Please could you tell us a little bit about complex spinal pathologies?
In the approximate $8 billion global spine market, the most specialized and demanding $1 billion complex spine segment includes deformity, trauma, and tumor pathologies.
What are K2M’s goals in relation to complex spinal pathology treatments?
K2M's mission is to develop and deliver technological innovations which enable surgeons to more effectively treat the world's most complex spinal disorders. Our concept is that if we can enter the market through the most complex of pathologies, then we should theoretically be able to easily address the one and two level procedures.
What previous innovative solutions for treating complex spinal pathologies has K2M offered?
K2M's RANGE® Complex Spine Technology represents the company's wide "range" of products that can be used in complex spine applications. Recent additions to this platform technology include the MESA® Small Stature Spinal System, a Ø4.5 mm line extension of the company’s revolutionary low profile zero torque family of products, and the SANTORINI™ Corpectomy Cage Systems, designed to replace collapsed, damaged, or unstable vertebral bodies due to trauma or tumor.
Please could you tell us a little bit about biologics?
VESUVIUS™ marks an entirely new family of products for K2M, designed specifically to enhance bone regeneration after spine surgery and in a variety of configurations and sizes to meet surgeons’ clinical needs. VESUVIUS Demineralized Fibers and Sponge are treated with LifeNet Health’s patented ALLOWASH XG® sterilization process and PAD® demineralization technology to protect Bone Morphogenetic Proteins (BMPs), while ensuring optimal osteoinductivity.
The LifeNet Health relationship also enabled K2M to extend its existing VIKOS® Cervical offering to include unicortical, tricortical, and iliac crest grafts, as well as add two new product lines, VIKOS Void Fillers and VIKOS Shafts. VIKOS has been designed specifically to enhance osteoconductivity after spine surgery and, in addition to LifeNet Health’s ALLOWASH XG process, also features proprietary PRESERVON® technology for storage at ambient temperature.
How do biologics differ from previous treatment strategies you’ve tried?
K2M entered the biologics market in 2010 with the introduction of our VIKOS Cervical Allograft System. The 2012 launch of VESUVIUS and additions to VIKOS represent a major expansion of the company’s U.S. biologics offering, and will complement K2M’s already comprehensive and innovative product portfolio focused in the areas of minimally invasive and complex spine surgery.
Are you planning on creating different biologics for different types of complex spinal pathologies?
We are confident that this recent expansion of our biologics product offering will be able to address a wide spectrum of spinal pathologies.
How has working with LifeNet Health helped you to generate new treatments?
LifeNet Health® is a leading allograft bio-implant and regenerative medicine company, and we are excited to further our relationship with them to bring quality implants to market to enhance bone regeneration and osteoconductivity. LifeNet Health has an extensive network of generous donors, which has allowed us to meet a significant demand for the high quality products surgeons have come to expect from K2M.
What are K2M’s plans for the future?
This summer, K2M is introducing the MESA Rail™ Deformity Spinal System featuring the breakthrough Rail 4D™ Technology to address the most complex spinal curves.
Inspired by structural I-beam geometry, the uniquely shaped Rail is an alternative to the traditional round spinal rods offered with other products. The Rail provides enhanced structural rigidity, while maintaining a lower-profile than set screw systems.
Due to the beam-like shape, reducing the Rail Cricket® instruments will inherently result in rotation of the vertebral bodies as they are pulled up to the Rail. The design offers fixation options for surgeons by helping to apply forces during axial correction of difficult spinal curvatures. It has the potential to reduce intraoperative rod “flattening” that is undesired by surgeons. The Rail may decrease the need for over-bending the construct and give surgeons more predictability and direct control over sagittal balance.
Where can people find more information?
For more information about K2M, Inc., visit www.K2M.com. Find K2M on Facebook at https://www.facebook.com/K2MInc or follow K2M on Twitter @K2MInc.
About Eric Major
Eric Major is the President, CEO and Co-Founder of K2M, Inc., a fast growing global medical device company focused on developing innovative surgical solutions for the most complex spinal pathologies. Mr. Major was previously the President and CEO of American OsteoMedix, Inc., a minimally invasive spinal device company that was acquired by Interpore International in 2001. Mr. Major served as President of the Minimally Invasive Division of Interpore International until 2002.
Mr. Major has nearly 20 years of experience in the spine industry. Prior to founding American OsteoMedix he served in several sales/marketing, strategic and product development capacities with various spinal companies including Acromed Spine (now a Johnson & Johnson company) and Synthes Spine, Inc. Mr. Major holds a B.S. degree from James Madison University.