T.K. has already been convicted for fraud, but seems that wants to repeat this experience. The human mind is very complex ....

Instead CTI no longer has a contract, has a old 510 (k) for old device out of production, and continues to provide false information to investors. Perhaps also C. M. wants to repeat the same experience.

Finally, I think that "Giuseppe" will be happy to explain exactly to a judge the strange CTI activities in recent years, and as the signatures have disappeared from the contracts. Probably these explanations also affect the SEC.

After these explanations will be interesting to see who must pay the damages, and if there will be a class action of the small shareholders against CTI.

Bitspirit, this is not entirely true.
The idea that the CTI contract is still valid it is in contrast with the legal procedure that has terminated the agreement. This procedure has followed the rules, and may be discussed in court, but until evidence to the contrary it is a legitimate legal pathway.

This means that a GSA contract in the position of dubious legality of CTI can open the door to further lawsuits against the company.
In this case a lawsuit against CTI would be advantageous because CTI would have the economic resources to meet the likely demands for compensation. In any case, another important lawsuit against the company definitely creates more problems than it can solve a GSA contract.

So, CTI even with the GSA can survive without issues only if can restore a clear legal situation.
Obviously it is to exclude any new agreement with the inventor, especially after CTI continues to try to discredit and defame him by any means.
Speaking of defamation and similar activities, I noticed that VC remains the source of inspiration of CTI in order to continue its work, but has retired. Maybe the next retired is some VC follower that believes he can remain anonymous forever

In conclusione currently the only pathway possible to avoid the exposure of CTI in other lawsuits seems a new distribution contract with DIS&L finalized to military supplies... but it is quite unlikely or impossible that this can happen.

In all other cases the risk of bankruptcy for CTI remains unchanged for the high degree of exposure to various types of lawsuits.

Continues to provide false information, but also if you wrote in pseudo Italian is always defamation, and it is always a crime. Perhaps you feel protected by anonymity, but inside the network no one can be anonymous for ever .

First, if you wrote "one of the inventors" it is clear that you want to continue to spread a slander. This choice seems also to anticipate other types of crimes, but this behavior it would not be a novelty.

Second, the inventor will be very happy if CTI can pay the debts with him. This conditions allow the inventor also to act to obtain a compensation for the damages suffered due to the CTI false and/or defamatory various communications that the company has used and continues to use against him.

Third, it is clear that you or CTI do not know a lot of things about the inventor, for example who has supported the development of his researchs, why it is heavily protected by the institutions, and many more things that cannot make you happy.

However it is likely that very soon these your / CTI gaps of "true knowledge" will be filled. The Justice is sometimes slow, but it is difficult to stop.

Is a well known fact that CTI is using every possible means to discredit the invento, and continue in this way the strategy began in 2010 that led to the failure of the commercial development of the therapy.r
The question is whether it is only inability to do business, or the real purpose of CTI is exactly prevent the correct development of therapy.
When you read "We found That the total costs ranged from $ 560 to $ 635 billion in 2010 dollars. The additional health care costs two to pain ranged from $ 261 to $ 300 billion. .... (Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug; 13 (8): 715-24. doi: 10.1016 / j.jpain.2012.03.009. Epub 2012 May 16) "
any hypothesis is possible. In fact it is symptomatic that you are in the same page with VC work. The difference is that VC has always stated his intentions to destroy this therapy with every means, but theoretically VC does not work for CTI ... also if everything is possible.

However you continue to provide false information to create a different reality and try to discredit the inventor, as did your CEO in this interview: http://nationalpainreport.com/inventor-calmare-scrambler-tries-block-sales- 8823560.html.

Do not believe me? .... I have heard how is really happened on this topic, and that this can be documented in court.
For example it seems that the inventor had renounced a significant part of its royalties in exchange of clinical trials of quality carried out properly, the respect of the standards of training and use of the therapy, and the spread of scientific informations correct. An agreement very beneficial to CTTC, but was refused.
If you discuss this story for example with O'Connell, you can have clearer ideas about the meaning of defamation, and more....

It is clear that you have a lot of unsolved problems with the inventor....and more.

I understand your desperation, but you use me to continue to provide false information and defaming the inventor. This is what that should really worry you.
No offense, but your threats are really ridiculous.

You should also learn to know better the concept of projection used in psychology:
"Psychological projection, also known as blame shifting, is a theory in psychology in which humans defend themselves against their own unpleasant impulses by denying their existence while attributing them to others. For example, a person who is rude may constantly accuse other people of being rude."
(https://en.wikipedia.org/wiki/Psychological_projection).

In short, what you wrote: "horrible businessman, control freak, You are a bully, you are dishones ..." is a clear example of this psychological phenomenon.

For example, anyone can verify that the inventor never wrote or claimed to be a medical doctor, as is also clear from the name of its research center. This was just one of many false information provided in the time (since 2010) to discredit the inventor.

The request of royalties to GEOMC or think that the old 510 (k) (old device discontinued) has value in Korea means having a strong sense of humor, there is no doubt about this.
However, the problem that still it escapes to you (in addition to the reasons of the cause of GEOMC against CTI) is this:

Hypothesis 1
Conrad Mir is right about the amendment "not signed" or unvalid. In this case CTI for over two years has acted illegally by providing false information to the stock market by using a fake agreement.
This fake agreement basically cheated even those who were directly or indirectly involved, because It seems clear that the CTTC Board has always shared JJ work and approved what he was doing, including the signing of the amendment, as documented also by the public CTI communications.
So, the CTI Board in this case is responsible of the fake agreement.

Hypothesis 2
Conrad Mir invented the story of the unvalid amendment, and this seems the most likely hypothesis according to public documents also provided by CTTC before Conrad Mir. Needless to comment on what this entails in terms of falsification of the stock market and issues with the law.

