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Super, I, for one, have only viewed you as a solid and articulate contributor here. I too have often felt the urge to blast away at the incessant bashers with greed or a shoulder chip ans their mantra. I find the ignore feature of iHub a terrific alternative for obliterating the nonsense. It's a little like abusive hecklers in sport - their having paid for a ticket gives them the right to abuse, yet if put on the field of play, their false bravado would become total silence and if put in the room, they would run for their lives.
With 'Ignore', you just don't see them, so reality prevails and hopefully the quality of the dialogue preserved somewhat. Don't change and please don't qualify the 'why' of your comments. Thanks
You nailed it Dubb - think they're on the right path to approval now.
Sorry, can't resist the opening here - badubb, badubb, badubb,... . . . da, da, da, daaat'!s all folks! Go BIEL.
If Knopick reacted to your being helpful and is the author of the negativity, he most probably was giving you thin skin push-back. Give us the flavor of his response please - where he sits in terms of his effectiveness and potential longevity will be evident. There are few secrets. The good thing is that if Knopick was pushing back, it may be a sign that Whelan may know nothing of the negativity and Knopick doesn't want the pot stirred. Thanks Just
Thanks yankee, Mary, just garden, and hustle for taking the time to read my thoughts from Friday. Of course, no conclusion cn come of it, I just wanted to get a feel for timing of applications, etc. Very impressive to me is the indication that the FDA is working with every applicant, clear evidence to me that it is better to listen than throw one's weight around if you don't at first succeed. There's a lesson!
Hustle, would it not make sense for the company to pay attention to garden's just posted observation, and I'm sure those of many others here, and immediately remove any acerbic comments, or even petulant innuendos about the FDA from the BIEL website? Not only is it childish and unprofessional to even have them there, it's stupid! I'm picced off at learning that they even exist! Surely the last thing Whelan, and the rest of management, and the Board at BIEL should want at this time is for someone at the FDA to be alienated, in the least. It has to be an oversight from the days of whining, no?
In my mind, Whelan has fiduciary duties to do all in his power to advance the financial lot of BIEL, to its shareholders, directors, the professionals who have thrown their weight and effort behind the company and particularly to his family members who have been instrumental in the survival of the company thus far. Pucker up Whelan, clean up the website and kick whomever's acc you have to in the interests of diplomacy, just getting along with people and getting OTC approvals! I'll feel better and less picced off, when I learn the bar of professionalism has been raised! Whatever happened to professionalism, civility and dignity? I'm shaking my head at how easy this could be . . . . .
Patented, drug-free, side-effect free in the current environment we have in this country when painkillers and prescription drugs are the scourge of our society? And the FDA has released news of its proposal to create a new category for SWT devices? And there is one sour word anywhere? Too stupid for words! No wonder I'm picced. I hope Mr. Knopick is as picced as I am when he reads this. Please go to the BIEL website and 'Management Team'. Do any readers here know any of the good folks listed there? If so, please give them a heads up, I'm confident they would be astounded that there is even a hint of negativity on the BIEL website about anyone! I think we shareholders have immense power here on iHub and the management team should know of these things!
p.s. after posting - I'm not sure I can fairly lay all this at the feet of Whelan - there is a chance that he has already terminated the idiot responsible for writing and posting whatever negativity or cynicism is on the BIEL website. What would be unconscionable is if he and his colleagues do not immediately have it removed. Then, simultaneously delegate, to whomever is responsible for the FTP uploading of code to the website, that all new code must be carefully edited for negativity. Here is the challenge of leadership and professionalism thrown up in the air for all to see. If anyone has any sense, it will all be removed yesterday! That would be a huge indicator of professional and prudent management, on the eve of a fresh 510K application to the FDA? How hard is this?
Sort of interesting waiting for a flight and thinking of next steps for BIEL. Went to FDA site, 2014 device approval page - link below.
Looked at 8 device approvals to date 2014, none in SWT category.
Shortest elapsed time application to approval 6 months with 3 amendments, longest time 50 months with 18 amendments. In the case of the longest elapsed time application-to-approval, there were 7 separate amendments in just the first 105 days following the original application and 18 amendments total in the 50 months elapsed time before approval. I checked the number of amendments to each device application and inserted those numbers below after the duration number.
Seems to me that the FDA worked with every applicant and the amendments kept rolling in until the FDA and the applicant were both satisfied, the FDA then took time to do its final assessment, review it, write an approval letter and issue it.
May one assume that in the classification space of devices that the FDA is proposing it create, and which if created BIEL will position itself, that there will be certain defined specification parameters of acceptability for the SWT devices that the FDA will instantly recognize as safe and efficacious? Like, frequency, current, pulses/whatever? I think, yes.
