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1) My response was to your post re Sofpulse, list of 7 Trials with no NIH results
<<<<<< Not sure why there is some much attention being paid here to the SofPulse product >>>>>
2) Trying to lump BIEL, OEM contracts with KT Tape/Scott-DJO/SAI Brands, in with ENDV, who had $73k in Sales for 2021, is ridiculous.
<<<<<< two different products, both FDA authorized, both clinically proven, are unable to find a market >>>>>>
3) Setting arbitrary deadlines for the success/failure of BIEL have not worked out well for the last 15 years.
<<<<<<<<< next 2 quarters are do or die for BIEL >>>>>>>>>>>
4) Quotes posted with no link to the actual Study/Trial, why not provide a link to the Study/Trial so that readers can see the source material?
<<<<<< "See Attached Study" >>>>>>
5) Serious Red Flag , Claims of 300% and 400% reduction in Pain. Pain is generally quantified with numers, a 1-10 scale being most common. If a patient's Pain is reduced from 10 to 5 that is a 50% reduction, from 10 to 1 would be a 90% decrease. There is no 400% decrease on a numerical pain scale.
7 Sofpulse Clinicals and Zero results per NIH
Device: SofPulse
NCT03654014 14-113 ,,,,,,, No Results, Status Unknown 8/2018
University of New Mexico
Albuquerque, New Mexico, United States
Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
Knee Osteoarthritis
Device: Ivivi SofPulse
NCT01457742 Ivivi-OAPain-001 ... Terminated, Sponsor Decision
Mytrus, Inc.
San Francisco, California, United States
Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery
Postoperative Pain
Device: SofPulse
NCT02365753 Delivery2 ..... No Results, Completed 10/2018
PEMF Effects on Pain After Abdominal Body Contouring
Abdominal Body Contouring Surgery
Postoperative Pain
Device: Active Device (IVIVI SofPulse)
Device: Sham Device
NCT01762423 PRO12070504 ...... Withdrawn, Funding Issues
UPMC Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, United States
Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery
Knee Injuries
Shoulder Injuries
Pain, Postoperative
Device: Endonovo SofPulse
NCT04109638 53013 ....... Start delayed, est completion 2/2024
Stanford University
Redwood City, California, United States
Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity
Shoulder Symptoms After Lymph Node Dissection
Device: PEMF Device
Device: Sham PEMF Device
NCT01255631 AAAE3803 ....... Terminated, Poor Enrollment
Columbia University Medical Center
New York, New York, United States
PEMF and PEC Blocks in Mastectomy Reconstruction Patients
Breast Cancer Female
Drug: Bupivacaine Hydrochloride
Other: Placebo Drug
Device: Pulsed Electromagnetic Field (PEMF) Device
(and 2 more...)
NCT03360214 AAAQ4708 ........ 12/2017 Start, No Results as of 3/2022
Columbia University Irving Medical Center
New York, New York, United States
I could give the 'bad management' theory more weight if it were not for the fact that Sofpulse is into its third ownership.
Started out as Ivivi Sofpulse with an FDA Clearance in 2008, no traction.
Went to Rio Grande Sofpulse, no traction.
Now its Endonovo Sofpulse for the last 4 years and no traction.
Did all 3 owners have 'bad management'?
And what is the track record of Collier's flashy PR's with grandiose claims?
One has to call Investor Relations to get the documentation for ENDV's grandiose claims??? Give me a break.
The Financials and Reverse Splits tell the ENDV Story, anything else from the company has been proven to be unreliable.
$73k in Revenue for 2021, Net Loss $3.1 million.
Big Red Flag in the Sofpulse v RecoveryRx PR
Lots of claims about Sofpulse efficacy gathered by comparing 3 BIEL Clinical Trials with 5 Sofpulse Studies.
The problem is no references are provided so that readers can look at how these efficacy claims were arrived at. A legitimate Comparative Analysis would provide source material in the PR for readers to confirm the claims made.
