Artificial Disc Replacement

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Artificial Disc Replacement

• presentation
• by
• Advanced Prosthetic Technologies Inc. (APT Inc.)
• 14 Michael Drive Metuchen, NJ 08840

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Artificial Discs for Motion Preservation

• It the past, the fusion of vertebrae was
  considered to be the Gold Standard for treating
  Degenerative Disc Disease (DDD) and meant Pain
  Free. Fusion still plays an important role in
  the treatment of DDD, but it also may disrupt the
  bio-mechanics of adjacent levels. Facet
  arthropathy, spinal stenosis, adjacent disc
  degeneration and osteophyte formation have all
  been reported to occur at levels adjacent to a
  fusion, and these pathological processes are
  responsible for continued pain in many patients.
  Approximately six years ago the Inter-Body
  Fusion(IBF) marketplace was at its height and
  there was a significant increased interest in
  Adjustable IBF devices in the restoration and
  fixation of the proper intervertebral space.
  Total Disc Replacement represented an alternative
  to fusion allowing for motion preservation, and
  is now at the forefront of the spine industry.
  The aim of Total Disc Replacement is to recreate
  normal dynamic function, restore the normal disc
  height and lordosis or kyphosis in the treatment
  of DDD. There are numerous total artificial disc
  design approaches with inherent deficiencies
  that may have significant implications affecting
  their performance.

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• At the present time there are 4 "types" of
  artificial disc being used, studied or tested.
  They include
• composite (Charite, Prodisc, )
• hydraulic ( PDN - Prosthetic Disc Nucleus)
• elastic (Acroflex Disc)
• mechanical discs ( Maverick, FlexiCore ,
  Prestige )
• The following is a brief description of each.

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• Composite Artificial DiscsThe most widely
  implanted disc to date is a composite disc called
  the Charité disc. This device is made of a
  polyethylene spacer and two separate metal
  endplates and is available in different sizes.
  The Prodisc is similar to the Charité and also
  uses a polyethylene spacer.
• Charite
  Prodisc

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• Hydraulic Artificial Discs Hydraulic artificial
  discs have a gel-like core covered with a tightly
  woven polyethylene "jacket". Before it is
  implanted, the pellet-shaped hydrogel core is
  compressed and dehydrated to minimize its size.
  Once it is implanted, the outer woven covering
  allows fluid to pass through to the core, which
  immediately begins to absorb fluid and expand.
  Most of the expansion takes place in the first 24
  hours after surgery, although it takes about 4-5
  days for the hydrogel core to reach maximum
  expansion. It is claimed that placement of two
  hydraulic implants within the disc space
  generally provides the lift that is necessary to
  restore and maintain disc space height in most
  patients.
• PDN (Prosthetic Disc Nucleus)

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• Elastic Artificial Discs Elastic type artificial
  discs are made of a rubber core bonded to two
  titanium endplates. The results of testing have
  been mixed. 6 patients who received this type of
  artificial disc were evaluated after a minimum of
  3 years, at which time the results were graded as
  follows 2 excellent, 1 good, 1 fair, and 2 poor.
  One of the elastic discs in a patient developed a
  tear in the rubber with a poor result. Since that
  time, a second-generation elastic disc made of
  silicone rather than rubber has been approved for
  more testing. A third generation is now also
  being tested.
• Acroflex Disc

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• Mechanical Artificial Discs Several pivot or
  ball type artificial discs have been developed
  for the lumbar spine. One device, made of
  metal-hinged plates with an interposed spring,
  has been tested on sheep with good results (not
  illustrated).
• Maverick FlexiCore
  Prestige

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ARTIFICIAL DISCS THEIR DEFICIENCIES
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APT Inc. - Mission

• To develop and commercialize APTs intellectual
  property for Total Disc Replacement (TDR) for
  restoring natural motion of the spine. Designed
  for use at multiple levels.
• To address patients with Degenerative Disc
  Disease (DDD) utilizing cutting edge technology
  in replacing a diseased or damaged intervertebral
  disc with a motion preservation Artificial Disc.
• Expand the technology platform in addressing the
  need for instrumentation and/or additional
  hardware to replace traditional hardware used in
  current spinal fusion. This may include
  endoscopic and/or computer-assisted navigational
  surgery.
• Simplify the surgical procedure thereby making it
  less technique sensitive.
• Vertebral endplate preparation should be precise
  and require minimum bone removal so as to reduce
  the incidence of misalignment of the endplates
  and subsidence following implantation of the TDR
  prosthesis.

