The orthopedic market thrives through the ideation and development of innovative technologies that advance precision, safety, accuracy and, ultimately, patient healing. Dozens of startups are worthy of coverage and poised to shake up the orthopedic space in the near-term and beyond. We start by examining five companies from different segments of orthopedics. These companies either recently reached market phase or plan to by 2022.
Rejoint Combines AI and 3D Printing for Total Knee
Technology Overview: Rejoint is the first company to develop a cohesive total knee replacement solution using artificial intelligence (AI) and 3D printing. Their technology, called YourKnee, produces an implant for knee replacement designed for the unique anatomy of the individual patient. The 3D printing technology allows cobalt chrome implants as well as specialized surgical instruments to be custom fabricated on-demand just-in-time for each patient.
During the preoperative phase, YourKnee uses AI tools and algorithms to determine the placement, shape and size of the implant for the perfect fit for each patient. The procedure is personalized further through AI-based surgery simulation and the creation of patient-specific surgical tools. Post-op, the rehabilitation process is continuously tracked using wearables and a web application. The expectation is that the Rejoint prosthetics, coupled with computer-assisted surgery and custom instrumentation, will improve patient outcomes by reducing bone loss, blood loss and infection rates.
Commercialization Status: Rejoint received initial CE Mark approval in 1Q20 and a second CE Mark for the complete extended range of YourKnee sizes in 2Q20. Rejoint offers more than 6,300 femoral variations, including multiple designs and coatings. FDA 510(k) clearance is expected in 2Q21.
“We have the unique opportunity to walk with patients and surgeons from the preoperative phase to the rehabilitation phase and beyond by introducing data science into orthopedics.” —Lorenzo Riva, Co-founder and Chief Revenue Officer of Rejoint
DiFusion Takes on Immune Response with Spinal Interbody
Headquartered: Texas, U.S.
Technology Overview: DiFusion’s Xiphos-ZF Spinal interbody is made of ZFUZE, a polymer engineered specifically for orthopedics. ZFUZE combines zeolite molecules with PEEK, changing the material to a negatively-charged substance that cultivates osseoconduction while preserving the polymer’s benefits of visualization, modulus and strength.
The material addresses major concerns about host rejection of implants, which is often dependent on the immune response. Animal studies confirm that the material elicits favorable immunomodulation, key to normal tissue regeneration and avoiding fibrous encapsulation. ZFUZE tested positively from a favorable immunomodulation standpoint, eliciting a pro-reparative M2 macrophage response and significant reductions in cytokine markers for prolonged inflammation and associated fibrous tissue formation.
Commercialization Status: DiFusion received FDA 510(k) clearance for its Xiphos-ZF Spinal interbody in November 2019. The company officially launched the Xiphos-ZF Spinal interbody in early 2020. DiFusion is selling devices direct, but seeks to be acquired by a company that can use the material to move market share and potentially expand the platform technology to other orthopedic applications.
“The market has gyrated from PEEK to titanium and back with a million minor changes to the surfaces. ZFUZE combines the best features of both the modulus of PEEK and the healing power of titanium. We are expecting it to basically be PEEK that fuses, because there’s only one thing wrong with PEEK—it doesn’t fuse—so we fixed that.” —Paul Kraemer, M.D., surgeon at Indiana Spine Group and a member of DiFusion’s Scientific Advisory Board
X-Bolt Orthopaedics Focuses on Hip Fractures
Technology Overview: X-BOLT Orthopaedics seeks to address the problem of screw cut out with its technology that replaces the lag screw for femoral head fixation in either a hip nailing or plating construct. Rather than a screw-based technology that rotates into the bone without good rotational stability, X-BOLT does away with the screw bit altogether and provides rotational stability and better anchorage. Studies indicate that the system significantly reduces the reoperation rate.
Similar to a molly bolt used in home wall hangings, the X-BOLT expands within the bone. The expanding bolt technology compresses surrounding bone, increasing density and giving better anchorage within the hip bone and providing rotational stability with a single device. The expanding bolt can compress and expand to close the fracture without spinning, pushing or pulling the femoral head. X-BOLT has an inner drive shaft featuring left-hand threads at the bottom and right-hand threads at the top. When the instrument is turned, it expands out like a carjack and can be closed just as easily. It’s designed to be reversible so if there’s a problem, it can be easily removed.
