New medical technologies at startups, January 2017

Below is a list of the technologies under development at medtech startups identified in January 2017 (thus far) and included in the Medtech Startups Database.

  • Devices and accessories for minimally invasive surgery.
  • Undisclosed surgical technology
  • Technologies for treatment of spinal and orthopedic deformities.
  • 3D visualization and printing for prototyping, surgical planning.
  • Point of care, portable breast cancer screening test.
  • Devices to enable delivery of autologous tissue at point-of-care.
  • Navigation and other technologies to facilitate laparoscopic surgery.
  • Tissue-to-bone reattachment systems
  • Products for bone, joint, and soft tissue conditions of the foot and ankle.
  • Soft tissue marker for ultrasound at surgical sites
  • System to locate breast abnormalities during surgical incision.

For a comprehensive listing of the technologies at medtech startups 2016 and earlier, see link.

Technology advances in spine surgery

Manufacturers, clinicians and others focusing on technology advancement in spine surgery are not developing radical innovations, but are making enough incremental improvements in a number of ways that result in growth in the industry.  Most improvements fall into a number of categories:

Screen Shot 2015-09-14 at 7.29.36 AMNew materials technologies: Historically, spinal fusion instrumentation was fabricated from metallic biomaterials, including stainless steel and titanium alloy, because of their strength and fatigue resistance. However, one key drawback of these metallic implants is incompatibility with diagnostic imaging, including MRI and CT scans, which are crucial for visualizing changes to the spinal cord and vital soft tissue structures of the spine. To overcome these issues a variety of new materials such as biocompatible carbon fiber-reinforced (CFR) thermoplastic materials and implantable polyetheretherketone (PEEK) polymers were examined as an alternative to the traditional materials. In addition to biocompatibility, biostability and compatibility with diagnostic imaging, these advanced thermoplastic polymers provide a range of mechanical properties that are well suited to the demanding environment of spinal implants.

Implantable PEEK polymers are available today in an array of formulations, ranging from unfilled grades with varying molecular weight, to image-contrast and carbon fiber-reinforced grades. The first implantable unfilled PEEK polymer–PEEK-OPTIMA was pioneered in 1999 by United Kingdom-based Invibio Biomaterial Solutions. Introduced by Invibio in 2007 to provide controlled visibility through X-ray, CT and MRI technologies, image-contrast grades offer tailored opacity that allows for easier post-operative device placement verification by surgeons and clear assessment of the healing site. Also launched by Invibio in 2007, carbon fiber-reinforced (CFR) grades provide significantly increased strength and stiffness as well as a modulus similar to that of cortical bone.

The CD HORIZON LEGACY PEEK Rod from Medtronic Sofamor Danek and the EXPEDIUM™ PEEK Rod System from DePuy Spine, Inc., are examples, in which these polyetheretherketone (PEEK) polymers are radiolucent and have the ability to reduce scatter and artifact from CT and MRI images. [Picture source: MRI scan via Shutterstock]

Screen Shot 2015-09-14 at 7.24.36 AMComputer aided fixation of spinal implants: A number of proprietary techniques are being developed that provide computer or robotic alignment for the placement of spinal implants. Current research ensures that further developments will occur resulting in more extensive use of computer aided fixation. [Picture source: NIH]

 

percutaneous spineMinimally invasive spine surgery: Manufacturers have development technologies in percutaneous and endoscopic approaches to spine surgery that are having (and will continue to have) a significant impact on patients, clinical practice and the market for spine products.  It is producing all the expected benefits of less invasiveness — less traumatic surgery results in shorter recovery times and better outcomes and opens up spine surgery to more elderly, infirm and other patients for whom traditional spine surgery would be contraindicated. [Image: Handbook of Minimally Invasive and Percutaneous Spine Surgery; allamericanspeakers.com]

 

Screen Shot 2015-09-14 at 7.19.47 AMVariable axis screw systems: A variable axis screw system is a pedicular screw system that features a variable-axis head, which offers a ±25 degrees of angulation. The system also offers a pre-contoured rod. The contoured rod, along with the angulation available in the screw head, alleviates the need for rod contouring. The screw also features a pre-assembled head and double lead thread. The pre-assembled head reduces the steps required for construct assembly and the double lead thread increase the speed of screw insertion and construct assembly so that the overall operative time can be shortened. [Picture source: DePuy Synthes]

Products, technologies, markets, companies and opportunities in the spine surgery industry are the focus of the MedMarket Diligence Report #M540, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” The next five purchasers of this report (any option) will receive a 25% discount off the published price online by entering the coupon code “spinepricectomy”.