Instead we get the following statement from Sofpulse,
"For full references regarding claims in this news release, contact Endonovo’s Investor Relations."
Sounds like a scam to get attention by a company that had Sales of $73k in 2021 and a Net loss of $3.1 million.
Good advice Hawk, it has been owned by 3 different entities over the last 15
years same result each time, bupkis.
What do shareholders think?
"It doesn't sell because it doesn't have large controlled clinical trials to support their claims, only tiny studies that cannot be used to get medical reimbursement nor interest from hospitals."
That is what their claims are based on "tiny studies".
510k evidence was 'Saline Tissue Equivalents', no human Trials.
I believe bulk device shipping was normal until the KT Tape orders Tantalos
BIEL's staff could grab the appropriate box/attachment method for each order and add the ActiPatch from a bulk supply. When your purchase orders start reading 35,000 units you need to upgrade your assembly line.
Weighing 9 grams it takes 111 ActiPatches to equal one kilogram. Shipping is more efficent in bulk but the manpower to do assembly is a lot higher in the US vs China.
KT wanted a shelf ready product so BIEL or KT produced the 'clamshell' box and probably had CICD fill the boxes with the devices they manufactured. Pallets of the Wave were shipped direct to KT in Utah, ready to distribute with no further prep needed.
Going forward all large distributor orders, think STADA's MENA, will have reduced transit time and a lower cost by having CICD do packaging and direct ship to the customer.
IMO. when our volume OEM Partners like SAI Brands need to add their own sleeve or wrap to complete their 'Powered By ActiPatch' product it would be cost effictive to have have it done in China also.
Some may lament the reduction in the Frederick office involvement but the large orders BIEL is receiving require production changes and that is a good thing.
Important to understand that 'Import Genius' tracks US Import data
Shipments headed from China direct to non US customers would not show up on a US Customs Import database.
I am sure that there are situations where BIEL would not be listed as the 'shipper' on US shipments like, KT or SAI wanting to use their own freight company as both have factories in China.
Nahhh, Exactly what BIEL Needs
Top Rated Institution + Top Rated Reseacher = Medical Industry Attention
Top rated institution -
UCSD ranked top-10 worldwide among biomedical science institutions – The Nature Index research database announced today that UC San Diego ranks in the top 10 worldwide among institutions researching biomedical science topics. UCSD ranked sixth among the top-200 academic institutions and ninth among healthcare institutions worldwide in biomedical sciences.
https://www.10news.com/news/ucsd-ranked-top-10-worldwide-among-biomedical-science-institutions
Top rated researcher -
Dr. Brian Ilfeld
Masters Degree of Medical Sciences in Clinical Investigation
Primary Investigator on 57 peer-reviewed publications
190 published Research papers
BIEL Scores another UCSD Study
Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
KEYWORDS
Postoperative Pain, AcutePain, PostoperativeAcute PainActive Pulsed Shortwave Treatment with BioElectronics Model 088
Lead Scientist at UCSD
Brian M. Ilfeld, MD, MS
Professor In Residence, Anesthesiology, Vc-health Sciences-schools. Authored (or co-authored) 190 research publications
Status - not yet accepting patients
Start Date - July 1, 2022
Completion Date- December 2023 (estimated)
Sponsor - University of California, San Diego
ID - NCT05399355
Study Type - Interventional
Participants - Expecting 200 study participants
SUMMARY
Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). Food and Drug Administration-cleared devices have been in clinical use for over 70 years. For decades, available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference, making them impractical for common use. However, small, lightweight, relatively inexpensive, noninvasive, Food and Drug Administration-cleared devices that function for 30 days are now available to treat acute and chronic pain, decrease inflammation and edema, and hasten wound healing and bone regeneration. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements, only without the limitations of opioids and peripheral nerve blocks. The purpose of this pilot study is to explore the possibility of treating acute postoperative pain with nonthermal, pulsed shortwave (radiofrequency) therapy, optimize the study protocol, and estimate the treatment effect in preparation for developing subsequent definitive clinical trials.
https://clinicaltrials.ucsd.edu/trial/NCT05399355
Three letters were omitted from the sentence that you quoted
"IMO, that is what the 12 patient Pilot Study was for, making a case for DOD funding for a 4th Phantom Limb Trial."
