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

April 28, 2009
Date of Report (Date of earliest event reported)
 

Non-Invasive Monitoring Systems, Inc.
(Exact Name of Registrant as Specified in Charter)
 
 
Florida
0-13176
59-2007840
(State of Other Jurisdiction
(Commission File Number)
(I.R.S. Employer
of Incorporation)
 
Identification Number)
 

4400 Biscayne Boulevard, Suite 180, Miami, Florida 33137
(Address of principal executive offices)  (Zip Code)

(305) 861-0075
(Registrant’s telephone number, including area code)

4400 Biscayne Boulevard, Suite 680, Miami, Florida 33137
(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 (see General Instruction A.2. below):

o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e- 4(c))
 
 
 
 
 
Item 1.01 
Entry into a Material Definitive Agreement

On April 28, 2009 (effective April 21, 2009) we amended a Letter of Agreement (the “Agreement”) dated as of April 21, 1999 between the Company and Cardinal Health 211, Inc.(“Cardinal”, as successor in interest to SensorMedics Corporation), to extend the term of the Agreement to April 21, 2019.  Pursuant to the Agreement, among other things, we granted Cardinal a license under which Cardinal is required to pay us royalties on sales of certain products.  The amendment to the Agreement and the Agreement are attached hereto as Exhibits 10.1 and 10.2, respectively.

Item 8.01 
Other Events

On June 9, 2009 we issued the Press Release furnished as Exhibit 99.1 announcing that the United States Food & Drug Administration granted us permission to market our Exer-Rest ® model acceleration therapeutic platform as a Class I (exempt) therapeutic vibrator in the United States with the following additional intended use: as an aid to reduce morning stiffness.

Item 9.01 
Financial Statements and Exhibits

Exhibit Number
Description
 
10.1
First Amendment to Letter of Agreement, dated as of April 21, 2009 between the Registrant and Cardinal Health 211, Inc. (as successor in interest to SensorMedics Corporation).
 
10.2
Letter of Agreement, dated as of April 21, 1999 between the Registrant and Cardinal Health 211, Inc. (as successor in interest to SensorMedics Corporation).
 
99.1
Press Release of the Registrant dated June 9, 2009.
 
 
 
 
 
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 thereunto duly authorized.
 
  NON-INVASIVE MONITORING SYSTEMS, INC.  
       
       
 
By:
/s/ Adam S. Jackson   
    Name: Adam S. Jackson   
    Title:   Chief Financial Officer   
       
Date:   June 9, 2009
 
 
 
 
 
Exhibit Index
 

Exhibit Number
Description
 
10.1
First Amendment to Letter of Agreement, dated as of April 21, 2009 between the Registrant and Cardinal Health 211, Inc. (as successor in interest to SensorMedics Corporation)
 
10.2
Letter of Agreement, dated as of April 21, 1999 between the Registrant and Cardinal Health 211, Inc. (as successor in interest to SensorMedics Corporation).
 
99.1
Press release of Registrant dated June 9, 2009.
 
 
 
 
 
Exhibit 10.1
 
FIRST AMENDMENT TO LICENSING AGREEMENT
 
THIS FIRST AMENDMENT ( THE “FIRST AMENDMENT”) DATED APRIL 21, 2009 TO THAT LICENSE AGREEMENT (THE “AGREEMENT”) DATED AS OF APRIL 21, 1999 BETWEEN NON-INVASIVE MONITORING SYSTEMS, INC. (“NIMS”) AND CARDINAL HEALTH 211, INC., AS SUCCESSOR IN INTEREST TO SENSORMEDICS CORPORATION (“CARDINAL”).

RECITALS
 
WHEREAS , NIMS and Cardinal (collectively, the “Parties”) are parties to the Agreement which was made as of April 21, 1999; and
 
WHEREAS, NIMS and Cardinal desire to amend the Agreement to extend the expiration of the term of the Agreement from April 21, 2009 until April 21, 2019.
 
NOW THEREFORE , in consideration of the mutual covenants and promises contained in the Agreement and this First Amendment and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, NIMS and Cardinal agree as follows:
 
AMENDMENT
 
1.             Extension of Term.   Section 4.1 of the Agreement is hereby amended and restated in its entirety as follows:
 
4.1 The term of this Agreement shall end on April 21, 2019 ; provided that this Agreement may be renewed upon the execution by both parties hereto of a written notice specifying the term of any such renewal.  All terms and conditions of this Agreement shall apply to any renewal term, except as expressly amended in the executed renewal notice.
 
2.             Governing Law .  This First Amendment shall be governed by the laws of the State of Florida without regard to its conflict of laws rules or principles.
 
3.             Amendments.   Except as expressly amended hereby, the Agreement shall remain unmodified and in full force and effect.
 
