MZOR: Mazor Robotics (OTC:MZRTF) Analysis and Research Report

2018-03-23 - by Asif , Contributing Analyst - 289 views

Important Note
Fintel Research Reports are free Wikipedia-style reports that are created and edited by people just like you. If you are an expert on a company and would like to help your fellow investors make more informed investing decisions, then you should become a Fintel Contributing Analyst. To do this, register on the site, message us in the online chat, and we will get you started.

Overview

Mazor Robotics is a medical device company developing and marketing innovative surgical guidance systems and complementary products. The company's expertise is computerized and imaging-based systems, primarily in the field of spine surgery. The company's Surgical Guidance Systems enable surgeons to advance from freehand surgical procedures to accurate, pre-planned, state-of-the-art, precision guided procedures. The company's Surgical Guidance Systems are used in multiple types of spine surgeries, whether open or minimally invasive, for a variety of clinical indications. The company's Mazor X System, its Renaissance system and its predecessor have been used in over 24,000 spine surgeries, including fusion, correction of spinal deformities, biopsy collection, tumor excision and cement augmentations. The company's Surgical Guidance Systems have the ability to improve clinical outcomes for patients, and may provide a safer surgical environment for surgeons and operating room staff by possible reduction of exposure to radiation.

The key elements of the Renaissance system include its RBT Device, which is a portable, computer-controlled Stewart platform that spatially positions and orients surgical tools, its Renaissance Work Station, houses its proprietary software, and several mounting platforms Mazor Robotics has designed to serve as an interface between the patient and the RBT Device. The core guidance technology implemented in the Renaissance system enables surgeons to perform procedures with a higher degree of accuracy and precision compared to the current freehand standard of care. A pre-operative plan for each patient is developed by the surgeon using its proprietary software based on a standard three-dimensional, or 3D, computed tomography, or CT, image. The surgeon performs the procedure using surgical tools attached to the RBT Device and is guided by the RBT Device to a precise location and trajectory along the spine or in the brain in accordance with the pre-operative plan. At the beginning of the surgical procedure, an automatic 3D synchronization process independently registers the location of the system relative to the position of the patient's spine or in his brain and the pre-operative plan. Unlike conventional robotic surgery, where the robot performs the procedure guided by the surgeon, the Renaissance system guides the surgeon who performs the procedure in accordance with the pre-operative plan.

The Renaissance system is FDA–cleared, CE–marked and has regulatory clearances in several other markets, including China, Taiwan, Thailand, Canada, Russia, Singapore, Israel and Australia.

The Mazor X platform builds on the core technology of the Renaissance and the cumulative experience in the operating room, with expanded features and capabilities. Key features of the Mazor X are sophisticated 3D planning software and advanced algorithms running on a workstation and a guidance system. The guidance system includes a surgical arm, an integrated 3D camera with spatial tracking and a surgeon control panel in the sterile area. The Mazor X system's platform integrates three processes: pre-op analytics, intra-op guidance, and intra-op verification. Pre-op analytics are performed using cutting-edge anatomy recognition abilities for surgical visualization and imaging-based 3D implant and trajectory placement planning. The planning may take place prior to the surgery or during the surgery using scan & plan, if a 3D image system is available in the operating room. Intra-op guidance utilizes precision mechanics and the surgical arm to guide tools and implants according to the surgical plan. Before instrumenting, the Mazor X eye camera provides intra-op verification of the surgical arm trajectory and position. Once verification is complete, the surgical arm and drill guide keep tools and implants on target for each trajectory. This process continues until all trajectories have been reached and implants are inserted safely and accurately into their planned position.

In September 2015, the company received 510(k) clearance from the FDA for the Mazor X system and Mazor Robotics is pursuing CE clearance which the company expect to receive in 2017.

In April 2017, the company received 510(k) clearance from the FDA for the Mazor X Align software, a spinal deformity correction planning software for the Mazor X system.

Mazor Robotics' products are currently active in 15 countries, with 12 distributors representing it in 18 countries.

