AAOS 2018 First-Time Exhibitors Emphasize Navigation, Orthobiologics, Outcomes

In examining the list of AAOS 2018 exhibitors, I see that a number of first-time exhibiting OEMs offer either orthobiologics or navigation…I’m not surprised, as it’s rare for a “new” hip or knee replacement device company to appear, any more. Rather, first-timer or not, I see numerous exhibitors addressing needs “beyond the device.”

Some are notable for their systems to manage patient care before, during and after a procedure; to deliver the implant to its destination or get it into the body in a more efficient manner; or make it work better once it’s in there.

You always ask us to keep you apprised of who is doing what, in the industry. I’m expanding on the following exhibitors to help you—and us—get to know them better.

We’d love to spend some time with you, too, in New Orleans, and invite you to stop in at ORTHOWORLD’s Booth #3820.

(First-time exhibiting companies are differentiated below with their names in green.)
OEMs

Anika Therapeutics | Booth #6933 | Bedford, Massachusetts, U.S.
anikatherapeutics.com
Orthobiologics

• First-time exhibitor…really? Yes, really! Aside from clinical trial progress on viscosupplements and mesenchymal stem cells, we expect that Anika folks will want to talk about their recent FDA 510(k)-cleared resorbable, injectable hyaluronic acid-based bone void filler. It reportedly represents one of just a few bone graft substitutes that can be administered in a minimally invasive manner.
• The timeline from submission to clearance? Submitted in 3Q17…cleared in 4Q17.

Burst Biologics | Booth #6947 | Boise, Idaho, U.S.
burstbiologics.com
Orthobiologics

• In 1Q17, Burst Biologics received IRB approval for a U.S. prospective clinical study of cellular allograft in spinal fusion patients. BioBurst Fluid, derived from umbilical cord blood, will be studied at 15 clinical sites enrolling 450 patients, with 1-year follow-up.
• A multicenter patient registry was created to document use of Burst Biologics’ products by spine and neurosurgeons, along with patient outcomes, focusing on fusion outcome, instrumentation integrity and clinical outcomes. Burst has also established a registry to observe use of its products by foot and ankle surgeons in bone grafting procedures. Estimated enrollment of 300 subjects is slated to complete in 4Q18.

EDGe Surgical | Booth #3375 | Chicago, Illinois, U.S.
edgesurgical.com
Trauma, Spine

• In mid-2017, EDGe closed a $1.4MM seed round to fund launch of Ortho EDG®, a single-use electronic depth gauge that assists surgeons in placing screws. The FDA 510(k) cleared device is designed to address precision limitations and infection risks associated with the standard depth gauge.
• EDGe has also opened a $2MM Series A funding to support development of an application for the spine market.

Genesis Biologics | Booth # 6914 | Anaheim, California, U.S.
genesisbiologics.com
Orthobiologic Tissue Bank

• This company was new to me, though it was founded in 2009; they offer a line-up of tissues: amnion-based allograft, bone plugs, tendons, ligaments, cervical spacers, DBM cancellous chips and putties.

GID Group | Booth #6931 | Louisville, Colorado, U.S.  and East Sussex, England, UK
thegidgroup.com
Orthobiologics

• Provides products and methods to process regenerative cells and adult stem cells from adipose and bone tissues.
• The company claims to have reduced an entire GMP cell-processing facility to a single sterile disposable device, so that scalable cell processing is available to hospitals, medical practices and other settings. GID provides the technology to provide the cells. In orthopaedics, this can have application in osteoarthritis, tendon and ligament repair, fracture healing and disc repair.

Greyledge Technologies | Booth #6912 | Vail, Colorado, U.S.
greyledgebiotech.com
Orthobiologics

• Greyledge can establish a lab within a clinic that is capable of manually producing customizable Platelet-rich Plasma and Bone Marrow Cell Concentrate preparations within 25 minutes.
• The preparations are produced by a sterile process in a closed tissue culture hood, and are characterized in a 27-parameter analysis with a hemoanalyzer.
• The Greyledge blog is a frequently-updated resource reporting on developments, news and published results pertinent to this therapeutic field and authored by Dr. Ted Sand, who previously wrote for the Celling Technologies blog.

HD Lifesciences | Booth #5419 | Stoneham, Massachusetts, U.S.
hdlifesciences.com
Spine

• HD markets additively-manufactured titanium implants in a variety of sizes and lordotic configurations
• In 2017, the company received FDA 510(k) clearance and commenced U.S. launch of NanoHive™, a system of interbody devices for ALIF, PLIF and TLIF procedures.
• The devices are based on HD’s proprietary Soft Titanium™ honeycomb lattice material, designed to provide optimum stiffness, ideal imaging and osteogenic nano-surfacing to support fusion.

