#Ifactor biologic trial#

This is a major accomplishment as the only other orthobiologic approved in spine as a class 3 drug-device orthobiologics was BMP which had achieved sales over $900M before declining to roughly $500M due to its high expense and safety concerns.В So, i-FACTOR has been used and had excellent clinical success in the OUS market as early as 2008.

#Ifactor biologic trial#

So, the technology was very much proven to be safe and effective as the company initiated the Investigational Device Exemption for ACDF.В As mentioned, we have successfully completed that IDE trial resulting in a PMA approval at the end of 2015 becoming only the second Class 3, PMA approved drug-device orthobiologic in the market.

At this point, we have well over 40,000 cases under our belt. GK:В As an added comment, regarding the transition from the initial base technology, the company received approval for i-FACTOR in OUS markets in 2008 via CE MARK and TGA approval so i-FACTOR has been available commercially for Spinal fusions as well as other general orthopedic indications. Along those lines we have also developed the next generation version of the product, and that is what we used in the TLIF trial that is about to get underway. Attach, Activate' mechanism of action of the P15 molecule in i-FACTOR, and have been applying that successfully in our commercial efforts, both outside of the United States since 2008, as well as in the United States since late 2015. So, we have learned an awful lot about the 'Attract. So, like most bone grafting technologies, there has been an evolution over time, both in terms of the understanding of how the material works, as well as slow improvements to technology for delivery, as well. Please tell me a little more about how the core technology has been enhanced and how this has inspired the launch of Cerapedics? From my understanding, the core technology of i-FACTOR, P-15, has been a proven bone substitute in dentistry since 2000, and has been available for ACDF since 2015. Gentlemen, thank you for your time.ДЇirst, congratulations on your recent MedTech Breakthrough Award and FDA approval to initiate an IDE Clinical Trial to evaluate i-FACTOR in TLIF surgery. With us today is Glen Kashuba, Chief Executive Officer, and Jeff Marx, Ph.D.

When applied directly into a surgical site, we recommend that a layer of autograft be placed on top of the Flex FR.This is Kim French with Biomed GPS and we are fortunate to meet with Cerapedics leadership to discuss the company and their peptide enhanced bone graft technology i-FACTOR.

We recommend placing Flex FR into the surgical site once all hardware has been secured in position and immediately prior to closure.

However, adding some blood or BMA improves flexibility and the ability to mold the strip.

Flex FR can be applied directly to the surgical site without the need to soak it with blood.

IMPORTANT: Do not irrigate once implanted.

Once in position, any loose surface granules should be removed by swabbing and suction prior to wound closure.

When used in conjunction with blood or bone marrow aspirate, leave the mixture to stand for 10 to 15 minutes to allow coagulation to occur.

Mix Putty until no obvious clumping of the bone graft can be seen.

The suggested ratio ensures that a physiologic quantity of natural growth factors is present for fast, safe, and effective fusion. We recommend a mix ratio of 30% Putty with 70% autograft (the maximum ratio is 50:50).

When mixing Putty with autograft, ensure a thorough mix resulting in an even spread of granules throughout the structure of the graft material.

I-FACTOR Bone Graft comes in a Putty or as a FLEX with purified silk fibers. As an engineered product, P-15 quantity and viability remain consistent from lot to lot. I-FACTOR Bone Graft is a peptide bone matrix ( PBM) вЂ“ a composite bone substitute consisting of a synthetic collagen fragment (P-15) bound to calcium phosphate particles. The novel i-FACTOR Bone Graft вЂњ Attract, Attach, ActivateвЂќ mechanism of action enhances the bodyвЂ™s natural bone healing process.

The high affinity between cells and P-15 supports the physiological mechanism of action in which cells bind to the P-15 and вЂњturn onвЂќ to perform their genetically programmed job of making bone. I-FACTOR Bone Graft facilitates and expedites the ingrowth of bone by promoting the migration of mesenchymal stem cells and other progenitor cells from surrounding tissue. These cells have an affinity for and attach to the P-15 found in i-FACTOR Bone Graft in a similar way they would naturally with Type I collagen in bone. This 15-amino acid peptide (P-15) is responsible for the attachment and proliferation of osteogenic cells. I-FACTOR Bone Graft is based on the biological activity of the synthetically derived 15-amino acid peptide found naturally in Type I human collagen.