And, can one safely assume that there is a fresh genre in the FDA that devices are being viewed differently today than 5 years ago when BIEL was going through its application phase? I think, yes.
My overwhelming conclusions, based on what I see in the devices approved data for 2014 and from my personal experience with the FDA on an oncology drug, is consistent; that they do indeed work with applicants to move forward, not backward, and that if respect and diplomacy are used at every step of the way, then good things happen. In other words, be thorough in the application, make sure the science and back-up are credible, never wing it, say you don't know if you don't know, never BS them because they know what they're doing and never, ever picc them off! Seems like a plan. I also think the shorter approval time the FDA suggested for complete and thorough applications with no amendments is because they know what they're doing.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm381097.htm
DEVICE
Supera Peripheral Stent System <17 months 7
Nucleus® Hybrid™ L24 Cochlear Implant Sys <11 months 5
Elecsys® HBeAg Immunoassay etc. <10 months 3
MONOVISC™ injectable Intra-articular Device 50 months 18
Dexcom G4 PLAT Cont Gluc Mon Sys <12 months 2
Medtronic Valiant Thoracic Stent Graft < 6 months 3
Medtronic CoreValve System <7 months 2
ReSure® Sealant <11 months 5
Good common sense Arizz
Suggest removing the second part of the hyphenated word in your post and then inserting the indefinite article 'a' after the word 'he's'. . . . reads better . . . . just sayin
Me too BULL
I read that BIEL had only 180 shareholders of record as of Dec 31 2011. Today there is virtually zero knowledge of BIEL on the 'Street' and therefor no volatility, except that engineered by MM's for daily swings and gains on the Pinks, or interest by the general investing public in acquiring shares .
It will be fascinating to see what happens at the various thresholds I expect the company to pass through this year:
1. FDA closes period for Administration requested comments to its proposal to create a new classification for SWT devices and thanks all contributors - they are so gracious and professional in their correspondence, as they should be;
2. The Administration will advise of its decision to create new classification as of date X, or not. Will it take 30 days to assess comments? Doubt it. My money says they are reviewing as received. And, why delay for the sake of delay, makes no sense. If this were a sick game, why make the proposal and ask for comments, only to say no? Also makes no sense;
3. New classification of devices created and requests for 510K's. My money says BIEL's 510K will be hand delivered that day or earlier.
4. My big questions are, (a) will BIEL submit proper data in sufficient format and quantity to give the FDA enough science and information to issue approval and, if so, (b) how long will it take the FDA to process, evaluate the 510K and issue its decision?; and
5. My little questions are, (a)if BIEL crosses over all the thresholds in 1 through 4 successfully, what will the SP be at each juncture, and (b) how many shareholders will there be at the finish line when BIEL goes OTC in America?
Shouldn't have put these thoughts to speculative print, only makes waiting more difficult. On reflection, it will be very cool when BIEL moves to a trading forum like the OTC:BB.
My take is that once ALLAY is approved here and American women find out about it the sales will explode globally. The power of word-of-mouth among women on many topics is phenomenal so why wouldn't the news of a drug-free, side-effect free solution to their monthly misery move like lightning? I am very thankful I don't have that issue and am sensitive and empathetic of those who do, but is there anything else on the market that helps women the way ALLAY does?
Hey BIELoney - greetings
Went on Boots.com and searched for ALLAY, as you probably did - not there.
Confirmed the search engine is working at Boots.com, entered ActiPatch and got 3 SKU hits - back, muscle & joint, and knee, so the engine is working.
I also have no idea why ALLAY is not available through Boots, company would know. Hope this helps
Thanks a lot G-star, positive feedback either for or against always make the world turn more smoothly.
The many 'good guys' (male and female gender of course), a name I coined here many months ago, have all contributed to disseminating BIEL info for those of us less learned and especially helpful to me on the science and Regs.
Imagine the reaction and results if and when BIEL can begin to help 10's of Millions of women, should I dare say 100's of Millions of women, who suffer from menopausal cramping and pain? When that catches fire, my take is that ALLAY will become the consumable that will release women from that burden in every country where literacy and disposable income will permit. The potential magnitude of it is nuts! I can't even begin to convert the upside to market cap, etc.
Got it 7up
PBS - "Your Inner Fish"
http://video.pbs.org/video/2365219509
Thanks again
Missed it 7up, but just went on PBS site and found "7 Back Pain Myths Busted" - that it? If so, thanks EDIT - don't think that's it - can you give me a link for watching it please?
