0001161697-11-000508.txt : 20110601
0001161697-11-000508.hdr.sgml : 20110601
20110601144434
ACCESSION NUMBER: 0001161697-11-000508
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 2
CONFORMED PERIOD OF REPORT: 20110531
ITEM INFORMATION: Other Events
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20110601
DATE AS OF CHANGE: 20110601
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: REPRO MED SYSTEMS INC
CENTRAL INDEX KEY: 0000704440
STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
IRS NUMBER: 133044880
STATE OF INCORPORATION: NY
FISCAL YEAR END: 0228
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 000-12305
FILM NUMBER: 11884732
BUSINESS ADDRESS:
STREET 1: 24 CARPENTER RD
CITY: CHESTER
STATE: NY
ZIP: 10918
BUSINESS PHONE: 9143438499
MAIL ADDRESS:
STREET 1: 24 CARPENTER RD
CITY: CHESTER
STATE: NY
ZIP: 10918
8-K
1
form_8-k.txt
FORM 8-K FOR 05-31-2011
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) May 31, 2011
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REPRO-MED SYSTEMS, INC.
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(Exact name of registrant as specified in its charter)
NEW YORK 0-12305 13-3044880
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
24 Carpenter Road, Chester, New York 10918
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (845) 469-2042
--------------
not applicable
--------------------------------------------------------------
(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):
[ ] 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 8.01 OTHER EVENTS.
The Company issued a press release announcing that it has received approval from
the Food and Drug Administration (FDA) to begin U.S. marketing of its new
Subcutaneous Needle Sets. The press release is furnished herewith as Exhibit
99.1.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits.
Exhibit Description
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99.1 Press release dated May 31, 2011.
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.
REPRO-MED SYSTEMS, INC.
(Registrant)
Date June 1, 2011 By: /s/ Andrew I. Sealfon
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Andrew I. Sealfon
President and Chief Executive Officer
- 2 -
EX-99
2
ex_99-1.txt
PRESS RELEASE DATED 05-31-2011
EXHIBIT 99.1
FOR IMMEDIATE RELEASE
---------------------
For further information:
Andrew I. Sealfon, President
RMS Medical Products
24 Carpenter Road, Chester, NY 10918
Telephone: (845) 469-2042
FAX: (845) 469-5518
FDA APPROVES MARKETING OF RMS SUBCUTANEOUS NEEDLE SETS
(Chester, NY - May 31, 2011) - Repro-Med Systems, Inc., (REPR.PK) announced
today that it has received approval from the Food and Drug Administration (FDA)
to begin U.S. marketing of its new Subcutaneous Needle Sets which the company is
promoting as the HIgh Flo(TM) RMS Subcutaneous Needle Sets. The needle sets are
intended for the delivery of medication to subcutaneous tissue. The needle sets
have previously been approved and available for use by patients in Canada and
Europe. Repro-Med Systems, Inc. utilizes the name RMS Medical Products.
"The FDA's approval allows patients here in the U.S., where our products are
manufactured, to enjoy the benefits realized currently by many patients
overseas," said Andrew I. Sealfon, president of the company, based in Chester,
NY. "Although we use a needle which is smaller in gauge than many needles being
used for subcutaneous administration of certain drugs, our design results in
flow rates comparable to, or better than, the flow rates of the larger needles.
This can result in less pain and discomfort for the patient, less insertion
difficulty for the patient and medical personnel, and shorter infusion times,"
Sealfon added.
The needle sets are an ideal companion for RMS Medical Products' FREEDOM60(R)
Syringe Infusion System, which has enhanced the lifestyle of numerous patients
requiring regular drug infusions due to its portability and ease of use.
FREEDOM60(R) enjoys widespread use by ambulatory patients at home as well as
those in healthcare facilities. "Even though the RMS Subcutaneous Needle Sets
provide advanced fluidics, the pricing will be highly competitive, just as
FREEDOM60(R) has been in the infusion pump market," Sealfon said.
The RMS Subcutaneous Needle Sets use custom designed, approximately 26-gauge
needles, which have a smaller outside diameter than commonly used 24-gauge
needles. This translates into less "ouch" when the needles are inserted, and
greater comfort throughout lengthy infusions. The sets have superior fluidics
resulting in faster flow rates. When used in multi-needle sets, as typically is
the case for subcutaneous immune globulin infusions, the RMS Subcutaneous Needle
Sets distribute equal volumes of drug to all needles. The sets are available in
single, double, triple, and quad configurations. RMS produces a low residual "Y"
connector, which allows up to eight needles to be used for a single infusion.
Needles lengths currently available are 6mm, 9mm, and 12mm.
"We believe that patients who may be fearful of needles, or are uncomfortable
with the thought of having to undergo lengthy infusions, will appreciate the
potential benefits, as will health care providers," Sealfon concluded.
RMS Medical Products is the manufacturer of the FREEDOM60(R) Syringe Infusion
System and the RES-Q-VAC(R) hand powered suction device. A primary use for the
FREEDOM60(R) Syringe Infusion Pump is in subcutaneous administration of immune
globulin due to its safe, controlled pressure and ability to adjust
automatically to the flow. The inherently safe pressures used to deliver drugs
to patients minimize discomfort, swelling and other complications sometimes
found with conventional electric infusion devices. There are additional
applications such as the delivery of antibiotics for the ambulatory patient.
FORWARD LOOKING STATEMENTS
Statements in this press release may contain "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, may be forward-looking
statements. These statements are based on management's current expectations and
are subject to uncertainty and changes in circumstances. These statements
involve risks and uncertainties that could cause actual results to differ
materially from those included in forward-looking statements due to a variety of
factors. More information about these factors can be found in Repro-Med's latest
Annual Report filed with Securities and Exchange Commission on Form 10-K. The
company undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
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