 

What is spine surgery?

What is spine surgery? Specifically it’s:

  • Anterior Lumbar Interbody Fusion (ALIF)
  • Anterior Cervical Corpectomy
  • Anterior Cervical Discectomy and Fusion (ACDF)
  • Axial Lumbar Interbody Fusion (AXiaLIF)
  • Cervical Laminaplasty
  • Cervical Posterior Foraminotomy
  • Direct Lateral Interbody Fusion (DLIF)
  • Discectomy
  • Endoscopic Surgery
  • eXtreme Lateral Interbody Fusion (XLIF)
  • Foraminotomy and Foraminectomy
  • Intradiscal Electrothermal Therapy (IDET)
  • Kyphoplasty
  • Laminectomy
  • Laminoplasty
  • Laminotomy
  • LASER Surgery
  • Microdiscectomy (Minimally Invasive Technique)
  • Oblique Lumbar Interbody Fusion (PLIF)
  • Posterior Lumbar Interbody Fusion (PLIF)
  • Scoliosis Correction
  • Spinal Decompression
  • Spinal Fusion
  • Spinal Instrumentation
  • Spinal Osteotomy
  • Thoracoscopic Release
  • Transforamenal Lumbar Interbody Fusion (TLIF)

These represent the range of options to address diseases and trauma of the spine. To varying degrees, these procedures can require multiple instruments and/or implants and other products, which encompass the following:

  • Cervical interbody cages or spacers
  • Anterior cervical plates
  • Artificial cervical discs
  • Thoracolumbar plate systems
  • Interbody fusion devices
  • Thoracolumbar screw/rod systems
  • Minimally invasive implants
  • Artificial disc replacement implants
  • Interspinous implants
  • Demineralized bone matrix
  • Synthetic bone graft substitutes

See pending Report #M540.

Wound Sealant and Securement Procedure Volumes by Clinical Area and End-Point

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

Sealants, glues, hemostats, and other products in wound closure and securement offer benefits that vary by clinical area, but the nature of that benefit also varies by the type of end-point (benefit) the product achieves — does it provide a life-saving benefit? A time-saving? Cost-savings? A cosmetic or aesthetic benefit?

Accordingly, by examining the volume of procedures for which closure and securement products provide which kind of benefit is crucial to understanding demand, especially between competitive products.

Below is a categorization of benefits ranging from the critical (I) to the aesthetic (IV).

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

Screen Shot 2015-06-23 at 7.24.29 AM

Source: MedMarket Diligence, LLC (Report #S192)

Considering these different categories, below are the volumes of procedures distributed by category across each of the major clinical disciplines.

Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Wound Closure Products, Worldwide (Millions), 2014

 

 

 

 

Screen Shot 2015-06-23 at 7.28.36 AM

Source: MedMarket Diligence, LLC (Report #S192)

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

The biggest revenue streams in spine surgery are not the fastest growing

Put simply, regardless of the relative share, differences in market growth rates or other metrics, some spine surgery technologies will generate substantially more sales than others during the 2012 to 2020 timeframe.

Looking at the MedMarket Diligence, “Worldwide Spine Surgery Data Forecast, 2010-2020”, posterior pedicle screw fusion systems and artificial cervical discs will generate the largest revenue increases over this period, since even at modest growth rates the size of the penetrated market results in big gains from 2012 to 2020. In other words, while AxiaLIF represents one of the fastest growing spine surgery device markets, the aggregate change in AxiaLIF revenues from 2010 to 2020 is only $270 million versus $2.97 billion for posterior pedicle screw fusion systems,  Here a growth rate of under 10% on such a large existing market greatly eclipses the absolute impact of a dramatic growth rate (i.e., >30%) of an emerging market.

