THE Best New Spine Technologies for 2019

The companies with the BEST new spine care technologies for 2019 are: A-Line Orthopaedics Corp., Camber Spine, ControlRad, Inc., icotec Medical Inc., joimax, Inc., LifeNet Health, NuVasive, Inc., Reflexion Health, Saluda Medical Pty Ltd, Tissue Differentiation Intelligence LLC (TDi) and Vivex Biologics, Inc.

CONGRATULATIONS to all of our winners for 2019!

Rewarding Innovation and Perspiration

This annual award rewards inventors, engineering teams, surgeons and their companies who’ve created the most innovative, enduring and practical products in 2018 to treat back care. To win the Orthopedics This Week Best New Technology Award for spine care, a new technology must meet the following criteria:

1. Be creative and innovative.
2. Bring long term significance to treating spine pathologies. Does this technology have staying power?
3. Solve a current clinical problem.
4. Improve standard of care
5. Is cost effective
6. I would use it.

Our expert panel scores every submission on a scale of 1 to 5 (5 being the highest score) for each of the above criteria.

Submitters

A record 41 technologies were submitted for the 2019 BEST SPINE TECHNOLOGY award. We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and companies for submitting their best ideas this year.

The Judges

(Top Row): Boyle Cheng, Ph.D., Reginald Davis, M.D.: FACS, Larry T. Khoo, M.D. and Isador Lieberman, M.D., M.B.A., FRCSC (Bottom Row): Andrew Manista, M.D., John Peloza, M.D. and Rick Sasso, M.D.: Rick Sasso, M.D.

Boyle Cheng, Ph.D.: Dr. Cheng is Professor of Neurosurgery at Drexel University – Allegheny General Hospital. He is the Director of Research for the Neuroscience Institute at Allegheny Health Network and maintains an adjunct appointment in the Department of Biomedical Engineering at Carnegie Mellon University. His grant-funded research has included topics including the evaluation of anterior cervical disc replacement in a sheep model, biomechanical studies of a biased angle posterior cervical system, facet motion preservation technologies as well as dynamic and physical modeling based on specimen specific imaging and kinematic studies.

Reginald Davis, M.D.: FACS: Dr. Davis is a board-certified neurosurgeon. He earned his undergraduate degree in biology, chemistry and mathematics from Marietta College in Ohio, followed by post-graduate study at Johns Hopkins University School of Medicine. Dr. Davis’ internship and residency in general surgery followed by neurosurgery residency was also at Johns Hopkins. He became, and remains, assistant professor at Johns Hopkins. Dr. Davis is one of the most published spine researchers and is active in numerous professional societies including the Florida Neurosurgical Society and the American Board of Neurological Surgery.

Larry T. Khoo, M.D.: Dr. Khoo is a board certified neurosurgeon whose degree in Biological Sciences is from Stanford University. He is also a magna cum laude graduate from Yale Medical School. He completed his internship and residency in neurological surgery at USC. In 2001, the Congress of Neurological Surgery awarded him the Ralph Cloward Medtronic’s Fellowship Award which he completed at Rush Presbyterian St. Luke’s Medical Center in Chicago, Illinois. Dr. Khoo is the author of over 60 peer reviewed journal articles, 10 patents, 60 book chapters, 2 full books, and 400 scientific presentations.

Isador Lieberman, M.D., M.B.A., FRCSC: Dr. Lieberman is a fellowship trained Orthopaedic and Spinal Surgeon. He completed medical school and residency at the University of Toronto. His Spine surgery and Trauma surgery fellowships were at the Toronto Hospital and Queen’s Medical Center in Nottingham. His clinical interests are adolescent and adult scoliosis, deformity reconstruction, spinal tumors, minimally invasive/robotic/endoscopic spinal surgery, treatment of vertebral compression fractures, cervical and lumbar degenerative disorders and trauma. Dr. Lieberman founded the Uganda Charitable Spine Surgery Mission, which treats patients who otherwise do not have access to care for spinal ailments, including tuberculosis and scoliosis.