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Technical Abstract

• Patented, novel, proprietary, next generation
  spinal disc prosthesis and related
  instrumentation.
• Spinal disc replacement designed for motion
  preservation addressing patients with varying
  degrees of disease severity.
• Advanced biomaterials, design and construction.
• Bio-erodible polymer technology to restrain the
  artificial disc during healing by preventing
  slippage and micro-motion thereby enhancing
  osseous integration prior to restoration of
  natural spinal motion.
• Drug eluting and other factors in combination
  with the APTs TDR devices.

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Technology Intellectual Property

• Three Patents issued and one pending
  
  US 6,454,806 B1 issued Sept. 24, 2002
  US 6,719,796 B2 issued April
  13, 2004
• US 7,282,063 B2 issued October 16, 2007.
• Pending C.I.P. application SN 11/974,654, filed
  10/15/07
• Detailed drawings and several conceptual
  prototypes of the devices have been made.
• Detailed and enhanced development of prototypes
• Additional IP forthcoming, and know-how
  inherent in model and design.

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APTs TDR Motion Restoring
Compressible Artificial Spinal Disc Patent
7,282,063

• Abstract
• A spinal surgical prosthesis such as an
  artificial disc having a pair of upper and lower
  plate members, a flexible disc interposes
  therebetween and a rigid collar made of a
  bio-compatible and bio-resorbable material
  surrounding the flexible disc between the upper
  and lower plate members. Prior to the resorption
  of the collar, the collar serves to provide
  stability to the flexible disc for enhancing
  osteo-integration of the prosthesis with adjacent
  vertebrae. Subsequent to the resorption of the
  rigid collar, the flexible disc provides
  flexibility and compressibility while maintaining
  the proper inter disc space and lordosis or
  kyphosis between adjacent vertebrae.

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APTs C.I.P. application for Improved Corpectomy
Vertebral Body Replacement Implant SystemPatent
pendingpublication

• ABSTRACT
• An improved artificial spinal implant system for
  replacing a disc or vertebral body that provides
  adjustability in height, and provides support and
  stability of the spine with proper lordosis or
  kyphosis, osseous-integration of the implant, and
  motion preservation (if desired) of the adjacent
  vertebrae while preserving the space. Motion
  preservation is achieved with compressible and/or
  tiltable artificial discs.

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APT Inc. Spinal Disc Technical Advantages

• Allows for temporary immobility with slight
  rotation to enhance bone healing and maximize
  osseous integration with end plates
• Minimal end plate preparation
• Adjustability for re-establishing proper
  inter-vertebral disc space and lordosis and
  kyphosis
• Prevent end-plate retropulsion without subsidence
• Restores motion after 6-8 weeks and closely
  mimics the natural disc
• Provides shock absorption

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Top view of APTs first generation Adjustable
Artificial Disc prototype and the Charite
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APTs adjustable Artificial Disc that allows
for distribution of heavy loads and restores
APT Spinal Device to Charite Comparison
functionality to the spine
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Adjustable Artificial Disc with Bellows and
Bio-Resorbable steps - prototype illustrated
(front view)
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Adjustable Artificial Disc with Bellows and
Bio-Resorbable steps - prototype illustrated
(side view)
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NEXT GENERATION OF APTs ADJUSTABLE ARTIFICIAL
DISC DEVICESAPTs Corpectomy and Modular Bi-pod
and Tri-Pod Artificial Discs
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Key personnel and team capabilities

• Inventors Howard Cohen, DDS and Les Biro
• Medical, spine, surgical and clinical expertise
  Fabien D. Bitan, MD, Chief, Spine Surgery
  Lenox Hill Hospital, New York City
• Biomedical expertise Cooper Union Research
  Foundation.
• For additional information or to arrange a
  meeting contact
• Dr. Howard Cohen, [phone] or (201)
  217-3434