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): SEPTEMBER 1, 2000
HENLEY HEALTHCARE, INC.
(Exact name of registrant as specified in its charter)
TEXAS
(State or other jurisdiction of incorporation)
0-21054 76-0511324
(Commission File Number) (IRS Employer Identification No.)
120 INDUSTRIAL BOULEVARD, SUGAR LAND, TEXAS 77478
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (281) 276-7000
NOT APPLICABLE
(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS
SONOPULS 190 ULTRASOUND SYSTEM
On Friday, August 25, 2000, Henley Healthcare, Inc., a Texas corporation
(the "Company"), announced that it had received government approval from the FDA
to sell the Enraf-Nonius' Sonopuls 190 Ultrasound System in the United States.
With the FDA approval, the Company will begin marketing the Sonopuls 190 in the
United States immediately.
The Sonopuls was developed by the Company's wholly-owned subsidiary
Enraf-Nonius B.V. located in Delft, The Netherlands. The Sonpuls 190 is the
latest product in the ultrasound line of Enraf-Nonius products and is already
approved for use in Europe. The Sonpuls 190, which retails for about $1,200,
works by bouncing sound waves off soft tissues, such as muscles or tendons. This
increases blood flow to the area and thus reduces inflamation. The important
features of this unit are simplicity and functionality. Other features include
continuous and pulsed ultrasound at 1MHz, large crystal clear parameter
displays, ergonomically shaped treatment head with permanent calibration
changeable contact level.
The Sonopuls 190 is expected to bring in $250,000 in U.S. sales in the
next 12-18 months. Globally, revenues from the product are $500,000 a year.
The Company also stated that it expects to market more Enraf-Nonius'
products in the United States as soon as they receive U.S. approval.
FDA INQUIRY
The Company has been notified that the FDA has inquired with respect to
certain issues relating to recordkeeping and labeling regarding the Company's
Medipad and Medigel products. Due to a raw materials problem, the Company has
not manufactured the Medipad since December 1999. The Company is currently
marketing the Medigel products which are in compliance with the FDA labeling
regulations for over-the-counter drugs. The Company is in the process of
responding to the issues raised by the FDA and is cooperating fully in this
inquiry.
NAME CHANGE
On Tuesday, August 29, 2000, the Company announced that it had received
shareholder approval to change its name from Henley Healthcare, Inc. to ePainRx
Inc. The board of directors has elected to delay the name change for an
unspecified time in order to allow for an orderly transition and to minimize the
impact on the Company's cash flow.
The Company plans to continue operating under its traditional business
structure, but has added the Internet as an additional tool for further
development and growth of the business.
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MICROLIGHT 830
In July 2000, the FDA requested clarification from the Company with
respect to certain points outlined in the PMA submitted to the FDA regarding the
Company's Microlight 830, a laser treatment for carpal tunnel syndrome. The
Company is in the process of responding to the FDA's questions and expects to
file its answers within the next ten days. The FDA will have six months to
respond to the Company with respect to the Microlight 830 after it receives the
Company's answers.
CHARTER AMENDMENT
The Company also announced that the shareholders had approved the
amendment to the Company's Articles of Incorporation to increase the number of
shares of capital stock that the Company is authorized to issue from 22,500,000
to 60,000,000, of which 50,000,000 will be shares of common stock, par value
$.01 per share, of the Company and 10,000,000 will be shares of preferred stock,
par value $.10 per, of the Company.
RESIGNATION
The Company announced that Michael M. Barbour, President, Chief Executive
Officer and a director, has resigned to pursue other interests. The Board of
Directors has appointed its Chairman, Dr. Pedro A. Rubio, as interim President
and CEO, and will initiate a search for a new President as soon as possible.
James L. Sturgeon, currently Executive Vice President - Finance and Chief
Accounting Officer, has been appointed Chief Operating Officer.
This document includes certain statements that may be deemed to be
"forward-looking statements" within the meaning of Section 27A of the Securities
Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934,
as amended. All statements other than statements of historical facts, included
in the this document that address activities, events or developments that the
Company expects, believes or anticipates will or may occur in the future are
forward-looking statements. Such forward-looking statements are subject to
certain risks, uncertainties and other factors, which could cause factual
results to differ materially from those currently anticipated, including the
risks and uncertainties set forth from time to time in the Company's public
reports and filings and other public statements. Readers are cautioned to
consider these risks and uncertainties and not place undue reliance on these
forward-looking statements. By making these forward-looking statements, the
Company undertakes no obligation to update these statements for revisions or
changes after the date of this document.
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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.
HENLEY HEALTHCARE, INC.
By:/s/JAMES L. STURGEON
James L. Sturgeon
Executive Vice President-Finance
and Chief Accounting Officer and
Secretary
September 1, 2000
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