Category: Articles

This patent issuance solidifies Cutting Edge Spine as an industry leader in 3D printed trabecular fixation for orthopedic applications.

Mineral Springs, NC June 17, 2020

Cutting Edge Spine (https://cuttingedgespine.com), a leader in the organic development and commercialization of novel technologies for the spine, today announced the notice of issuance from the U.S. Patent and Trademark Office regarding Patent No. US 10,993,754 B2: IMPLANTS FOR TISSUE FIXATION AND FUSION.

This patent differentiates Cutting Edge Spine as a leading provider of 3D printed trabecular screws for orthopedic fixation.

“Our proprietary position relative to 3D printed trabecular fixation technologies is the culmination of our team’s expertise and dedication. This designation will allow us to lead the way towards superior fixation outcomes in a broad range of orthopedic applications” said Randy Roof – President, CEO & Founder of Cutting Edge Spine. “Being at the forefront of development of revolutionary orthopedic solutions is a tremendous challenge, but we continue our commitment to ‘passively smart’ implants in an effort to positively impact patient care for many years to come.”

About Cutting Edge Spine

Founded in 2009, Cutting Edge Spine (CES) is a privately-owned medical device organization, headquartered in Mineral Springs, NC. The Company is dedicated to developing and commercializing novel orthopedic technologies that provide optimal fiscal value to patients, payors and healthcare providers. For more information, please visithttps://cuttingedgespine.com.

Contact:
Randy Roof [email protected]

Cutting Edge Spine, a leader in the development and commercialization of bioactive spinal solutions, today announced the 510(K) clearance and commercial launch of the latest addition to its bioactive portfolio of interbody systems, the EVOL®ha-DLIF direct lateral interbody fusion system.

The EVOL®ha-DLIF is made of PEEK-OPTIMA HA Enhanced material supplied by Invibio Biomaterial Solutions. Cutting Edge Spine implants made with this material have demonstrated early onset bone formation and apposition to its implants.

“Leveraging our expertise with the PEEK-OPTIMA HA Enhanced material as applied to interbody systems development and clinical validation is paving the way for Cutting Edge Spine to offer the largest worldwide bioactive interbody fusion system portfolio,” said Randy Roof – President, CEO & Founder of Cutting Edge Spine. “Maintaining a concentrated focus on the development and commercialization of novel bioactive interbody fusion solutions is at our core as a company and we believe that is how we can best serve patients and surgeons on a global scale.”

In addition to the EVOL®ha-DLIF, Cutting Edge Spine offers numerous other interbody fusion systems made with the PEEK-OPTIMA HA Enhanced material: EVOL®ha-C, EVOL®ha-ALIF, EVOS®ha.

About Cutting Edge Spine

Founded in 2009, Cutting Edge Spine (CES) is a privately-owned medical device organization, headquartered in Waxhaw, NC. The Company is dedicated to developing and commercializing a novel, comprehensive portfolio of bioactive spinal interbody fusion systems and providing optimal fiscal value to patients, payors and healthcare providers. The Company currently possesses seven 510(K) cleared proprietary technologies and plans to add several more in 2020. For more information please contact our team at Cutting Edge Spine.

The commercialization of the EVOL-SI system addresses the needs of orthopedic surgeons and neurosurgeons seeking superior clinical outcomes following sacral-iliac surgery. Waxhaw, NC August 20, 2019 Cutting Edge Spine (https://cuttingedgespine.com), a leader in the organic development and commercialization of bioactive technologies for the spine, today announced the 510(K) clearance of its novel SI joint fusion system, the EVOL-SI. The EVOL-SI features a unique surface modification that is proven to improve osseointegration through superior hydrophilicity and optimized surface chemistry, as demonstrated in over 20 in vitro and in vivo studies. This combination, with optimized nano-roughness, mediates bioactivity and influences tissue regeneration that yields early bone formation, improving mechanical stability, while promoting faster fusion and stronger fixation. “Once again, Cutting Edge Spine has demonstrated its ability to lead the development and commercialization of bioactive spinal solutions that improve patient care,” said Randy Roof, President, CEO & Founder. “Raising the bar in patient care is our core objective, and the EVOL-SI system fully supports this objective; providing a solution that potentially eliminates unfavorable issues historically associated with devices utilized in lateral SI joint fusion procedures.”Cutting Edge Spine is currently in the process of launching the EVOL-SI technology. The company will be exhibiting at the North American Spine Society Annual Meeting in Chicago, IL September 25-28, Booth #2005. Please visit the booth or contact [email protected] for more information about the
EVOL-SI technology and Cutting Edge Spine.

