FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy

   FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy
  Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures

- Reduces risks associated with oversedation, facilitates faster patient
recovery and increases physician satisfaction -

PR Newswire

CINCINNATI, May 3, 2013

CINCINNATI, May 3, 2013 /PRNewswire/ --Sedasys, a Division of Ethicon
Endo-Surgery, Inc. (Ethicon), today announced that the U.S. Food and Drug
Administration (FDA) has granted PMA approval for the SEDASYS^® System, the
first computer-assisted personalized sedation (CAPS) system.

(Logo: http://photos.prnewswire.com/prnh/20130503/NY07585LOGO)

The SEDASYS System is indicated for the intravenous administration of 1% (10
mg/mL) propofol injectable emulsion for the initiation and maintenance of
minimal-to-moderate sedation, as defined by the American Society of
Anesthesiologists (ASA) Continuum of Depth of Sedation, in ASAphysical status
I and II patients greater than or equal to 18 years old undergoing colonoscopy
and esophagogastroduodenoscopy (EGD) procedures.

The SEDASYS System has the potential to redefine sedation delivery by enabling
physician-led teams to administer minimal-to-moderate propofol sedation,
personalized to the needs of each patient, by precisely integrating drug
delivery and comprehensive patient monitoring. The company estimates that 15
million patients in the U.S. are candidates for these procedures.

In introducing this first-of-its-kind technology, the company will offer the
SEDASYS System to facilities where an anesthesia professional is immediately
available for assistance or consultation. In addition to receiving
device-specific training, the member of the physician-led team who is
administering sedation must have training in the management of
cardiorespiratory effects of propofol. The SEDASYS System is expected to be
introduced on a limited basis beginning in 2014. The company will collaborate
with the gastroenterology, anesthesiology and nursing communities to
successfully integrate the SEDASYS System, and conduct two post-approval
studies to monitor the use of the technology in actual clinical practice.

"The SEDASYS System will address the growing preference for propofol sedation
in gastroenterology by more closely matching the skill level of the sedation
delivery team with the actual requirements of less complex cases," said Daniel
Pambianco*, M.D., Medical Director, Charlottesville Medical Research,
Charlottesville, Va., and Principal Investigator. "The technology will
empower health care facilities to more effectively use their limited resources
to deliver greater value in the increasingly resource-constrained U.S. health
care environment."

Dr. Pambianco added, "Anesthesiologists and gastroenterologists were key
participants in the development of the SEDASYS System, and we believe the
technology has the potential to improve the experiences of both the clinical
team and the patient."

Data included in the company's PMA application demonstrated that the System
reduces the risks associated with oversedation, because patients who received
sedation with the SEDASYS System experienced fewer and less significant oxygen
desaturation events than patients in the control group who received
traditional sedation with benzodiazapines and opioids. The data also
demonstrated that patients sedated with the SEDASYS System recovered faster
than the control group, with 99 percent recovered from the effects of sedation
within 10 minutes, and that patients were highly satisfied. In addition,
physicians were significantly more satisfied with administration of sedation
they provided to patients in the SEDASYS System group compared to sedation
provided to patients in the control group.

Propofol (brand name DIPRIVAN^®) is considered by physicians to be a preferred
sedative because it provides a rapid onset and quick, clear-headed recovery
for patients, which enables them to return promptly to activities of daily

The SEDASYS System will be marketed by Sedasys, a Division of Ethicon
Endo-Surgery, Inc. (Ethicon), which is part of the Johnson & Johnson Family of
Companies. The Sedasys division is committed to redefining the practice of
sedation by developing and facilitating access to innovative solutions that
enable health care systems to deliver greater value.

* Dr. Pambianco is a paid consultant to the company.

SEDASYS^® is a trademark of Ethicon Endo-Surgery, Inc.

DIPRIVAN^® is a registered trademark of the AstraZeneca group of companies.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Ethicon Endo-Surgery,
Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not
limited to, general industry conditions and competition; economic factors,
such as interest rate and currency exchange rate fluctuations; technological
advances, new products and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory approvals;
challenges to patents; changes in behavior and spending patterns or financial
distress of purchasers of health care products and services; changes to
governmental laws and regulations and domestic and foreign health care
reforms; trends toward health care cost containment; increased scrutiny of the
health care industry by government agencies; and manufacturing difficulties or
delays. A further list and description of these risks, uncertainties and
other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report
on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form
10-K, as well as subsequent filings, are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. Neither Ethicon
Endo-Surgery, Inc. nor Johnson & Johnson undertake to update any
forward-looking statements as a result of new information or future events or

Media Inquiries Investor Relations
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SOURCE Sedasys, a Division of Ethicon Endo-Surgery, Inc.
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