Alongside the industry’s top companies are many orthopedic device manufacturers with novel offerings that are worth shining a spotlight on. While this issue’s Top 10 focuses on the highest revenue-producing organizations in this technology sector, the following six firms have garnered the attention of the editors for their innovative offerings, technology advancements, or unique products. 

eCential Robotics & ONWARD Medical

Sam Brusco • Associate Editor

Robotic surgery and spinal cord stimulation technologies are well-established in the orthopedic device industry. As such, it can be difficult to break into the respective markets—something truly groundbreaking must be invented to make a splash in the industries.

Typically, if a company offers robotic assistance for orthopedic surgery, it must also be paired with that company’s implant. A number of firms offer spinal cord stimulators to manage chronic pain, so a new indication must be pursued in order to have success.

The two companies I selected as those to watch have broken away from these ideas and created technology poised to disrupt markets and truly benefit patients. 

Implant-Agnostic Surgical Robotics

First entitled Surgivisio, the company came to be in 2009 in Grenoble, France. Surgivisio was founded by Stéphane Lavallée with the mission to unify 2D/3D robotic imaging, real-time navigation, and surgical robotics in minimally invasive surgery with a universal option open to all screws.  

The platform is an implant-agnostic solution enabling surgeons to use their choice of system, designed to expand to a wide range of surgical applications and connect to commonly used 2D/3D imaging devices. The platform aims at becoming a standard in the OR, covering all neuro-musculo-skeletal procedures and targeting profitable shared use of the platform across hospital departments.  

The first prototype of the imaging and navigation system followed in 2014. Three years later, the system obtained CE mark certification and made its world premiere at Grenoble Alpes University hospital that same year.  

In 2018, Surgivisio won the three phases of the BPI Innovation competition run by Bpifrance, an investor into innovation funds. Three years after that, the company was renamed eCential Robotics. That same year, eCential created two subsidiaries in Italy and U.S. and concluded its first German partnership with spinal surgery product maker SIGNUS.  

The company revealed its first FDA 510(k) clearance in September 2022 for the platform’s imaging, navigation, and robotics arm. eCential also initiated its first U.S. and French partnerships that year as well.  

The first of these collaborations was revealed in April 2022 with French lower limb orthopedics company Amplitude Surgical. The two began working on a joint robotic solution for knee surgery. Next came a partnership with U.S.-based spinal implant ChoiceSpine in June for spine robotic surgeries.  

Swiss-based spine implant maker Spineart and eCential announced their agreement in December 2022 for augmented spine surgery. The latest collaboration was revealed in October 2023, a co-development agreement with U.S.-based spine surgery solutions manufacturer Spine Wave.  

Clément Vidal was named CEO in mid-July, succeeding eCential founder Stéphane Lavallée. Vidal transition from the chief executive spot at Endocontrol, another surgical robotics firm.  

A few days later, the company also announced FDA clearance for its solution to plan and instrument spinal fusion procedures. The spine navigation and robotic-assistance device was developed in collaboration with Johnson & Johnson MedTech company, DePuy Synthes.

Bypassing Paralysis

ONWARD Medical was founded in 2015 by neuroscience researchers at the Swiss Federal Institute of Technology (EPFL). The Netherlands-based company hopes to create therapies to restore movement, function, and independence in people with spinal cord injuries (SCI). The company underwent an IPO in October 2021 and has received over $170 million in funding since its inception.

The company’s ARC Therapy consists of targeted, programmed spinal cord stimulation that’s used to restore movement and other functions in people with SCI. It mimics the natural pattern of nerve signals sent by the brain and when combined with voluntary efforts to move, allows motor control to be regained. The therapy also has the potential to improve management of internal functions like blood pressure regulation, as well as improved bowel and bladder control.  

The therapy is delivered in two configurations: transcutaneously through the skin (ARC-EX) or fully implantable (ARC-IM) technology platforms. ARC-IM also pairs with and implanted brain-computer interface to restore thought-driven movement via a wireless “DigitalBridge” in the ARC-IM-BCI application.  

