Tag Archives: spinal surgery

Spine surgery technologies: changes in market composition

 

Markets for products in spine surgery show a decline in spine fusion and total disc replacement, but an increase in intraspinous process spacers and nucleus replacement.  Although the exhibit below displays this only for Asia/Pacific markets, the trend is true globally.

asia-pacific-spine-fusion

Source:  Exhibit 3-107 is taken from MedMarket Diligence report #M510, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

 

Despite the recent challenge to vertebroplasty, indicating that its results are equivalent to controls, kyphoplasty offers a more progressive approach, via balloon expansion, to disc compression.

Minimally invasive spine surgery becoming technology-enabled

While patient concerns remain a significant driver in the development of minimally invasive techniques, technological advances in surgical instrumentation have transformed the theoretical to the practical. Advanced fluoroscopy, or x-ray imaging during surgery, has markedly improved the accuracy of incisions made and hardware placed. A variety of endoscopes, camera-tipped wands, can be inserted through small incisions and provide the surgeon with excellent visualization of the operative site. New surgical instruments were developed to work in tandem with endoscopes. The past several years have brought numerous innovations to spine surgery. These innovations include the development of imaging systems that interpret anatomical data for three-dimensional display; the use of lasers, ultrasonic frequencies, and high-pressure water jets remove tissue; and new monitoring devices that help the surgeon to optimally position instrumentation as well as to warn of potentially damaging neural contact during a procedure. Spine operations that lend themselves particularly well to minimally invasive approaches are intervertebral disc decompressions and discectomies. Progress has been made in adapting certain kinds of spinal fusion procedures to a minimally invasive approach, and certain forms of scoliosis of the thoracic spine have been treated with minimally invasive surgery.

mis-spine

Source:  MedMarket Diligence, LLC; Report #M510, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

MIS has many enthusiastic supporters. However, caution needs to be exercised, as even though a technique is less traumatic, if the rate of successful spinal fusion is much lower, then there is really not an advantage. Also, it has yet to be demonstrated that minimally invasive spine fusion systems actually cause better outcomes than some other surgical techniques used in the traditional open approach.

Increasingly, minimally invasive techniques are becoming the preferred method for autologous bone graft procedures. Traditional procedures involve the surgeon making a 3- to 5-inch incision to harvest bone from the patient’s hip area, and some studies have shown that complications arise in nearly a third (31%) of these patients. These studies also show that about 27% of patients still feel pain in the hip area up to two years after the surgery.
 

 

Dynamic stabilization (posterior): interspinous process spacers in spine surgery

Posterior dynamic stabilization systems for use in spine surgery can be roughly divided into interspinous fixation devices and transpedicular fixation devices. Both categories include some devices that have been on the market (sometimes only in the EU) for some time, as well as new devices either still under development or under clinical testing in the US.

Interspinous fixation devices include the X-Stop (Kyphon, now owned by Medtronic), the Wallis (second generation), the DIAM Spinal Stabilization System (Medtronic Sofamor Danek), the coflex (from Paradigm Spine, not yet FDA approved), and the ExtenSure and CoRoent devices (NuVasive).

Interspinous process spacers fall under this category. These devices relieve stress and loading on the intervertebral disc and thus hopefully relieve pain. The spinous processes are the small prominences that are on the very back edge of the spinal column, just under the skin. Because the spinous processes are so close to the skin, interspinous process spacers may be inserted with `minimal cutting and dissection of tissues. The spacers are designed to distract (open up) the foramen, thus giving the nerves more room and relieving painful pinching of the nerves.

Developers of Interspinous Process Spacers

 interspinous-process-spacers

(note: see report #M510 for product status.)

Source: MedMarket Diligence, LLC; Report #M510, "Worldwide Spine Surgery."

These spacers may be inserted under only a mild sedative and local anesthesia, with the patient returning home the same day. The same-day surgery procedure makes this especially attractive to elderly patients, who may not be able to tolerate a longer, more extensive surgery performed under general anesthesia.
 

Mechanical disorders among many targeted by treatments of the spine

Spine surgery technologies are many, driven by many factors.  

  1. Diseases, disorders and trauma of the spine are many  – and growing in prevalence with an active senior population.
  2. Conditions of the spine can severely limit the quality of life creating significant demand.
  3. Spine and orthopedic surgeons, as well as the device manufacturers, have established strong precedents in reimbursement that support many new technology developments, from incremental to major advances.
  4. Advances in different technologies and surgical techniques have further accelerated technology development, such as minimally invasive approaches to spine surgery, advances in materials technologies that have led to artificial discs and other developments

Considering only the first factor, above, there are large populations of prospective patients with the many possible spine problems: congenital disorders of the spine, inflammatory and infectious diseases of the spine, degenerative diseases of the spine, spine trauma, tumors of the spine and mechanical disorders of the spine.  Each of these has multiple categories within them.

For example, mechanical disorders of the spine refer to conditions caused by, resulting from, or relating to physical as opposed to biological or chemical processes or change and there are many types. The following table presents six commonly diagnosed mechanical disorders of the spine.

