Safis clients win market clearance!

Thomas (Tom) Stergar II
Office: 317-777-6203
October 29, 2013

Safis Solutions is announcing that two of its clients, Stereotaxis, Inc. (Nasdaq:STXS) and Dermal Life LLC, are cleared to market four products by 510(k) approval from the Food and Drug Administration (FDA). Stereotaxis, St. Louis, MO., is marketing its Vdrive™ Robotic Navigation System with V-Sono™ Intracardiac Echocardiography (ICE) catheter manipulator to help improve the efficiency of cardiac catheterization procedures. This represents the first FDA clearance for the Vdrive family of products, which has been utilized in Europe since 2011. Karen Duros, Senior Vice President & General Counsel, said, “Safis helped lead us through this crucial regulatory hurdle. They are a trusted partner and valued member of the Stereotaxis Team, and we are grateful for their involvement.” The Safis team was led by John Nadelin, Vice President of Regulatory & Compliance. Nadelin expressed, “We are very happy for Stereotaxis. It is very gratifying to be part of the Stereotaxis team whose work is important to improving the lives of not only thousands of cardiac patients, but the physicians that perform these delicate procedures.” Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab.

Dermal Life LLC, a Florida company founded in 2010 and also a Safis client, has a mission to develop advanced skin care products that maximize skin health. In May 2013, Dermal Life received FDA 501(k) clearance for Hydropermeate™ Topical Emulsion (Rx) with indications for full-thickness wounds, pressure sores, dermal ulcers, including lower leg ulcers; superficial wounds; 1st and 2nd degree burns, including sunburns; dermal donor and graft site management; radiation dermatitis; and minor abrasions. Additionally, Dermal Life received FDA clearance for Answer2Skin™ Sunburn Relief Cream (OTC) for minor burns, including minor sunburns, and Answer2Skin™ First Aid Cream (OTC) for minor superficial wounds and minor abrasions, including cuts and scrapes. Randy Hitchens, Senior Vice President Business Development, reports that “Dermal Life leveraged the regulatory and quality skills of Safis Solutions to select our CMO partner, develop our formulation, create lab-validation-stability batches, pass required-FDA toxicology testing, successfully complete stability testing, file our FDA 510(k) application, respond to FDA requests for additional information and achieve FDA clearance in a 2.5 year period. Our team was highly impressed with the Safis Solutions team of Ping Poulsen, John Nadelin, John Lockwood and John Steichen. Dermal Life has actively recommended Safis Solutions to other health care companies.

Safis Solutions provides consulting services in the areas of regulatory affairs, quality compliance (cGxP), audits, computer system validation, and IT services for pharmaceutical, medical device and biotechnology clients worldwide. Services successfully executed by Safis have helped more than 150 clients over the past 11 years meet regulatory compliance and quality standards and gain government agency approvals for their products, manufacturing systems, clinical and laboratory systems. Safis originated at the Indiana University Emerging Technologies Center (IUETC), and has been certified as WBE by WBENC, MBE by MSDC, both MBE and WBE by the state of Indiana and the city of Indianapolis.

For more information, contact Thomas (Tom) Stergar II at 317-777-6203.




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