Can't help himself - I love the ignore button. If the situation persists, Mods will simply give him another time-out. I was given one many months ago because I was reacting to inane bashing-for-bashing and bitterness sakes by fighting fire with fire, when I should simply have used 'Ignore'.
Did my time, sat in the corner and perhaps have had one or two reactive-to-senseless-bashing posts deleted since. System works well and intelligent dialogue prevails, which is what iHub is really all about.
Great work ravens - thank you very much.
I focused on one particular paragraph which may just pry the door of approval for BIEL and similar companies a bit more. Don't want to hype a thing here, just simple common sense works best for me.
Quote:
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology. Unquote
Seems to me that BIEL slides right in here on several counts:
1. It is low-risk;
2. Serious conditions, whose medical needs are unmet by current technology. No question in my mind that chronic pain is a serious condition here in the US. It is costing us many Billions of dollars every year in lost time, lost earnings and lost productivity. And we are drugging the "serious conditions with harmful chemicals that often exacerbate the issues;
3. Great to see the feds and the FDA shining intelligent and proactive lights on the issues surrounding Rx and non-RX drugs;
4. How many Americans, male and female and of all ages, suffer from chronic pain every day of their lives?;
5. Among those, how many are women who suffer from chronic cramping and pain from menstrual issues, month after month, year after year from high school to senior years, only to drug themselves, sometimes senseless, to carry on functioning at work or in their critical role running families and homes? Awful how we can maintain ways of hurting ourselves when there are options available; and
6. Best parts? Drug-free, side-effect free and patented! Let's go folks, cautiously, prudently, yes, but time's a wasting. There is nothing I can see but upside, for Americans suffering pain of allsorts, both temporary and chronic and the company and its shareholders. The American way, but we are late since many very civilized countries, like Canada and the UK already have BIEL approved for OTC sales. We're a little behind, but we're coming like a train with this one.
Thanks again ravens
Great timing and find as far as I', concerned 7up - I may have missed this if it was posted before - thanks.
Hey Imrich, would you please do me a favor? Go to the link on 7up's post 37098 and look at the FDA release and attachments.
Whelan writes a letter, dated April 2 2014, in which he requests a shift from Rx to Class II for OTC, I presume for Recovery RX.
His letter also discusses ActiPatch in a couple of places. All this is labeled as a supplement. Note: "Supplement submitted to FDA" and "Supplement from BioElectronics Corporation" Is there a possibility that this is in fact a supplemental application, or request, sort of, to the current approved status of Recovery Rx asking that it be immediately re-positioned, re-identified, or re-whatever as Class II? Supplement as a stand alone word needs a little Viagra; Supplement to what? It appears to me to be the previous approval of RecoveryRx.
And, further the references to ActiPatch are interesting. Is RecoveryRx actually ActiPatch in every way? The names simply merchandising or Brand or use identity names?
Seems to me Whelan would never do this without having received very solid advice, even "direction" from legal or scientific counsel, or 'elsewhere', to submit it as a possible effective way through the maze, as it were . . . . .
I would very much appreciate your cautious thoughts and from any other good guys as well. Thanks.
You're most welcome Mary, for whatever I may have done to help shareholders here. Simply trying to share my perceptions and experience, based on 1st hand knowledge and facts. Thank you again.
Sorry stockin - my references to Allan Green refer back to a post I fired up a couple of weeks ago and what I would do if I were BIEL, seriously consider taking a pro into any FDA discussions this round, give him or her a whack of shares and let's go. I happen to know Allan, and what he has accomplished for others, and am absolutely without conflict of any kind.
In my own experience, I was part of a team that presented an oncology opportunity at the FDA. I stayed out of the discussions, as I am not a scientist, but my involvement in the company was well known. I can state, without reservation, that the folks at the FDA were professional and respectful; they were enthralled with what we were doing; offered us 'Orphan status' in preparation and submission of trial data; offered to fast-track us in every way possible; and helped us in numerous other ways.
It was a pleasurable experience. Unfortunately, the company was about $100Million short for obtaining FDA approval and not an American company, so we obtained approval in the EU and it is helping people there and elsewhere. I can't say more because of NDA's, fiduciary duty, and mostly respect for my fellow shareholders, but my experience concerning the FDA was proof positive that if you get people working with you, you can move mountains, because they were moved to excitement and willingness to help. I would go back to the FDA in a heartbeat. The experience also proved something I learned well previously; that if you're not prepared to be a team player, don't put the sweater on. I think the saving grace here with BIEL is that Whelan learned and now recognizes he needed a team, he just needs to keep a lid on himself and let them get it done and I expect he will.