Mechanical Disorders of the Spine

spine-mechanical-disordes

Source: MedMarket Diligence, LLC; Report #M510, "Spine Surgery Worldwide."  See complete description, table of contents, list of exhibits at link.

 

Why the spine surgery market is so strong

The global spine market is large, active and growing rapidly in revenues. Several dynamic forces, in addition to the aging of the population, are expected to affect the market and treatments during the next several years. While spinal fusion will always have a place, its share of the treatment market is expected to decline. Newer treatments such as total disc replacement and nuclear arthroplasty will erode the spinal fusion market, as these and other treatments which preserve spinal motion gain favor over the invasive and traumatic fusion of two or more spine segments.

Fundamentally, demographics are a huge driver of spine surgery growth, but the number and variety of different spine disorders and diseases supports and ongoing need for treatments, technologies and products.

Below are select data in support of the huge and growing worldwide spine surgery market (drawn from report #M510).

 

Number & Percentage of U.S. Population over Age 65, 1910–2050

spine-demographics

Source:  U.S. Bureau of the Census and MedMarket Diligence report #M510.

 

 

Congenital Disorders of the Spine

 

Disorder
Description
 
Kyphosis (hyperkyphosis)
Exaggerated curvature. Excessive kyphosis results in “hunchback” appearance. Can result from segmentation or formation defects.
Lordosis
Exaggerated curvature. Excessive lordosis results in “swayback” appearance. Usually appears in lumbar spine.
Scheuermann’s Kyphosis
Hyperkyphotic deformity observed in from 1% to 8% of children over the age of 20 or 11. Typically appears in thoracic spine.
Scoliosis
Lateral curvature of the spine exceeding 10°. Primary age of onset between 10 and 15 years. Scoliosis in females much more likely to require treatment as it progresses.

 

Source: MedMarket Diligence report #M510.

 

Inflammatory and Infectious Diseases of the Spine

 

Disorder
Description
Discitis
An inflammation of the disk space often related to infection. Most commonly appears in lumbar region.
Sacroiliitis
Also called Sacroiliac Joint Injury. Can result from inflammation, infection, trauma, or other causes.
Arachnoiditis
Describes inflammation of the meninges and subarachnoid space. Can result from bacterial, fungal, viral or parasitic agents; can also result from surgery or the administration of intrathecal agents.

 

Source: MedMarket Diligence report #M510.

 

Degenerative Diseases of the Spine

 

Degenerative Disease
Description
 
Degenerative Disc Disease (DDD)
Can encompass degradation of bony architecture, discs,
or supporting muscles and ligaments of the spine.
Frequency increases with age.
Spinal Stenosis
Narrowing of the spinal canal, neurorecesses, and
neuroforaminal canals at any part along the spinal axis.
Can result from disc protrusion or other degenerative
factors.
Osteoporosis
Systemic skeletal disorder characterized by low bone
mass and loss of bone tissue. Especially prevalent in
postmenopausal women
Rheumatoid Arthritis
An inflammatory disease of no known cause that
primarily affects the peripheral joints. The disease has a
significant genetic component.

 

Source: MedMarket Diligence report #M510.

Mechanical Disorders of the Spine

 

Mechanical Disorder
Description
Herniated Disc
Refers to the bulging or protrusion of the interior disc nucleus against or through the wall of the intervertebral disc. Predominantly appears in the lumbar spine.
Spinal Stenosis
Narrowing of the spinal canal, neurorecesses, and neuroforaminal canals at any part along the spinal axis.
Often due to age-related degenerative changes.
Myelopathy
Usually refers to symptomatic compression of the spinal cord itself, sometimes linked to spinal stenosis.
Radiculopathy
Describes symptoms associated with compression of the nerve roots of the spine, often due to disc herniations or other factors.
Spondylolysis
Describes bony overgrowths or spurs (osteophytes) on vertebra, often linked to aging.
Spondylolisthesis
Describes the (usually) forward slippage of a vertebra relative to the one below. Most frequently occurs in the lumbar spine.

Source: MedMarket Diligence report #M510.

 

 

 

Startup and early stage spine surgery companies

If there is a more robust area of medtech development — one with more success in creating clinical and market value while resisting pricing pressures — than spine surgery, I would be surprised.

The global spine market is large, active and growing rapidly in revenues. Several dynamic forces, in addition to the aging of the population, are expected to affect the market and treatments during the next several years. While spinal fusion will always have a place, its share of the treatment market is expected to decline. Newer treatments such as total disc replacement and nuclear arthroplasty will erode the spinal fusion market, as these and other treatments which preserve spinal motion gain favor over the invasive and traumatic fusion of two or more spine segments.