Industry Overview - Spine

Spine Disorder Market Overview

Spine disorders are a leading driver of healthcare costs worldwide. Spinal disorders also are a leading cause of disability among people aged between 19 and 45 in the United States, and are the most common cause of job-related disability. Spine disorders afflict women and men equally and are the second most common neurological ailment in the United States - only headaches are more common. In the United States, according to the Orthopedic Network News, there are approximately 1.48 million spinal operations performed annually.

The company believe the spine disorder market will continue to grow as a result of a growing, aging and more active population and rising obesity rates, which all are expected to be key drivers in the continued growth of incidence of spine disorders. The U.S. Census Bureau projects that the 65 and older age group in the U.S. will almost double from 48 million in 2015 to 88 million in 2050. In addition, improvements in healthcare have led to increasing life expectancies worldwide and the opportunity to lead more active lifestyles at advanced ages. These trends are expected to generate increased demand for spine surgeries.

Overview of Spine Disorders

Spine disorders range in severity, causing symptoms ranging from mild pain and loss of feeling to extreme pain and paralysis. These disorders are primarily caused by degenerative disc diseases, stenosis, deformity, osteoporosis, tumors and trauma.

      

  • Degenerative disc disease describes the most common type of spine disorder which primarily results from repetitive stresses experienced during the normal aging process. Disc degeneration occurs as the outer layer starts to shear and the inner cores of intervertebral discs lose elasticity and shrink. Over time, these changes can cause the discs to lose their normal height and shock-absorbing characteristics, which leads to back pain and reduced flexibility. Herniated discs are a common form of degenerative disc disease.
  • Lumbar stenosis is a condition whereby either the spinal canal or vertebral foramen becomes narrowed in the lower back impinging the nerves in the lumbar spine. This condition is often caused by the degenerative processes in the spine and the resulting compression can lead to back and leg pain. If the narrowing is substantial, it causes compression of the nerves and the painful symptoms of lumbar spinal stenosis.
  • Spine deformity is a term used to describe any variation in the natural curvature of the spine. Natural curves help the upper body maintain proper balance and alignment over the pelvis. Common forms of deformity include scoliosis, which is a lateral or side-to-side curvature of the spine, and kyphosis, which is an abnormal concave curvature leading to a rounded (humped) back.
  • Vertebral compression fractures are fractures of the vertebrae that result in the collapse of the vertebral body. These fractures, which can be very painful to the patient, are often the result of osteoporosis, which causes the vertebrae to weaken and become brittle, or spine tumors, but can also result from trauma.
  • Primary spine tumors are relatively rare. Benign tumors are typically removed surgically while malignant tumors are more difficult to treat and are often metastases which originate from tumors in other organs.

Current Treatments for Spine Disorders

Treatment alternatives for spine disorders range from non-operative conservative therapies to surgical interventions. Conservative therapies include bed rest, medication and physical therapy. Surgical treatments for spine disorders can be instrumented, which include the use of implants, or non-instrumented, which forego the use of any such implants. The most common instrumented treatment is spinal fusion, where two or more adjacent vertebrae are fused together with implants to restore disc height and provide stability.

Introduction of Minimally Invasive Surgery

Over the past 30 years, minimally invasive surgical techniques have transformed many surgical procedures. Compared to traditional open surgical techniques, minimally invasive techniques potentially offer benefits for patients, surgeons and hospitals. For patients, these techniques can result in significantly reduced trauma, risk of infections, faster convalescence and better aesthetic outcomes. For the surgeon, these techniques can reduce procedure-related complications and have the potential to reduce risks associated with more invasive procedures. For the hospital, these procedures can result in reduced hospital stays due to faster recovery times, lower rates of complications and a higher level of patient satisfaction.

