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: September 24, 1996
PLC SYSTEMS INC.
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(Exact Name of Registrant as Specified in Charter)
British Columbia, Canada 0-19561 04-3153858
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(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification
Number)
10 Forge Park, Franklin, Massachusetts 02038
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(Address of Principal Executive Offices) (Zip Code)
(508) 541-8800
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(Registrant's Telephone Number, Including Area Code)
TABLE OF CONTENTS
FORM 8-K
September 24, 1996
Item Page
---- ----
Item 5. Other Events 1
Item 7. Exhibits 1
Signature 2
Exhibits 3
i
ITEM 5. OTHER EVENTS.
A copy of the press release of the Registrant dated September 10, 1996
is filed herewith as Exhibit Number 99a. The press release describes the
notification of the Food and Drug Administration to the Registrant allowing the
Registrant to halt the randomization of patients to medical management in
multicenter Transmyocardial Revascularization clinical trials.
A copy of the Complaint for declaratory relief filed September 10,
1996, Cardiogenesis Corp. v. PLC Systems, Inc., et al., U.S.D.C. (N.D. - S.J.),
Civil Action Number C-96 20749 SW (EAI), is filed herewith as Exhibit Number
99b. The Registrant has been named as a defendant in a complaint for declaratory
relief of patent invalidity and non-infringement under 28 U.S.C., Sections 2201
and 2202, with a demand for jury trial.
ITEM 7. EXHIBITS
The following exhibits are filed herewith:
Exhibit
No. Title
99a Press Release of the Registrant dated September 10, 1996
99b Complaint for declaratory relief filed September 10, 1996, CardioGenesis
Corp. v. PLC Systems, Inc., et al., U.S.D.C. (N.D. - S.J.), Civil Action
Number C-96 20749 SW (EAI).
1
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.
PLC SYSTEMS INC.
By:/s/ Patricia L. Murphy
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Patricia L. Murphy
Chief Financial Officer
Date: September 24, 1996
2
EXHIBIT INDEX
Exhibit
No. Title
99a Press Release of the Registrant dated September 10, 1996
99b Complaint for declaratory relief filed September 10, 1996, CardioGenesis
Corp. v. PLC Systems, Inc., et al., U.S.D.C. (N.D. - S.J.), Civil Action
Number C-96 20749 SW (EAI).
3
PRNEWSWIRE NEWSFAX
Food and Drug Administration Says PLC Systems Can Stop Randomizing Patients to
Medical Management in Multicenter TMR Clinical Trials
Patients Previously Randomized to Medical Management
can be Crossed-Over to TMR after 12 Months
FRANKLIN, Mass., Sept. 10 /PRNewswire/ -- PLC Systems Inc. (AMEX: PLC)
today announced that the Food and Drug Administration (FDA) has notified the
Company that it can halt the randomization of patients to the medical management
group in a study comparing patients who receive Transmyocardial
Revascularization (TMR) using the Company's CO2 Heart Laser to medical therapy.
In addition, those patients previously randomized to the medical management
group may then receive TMR using The Heart Laser after 12 months follow-up.
"Due to the dramatic differences in the clinical outcomes between the TMR
group and the medical therapy group the FDA has allowed PLC Systems to stop
randomizing patients to medical management at centers which are performing TMR
using The Heart Laser. The principal investigators at each hospital center have
been notified of this recent developement," stated M. Lee Hibbs, President and
CEO of PLC Systems Inc. "Moreover, the patient outcome data shows medical
management to be ineffective, and supports the use of TMR using The Heart Laser
as a replacement for medical/drug therapy in end-stage coronary artery disease
patients."
Results of a controlled, randomized study comparing patients who receive
TMR using the CO2 Heart Laser to medical management demonstrated that 71% of the
TMR patients recorded a decrease of at least two angina classes, whereas all
patients within the medical therapy group either remained the same or their
condition worsened. This study also provided a direct comparison of the
mortality rates associated with TMR and medical therapy. The overall mortality
in the TMR group was 6%. In contrast, the mortality rate in the medical
management group was 16%.
Mr. Hibbs concluded, "Although the randomized clinical trial of TMR using
The Heart Laser in end-stage coronary artery disease patients has ended, this
patient group will continue to be treated at the Company's sites with no risk of
randomization. As well, the Company is managing two additional studies for The
Heart Laser -- TMR versus repeat cardiac bypass surgery and TMR as an adjunct to
cardiac bypass surgery."
