<PAGE>
================================================================================
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
February 12, 1997
---------------------------------
Date of Report
(Date of earliest event reported)
ELECTROPHARMACOLOGY, INC.
-------------------------
(Exact Name of Registrant as Specified in Charter)
DELAWARE 0-25828 95-4315412
- --------------------------------- ------------------------ ----------------
(State or other Jurisdiction of (Commission File Number) (I.R.S. Employer
Incorporation) Identification No.)
2301 N.W. 33RD COURT, SUITE 102
POMPANO BEACH, FLORIDA 33069
- --------------------------------- ----------
(Address of Principal Executive (Zip Code)
Offices)
(954) 975-9818
----------------------------------------------------
(Registrant's telephone number, including area code)
================================================================================
<PAGE>
ITEM 5. OTHER EVENTS.
Electropharmacology, Inc. ("EPi") announced on February 12, 1997 that it has
decided to conduct new clinical trials as the basis for seeking a Pre-Market
Approval ("PMA") from the U.S. Food and Drug Administration for its SofPulse(TM)
device.
The announcement is based on EPi's determination that the data from a previous
clinical trial conducted at 14 recognized universities and medical centers, and
an analysis of results by an independent statistician announced in March 1996,
regarding the effectiveness of SofPulse(TM) to reduce edema in Grade I and II
ankle sprains, could not be substantiated by rigorous analyses. The
determination was made after EPi had undertaken a rigorous review of the data
and patient records of the clinical trial for the proposed PMA. The examination
of the data revealed certain noncompliance by several patients with the
protocol, which caused EPi to conduct a careful patient data audit and
exhaustive biostatistical analysis, including additional independent expert
reviews.
EPi announced that it is committed to additional clinical trials in order to
establish and expand the utility of its proprietary PRF technology in broad
markets and specific indications where pain and edema have significant
implications in patient outcomes, and that it would select more specific
clinical indications to submit one or more PMA applications for the SofPulse(TM)
device. Such trials would be designed in concert with the key market
opportunities for the device which is currently in extensive clinical use and
has provided over 250,000 patient treatments during the past five years.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Electropharmacology, Inc.
By: /s/ JOSEPH MOOIBROEK
-------------------------------
Joseph Mooibroek
President and Chief Executive
Officer
February 12, 1997
-2-