Source: MedMarket Diligence, LLC; “Spine Surgery Worldwide Data Forecast, 2010-2020.” See link.

On a country-by-country basis, these differences are more pronounced.

Vertebral Compression Fracture Treatment Technologies

From “Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020”, Report #M520, published 2011 by MedMarekt Diligence:

Vertebral compression fractures result primarily from osteoporosis and the consequent weakening of bones, including those in the spine. VCFs can result in tremendous back pain both in the short and long term. Because the injured vertebra is compressed and loses height, kyphotic deformity of that particular vertebra and the spine as a whole often results. Kyphosis in and of itself can produce pain long after the vertebral compression fracture has healed. As discussed earlier, several conditions can lead to osteoporosis, including estrogen deficiency, multiple myeloma, radiation therapy, and natural aging. Bones weakened either due to the primary disease process or as a result of treatment of such diseases are more prone to fracture. Common sites osteoporotic fracture include the spine, hip, and wrist.

The traditional treatment for VCFs is conservative care with back braces, bed rest, and analgesic medications for alleviating pain. Although given time the fracture eventually heals, the vertebral body remains in a collapsed, compressed state. This can result in prolonged pain, impaired function, and decreased activity. Additionally, bone and muscle loss resulting from a lack of activity can make recovery even more difficult, leading to the so-called ‘downward spiral’ of vertebral osteoporosis.

In recent years, two minimally invasive procedures have been introduced to treat VCFs: vertebroplasty and kyphoplasty. The procedures are very different, in that vertebroplasty is designed to stabilize the break, while kyphoplasty attempts to both stabilize the break and bring the collapsed vertebra back to its original height. 

Companies with products in vertebroplasty and/or kyphoplasty on the market or under development include: Alphatec, ArthroCare, AscendX, Benvenue Medical, Biomet, BoneSupport, CareFusion, Cook, DePuy Spine, Dfine, Integra Spine, Lafitt, Medtronic, Orthovita, Osseon Therapeutics, Signus, Sintea, Skeltex, Soteira, Spine Wave, SpineAlign, Stryker, Synthes, Tecres, Teknimed, Vexim.

Kyphoplasty is currently the bigger market, but trends in procedure volume, pricing and unit sales are causing the gap in global market between kyphoplasty and vertebroplasty to disappear during the forecast period.

 

Vertebro-kypho

Source: MedMarket Diligence, LLC; Report #M520.

 

 

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Degenerative disc disease driving spine surgery

Degenerative disc disease (DDD) is one of the most common conditions affecting adults.  While it does not always manifest itself in symptoms (it can be seen by MRI in 25% of asymptomatic individuals under 40, and in 60% of asymptomatic individuals over 40), its prevalence in an aging population, in which its prevalence increases, is a big driver of spine surgery procedures.  DDD can encompass degradation of bony architecture, discs, or supporting muscles and ligaments of the spine. 

 

Spine-surgery-ddd2

Source: Report #M520, "Worldwide Spine Surgery Market 2010-2020."

DDD is addressed surgically by procedures that fuse adjacent vertebra or replace the disc. In the graph are shown these global procedure volumes in 2010 for treatment of DDD.

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Devices, Global Markets and Opportunities in Spine Surgery

The MedMarket Diligence report #M520, "Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities 2010-2020" reveals the worldwide current and emerging market and opportunities for spine surgery devices. The report also provides an overview of the disease states treated by spine surgery, an overview of the related technologies, and the geographical markets for spine surgery devices. Summaries are provided for several spine surgery-related clinical trials, and new and emerging products and technologies in development are described. Both market-leading companies and those with promising products in development are profiled, and contact details are listed for all companies named in this report.