It is in any cases a fact that in both Hypothesis CTI acted or act outside the legality.

You must added that:
- the press release that announcing the cancellation arbitrary amendment Conrad Mir has produced a termination of the contract with the inventor.
- This termination of the contract (never canceled) did not occur with a press release, but with a legal pathway complies with US laws.

In summary the validity of the contract is only in the mind of CTI. However without the inventory of old devices to be withdrawn, CTI not have other devices to sell (see press release and lawsuit of GEOMC against CTI).

P.S.
if you want to talk with the inventor, you can use such as me this link: http://www.deltard.com/contact-us.php
and your real first and last name.

These are always the same old false information disclosed by Conrad Mir.
Finally, it is easy to verify that CTI has no rights on patents or other IP of Marineo.
In summary, other misleading information to confuse the stock market.

I think that as a whole this false information can becaume the basis for quantities charged of financial fraud and scam.

OK, but you only highlighted the huge difference in results of success between the clinical trials that using standard training and methods of use, and those that instead use the different training and the different methods of use wanted by CTI.
In short seems that the only real result that produces CTI is always to scuttle this therapy.
This fact combined with the CTT choice made in 2010 (the company comes out of the 'AMEX and loses $ 4 million for the startup) is really strange.

Bigspirit, friendly negotiations and much other information provided by CTI were proven wrong several times, see:

http://www.st-team.eu/correction.htm

In addition it is true that the signature of JJ was not valid, CTI has consciously used for more than two years a "fake" agreement as a valid.
In most nations ( I assume also in the US) this is translated into criminal offenses of fraud and scam .
It is therefore enough astounding that CTI continues to use these arguments with the SEC.

New 10-Q
Is worth noting that CTI continues to provide information to the SEC that have been publicly denials from those directly involved.

There is another possibility more realistic .....
the one that the judge reads the contract, the amendments, the information send to the SEC by CTT, the press release of CTT on the amendments, and reads the communications that are surely between both the parties in the protracted negotiations,
In this case the judge can even decide that CTT has acted illegally,with all the consequences of the case, even with the SEC.

Zizion Group and FDA Inspections, Compliance, Enforcement, and Criminal Investigations

Source: FDA - http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438226.htm

MAR 12, 2015

CBER-15-01

UPS EXPRESS MAIL

Mr. Bruce Bertman
Zizion Group LLC.
141 BW 20th Street Suite F5
Boca Raton FL, 33431

Dear Mr. Bertman:

The Food and Drug Administration (FDA) has reviewed your Internet website http://yesprpkit.com. Your website states that your Yes PRP Kit is an ““Easy and accurate PRP-Kit” for medical staffs.” Copies of the pertinent Internet website pages are enclosed for your reference.

The Yes PRP Kit is a medical device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) in part because it is intended for use in the cure, mitigation, or treatment of disease. Your website describes the device as a kit for extracting blood from a patient, and preparing from that blood platelet rich plasma for re administration as a treatment for a number of conditions. Your device has an intended use similar to the intended use of previously cleared PRP devices under 510(k) premarket notification. The law requires that manufacturers of medical devices obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that medical devices are safe and effective or substantially equivalent to other devices already legally marketed in the United States.

(b)(4)

A review of our databases disclosed that your firm has not obtained premarket approval or clearance for these Kit in the United States and has not received an investigational device exemption from premarket approval for these Kit either. Nevertheless, the Internet website above offers the Yes PRP Kit for sale to buyers in the United States. For example, the United States is included in the “drop-down” box on the contact page, inviting orders for shipment of the product within the United States. We also note that you include the FDA logo on your description of the product (linked to the phrase “in progress” in very small letters), which misleads the reader into concluding that your product is legally marketed in the United States. Because you do not have marketing approval or clearance from FDA, marketing these products in the United States is in violation of the law.

These devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e (a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. 360j (g). Additionally, the devices are misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because notice or other information respecting the device was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. 360(k).

You should take prompt action to correct the violations addressed in this letter. Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Your reply should be sent to the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, 10903 New Hampshire Avenue, Silver Spring, MD 20993. If you have any questions regarding this matter, you may contact Najma Khan at (240) 402-9156. Please be advised that only written communications are considered official.

Sincerely,
/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

If you write to Delta or DIS&L , both confirm that the news reflect the current situation, and that:
"...after breaking the contract Prof. Marineo has refused any further contact with CTI, and particularly with Mr. Conrad Mir who tried in every way to discredit him also with false information spread on the network (see nationalpainreport.com/inventor-calmare-scrambler-tries-block-sales-8823560.html )....."

However, the most interesting part is that relating to the CTI Board. Together with the documents sent by CTTC to the SEC, confirmed that JJ had acted with the consent of the Board.

Correction to the information present in CALMARE THERAPEUTICS INCORPORATED (OTCQX: CTTC) Quarterly Report filed to SEC
SOURCE: Delta International Service & Logistics News - http://www.st-team.eu/correction.htm

FORM 10-Q, October 14, 2015, recently filed by CALMARE THERAPEUTICS INCORPORATED (OTCQX: CTTC) to SEC once again provides incorrect and misguiding information to the investors and world market of hospital medical devices, and more specifically:

Delta International Services & Logistics holds all the agency’s world rights on the “Scrambler Therapy®” technology granted through the exclusive agreement signed by Prof. Giuseppe Marineo, the sole inventor and sole owner of all intellectual right pertaining to the technology. This technology has been patented in Europe, the US, Asian Countries, Arab countries and other countries. We also clarify that Prof. Marineo is not the founder of “Delta International Services & Logistics”, nor its sole owner or sole beneficiary of all proceeds, but simply beneficiary of the royalties derived from commercial exploitation of his intellectual property similarly to how it previously occurred with CTTC.