Despite the potential benefits of minimally invasive spinal surgery techniques, they can also present several notable limitations, including the need for additional training for the surgeon, increased intraoperative use of X-ray radiation, and longer operations, and have been shown in some studies to lower the accuracy of implant placement. As a result, while minimally invasive approaches have seen substantial adoption in various surgical fields where procedures can be performed within existing anatomical cavities, they are currently used in only 10-15% of spinal fusion procedures which are currently performed in a minimally invasive approach, according to the SRS database (Hamilton et al. Spine 2011) and the Orthopedic Network News report from October 2015.

Robot Assisted Surgery

The company believe that the application of robotics technologies in minimally invasive surgical procedures represents the next generation in the evolution of the surgical technique. These technologies are being developed to provide surgeons with a more precise, repeatable and controlled ability to perform complex procedures. With the assistance of robotic technology, an increasing number of surgeons have been able to perform procedures previously limited to a small subset of highly-skilled surgeons. In addition, robotic technology has enabled these procedures to be performed in a more minimally invasive manner, requiring only small incisions, which result in reduced procedure related trauma, fewer infections and post-procedure complications, and reduced recovery and hospitalization times.

The Limitations of Current Spine Procedures

Although minimally invasive techniques have been widely adopted in many fields of surgery, they have had limited adoption in spine surgery. The company believe that the principal barriers to the adoption of minimally invasive techniques for spine surgery are:

  

  • restricted or even no line-of-sight at the anatomical site;
  • cumbersome handling of surgical instruments, limiting the procedure;
  • dependence on two-dimensional imaging for three-dimensional surroundings; and
  • intra-operative exposure to radiation.

As a result, the majority of spine surgeries are performed freehand. According to a review of over 108,000 cases (Hamilton et al., Spine 2011) only 13.2% of spine surgeries are performed in a minimally invasive manner. This was echoed in a report by the Orthopedic Research Network reporting that cannulated pedicle screws (designed and used for minimally invasive spine surgeries) have hovered between 9-15% since 2008. Although freehand surgery allows for direct visualization of the anatomy, open freehand surgeries may result in:

  • increased procedure-related blood loss, pain and scarring at the incision site;
  • increased likelihood of complications, such as infections;
  • slower recovery times and longer post-operative hospital stays; and
  • undesirable aesthetic outcomes.

Industry Overview - Brain-

Neurosurgical Market Overview

It is estimated that 50 million Americans suffer from neurological illnesses, at an annual cost of over $450 billion in direct and indirect costs. Only a fraction of them are candidates for neurosurgical treatments, and fewer still require stereotactic brain surgeries. Based on demographic trends, it is forecasted that the volume of intracranial neurosurgical procedures will continue to grow at about 1.2% per year. But this statistic does not take into account changes in indications for surgeries and new treatment options. New indications may increase the market potential, while new, less-invasive, treatment options may decrease the market potential for open neurosurgical treatments. Costs of procedures are expected to grow, driven by more sophisticated technologies and treatment options.

In 2016, there were about 35,000 stereotactic brain surgeries performed globally, in about 2,800 medical centers, almost half of them in the United States. Currently, three procedures, namely Deep Brain Stimulation (DBS), Stereoelectroencephalography (sEEG), and Stereotactic Brain Biopsies, account for over 95% of the stereotactic brain surgeries market.

Overview of Brain Biopsies

The incidence of primary brain tumors for 2013 is estimated by the American Brain Tumor Association at almost 70,000 cases. Of these cases, almost 25,000 cases are malignancies and over 45,000 are benign. The majority of brain tumors are metastases from malignancies in other organs (mainly lung and breast), but statistics for brain metastases are not readily available. Therefore, the incidence of primary and secondary brain tumors is estimated at more than 140,000 cases annually.

In some of the cases, the CT- or Magnetic Resonance Imaging (MRI) generated images are insufficient for the determination of the appropriate treatment option. In such cases a biopsy is usually indicated. It is estimated by MedTech Insight that in 2010, 19,700 biopsies were performed and that the incidence of this procedure is slightly declining at about 1.4% annual rate.