It looks like some wires were crossed here, sorry for the confusion
The 12 patient Study that Dr. Ilfeld conducted was a Pilot to test the theory that PSWT may help Phantom Limb Pain, funded by UCSD.
Dr Ilfeld has done 3 Phantom Limb Pain Trials for the DOD at a cost of over $9 million so it is a condition that the DOD is very interested in.
To submit a funding request to the DOD Dr. Ilfeld has to draw up a Proposal that shows evidence as to why his PSWT research is worth investing in. IMO, that is what the 12 patient Pilot Study was for, making a case for DOD funding for a 4th Phantom Limb Trial.
Dr Ilfeld's conclusion from the Pilot Study,
"These cases suggest that pulsed electromagnetic field therapy may be an effective treatment for intractable postamputation pain. Considering the low patient burden of noninvasive, wearable devices, combined with few contraindications and no significant side effects or adverse events, further study with a randomized, controlled trial is warranted."
Dr Ilfeld's 3 Pantom Limb Trials:
Improving Postamputation Functioning by Decreasing Phantom Limb Pain and Opioid Use With Perioperative Continuous Peripheral Nerve Blocks: A Multicenter RCT
Department of Defense Congressionally Directed Medical Research Programs, Peer Reviewed Orthopaedic Research Program (PRORP)W81XWH-17-1-0671 (OR160012)Sep 30, 2017 - Sep 29, 2023
Role: Principal Investigator
Description: $2,847,215
Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Definitive Human Subjects Clinical Trial
Department of Defense Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program (PRMRP)W81XWH-17-2-0051 (PR160263)Sep 30, 2017 - Sep 29, 2023
Role: Principal Investigator
Description: $3,950,572
Treating Intractable Post-Amputation Phantom Limb Pain with Ambulatory Continuous Peripheral Nerve Blocks
Department of Defense Congressionally Directed Medical Research Programs Defense Medical Research and Development ProgramW81XWH-13-2-009Jan 25, 2012 - Dec 24, 2020
Role: Principal Investigator
Description: $2,617,000
The only other association with BIEL and the Military that I recall goes back to 2019. The Naval Post Graduate School was working with Circadian Positioning Systems, who discribes themselves as a developer of circadian solutions for optimizing performance in mission-critical scenarios, on fatigue issues.
The Navy issued a 'Sole Source' RFQ for 250 Actipatches supplied by Circadian.
https://www.rfpdb.com/view/document/name/Notice-of-Sole-Source-to-Circadian-Positioning-Systems%2C-Inc.-for-250-Actipatches._N6227119Q5015
Currently 16.5 million Buys, 11.3 million Sells
mBell4466
Friday, July 22, 2022 9:24:51 AM
Re: InvestInBiel post# 294379
Post#
294386
of 294598
If you look at the funding information in the link from Kelly’s post on Facebook yesterday, it shows all of the funding ($2,847,215.00 yes that’s millions) for the phantom limb pain studies were from the department of defense congressionally directed medical research program. That’s huge! The US Department of Defense sees the potential value in BIEL!
Thanks Gaffer, KN's return to posting is great news for BIEL Longs
Wrong Again, Time for some BIEL history
Pulsed Showtwave Therapy devices were incorrectly classified as 'Type 3' Devices for decades, subjected to the most stringent controls that the FDA has for Medical Devices. Devices like Pacemakers are Class 3 because they are life sustaining.
BIEL received their first FDA Clearance in 2002 for use post Eyelid Surgery, but as a Class 3 Device it was available by Prescription Only. BIEL lobbied the FDA for years to move their safe, easy to use, non-life sustaining devices to a Class 2 status where they could gain further Clearances and have the possibility of 'Over the Counter' use.
