The Best Spine Technologies of 2010

Thousands of lab, machine shop and operating room hours by 210 inventors and engineers resulted in 43 spine technology submissions to the 2nd annual Orthopedics This Week Spine Technology Awards.  Those submissions were then analyzed by 6 judges and the best 19 in 8 categories were selected to receive the crystal Best Spine Technology of 2010 award.

The Orthopedics This Week spine technology awards honor the process, hard work and, most especially, the inventors and engineers who take a dream and run the regulatory and organizational gauntlet to market.

Bringing a new technology to the spine arena is hard.  It is an honor to celebrate the inventors and engineers who get to the finish line.

As was the case last year, this year’s submissions reflected the state of innovation in spine.  Last year, motion preservation and dynamic stabilization technologies were predominant.  This year a combination of biologics, diagnostics and practical “low-tech” innovations dominated the submissions.  Only three companies submitted a motion preserving implant.

Sign of the times.

In 2009, the spine technology awards were held in a gold, gilt covered ball room.  This year it was held in a restaurant surrounded by tanks of sharks.  The metaphor was apt.  Not since the days of the pedicle screw suits has the process of innovation in spine been subject to so much nay-saying.  The regulatory, blogging and financial sharks seem to be circling.

The six judges for this year’s awards were:

• Jim Youssef, M.D. is co-founder of SpineColorado, a multidisciplinary comprehensive facility, which focuses on the treatment of spinal disorders by combining the latest in non-operative and operative techniques.
• Alex Vaccaro, M.D., FACS Professor of Orthopedic Surgery, Thomas Jefferson University Hospital, is Co-Director of the Regional Spinal Cord Injury Center of the Delaware Valley, and of the Spine Fellowship Program, both of Thomas Jefferson University Hospital.
• Jeffrey Wang, M.D. Chief of the UCLA Spine Service, Director of the UCLA Spine Surgery Fellowship, and board certified. Dr. Wang is Professor of Orthopaedics and Neurosurgery and Biomechanical Engineering with expertise in the surgical treatment of all neck and back disorders. Dr. Wang is the Executive Director of the UCLA Comprehensive Spine Center.
• Gil Tepper, M.D. F.A.C.S., Medical Director Miracle Mile Medical Center; Diplomate, American Board of Orthopedic Surgery, QME
• Dilip Sengupta, M.D., Ph.D. is Professor of Orthopedic Surgery, Dartmouth-Hitchcock Medical Center, Lebanon Spine Center.
• Maryellen Keenan Industry Advisor, Special Consultant, Hospital for Special Surgery, New York, New York; Founder, Da Vinci Center, Miami, Florida, Founder, Latin Angels, Partner, Ariel Savananah Angel Investors; Industry Analyst & Speaker, Bear Stearns, Industry Analyst & Speaker, Piper Jaffray

Each submission was scored on a scale of 1 (worst) to 5 (best) for the following criteria:

1. Is this technology innovative? (To what extent does the submitted technology represent a creative and innovative technology?)
2. Does this technology have long-term significance? (To what extent does this technology have staying power?)
3. How well does this technology address a clinical problem? (Does this technology solve a current clinical problem or a problem that is inadequately solved today?
4. Does this technology improve the current standard of care?
5. Would I use it?

The judges diligently read and scored all 43 submissions according to the five criteria outlined above. Adding up the scores we found some expected winners but also some unexpected winners!

Applause please for the people who created the BEST SPINE TECHNOLOGIES for 2010!

The Best Biomaterial Technology of 2010

Most votes – OsteoAMP Antibacterial

Inventor(s):

• Amit Govil
• Scott Cadotte

Engineer(s):

• Amit Govil
• Neil Thompson

OsteoAMP antibacterial is an allograft biomaterial which has been processed in a way which creates a material with significantly higher levels of growth factors than are available in other putty materials. (BMP-2 concentrations are 100x more than the concentrations found in market-leading DBMs). In addition the material is also extremely anti-bacterial.

2nd most votes – AOC Technology

Inventor(s):

• Tim Fischer
• Dr. Tadeusz Wellisz
• Jon Armstrong
• John Cambridge

AOC is a carrier system for synthetic, DBM or BMP bone grafts suspended in a matrix to use in spine surgery.  It dissolves and is eliminated from the body unchanged without any metabolic processes in 24-48 hours or as needed.  It is non-inflammatory, does not swell as it dissolves and does not disperse particulate matter.  AOC can be formulated to NOT contain water so that it can be a carrier for all manner of compounds including proteins.

3rd most votes – VALEO AL

Inventor(s):

• Ashok C. Khandkar, Ph.D.

Engineer(s):

• Alan Lakshminarayanan, Ph.D.