The global market for spine surgery devices is projected to reach approximately $23.90 billion by 2020, and although exhibiting only a modest growth rate, is expected to eclipse growth many medtech markets during this period. The device segments considered in this report are:

  • Posterior Pedicle Screw Fusion Systems
  • Anterior Cervical Plate Systems
  • Anterior Thoracolumbar Plate Systems
  • Anterior Lumbar Interbody Fusion (ALIF) devices
  • Transforaminal Lumbar Interbody Fusion (TLIF) devices
  • Posterior Lumbar Interbody Fusion (PLIF) devices
  • Axial Lumbar Interbody Fusion (AxiaLIF) devices
  • Interspinous Process Spacer (ISP)
  • Cervical Artificial Discs
  • Lumbar Artificial Discs
  • Vertebroplasty
  • Balloon Kyphoplasty
  • Allografts
  • Demineralized Bone Matrix (DBM)
  • Bone Morphogenetic Proteins (BMPs)

This growth will be driven by a number of factors, including:

  • The aging population worldwide
  • Increasing incidence of obesity
  • A growing middle class in developing countries, with the ability to pay out of pocket for spine surgery
  • Improving worldwide economy
  • Technological device enhancements, leading to improved surgical results
  • Developments in minimally invasive spine surgery (MISS) devices driving a strong increase in MISS, with its numerous advantages
  • In the US, improvements in reimbursement as clinical trials demonstrate the efficacy of treatments using the devices
  • US healthcare reform leading to medical insurance coverage for more people, allowing those suffering from intractable back pain to receive surgical treatment

Based on the CAGR (2011-2020), the fastest growing segment is forecast to be a lumbar interbody fusion devices, and followed by Cervical Artificial Discs, Lumbar Artificial Discs with a CAGR of 10.9%. The overall lumbar disc market is driven by improved discs, an increased number of orthopedic surgeons trained and experienced in total disc replacement (TDR), and the growth of baby-boomer and younger patients who wish to remain active and seek treatment for degenerative disc disease (DDD).

The largest single segment in 2010 was Posterior Pedicle Screw Fusion Systems, followed by Demineralized Bone Matrix (DBM). In 2020, Posterior Pedicle Screw Fusion Systems is predicted to continue to be the largest single segment, followed by Cervical Artificial Discs.

In 2010 (Exhibit shown in Report #M520), the largest segment was Posterior Pedicle Screw Fusion Systems, which accounted for around 21.5% of the total market. This was followed by DBM, Allografts and Bone Morphogenetic Proteins (BMPs). The other product segments accounted for decreasing percentages of the entire global market. 

By 2020 this picture is predicted to change dramatically. Although the largest segment in terms of revenue will continue to be Posterior Pedicle Screw Fusion Systems, by the end of the forecast period the runner-up is expected to be Artificial Cervical Discs with almost half the market revenues. Cervical Discs will be followed by DBM, then Allografts. BMPs, which accounted for a significant share of the 2010 revenues, will fall in share substantially by 2020. 

Because their markets are much larger, the CAGRs for Cervical Artificial Discs and for Lumbar Artificial Discs are of greater interest to current and potential market particiopants. Together, these segments will see significant growth during the forecast period as the technology improves and as surgeons become trained in and accustomed to the procedures and devices.

There are several conditions which are often treated using spine surgery. Degenerative spinal conditions indicate gradual deterioration of tissues or structures over time.  The following table presents four commonly diagnosed degenerative diseases of the spine.

One of the largest in terms of sheer numbers is degenerative disc disease (DDD.)  The stresses and microtraumas associated with lumbar degenerative disk disease (LDDD) degrade the many structures that stabilize the spine, from the bony architecture to the intervertebral discs to the complex array of supporting muscles and ligaments. The back pain associated with DDD occurs with equal frequency among men and women, with peak incidence occurring around the age of 40. The condition accounts for more lost productivity than any other, with estimates running around 89 million lost work days per year. According to the US National Center for Health Statistics, 14.3% of new patient visits to primary care physicians are for lower back pain, and about 13 million physician visits are made in connection with back pain complaints.

Osteoporosis is another disease which often leads to some spine surgery procedure. Osteoporosis, a systemic skeletal disorder characterized by low bone mass and loss of bone tissue, leads to weak and fragile bones. People with osteoporosis are at increased risk of fractures, especially in the hip, spine, and wrist. Women make up 80% of all osteoporosis sufferers. A collapsed vertebra might manifest itself in severe back pain, loss of height, or in spinal deformities such as the stooped posture characteristic of kyphosis. Worldwide, according to the International Osteoporosis Foundation, the disease affects about 1 in 3 women and about 1 in 8 men. In Type I and Type II osteoporosis, women are affected more often than men. Both sexes exhibit equal incidence for Type III.