Regarding the presumed validity of the Agreement with CTI Professor Marineo said:
“ I have previously clarified, in April 8, 2014 press release, that the Amended, Restated and Extended Service and Representation Agreement dated April 1, 2011 between CTTC, Professor Marineo and Delta Research & Development S.r.l. (the “SRA”), had been terminated as of March 9, 2014. CTTC also confirmed the validity of the Amendment by executing subsequent amendments on August 31, 2012, September 31, 2012 and October 31, 2012. CTTC/CTI has not taken any legal action in order to challenge the validity or enforceability of the Amendment or the letter of termination sent by Professor Marineo and Delta on March 9, 2014, and subsequent cease and desist letter (“Cease and Desist Letter”).

He also added that from the communication exchanged between the parties, CTTC/CTI’s board through its official representatives has always been informed of the negotiation activity underway with Mr. Johnnie Johnson, CEO who signed a series of amendments. The Board has never questioned or raised any reserve on the validity of Johnnie Johnson’s signature before the appointment of Mr. Conrad Mir as new CEO.

Furthermore he states: “there is no validity to Mr. Mir’s statement in CTTC’s April 11, 2014 press release and SEC file that my statements had been “purged by the overseeing body of wire services.” “This press release has been published by many media and relaunched by other international press agencies still visible online”.

Professor Marineo concludes by saying: “I confirm that there are no negotiations on additional amendments to the SRA with CTI and have no intention to reestablish any commercial relationship with CTI. “

Furthermore GEOMC has publically acknowledged on a press release (“SEOUL, South Korea, May 14, 2014 /PRNewswire/ -- GEOMC Co., LTD. announced today that it has honored the June 30, 2012 Amendment ("Amendment") between Professor Giuseppe Marineo/Delta Research & Development (correctively "Professor Marineo") and Competitive Technologies, Inc. ("CTTC" or "CTI") which was publicly disclosed in the SEC filing.”) the validity of the amendment, and signed a exclusive production agreement with DIS&L that annuls any other previous agreement with CTTC/CTI. After these agreements the FDA authorized the marketing of the Scrambler Therapy® Technology MC-5A device (FDA 510(k) Clearance: # K142666, only for Delta International Services & Logistics). This medical device has been developed in Italy for the treatment of chronic neuropathic and oncologic pain resistant to opiates and other types of treatment, replacing the previous version, known in the US as the Calmare® device.

About Delta International Service & Logistics
DIS&L is an agency created for the international development of Scrambler Therapy® Technology, and selecting of medical device distributors in all international area. DIS&L through its law firm is the only company authorized to sign international exclusive agreements, provide maintenance and distributor support for method usage training and other logistics needs. For more information visit http://www.st-team.eu .

About Scrambler Therapy® Technology MC-5A (FDA 510(k) Clearance: # K142666
Scrambler Therapy® scientific research and development technology have been developed in Italy by Professor Giuseppe Marineo, who is the sole owner of its intellectual property rights. The official "Scrambler Therapy"® scientific and clinical information website is at http://www.scramblertherapy.org/english.htm .
Scrambler Therapy® Technology MC-5A replacing the previous version, known in the US as the Calmare® device.

About GEOMC Co., LTD
GEOMC Co., LTD is the exclusive licensed manufacturer of the patent-protected Scrambler Therapy® Technology for Delta International Services & Logistics.

Always talking about blissful ignorance ...

Alternative therapy does not mean "not pharmacological ", but not scientifically proven such as effective, so it is obvious that no one wants to pay for this.

It is a public fact that CTT/CTTC/CTI has created its own autonomous therapy management and "support" for the US clinical trials, and this has produced very poor clinical trials.

It is obvious that also if this therapy works well abroad, but this does not happen in the country where should pay the insurance.... the insurance not pay.

Linda, your real problem is not "the bad guys" of the Insurances, but the way in which CTT / CTTC / CTI has managed this therapy.
Now if you want to do worse, continues to write petitions of this kind. Are the best way to convince the insurances that this therapy has no scientific credibility, and to pay cash the various D'Amato &C, who surely will not be sorry about this.

Now all is clear. CTI & friends live in the parallel universe where everything works in reverse, and this explains what we read.

Despite my blissful ignorance, by moving to this parallel universe finally I can understand the brilliant history of economic success of CTI, the financial transparency of this company, and especially the great correctness of the management team and the compliance with the rules that many of us did not understand.

I'm so happy of this parallel universe where everything works in reverse, that I will write to OTCmarkets to ask to remove the warning on CTI: "SEC Reporting - Delinquent", promised.

I hope that your posts are not removed, because is a clear evidence of bad faith,but you already know this.

CTI legal issues with the inventor not concern me, but I think is only the extreme and desperate attempt of CTI to mask activities that seem everything except that legal or truthful, and the bankruptcy of the company. Your post is another proof of this.

True. Currently CTI is in a position that allows any person to document with certainty a number of wrong/false information sent to the SEC and/ or disseminated by press releases. This information, either before or after the appointment of Conrad Mir, have certainly distorted the value of the company and the status of its contracts. This does not appear to be legal.

More generally, it is not credible that after two years of different information sent to the SEC and many press releases, the CTI Board notes that JJ, its CEO, had no authority to sign contracts.

However even if we wanted to believe the unbelievable, the result is that for two years the stock market has been deceived over the lease term, in this case falsely extended to five years. An increase of 5 years has completely changed the value of the company, and all the decisions that the investors had make on this data.

It is clear that in any case the company is always the subject legally responsible of the actions of its employees, of its board, and of its CEO. Internal issues on the various powers assigned by the Board, or the lack of control exercised by the Board on the legality of the agreements, does not affect the legal liability of the company outwards.