In October of 2015 the FDA finally Reclassified BIEL's type of device, originally Product Code 'ILX', 'Shortwave Diathermy', into its own new Product Code, 'PQY', “Nonthermal Shortwave Therapy” (SWT). BIEL had their first Indications Cleared by the FDA, plantar fasciitis of the heel; and osteoarthritis of the knee, under this new category as OTC products in 2/2017.
This is where the PSWT clock begins.
On 1/31/2020 BIEL received the Musculoskeletal Pain FDA Clearance that its potential Partners were looking for. ActiPatch was now FDA Cleared for use on evey Muscle, Joint, Ligament and Tendon in the body.
ActiPatch is still the only Medical Device that has been granted 'PQY' status by the FDA.
In the 2.5 years that ActiPatch has been Cleared for Full Body Use they have signed these Partners:
KT Tape, The Wave, stand alone device, OEM Partner
Scott Specialties (sold by DonJoy), EME stand alone device, back wrap, knee sleeve, OEM Partner
SAI Brands, 10 'Powered By ActiPatch' products, OEM Partner
Airway Surgical (Canadian arm of SAI) 10 'Powered By ActiPatch' products, OEM Partner
STADA, ActiPatch Distribution Partner
PRIM Group, RecoveryRx Distribution Partner
e Novro Med S.A. de C.V., RecoveryRx Distribution Partner
Modern Development Medical Company, ActiPatch/RecoveryRx Distribution Partner
https://www.federalregister.gov/documents/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-diathermy-for-all-other-uses-henceforth-to
LOL, If the Facts are not on one's side Pound the Table and hurl insults
STADA a $3.5 billion company in business for 125 years did their DD on ActiPatch
STADA decided to move forward with distribution in 2 small markets, Saudi Arabia and Bahrain. This was most likely a Test Market for STADA to gauge consumer interest in ActiPatch.
5 months later STADA has signd a new distribution agreement with BIEL. No specifics on what countries are involved yet, STADA sells in 120 countries, but BIEL states, "We are now in the process of meeting the demand for their first order."
BIEL and ActiPatch have value and STADA's distribution agreement with them proves that fact.
Thanks mBell and GG, I was wondering where the money came from for a UCSD Clinical Trial
$2.8 million for a 200 person Trial.
Good to see the DOD investing in improving wounded veterans lives.
PC Medical CHAMPION ACTIPATCH PLANTAR FASCIITIS 2217
https://pcmedical.ca/products/champion-actipatch-plantar-fasciitis-2217?_pos=1&_psq=Acti&_ss=e&_v=1.0
The Great thing about Stock ownership is that if at anytime a shareholder does not have confidence in the future of the company they can sell and move on.
I have confidence in BIEL's future. If I did not I would sell and move on.
ROW, Rest Of World
The term can have a couple of different meanings. I am using it as everything outside of North America.
STADA has significant operations in the following countries and has its products sold in another 80 countries.
Europe
Austria
Belarus
Belgium
Bosnia-Herzegovina
Bulgaria
Czech Republic
Croatia
Denmark
France
Germany
Hungary
Ireland
Italy
Lithuania
Montenegro
Netherlands
Poland
Portugal
Romania
Russia
Serbia
Slovakia
Slovenia
Spain
Switzerland
Ukraine
United Kingdom
Worldwide
Australia
China
Kazakhstan
Phillippines
Saudi Arabia
Thailand
United Arab Emirates
USA
Vietnam
2022 is Turning into a Blockbuster Year for BIEL!!
SAI Brands with 10 New OEM 'Powered By ActiPatch' Products for the USA and Canada.
STADA, with $3.5 Billion in Sales, Signed as a New ROW ActiPatch Distributor.
BIEL's factory better hire a second and third shift.
The New Partnership with STADA will get a PR
BIEL told shareholders what they could ahead of an official joint PR with STADA. This will occur closer to the shipment of STADA's Opening Order.
Some will complain that this acknowledgement of a STADA deal did nothing for the SP when it went to a few thousand shareholders many of whom are already 'All In' on BIEL.
