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Artes Medical Names VP of Manufacturing; Veteran Manufacturing Manager to Lead U.S. Production of ArteFill.


SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay.  -- Artes Medical Inc., a privately held specialty pharmaceutical and medical device company, today announced the promotion of Larry J. Braga to Vice President of Manufacturing wherein he will lead the company's facility preparation for its upcoming FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 inspection and the GMP GMP (guanosine monophosphate): see guanine.  manufacture of ArteFill(R). In January 2004, the FDA issued an approvable letter for ArteFill's pre-market approval application. Once ArteFill receives final approval, it will be the only FDA-approved permanent injectable implant for the treatment of smile lines or naso-labial folds on the market.

"With his vast experience in the management of GMP drug and device manufacturing, Mr. Braga is a significant addition to our leadership team," said Dr. Stefan Lemperle, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Artes Medical. "Mr. Braga has played a vital role in readying our facilities for the qualification of U.S. manufacturing of ArteFill and will now oversee its entire manufacturing process, including facilities, supply chain management, collagen manufacturing, filling, packaging and international distribution."

Mr. Braga joined Artes in June 2004 and most recently served as senior director of collagen manufacturing. He successfully led the construction and validation efforts for Artes' current GMP manufacturing facility. Prior to joining Artes Medical, he served at Anosys, Inc. (formerly AP Cells, Inc.) where he directed domestic and global cGMP clinical manufacturing operations for autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
 cancer vaccines Cancer vaccines
A treatment that uses the patient's immune system to attack cancer cells.

Mentioned in: Pancreatic Cancer, Exocrine
. He also managed purification activities for Cohesion Technologies, Inc. and focused on the purification and production of bovine thrombin thrombin: see blood clotting. . Mr. Braga served for six years at Collagen Corporation (currently Inamed Corporation) managing the clinical formulations group. From 1996 to 1998, he founded and served as president of Pharmaceutical Consulting, providing manufacturing and quality system consulting services for the medical device and biotechnology industries. Mr. Braga began his career in 1986 at Genentech in the commercial production of human recombinant products, Protropin(R) and Activase(R). Mr. Braga holds a Bachelor of Science Noun 1. Bachelor of Science - a bachelor's degree in science
BS, SB

bachelor's degree, baccalaureate - an academic degree conferred on someone who has successfully completed undergraduate studies
 in Biology from California State University Enrollment
 Hayward. He currently holds a pharmacy exemptee license with the State of California.

Larry Braga has nearly 20 years of clinical and commercial manufacturing experience in the management of medical devices and biologics. His extensive background includes validation, facilities and materials management. In addition, he has extensive experience in the design, commissioning and validation of biopharmaceutical manufacturing facilities in the United States and Europe.

About Artes Medical Inc.

Artes Medical helps physicians in the facial aesthetics market significantly improve patient outcomes through Aesthetic Tissue Engineering(TM) and partners with physicians to build their practices.

The company's lead product is ArteFill(TM). ArteFill is a unique combination of synthetic microspheres (20%) evenly suspended in bovine collagen(TM) (80%). After ArteFill is injected, the microscopic spheres stimulate the body's own natural collagen production to replace the purified collagen. The autologous collagen builds volume and encapsulates each permanent microscopic sphere to achieve enduring wrinkle correction. ArteFill's pre-market approval application (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
) received an approvable letter from the FDA in January 2004. Once ArteFill receives final approval, it will be the only FDA-approved permanent injectable implant for the treatment of smile lines or naso-labial folds on the market. Over the last decade, Artecoll, ArteFill's predecessor, has been used in over 250,000 patients outside the United States.

For more information about the company and its products, visit the company's website, www.artesmedical.com. Artes Medical, Artecoll and ArteFill are trademarks of Artes Medical Inc.
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Publication:Business Wire
Geographic Code:1USA
Date:Jun 22, 2005
Words:556
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