Overview of Deep Brain Stimulation (DBS) Electrode Placement Surgeries

The FDA approved DBS as a treatment for essential tremor in 1997, later adding further indications, including Parkinson's Disease (2002), dystonia (2003) and Obsessive Compulsive Disorder (OCD) (2009). Several other indications are in various phases of research, like chronic pain, various affective disorders, including major depression, and other neurological disorders, mainly in severe cases and/or refractory to medication or other treatments.

In 2015, there were over 16,000 DBS surgeries globally, of which over 9,000 were performed in the United States. Parkinson's disease accounts for about 75-80% of the DBS surgeries, even though of the 1% of people over the age of 60 who are affected by Parkinson's disease, only 1 to 10% are eligible for DBS according to treatment guidelines. The DBS market was estimated at $493 million in 2014 and expected to grow at about 7% CAGR to $692 million in 2019.

Overview of Stereoelectroencephalography (sEEG)

Introduced in March 2009, by surgeons at the Cleveland Clinic, the objective of sEEG is to locate the epileptic focus/foci (point of origin) in cases refractory to conservative treatment that necessitate surgical intervention. The patients are frequently under 10 years old and remain hospitalized for monitoring for 1-2 weeks following the sEEG procedure. It is estimated that there are about 5,000 sEEG procedures annually, of which about 3,000 are performed in the United States, in about 300 medical centers. Medtech SA, which was recently purchased by Zimmer Biomet Holdings Inc., is considered the market leader in this procedure, with systems in 35 medical centers performing sEEG currently.

Current Neurosurgical Options

Treatment options for neurological illnesses range widely by diagnosis and disease state from "watchful waiting" to non-operative conservative therapies (e.g., medications), External Beam Radiation Therapy, and a number of surgical interventions.

When neurosurgical procedures are indicated, much care is taken to avoid damage to neighboring regions of the brain and the vascular system, as well as along the surgical pathway to the lesion. Careful planning of the surgical approach is based on advanced imaging modalities. Execution of the required precise spatial localization according to the surgical plan is performed using intra-operative guidance systems, which are generally categorized as either frame-based or frameless systems. Frame-based systems, or standard stereotaxy, are considered a more accurate option but, among their limitations are that they cumbersome to use, difficult to modify trajectories during surgery, and uncomfortable for the patient. Frameless trackable/fiducial marker-based systems use image guided navigation or patient-specific, custom-made mounts to improve accuracy.

The clinical benefits of Image Guided Surgery (IGS) include:

  • precision in lesion localization;
  • reduced risk of damage to adjacent vital structures;
  • enhanced ability to execute the surgical plan; and
  • allowing for less invasive surgical approaches.

According to MedTech Insight in 2011, the U.S. market for computer-assisted IGS intraoperative navigation systems (including hardware and software) was approximately $273.8 million in 2010, of which cranial/neurosurgery-attributable revenues were estimated at $76.7 million, with an estimated compound annual growth rate of 3.5%, reaching an estimated $91.0 million in 2015, reflecting the maturity and saturation of this market segment.

Of the 19,700 biopsies performed in 2010, about 17,000 were performed with a frame-based system and about 2,700 used a frameless system. It was estimated in 2011 that by 2015 frameless systems will be used more frequently in these procedures, from 13.7% of the cases to over 20%.

Of the 7,900 DBS procedures in 2010, about 5,200 were frameless procedures and 2,700 were frame-based. It was estimated in 2011 that by 2015 frameless systems will be used more frequently in these procedures, from 66% of the cases to over 75% by 2015.

An emerging market segment in brain surgery is robotic neurosurgical systems. Of the various developments and companies involved in this field there are 3 main players in this market segment which are commercially available: Mazor Robotics, Zimmer Biomet (Medtech) and Renishaw.

The Limitations of Current Neurosurgical Procedures

Frame-based systems limit the surgeon's movement and are difficult to redirect intra-operatively. The rigid frames are cumbersome for the patients and the complex set-up can make operating times longer.