4.             Entire Agreement .  This First Amendment and the Agreement and any schedules or exhibits attached to the Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede all prior understandings and writings between the parties relating thereto.
 
5.             Interpretation .  Any capitalized terms used in this First Amendment but not otherwise defined shall have the meaning provided in the Agreement.
 
6.             Counterparts .  This First Amendment may be executed manually, electronically in Adobe® PDF file format, or by facsimile by the Parties, in any number of counterparts, each of which shall be considered one and the same amendment and shall become effective when a counterpart hereof shall have been signed by each of the Parties and delivered to the other Party.
 
IN WITNESS WHEREOF, the Parties hereto have caused this First   Amendment to be executed in their names as of the date first written above.

CARDINAL HEALTH 211, INC.
By: /s/ Ed Pulwer                              
Name: Ed Pulwer
Title: Sr. Operating Executive
 
NON-INVASIVE MONITORING SYSTEMS, INC.
By: /s/ Steven B. Mrha                              
Name: Steven B. Mrha
Title: Chief Operating Officer
 
 
 
 
 








 
Exhibit 99.1
 
NIMS Announces FDA Grants Approval to Expand Exer-Rest ®   Indications to Include Reduction of Morning Stiffness

Miami, FL June 9 , 200 9   – Non-Invasive Monitoring Systems, Inc. [NIMS] (NIMU.OB) announced that the FDA has cleared NIMS to market the Exer-Rest ® , a Class I (exempt) medical device, with the expanded indication to reduce morning stiffness.  Exer-Rest ® is currently being marketed as an aid to temporarily increase local circulation, to provide temporary relief of minor aches and pains, as well as to support local muscle relaxation.

Exer-Rest ® produces Whole Body Periodic Acceleration (WBPA) through repetitive movements of the body in a head to foot direction at approximately 140 times per minute as the individual lies horizontally and comfortably on the device during a 30 to 45 minute session.  WBPA treatments are usually administered daily five to seven days a week for symptomatic relief.  WBPA technology is protected by five US patents.

The approved expanded indication is based upon submission to the FDA of a controlled, four week clinical trial conducted at the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania Medical School.  In the trial involving 57 patients with chronic pain associated with fibromyalgia, treatments using Exer-Rest ® WBPA technology significantly reduced the intensity of morning stiffness.

Dr. Marvin A. Sackner, NIMS’ Founder and CEO noted that “these patients were questioned about the intensity of morning stiffness because of its high prevalence in fibromyalgia.”  Morning stiffness is defined as slowness or difficulty moving the joints when getting out of bed or after staying in one position too long, which involves both sides of the body and improves with movement.

Dr. Sackner added that “morning stiffness is also a prominent, disabling clinical feature of rheumatoid arthritis and substantial reduction in its duration or intensity is a key element in the criteria for remission of disease activity.  Morning stiffness is also prevalent in osteoarthritis, polymyalgia rheumatica, ankylosing spondylitis, psoriatic arthritis, and Achilles tendonopathy. A home interview survey conducted by others in over 4,000 persons above age 55 years revealed the presence of morning stiffness in 5% of men and 10% of women reporting joint complaints of all causes. NIMS Exer-Rest® is now available to provide symptomatic relief for this condition.”

In a medical publication dealing with rheumatoid arthritis patients who were categorized with mild, moderate, or severe morning stiffness, 10% with mild, 16% with moderate, and 38% with the severe category opted for early retirement within three years, independent of age, presumably because of their inability to promptly report to work in the morning. In over 2,500 individuals with fibromyalgia, it has been reported that the most common symptom in terms of the greatest intensity was morning stiffness during the week prior to a survey.  Dr. Sackner commented that “these preceding investigations indicate that morning stiffness is a major cause of disability and that its reduction has major potential favorable clinical and economic consequences.”

Steven B. Mrha, NIMS’ Chief Operating Officer, states “this expanded indication supports our focus to market the Exer-Rest ® for those incapable or unwilling to exercise.  The Exer-Rest ® has been especially beneficial in treating individuals with symptoms commonly associated with chronic cardiovascular, neurological and inflammatory disorders.  The Exer-Rest ® is an excellent alternative and/or complement to moderate aerobic exercise and can be used by all individuals to enhance their overall quality of life.”  Mr. Mrha added that “NIMS has opened demonstration centers in Miami, Florida and Toronto, Canada where healthcare professionals and private individuals can receive personal Exer-Rest ® treatments.
 
 
 
 
 
NIMS, an ISO 13485 certified company, is also licensed to sell Exer-Rest ® in Canada, the European Common Market and other major world markets. Exer-Rest ® is regulated as a Class IIa medical device with CE certification.

This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995(PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements.  These factors include those described in our filings with the Securities and Exchange Commission, as well as risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.  We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.