0001161697-24-000196.txt : 20240411 0001161697-24-000196.hdr.sgml : 20240411 20240411164429 ACCESSION NUMBER: 0001161697-24-000196 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240408 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240411 DATE AS OF CHANGE: 20240411 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KORU Medical Systems, Inc. CENTRAL INDEX KEY: 0000704440 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 133044880 STATE OF INCORPORATION: NY FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39086 FILM NUMBER: 24839026 BUSINESS ADDRESS: STREET 1: 100 CORPORATE DRIVE CITY: MAHWAH STATE: NJ ZIP: 07430 BUSINESS PHONE: 845-469-2042 MAIL ADDRESS: STREET 1: 100 CORPORATE DRIVE CITY: MAHWAH STATE: NJ ZIP: 07430 FORMER COMPANY: FORMER CONFORMED NAME: REPRO MED SYSTEMS INC DATE OF NAME CHANGE: 19920703 8-K 1 form_8-k.htm FORM 8-K CURRENT REPORT FOR 04-08-2024 Form 8-K Current Report for 04-08-2024
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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)   April 8, 2024

 

KORU Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware 0-12305 13-3044880
(State or other jurisdiction
of incorporation)		 (Commission
File Number)		 (IRS Employer
Identification No.)

 

100 Corporate Drive, Mahwah, NJ 07430
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code   (845) 469-2042

 

______________________________________________

(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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading symbol(s) Name of each exchange on which registered
common stock, $0.01 par value KRMD The Nasdaq Stock Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  [_]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  [_]

 

 

ITEM 8.01   OTHER INFORMATION.

 

As previously reported, in March 2024, KORU Medical Systems, Inc. (the “Company”) received an assessment report from its notified body in the European Union, BSI, stating that, following BSI’s review of technical documentation submitted by the Company in connection with a prior audit nonconformance, a recommendation for continued certification cannot be made. The Company filed an appeal to that determination. On April 8, 2024, the Company’s appeal was upheld. The Company intends to address the identified nonconformance through the routine BSI assessment process.

 

Forward-Looking Statements

 

This Current Report on Form 8-K contains “forward-looking” statements regarding the nonconformance and BSI assessment process and that are based on the Company’s beliefs and assumptions and on information currently available to the Company on the date of this Current Report on Form 8-K. These forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause the Company’s actual results to differ materially from the results anticipated by the Company’s forward-looking statements is included in the reports the Company has filed with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023.

 

ITEM 9.01   FINANCIAL STATEMENTS AND EXHIBITS.

 

Exhibits.

 

Exhibit No. Description
   
99.1 Press Release dated April 11, 2024
   
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

- 2 -

 

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.

 

  KORU Medical Systems, Inc.
(Registrant)
     
Date:  April 11, 2024 By: /s/ Linda Tharby
  Linda Tharby
President and Chief Executive Officer

 

- 3 -

 EX-99 2 ex_99-1.htm PRESS RELEASE DATED APRIL 11, 2024

 

EXHIBIT 99.1

 

 

KORU Medical Systems Announces Successful Appeal in EU Notified Body Review

 

MAHWAH, NJ – April 11, 2024 – KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a successful appeal related to an ongoing audit by its notified body in the EU, The British Standards Institute (BSI).

 

The Company’s appeal of an assessment report from BSI regarding a recommendation against continued certification in connection with prior audit nonconformance, was upheld. As a result, the Company will proceed through the routine BSI assessment process without suspension or interruption of the Company’s sale of products in the EU.

 

“We are pleased by our successful appeal to BSI’s assessment report. Our team’s swift response and positive interaction with BSI, resulted in no interruption of sales of KORU Medical’s products to the market and our patients,” said Linda Tharby, KORU Medical’s President and CEO. “Our products remain certified, marketed and sold in the EU, and we are excited by the continued expansion of our international business.”

 

About KORU Medical Systems

 

KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (the “Freedom System”) currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit www.korumedical.com.

 

Forward Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including but not limited to sales expansion into new regions.  Actual results may differ materially from these statements due to potential risks and uncertainties such as those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023 which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of April 11, 2024. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

 

Investor Contact:

Louisa Smith

investor@korumedical.com

 

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Cover
Apr. 08, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Apr. 08, 2024
Entity File Number 0-12305
Entity Registrant Name KORU Medical Systems, Inc.
Entity Central Index Key 0000704440
Entity Tax Identification Number 13-3044880
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 100 Corporate Drive
Entity Address, City or Town Mahwah
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 07430
City Area Code 845
Local Phone Number 469-2042
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security common stock, $0.01 par value
Trading Symbol KRMD
Security Exchange Name NASDAQ
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