July 30, 2014 9:49 PM ET

Biotechnology

Company Overview of CeraPedics, Inc.

Company Overview

CeraPedics, Inc., a medical device company, focuses on developing and commercializing novel osteobiologic products. It offers i-FACTOR Biologic Bone Graft products for replacing or augmenting the use of autograft bone commonly utilized in spine, trauma, and orthopedic procedures. The company’s bone graft products include i-FACTORTM Flex and i-FACTOR Putty, which combine a unique anorganic bone mineral and P-15 small peptide that acts as an attachment factor for specific integrins on osteogenic cells. It serves spine, trauma, and orthopedic communities. CeraPedics, Inc. was incorporated in 2000 and is based in Westminster, Colorado.

11025 Dover Street

Suite 1600

Westminster, CO 80021

United States

Founded in 2000

Phone:

303-974-6275

Fax:

303-974-6285

Key Executives for CeraPedics, Inc.

Chief Executive Officer
Age: 51
President and Chief Operating Officer
Age: 46
Vice President of Finance
Director of Quality Systems and Regulatory Affairs
Executive Officer
Compensation as of Fiscal Year 2014.

CeraPedics, Inc. Key Developments

GE Capital, Healthcare Financial Services Provides $9 Million to Cerapedics, Inc

GE Capital's Healthcare Financial Services (HFS) business has provided a $9 million term loan to Cerapedics, Inc. The funds will be used to support Cerapedics' general business operations, including the advancement of its U.S. regulatory process.

Cerapedics, Inc Announces Preliminary Data from Bone Graft Trial

Cerapedics, Inc. announced preliminary data from the FDA investigational device exemption (IDE) clinical trial for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures. Preliminary analysis of the results indicates that treatment with i-FACTOR met the pre-specified primary end points. The study was a randomized, controlled, multicenter, prospective trial involving the use of i-FACTOR bone graft vs. autograft for single-level instrumented ACDF procedures inside of a structural allograft ring. According to preliminary analysis of the trial results, treatment with i-FACTOR showed statistically significant non-inferiority to the autograft control group for fusion rate, neck disability index (NDI) scores, and neurological outcomes. Additionally, i-FACTOR achieved an 89% fusion rate vs. 85% for the autograft control at 12 months; this was also statistically non-inferior with a p value of 0.0003. These results have not yet completed the final phase of quality testing, which could minimally affect final outcome data. The data for the IDE have been unblinded and results are being finalized for submission to the FDA. Cerapedics has been submitting the PMA for i-FACTOR in modules, with only the clinical module remaining to be filed.

CeraPedics, Inc. Presents at Canaccord Genuity Musculoskeletal Conference, Mar-11-2014 02:00 PM

CeraPedics, Inc. Presents at Canaccord Genuity Musculoskeletal Conference, Mar-11-2014 02:00 PM. Venue: Sheraton New Orleans Hotel, 500 Canal Street, New Orleans, Louisiana, United States.

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