UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(D) of The Securities Exchange Act of 1934

 

 

Date of Report (Date of earliest event reported): August 14, 2014

 

 

Calmare Therapeutics Incorporated
(Exact name of registrant as specified in its charter)

 

 

Delaware 001-08696 36-2664428

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

1375 Kings Highway East, Fairfield, Connecticut 06824
(Address of principal executive offices) (Zip Code)

 

 

Registrant's telephone number, including area code: (203) 368-6044

 

 

Competitive Technologies, Inc.
(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
 

 

 

Item 5.03Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

 

On August 20, 2014, Competitive Technologies, Inc. changed its name to Calmare Therapeutics Incorporated (the “Company”), pursuant to the filing of an Amendment to the Company’s Articles of Incorporation with the Secretary of State of the State of Delaware. A copy of the Amendment is attached to this Current Report on Form 8-K as Exhibit 3.1.

 

Item 5.07 Submission of Matters to a Vote of Security Holders.

 

The annual meeting of shareholders of the Company was held on August 14, 2014. Of the 24,531,477 shares of common stock outstanding on the July 7, 2014 record date, a total of 18,485,084 shares of common stock were represented in person or by proxy. Results of votes with respect to proposals submitted at that meeting are as follows:

 

a. To elect six nominees to serve as directors to hold office until the next annual meeting of our shareholders or until their successors have been elected and qualified. Our shareholders voted to elect all six nominees to serve as directors. Votes recorded, by nominee, were as follows:

 

Nominee

 

For

 

Withheld

 

Peter Brennan

 

6,384,459

 

139,811

 

Rustin R. Howard

 

6,023,661

 

500,609

 

Conrad Mir

 

6,384,459

 

139,811

 

Robert G. Moussa

 

6,023,458

 

500,812

 

Carl D. O’Connell

 

5,982,436

 

541,834

 

Stanley K. Yarbro, Ph. D.

 

6,425,680

 

98,590

 

b. To ratify the selection of Mayer Hoffman McMann, CPAs as our independent registered public accounting firm firm for the fiscal year ending December 31, 2014. The Company’s shareholders voted to approve this proposal with 18,329,978 votes “For” and 154,105 votes “Against.” There were 1,001 abstentions.

 

c. To amend the Certificate of Incorporation to change the name of the Company from Competitive Technologies, Inc. to Calmare Therapeutics Incorporated. The Company’s shareholders voted to approve this proposal with 18,196,051 votes “For” and 230,189 votes “Against.” There were 58,844 abstentions.

 

d. To amend the Certificate of Incorporation to effect a one-for-ten reverse stock split of the Company’s common stock. The Company’s shareholders voted to approve this proposal with 16,128,205 votes “For” and 2,323,788 votes “Against.” There were 33,091 abstentions.

 

 
 

 

Item 7.01 Regulation FD.

 

The power point presentation information furnished on Exhibit 99.1 is hereby incorporated by reference under this Item 7.01 as if fully set forth herein.  The presentation was used by the Company at the shareholder meeting held on August 14, 2014.

 

The slides used in this presentation attached as Exhibit 99.1 are being furnished and not filed pursuant to Item 7.01 of Form 8-K. Such information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits

 

Exhibit No.   Description
     
3.1   Certificate of Amendment, dated August 20, 2014
99.1   Shareholder presentation, dated August 14, 2014 (furnished herewith).

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Calmare Therapeutics Incorporated  
       
Date: August 20, 2014 By: /s/ Conrad Mir  
    Name: Conrad Mir  
    Title: Chief Executive Officer  

 

 



 

Exhibit 3.1

 

 



 

Exhibit 99.1

 

Annual General Meeting August 2014 © 2014 Calmare Therapeutics, Inc..