The impact of this STADA news comes with the PR and the release of the distribution scope. This news will be a big boost to BIEL's reputation and the interest in future deals.
STADA had its DD and a 'Trial Run' with ActiPatch in SaudiArabia/Bahrain as announced earlier this year.
Yesterday's announcement that a new agreement had been signed with STADA was based on that 'Trial Run'.
BIEL dropped a hint in Dr. Staelin's Letter that this was not just the addition of a country or two.
"We are now in the process of meeting the demand for their first order."
LOL, how many Americans know the names AmerisourceBergen, Cardinal Health, McKesson, all multi billion dollar medical distributors
<<<<<<<< Most people have never heard of the word STADA >>>>>>>>>
Distributors operate behind the scenes but you know and use the products that they bring to the stores where you shop.
STADA is a 127 year old German company founded in 1895. Europeans know the name as it appears on some of their generic drug products. STADA is a major player in the Generic Drug business.
The STADA deal is about ROW distribution as ActiPatch is no longer for sale in the US per OEM contracts. ROW encompasses 7 billion people.
The STADA deal is a 'Big Deal'.
MMs working overtime to contain todays News
43.9 million shares out of a 54.7 million total volume could not be delivered Today.
20220720|BIEL|43960456|54733007
https://cdn.finra.org/equity/regsho/daily/FORFshvol20220720.txt
Congrats BIEL Longs!!!, Major Distribution w/ STADA
Congratulations to Erin Sanders for bring STADA on board as a BIEL Distrbutor!!! Ertin signed STADA for Saudia Arabia and Bahrain in 2/2022. Apparently STADA liked ActiPatch and is now expanding ActiPatch Distribution into other markets.
STADA is the Big Leagues Ladies & Gents:
* Servicing customers in 120 countries
* 2021 Revenue of $3.59 Billion
* 8% Revenue gain from 2020 to 2021
* 12,300 Employees
* STADA has been growing agressively for several years since the deep pocket investment firm of Bain Capital accquired them in 2017 for $5.6 Billion
* 1/2022 STADA expands production network with EUR50m project in Romania
* 6/2021 STADA further grows European Consumer Healthcare portfolio by acquiring 16 well-established brands from Sanofi
* 12/2020 STADA delivers double-digit growth in 2019 as it invests to lead Consumer Healthcare and Generics core segments
* 5/2020 STADA closes acquisition of Walmark, creating a winning portfolio for Central Europe
* 4/2020 STADA takes clear lead in Russian consumer healthcare sector $660 million transaction of a Russian brand portfolio from Takeda
* 2/2020 STADA becomes a major Consumer Healthcare player by acquiring 15 well-established GSK brands
* 2/2020 STADA to acquire established OTC and food supplement portfolio in the Philippines
As well as Up 11.8 Percent Today!!
With 750k in BS 'avg' Trades at 8 with a 9 Bid/10 Ask.
Including 1.9 million Neutral shares at .00095, which is the MMs using their 5 digit privlidge to make a few extra dollars
DD shows BIEL did Not Own the HealFast/PetPatch Names
Mary's company, eMarkets Group a seperate company from BIEL, had the 'HealFast' rights starting in 2003 and 'PetPatch' rights in 2011.
HEAL FAST THERAPY
registration #78203325 eMarkets Group, LLC 2003-01-03
PETPATCH
registrartion #4141974 85414943 eMarkets Group, LLC 2011-09-04
https://uspto.report/Search/eMarkets%20Group
*****************************************************************
The first time BIEL shows up relating to the 'HealFast' name is 11/8/2020, after Mary's death in January 2020. BIEL never shows up relating to PetPatch.