If instead JJ had all the necessary powers to sign the agremments (as actually seems from the documents submitted to the SEC and more), or simply the Board was fully aware of the actions of its CEO, it is clear that CTI is acting in a situation of complete lawlessness .

In both cases the delay of the report to the SEC does not seem to be the most serious problem of CTI in case of a SEC depth investigation.

Strange, it disappeared a post that belied some false information.

Let's try again. I wrote to Delta R & D on the post that I have read in this blog about some strange communications between CTI (or people connected) and "Giuseppe".

Delta R & D also on behalf of "Giuseppe" responds as follows:

"The contract with CTI was concluded correctly and forever. After breaking the contract with CTI there is no longer any relationship / negotiation/ contact with CTI, or with any other person who legally represents the company.
The dissemination of information that suggest again any type of relationship / negotiation/ contact with CTI is to be considered a fake."

About Securities fraud (source: https://en.wikipedia.org/wiki/Securities_fraud )

Summary of some of helpful information:
Securities fraud, also known as stock fraud and investment fraud, is a deceptive practice in the stock or commodities markets that induces investors to make purchase or sale decisions on the basis of false information, frequently resulting in losses, in violation of securities laws. Offers of risky investment opportunities to unsophisticated investors who are unable to evaluate risk adequately and cannot afford loss of capital is a central problem.

Internet fraud
According to enforcement officials of the Securities and Exchange Commission, criminals engage in pump-and-dump schemes, in which false and/or fraudulent information is disseminated in chat rooms, forums, internet boards and via email (spamming), with the purpose of causing a dramatic price increase in thinly traded stocks or stocks of shell companies (the "pump").

Microcap fraud
In microcap fraud, stocks of small companies of under $250 million market capitalization are deceptively promoted, then sold to an unwary public. This type of fraud has been estimated to cost investors $1–3 billion annually. Microcap fraud includes pump and dump schemes involving boiler rooms and scams on the Internet. Many, but not all, microcap stocks involved in frauds are penny stocks, which trade for less than $5 a share.

Many penny stocks, particularly those that sell for fractions of a cent, are thinly traded. They can become the target of stock promoters and manipulators.These manipulators first purchase large quantities of stock, then artificially inflate the share price through false and misleading positive statements. This is referred to as a pump and dump scheme. The pump and dump is a form of microcap stock fraud. In more sophisticated versions of the fraud, individuals or organizations buy millions of shares, then use newsletter websites, chat rooms, stock message boards, press releases, or e-mail blasts to drive up interest in the stock. Very often, the perpetrator will claim to have "inside" information about impending news to persuade the unwitting investor to quickly buy the shares.

When buying pressure pushes the share price up, the rise in price entices more people to believe the hype and to buy shares as well. Eventually the manipulators doing the "pumping" end up "dumping" when they sell their holdings.The expanding use of the Internet and personal communication devices has made penny stock scams easier to perpetrate. But it has also drawn high profile public personalities into the sphere of regulatory oversight.


Penny stock companies often have low liquidity. Investors may encounter difficulty selling their positions after the buying pressure has abated, and the manipulators have fled.

"Against me? ...."
If you're referring to my post you are off topic, but if you want to threaten other people, then you should contact them directly,and take all responsibility for what you wrote in this blog.

In any case, my *personal thought* about the "...sued for 50 million dollars for Tortious interference" is that of another "inventions" of CTI that led the company to bankruptcy, but now can have effects more devastating on CTI.

I'll explain better. Considered the existing legal documentation (and more...) probably this type of action will obtain as only result to put under investigation CTI for fraud on the stock markets, infringement of intellectual property (that in the US seem to me is a criminal offense), and a strong actions of claims for *true* damages against CTI.

So, what you wrote seem a good start to get this. Again compliment for this brilliant strategy!....

OK, D'Amato is not the best possible image for the University of Padua ....
especially considering the inconsistency of its scientific research activities (zero publications indexed in Medline).

However the University of Padua is considered one of the most historically important in the world ( https://en.wikipedia.org/wiki/University_of_Padua ).

Always from 'University of Padua comes Federico Faggin, the inventor of the microprocessor ( https://en.wikipedia.org/wiki/Federico_Faggin ).

Without Federico Faggin, probably did not exist giants like Microsoft , Apple, and all the modern technology based on the microprocessor.

Obviously the great story of a great University not guarantee that everything that comes out from this University is just as great, and vice versa.
For example it seems useless to remember that Bill Gates ,Steve Jobs or Mark Zuckerberg have built and an economic empire and a technological/social revolution solely with their intelligence and their vision of the economy and technology.

Although this character have in common the fact of being outsiders, seems to me that They have achieved some success ....

In the photo the Board looks very aged...
Too much waste of mental energy?

In the photo the Board looks very aged. Too much waste of mental energy?

Yes, ma the problem is that CTI declared to the SEC .....

- The company still has a valid contract with the inventor
But the unilateral "reasons" of this thought are denials from public documents, including those previously deposited to the SEC by CTTC

- "..The Company holds the U.S. Food & Drug Administration 510k clearance on its device..."
Sure, but FDA also tell that the old 510 (k) CTI is connected to a the old device, and the new 510(k) is only for DIS&L. In add seems that the old device is out production,

- "...which grants it the exclusive right to sell, market, research and develop the medical device..."
Develop the medical device????..... Ok, but this usually means violate a lot of laws on the intellectual property, and even all the contracts signed prior the amendment "signed but not signed" by Johnnie Johnson.

At this time the Company does not seem to have much money to pay off old debts and possible compensation for damages. However it's hard do not think that if this situation changes, CTI will be overwhelmed by an avalanche of new problems.