:) - I may have missed your meaning Stockin, but I'll run it up the pole and see what u think. . . . . and this relates to BIEL, of course. I disagree oh wise stickler. In the modern version of the old adage, silence does not equal wisdom. Indeed, that was the old version.
Modern version, with the element of sarcasm, Silence creates the 'appearance' of being foolish, thus the sarcastic emphasis on the word 'appear' when saying it.
In Whelan's case, as president of BIEL, stately, portly, white haired gentleman, in the old context he can 'appear' to be wise by his mere presence, especially when with his chairman who is a brain trust on the subject at hand. In the modern context, he could 'appear' to be foolish or unknowing by not engaging in technical discussions about the efficacy of BIEL products, etc., etc.
Then, as actually happened, he opened it up and let go and 'Whelaned' himself, as it were, by his words and dark attitude into very deep technical waters and 'appeared' foolish because he just alienated a director of something or other at the agency because he didn't get instantaneous approvals. . . . . In the business, or science, of obtaining approvals, one is often in a position of fighting to avoid getting a 'no', rather than pushing too quickly to get a yes. Enter the often elusive wisdom Mary writes of in her reference to Proverbs 3:13. To digress further, Whelan would have been very happy, had he kept it buttoned, sat quietly, 'appeared' foolish and used a professional like Allan Green over at FDARegs.com. Read the 2nd sentence of Allan's 1st paragraph left side and ask this question.
Would it have been helpful for Whelan to have had a diplomat like Allen Green at the table to say, "I don't disagree with you, but we would like to go back and look at this again and come back and see you." That would have made life easier than trying to sell ActiPatch stateside without approval and after you've been advised you need more muscle in your data. Obtaining Regulatory approvals is an art, not just at FDA, anywhere in the world! It's called diplomacy and if you don't have a diplomat at the table, back off until you do. It's a rule! I qualified I was digressing, but are we ok on the 'appear' and foolish and wisdom?
Point is, I submit that all this could have been avoided, personalities left in the parking lot and we would all be further ahead, not just shareholders, but American representing 4.5% of the world's population and using 80% of the annual global consumption of pain medication. I appreciate the numbers are skewed and required a 100 point list of assumptions, like take palliative out, take serious oncology out, etc., but you get my points, I'm sure, it's all about diplomacy when you get as far in the approval process as BIEL was. You never argue or bristle, you retreat and that did not happen.
yankee, you are soooo on target.
Questions are when and how the American people will learn of BioElectronics, the little American company from Maryland which has a patented, drug-free, side-effect free solution for much of the general muscle, joint and menstrual pain that Americans of all ages are currently masking with pain killers making them consumers of 80% of all the painkillers taken every year all over the world. It amazes me every time I think of this - 80% of the global pain drugs taken right here and what are we, 4 1/2% of the world's population?
I know many of the sides of this story, we have access to drugs while many don't; our life expectancy is higher than many countries, etc., etc. But 4% of the world's population taking 80% of the drugs for pain? That's just nuts. And, it's probably bigger than ObamaCare as an opportunity to improve the quality of life in this country.
I can't say enough good about the FDA proposal that it wishes to create a new classification of devices that can deal with pain in this country. A Peter Lynch "Hidden Gem"? Absolutely. Question now is what smart elected luminary in DC will let this cat out of the bag, or will it be a Sanjay Gupta story? CNN should be all over this, or CNBC, someone will crack it open, you're right yankee. I just hope I'm not on a plane when the news hits the street, it'll be fun to watch.
Whelan is quoted as saying"
“The data from these high quality clinical trials will be available before the FDA’s May 21st deadline for comments on proposed reclassification of our devices to Class II. This schedule will allow us to submit the 510K application without any delay once the final ruling is made by the FDA”
If accurate, is that not different from my perception that the FDA has requested comments until May 21 on its proposal to create a new classification of devices which BIEL products will fall under, along with other firms in the same space for OTC sales?
The two scenarios above are very different and I may be splitting hairs here, but Whelan and others at BIEL had better be cautious and get it right this time. This is the FDA show here and humility and no mention of the FDA is the only way to go. There are a few versions of this, sometimes attributed to Mark Twain, Abe Lincoln and others. In fact, it's biblical, found in Proverbs 17:28 - "Even a fool is thought wise when he holds his peace"
Before that, Job 13:5 has it as, "Oh, that you would be silent, and it would be your wisdom.”
I kind of like a more current, in-your-face with sarcasm version myself, "It is sometimes better to remain silent and APPEAR foolish, than to open one's mouth and remove all doubt".