Insight Medical Systems | Booth #7013 | Laguna Hills, California, U.S.
insightmedsys.com
Navigation/VR, Joint Reconstruction, Spine, Soft Tissue Repair

• Leveraging mixed-reality technology to provide a cost effective alternative to surgical navigation systems and robots
• The surgeon’s headset projects virtual models of the patient’s anatomy into the surgeon’s field of view so that structures beneath the surface are visible
• Focusing on spinal fusion, joint replacement and anterior cruciate ligament reconstruction
• CEO was Vice President of Engineering and founder and CTO developed knee and hip replacement algorithms at OrthAlign

Marksman Targeting | Booth #6913 | San Diego, California, U.S.
marksmantargeting.com
Navigation, Spine

• Developing an economic, scalable open platform technology to reduce radiation exposure using the C-arm, obviating the need to purchase a new 3-D imaging device or robot
• Surgeons can translate DICOM data to determine proper placement of the SCKOPE Collinear Targeting Laser and the Jamclometer Surgical Access Needle to plot angles in coaxial and collinear trajectories
• Has also designed the Vision preoperative planning app

Micro C Imaging | Booth #7018 | Atlanta, Georgia, U.S.
microcimaging.com
Portable Imaging, Extremities

• Developer of a portable system comprising an ergonomically-designed, hand-held fluoroscopy device that is a little bigger than a household iron with a separate, book-sized image receptor. The extremity is placed on top of the broad, flat receptor and the Micro C is aimed at the extremity. It can be held in one had while the surgeon operates another instrument (like a drill) in the other hand.
• System emits considerably less radiation than the industry standard, due to its smaller power requirement
• The device’s clinical embodiment will be suitable for use in the outpatient setting, ambulances or on sidelines at a sporting event, in remote geographies or in a patient’s home
• Founders have raised $1MM in seed and pre-Series A funding; future rounds will support product development, manufacturing, marketing, compliance and sales

Naviswiss | Booth #7025 | Brugg, Switzerland
naviswiss.eu
Handheld Navigation

• Startup developing miniaturized, cost-effective surgical measurement and navigation systems, beginning with landmark-based handheld hip navigation to support minimally invasive surgery—no pre-op CT required (knee application under development)
• Scalable, modular and open system can also be tailored to one manufacturer’s implants, instruments and surgical technique
• CEO employed at Smith & Nephew CAS for 10-plus years, also founded MEDivation, provider of prototyping/engineering/etc. services to the orthopaedic industry

OrthogenRx | Booth #3423 | Doylestown, Pennsylvania, U.S.
orthogenrx.com
Orthobiologics/Viscosupplements

• Markets GenVisc 850, a five-injection hyaluronic acid/viscosupplement to treat knee OA pain, produced from non-avian source material
• In November 2017, received FDA approval for TriVisc, three-injection treatment
• Executive team’s ortho industry experience includes positions with BioMimetic Therapeutics, Smith & Nephew Biologics/Bioventus, as well as TiGenix and Sanofi (Hyalgan)

OrthoXel | Booth #7041 | Bishopstown, Cork, Ireland
orthoxel.net
Trauma

• In December 2017, received FDA 510(k) clearance for Apex Tibial Nailing System, designed to offer both controlled axial motion and minimal twisting to support optimum healing conditions at the fracture site
• Claims to offer the greatest range of locking options of any nail on the market, and features reusable implantation kit
• Developing a femoral version

Surgical Specialties | Booth #2540 | Wyomissing, Pensylvania, U.S.
quilldevice.com
Joint Reconstruction/Wound Closure

• Compared to traditional sutures, the barbed Quill device reportedly achieved a 40% reduction in closure times; obviates the need to tie a knot
• Comes in a range of range of absorbable and nonabsorbable materials and configurations, including Monoderm, PDO, Nylon and Polypropylene, dyed or clear
• Can be used in hip, knee, spine

Surgivisio | Booth #7034 | La Tronche, France
surgivisio.com
Navigation, Spine

• Markets a CE-Marked all-in-one 2D/3D imaging plus real-time navigation/tracking platform
• Fast set-up time: five minutes to start navigating, including complete patient registration procedure, 3D image acquisition and reconstruction
• Low x-ray radiation exposure, with up to 4x fewer images than are needed by other systems to complete the 3D reconstruction
• First application is in spine, with other orthopaedic and trauma applications expected (first vertebroplasty procedure performed in the close of 2017)
• Company president co-founded Blue Ortho, developer of compact navigation systems for orthopaedics that was acquired by Exactech in 2015

Service Providers

These represent standalone companies that have formed to support the OEM’s customers—surgeons.

Claris Healthcare | Booth #2822 | Vancouver, British Columbia, Canada
clarisreflex.com
Patient Engagement, Joint Reconstruction Episode Management

• We wrote about Claris late last year when they launched Reflex, a coaching system designed to monitor and maximize TKR patient recovery and assist clinics participating in bundled care programs. The platform includes patient management tools and compliance reporting to care providers.

ConnectSx | Booth #5225 | Mokena, Illinois, U.S.
connectsx.com
Supply Chain Management

• Creators of a technology suite that helps device manufacturers and health systems with inventory management, UDI compliance, just-in-time training/knowledge delivery and overall device use statistics that can be tied to the patient record
• Elements include a browser-based console, smartphone inventory apps and UDidentify to scan UDI barcodes, validate against HIBCC, GS1 and ICCBA standards, verify them in the GUDID database and see critical device information on screen
• Avoids the manual management and manipulation of data through the surgical lifecycle

Swiftpath DTC | Booth #1831 | White Plains, New York, U.S.
swiftpath.com
Patient Engagement, Outpatient Program Management

• Founded in 2014, establishing a program of “paths” for patients include engagement and education, online and in person (including Joint Camp for patient and home caregiver/family), pain management methods designed to decrease narcotic use, digital communication between patient and healthcare provider
• Surgeons are able to involve the patient in optimization and selection, which helps yield better outcomes; they attend RoundTables to learn and share research and innovations in surgical techniques, proper administration of modern pain management, effective recovery methods, etc.

Sources: Company websites, information in the public domain

Julie A. Vetalice is the Editorial Assistant at ORTHOWORLD. Reach her by email.