According to figures supplied by the National Osteoporosis Foundation, the estimated national direct expenditures for osteoporosis totaled $17 billion in 2001. By 2020, the cost of fall injuries is projected to reach $32.4 billion. The incidence of osteoporotic fractures—and the costs associated with them—increase with age. As life expectancy increases for much of the world’s population, these costs are expected to multiply exponentially.

US Census Bureau estimates show that, in 2010, about 14% of the US population, or about 39.7 million people, had reached the age of 65 or older. By 2030, this percentage is forecast to increase to about 20% of the population, or approximately 70.3 million. By 2050, the forecast predicts nearly 82 million people in the USA will be 65 or older.

In terms of share of global revenues (and as illustrated in Report #M520), Medtronic leads with [a commanding share] of the overall market. For the products considered in this report, Synthes (now owned by JNJ) and DePuy (JNJ) follow, with about 15% and 13% share, respectively. Stryker follows with 12%. Zimmer has about 9% of the 2010 market, while NuVasive is fast coming up and currently registers about 2% of the market. Cook also holds about 2% share of the markets included in this report. There are hundreds of other companies which together account for the remaining 4% of this market.

 

Global-spine-pie

 

 


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Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020 (Report)

Published July 2011. This MedMarket Diligence Report #M520 is a detailed worldwide market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine as outlined in the following table of contents. The report describes the diseases and disorders of the spine, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. This report details the currently available products and technologies, and the manufacturers offering them, for posterior pedicle screw fusion systems, anterior cervical plate systems, anterior thoraco-lumbar plate systems, anterior lumbar interbody fusion, transforaminal lumbar interbody fusion, posterior lumbar interbody fusion, axial lumbar interbody fusion, interspinous process spacer systems, cervical artificial discs, lumbar artificial discs, vertebroplasty, balloon kyphoplasty, allografts, demineralized bone matrices, and bone morphogenetic proteins. The report details the products and technologies under development and markets for each in spine surgery. The report provides a current and ten-year forecast by region/country of procedures, unit sales, average selling price and manufacturer revenues for, specifically, Americas (USA, Canada, Mexico, Brazil), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Australia/New Zealand) and Rest of World. The forecasts address product- and country-specific impacts in the market of new technologies through the coming decade. The report profiles 46 key companies in this industry, providing data on their current products, current market position and products under development.  

For a complete description, table of contents a list of exhibits for this report, see http://mediligence.com/rpt/rpt-m520.htm

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Spine surgery is an exception to the usual country market rules

A great many markets for medical technologies have similar market drivers, economics, regulatory restraints and other features, resulting frequently in market sizes that can be fairly accurately predicted on the basis of population.  Hence, U.S. markets are often a consistent size relative to European markets. 

Spine surgery device markets are a decided exception to this rule.

Source: MedMarket Diligence, LLC; Report #M520.

 

Numerous facets of the underlying market size determinants for America and Europe for spine surgery devices are just plain different.  Reimbursement levels are different (and changing), regulatory policies have trended in different directions at varying paces, clinical practice patterns are influenced by local variables — the result is surprising variability in the relative market size of spine surgery device markets in the Americas and the European Union.

(This is only a consideration of the Americas and Europe.  Individual European countries also vary from the European aggregate. Further, spine surgery device markets in China, Japan, India, Australia and other countries have their own unique drivers.)


Global markets for spine surgery devices are the subject of the July 2011 MedMarket Diligence, LLC, Report #M520.  

The MedMarket Diligence report #M520, "Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020", is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine as outlined in the following preliminary table of contents. The report describes the diseases and disorders of the spine, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. This report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in spine surgery. The report provides a current and ten-year forecast by region/country of procedures, unit sales, average selling price and manufacturer revenues for, specifically, Americas (USA, Canada, Mexico, Brazil), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Australia/New Zealand) and Rest of World. The forecasts address product- and country-specific impacts in the market of new technologies through the coming decade. The report profiles 46 key companies in this industry, providing data on their current products, current market position and products under development.