St. Renatus LLC Planning Phase 3 Trials, Joins SAFE-BioPharma Association

St. Renatus, LLC, which is dedicated to commercialize the world’s first dental anesthetic administered through the nasal cavity, has joined SAFE-BioPharma Association. SAFE-BioPharma manages the SAFE-BioPharma® digital identity and signature standard, used throughout the biopharmaceutical industry to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.

As the anesthetic nasal mist enters U.S. Food and Drug Administration (FDA) Phase 3 clinical trials, St. Renatus will rely on SAFE-BioPharma digital signatures to accelerate and simplify handling electronic forms, contracts and other documents. By using the SAFE-BioPharma standard, the company will be able to eliminate paper records and securely provide identity verification.

“We view SAFE-BioPharma as the most practical and economical way to avoid the cost and time burden associated with paper. The big pharmaceutical companies have been using it for several years. We’re pleased that the standard is available, and economical, to small companies as well,” said Steven T. Merrick, St. Renatus’ CEO.

SAFE-BioPharma digital signatures are uniquely linked to the individual’s authenticated identity, and are more secure and legally binding than conventional electronic signatures. They are recognized by regulatory agencies throughout the U.S. and Europe.

“St. Renatus is one of a growing number of smaller companies that have decided to join the association so they can enjoy the cost and time-saving benefits of the SAFE-BioPharma standard,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.

Under recent changes to its pricing structure, organizations in the biopharmaceutical industry with fewer than 2,000 employees can join the association for $50 per user per year.

SAFE-BioPharma

SAFE-BioPharma® was developed by a consortium of biopharmaceutical and related companies, with participation from the U.S. Food and Drug Administration and the European Medicines Agency. www.safe-biopharma.org

Association members include:

• Abbott (NYSE: ABT)
• Amarin Corp. (NASDAQ: AMRN)
• Amgen (NASDAQ: AMGN)
• AstraZeneca (NYSE: AZN)
• Bristol-Myers Squibb (NYSE:BMY)
• GlaxoSmithKline (NYSE: GSK)
• IPS Research Company
• Johnson & Johnson (NYSE: JNJ)
• Eli Lilly (NYSE: LLY)
• McDougall Scientific
• Merck (NYSE: MRK)
• MWB Consulting Limited
• National Notary Association
• Oxford Outcomes
• PDC Biotech
• Pfizer (NYSE: PFE)
• Premier Inc.
• Roche
• St. Renatus
• Sanofi-Aventis (NYSE: SNY)
• SNAP Diagnostics

SAFE-BioPharma® is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.

St. Renatus

St. Renatus, LLC was founded to commercialize and distribute the world’s first dental anesthetic administered through the nasal cavity and suitable for use in procedures involving most of the upper teeth. There are more than 250 million dental injections annually in the U.S. alone. St. Renatus’ anesthetic nasal mist could qualify for up to 40% of these annual injections. By bringing this product to market, St. Renatus aims to create a better experience for dentists and qualifying patients by using an accurate and sophisticated method to anesthetize the upper teeth without the risk and pain of a needle. For more information on St. Renatus, visit www.st-renatus.com or call 970.282.0156.