 
 

THIS PRESENTATION CONTAINS “FORWARD - LOOKING STATEMENTS” WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH FORWARD - LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS WHICH MAY CAUSE THE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF THE COMPANY, OR INDUSTRY RESULTS, TO BE MATERIALLY DIFFERENT FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH FORWARD - LOOKING STATEMENTS. WHEN USED IN THIS PRESENTATION, STATEMENTS THAT ARE NOT STATEMENTS OF CURRENT OR HISTORICAL FACT MAY BE DEEMED TO BE FORWARD - LOOKING STATEMENTS. WITHOUT LIMITING THE FOREGOING, THE WORDS “PLAN,” “INTEND,” “MAY,” “WILL,” “EXPECT,” “BELIEVE,” “COULD,” “ANTICIPATE,” “ESTIMATE,” “CONTINUE” AND/OR SIMILAR EXPRESSIONS, OR OTHER VARIATIONS OR COMPARABLE TERMINOLOGY ARE INTENDED TO IDENTIFY SUCH FORWARD - LOOKING STATEMENTS. READERS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD - LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE HEREOF. THE COMPANY UNDERTAKES NO OBLIGATION TO UPDATE ANY FORWARD - LOOKING STATEMENTS, WHETHER AS A RESULT OF NEW INFORMATION, FUTURE EVENTS OR OTHERWISE, EXCEPT AS REQUIRED BY LAW. © 2014 Calmare Therapeutics, Inc..

 
 

Our future … Our past …

 
 

We are a bio - therapeutic company focused on the development and commercialization of our proprietary and patented flagship medical product: the Calmare ® Pain Therapy device © 2014 Calmare Therapeutics, Inc..

 
 

• h eadquartered in Fairfield, CT since 1968 • publicly traded and in good standing on the OTCQX (“ CTTC ”) • the exclusive holder of global distribution and sales rights of the Calmare pain therapy device: 510(k) clearance • a U.S . Dept. of Defense contractor: GSA No .: V797P - 4300b © 2014 Calmare Therapeutics, Inc..

 
 

© 2014 Calmare Therapeutics, Inc..

 
 

 
 

© 2014 Calmare Therapeutics, Inc.. Chronic neuropathic pain is a major health issue with up to 25% of the US population suffering from chronic pain . To assess the degree of pain a patient is in, physicians and the FDA alike, use “The” Pain Scale.

 
 

Prescription painkiller overdoses killed more than 6,000 people in the U.S. in 2010. © 2014 Calmare Therapeutics, Inc..

 
 

Dr. David Borsook, MD. PhD Director of Pain, Children’s Hospital Mass General Hospital, Boston. Mass . “ We do not yet have medications or other treatments that can effectively alleviate chronic pain with speed or efficiency in the majority of patients . Doctors treat patients with a trial - and - error approach , initially prescribing drugs with fewer side effects, reflecting the lack of effective treatment options.” © 2014 Calmare Therapeutics, Inc..

 
 

© 2014 Calmare Therapeutics, Inc..

 
 

Our proprietary, patented, non - invasive medical device developed to treat high intensity oncologic and neuropathic pain without the harmful side effects of narcotic painkillers. • Immediate to prolonged pain relief • Procedure regimen : — 10 to 15 treatments over 2 weeks — 1 or 2 “Booster” treatments ( Year One), subject to diagnosis and pain severity • 510 (k) cleared for sales in the U . S . • CE marked for sales i n Europe • E . M . E . N . A . distribution © 2014 Calmare Therapeutics, Inc..

 
 

1. Certified practitioners place surface electrodes on the patient’s skin close to the pain source in order to access their C - fiber 2. Our patented multi - processor sends algorithmically - derived pain messages to the brain along the patient’s C - fibers No known side effects reported in use with over 6 , 000 patients Result: “ Pain ” signal – from pain site to brain – becomes “ No - Pain ” signal © 2014 Calmare Therapeutics, Inc..

 
 

1. Chemotherapy - Induced Peripheral Neuropathy (CIPN) 2. Chronic Regional Pain Syndrome (CRIP) 3. Failed Back Surgery Syndrome 4. Chronic Post - herpetic Neuralgia (Shingles) 5. Sciatic and Lumbar Pain 6. Low Back Pain (LBP) 7. Post - Surgical Pain 8. Brachial Plexus Pain 9. Phantom Limb Syndrome 10. Neuropathic Pain © 2014 Calmare Therapeutics, Inc..