I'm inventing another here, "Whelan, STFU and do not picc off the FDA, again!" Even a stubborn old, Irish, ex-marine would get the message, one would think.
So, Whelan may have put it a little more softly had he said, “The data from these high quality clinical trials by BioElectronics will be completed before the FDA’s May 21st deadline for comments on its proposal to create a new classification for devices, such as ours, as Class II products. This schedule will allow us to submit our 510K application immediately after the FDA releases its decision.”.
This doesn't make it sound as if its only about BIEL. If I were Whelan and therefor knowing my own history of shooting from the lip as BIEL's president, I would make it corporate policy today, now, that any release of information to the media must first be approved by the Chairman of the board. Next, Whelan must be immediately coached by his chairman and the PR guy Paul Knopick, who seems quite sensible, to have a six-pack of comments he is permitted to make when asked questions. There are hundreds of millions of dollars at stake here for the Whelan family and shareholders and it is no place for loose cannons. One would hope Whelan would be big enough to be all over considering these suggestions, or perhaps just consider remaining silent? Difficult for the Irish sometimes, but critical to the success of BIEL, Andy boy!
There is a story sausage, but that ain't what I got at all.
My college buddy up in Toronto, who sent me some ActiPatches when I sprained my ankle badly playing tennis, called a senior exec he knew at Shoppers Drugs, the biggest players Canada.
Seems a west coast Rep company named Losin pitched Shoppers and was told they only review product lines once a year, which they passed back to BIEL. BIEL found out later from another Canadian company that the info from Losin was crap and that ended that. But apparently another company BIEL was involved with had already pitched Shoppers when Losin went there plus the Losin numbers were way too high for Shoppers to generate sales and have their required margins and BIEL was inflexible on pricing, so that was that. Only later did BIEL take a look at its pricing, but it was too late for Losin.
The other company representing BIEL kept the door open and pitched Shoppers the new prices and after a couple of months a deal was close, but BIEL backed away from it and wanted to cut out the second rep company and represent themselves, They didn't have a relationship with Shoppers and apparently Shoppers and everyone else was picced at the games BIEL was into, playing both sides against the middle, so it went nowhere. My buddy asked who the second rep company was and the exec wouldn't tell him except they already had a large line of products in Shoppers and that's not how they do business up in Canada, but he couldn't find out who they were. My buddy's take was that people were picced at being jerked around. Hopefully the company learned its lesson on that one, just like at the FDA. Can you add to this sausage? I thought I had written this to you before, no?
Golden, indeed yankee - thank you. . . .
Hey yankee - you're right - read my 37030 again please. . . . . .
You would be amazed at who reads this board. There is no sense right now in alienating anyone, in my view.
Annnnnnd, the really beautiful thing mad and super is this. In order for Whelan to make really serious money, he must attract a few hundred thousand shareholders and to do that he must move BIEL to another board and I know 'first-hand, not by hearsay' that he knows that.
Now, read my message again. . . .
I know we're all picced, with the exception of parasitic traders, good luck to them. I am picced too, but my belief is that it is only the MM's manipulating prices for profit while they can. No Regs, so who is going to hold them accountable or litigate against them? No one. They could be trading on behalf of friends and family - there's a unique thought.
This stock is probably so thinly treaded. in terms of number of investors outside the business and a few of us here, I think I read somewhere that there are only a couple of hundred shareholders of BIEL,. that it could not possibly trade the shares it does, day after day after day. Look at the annual return of 10% per day and the answer is there.
Until BIEL moves itself to a trading spot (OTC:BB) where there are Regs, it will continue. Whelan is not stupid enough to leave himself vulnerable to a very inexpensive, yet damaging, lawsuit.
Remember, he was quoted here as stating something like, "we have sold shares to raise money in the past, but we wouldn't do it here at these prices, it's not worth it.". So, even though it's hearsay, under the Federal Rules of Evidence, (and not one of the 30 or so exceptions) Whelan and the publisher of that stand open to questioning. Nope, in my view, it's not the company, Whelan is the senior officer and a director of a publicly traded company - it's too stupid for him to do it, which is perfectly legal, and then lie about it, which is not. He has a fiduciary duty to honesty with shareholders and would be totally vulnerable if he jerked shareholders around like that. Nope, it's the MM's, nothing else makes sense at this time. They can do it without accountability. The truth test is; ask yourself if the bashers here would trade the dips and pops like crazy if they could. And then ask the final question; - are the bashers and MM's related somehow?