Andrew Manista, M.D.: Dr. Manista is, among other claims to fame, an accomplished musician with a BA in Music Performance from the University of Miami Frost School of Music. He parlayed that training into a Doctor of Medicine degree from Case Western Reserve University School of Medicine, a Halsted Surgical Internship, an Orthopaedic Surgery Residency and then a Spine Surgery Fellowship at Johns Hopkins Hospital. Dr. Manista is a member of the American Academy of Orthopaedic Surgeons and specializes in complex surgery of the spine at the Olympia Orthopaedic Associates in Olympia, Washington.

John Peloza, M.D.: Dr. Peloza is a pioneer and an internationally recognized leader in minimally invasive spine technology. He was instrumental in helping to launch several minimally invasive orthopedic spine treatments including SEXTANT™, MET-Rx™ and the MAVERICK™ total disc replacement as well as adult stem cell therapy. Dr. Peloza attended the United States Air Force Academy and the University of Illinois. His medical degree with highest honors is from Northwestern University Medical School. He is active in the International Spine Injection Society, North American Spine Society, American College of Sports Medicine, American Medical Association, and the American Academy of Orthopedic Surgeons.

Rick Sasso, M.D.: Dr. Sasso is a founding member, and the president of Indiana Spine Group. He is a board-certified orthopedic surgeon, specializing in spine surgery. Additionally, he is a professor and chief of spine surgery at the Indiana University School of Medicine, Department of Orthopaedic Surgery. Dr. Sasso has dedicated his medical career to the comprehensive treatment and surgery of spinal disorders and abnormalities and is actively involved in spine surgery research including the research and development of spinal implants and techniques of minimally invasive spine surgery, as well as the development of instrumentation technology used to treat spinal disorders.

So, without further delay, here are the ten best new spine technologies for 2019 in alphabetical order:

Top Ten Spine Technologies for 2019

A-Line Orthopaedics Corp

Winning Technology:  Edge Upper Cervical System™

Inventors and Engineers: Timothy Lasswell, MASc, Parham Rasoulinejad, M.D., and John Medley, Ph.D.

Tim Lasswell, MASc, CEO and Robin Young

Technology Description: The Edge Upper Cervical System (UCS) is a novel C1 posterior arch clamp, and associated instruments/hardware, that replaces C1 lateral mass screws in posterior fusion procedures that require fixation at the C1 vertebrae. The implant was designed to integrate with any posterior cervical system that uses 3.5mm rods.

Edge UCS has two stationary inferior jaws and two independent polyaxial superior jaws. To achieve fixation on the posterior arch, tighten the jaw locking screws that progressively close and form fit (due to the polyaxial mobility) the superior jaws around the posterior arch.

Edge UCS is a 3D printed titanium alloy. 3D printing allows the ball and socket joint of the polyaxial jaws to be manufactured in a single step—which cuts costs. Further, minimizing components in the implant assembly reduces unnecessary stress concentrations and risk of device failure.

Finally, Edge’s instrumentation is very simple due to the inserter tool being a 3-in-1 device that also acts as an anti-torque and fracture reduction tool.

Camber Spine

Winning Technology:  ENZA-C™

Inventor and Engineer: David Rathbun

Seth Anderson, David Rathbun, Robin Young, Jason Cianfrani, Dan Pontecorvo, and Joe Paone

Technology Description: ENZA-C is the first self-contained cervical implant that deploys its own internal fixation blades. There are no additional screws or other implants required for fixation.

ENZA-C deploys two nested fixation blades, which penetrate the endplates and firmly keep the implant in place, resisting migration.

Additionally, ENZA-C is manufactured using Direct Metal Laser Sintering of Implantable Titanium alloy. As a result, ENZA-C has an intricate surface structure that presents an osteo-conductive surface to the vertebral endplates.

ControlRad

Winning Technology: ControlRad™ Trace™

Inventors and Engineers: Allon Guez, Ph.D., Haim Melman, and Maxim Itkin, M.D.

Brad Downer, Joe Ross, Robin Young, Guillaume Bailliard, Chris Fair

Technology Description: The ControlRad Trace technology is hardware and software that can be retrofitted onto existing mobile C-arms and subsequently lower radiation exposure to the patient and to the surgical team by up to 89%, without hurting operating room workflow or reducing image quality.

ControlRad Trace employs an intelligent, dynamic system of translucent collimators, proprietary processing algorithms, and a smart tablet interface.