ARC-EX touts FDA breakthrough status for both upper limb and mobility indications. Both of those indications have gone through pre-clinical and human proof-of-concept trials. The upper limb indication has also completed clinical feasibility and pivotal trials. ONWARD submitted a de novo application to the FDA for ARC-EX to restore upper extremity function in late March 2024 and expects to begin U.S. commercialization in the second half of this year.

The ARC-IM (implantable) spinal cord stimulation system. Photo: ONWARD Medical.

ARC-IM has pre-preclinical study data for blood pressure, mobility, Parkinson’s, and bladder indications—all but the Parkinson’s indication also have breakthrough status. The blood pressure, mobility, and Parkinson’s applications went through human proof-of-concept and clinical feasibility trials. Human proof-of-concept trials for the bladder indication are expected later this year.

ARC-IM-BCI has breakthrough designation for mobility and has undergone preclinical and human proof-of-concept studies. Its upper limb indication has preclinical and human proof-of concept studies under its belt. ONWARD also has a deep brain stimulation application (ARC-DBS) for mobility that has gone through preclinical and human proof-of-concept studies.  

The company plans to reveal detailed results from its Up-LIFT pivotal study this year after already revealing 72% of participants responded to ARC-EX therapy. ONWARD plans to apply for an FDA IDE approval and begin the Empower BP (blood pressure) global pivotal trial for ARC-IM in the back half of this year.  

The company also plans to work with the Michael J. Fox foundation this year to obtain more clinical data on ARC-IM-BCI for Parkinson’s disease.

---

OrthAlign & THINK Surgical

Sean Fenske • Editor-in-Chief

Many have traditionally referred to orthopedic care as an “artform” instead of a practice based in science. In reality, the mix was closer to including both as surgeons were more like craftsmen guided by science alongside “feel” and “technique.” Solid data or intelligent feedback was not available until they had a post-operative patient who could tell them how they felt or they could observe a person’s gait or range of motion following a procedure.   

Fortunately, this changed in recent decades as more smart innovations tipped the balance substantially toward the science aspect, leaving the art and feel behind. The following two firms are examples of those that provide intelligent solutions to surgeons to help ensure the accuracy of their procedures. These companies are putting the science into the hands of those who can wield it best for the greatest outcome. Further, they both allow for surgeon preference in an implant system. 

Balancing Act

OrthAlign provides its flagship product, the Lantern system, which guides surgeons during a knee or hip implant procedure to ensure they achieve a well-balanced result. Using the solution does not add steps or time to a procedure as it integrates with a typical surgical routine. In addition, the system can be used when placing the surgeon’s implant system of choice; they do not need to adopt a new brand or change company preference. 

Lantern offers surgeons a handheld navigation tool to ensure the precise alignment of implants. Photo: OrthAlign.

For a total knee or partial knee replacement, Lantern provides guidance on the resection plane for the distal femur and proximal tibia. In addition, gap balancing for total knee and revision procedures is also supplied to the surgeon. The navigation system provides a unique alternative to larger, more expensive robotic surgical solutions and is optimized for the rapidly growing ambulatory surgical center (ASC) space.   

In 2023, the company experienced a record year for annual revenue—$50 million—noting the technology was used in 56,000 procedures (a 27% rise and also a single-year record for the firm). Within the aforementioned ASC space, the organization enjoyed 37% revenue growth and added 25% more facilities to its customer base.   

“Technology adoption and the shift to the ASC in orthopedics are happening faster than ever and we firmly believe that it takes a portfolio of technologies to address the needs of the entire market. Robotics certainly has its place, but Lantern is the simplest, universal solution for surgeons transitioning from manual to technology-assisted total joints. Our results speak to that. Technology in every surgery is the future, and we’re here to help drive that transition,” stated Eric Timko, chairman and CEO of OrthAlign.   

In 2023 at the American Association of Hip and Knee Surgeons annual meeting, the company was awarded an Industry Innovation Award. The key factor that resulted in the receipt of the award, according to OrthAlign, was the addition of Lantern Balance to the system. The application expansion was designed to provide computer-assisted alignment and soft-tissue balance for accurate component positioning during partial and total knee arthroplasty.

