15 Feb It’s Time for a Robot Uprising in the Spine Surgery Market
The growing incidence of posture induced back pain, age related spinal degeneration, rising incidences of spine related accidents and rapid technological advancements will propel the growth in the Spinal Surgery Products market which is projected to reach $16.7 billion by 2025 from $10.2 billion in 2016, according to a study by Transparency Market Research.
Chronic Back pain is the fifth leading cause of hospital admission and the third most common reason for surgery in the U.S alone. Owing to the advancement of minimally invasive surgical options which reduce the cost of surgery, discomfort and improve recovery time, this segment of the market along with Fusion Sector are poised for rapid expansion.
The biggest challenge that the industry is facing is the inordinate time for product approvals and medical device failures. In addition lack of success in clinical trials is preventing novel treatment ideas from reaching fruition which in turn is hindering the industry from reaching its full growth potential.
However, the industry is in store for some path-breaking innovative solutions that are being developed to overcome the limitations of existing therapeutic and surgical options.
Here are some companies that are using robotic assisted surgery options as well as newer and better implants that are minimally invasive and high quality as well.
OZOP Surgical (OTCPK: OZSC)
Market Cap: $25.87M; Current Share Price: 0.89 USD
The company which invents, develops and manufactures cutting edge endoscopy instruments, surgical implants, devices, instrumentation and related technology targeted towards spine, neurological and pain management procedures aims to disrupt the market with its innovations that can result in significant savings in cost, time and recovery for providers and patients as well.
Most spine surgeries involve complicated procedures and large incision sites that take an inordinate amount of time for surgery and recovery and can cause pain, complications and down-time or immobility. The company’s proprietary Minimally Invasive Procedures (MIP) can overcome these limitations by way of smaller incisions, less collateral tissue damage leading to shortened hospital stays and faster recovery times. It also helps in lessened instances of post-operative infections, minimal scarring and reduction in the cost of surgery.
A typical Anterior Lumbar Interbody Fusion (ALIF) is often larger than 12 inches, no company until now has been able to offer a minimal invasive endoscopic fusion with a potential 8 mm incision except for OZOP’s proprietary Balloon Lumbar Interbody Fusion (BLIF), that can easily accommodate a endoprosthesis or spinal implant down the working channel of an endoscope in a fluid state, which then solidifies upon being secured in place.
Balloon Lumbar Interbody Fusion (BLIF) allows the company to produce an implant of any size, shape or dimensions using the balloon as a mould to emulate the shape of the ultimate implant, it is made with a material that is in a flowable form which then hardens when it is securely in place. It is far less invasive than traditional surgical options, costs much less than an Anterior Lumbar Interbody Fusion (ALIF) can be performed as an outpatient procedure and can easily be done under a simple nerve block or local anesthesia.
OZOP and its subsidiary, Spinus LLC, offer complete MIS solutions besides FDA approved traditional spine surgery products such as spine endoscopes, forceps and graspers, Endoscopic Kerrison, ACDF, Cervical Plates, ALIF, Buttress Plate, PLIF, TLIF, Pedicle Screw, Cross Connector, etc.
The company has a strong intellectual property rights portfolio which it plans to leverage to introduce first – in-class MIP products. In the pipeline are visualization tools for MIS involving light filtration using 3D technology that can give better depth perception , improved anatomical view and surgical performance and a first-in-class Interbody Device and Fusion Procedure that can truly revolutionize the orthopedic device and procedure space.
Mazor Robotics (acquired by Medtronic plc in 2018)
Mazor Robotics, a company recently acquired by Medtronic plc (NYSE: MDT), uses a combination of 4 key technologies to provide precise surgical procedures.
It uses Precise Surgical Planning suite for a 3D analysis of surgical plans by creation of a blueprint that helps eliminate surprises. Anatomy Recognition Engine uses advanced algorithms to recognize anatomical features to get accurate vertebral segmentations and alignment calculations. This is followed up by use of Patient Connection Platform that can firmly fix the robotic arm to the patient’s skeletal anatomy ensuring patient-machine unity and accuracy during operation. Lastly, it uses Cross Modality Image Registration to analyze images from varied body positions e.g. pre-op CT with Intra-Op Fluoroscopy.
As part of its Precision Guidance Technology, the company offers Mazor X™ Robotic Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System (Renaissance), targeted at various stereotactic brain procedures. It provides highly accurate access to the brain and spine, and is a frameless platform with a 360 degree working volume that allows surgeons to change trajectories intra-operatively. The technology has numerous applications such as minimally invasive and percutaneous degenerative repair, pedicle screw fixation for complex spinal deformity, and vertebral augmentation.
The company merged with Medtronic Plc in December 2018 for approximately $1.64 billion. Medtronic is a market leader in spine implants, navigation, and intra-operative imaging technology which when combined with Mazor’s robotic-assisted surgery (RAS) systems, will allow Medtronic to offer a fully-integrated procedural solution for surgical planning, execution and confirmation according to a company statement.
Medtronic has already launched its Mazor X Stealth robotic-assisted spinal surgical platform that combines its stealth software along with Mazor’s Robotics Mazor X robotic-assisted surgical platform in the U.S in January 2019.
As of September 30, 2018, cash, cash equivalents and investments totalled $107.6 million, according to the company’s Q3 2018 financial statements.