Chronic pain treatment and scrambler therapy: a multicenter retrospective analysis

This clinical trial ( http://www.mattioli1885.com/onlinejournals/index.php/actabiomedica/article/view/4306/3288 ) is more reliable because independent and multicenter.
But this clinical trial also shows the huge difference in results of success (quality and quantity) between the clinical trials who have used "Calmare strategy" for training courses, methods, and "centers of excellence" managed by CTT/CTTC/CTI, and the standard methods of therapy use and training courses (the originals).

These differences should be a source of great embarrassment for CTI and some "Center of excellence" when they advertise certain clinical trials as a great success, when in reality in comparison with the normal results are very poor,or more honestly, true failures.

I would love to be the inventor, but unfortunately I am only an ordinary person who along with others small share holders lost a lot of money with CTT/CTI when in 2010 the company comes out from AMEX, and in this way losing $ 4 millions for the start up of the therapy. The rest of this history is even worse.So, You must to be careful what you write. You provided false information about people (me and the inventor) and public events.

To be more clear, you can find the information about the new 510 (k) and more in press releases and/or scientific papers peer review.
Enjoy the reading:

Source: PR Newswire
Delta International Service & Logistics receives FDA 510(k) Clearance for Scrambler Therapy® Technology MC-5A

ROME, June 15, 2015 /PRNewswire/ --

The FDA authorized the marketing of the Scrambler Therapy® Technology MC-5A device. This medical device has been developed in Italy for the treatment of chronic neuropathic and oncologic pain resistant to opiates and other types of treatment, replacing the previous version, known in the US as the Calmare® device.

Scrambler Therapy® Technology MC-5A development in the US

Delta International Service & Logistics' main goal in the US is to create the conditions to fully implement the methodology in line with the original standards which are the only ones to guarantee a meaningful increase of success rates in hospitals and independent clinical trials.

In the coming months this enterprise will create a series of excellence centers to guarantee an optimal quality system for ST usage including ST-NET support, a clinical "intelligent" network based on a dedicated software designed exclusively for Scrambler Therapy®. This software informs in real time the operator of possible critical features, and suggests most fit treatment protocols for any patient.

In the future some of these centers will be selected for the development of an adequate training and support system to optimize the users' learning curve. These elements are necessary to reduce to a minimum operator dependent bias, that as recorded in statistical data from some independent clinical trials is currently very high, and well beyond the norm.

About Delta International Service & Logistics

DIS&L is an agency created for the international development of Scrambler Therapy® Technology MC-5A, and selecting of medical device distributors in all international area. DIS&L through its law firm is the only company authorized to sign international exclusive agreements, provide maintenance and distributor support for method usage training and other logistics needs. For more information visit http://www.st-team.eu .

About Scrambler Therapy® Technology MC-5A

Scrambler Therapy® scientific research and development technology have been developed in Italy by Professor Giuseppe Marineo, who is the sole owner of its intellectual property rights. The official "Scrambler Therapy"® scientific and clinical information website is at http://www.scramblertherapy.org/english.htm .

And:

http://www.prnewswire.com/news-releases/geomc-co-ltd-states-on-recovering-the-inventory-of-the-scrambler-therapy-device-260925071.html

http://www.prnewswire.com/news-releases/geomc-co-ltd-took-a-legal-action-in-recovering-the-inventory-of-the-scrambler-therapy-device-in-the-us-272540301.html

Abdi S, Smith TJ, Marineo G. Letter to the Editor. Clin J Pain. 2014 Nov 3.[Epubahead of print] PubMed PMID: 25370140.

This means that the government to save CTI should buy old devices (CTI does not have the new 510(k) and the new devices) out of production, and considered unreliable by the manufacturer. Great.

New clinical trials? ... It sounds like a threat.
CTI probably continue to spread the "CTI creative training" and the "CTI creative protocol of use". This will produce other clinical trials considered "extraordinary" for CTI, but disastrous for anyone who has a minimum knowledge of this treatment.

Nothing new. In 2010, CTI began a systematic work of destruction of this therapy. This caused to lose a lot of money to small shareholders, but seem that for the same reason "others" have earned a lot of money. The mysteries of the stock exchange .

VC, if you really want to destroy this therapy, you must hope that CTI remains alive ...

OTCMarkets reports for CTI:"SEC Reporting - Delinquent"

However, if the SEC performs a more detailed investigation on the contents of the press releases of CTI and the SEC reports, it is very likely that the situation will worsen further (see also below the specific response to this press release).

It was also always very strange what happened in 2010. The CTTC choices made in 2010 and other related events seem to be the key to understanding in deep the "mysteries" of CTI.

Source: Delta Research & Development/Marineo, April 18, 2014

In response to the recent public release of false information by Conrad Mir, President and CEO of Competitive Technologies, Inc. ("CTTC" or "CTI")

Rome, Italy, April 18, 2014 In response to the recent public release of false information by Conrad Mir, President and CEO of Competitive Technologies, Inc. ("CTTC" or "CTI") on April 11, 2014,Prof. Giuseppe Marineo, developer of the Scrambler Therapy® technology and rightful owner of related patents, issues the following statement.

Professor Marineo had previously clarified, in his April 8, 2014 press release, that the Amended, Restated and Extended Service and Representation Agreement dated April 1, 2011 between CTTC, Professor Marineo and Delta Research & Development S.r.l. (the “SRA”), had been terminated as of March 9, 2014, and responded to certain misleading statements from CTTC concerning its authority to distribute the Scrambler Therapy® devices under the SRA and the validity of the Amendment to the Agreement dated June 30, 2012 (the “Amendment”).