Navigation based systems (e.g. Brainlab AG's VectorVision) depend on direct line of sight between an infra-red camera and specialized, reflective markers. These systems are considered to be less accurate by surgeons than frame-based systems. Their online representation of spatial location in real-time does not represent the actual location of the surgical instruments but rather the system's perception of the location of the instruments. The representation of the instruments in 3 planes can lengthen the learning curve of these systems as the surgeon needs to correct the position in a single plane in a three dimensional world.

The Mazor Robotics Solution

The company's Surgical Guidance Systems enable surgeons to advance from freehand surgical procedures to accurate, state-of-the-art, precision guided procedures. It has the ability to improve clinical outcomes for patients, may provide a safer surgical environment for surgeons and operating room staff by possibly reducing exposure to radiation, and deliver economic value to hospitals and payors. The company believe its Mazor X and Renaissance systems offer the following benefits to patients, surgeons and hospitals:

Potential Reduction in Surgical Complications and Revision Surgeries. Preliminary findings from a four-center, prospective, controlled study which were presented in professional spine conferences during 2016 have shown a statistically significant reduction in both complications and revisions. The data compares lumbar fusion surgeries of one to three levels in a minimally invasive (MIS) approach using the Renaissance system for guidance or fluoroscopy based-guidance. These findings have been echoed in a retrospective, comparative study by four surgeons who also found a statistically significant reduction in surgical complications and revisions. When they compared 403 fusion surgeries in which Renaissance was used in a MIS approach to similar procedures performed in a MIS approach with fluoroscopy-guidance in 228 patients and 78 case freehand in an open approach, the authors saw that the odds ratio of a surgical complication were 3.0 and 3.1, respectively. In other words, the risk of a complication was 3 times higher in the fluoroscopy and freehand arms of the study. When comparing surgical revision rates, the odds ratio for a revision was 3.8 times higher in the fluoroscopy-guided MIS group compared to the Renaissance-guided MIS procedures. These data have also been presented in professional spine conferences and are being prepared for publication in peer-review literature.

Reproducible Precision and Accuracy. Clinical studies performed with the Renaissance system have shown very high levels of accuracy, with most ranging between 98.5-100% accurately placed implants. By contrast, the scientific literature on accuracy of freehand implant placement varies; however, a meta-analysis of 12,299 thoracolumbar screws, published in Spine, demonstrated 90.3% of implants were placed accurately in freehand surgeries.

Use in a Variety of Procedures. The company's Surgical Guidance Systems are particularly advantageous in complex spinal procedures, such as the correction of scoliosis and other spinal deformities, long fusions and repeat/revision surgery. Precision and planning is of particular importance in complex procedures where accuracy and precision are a challenge for even the most experienced surgeons.

Possible Reduced Exposure to Radiation. Spine surgeries, particularly minimally invasive surgeries, require the use of high levels of X-ray imaging, and exposes surgeons and patients to harmful radiation. The use of its Surgical Guidance systems may significantly reduce the need for X-ray imaging during the surgery and provide for a safe overall surgical environment.

Ease of Use. The company's Surgical Guidance Systems leverage and complement the surgical skills and techniques already familiar to the surgeon. This familiarity in approach combined with greater accuracy and precision accelerates the learning curve, making it usable by surgeons with a broad range of training and skills.

Reduced Costs. The company believe the use of its Surgical Guidance Systems result in shorter hospital stays due to faster recovery times, lower rates of complications and a higher level of patient satisfaction.

Clinical Differentiation. The company believe the benefits mentioned above will help surgeons and hospitals differentiate themselves, attracting more patients to seek medical care from them, over competitors offering less innovative and precise alternatives.