NuVasive (NASDAQ: NUVA)
Market Cap: $2.55 B; Current Share Price: 49.55 USD
NuVasive is a leader in spine technology industry. The company’s focus is on developing minimally invasive procedural solutions for the spine using its surgical platform named Maximum Access Surgery (MAS) that is an improvement over traditional surgery. Its industry-leading XLIF procedure is used for treating a number of conditions ranging from complex spinal deformity to degenerative spinal conditions.
Besides reducing radiation emission through its Lessray feature that can capture low-dose fluoroscopic images, its Integrated Global Alignment (iGA) platform is designed to achieve global alignment in spinal procedures that will ensure surgical efficiency and optimal spinal alignment.
The iGA platform is used for a wide variety of applications such as Thoracolumbar and Cervical lordosis. Its NVM5 platform is a set of intraoperative technologies specifically designed for spine surgery, that include multimodality monitoring of the spinal cord and nerves and spinal rod-bending technology Bendini®. The company believes in offering solutions that are comprehensive and can deliver measured outcomes for their partners.
NuVasive’s Lateral lumbar interbody fusion (XLIF), a minimally invasive surgical procedure has varied applications such as XLIF ® CORPECTOMY. In addition, the company offers various other solutions such as Posterior Cervical Fusion, Anterior Cervical Discectomy and Fusion, MAS® PLIF, MAS® TLIF, ALIF, IGA®, Posterior Fixation, the Magec System for pediatric deformity and the Precise system for limb strengthening.
The company offers treatment solution encompassing conditions such as degenerative disc disease (DDD), lumbar spinal stenosis, degenerative spondylolisthesis, adult degenerative scoliosis, cervical disc degeneration, back pain, early onset scoliosis and limb length discrepancy. The company also provides clinical services for Interoperative Nuero Monitoring (IOM).
As per its preliminary unaudited Q4 2018 results, the revenues are expected to be approximately $288 million and the full year revenue is estimated to be $1,102 million for the period.
RTI Surgical (NASDAQ: RTIX)
Market Cap: $283.04M; Current Share Price: 4.46 USD
RTI is dedicated to offering best-in-class biologic, metal and synthetic implants for application in orthopedic, sports, spine, dental surgeries and trauma procedures. Its proprietary, TETRA fuse 3D technology consists of a 3D printed interbody material featuring a nano-rough surface showing deeper implant osseointergration with antibacterial characteristics uniquely combined in one radiolucent bone-like material.
The company recently celebrated its 20th anniversary in the surgical implant field along with reaching a milestone of providing 8 million biologic implants with zero-confirmed incidences of implant-associated infections. The company offers tissue allografts, metal implants, synthetic bone grafts and xenografts.
RTI has won the 2018 Orthopedics This Week Spine Technology Award for its TETRAfuse® 3D Technology.
RTI acquired Zyga technology Inc., a company producing minimally invasive devices for the lumbar spine and known for its proprietary SImmetry® Sacroiliac Joint Fusion System. The company entered into an exclusive agreement with Aziyo® Biologics to develop and distribute ViBone®, a bone repair product that can replicate an autograft in orthopaedic procedures. It is also acquiring Paradigm Spine LLC, a leader in motion preservation and non-fusion spinal implant technology in a cash and stock transaction valued at up to $300 million, consisting of $150 million at closing plus potential future milestone payments.
The company has a patent for assembled bone implants issued by the USPTA in 2002.
As per the company Q3 financial results, the company reported revenues of $69.1 million, a 4% increase over the same quarter last year and a net income of $2.9 million, inclusive of $0.9 million of net non-recurring income during the period.
Zimmer Biomet (NYSE: ZBH)
Market Cap: $24.6B; Current Share Price: 120.58 USD
A pioneer in the musculoskeletal space, Zimmer Biotech is committed to the design, production and marketing of orthopaedic reconstructive products to be used in sports medicine, biologics, extremeties and trauma surgeries. The company was formed as a result of Zimmer holdings acquiring Biomet in 2015 for $14 billion. Together they now offer comprehensive muscoskeletal treatment options right from intervention treatments to complex surgical procedures.
In January 2019, FDA cleared the company’s robot-assisted total knee replacement surgery ROSA Knee based on its proprietary X-Atlas™ imaging protocol that uses 3D pre-operative planning tools and real time intraoperative data on soft-tissue and bone anatomy for accuracy and precision and restoration of natural joint movement. The product leverages on Zimmer Biomet’s ROSA Robotics platform including ROSA Brain for neurosurgical procedures.
The company uses its novel technologies namely, Prolong Highly Crosslinked Polyethylene and Trabecular Metal technology, to offer a range of products such as NexGen Gender Solutions LPS – FLEX for knee arthroplasty, Patello – Femoral Joint (PFJ) system for partial knee systems, knee components such as Trabecular Metal CR/LPS Monoblock Tibia and Femoral and Tibial Cone Augments in addition to a plethora of products for knee revisions, knee instrumentation etc.
It entered into a collaboration with Apple Inc. for development of mymobility™, an app that allows patients undergoing knee and hip replacement surgeries to connect with their surgical care teams, that will help them improve their outcomes and the overall standard of care. The app allows for surgeons to continuously provide care and guidance based on the metrics derived from the patients Apple watch, including sending reminders for scheduled therapy.
As per the company 2018 Annual report, for the full-year 2018, net sales were $7.933 billion, an increase of 1.7% over the prior year. In Q4 2018, the company paid $49.0 million in dividends at $0.24 per share.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.