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): December 6, 1996.
POSSIS MEDICAL, INC.
(Exact name of registrant as specified in charter)
MINNESOTA 0-944 41-0783184
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification Number)
9055 Evergreen Boulevard NW
Minneapolis, Minnesota 55433-8003
(Address of principal executive offices)
Registrant's telephone number, including area code: 612 780-4555
<PAGE>
Item 5. Other Events.
Possis Medical, Inc., on December 6, 1996, announced that it had issued a
notice of termination concerning its Supply and Distributor Agreement with C. R.
Bard, Inc. ("Bard"). Under the Agreement, Bard has the exclusive right to
distribute the Possis Perma-Seal Dialysis Access Graft worldwide. This event is
further described in the News Release dated December 6, 1996, which is
incorporated herein by reference. Possis Medical also announced on December 6,
1996,, that it has received 510(k) clearance from the FDA to market its AngioJet
rapid Thrombectomy System in the uited States for A-V access graft applications.
This event is further described in the News Release dated December 6, 1996,
which is incorporated herein by reference.
Item 7. Financial Statements and Exhibits
The Agreement provides for an initial term of three years, an initial cash
payment and additional cash payments over the life of the Agreement.
Exhibit 99.1: News Release dated December 6, 1996.
Exhibit 99.2: News Release dated December 6, 1996.
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 undersigned
hereunto duly authorized.
POSSIS MEDICAL, INC.
Date: December 13, 1996 By: Robert G. Dutcher
President and Chief Executive Officer
NEWS RELEASE
FOR IMMEDIATE RELEASE FOR MORE INFORMATION CONTACT:
Robert G. Dutcher
President and Chief Executive Officer
POSSIS MEDICAL, INC.
(612) 780-4555
POSSIS MEDICAL, INC. RECEIVES 510(K) CLEARANCE FROM FDA TO MARKET
ANGIOJET RAPID THROMBECTOMY SYSTEM
Company to Immediately Launch Blood Clot Removal System
MINNEAPOLIS, MN (December 6, 1996) -- Possis Medical, Inc. (Nasdaq-NNM:
POSS) announced today that it has received 510(k) clearance from the U.S. Food
and Drug Administration (FDA) to market its AngioJet Rapid Thrombectomy System
in the United States with labeling claims for removal of blood clots (thrombus)
from grafts used for kidney dialysis.
The AngioJet System is designed to safely, quickly, non-surgically and cost
effectively remove blood clots from arteries, veins and grafts throughout the
body. Each year, blood clots affect more than 10 million people worldwide and
are a leading cause of death and morbidity. A clot that blocks normal blood flow
in a vessel or graft can cause serious medical conditions including heart
attack, stroke, pulmonary embolism, vascular access failure and limb loss.
The AngioJet System includes a drive unit, single-use pump and a variety of
single-use catheters. Two catheters, the F105 and the LF140, were included in
the clinical trial for peripheral (arm and leg) artery and vascular access
applications. Both of these catheters, which differ in length, tip configuration
and other characteristics, received FDA marketing clearance.
The AngioJet System delivers jets of pressurized saline solution through
tiny openings in the tip of a catheter positioned near the blood clot, breaking
the clot into microscopic fragments that are propelled back through the catheter
and into a disposable collection bag.
Robert G. Dutcher, president and chief executive officer of Possis Medical,
said: "We are pleased that we can provide the AngioJet System's revolutionary
technology to U.S. physicians and their patients. We now look forward to growing
product sales and expanding labeling claims, pending further FDA clearances, to
include dangerous and often life-threatening blood clots in vessels and grafts
that affect patients' legs and vital organs such as the heart, lungs and brain."
<PAGE>
Dutcher continued: "During extensive clinical trials, the AngioJet System
has been shown to offer significant medical benefits when compared to the most
common treatments for removing blood clots -- clot-dissolving drugs and the use
of medical devices that require surgical intervention. In addition, we believe
the AngioJet System offers significant cost savings over these traditional
treatments."
Possis Medical's regional sales representatives will begin selling the
AngioJet System immediately to vascular interventionalists throughout the United
States. International sales for peripheral and coronary use are already
underway, primarily in Europe. The Company estimates that the annual worldwide
market potential for all AngioJet System applications exceed 2.5 million
disposable units.
A Phase 2 U.S. clinical trial involving the LF140 catheter will continue
for coronary applications. Possis Medical plans to seek FDA approval for this
application during 1997. To date, clinical results for coronary use have been
extremely encouraging, as evidence grows that the AngioJet System may be
important in savings the lives of heart attack patients in emergency situations.
Additionally, plans are underway for U.S. clinical trials for stroke and venous
applications. Emergency, off-protocol clinical uses of AngioJet for treating
stroke and venous thrombosis have been very encouraging.
Possis Medical, Inc. develops, manufactures and markets pioneering medical
devices for the growing cardiovascular and vascular treatment markets. Its three
products - the AngioJet Rapid Thrombectomy System, the Perma-Flow Coronary
Bypass Graft, and the Perma-Seal Dialysis Access Graft - are highly
differentiated, next-generation medical devices that have the potential to
become preferred treatment options.
###
NEWS RELEASE
FOR IMMEDIATE RELEASE FOR MORE INFORMATION CONTACT:
Robert G. Dutcher
President and Chief Executive Officer
POSSIS MEDICAL, INC.
(612) 780-4555
POSSIS MEDICAL TO TERMINATE SUPPLY AND DISTRIBUTION AGREEMENT
FOR PERMA-SEAL DIALYSIS ACCESS GRAFT
MINNEAPOLIS, MN (December 6, 1996) -- Possis Medical, Inc. (Nasdaq-NM:
POSS) announced today that it has sent a notice terminating its Supply and
Distribution Agreement with C.R. Bard, Inc. for the Possis Perma-Seal Dialysis
Access Graft, based on Bard's breach of the Agreement. Under the Agreement, Bard
has 30 days to correct its breach. The impact of Bard's purchase of IMPRA, Inc.,
a direct competitor for sales of the Perma-Seal Graft, and placing IMPRA in
control of marketing the Perma-Seal Graft, made it impossible for Possis to keep
Bard/IMPRA as its distributor. Possis Medical is currently in negotiations with
Bard concerning settlement and the terms of separation.
The Supply and Distribution Agreement, signed on December 30, 1994, grants
Bard worldwide rights to sell Perma-Seal Grafts manufactured by Possis Medical.
On August 5, 1996, Bard announced that it had agreed to acquire IMPRA, Inc., a
leading supplier of synthetic vascular grafts and one of two major suppliers of
competitive vascular access grafts for kidney dialysis patients. Responsibility
for the Perma-Seal Graft sales program was delegated to IMPRA, together with the
rest of Bard's vascular graft business.
Possis Medical, Inc. develops, manufactures and markets pioneering medical
devices for the growing cardiovascular and vascular treatment markets. Its three
products - the AngioJet Rapid Thrombectomy System, the Perma-Flow Coronary
Bypass Graft, and the Perma-Seal Dialysis Access Graft - are ighly
differentiated, next-generation medical devices that have the potential to
become preferred treatment options. According to Possis Medical's long-term
plans, the Perma-Seal Graft represents the smallest market opportunity of its
three product lines.
# # #