Valeo AL is a Silicon Nitride ceramic based technology which offers the surgeon superior strength with bone-like imaging and hydrophilic characteristics. It is cell friendly and presents superior cellular adherence on surface. The material is biologically inert, presents no visual artifacts or interference with CT scans, X-rays or MRI

The Best Cervical Care Technology of 2010

Most votes – VISTA TX

Inventor(s):

• Geof Garth
• Wayne Calco
• Erik Zimmer
• Joe Horvath

Engineer(s):

• Joe Horvath

Vista TX is a fully adjustable CTO and comes in six sizes in one adjustable collar. Multiple adjustment points for customized fit. Metal free, MRI compatible, NO tools required to fit.  Vista TX offers motion restriction without cumbersome shoulder straps and is the new standard in patient comfort and care.

2nd most votes – Valeo C

Inventor(s):

• Ashok C. Khandkar, Ph.D.

Engineer(s):

• Alan Lakshminarayanan, Ph.D.

Valeo C is a silicon nitride ceramic based technology which offers the surgeon superior strength with bone-like imaging and hydrophilic characteristics. It is cell friendly and presents superior cellular adherence on surface. The material is biologically inert, presents no visual artifacts or interference with CT scans, X-rays or MRI.

3rd most votes – PERPOS Cervical System

Inventor(s):

• Bob Flower
• Brad Culbert
• Larry Khoo, M.D.
• Chris Warren

Engineer(s):

• Bob Flower
• Chris Warren
• Fausto Olmos

PERPOS is a transfacet compression device which can be placed posteriorly.  It is the first and only FDA approved posterior percutaneous device for cervical spine stabilization.  PERPOS can be precisely placed and then compressed axially without the need for additional rotation. Design improves compression strength 45% and pullout strength by 24% over typical lag screws.

The Best Diagnostics and Imaging Technology of 2010

Most votes – ScoliScore

Inventor(s):

• Kenneth Ward, M.D.
• Axial Biotech

Engineer(s):

• Kenneth Ward, M.D.

ScoliScore Adolescent Idiopathic Scoliosis (AIS) Prognostic Test received the most votes of ANY submission to the Spine Technology Awards.  It is the first DNA‐based prognostic test for a spinal disorder. ScoliScore is a clinically validated, multi‐gene test with a 99% Negative Predictive Value that accurately determines the likelihood of curve progression into a severe range (spinal fusion surgery indicated) for children diagnosed with Adolescent Idiopathic Scoliosis (“AIS”). Publication of the test validation is in press (Spine 2010).

2nd most votes – Molecular Discography

Inventor(s):

• Gaetano Scuderi, M.D.
• Lewis Hanna, Ph.D.
• Robert Bowser, Ph.D.

Molecular Discography received the second most votes of ANY submission to the Spine Technology Awards. The inventors identified a biomarker that identifies the exact spinal location responsible for low back pain (LBP).  They then developed and validated an ELISA assay based on that biomarker. The biomarker is a protein complex of Fibronectin and the G3 fragment of Aggrecan.  The inventors found that FACT test accurately predicts the level of LBP in patients with degenerative disc disease (DDD). Molecular Discography is designed to use this protein complex to prospectively identify patients with DDD for future treatments as an alternative to provocative discography

The Best Lumbar Care Technology of 2010

Most votes – Allen Spine System

Inventor(s) and Engineer(s):

• George T. Wong
• Paul A. Licari
• David Warburton
• Edward J Daley II
• Thomas K. Skripps

The Allen Spine System is an extension of the OR table that allows surgeons to turn any OR table into a surgical spine table. It costs a FRACTION of the price of a Jackson table and offers intraoperative lumbar flex and a small storage unit.  Advanced accessories adjust to fit the individual patient’s anatomy.

2nd most votes – MicroBlade Shaver and iOFlex

Inventor(s):

• Jeffery Bleich
• Vahid Saadat
• Roy Leguidleguid
• Gregory Schmitz
• Robert Garabedian
• Ronald Leguidleguid
• Nestor Cantorna
• Michael Wallace
• Arnie Borgstrom

Engineer(s):

• Robert Garabedian
• Roy Leguidleguid
• Ron Leguidleguid
• Greg Arcenio
• Paul Mircik
• Michael Wallace
• Martina Hrncir
• Greg Welsh

MicroBlade Shaver is a new device for removing bone and soft tissue in the foramen, lateral recess and central canal.  It allows the surgeon to decompress up to four lumbar nerve roots through a single incision. Using the MicroBlade shaver, the surgeon can achieve comprehensive decompression while preserving the facet joints and lamina. MicroBlade’s “inside out” approach maintains biomechanical stability and offers greater bone preservation for other procedures such as fusion fixation.  Finally, it directly removes impinging ligament and bone with controlled bimanual reciprocations.

iO-Flex is a 3-step surgical technique that consists of access with the Ipsi or Contra Probe, localization of neural tissue using NeruoCheck and decompression with MicroBlade Shaver. Up to four nerve roots can be decompressed through a single point access with the iO-Flex System.