The Amendment was an enforceable agreement among CTTC, Professor Marineo and Delta Research & Development S.r.l. (“Delta”, a respectable and well-known research company), fully executed and expressly acknowledged by CTTC, which filed the Amendment with the U.S. Securities and Exchange Commission and publicly announced the benefits deriving from it in a press release. CTTC also confirmed the validity of the Amendment by executing subsequent amendments on August 31, 2012, September 31, 2012 and October 31, 2012. CTTC has not taken any legal action in order to challenge the validity or enforceability of the Amendment or the letter of termination sent by Professor Marineo and Delta on March 9, 2014.

The SRA was duly terminated by Professor Marineo and Delta on March 9, 2014 in accordance with their rights under the Amendment. Professor Marineo and Delta confirm, in response to Mr. Mir’s series of recent misleading public statements, that they are not negotiating any additional amendments to the SRA with CTTC and have no intention to reestablish any commercial relationship with CTTC. Professor Marineo further confirms that he has no intention to speak with Mr. Mir in the next month or at any other time.

There is no validity to Mr. Mir’s statement in CTTC’s April 11, 2014 press release, that Professor Marineo’s statements had been “purged by the overseeing body of wire services.” Mr. Mir has also falsely asserted that Professor Marineo’s statements are subject to CTTC's authorization or approval; they are not.

Professor Marineo and Delta reiterate their intention to take all steps necessary to protect their patent and other intellectual property rights and prevent any actions that could jeopardize agreements and negotiations with agents and distributors for the Scrambler Therapy® technology around the world. Professor Marineo and Delta further reserve their right to seek damages for injuries resulting from the recent statements made and actions taken by Mr. Mir and CTTC.

Professor Marineo reaffirms his resolve to improve and disseminate the Scrambler Therapy® technology in order to achieve his ultimate goal of relieving pain and helping patients affected by it. He has dedicated his research and his life to improving the lives of suffering patients and intends to take any necessary action in order to protect the result of his efforts."

Information, disinformation, defamation

Marineo wrote a book, where reestablishes the objective truth of the documented facts, and clearly state circumstances and names of those involved. This book is still available in the most important Italian national libraries or University libraries.

The book's press conference took place in a Ceremony room in the Municipality of Rome (February 25, 1996) with the support of:
- The Municipal council deputy president
- The USL (local healthcare unit) Director
- The Councilor for Social policies
Under the Aegis of the councillorship of Social policies Municipality of Rome


Brief chronology of the facts (verified by the autorithy):

Criminal falsification of information about Marineo research activity through an anonymous allegation (mafia-style) created a judicial case. The “anonymous” person turned out to be a journalist of “Messaggero”. This reporter criminally denounced with succes by Marineo, never appeared in court to defend himself or justify his work and other newspapers that reported this journalist's slanderous accusations.
This reporter also disclosed the name of a sick, a very well know artist in the Italian cultural environment, who was often on television. Just by this fact one can see how immoral and illegal this operation was. AIDS privacy was an absolute right, strongly enshrined by the law. However, just by publishing the name of this sick on the “Messagero” it attracted the attention of all other media, and triggered a snowball effect. This was done exclusively to discredit Marineo in such a strong way that even when eventually the truth would have emerged everybody would remember this barbaric media harassment based only on distortion and falsification of facts and circumstances, like Marineo was able to subsequently prove.


1993 The AIDS unit of the San Gallicano Hospital (one of the most important hospitals in Rome) asked Marineo help to try and find new therapies to cure AIDS patients. At that time only AZT was used to fight AIDS, a cure that today is considered ineffective ( look at FDA documentation) and suspected of having reduced the patients' life.
At first Marineo refused the offer. The medical devices created for immune system couldn’t be transported to the Hospital, and his laboratory is not designed to do therapies. The hospital continued to pressure Marineo, and the general director of the San Gallicano Hospital, personally asked Marineo to start a trial on hopeless patients, offering his personal support. After this new request Marineo decided to accept. It was January 1994.

1994 The results of both clinical and lab data are immediately good. Especially opportunist infections and other symptoms connected to AIDS decrease. Also viral charge, at the time measured without PCR, drops rapidly and in some cases even disappears. All of the young patients resume a normal life, substantially symptomless.
Marineo showed these preliminary results to the Director of the Istituto Superiore di Sanità (equivalent to NIH), hoping to set up a collaboration sponsored by the ISS that would have enabled me to transfer this work directly to the hospitals. The answer was that the results were interesting but cases were too few, and needed to produce at least 50 cases.
However the important data was that Italian Healthcare in its highest expression of institutional scientific research was completely informed about this research.
Instead in the anonymous allegation Marineo was described as an isolated person who was working in the shadow outside the institutions

- Marineo could not be accused of unauthorized medical practice because worked with the Hospital, where sick patients were continuously followed and monitored, and on request of the hospital. For this reason the anonymous allegation has been immediately denied by the patients, bank account audits, and by the Hospital.

- Marineo never been arrested, and this never written by any newspaper. However some journalists after having personally apologized for what they wrongly wrote, officially informed Marineo that a “very well known immunologist” before the blitz had sent a fax to the pressroom claiming that Marineo would have been arrested and to prepare for the scoop.
Note that this Immunologist has been publicly accused of being involved in irregular research funding and sponsorship by pharmaceutical companies. Minister of Health Bindi spoke about him publicly and described him as an “arrogant and dangerous” person. Due to these events this Immunologist lost important roles he previously held.


- The same magistrate who blocked the AIDS trial, after investigation ordered the immediate reopening of the clinical trial with immediate priority to cure patients that were enlisted, and Marineo never been condemned for any type of criminal offense or other.

- Marineo could not take care again of the sick. After abrupt discontinuation for months of the treatment the clinical situation was too compromised. However, the same authorities who had interrupted the trial are those who have ordered the reopening in any case.