The company's Strategy

The company's goal is to continue to drive sales of its Surgical Guidance Systems and generate recurring revenues through sales of disposable products and service contracts by establishing its Surgical Guidance Systems as the standard-of-care in the eyes of surgeons, patients and medical facilities. The company believe that the company can achieve this objective by working with hospitals to demonstrate the key benefits of the Mazor X and Renaissance systems. The company's strategy includes the following key elements:

  

  • Continue to commercialize its Surgical Guidance Systems globally. The company continue to focus on commercializing its Surgical Guidance Systems by expanding its sales and marketing infrastructure through internal resources and externally through arrangements, such as through the Medtronic Agreement s. Mazor Robotics has a presence in more than 150 hospitals in 14 countries, including over 100 Surgical Guidance Systems installed in the United States. Within the United States alone the addressable market includes over 2,000 hospitals and surgical centers, creating significant opportunity for it to expand its presence and accelerate its revenue growth.
  • Drive utilization of its installed base of its Surgical Guidance Systems. Following the initial installation of its Surgical Guidance Systems at a given hospital, the company take steps to expand the number of surgeons who use its system and work with the hospitals and their surgeons to promote patient education on the benefits of its Surgical Guidance systems. Increased usage of its installed Surgical Guidance Systems through surgeon education and training accelerates its recurring revenues through increased sales of its disposable products. The company also intend to include in its product offerings end-to-end solutions that address more steps in Spine surgical procedures. This is expected to increase its portfolio of disposable and ancillary product offerings and to promote the use of its Surgical Guidance Systems.
  • Demonstrate the clinical and financial value proposition of its Surgical Guidance systems. Following its overall penetration strategy, the company installed systems at leading academic centers and entered new U.S. metropolitan area markets. The company intend to collaborate with leading surgeons and early-adopting hospitals to build additional data that supports the clinical and financial benefits of its Surgical Guidance systems. The company intend to demonstrate that using its Surgical Guidance systems promotes and differentiates surgeons and hospitals as leaders for the treatment of spine disorders, while demonstrating to hospitals the financial benefits of its Surgical Guidance systems.
  • Invest in research and development. The company will continue to make significant investments in research and development including investments to upgrade the hardware and software components of its Surgical Guidance Systems and to develop additional applications using its proprietary technologies and to develop future products. In addition, as part of the Medtronic Agreement s the company intend to collaborate with Medtronic to further develop additional innovative solutions with its Mazor X system in combination with Medtronic product offerings for spine applications.
  • Explore new ways to accelerate adoption of its products. The company intend to achieve this by striving for partnerships with strategic players and to gain the benefits associated with the synergy between Mazor and potential partners.
  • Explore new ways to utilize its core knowledge and intellectual property to enter new applications. The company intend to achieve this by its continued effort of its research and development team and potentially with synergy between Mazor and potential partners in areas out of spine surgery.

The company's Products

Components of the Mazor X system - A surgical assurance platform for spine surgery, integrating data sources, analytical tools, guidance and imaging technologies to maximize procedure predictability and patient benefit. The Mazor X system, which is based on the same core guidance technology as the Renaissance, expands beyond trajectory guidance to address additional needs of spine surgeons and their patients.

The Mazor X Platform includes:

       Mazor X Guidance system including the following key components:

  • A precision Surgical Arm - The Surgical Arm comprises a set of links, joints and motors. With its unique design and innovative structure, the device has six joints, each with its own range of motion enabling the arm to reach a wide variety of trajectories. The Surgical Arm is controlled by the Mazor X Workstation computer and a Central Control Unit. Arm movement is as a result of the surgical plan (described below) and is monitored in a closed loop controlling process.
  • An integrated 3D camera with spatial tracking – The Mazor X-Eye camera provides positioning verification and enables tracking functionality. The surgeon activates the tracking features using on-screen controls.
  • surgeon control panel in the sterile area – The surgeon's screen is a table-type LCD mounted on a movable screen arm located at the top of the surgical system. Use of this multi-touch screen provides the surgeon with a close and convenient method of interaction with the system. Information displayed on the surgeon's screen and Workstation monitor is dynamically updated in real-time, simultaneously.
  • Mazor X Workstation running sophisticated software and algorithms and including a large touch screen serving as a surgeon control panel, hardware components and storage for the Guidance System when not in use. The Workstation is the main console from which the user interacts with the Mazor X system. The Workstation is a compact, fully-portable unit that facilitates easy mounting of the Surgical Arm onto an operating room table in preparation for an operation.
  • Specialized applications that will run on the Mazor X platform (under development).
  • Mazor X Spine Disposables. Mazor X disposable kits are designed to easily adapt the surgical arm to a multitude of surgical applications and for the different mounting platforms utilized by the surgeon.
  • Mazor X Spine Accessories. Mazor X accessories include trays of reusable surgical tools.