Commercialization Status: X-BOLT received approval under the CE Mark and FDA 510(k) clearance. Using feedback from clinical trials that included more than 1,000 patients, X-BOLT Orthopaedics plans to update X-BOLT’s design with improvements such as reduced tip apex distance, easier manufacturability and better fatigue characteristics at the hinges where X-BOLT opens and closes.
The company seeks commercialization partners.
“I realized at the early stage with the X-BOLT device that we needed a big trial to change surgeon perception on using it. If you’re a big brand company, you can introduce a new product quite easily and surgeons will accept it because of your brand value. But as a small startup, you need to either have brand value, of which we had none, or have very good scientific evidence. And to get very good scientific evidence, we needed a big trial.” —Brian Thornes, M.D., Chief Executive Officer of X-BOLT
Indago Targets Sports Medicine Market with Wireless System
Headquartered: Ohio, U.S.
Technology Overview: Indago designed a patented, integrated, fully wireless arthroscopic camera system for hip, knee and shoulder surgeries. The arthroscope completely eliminates cables while maintaining the higher image quality.
The product, called ArthroFree, utilizes a patented, novel light source that also addresses the problem of fires in the O.R. caused by overheating. Indago developed a miniaturized integrated light source that produces a comparable amount of light to an external light source, but with far less power and nominal heat.
Furthermore, safety from a sterilization perspective has been a key focus for Indago when developing ArthroFree. The device is drop-in compatible with existing systems to reduce friction for implementation.
Commercialization Status: Indago expects to seek FDA clearance for ArthroFree in 4Q20, with market entry in 2021. The first marketing opportunity will be focused on private practice physicians. While ArthroFree is targeted explicitly at arthroscopic sports medicine, Indago is already discussing other endoscopic surgeries, including small joints and other non-ortho procedures.
“We view this device as the first step in opening the door to the operating room of the future. We don’t want to lock the technology in a walled garden and charge people through the nose for it.” —Daniel Dudley, Co-founder and Chief Operating Officer of Indago
Carmell Therapeutics Develops Controlled Degradable Biologic
Headquartered: Pennsylvania, U.S.
Technology Overview: Carmell Therapeutics is a regenerative medicine company that has a unique technology to accelerate and enhance healing and reduce infections by delivering regenerative growth factors locally to an injured site with a time-release mechanism. Carmell’s proprietary process is designed to bind and cross-link regenerative factors in lyophilized platelet-enriched plasma into solid and semi-solid plasma-based materials to accelerate healing in bone, tendon and wound care.
Carmell Therapeutics’ technology is an allogenic plasma source material used for decades in medical applications. However, the company does not separate, isolate or fractionate the allogeneic plasma, keeping the growth factors and platelets present as well as regenerative factors that participate in the healing process. The plasma is lyophilized, then the resulting powder is mixed with glycerol to create different solid forms including putty, paste, sheets, screws and more.
Using genipin to cross-link the processed plasma prior to site delivery, the active growth factors are released over time, slowing the breakdown of the final product once implanted. The product is standardized for consistent quality.
Commercialization Status: FDA-cleared Carmell Therapeutics’ Investigational New Drug application for its Bone Healing Accelerant (BHA) in December 2019. This prepared them to launch a pivotal study in the U.S., Europe and South Africa. In April 2020, Carmell was granted Fast Track designation by FDA for its BHA in its quest for a Biologic License Application. The company plans to have CE Mark approval in 2021.
“One of the most exciting things is the safety profile. We’ve done a complete biocompatibility series in which we look at the results in animals, and we haven’t seen any adverse effects. Specifically, in our clinical trials, there were no implant-related adverse events.” —Stephanie Kladakis, Ph.D., Chief Scientific Officer at Carmell Therapeutics
Heather Tunstall is an ORTHOWORLD Contributing Editor.