Handheld Robot

A robotic surgical system for orthopedic procedures is almost commonplace at this point. The industry has such an offering from almost every major player in the sector, in addition to a number of smaller organizations supplying a solution of their own. While many of these robotic innovations provide similar capabilities and benefits, a few are noteworthy enough to raise the industry’s eyebrow (or that of an editor covering said industry). THINK Surgical is guilty of drawing such attention. 

While the organization’s TMINI Miniature Robotic System is held by the surgeon, it automatically compensates for the surgeon’s hand movement to locate bone pins along precisely defined planes. The surgical team can then connect cutting guides to the pins to ensure accurate bone resection in a total knee replacement procedure. The handheld device is used in place of several traditional instruments that would typically be called for in the surgery.   

In July 2024, the TMINI 1.1 software gained clearance from the U.S. FDA. The new offering added capabilities that enable surgeon choice throughout the procedure (TMINI is implant agnostic, much like OrthAlign’s innovation). The new workflow permits positional refinement and optimization of the implant tailored to the patient’s needs. The workflow’s data capture and real-time feedback allow surgeons to make adjustments to aid in finetuning implant positioning and stability.   

“This software release is a major enhancement to our TMINI Robotic System that not only meets our customers’ needs but is a differentiator for our platform in this industry,” proclaimed Stuart Simpson, the company’s president and CEO. “It is a major accomplishment for our company to receive a 2nd FDA clearance for our TMINI System in less than 15 months. This demonstrates our development capabilities and commitment to innovation as a focused robotics and digital surgery company.”  

THINK has entered into a number of agreements with other orthopedic device and implant manufacturers to gain greater distribution or for specific development opportunities. Among those on this list are Signature Orthopaedics, Zimmer Biomet, b-ONE Ortho Corp., Waldemar Link GmbH & Co. KG, and Maxx Orthopedics Inc., among others.   

“With our current implant partners, we are excited to support about 40% of the total knee implants on the market today. Looking to the future, because THINK Surgical’s technology is capable of supporting all total knee implant brands, we expect to continue to expand market coverage by adding additional implant brands,” explained Chris Fronk, chief commercial officer.

---

RELJA Innovations & Voom Medical Devices

Michael Barbella • Managing Editor

Think about it: Human beings spend two-thirds of their existence on their feet, logging roughly 100,000 miles in an average lifetime. The feet are used every day (usually while stuffed inside ill-fitting shoes) but rarely given a second thought.

Our feet only command attention when something goes wrong. And even then, they can be subject to subpar treatment options compared with other parts of the musculoskeletal system.  

Bunions, for example, are one of the most common culprits of foot pain. A deformity of the metatarsophalangeal joint at the big toe base, bunions develop when the foot’s first metatarsal bone turns outward and the big toe points inward (toward the other toes), causing the joint to jut out. The condition is treatable through surgery, but many of the procedures still being used have long outlived their efficacy.   

However, technological advancements and an industry-wide penchant for minimally invasive solutions have helped modernize and improve bunion treatment. Minimally invasive surgeries use a burr rather than a saw to cut bone, allowing the cuts to be made through tiny incisions, thereby minimizing recovery time and complications. Some procedures, like the flexor tenotomy, can correct painful bunions without major surgery.  

It’s been a long time coming, but our feet are finally getting the care and professional attention they deserve. 

Breaking a Bad Surgical Stigma

Sometimes the best inventions are born of frustration.  

Such was the case with Wauwatosa-based RELJA Innovations LLC, a company founded by board-certified foot and ankle surgeon Rob Amiot, M.D., DPM, FACFAS.   

Having performed more than 1,500 bunion procedures, Amiot noticed a troubling trend among his patients—many were experiencing prolonged pain and stiffness after undergoing correction surgery. He attributed the protracted suffering to some of the archaic techniques still being employed and realized these procedures had begotten a stigma about the significant pain and long recovery time associated with bunion surgery.   

The RELJA Clamp is a first-of-its kind radiolucent, single-use 

bunion reduction clamp that can be applied in less than four 

minutes. Photo: RELJA Innovations LLC.