Surgical Workflow using Mazor X system

Surgical workflow using Mazor X involves the following basic 3D Planning and Intra-Operative steps:

  • 3D Planning
  • Pre-Op Analytics – 3D Planning is performed using cutting-edge anatomy recognition and vertebral segmentation algorithms for surgical visualization based on a patient's images. The resulting Surgical Plan includes implant and trajectory placement planning. The Surgical Plan may be created prior to the surgery or during the surgery using Scan & Plan.
  • Scan & Plan– Utilizes 3D intra-operative imaging systems, such as a Medtronic O-Arm system, to perform a patient scan that is then used to create the surgical plan instead of a pre-op CT. Scan & Plan is especially useful in trauma cases or when a pre-op CT is not available.

Mazor's "PRO" Solutions

In October 2015, the company launched the ‘PRO’ (Predictable Renaissance® Operation) Solutions at the annual meeting of the North American Spine Society (NASS) which was held in Chicago, IL. The PRO Solutions are designed to support Renaissance procedures and include:

PROceph Brain Procedures

Mazor Robotics has developed the Renaissance Brain Module, a new application of its Renaissance system intended to provide precise control over the insertion of surgical instruments (drills, cannulas, electrodes, needles, etc.) during brain surgery. The Renaissance Brain Module can be used for guiding high accuracy linear trajectory into the brain. The company's head-mounted Renaissance Brain Module was cleared by the FDA in July 2012 and CE-marked in August 2012. The company initially launched the Renaissance Brain Module at the annual meeting of the American Association of Neurological Surgeons in April 2014.

The Renaissance Brain Module utilizes a small, frameless platform with three points of fixation to the skull to provide highly accurate access to the areas of the brain where surgical intervention is needed. This helps to minimize incisions and scarring while providing surgeons with high versatility in their surgical approach as well as facilitating intra-operative changes of trajectories.

Surgical workflow using the Renaissance Brain Module for brain surgery involves four basic steps:

pre-operative planning;

  • attachment of hardware;
  • synchronization; and
  • surgical execution.

Seasonality of Business

While its business is growing and changing rapidly, the company believe it is subject to quarterly seasonal fluctuations because of customary capital expenditure trends by hospitals due to various hospital budget considerations which are not in its control. Hospitals tend to group purchases at the beginning of their budgetary cycle, which is different among hospitals. Therefore, it is hard to predict results of a certain quarter and some quarters may be weaker than others. For the year ended December 31, 2016, no single hospital customer accounted for more than ten percent of its total revenue and the loss of any single hospital customer is not expected to have a material adverse effect on it.

Recent development

January 8, 2018 – Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic systems, expects to report record revenue of approximately $65 million for the full year ended December 31, 2017. In addition, the Company expects to report record revenue of approximately $19 million for the fourth quarter, which is the Company’s strongest quarter for system orders and revenue.

In the fourth quarter of 2017, the Company received purchase orders for 27 robotic guidance systems. This is the first full quarter since Medtronic assumed exclusive worldwide distribution of the Mazor X™ system for spine surgeries, as part of the second phase of the commercial agreement between the companies.

The 27 orders are comprised of:

24 Mazor X systems, of which 23 were ordered by Medtronic. Three Renaissance system purchase orders from a U.S. customer and distribution partners in Germany and Thailand

The Company’s system backlog on December 31, 2017 was 16 systems (14 Mazor X and two Renaissance systems).


Comments

Add a Comment

Asif - 2018-03-23

March 2018 investors presentation can be found here https://www.mazorrobotics.com/images/InvPresentations/Corporate_Presentation_March%202018.pdf