Obviously no coincidence, but deliberate. Called Saving F---. Love it! I suggest we just leave it alone folks. . . . . for all the right reasons. Great find 7up, fabulous find. Now we just STFU.
Probably at $7.00 sometime next year, but there will be a lot of support at $5.75
Thank you Mary, for your gracious appreciation, makes my sharing my opinions worthwhile. I too have read some of my research again and it just makes sense to me,. As you probably surmised, I am more motivated by what BIEL can do for Americans, who now consume 80% of the world's painkillers, than by avarice, or trying to buy some crumbs at a slightly lower share price. I have my investment, I'm good.
On balance, I see with clarity that there is a lot of upside to BIEL, providing management acts as a team rather than a dictatorship and lets the FDA do its job.
And, is spite of your appreciation, still, you probably won't marry me . . . . . .
Wistfully yours
Yup, another naysayer super - biel on!
This gyrating at the bottom end will continue as long as MM's can pound it down and catch 20% daily up-swings - imagine the annual return % on a few thousand $$$. There is little, if any regulatory oversight on the Pinks.
Whelan was quoted in a post in the last 100 or so that he had sold shares to keep things going but would not be diluting at these low prices because it's not worth it. Who knows? If that is anywhere near the truth then we are all victims of the MM's and why I have wished that Whelan would do whatever needs doing to get to a credible trading place. I know it requires certain thresholds and meeting standards of price and performance, but I can't wait for the day. More exposure to American investors, more brokers, more stability, more credibility, higher SP.
Maybe in concert with new classification by FDA, application by BIEL and approval process. Can't wait!
Thanks a lot 7up - I went to the site and have inserted the Regenesis Medical cover letter and Table of Contents below. Don't know how anyone can bash common sense with any credibility. I pulled the info from PDF's so it may not be complete or accurate. If not, readers can go to the site link you provided in your post - thanks again.
COVER LETTER
REGENESIS MEDICAL
By Hand Delivery
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
July 23, 2012
To Whom it May Concern:
Under cover of this letter, Regenesis Biomedical Inc. is respectfully submitting one original and two copies (one hard copy and one electronic copy, respectively) of its Petition for
Reclassification of Nonthermal Shortwave Diathermy Devices from Class III to Class II under Section 513(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This Petition includes the information required by 21 C.F.R. § 860.123 and responds to FDA's July 6, 2012 Proposed Rule to require premarket approval for these devices (77 Fed. Reg. 39953). The Petition is submitted within 15 days of the Proposed Rule and thus obligates FDA to consult with its Medical Devices Classification Panel regarding the action requested (see 21 U.S.C. § 360e(b)(2)(B) and 21 C.F.R. § 860.132(b)).
This Petition seeks the reclassification of Nonthermal Shortwave Diathermy Devices, as described in the Petition. Although the Petition has been prepared solely by Regenesis, the
Petition's request that these devices be reclassified into Class II is supported by the other companies that currently market the devices in the United States.
As detailed in the Petition, Nonthermal Shortwave Diathermy Devices have been safely and effectively marketed in the United States for many years under FDA's 510(k) premarket clearance pathway and related postmarket controls. Accordingly, Regenesis believes reclassification of these devices into Class II would appropriately protect and promote public health. Additionally, Regenesis believes that the risks of Nonthermal Shortwave Diathermy devices are well-characterized and well-understood, and that the special and general controls identified in the Petition provide reasonable assurance of the safety and effectiveness of these devices. As such, Regenesis believes Nonthermal Shortwave Diathermy Devices meet the statutory definition for Class II devices (see 21 U.S.C. § 360c(a)(1)(B)) and that reclassification
to Class II is thus appropriate. Regenesis further believes that reclassification is warranted in light of FDA's stated commitment, pursuant to the FFDCA's "least burdensome" principles and principles underlying device reclassification, to apply "the lowest appropriate level of regulatory control sufficient to provide reasonable assurance of the safety and effectiveness of the device."
FDA, The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry (October 4, 2002).
We appreciate FDA's attention to and thoughtful consideration of the Petition.
Sincerely,
Virginia Rybski
President and Chief Executive Officer
Regenesis Biomedical Inc.
