Coapt Systems, Inc. Launches Hydrelle(TM) a New, FDA-Approved Dermal Filler with...

Mon Jul 6, 2009 5:45am EDT
 
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Coapt Systems, Inc. Launches Hydrelle(TM) a New, FDA-Approved Dermal Filler
with Lidocaine for Significant Wrinkle Correction and Greater Patient Comfort

PALO ALTO, Calif., July 6 /PRNewswire/ -- Coapt Systems, Inc.
(www.coaptsystems.com) announced the launch of Hydrelle(TM) a new,
FDA-approved hyaluronic acid based dermal filler for the treatment of facial
wrinkles, such as nasolabial folds, also called "smile lines."  Hydrelle is
the first FDA-approved hyaluronic acid filler formulated with an anesthetic
(lidocaine) for greater patient comfort.  Proven safe and effective, Hydrelle
is also a financially attractive alternative to traditional fillers such as
Juvederm(R) by Allergan Medical, and Restylane(R) by Medicis Pharmaceutical.

Hydrelle has been specifically formulated to deliver rapid results comparable
to other hyaluronic acid fillers; and the lidocaine anesthetic is integrated,
providing a more comfortable injection experience for patients.  Hydrelle
represents an attractive value for patients seeking a safe and cost-effective
filler option, since patients only require approximately 50% of typical
injection volumes, thus requiring fewer syringes to fully correct facial
wrinkles.  Hydrelle also represents a significant opportunity for aesthetic
professionals to expand their respective practices by offering patients an
advanced, long-lasting dermal filler with an affordable price, particularly
during volatile economic times.

Hydrelle is indicated for the correction of moderate to severe facial wrinkles
and folds, such as nasolabial folds.  In a randomized, controlled pivotal U.S.
study of 208 patients, Hydrelle was proven safe and effective.  In a
multi-center, international study, Hydrelle demonstrated patient and physician
satisfaction, and filler effectiveness for up to one year.  

Laureen DeBuono, President and CEO for Coapt Systems stated, "Coapt Systems
has established an excellent reputation as a provider of superior,
bioabsorbable suspension devices for face lift procedures within the aesthetic
marketplace.  Now we have a perfect opportunity to compliment our product
portfolio with the Hydrelle dermal filler product line."  "Hydrelle represents
an important clinical and business distribution milestone between Coapt
Systems and the world-class hyaluronic acid product developer and
manufacturer, Anika Therapeutics (Nasdaq: ANIK)," said DeBuono.

"I look forward to using more Hydrelle and to continuing to offer it to my
patients because I have experienced excellent results," said Michael C.
Pickart, M.D., F.A.C.S.  "The wrinkle correction is very good compared to
competitive products currently on the market, and patients have found Hydrelle
to be more comfortable during injection, with less pain.  In particular,
Hydrelle is definitely my preferred filler of choice for the oral commissures,
since they are so hard to numb with dental blocks and topical creams."

Coapt Systems Executive Vice President, Global Marketing and Sales, David
Barella stated, "The Coapt Systems sales and marketing team is delighted to
introduce Hydrelle to the facial aesthetic community throughout the U.S.  I
believe that a long-lasting, more comfortable, and cost-effective dermal
filler represents a valuable advantage to the millions of women and men that
seek to improve their facial appearance every year."  Additionally, Barella
said, "Physicians will also enjoy the convenient, ready-to-use benefits that
Hydrelle with lidocaine offers, without costly and labor intensive
pre-injection mixing."   

To order Hydrelle, please contact Coapt Systems at 800.963.7670, or visit the
worldwide web at www.coaptsystems.com.  Hydrelle is available to qualified
physicians, or properly licensed practitioners only.  

About Hydrelle:
Hydrelle is the first FDA-approved injectable dermal filler to combine
hyaluronic acid and lidocaine, a local anesthetic that improves patient
comfort, and provides physicians with a new alternative for their aesthetic
practice.  Designed, developed and manufactured by Anika Therapeutics,
Hydrelle is formulated for durability based on its proprietary cross-linking
technology and the highest concentration of hyaluronic acid.  Hydrelle is
exclusively distributed within the U.S. by Coapt Systems.

Hydrelle is indicated for injection into the mid-to-deep dermis for the
correction of moderate to severe facial wrinkles and folds (such as nasolabial
folds).  In clinical studies, adverse events were usually mild to moderate in
nature and generally resolved within seven days.  The most common side effects
were injection site reactions of swelling, redness, bumps, bruising and
tenderness.  Hydrelle should not be used by patients with severe allergies. 
For complete patient safety information, please consult the Hydrelle
Instructions for Use.

About Coapt Systems, Inc.:  
Coapt Systems develops and markets unique facial rejuvenation products that
help produce beautifully natural, long-lasting results for forehead, brow,
cheek, and neck lifts.  Endotine(R) and Ultratine(TM) are clinically-proven
products that provide face lift patients with minimally invasive treatment and
rapid recovery.  NovielleTM biocompatible hydrogel injectable fillers can
provide immediate voice restoration for patients suffering from vocal fold
insufficiency.  Coapt Systems is venture-backed and headquartered in Palo
Alto, California.  For more information, please visit www.coaptsystems.com.

About Anika Therapeutics, Inc.:
Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops,
manufactures and commercializes therapeutic products for tissue protection,
healing and repair. These products are based on hyaluronic acid (HA), a
naturally occurring, biocompatible polymer found throughout the body. Anika's
products include ORTHOVISC(R), a treatment for osteoarthritis of the knee
available internationally and marketed in the U.S. by DePuy Mitek; HYVISC(R),
a treatment for equine osteoarthritis marketed in the U.S. by Boehringer
Ingelheim Vetmedica, Inc.; a family of aesthetic dermatology products for
facial wrinkles and scar remediation; AMVISC(R), AMVISC(R) Plus,
STAARVISC(TM)-II and Shellgel(TM) injectable viscoelastic HA products for
ophthalmic surgery; INCERT(R), an HA-based anti-adhesive for surgical
applications; ORTHOVISC(R) mini a treatment for osteoarthritis targeting small
joints and available in Europe; MONOVISC(TM) a single-injection osteoarthritis
product based on Anika's proprietary cross-linking technology and also
available in Europe and Turkey; and next generation products for joint health
and aesthetic dermatology based on the Company's proprietary, chemically
modified HA.



SOURCE  Coapt Systems

Laureen DeBuono, President and CEO, or David Barella, Senior Vice President,
Global Marketing and Sales, both of Coapt Systems, Inc., +1-650-461-7600

 

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