Intersting article from Dow Jones:
By Ted W. Kemp
NEW YORK (Dow Jones)--Eclipse Surgical
Technologies Inc. (ESTI) shares leaped to a 52-week
high Wednesday on news that the company called an
early halt to its clinical trial studying transmyocardial
revascularization, or TMR, due to positive clinical
results.
Clinical data showed eight times fewer early deaths
among a group of patients treated with a combination of
TMR and coronary bypass graft surgery than among
patients undergoing just the surgery.
A safety-monitoring committee of independent surgeons,
cardiologists and a statistician concluded that no other
patients needed to be enrolled in the study because the
early results were compelling enough to indicate TMR's
effectiveness.
"This is a very positive development," said Sheryl
Zimmer, medical-device analyst at Deutsche Morgan
Grenfell Inc.
TMR uses lasers to create channels in oxygen-deprived
heart tissue, which allows fresh blood to permeate the
heart wall from the inside. Some researchers believe the
process stimulates the development of new blood
vessels.
The Sunnyvale, Calif., research and development
company said it has notified the Food and Drug
Administration of the developments and requested
guidance.
"We're kind of on new ground here," Eclipse President
and Chief Operating Officer Richard Mueller told Dow
Jones. He said he couldn't speculate on what to expect
from the FDA, but the company is "optimistic and
excited."
Zimmer concurred that the FDA's course of action is
difficult to predict, saying the regulatory body might want
the study to continue until all the patients involved have a
full 12-month follow-up.
But the FDA could ask Eclipse to add the data to its
separate initial protocol study, which compares TMR
with drug therapy in patients who are too sick to undergo
any conventional bypass procedure, she said.
A company spokeswoman said Eclipse this month will
release 12-month results from the initial protocol study,
which she called the company's "flagship" TMR study.
Eclipse shares recently were trading at 10 5/8, adding 3
11/16, or 53.2%, on volume of 2.5 million, compared
with a daily average of 67,200. The intraday high of 10
15/16 beat the previous 52-week high of 10 set on July
17.
Eclipse Surgical Technologies currently is involved in
six TMR studies, including the initial protocol study and
the study that combines TMR with bypass, the company
spokeswoman said.
Analysts said Eclipse Surgical Technologies's
Wednesday announcement spells positive news for TMR
treatment in general, which hasn't yet had consistent data
presented.
"No one really anticipated this kind of result," said
analyst Cathy Reese of Avalon Research.
TMR data presented by medical-device company PLC
Systems Inc. (PLC) last summer was seen as
inconclusive by the FDA's circulatory system devices
panel, Reese said. The panel recommended the FDA
reject PLC's request for U.S. market clearance on its
Heart Laser system.
Reese added that PLC's system uses a carbon dioxide
laser, while Eclipse Surgical Technologies uses a
holmium laser.
As reported in February, PLC said it has since received
a date for a panel hearing for its heart laser system.
A spokeswoman at PLC said the company is deferring to
the FDA and not announcing the date until the regulatory
agency makes it public.
Alan Jacobs, director of research at Avalon, said Eclipse
Surgical Technologies might have learned from PLC's
experience from last year.
The company may have decided that if the study "takes
longer to file and longer to research, so be it," he said.
Analyst Zimmer of Deutsche Morgan Grenfell has a buy
rating on Eclipse Surgical Technologies, which she sees
breaking even sometime in the first half of 1999.
A First Call Corp. consensus estimates the company will
post a loss of 62 cents a share in 1998.
-Ted W. Kemp; 201-938-5392 |
