Clinical

Patients Treated with i-FACTOR Containing P-15

Research needs to translate into patient outcomes. Learn more about how i-FACTOR is transforming patients’ lives by providing clinicians with Level-1 data demonstrating the safety and efficacy of this new category of bone graft

i-FACTOR Peptide Enhanced Bone Graft Exhibits Superior Clinical Outcomes Compared to Autograft (The ‘Gold Standard’) in Anterior Cervical Discectomy and Fusion ACDF.

Arnold PM, Sasso RC, Janssen ME, Fehlings MG, Smucker JD, Vaccaro AR, Heary RF, Patel AI, Goulet B, Kalfas IH, Kopjar B. i-Factor™ Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion. Results of the Prospective Randomized Single-blinded Food and Drug Administration Investigational Device Exemption Study. Spine. 2016; 41 (13): 1075–1083.

Read me

Fehlings MG, Janssen M, Sasso R. P-15 Bone Putty – A Novel Bone Graft Substitute for Use in Cervical Spinal Fusion: Early Results of A Multi-Center Randomized Controlled Trial with Independent Outcomes Assessment. AANS/CNS Section on Disorders of the Spine and Peripheral Nerves, February 27 – March 1, 2008, Orlando, FL, Poster No. 348.

Patel A, Sasso R, Fehlings M. P-15 Bone Putty in Cervical Spinal Fusion for Degenerative Disk Disease: Intermediate Results of Randomized Controlled Trial Spineweek 2008, May 26-31, 2008, Geneva, Switzerland, Poster No. P49.

Patel A, Sasso RC, Janssen ME. i-FACTOR Bone Graft – a novel bone graft substitute for use in cervical spinal fusion. Early results of an FDA IDE multi-center randomized controlled trial with independent outcomes assessments. 25th Annual Meeting of the Cervical Spine Research Society – European Section, June 10-13, 2009, Uppsala, Sweden, Poster No. P6.

 

 

 

View our evidence & publications

Mechanism of Action

Key to choosing the appropriate graft material is an understanding of how it works. Learn more about the natural process and what to expect from i-FACTOR Bone Graft.

View evidence

Preclinical

Studies have shown that P-15, in combination with ABM, mimics the behavior of autograft bone. Learn more about the depth of scientific research supporting this novel bone graft.

View evidence

The proof you require, the safety you demand.

Clinical Superiority

Clinical Superiority

Level 1 data supports your evidence based clinical decision making.

Peptide Power

Peptide Power

The only bone graft to harness the intense biological activity of a peptide (P-15).

Ready to use

Ready to use

Store at room temperature. Ready to use without mixing.

Fill and forget

Fill and forget

Don’t assume your bone graft will perform. Know it will.

Tried and trusted

Tried and trusted

FDA PMA approved (2015) drug device combination and has been CE Marked since 2008.

Safety by design

Safety by design

The unique P-15 action is surface bound and unlike growth factors only grows bone where you need it.

Mechanism of action of i-FACTOR

i-FACTOR Biologic Bone Graft novel mechanism of action enhances the body’s natural bone healing process, resulting in safe, predictable bone formation. ABM/P-15 has been in human clinical use for more than 17 years in an estimated 500,000 patients worldwide.

Learn more about the science