Cutting Edge Spine, a US leader in the development and commercialization of bio-active technologies for the spine, today announced the 510(k) clearance and commercial launch of it’s latest innovation, the EVOL® ha-C cervical interbody system.

The EVOL® ha-C system is made of PEEK-OPTIMA™ HA Enhanced material supplied by Invibio™ Biomaterial Solutions. Cutting Edge Spine implants made from the material have demonstrated early onset bone formation and apposition to it’s implants; as presented at NASS 2016, NASS 2017, Selby Spine Society 2017, and Becker’s Spine Symposium. The EVOL® ha-C system leverages Cutting Edge Spine’s acuity relative to developing systems made from the material in order to offer superior inter-body options to Surgeons looking for superior and early onset new bone formation and bony apposition to the implant during the fusion process.

“The EVOL® ha-C cervical inter-body system demonstrates the strong confidence we have in our ability to deliver improved clinical outcomes,” said Randy Roof, President and Co-Founder. “The EVOL® ha-C cervical system is our second HA Enhanced PEEK-OPTIMA™ system to be 510(K) cleared this year; and with an ALIF, DLIF and OLIF system forthcoming in 2018 Cutting Edge Spine, arguably, will be offering the world’s largest Bio-Active interbody portfolio.”

“The EVOL® ha-C system combines Invibio’s leadership in PEEK and Cutting Edge Spine’s second to none clinical experience and engineering expertise in HA enhanced PEEK Interbodies,” said Kyle Kuntz, manager of Research & Development at Cutting Edge Spine. “Our growing and compelling body of work demonstrates improved outcomes with HA enhanced PEEK. We are proud to have the opportunity to make it available to patients and surgeons.”

Cutting Edge Spine is currently in the process of launching the technology nationwide. The leadership team will be attending NASS in Los Angeles, September 26-29, 2018 and looks forward to meeting anyone looking to make a difference.

1) Comparative Study Finds Performance Advantages with PEEK-OPTIMA™ HA Enhanced Polymer

Cutting Edge Spine, a technology driven developer and marketer of highly differentiated implant systems, announced that the US Food and Drug Administration has cleared the EVOS-ha, a groundbreaking lumbar interbody system that combines two proven biomaterials, PEEK-OPTIMA® and Hydroxyapatite, to enhanced fusion.

“With the approval of the EVOS system, offered in both PEEK-OPTIMA® Natural and PEEK-OPTIMA HA® Enhanced (i.e. Hydroxyapatite), we are proud to be the first-to-market in the US lumbar spine space with the HA enhanced option,” said Randy Roof, President.  He added, “Our strategic partnership with the Invibio™ Biomaterial Solutions (“Invibio”), was key to successful technology development and approval by the FDA.  We look forward to the positive impact the EVOS will have on fusion rates, and ultimately, patient care.”

The innovative PEEK-OPTIMA® HA Enhanced, offered by Invibio™ Biomaterial Solutions (“Invibio”), has similar mechanical properties to PEEK-OPTIMA® Natural and a modulus similar to that of cortical bone.  The introduction of HA, which is fully integrated into the PEEK-OPTIMA® Natural grade, provides a complete homogeneous compound that ensures HA is present at all surfaces of a device.  Like PEEK-OPTIMA® Natural, PEEK-OPTIMA HA® Enhanced is radiolucent, allowing visualization of the fusion mass, and has proved to be fully biocompatible.

“Our goal is to provide today’s market with tomorrow’s technology,” said John Souza, Director of Research and Development at Cutting Edge Spine. He added, “to that effect, we have also made the decision to maximize safety by having all EVOS implants packaged in a single use, bar coded, and pre-sterilized blister.” He added, “We also provide surgeons with over 2,500 footprints to choose from, allowing physicians to precisely adapt the EVOS system to their clinical requirements.” The combination of a cutting edge design, a novel material, 2,500 footprints, and sterile packaging makes the EVOS an industry game-changer and the solution of choice for lumbar interbody fusion. Cutting Edge Spine is currently in the process of commercializing the new technology and establishing distribution throughout the United States.