1435 N. Hayden Road
Scottsdale AZ 85257-3773
480-970-4970
5301 North Pima Road
Scottsdale, AZ 85250
1-877-970-4970
TABLE OF CONTENTS
Section Page
I. INTRODUCTION 1
II. IDENTIFICATION OF THE TYPE OF DEVICE FOR WHICH RECLASSIFICATION IS REQUESTED
A. Intended Use 8
B. Physical Description 10
HI. HISTORY OF NONTHERMAL SHORTWAVE DIATHERMY 12
IV. KNOWN POTENTIAL BENEFITS 15
V. RISKS TO HEALTH 21
A. Introduction 21
B. Literature Search 22
C. Summary of Potential Risks to Health 24
VI. MDR, COMPLAINT, AND RECALL ANALYSES 53
A. MDRs 53
B. Complaints 54
C. Recalls 55
VII. SPECIAL CONTROLS 56
A. Summary of Reasons for Reclassification 56
Recommendation and Special Controls
B. Statutory Criteria for Reclassification 57
C. Summary of Special and General Controls 58
D. Proposed Special Controls 61
Section Page
VIII. ACTION REQUESTED 89
A. Petitioner Requests that Nonthermal SWD 89
Devices be Reclassified from Class III to Class II
B. Summary of Reasons Supporting the Action Requested 89
C. Basis for Disagreement with the Present Classification 91
Status of the Device
IX. REPRESENTATIVE DATA AND INFORMATION THAT ARE UNFAVORABLE TO THE PETITIONER'S POSITION 93
X. SUMMARY OF NEW INFORMATION 93
A. Summaries of Published Studies Reporting Valid Scientific 94
Evidence on the Effectiveness and Safety of Nonthermal SWD
B. Summary of Study Design Characteristics 111
C. Summary 112
XI. DEVICE CLASSIFICATION QUESTIONNAIRE 116
XII. SUPPLEMENTAL DATA SHEET 117
XIII. BIBLIOGRAPHY OF REFERENCES CITED 117
XIV. FINANCIAL CERTIFICATION 117
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
FOOD AND DRUG ADMINISTRATION
Petition for Reclassification from Class III to Class II
Under Section 513(e) of the Federal Food, Drug, and Cosmetic Act
Nonthermal Shortwave Diathermy Devices
Regenesis Biomedical Inc., Petitioner
END
Followed by 5 Volumes of information
I've sniffed around and felt you would have done the same with greater success than I would have because of your experience.
I strongly suspect they haven't done it yet rich, but are waiting for the FDA to release information relevant to its assessment of comments submitted about its proposal of creating a new device classification. I think this is the best tactic so as not to miss any late developments in the process. I would expect that BIEL has drafted the new application docs and inserted the latest trial data, but I feel it would be foolhardy to be early here. If I were running BIEL, I would have been working for a long time with the FDA on (a) what the company needs to do; and (b) how to best go about it. And, with a large dose of humility, given what's happened before!
Hey rich, how are you?
I suspect Whelan remains silent on all matters FDA because he's been burned by running his mouth before, and he should. There was a recent blip that escaped his lips in the UK recently and I hope someone put a new layer of duct tape on his yapper. Irish, ex-marine and picced off do not make good company. He's obviously got some good people and legal counsel on board now - my bet is they have told him to shut the hey up and let the process work, rather than trashing anyone and shooting himself in the foot again. That would be my advice to him and I think the reason we saw a PR recently by the BIEL Chairman of the Board.
On the other hand, would it not be prudent for the IBEX financiers, family or not, to ride the expected rise in SP if and when BIEL receives OTC approval in the US for its products? I've seen the bashers go nuts with criticism of IBEX and family this and that. But, obviously BIEL has received financial counsel on how to structure its financings, I see nothing wrong with it and might do the dame thing!
Bottom line is they put up money, BIEL is surviving the long and costly process of regulatory approvals in this country and has another opportunity to apply for OTC designation under a new class of devices proposed, out of the blue, by the FDA. I wrote many months ago about allowing others to save face without hammering the crap out of them and it might be a good idea for Whelan to don a muzzle and allow the face-saving to play out. All I suggest now is for him to swallow his Irish, ex-marine, hard done by ego and tighten that muzzle a notch for the final steps of a new 510K application, FDA assessment and hopeful approval. I want to ride the BIEL wave and I make no bones about it.
If it plays out well, as I hope it will, I will profit and Americans will win by being able to purchase a drug-free, side-effect free pain management device; tens of millions suffering regular muscle and skeletal pain and tens of millions of women suffering severe menstrual pain and cramping - Go BIEL!
Thanks Erbb - sorry for running behind the pack here. . . .
This excerpt from the link you provided is dated 2013 and does address the non-heat aspects of the new application philosophy. Many references to producing small amounts of this and that leads one to believe the products are not powerful enough to cause harm but do ease pain and promote healing. Another sentence in the link refers to it's ok for prolonged use, another side-effect plus. My curiosity remains about whether the 2003 patent application or the RecoveryRx application to the FDA contained any verbiage about non-heat. I recall reading somewhere in early on documents that stimulating heat is used. The whole non-heat aspect implies no risk of overheating skin or damaging underlying tissue.
