Healthcare Industry News: Restylane
News Release - July 6, 2009
Coapt Systems, Inc. Launches Hydrelle(TM) a New, FDA-Approved Dermal Filler with Lidocaine for Significant Wrinkle Correction and Greater Patient ComfortPALO ALTO, Calif., July 6 -- (Healthcare Sales & Marketing Network) -- 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® by Allergan Medical, and Restylane® 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.
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® 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®, 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
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