8-K

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 23, 2019

AMERICAN BIO MEDICA CORPORATION 

(Exact name of registrant as specified in its charter)

New York	0-28666	14-1702188
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification Number)

122 Smith Road, Kinderhook, NY	12106
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: 518-758-8158

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))

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	ABMC	Over-the-counter-Pink Sheets

Indicate by check mark whether the registrant is an emerging growth company 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 1.02                                  TERMINATION OF A MATERIAL DEFINITIVE AGREEMENT

On May 24, 2019, American Bio Medica Corporation (the "Company") announced that its Consent Decree of Permanent Injunction (Consent Decree) with the U.S. Food and Drug Administration was vacated on May 23, 2019, and the case has been closed. A copy of the press release issued May 24, 2019 is attached hereto as Exhibit 99.1 and is incorporated by reference in this Item 1.02 (the “Press Release”). The Press Release is also available on the Company’s website.

ITEM 8.01                                  OTHER EVENTS

Risk Factor Disclosure

Pursuant to the disclosure provided under Item 1.02, the Company is providing the following update to a risk factor from its Annual Report on Form 10-K filed with the Commission on April 16, 2019:

Any adverse changes in our regulatory framework could negatively impact our business, and costs to obtain regulatory clearance are material.

Although we are unaware of any recent or upcoming changes in regulatory standards related to the marketing of our products, history supports that change in regulatory requirements could negatively impact our business. We became unable to sell our oral fluid products in the Employment/Workplace market in November 2013 as a result of FDA’s change in position regarding Employment/Workplace drug testing. Prior to this regulatory change, we typically had annual sales of $2,000,000 of oral fluid sales in the Employment/Workplace market. In July 2017, there was another change in marketing regulations. The FDA issued a limited exemption that would allow companies to sell certain drug tests in the Employment/Workplace market (see “Government Regulations”). While this change could be determined to have a positive impact on our sales (as it reopens a market for ABMC), until our consent decree with FDA was vacated on May 23, 2019, we were unable to take advantage of the limited FDA exemption and, this has negatively impacted our ability to regain sales of oral fluid drug tests. In addition to the sales and marketing restrictions regulatory changes can cause, the cost of filing 510(k) marketing clearances is material. Therefore, these costs can have a negative impact on efforts to improve our financial performance. If regulatory standards change in the future, there can be no assurance that we will receive marketing clearances from FDA, if and when we apply for them.

ITEM 9.01                                  FINANCIAL STATEMENTS AND EXHIBITS

(d)           

99.1           

The Press Release

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.

	AMERICAN BIO MEDICA CORPORATION (Registrant)
Date: May 24, 2019	By:	/s/ Melissa A. Waterhouse
		Melissa A. Waterhouse
		Chief Executive Officer (Principal Executive Officer) Principal Financial Officer

EX-99.1

  Exhibit 99.1

           

Contacts:  

Melissa A. Waterhouse

Chief Executive Officer

(800) 227-1243, Ext 107

FOR IMMEDIATE RELEASE:

ABMC ORAL FLUID CONSENT DECREE VACATED

--Company will re-enter the employment market with oral fluid drug tests--

Kinderhook, N.Y., May 20, 2019 – American Bio Medica Corporation (OTCPK: ABMC) announced today that on May 23, 2019, its Consent Decree of Permanent Injunction (Consent Decree) with the U.S. Food and Drug Administration (FDA) has been vacated and the case has been closed. This action resolves a long-standing inability of the Company to market and sell oral fluid drug tests in the employment market. The Company is now allowed to sell oral fluid drugs tests in the employment and insurance markets under a limited exemption set forth by the FDA on July 11, 2017. Notwithstanding the Consent Decree (which initially resulted from a jurisdictional issue in the employment market), the Company, through FDA audits, has remained fully compliant with cGMP regulations.

Chief Executive Officer Melissa A. Waterhouse stated, “We are excited about the new sales opportunities that now exist for ABMC. We have been out of the employment market for oral fluid drugs tests since 2013. We have continued to sell OralStat in the U.S. forensic markets and in markets outside the United States but, certainly not at the sales levels we were reporting pre-2013. We are very hopeful that gaining access to this market again will enable us to see near term revenue growth and in the longer-term, enable us to add significantly to our annual revenue.”

For more information on ABMC or its drug testing products, please visit www.abmc.com.

About American Bio Medica Corporation

American Bio Medica Corporation manufactures and markets accurate, cost-effective immunoassay test kits, primarily point of collection tests for drugs of abuse. The Company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets.ABMC’s Rapid Drug Screen®, Rapid ONE®, RDS® InCup®, Rapid TOX® and Rapid TOX Cup® II test for the presence or absence of drugs of abuse in urine, while OralStat® tests for the presence or absence of drugs of abuse in oral fluids. ABMC’s Rapid Reader® is a compact, portable device that, when connected to any computer, interprets the results of an ABMC drug screen, and sends the results to a data management system, enabling the test administrator to easily manage their drug testing program.

This release may contain forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ, and such differences could be material. Such risks and uncertainties include, but are not limited to, risks and uncertainties related to the following: continued acceptance of our products, increased levels of competition in our industry, acceptance of new products, product development, compliance with regulatory requirements, including but not limited to our ability to obtain marketing clearance on our product for our intended markets, intellectual property rights, our dependence on key personnel, third party sales and suppliers, trading in our common shares may be subject to “penny stock” rules, our history of recurring net losses and our ability to continue as a going concern. There can be no assurance that the Company will be successful in addressing such risks and uncertainties and the Company assumes no duty to update any forward-looking statements based upon actual results. Investors are strongly encouraged to review the section entitled “Risk Factors” in the Company's annual report on Form 10-K for the year ended December 31, 2018, quarterly reports on Form 10-Q, and other periodic reports on file with the Securities and Exchange Commission for a discussion of risks and uncertainties that could affect operating results and the market price of the Company's common shares.