Territories to the 7 that they have current distribution rights to.
* BIEL is developing a line of Active(ActiPatch)/Passive(Compression) Products. These new products will be marketed to both pharmacies and medical professionals.
* The Journal 'Pain Management' is publishing the research of Dr.Sree Koneru/Dr.Richard Staelin/Dr. Ian Rawe, 'Chronic pain intervention using pulsed shortwave therapy: the relationship between pain demographics and central sensitization inventory'
https://www.futuremedicine.com/doi/abs/10.2217/pmt-2018-0032
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