PLC Systems Inc. is a cardiac revascularization company whose mission is
to be the global leader in Transmyocardial Revascularization (TMR) by
pioneering, developing and supplying TMR systems and their components. TMR has
the potential to provide patients suffering from coronary artery disease a third
alternative or adjunct to angioplasty and cardiac bypass surgery. PLC Medical
Systems, Inc., a wholly owned subsidiary of PLC Systems Inc., has developed the
CO2 Heart Laser which employs the Company's patented heart-synchronized pulsed
laser system technology for TMR. PLC Systems has been granted expedited review
of its PreMarket Approval (PMA) application for TMR using The Heart Laser (TM)
to treat cardiac patients with a medically refractory angina who are not
canidates for angioplasty or bypass surgery.
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NOTE: Certain of the above statements may be forward-looking statements
that involve risks and uncertainties. In such instances, actual results could
differ materially as a result of a variety of factors including competitive
developments and risk factors listed from time to time in the Company's SEC
reports.
SOURCE PLC Systems Inc.
- -0- 9/10/96
/CONTACT: Michele Fasano, Director of Corporate Communications of PLC
Systems, 800-211-7327, or Tom Wicky of Grob Strategic, 617-497-8400/ (PLC)
LYON & LYON LLP
A Limited Liability Partnership
Including Professional Corporations
COE A. BLOOMBERG (CA Bar No. 54896)
A Professional Corporation
DAVID A. RANDALL (CA Bar No. 156722)
MICHAEL A. TOMASULO (CA Bar No. 179389)
633 West Fifth Street, Suite 4700
Lon Angeles, California 90071-2066
(213) 489-1600
Attorneys for Plaintiff
CARDIOGENESIS CORPORATION
IN THE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
SAN JOSE DIVISION
CARDIOGENESIS CORPORATION, a Case No.
Delaware corporation,
COMPLAINT FOR DECLARATORY
Plaintiff, RELIEF OF PATENT INVALIDITY
AND NON-INFRINGEMENT UNDER 28
v. U.S.C. ss.2201 AND 2202
PLC SYSTEMS, INC., a British
Columbia, Canada corporation, (DEMAND FOR JURY TRIAL)
and its wholly-owned subsidiary,
PLC MEDICAL SYSTEMS, INC., a
Massachusetts corporation,
Defendants.
Plaintiff, CardioGenesis Corporation, files this Complaint against the
above-named defendants and, demanding a trial by jury, alleges as follows:
Complaint for
Declaratory Relief
THE PARTIES
1. Plaintiff, CardioGenesis Corporation ("CardioGenesis"), is a
corporation organized and existing under the laws of the state of Delaware,
having its principal place of business at 540 Oakmead Parkway, Sunnyvale,
California 94086.
2. Based on information and belief, Defendant PLC Systems, Inc. is a
corporation organized and existing under the laws of British Columbia, Canada
and is registered to do business under the laws of the State of Massachusetts,
with its principal place of business at 10 Forge Park, Franklin, Massachusetts
02038. Defendant PLC Systems, Inc. is doing business in the Northern District of
California, and is causing economic injury to Plaintiff in this district.
3. Based on information and belief, Defendant PLC Medical Systems, Inc. is
a wholly-owned subsidiary of Defendant PLC Systems, Inc., organized and existing
under the laws of the State of Massachusetts, with its principal place of
business at 10 Forge Park, Franklin, Massachusetts 02038, and is doing business
in the Northern District of California, and is causing economic injury to
Plaintiff in this district. It is further alleged on information and belief that
Defendant PLC Medical Systems Inc. was formerly known as Laser Engineering Inc.
until its name was changed to PLC Medical Systems, Inc on January 1, 1995.
Defendants PLC Systems, Inc. and PLC Medical Systems, Inc. shall be referred to
collectively as "PLC".
JURISDICTION AND VENUE:
4. This is an action for a declaratory judgment.
Complaint for
Declaratory Relief
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Included in the relief sought is a determination that United States Patent No.
5,125,926 is invalid, unenforceable and not infringed by Plaintiff. The action
arises under the Declaratory Judgment Act, 28 U.S.C ss. 2201-2202, and the
patent laws of the United States, Title 35, United States Code. Subject matter
jurisdiction is vested in this Court by 28 U.S.C ss. 1331 and 1338(a). Venue is
proper based on 28 U.S.C. ss. 1391(b)and (c).
INTRA DISTRICT ASSIGNMENT
5. Assignment of the instant action to the San Jose Division is proper as
Plaintiff CardioGenesis is located in Santa Clara County and a substantial part
of the events or omissions which give rise to the claim occurred in this County.