 
 

• 33 patients • P ilot study • T erminal cancer patients • S evere drug resistance • 10 treatments Marineo G et al International Congress Series 1255(203) 381 - 388 Calmare Treatment Pilot Study Results The pain was reduced to zero. © 2014 Calmare Therapeutics, Inc..

 
 

© 2014 Calmare Therapeutics, Inc.. Ave. Daily CIPN Scores With Calmare Treatments Pachman D, Loprinzi C, et al. Proc ASCO 2014, submitted • 53% reduction in pain score from baseline to day 10 • a 44% reduction (6.0 to 3.3) in tingling • 37% reduction in numbness

 
 

Calmare v. Clonazepam : Drugs (control group) and one treated with Calmare (26/Drug – 26/ST) G. Marineo, T . Smith, et al, JPSM 2011 72 % of patients pain and drug free 20 % of patients on reduced drug dosages © 2014 Calmare Therapeutics, Inc..

 
 

64% reduction in pain score Smith T. et al Journal of Pain And Symptom Management 2010 © 2014 Calmare Therapeutics, Inc..

 
 

• Mayo Clinic: Charles Loprinzi, MD ( Third Annual Cancer Pain Conference) − “(Calmare) therapy looks very promising in 3 pilot trials; a randomized trial is in development” • Johns Hopkins Medical Institute: Tom Smith, MD ( Journal of Pain & Palliative Care Pharmacotherapy . 2013;27:359 – 364) − “…Calmare therapy appeared to reduce both acute and chronic pain; and, substantially reduced the interference of pain with normal life in every scale measured . • Virginia Commonwealth University : Angela Starkweather, Ph.D., (Associate Professor, Presentation on Scrambler Therapy for Persistent Low Back Pain ) − A potentially effective non - pharmacological therapy for ameliorating pain intensity in patients with persistent low back pain ... © 2014 Calmare Therapeutics, Inc..

 
 

T his market is how big?

 
 

$ 28 . 6 billion : Global pain management therapeutic market ( CAGR of 5 . 3 % between 2002 and 2010 ) 116 million : Amount of U . S . adults experiencing chronic pain daily 15 million : Amount U . S . adults suffering from neuropathic pain * CTI is targeting : 1% of the global market © 2014 Calmare Therapeutics, Inc..

 
 

Each New Patient : 12 treatments over 2 weeks Primary Treatment Cost: $250 per patient = $3,000 1 over 2 weeks (est.) Practice Income (per month): 12 patients $ 36,000 Product Leasing: $ 1,900 2 Monthly Profit: $ 34,100 1 Average per patient cost Nationwide. 2 5% interest, 60 month lease, Calmare Credit Corp, subject to credit approval © 2014 Calmare Therapeutics, Inc..

 
 

What happens now?

 
 

© 2014 Calmare Therapeutics, Inc.. GSA contract line item (1Q 2015) : - $2.0 billion (announced Aug 2014): $187 million available - $3.0 to 5.0 million in unused funds: available to pain (VA) Raise $8.0 million (2Q 2015) : $3.0 million bridge (4Q 2014) - $2.0 million – Pivotal Study (CIPN: 200 patients, multi - site, sham control) - $1.0 million – Operations (CMO and two nurses practitioners) $5.0 million offering (2Q 2015) - $2.0 million – Pivotal Study (CRIPs, Failed Lower Back) - $1.5 million – R&D - $1.5 million – Operations

 
 

A. Private practices in the United States - Nurse/Sales Rep duo B. U.S. military - Authorized GSA vendor C. International Calmare distributors - E urope, M id. E ast, N o. A frica - Far East and Oceana Break Even © 2014 Calmare Therapeutics, Inc.. 1 Device per Week

 
 

 
 

 
 

 
 

 

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