ControlRad Trace can be used in any spine procedure where a C-arm is used. Actually, wherever a mobile C-arm is used.

ControlRad Trace is 510(k) cleared to be retrofitted onto OEC 9800 and 9800+ C-arms, and 510(k) Cleared for OEC 9900. Other models are in process.

icotec Medical, Inc.

Winning Technology: VADER®one MIS or Open Carbon/PEEK Tumor Spine Screw

Inventors and Engineers: Roger Stadler, Kurt Zoller, Marina Hess, Remo Keller, Jochen Fend

Technology Description: VADER®one, made from icotec’s unique BlackArmor® material consisting of continuous carbon fibers combined with PEEK (polyetheretherketone) and produced using icotec’s injection molding CFM (Composite Flow Molding) manufacturing technology, is a pedicle system for fixation of spine tumor patients which may be used with either MIS or open approaches. In other words, no change in surgeon technique required.

VADER®one has FDA clearance for spinal tumor cases and is ideal for reduced artifact, which allows for exact targeting when using radiation therapy, proton therapy and will not interfere with post-op tumor detection imaging, specifically enhancing the outcome of x-ray, CT and MRI modalities.

joimax, Inc.

Winning Technology: Intracs^®em Integrated Navigation Tracking & Control System

Inventors and Engineers: Wolfgang Ries, Dr. Rainer Steegmüller, Martin Germann, Tim Wang, Florian Faller, Jens Fiala

Technology Description: Intracs^®em is a paradigm shifting combination of navigation and endoscopy which increases endoscopic spine surgery safety and accuracy.

The Intracs^®em system is designed specifically for endoscopic spinal decompression, deherniation, and soon endoscopic navigated stabilization.

It’s designed to be compatible with all C-arms and needs only an AP and lateral X-ray shot to register the patient. From there, the surgeon can navigate needles, dilators, reamers, and the endoscope.

This can cut procedure time safely while also reducing radiation exposure.

Because Intracs^®em is electromagnetic, surgeons can navigate flexible needles accurately at the tip and know where they are during the entire procedure.

Secondly, Intracs^®em helps surgeons orient themselves by displaying the endoscope with the viewing angle on the navigation screen at all times.

Lastly, since Intracs^®em only requires two fluoro shots, radiation exposure is significantly reduced.

LifeNet Health

Winning Technology: PliaFX®

Inventors and Engineers: Dennis Phelps, Austin Johnson, Adam Entsminger, Jingsong Chen, Joe Peterfeso, Jason Bryant, Kelsey DeCrescenzo

Technology Description: The PliaFX suite of moldable demineralized cortical bone fibers, which combine micro-topography (to support cell attachment, migration and infiltration) with the undiluted osteoinductive potential of a carrier-free implant (NO additives), has established a new benchmark in moldable osteobiologics.

PliaFX’s interlocking fibers feature microhooks that naturally link together, allowing each graft to become moldable upon rehydration while also resisting migration during implantation.

LifeNet’s proprietary technology creates long fibers with multiple protrusions and a rough surface area and many contact points for cellular attachment. MSCs quickly incorporate into the fiber network and begin division. The interconnected topography of fibers allows cells to easily spread out and make connections with each other.

PliaFX is 100% bone.

NuVasive, Inc.

Winning Technology: LessRay™

Inventors and Engineers: Dr. Rob Isaacs, Eric Finley, Sean O’Connor, Alex Hsu, Julianne Harrington, Matt Eklund, Edward Aminov, Ramzy Saoud, Kara Robinson, Nicholas Paladino, Peter Klemm, Chris Ryan

Technology Description: NuVasive’s LessRay is a hospital operating room (OR) smart imaging platform that’s shown to reduce radiation exposure by as much as 80%, enhance OR workflow and do so without sacrificing image quality or clarity.

LessRay integrates with traditional, mobile C-arm imaging systems.

LessRay uses machine-learning techniques to eliminate the interference of artificial objects (e.g., metal instruments) and visually enhance patient anatomy and/or boost the appearance of metal instruments when desired.

NuVasive’s LessRay image-enhancement system captures and enhances low-dose, low-radiation images to produce images with similar diagnostic capabilities as conventional full-dose images.