Quote
Therapeutic value may be achieved by applying an electromagnetic field to injured bodily tissue. Application of a high-frequency electromagnetic field at a sufficiently low field strength so as not to produce tissue heating may result in a beneficial effect on healing of the tissue. Unquote
And, earlier in the application:
Quote
This application is a continuation-in-part and claims the benefit of priority from U.S. patent application Ser. No. 10/384,101, filed Mar. 6, 2003 now U.S. Pat. No. 7,551,957 and entitled “Electromagnetic Therapy Device and Methods,” which is incorporated herein by reference in its entirety. Unquote.
This application establishes new IP dating and protection. BIEL know what it is doing in beefing up its IP.
Agreed 7up, the USPTO processes the assessment and issuance of IP rights to applicants for same. But, is the wording of this:
Excerpt from BIEL application to USPTO:
Establishment
NameSort by Establishment Name [A-Z]7
Sort by Establishment Name [Z-A]8 Registration Number Current
Registration Yr
BIOELECTRONICS CORPORATION9 MD/USA
3004837702 2014
diathermy, shortwave, for use other than applying therapeutic deep heat - ActiPatch Therapy; Allay; RecoverRx 10
END
"for use other than applying therapeutic deep heat"
the same as previous applications for IP protection at the USPTO? I don't want to spend a lot of time researching this, as fellow posters may recall if the wording is familiar. Or, is the wording excluding heat a crafty side-shift to move into the upcoming 510K, which is the FDA and would address the non-heat issues of the past.
Clearly BIEL is working on IP using legal and scientific professionals and we are now only a month or so away from the FDA period of receiving comments to its own proposal to create a new class of devices in which BIEL products will fit.
Btw, does anyone know if BIEL itself submitted written comments to the FDA in support of the new classification? And, is there somewhere that FDA might publish the comments of other firms in the space?
Didn't know that StockinUp, but thanks for the news.
There is no substitute for truth and fair play, why should posting on iHub be an exception? If what you're saying is correct, we can infer that it was a result of inappropriate behavior concerning BIEL or another site.
I salute iHub and its Moderators for their actions. I have big foot on ignore because of posting untruthful information. I have no interest or time to read post after post of self-serving, mindless bashing and libel of companies and the officers and directors.
If he complies with the iHub rules, I take him off ignore, simple as that. Thanks again.
Best and only way mad is to stop pounding the company and CEO with high emotion. It's business, you're making it only personal.
Buy more stock and make money, there's your justice, otherwise you're hurting the rest of us who read your negative posts! So, the guy lied to you or skated around your questions, or whatever. The company has survived, the FDA is creating a new classification, we are all positive and you're bitter. We know you're upset, we're not stupid, but get over it, anger is bad for the health. Good luck.
Good post and link Super. What I find interesting is that the timing of the feedback on the FDA proposal for a new device category for BIEL, and other firms, roughly coincides with possible changes to SEC regulations. Seems to me that Whelan will not trigger a R/S; it works against him if forecasts of MMs pounding the price back down become reality.
He and family own hundreds of millions of shares and fair enough, but if he makes a couple of hundred million dollars on FDA establishment of its proposed device classification, then receives BIEL's 510K and grants approval for OTC sales in the USA, it's all academic, BIEL gets smoking hot. And don't think the shift of oversight won't be to the SEC reviewing everything to do with BIEL and its trading, if it explodes, because the regulators will be all over it! That would be fun, BIEL cease trading order for a few hours to match orders and let it get a breather, while it blasts through 50 cents, at the same time as the SEC revs up its inspectors! Beautiful. Whelan wins for his hard work and risk, we win too. As an Irish, ex-Marine Whelan is too stubborn and savvy, with very smart people now onboard with him, all with stock, to allow himself to be raped by the MM's.
Easily done Super:
Go to my 36046 – I advise Pollux to print stuff – it’s my response to Super’s post 36012. Flip back to Super 36012 and he mentions Pollux word one in answer to Pollux 35951 BUT look up and you see Seshet! Clik on 35951 and it’s Seshet again.....
Second, irrefutable confirmation – go to my 36005 – I’m responding to bieliever post 35954 and I mention Pollux up front. Go to bieliever post 35954 and he is also responding to 35951 showing author as Seshet – go to 35951 and you have landed twice on Pollux / Seshet – one and the same. Two different routes numerous players. Busted and so childish!