FDA Approves EVARREST™ Fibrin Sealant Patch

                 FDA Approves EVARREST™ Fibrin Sealant Patch

A Novel Product to Rapidly and Reliably Stop Problematic Bleeding During

PR Newswire

SOMERVILLE, N.J., Dec. 7, 2012

SOMERVILLE, N.J., Dec. 7, 2012 /PRNewswire/ --Ethicon Biosurgery, Division of
Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions,
announced today that the U.S. Food and Drug Administration (FDA) has approved
EVARREST™ Fibrin Sealant Patch, a novel product that rapidly and reliably aids
in stopping problematic bleeding during surgery. Unexpected and
uncontrollable bleeding during surgery poses a significant challenge to
surgeons, and in some surgical procedures can raise the patient's mortality
rate to 20%.[1]

(Logo: http://photos.prnewswire.com/prnh/20121207/NY25961LOGO)

EVARREST™ has been indicated for use with manual compression as an adjunct to
hemostasis for soft tissue bleeding during open retroperitoneal,
intra-abdominal, pelvic and non-cardiac thoracic surgery, when control of
bleeding by standard surgical methods of hemostasis (e.g., suture, ligature,
cautery) is ineffective or impractical. It is not for use in children under
one month of age and it cannot safely or effectively be used in place of
sutures or other forms of mechanical ligation in the treatment of major
arterial or venous bleeding.

"The FDA approval of EVARREST™ is a significant milestone in advancing patient
care. We believe this technology has the potential to drive a paradigm shift
in the treatment of problematic bleeding during surgery," said Dan Wildman,
Worldwide President, Ethicon Biosurgery. "EVARREST™ combines the company's
expertise in biomaterials and plasma-derived biologics to bring true
innovation to surgeons and their patients."

EVARREST™ consists of a coating of biologics and a flexible patch that, when
combined, form a distinct delivery system that will raise the standard of care
for surgeons and their patients. Each component of EVARREST™ ^ plays an
active role in the hemostasis process -- the biologics (human thrombin and
fibrinogen) react and initiate a fibrin clot, which then integrate into the
patch, providing mechanical support and adherence to the wound site.

To use the product, surgeons place EVARREST™ upon the bleeding wound surface
and apply manual compression for approximately three minutes. EVARREST™
remains in the patient's body once surgery has been completed as it is fully

Clinical studies demonstrate that EVARREST™ is 98% effective in stopping
bleeding and maintaining hemostasis compared to the current standard of care
at 53%, potentially minimizing disruption to the surgical procedure.[2]

Important Safety Information

For topical use only. Do not apply intravascularly.

Do not use to treat bleeding from large defects in arteries or veins.

Do not use in individuals known to have anaphylactic or severe systemic
reaction to human blood products.

Thrombosis can occur if absorbed systemically.

Can cause hypersensitivity reactions including anaphylaxis.

Avoid application to contaminated areas of the body or in the presence of
active infection. Infection can occur.

EVARREST™ contains oxidized regenerated cellulose which adheres to bleeding
surfaces. Inadvertent adhesions can occur.

Avoid use in closed spaces where swelling may cause compression.

Use the least number of patches required to cover entire bleeding area. Do not
use more than four patches.

May carry a risk of transmitting infectious agents, e.g., viruses, the variant
Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent. 

The most common adverse reactions reported during clinical trials (≥ 1%) were
abdominal distension, blood fibrinogen increased, post procedural and
intra-abdominal hemorrhage, and pulmonary embolism.

Please see package insert for EVARREST™ Full Prescribing Information.

About Ethicon Biosurgery

The EVARREST™ Fibrin Sealant Patch joins a portfolio of best-in-class products
that complement surgical techniques and surgeon experience so they can achieve
efficiencies and success in surgery. With nearly 50 years of proven experience
in hemostasis, Ethicon Biosurgery is committed to delivering innovative and
life-saving surgical solutions to surgeons that address a range of bleeding
and leaking situations – from routine to problematic – during surgical
procedures. These solutions can be used for open and minimally invasive
procedures across a broad range of specialties and includes proprietary
oxidized regenerated cellulose hemostats; gelatin powder and sponges; a
flowable hemostatic matrix; human thrombin, and fibrin sealant. Ethicon
Biosurgery is a division of Ethicon, Inc., a trusted leader in surgical care.

(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, 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; manufacturing difficulties or delays; and product
efficacy or safety concerns resulting in product recalls or regulatory
action. 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 January 1, 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, Inc. nor
Johnson & Johnson undertake to update any forward-looking statements as a
result of new information or future events or developments.)

[1] Marietta, M et al. Pathophysiology of bleeding in surgery.
Transplantation Proceedings, 38, 812-214 (2006)

[2] Data on File. Effectiveness defined as stopping bleeding within four
minutes of identification of mild to moderate bleeding without re-bleeding up
to 10 minutes.

SOURCE Ethicon Biosurgery

Contact: Media, Kristen Wallace, +1-908-218-2185, kwallace@its.jnj.com, or
Investor Relations, Ellen Sipos, +1-732-524-3709
Press spacebar to pause and continue. Press esc to stop.