HEALFAST
90326666 BioElectronics Corporation 2020-11-18
https://uspto.report/Search/Bioelectronics%20Corporation
********************************************************************
Linkedin- Mary Whelan
President
eMarkets Group / HealFast Therapy
North Caldwell, New Jersey
eMarkets Group is a marketing company committed to helping businesses reach new customers and serve existing customers better. We create strategic programs using both traditional marketing and new web and electronic CRM technologies.
eMarkets Group has developed the brand and market program for an innovative pet health care product, HealFast Therapy. Visit www.healfasttherapy.com to learn more about our breakthrough product that delivers drug-free pain relief for those you love.
https://www.linkedin.com/in/mary-k-whelan-8537166
*******************************************************************
The distinction between BIEL and eMarkets Group is made clear in this 2009 statement regarding a distributor agreement,
"BioElectronics signed a distribution agreement on February 9, 2009 with eMarkets Group, LLC (eMarkets) a company owned and controlled by a member of the board of directors and sister of the Company's president. The agreement provides for eMarkets to be the exclusive distributor of the company's line of products to customers in certain countries outside of the United States for a period of three years. The distribution agreement lists the prices to be paid for the company's products by eMarkets and provides for the company to provide training and customer support at its own cost to support the distributor's sales function."
Good catch imklo, HealFast was Mary Whelan's business
She passed away a couple of years ago.
Thanks GG, good explanation of Electroceuticals and how they differ in Mechanism of Action, Risks, Side Effects.
ActiPatch has clear advantages when risks/benefits/side effects/cost are compared.
http://www.actipatch.com/actipatch/wp-content/uploads/2014/11/ActiPatch-Mechanism-of-Action-and-Clinical-Evidence-Packet.pdf
The recent AMA Code additions are a positive sign in regards to the AMA being more receptive to new Therapies.
The reason was the same as for every stock that goes up
More Buyers than Sellers,
MMs had to provide a 10k share opening Ask for the first 8 minutes because Nobody Else Wanted to Sell at 9 .
541k shares of the 2 million Sell Volume was BS 'avg' transaftions at 8 .
Congrats BIEL Longs, Up 25%
Sells accounted for only 18% of today's Trades.
Go BIEL !!!
Yes, SP manipulated down, 71 percent Buys today and BIEL drops 11%
<<<<<<<< This things manipulated more than a marionette >>>>>>>>>>
Buys = 19.9 million shares (4.7 million of those shares bought at .001)
Sells = 6.7 million shares
Neutral = 1.6 million shares
Lots of differing Opinions ......
<<<<<<<<< Junk stock … don’t waste your money >>>>>>>>>
Guess it depends on which side of the bed one gets up on.
'My goodness..you can feel this thing wants to run …cmon let’s go'
'Crank it up BIEL…let roll !'
'So far so good …let’s keep it rolling'
'Better get em now , Friday is going to be HUGE !!'
9 Million 9s Snapped Up
10s printing
Go BIEL !!!
You might want to try reducing the antenna diameter Pro
Easy to do, just cut the wire to desired size, braid the ends together, solder together if you have an iron or tape securely if no iron. Make it a quick solder as heat will carry back to the electronics.
I do a 3" loop for my neck and works great. Reducing size focuses more of the energy in a smaller spot.
You might want to go down to a 2" loop for a toe. That is about the same size as the eyelid surgery RecoveryRx product.
Pretty sure BIEL monitors the market Miami
A complaint would have to be filed with the SEC.
"Report Suspected Securities Fraud or Wrongdoing
NOTICE:
We strongly encourage the public (whistleblowers and non-whistleblowers) to submit any tips, complaints, and referrals (TCRs) using the SEC's online TCR system and complaint form at https://www.sec.gov/tcr. If you submit your TCR using the online TCR system, you will receive a notice confirming that your submission has been received successfully and providing the submission number for your records."
https://www.sec.gov/tcr
The problem is providing enough evidence for the SEC to be interested in investigating. You almost have to be working inside the Broker/MM industry to get the evidence. This is especially true for volatile Pink Sheet companies.
A large trade in the final minutes of trading looks very suspicious but proving it was manipulation is difficult.
Thanks Hawk, Shephard Group with operations in 10 states and growing quickly will provide further exposure for RecoveryRx.