Replies to post #34083 on Bioelectronics Corp (BIEL)

[yankee55]

Awesome and very thorough report!!! Thanks for the post NB!!!

[yankee55]

Love this part:

Exhibit “A”

Summary of Evidence and Effectiveness

The Company has presented the following summary of evidence of safety and effectiveness:

1. US FDA market clearance for the treatment of edema following blepharoplasty (approved for over the eye and brain)
2. US FDA advisory panel meeting May 2103 recommended re-classification to class II for postoperative pain and edema. Musculoskeletal pain was disregarded. No ruling has currently been made. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm346715.htm
3. Over the counter Class IIa market clearance in Canada, European Union (CE Mark) and multiple countries worldwide for the treatment of musculoskeletal, postoperative and menstrual pain.

4. Randomized, Double Blind Placebo Controlled Trials (published):

Plantar Fasciitis: plantar-study-pdf The American College of Foot and Ankle Surgeons in The Journal of Foot & Ankle Surgery stated, “… worn on a nightly basis appears to offer a simple, drug-free, noninvasive therapy to reduce the pain associated with plantar fasciitis.” (p.18) *
Breast Augmentation (Pectoral Muscle Pain Relief) Aesthetics Plastic Surgery – official journal of the European Assoc. of Societies of Aesthetic Plastic Surgery (EASAPS) and Sociedade Brasileira de Cirurgia Plastica (SBCP) BioElectronics-Postoperative-Pain.pdf The CDRH Medical Devices Advisory Committee and Orthopaedic and Rehabilitation Devices Panel’s review of the literature on 5/21/13 noted that the “study did use valid pain assessments and report a reduction in post-operative pain, an effect that was supported by a reduction in the use of analgesic medications”. (p.85)
Blepharoplasty: Aesthetics Plastic Surgery accepted by the former Directors of the Office of Device Evaluation, FDA, Bernard Statland, MD, Ph. D. and Daniel Schultz, MD. (p.82)
5. Randomized, Double Blind Placebo Controlled Trials (not published)

Delayed Onset Muscle Soreness in Marathon Runners (independent study) (p.60)
Menstrual Pain Study (p.64)
Delayed Onset Muscle Soreness bicep muscle compared to acetaminophen (Tylenol) (p.52)
A confirming clinical study (University British Columbia) on subjects with recalcitrant Plantar Fasciitis (average 29 months), with 6 month follow up showed significant improvements in pain and function (foot and ankle disability index) publication 2014.
6. Well-documented case histories (published)

Wound healing of Recalcitrant Ulcers http://www.bielcorp.com/biel/wp-content/uploads/2013/03/ BioElectronics-Chronic-Wound-Case-Series.pdf: (published) International Wound Journal (p.118)
7. Significant human experience with a marketed device

ActiPatch® Consumer Survey – average pain reduction 50% (3.5 VAS points) with ActiPatch® use (p.23)
ActiPatch Marketed in 57 countries – 500,000 units sold; 40+ million treatments
This form of therapy has been used for 80+ years to reduce pain, inflammation and to accelerate healing (over 600 published studies)
6. In Vitro cell studies

Studies on human dermal fibroblasts show increased cell migration to close a “wound” in the cell monolayer. Indicative of a direct action of the electromagnetic field produced by the device to enhance tissue healing.
7. New York State University, Binghamton Clinical Science and Engineering Research Centers research, testing and confirming a physiological response in human soft tissue. A significant development as it has been found that the mechanism of pain relief and promotion of tissue healing is due to the phenomena of Stochastic Resonance – where a weak period signal is elevated by noise, in this case the medical device pulsed/periodic signal has been shown to activate sensory nerves, feedback loop activation of motor nerves and enhanced blood flow into the treatment area. Stochastic Resonance is being utilized in a growing number of medical applications e.g. cochlear ear implants

8. Ongoing clinical research: Tufts Dental and Medical Schools (3rd Molar Extraction, Pain & Edema, Myofascial Pain, and Chronic Wounds); Univ. of Chicago, Medical School (osteoprogenitor); Univ. of British Columbia (Plantar Fasciitis recovery at 26 weeks); Aarhus Univ. Hospital, Denmark (Venous Ulcer Wound Healing); Univ. Hospital Ghent, Belgium (Bilateral Hernia Surgical Recovery); Univ. Hospital G. Martin, Messina, Italy (Osteoarthritis); and Univ. of Otago, Dunedin, New Zealand (Lower Back Pain)

[N_B]

You can see the Investor Update here too:

http://www.bielcorp.com/investors/investor-updates/

[uksausage]

I just stickied this. Great company update doing more than even I knew about!

[Supernova12]

Thanks N_B ! In spite of the current PPS - now wasn't that one of the most comprehensive articles about BIEL? I was very impressed and the best part to me was what makes these products work: "the phenomena of Stochastic Resonance."

[robert-1]

JOE NOEL and BIEL. JUST LIKE MDHI and JOE NOEL
Information on MDHI's Joseph Noel---Manipulation: SEC v. Noel, Civil Action No. 3:14-CV-5054 (N.D. Cal. Filed November 17, 2014) names as a defendant Joseph Noel, the CEO of YesDTC Holdings, Inc., a firm he created through a reverse merger in 2009. In February 2009 Mr. Noel formed Sonoma Winton, LLC and appointed his daughter as the sole member, although he continued to control the entity. During 2011 Mr. Noel is alleged to have conducted two pump-and-dump schemes. In each of the schemes Mr. Noel prepared and had issued false and misleading press releases touting the business of the firm which supposedly specialized in direct-to-consumer marketing. In each instance the share price spiked upward significantly. In each instance Mr. Noel secretly sold shares through Sonoma. Overall he netted about $300,000 in profits from the two schemes. The complaint alleges violations of Exchange Act Sections 10(b) and 16(a), and Securities Act Sections 5(a), 5(c) and 17(a). The action is pending. See Lit. Rel. No. 23134 (November 17, 2014).------Joseph is a major player with MDHI as shown by the current 10K----devastating news IMO for Ron who bought Motorbooster scam pills and has used Noel for years.