DECLARATORY RELIEF OF PATENT INVALIDITY AND NON-INFRINGEMENT
6. Based on information and belief, defendants PLC Systems and PLC Medical
Systems have ownership interests in the proprietary rights granted by United
States Patent No. 5,125,926 ("the '926 patent"). The `926 patent claims a
certain heart-synchronized pulsed laser system for performing transmyocardia1
revascularization ("TMR") on a beating heart.
7. Laser TMR typically involves the use of a laser to create between 15 and
30 channels in the ischemic regions of the myocardium. It is believed that TMR
provides a means for oxygenated blood to perfuse the ischemic areas of the
heart, relieving angina and increasing patient exercise tolerance.
8. Plaintiff CardioGenesis makes Transmyocardial Revascularization medical
devices that employ a laser. One such
Complaint for
Declaratory Relief
-3-
device made by CardioGenesis is its Intraoperative Transmyocardial
Revascularization device ("ITMR device"). CardioGenesis is in clinical trials
for FDA approval of its ITMR device here in the U.S. Plaintiff CardioGenesis has
received European Community approval to market its ITMR device in Europe;
plaintiff received the Conformite Europeen (CE) mark approval for use of its
ITMR products in patients with severe coronary artery disease who are not
candidates for conventional therapies, including coronary artery bypass surgery
or percutaneous balloon angioplasty. Pursuant to this approval, CardioGenesis is
presently manufacturing its ITMR devices for the European market. Plaintiff is
also presently marketing its ITMR device in Europe.
9. PLC's actions have created on the part of CardioGenesis a reasonable
apprehension that Defendants will initiate litigation against it for alleged
infringement of United States Patent No. 5,125,926. Examples of such actions by
PLC include, but are not limited to, the following: (l) PLC has charged that
Plaintiff's ITMR device infringes the claims of the '926 patent; (2) PLC has
sent threat letters to CardioGenesis and its domestic and European customers
identifying CardioGenesis' ITMR device and stating that PLC intends to enforce
its patent rights; and (3) PLC has issued press releases in which PLC has
expressed the position that the '926 patent covers the synchronization, or
timing, of the firing of any laser used in TMR to a patients heartbeat and in
which PLC has stated that the '926 patent is extremely important to PLC and that
PLC intends "to vigorously pursue any company which attempts to infringe upon it
anywhere in the world."
Complaint for
Declaratory Relief
-4-
10. CardioGenesis is not infringing and is not threatening to infringe the
'926 patent, directly or indirectly.
11. The '926 patent is invalid, unenforceable, and/or void for failure to
comply with the requirements of Part II of Title 35, United States Code.
12. An actual and justiciable controversy within the meaning of 28 U.S.C.
ss. 2203 and ss. 2202 exists between Plaintiff and Defendants with respect to
the validity and infringement of the '926 patent.
13. This case is an exceptional case under 35 U.S.C. ss. 285 such that
CardioGenesis is entitled to recover its attorneys fees.
PRAYER FOR RELIEF
WHEREFORE, Plaintiff, Cardio&enesis, prays that this Court enter a judgment
that:
A. United States Patent No. 5,125,926 is invalid, unenforceable, and not
infringed by any produce made, used or sold by or for CardioGenesis;
B. Defendants and all officers, agents, employees, representatives and
counsel of Defendants, and all persons in active concert or participation with
any of them, directly or indirectly, be enjoined from charging infringement of,
or instituting any action for infringement of United States Patent No. 5,125,926
against CardioGenesis, its customers, or any distributor or user of its TMR
Devices;
C. That this case be declared "exceptional" under 35 U S.C ss. 285
and CardioGenesis be awarded its reasonable attorneys
Complaint for
Declaratory Relief
-5-
fees and costs upon prevailing in the action; and
D. Plaintiff be granted such other and further relief as this Court may
deem just and appropriate.
Respectfully submitted,
LYON & LYON LLP
A Partnership Including
COE A. BLOOMBERG
A Professional Corporation
DAVID A. RANDALL
MICHAEL A. TOMASULO
By: /s/ COE A. BLOOBERG
------------------------------
COE A. BLOOMBERG
Attorneys for Plaintiff,
CARDIOGENESIS CORPORATION
DEMAND FOR JURY TRIAL
Plaintiff hereby demands a trial by jury of all issues so triable pursuant
to the Federal Rules of Civil Procedure, Rule 28(b), 28 U.S.C. Rule 28.
Respectfully submitted,
LYON & LYON LLP
A Partnership Including
COE A. BLOOMBERG
A Professional Corporation
DAVID A. RANDALL
MICHAEL A. TOMASULO
By: /s/ COE A. BLOOBERG
-----------------------------
COE A. BLOOMBERG
Attorneys for Plaintiff,
CARDIOGENESIS CORPORATION
Complaint for
Declaratory Relief
-6-