Reflexion Health

Winning Technology: VERA (Virtual Exercise Rehabilitation Assistant)™

Inventors and Engineers: Sudipto Sur, Ph.D., Anang Chokshi, P.T., D.P.T, O.C.S, S.C.S., Joe Smith, M.D., Ph.D.

Technology Description: VERA is an FDA-cleared Virtual Exercise Rehabilitation Assistant that supports and remotely monitors physical therapy exercises in real time.

VERA brings the services of a physical therapist into the home—virtually. VERA coaches, motivates and assesses exercise rehab compliance with prescribed physical therapy.

VERA’s avatar—which combines non-contact 3D biometrics, comprehensive remote monitoring by clinicians, and telehealth visits—saves time, steps and money for patients, providers, and payors.

VERA comes with three components:

1. An engaging avatar that coaches patients through their prescribed PT.
2. A 3D pose-tracking camera that measures 26 joints and limbs in motion, 30 times per second.
3. Remote oversight and telehealth visits with a licensed PT.

With a Net Promoter Score of 91, patient affinity for VERA exceeds Apple products and Amazon services.

Saluda Medical

Winning Technology: Evoke^® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System

Inventors and Engineers: John Parker, Ph.D., Peter Single, Dean Karantonis, Robert Gorman, Ph.D., James Liard Wah, Milan Obradovic

Technology Description: Evoke is the first Closed-Loop Spinal Cord Stimulation (SCS) System.

Spinal Cord Stimulation Systems (SCS) operate by inhibiting the pain pathway by activating mechano-sensory fibers in the dorsal spinal column.

One issue with other SCS systems is patient tolerance to stimulation.

Evoke measures the spinal cord’s response to stimulation and adjusts every pulse to optimize activation within the patient’s therapeutic window.

Because of the closed-loop feedback, Evoke provides an objective measure based on the patient’s neurophysiological response.

Evoke automatically adjusts to match the patient’s preferred level of stimulation to provide pain relief—while generating 60 pulses per second, 5 million times a day.

Impressive.

TDi (Tissue Differentiation Intelligence)

Winning Technology: SonoVision™

Inventors and Engineers: Kern Singh, M.D., Kevin Foley, M.D., Goutam Ghoshal, Ph.D., Richard Tobias, Bob Uvacek, Ph.D., Michael Oelze, Ph.D., Dimitri Protopsaltis, Mike Sherman

Technology Description: SonoVision is a real-time surgical ultrasound imaging system, which incorporates machine learning (artificial intelligence) to differentiate muscle, nerve, bone and blood vessels for surgeon visualization intraoperatively.

It is the first technology of its kind specifically designed for spine surgery.

The system applies layers of data-trained machine learning algorithms to ultrasonic images collected real-time with surgically integrated instruments designed for spine surgery.

The resulting images are simple and intuitive for the operative surgeon to interpret, offering procedurally relevant information that is integrated seamlessly into the surgical workflow.

SonoVision is an artificial intelligence enabled visualization system that layers colored tissue indicators over high-quality black and white (b-mode) ultrasound images for confident visualization of tissue structures in real-time.

The initial application for SonoVision is in direct lateral transpsoas approach surgery. The tissue differentiation capabilities enable surgeons to confidently visualize the psoas muscle, nerves within the psoas, the bony contours of the subjacent vertebral body surface, and adjacent blood vessels.

Vivex Biologics, Inc.

Winning Technology: VIA Disc Matrix ™

Inventors and Engineers: H. Thomas Temple, M.D., Timothy Ganey, Ph.D., Stephanie Gonzalez, Tracy Anderson, Shabnam Namin, Ph.D., Lou Barnes, Renaud Sicard, Ph.D., Vanessa Baron

Technology Description: VIA Disc Matrix is a human allograft tissue product intended to supplement intervertebral disc (IVD) tissue loss in patients with disc degeneration.

VIA Disc Matrix supplements otherwise deficient intervertebral discs due to desiccation and tissue loss—thereby providing additional cushioning to support intervertebral disc function.

VIA Disc Matrix consists of two components:

• Dried Nucleus Pulposus (NP) particulate allograft scaffold
• Viable cellular component

When implanted, it is placed centrally within the nucleus pulposus using a percutaneous procedure and image guidance.