Early Stage / Startup Spine and Orthopedic Surgery Companies

 

Company
Year founded
Area of interest
3Cor Medical, Inc.
2002
Distraction screws for plating and interbody fusions.
Allez Spine LLC
2003
Pedicle screw systems and cervical plating systems for use in spine surgery.
AOI Medical, Inc.
2005
Develops innovative orthopedic medical devices for spine and trauma markets
Archus Orthopedics
2002
Total Facet Arthroplasty System® (TFAS®), an articulating joint prosthesis.
Baxano, Inc.
2005
Tools that restore spine function and preserve healthy tissue
Cartilix, Inc.
2004
Biomaterials for repair of tissues in articular joints.
CoreSpine Technology LLC
2005
Spinal arthroplasty
Creaspine
2005
Instrumentation and devices for use in spine surgery.
Custom Spine, Inc.
2003
To create the next generation of surgeon-friendly spinal implants.
Eden Spine, LLC
2006
Motion-preserving spine therapies.
Expandis Ltd.
2002
Minimally invasive orthopedic surgery instrumentation.
Facet Solutions, Inc.
2003
Facet arthroscopy
ForSight Labs, LLC
2005
Ophthalmic device company incubator
Globus Medical, Inc.
2003
To drive significant technological advancements across the complete suite of spinal products including Fusion, MIS, Motion Preservation and Biomaterials.
IB Medical LLC
2006
Static compress device technology in spine surgery.
Innovative Spinal Technologies, Inc.
2002
Spine surgery technologies.
InteliFUSE, Inc.
2005
Shape memory technology for bone fracture fixation/fusion and bone remodeling
MI4 Spine, LLC
2006
Minimally invasive spinal instrumentation.
NBI Development, Inc.
2007
Implantable spine neuromodulation devices.
OrthoMEMS, LLC
2005
Implant systems for spine and orthopedic applications using MEMS and wireless technology.
Ouroboros Inc.
2005
Medical devices for minimally invasive spinal fusion
Paradigm Spine, LLC
2005
Non-fusion interspinous spinal implant.
PNIR (Peripheral Nerve Injury Repair), LLC
2008
Implant technologies for peripheral nerve repair.
RE Spine, LLC
2007
Intervertebral disc and facet joint prosthesis in spine surgery.
Signus Medical LLC
2004
Pioneering the introduction of new biomaterials such as PEEK-Optima®, and research into the next generation of materials
Small Bone Innovations, LLC
2004
Orthopedic technology focus on small bones and joints (hand, wrist, elbow).
Spartek Medical, Inc.
2006
Motion preserving spine fusion implant, inserted minimally invasively, for treatment of degenerative disc disease.
Spinal Elements, Inc. (formerly Quantum Orthopedics, Inc.)
2003
Working with prominent surgeons to develop medical device technologies in the areas of spine arthroplasty (joint motion preservation) and spinal fusion.
Spine Form, LLC
2005
Medical device technology based on treatment of scoliosis.
SpineForm, LLC
2004
Spine staple
SpineFrontier, Inc.
2006
Spine implant technologies.
SpineMatrix, Inc.
2006
Spinal imaging to improve diagnosis of lower back pain.
SpineMedica Corp.
2005
Device technologies for spine and chronic back pain.
Spinus LLC
2005
Instruments for neurological, orthopedic and spine surgery.
Vertebral Technologies, Inc.
2005
Biocompatible polymers for joint restoration within the spine
Vertebron
2003
Developing several product for spinal fusion and fixation (arthrodesis), as well as new products and intellectual property (IP) that focus on motion preservation (arthroplasty) and dynamic stabilization.
Vertech, Inc.
2007
Device to ease the pain of compression fractures of the spine by separating spinal bones and injecting fast-hardening cement.
Vertiflex (fka DK Spine Technology, Inc.)
2004
Medical devices for spine surgery

Source:  MedMarket Diligence, Report #M510 (Worldwide Spine Surgery 2008-2017) and the Medtech Startups Database.

 

Products, technologies and markets in spine surgery worldwide

Below is a report from MedMarket Diligence on the worldwide market for spine surgery technologies. The report is described at link.

Spine Surgery Worldwide 2008-2017: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017

· 380 pages · 190 Exhibits · 98 Company Profiles · Report #M510 · Published March 2008

This report details the complete range of products and technologies in, spine surgery, the surgical management of spine disorders, diseases and trauma, from grafts, demineralized bone, fusion, stabilization, disc replacement, nucleus replacement, vertebroplasty, kyphoplasty, imaging, minimally invasive surgical technologies, energy-based therapies and biologics. The report details current clinical and technology developments in the huge and rapidly growing spine surgery technologies worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

This report is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes diseases and disorders of the spine, encompassing congenital disorders, inflammatory and infectious diseases; degenerative diseases; herniations, stenoses, myelopathies and other "mechanical" disorders of the spine; spinal trauma; tumors of the spine; and others. The report characterizes the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and manufacturer offerings. The report details products and technologies under development and markets for each in spine surgery. The report provides a current and forecast assessment of the worldwide markets for these technologies, with geographic segmentation by U.S. & Canada, European Union (detailing France, United Kingdom, Germany, Italy and Spain), Japan and Rest of World. The report provides emphasis on the market impact of new technologies through the coming decade, profiling nearly 100 active companies in this industry, with comprehensive detail on key companies, providing data on their current products, current market position and products under development.

(For more information, contact Patrick Driscoll, patrick at mediligence dot com, or tel: 949-859-3401.)