In an interview on the most important Italian national newspaper one of the sick says":

“...I traveled around Europe looking for therapies- he said. “I even visited Montagnier, but I found the only true improvement with the medical device. Apart from scientific explanations, I am unable to provide, the only important thing is that before interrupting the cure I felt definitely better”. He also complained that a newspaper disclosed the names of the patients treated with the electromagnetic cure. “The event- added – was for me a double trauma: having to interrupt an effective cure and of having disclosed my illness with absurd inhumanity, violating the law that prohibits the disclosure of the names of AIDS patient”. From the day when the names were published, ..... said “my life changed. People in the street point me out, my everyday life broke to pieces.”


About Cirrhosis

"Cirrhosis progression as a model of accelerated senescence: affecting the biological aging clock by a breakthrough biophysical methodology. Ann N Y Acad Sci. 2004 Jun;1019:572-6. PubMed PMID: 15247089."

The New York Academy of Sciences is the world's nexus of scientific innovation in the service of humanity. For nearly 200 years — since 1817 — the Academy has brought together extraordinary people working at the frontiers of discovery and promoted vital links between science and society. One of the oldest scientific organizations in the United States, the Academy has become not only a notable and enduring cultural institution in New York City, but also one of the most significant organizations in the international scientific community.
Throughout its history, the Academy's membership has featured leaders in science, business, academia, and government, including U.S. Presidents Jefferson and Monroe, Thomas Edison, Louis Pasteur, Charles Darwin, Margaret Mead, and Albert Einstein. Today, the NYAS President's Council includes 26 Nobel Laureates as well as CEOs, philanthropists, and leaders of national science funding agencies. The Academy numbers more than 24,000 members in 140 countries and more than 50,000 unique visitors access the NYAS website each month.

">Geez, talk about a desperate attempt to discredit someone..."

Honestly, I have avoided adding official references because I think that the true problem is different. However on whether your impression is of an attempt to discredit, you should read:

Schott G, Dünnweber C, Mühlbauer B, Niebling W, Pachl H, Ludwig WD. Does the pharmaceutical industry influence guidelines?: two examples from Germany. Dtsch Arztebl Int. 2013 Sep;110(35-36):575-83.doi:10.3238/arztebl.2013.0575. Epub 2013 Sep 2. PubMed PMID: 24078837; PubMed Central PMCID: PMC3783818.


"....A judicially ordered expert review revealed that the market authorization holder (MAH) of gabapentin manipulated study data. Gabapentin was,therefore, chosen as an example for this article to analyze whether manipulated data serve as a basis for recommendations in German clinical guidelines..."

Full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3783818/

Do you really think that the NIH accept in PubMed papers that are meant to discredit someone? ...

It may be that you are right and "Calmare" does not work, but certainly CTT has created more doubts about the credibility of this treatment than your posts.
For example, the registration as TENS has not been a choice or a request of the FDA, but of CTT. Obviously this has created the first serious issues of credibility. In fact, this device before coming to the US had already been approved in Europe as a new device. CTT had only to choose the same procedure for the US, but the company has chosen to record improperly the device using two TENS as predicate device. However this "similitude" was disputed
by the FDA. If the device technology and clinical features are different from the ones of reference predicate device, FDA calls for specific clinical trials that must demonstrate that the new device has equal or higher efficacy and safety features than the ones already authorized. This was the procedure followed to market ST in the US, but by this time the pathway of authorization was to be completed as the 510 (k) originally requested by CTT.

In short CTT has obtained all the disadvantages derived from the improper registration that uses two TENS as a predicate device, and all the risk and the time disadvantages associated with the registration procedure of a new device. These are official documents traceable into FDA, so there is not much to understand.

Potential Conflict of interest. Some official references

The comments on the - potential - conflict of interest is not an accusation, but derived from the public statements correctly made by the author himself . Conflict of interest and ethical issues in research field is analyzed in a general or specific way in the official scientific literature, and by the FDA.

source: https://neurology.wisc.edu/publications/2009/Neuro_26.pdf
Misha-Miroslav Backonja, MD, PhD, has served on the Speakers Bureau for Eli Lilly and Company and Pfizer Inc; has worked as a consultant to Allergan, Inc., Eli Lilly and Company, Johnson & Johnson, Medtronic,Inc., Merck & Co., Inc., NeurogesX, Pfizer Inc, and UCB Pharma; and has received research/grant support from Allergan, Inc., Eli Lilly and Company, Johnson & Johnson, Merck & Co., Inc., and NeurogesX.

source: www.mayoclinicproceedings.org/article/S0025-6196(11)61475-4/fulltext
Dr Backonja receives grant and research support from Pfizer Inc, NeurogesX Inc, and Avanir Pharmaceuticals. He is a consultant to Pfizer Inc and Eli Lilly and Company.

FDA general concerns
Bramstedt KA. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration. Clin Invest Med. 2004 Jun;27(3):129-34. PubMed PMID: 15305804.

Abstract
PURPOSE:
This study explores the ethical issues contained in warning letters issued to clinical researchers by the Food and Drug Administration (FDA) in the USA.
METHODS:
The online FDA Warning Letter Index was reviewed for letters issued to drug and device researchers in the USA and Canada under the violation subject "Clinical Investigator" for the period February 2002 through February 2004. The resultant letters were evaluated for the presence of 7 research ethics themes: deviation from investigational plan; informed consent; adverse event reporting; study reporting; study supervision; institutional review-board approval; and misconduct.
RESULTS:
Thirty-six FDA warning letters addressing violations of 58 protocols were issued to researchers during the 25 months studied. Researchers performing pulmonary medicine studies received the most warning letters (12), followed by oncology (10) and cardiology (9) researchers. The most common regulatory violations were deviation from the research plan, a flawed or nonexistent consent process, and failure to report or late reporting of adverse events. Three warning letters (8%) mentioned study misconduct, including data fabrication.
CONCLUSIONS:
Warning letters are informative about good practice, ethics and participant protection in research. As distressing as the content in an FDA warning letter may be to investigators receiving it, that information can become an educational tool for all members of the research team. These letters are also informative as to what the FDA is looking for when they audit clinical trials

Class action? ....
Maybe you must check the cost of CTT share value between 2009 and 2010, estimate the average value, and recalculate the residual value (to be optimist 0.20) established by the brilliant marketing of CTT. In addition the present value is based on the assertion that CTI "can sell" because after two years and two CEO miraculously have disappeared the signatures from a contract.
Class action? .... Why not.