Determined to debunk the stigma, Amiot established RELJA Innovations (he’s the CEO) and set out to create superior, less invasive bunion surgery products. “I’ve been in this space for some time, so I see the upsides and downsides of the old methods and current methods,” Amiot, a practicing surgeon for about 19 years, told BizTimes – Milwaukee Business News in May. “I thought it was time that we bring some new innovation to bunion surgery and try to get patients better outcomes.”  

Amiot has succeeded in both missions: In the four years since RELJA Innovations’ founding, the company has introduced four products to the market, manufactured at production sites in Indiana, Texas, and Wisconsin. 

Among those solutions is the MIS Precision Chevron Bunion System, a product that allows surgeons to minimally invasively perform a mild to moderate chevron bunion osteotomy, and subsequent osteotomy fixation. The system consists of a single pre-sterilized part number that contains both implants and instruments needed for the procedure. The same kit can be used for left or right feet, and on any size foot. Fixation is achieved by a 3.5 mm diameter cannulated screw, precisely placed by the system instrumentation. Two screw lengths are provided that were shown to provide adequate fixation on any size foot.  

Another of the company’s bunion correction solutions is the RELJA Clamp, a first-of-its-kind radiolucent, single-use bunion reduction clamp. Simple and intuitive by design, the RELJA Clamp is applied in less than four minutes. Although it is mainly used for the Lapidus Bunion Procedure, it can also be used for minimally invasive bunion procedures, Lisfranc fracture reductions, and midfoot and hindfoot Fusions.  

Launched in April this year, the patented RELJA Clamp for the Lapidus Procedure allows for correction in the frontal, transverse and sagittal planes along with compression across the fusion site, all without incisions.

MIBS 2.0

The Revcon screw system is touted as the only single-screw minimally invasive surgery solution available. Photo: Voom Medical Devices Inc. 

Dr. Neal M. Blitz, D.P.M., realizes minimally invasive bunion surgery (MIBS) has a bad reputation.   

And he knows it will take time for that reputation to dissipate (decades, perhaps). But he’s confident such a shift will eventually occur as MIBS becomes more mainstream and accepted by the orthopedic surgical community.  

“These visceral feelings mostly stem from the ‘70s and ‘80s when surgeons exploited MIS techniques, resulting in disaster after disaster. Foot surgeons rushed away from MIS and embraced open AO techniques, which have dominated the United States bunion market for the last 40 years,” Blitz, DPM, FACFAS, wrote in the April 15, 2023 issue of Foot & Ankle Surgery: Techniques, Reports & Cases.   

“And now, in 2023, there’s MIBS 2.0. We’ve seen this movie before and here come the trainwrecks again,” Blitz wrote. “But, this minimally invasive so-called ‘upgrade’ is even worse, as it violates all classic bunion surgery principles. It’s an unorthodox technique with extreme metatarsal head shifts, leaving minimal to zero bone contact between segments.¹ There is a large bony defect that is spanned by small screws. And to top it all off, patients are walking immediately after surgery.”  

For better or worse, Blitz is part of this MIBS 2.0 movement, having founded New York, N.Y.-based Voom Medical Devices Inc. in 2018. Specializing in MIBS solutions, the firm has developed and introduced minimally invasive screws designed specifically for its Bunionplasty® procedure.  

Officially launched last fall, the Revcon Anchor Minimally Invasive Screw System offers a “No-Fusion Bunion Solution” with patented screws tailored for a minimally invasive technique. Both the Revcon Neutra v1.0 and Revcon Anchor v2.0—designed by surgeons—feature a neutral, non-compressive screw pitch that is engineered to stabilize bone segments, thereby fostering bony healing and regeneration, an essential aspect of MIBS.  

“The Revcon Anchor screw stands as the only dual-zone pitched screw explicitly designed for capturing different bone densities in bunion repair, using Voom’s proprietary Transveron bone cutting and realignment techniques,” Blitz (Voom Medical’s CEO) noted in a news release.  

Both screws are part of the Revcon Minimally Invasive Screw System, and have received U.S. Food and Drug Administration clearance for various foot indications and osteotomies, particularly for bunion treatment.

Reference

¹ Blitz NM. Game-Changing New Modern Minimally Invasive Surgery. Foot Ankle Q. 2020; 31: 181-191.