3rd most votes – Deformity CRICKET

Inventor(s):

• Dr. Oheneba Boachie-Adjei
• Dr. Pierce Nunley
• Dr. Raymund Woo
• Michael Barrus
• Scott Jones
• Andrew Rock

Engineer(s):

• Michael Barrus
• Scott Jones

CRICKET is a threaded anvil instrument that provides up to 27 mm of rod reduction when used with the MESA screw, thereby eliminating the need for reduction screws. When the rod is fully reduced, the anvil is capable of applying a very large force on the rod, such that the rod cannot translate or rotate within the screw housing.

The Best Minimally Invasive Care Technology of 2010

Most votes – NeuroVision Guidance

Inventor(s):

• Josef Gorek, M.D.
• Martin Herman, M.D.
• Thomas Scholl
• Albert Kim
• Eric Finley

Engineer(s):

• Rick Eis
• Shannon White

NeuroVision is a system which improves pedicle screw placement. The product uses a unique combination of technique with technology so that surgeons can achieve more precise compound and optimal angle for a given pedicle. NeuroVision delivers real-time dynamic EMG guidance.

2nd most votes – HeliFix Interspinous

Inventor(s):

• James J. Yue, M.D.

Engineer(s):

• Danielle Richterkessing

HeliFix is a tapered helical tip which is rotated into the interspinous process and self distracts up to the final implant distraction height. The implant seats itself into the interspinous space using a built-in saddle feature which creates “wings” to prevent medial lateral migration. It is made with PEEK material and comes in five different sizes.

3rd most votes – INTRABEAM TARGIT Therapy System

Inventor(s) and Engineer(s):

• Matthias Benker
• Holger Fuchs
• Udo Obertacke
• Frederick Wenz
• Frank Schneider

INTRABEAM TARGIT Therapy System miniature X-ray source delivers radiation directly into tumor cavities by generating a high dose of LOW energy (50kV) X-rays in a precise, spherical distribution pattern. Penetrates to a depth of 1-2 cm. Better flexibility, versatile, single dose treatment alternative, low energy

The Best Motion Preservation Technology of 2010

Most votes – Elaspine Implant System

Inventor(s):

• Dr. Thomas Zehnder
• Reto Braunschweiler

Engineer(s):

• Reto Braunschweiler
• Jonathan Clark

Elaspine is a pedicle screw based posterior motion preservation system.  The key element of the system is an elastic polymer rod with a patented form-fit connection to a mono-axial pedicle screw head. Elaspine shares the load within the vertebral tripod and thereby enhances stability mainly of the sagittal and frontal planes.  By reducing the effects of peak loads, helps protect screw anchorage.

The Best Pain Management Technology of 2010

Most votes – Biomarker for low back pain patients

Inventor(s):

• Gaetano Scuderi, M.D.
• Lewis Hanna, Ph.D.
• Robert Bowser, Ph.D.

This biomarker identifies the exact location in the spine responsible for low back pain.  The inventors developed and validated an ELISA assay based on their discovery that a protein complex of fibronectin and the G3 fragment of Aggrecan is just such a biomarker for pain. This biomarker accurately predicts which LBP patients will respond to epidural steroid treatment (sensitivity of > 90%).

The President’s Award for Best New Spine Technology of 2010

The President’s Award recognizes innovative technologies that either don’t fit into a particular category or, for whatever reason, did not get submitted for consideration.  After roughly 25 years as a Wall Street medical technology analyst, I use my own judgment as to which technologies qualify for the President’s Award.  Last year I selected a software program that improved billing and receivables management for spine surgery practices.  This year I selected two stem cell technologies one of which I helped to invent and in which I have a financial interest.  These selections are not subject to independent review or scoring and reflect my own opinions and biases.  Of course, considering all of the successful medical technologies I’ve uncovered over the years, my biases and opinions are not too shabby.  The two stem cell technologies that are this year’s President’s Award winners are:

PureGen ELA Stem Cell

Inventor(s) and Engineer(s):

• Keith Crawford, M.D.
• Pamela Layton
• Sri Vishnubhotla

Early Lineage Adult stem cells are a NEW population of adult stem cells which reside throughout the body and are more abundant than MSCs in bone marrow. ELA are pluripotent and have the capacity to differentiate into fat, cartilage and bone.  In rat studies, ELA formed bone earlier and more consistently than bone marrow aspirate or bone marrow derived MSCs. ELA delivers consistent numbers and quality of cells to the bone repair site.

NuCel

Inventor(s):

• BioD
• AFCell

NuCel is non-cadaveric human allograft tissue which is derived from living donor birth tissues.  It is a combination of amniotic fluid and other birth tissues.  It is an HCT/P, multipotential Cellular Matrix. The allograft is cryo-preserved in vials and contains collagens, hyaluronic acid, trophic proteins and cells including BMPs and MSCs.