Potential conflict of interest

We have investigated again about the management of CTT clinical trials of Madison. In addition to information on the anomalies of CTT management previously posted, there are other items of interest to evaluate.

Miroslav Backonja, one of the signers of the study, is also recognized as the mentor of Toby Campbell. Backonja is an international opinion leader who has contributed significantly to the success of Neurontin, a drug of Pfizer widely used in the treatment of neuropathic pain. However on this drug and the same Miroslav Backonja have been the focus of several problems http://www.newsweek.com/pfizer-accused-deception-neurontin-92239.
Pfizer is also known for other serious legal issues:http://en.wikipedia.org/wiki/Pfizer

The Scrambler Therapy is a direct competitor of Neurontin and Lyrica, another similar drug always produced by Pfizer. Both these drugs should not be used in conjunction with ST. With these two drugs Pfizer earns billions of dollars/year, but the spread of ST would entail a relevant loss of this revenues.
Obvious that the research activities of Miroslav Backonja and the sponsorships received from Pfizer are legitimate, but in this context implies a potential conflict of interest.

However,despite the potential conflict of interest, CTT chose to entrust the first double-blind clinical trial vs placebo to a group that include an international opinion leader evidently in good relationship with one of the largest pharmaceutical companies in the world, a company that can lose billions of dollars with the spread of ST.

Ok?....

I can reply on behalf of small shareholders that have lost a lot of money(who cares European marketing). They would like you "in person" what they think of marketing of CTT. I try to synthesize civilly some key points:

- CTI has no legal right to sell in the US or in any other part of the world, except that you confirm that a false statement to the SEC and to the investors on contracts "unsigned" is legal.

- We know that the main reason for which the inventor has not reached an agreement with CTI concerns the lack of guarantees about the development of credible clinical trials (also useful for Medicare), a CTT capacity to do really a "standard" training course, a quality system and monitoring mandatory to release and maintain the certification of "Calmare certified" and similar issues.

Now the more strangest things. CTT wanted to manage directly the study of Madison, against the opinion of the inventor who considered the "training" made to ??Toby Campbell ridiculous, and the information protocols for ST use sent by CTT therapy wrong. In fact, the result obtained in Madison is zero, In addition if you check the numbers, this results do not even highlights the placebo effect in neither of the two arms.

However CTI seem happy about this, and even if it does not speak of the new clinical trial ("terrible", but presumably for the same reasons of Madison), you can try to read:

Moon JY, Kurihara C, Beckles JP, KE Williams, Jamison DE, Cohen SP. Predictive Factors Associated with Success and Failure for Calming (Scrambler) Therapy: A Multi-Center Analysis. Clin J Pain. 2014 Sep 17 [Epub ahead of print] PubMed PMID: 25232861.

The "professional training" and the "genial marketing management" of CTI seems that has once again altered all protocols of treatment , and obviously the results are very bad.

Who benefits in all this?

In network nobody is anonymous....

so, you are wrong. Calmare it is not "my technology", and I do not care to discuss this. Instead I think that people need to know the truth about this company, which is responsible of "very strange" financial operations. It is interesting understand who really controls these operations, because these operations were made, who benefits,and why many small investors have lost a lot of money. Management errors so huge cannot be only due to incompetence. Discuss about TENS or C-fibers is useful only to shift the focus from the fact that CTI communicates false information about contracts, intellectual property and similar issues.

As for the rest, if CTI sell the Ferrari, I start to doubt that Ferrari is a top car. Nobody can believe in a company like CTI.

>Fair Play may be able to add more input on this discussion.


Yes. If you want defend (I'm just assuming) your investment in Calmare, I have a few "suggestions".

- CTI is a company not credible, this automatically makes any product or people connected with CTI not credible. So starts to get pissed with Conrad Mir which changed also the company name.

- Of advertising based on the "patients" is full the web. Credibility is gained through other pathway.

- I read the attempt of speculation about the suffering of children. I agree with VC, is repulsive. Also this type of action make Calmare not credible (and in this case also nauseating).

- "Calmare explanations" incorrect or fanciful convince people even more that there is something not clear.

So, we will know only after CTI what is really "Calmare". However, If your aim is only to defend CTI, You work against the interest of the sick.

About the patents.....and more.

Many small investors in 2010 with CTT out of AMEX have lost a lot of money in a few days, and this has not happened only in US. Bad luck? ... It seems not.

By reading this blog have emerged many interesting information, but we had to check all with a trusted source, and also obtain documentation in support. It served a lot of work, but now at least a part of this documentation "no confidentiality for us" was collected.

About the patents seems that CTTC has only created a lot of issues, and that everything has been resolved only when the inventor has taken again the full control of its intellectual property with his law firm with and his own money.

It also seems that if the SEC starts an investigation on CTI, the CEO and the Board has to explain a lot of things, starting with the signatures "disappeared" only from CTTC contracts after two years. Seems to me a very hazardous game.

Now even an attempted theft of intellectual property? ...


In all the official documentation only Marineo is the only creator and owner of the patents. If it is not a mistake, what you write is therefore the announcement of a serious crime.