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The trauma market remains more resilient than other orthopedic segments due to the need to fix bones damaged in sudden, unexpected ways and correct debilitating deformities.
Companies of all sizes have been active in the space this year with new regulatory clearances, product launches, funding rounds and acquisitions.
In examining the dozens of announcements from this year, a few smaller companies stood out to us for their different approaches to fracture and deformity care. Companies are paying greater attention to personalized care, non-permanent implants, infection prevention and imaging.
BMB Builds Patent Portfolio
Swedish biotech company Biomedical Bonding (BMB) seeks to commercialize Bonevolent, a line of medical adhesives for fracture fixation. Bonevolent technology is designed to be customized by the surgeon, and enables patient-specific adaptation to fractures and bone geometry.
The technology is also biocompatible and does not cause irritation or soft tissue adhesion, which is a common issue with metal implants leading to patient discomfort and post-surgery complications, according to the company’s website.
The company’s strategic activity in 2022 has focused on funding and expanding its patent portfolio. BMB recently received a Chinese patent based on a unique primer formulation that is intended to work in tandem with its resin-based composite technology, which applies directly to wet bone substrates or metal implants. The patent is the company’s second granted in China, and the news represented an important step toward product commercialization.
“BMB continues to expand its Bonevolent IPR portfolio in key geographical positions; China is considered an attractive market for the company’s fracture fixation products,” said Founder and CEO Michael Malkoch, Ph.D. “With this patent approved, the IPR for our primer technology is further strengthened as it protects all key components facilitating exceptional resin-based fixation of bones, metal or teeth. As a company, such approval is a crucial element and allows BMB to pursue the commercialization of its composite-based fixators toward patient-customized treatment of both bone fractures as well as dental restorations.”
BMB specializes in the development of cutting-edge medical adhesive fixators and novel surgical methodologies with a specific focus on the ever-growing market of hard tissue restorations. The company’s mission is to overcome the current pain points in today’s bone fracture surgery and dental restoration markets by offering a technology platform based on a novel category of adhesive resin-composites with a focus on biocompatibility, tissue-friendliness and high mechanical strength.
RedPoint Medical 3D Expands PSI in Foot and Ankle
RedPoint Medical 3D (RPM-3D) received FDA 510(k) clearance to market patient-specific bone-cutting guides for use in foot and ankle reconstructive surgeries, such as bunion correction. The Indiana-based company specializes in patient-specific tools and surgical processes for surgeons. RedPoint Medical 3D claims it is the first patient-specific instrumentation (PSI)-based company to gain FDA clearance for patient-specific bone-cutting guides for use in foot and ankle reconstructive surgeries.
The company’s surgical guide system leverages proprietary AI software (RedPoint Intelligence) to deliver imaging data taken from a CT scan of the patient’s foot and/or ankle and generate it into the desired correction as prescribed by the surgeon. The platform allows surgeons to rehearse the surgery on a 3D-printed model and provides them with a fully customized technique guide and 3D-printed custom surgical cut guide that is optimized and personalized to correct complex surgical deformity with precision.
The first product offering of RPM-3D customized guides will be marketed as The Better Bunion, which is now ready for the U.S. market. The platform is expected to simplify surgical steps associated with common bunion corrective techniques (Lapidus, MIS, Akins). The Better Bunion is designed for precise bone osteotomies and deformity reduction, and decreased operating room, tourniquet, anesthesia and radiographic exposure times relative to other generic instrumented bunion corrective procedures. Conventional surgical treatment systems on the market for bunions require 15 to 22 steps and the use of proprietary hardware. According to RPM-3D, their system cuts that number down to only six steps to prepare the bone before surgeons can begin focusing on their preferred fixation.
The company announced an efficiency milestone for the product in October. “We continue to enhance our RPM-3D proprietary, AI-enabled software called RedPoint Intelligence. Our advancements on the software front have significantly improved our processing techniques, and as a result we have achieved a 63% reduction in our guide development time,” said CEO Ben Coburn. “With our continued efforts to enhance our patient-specific guide design through intelligent software improvements, we are now capable of completing one custom guide every 15 minutes per technician level operator. This achievement reduces our overhead costs and drastically improves our PSI guide turnaround time.”
OSSIO Expands Indications for Bio-integrative Implant
The biomedical company OSSIO is currently focused on the trauma and sports medicine market with its OSSIO-fiber Intelligent Bone Regeneration technology. OSSIO’s compression screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis and bone grafts of the upper extremity, fibula, knee, ankle and foot.
OSSIOfiber is engineered to securely fixate and fully integrate into a patient’s native anatomy and leave nothing behind. The technology contains the same organic minerals found in bones, but is designed to provide more strength. Over time, the implant integrates with bone and facilitates a return to full strength naturally and without the risks and costs associated with permanent hardware, according to the company.
“We have created a new category in fixation materials,” said Brennan Marilla, Chief Commercial and Operating Officer for OSSIO. “What makes OSSIOfiber different is that the fibers are the secret sauce. …This is the first non-permanent, FDA-cleared implant that is stronger than cortical bone.”
The Israel- and U.S.-based company received multiple FDA 510(k) clearances in 2022. To catapult their commercialization strategy, the company also announced that it closed a $38.5 million Series C round of financing and received a three-year contract with Vizient’s group purchasing organization.
aap Implantante Reaches Clinical Study Phase for Antimicrobial Coating Technology
In its quest to prevent bacterial infections, aap Implantate has been working on an antibacterial silver coating technology for several years. The company announced in April that a first round of surgeries were completed as part of a human clinical trial. The clinical trial began in late 2021 and represented a critical step toward the planned CE Mark approval of aap Implantate’s proprietary coating technology.
In addition, the company reported that its antibacterial silver coating technology is effective against the antibiotic-resistant hospital germ methicillin-resistant Staphylococcus aureus (MRSA), which was responsible for 100,000 deaths worldwide in 2019, according to published studies. aap Implantate’s silver coating is intended to offer an alternative solution to antibiotics as a treatment for bacterial infections. As a platform technology, the coating has a broad range of applications and can be used in trauma cases and other areas of orthopedics.
Based in Berlin, Germany, aap Implantante is a globally active medical technology company that manufactures, develops and markets products for the trauma market. The company is also focused on producing resorbable magnesium implants.
GLEAMER Receives FDA Clearance for AI Software
GLEAMER gained FDA clearance to market BoneView AI software for use by U.S. healthcare specialists to aid in diagnosing fractures and traumatic injuries on X-rays. BoneView was approved by the CE Mark in Europe in 2020. BoneView helps detect and localize fractures over the entire appendicular skeleton, rib cage, and thoracic and lumbar spine, improving sensitivity and specificity while reducing reading time.
The technology works by detecting fractures in X-ray images and submits them to radiologists for final validation. The BoneView AI algorithm is cleared as a Computer-Aided Detection (CADe) and Computer-Aided Diagnosis (CADx) system by FDA and highlights regions of interest with bounding boxes around areas where fractures are suspected, so radiologists can prioritize reading those X-rays.
Study results showed that BoneView AI assistance provided a 10.4% improvement of fracture detection sensitivity and shortened the radiograph reading time by 6.3 seconds per patient. Six types of specialists participated in the study. The combination of AI and health professionals’ interpretations lowered the false negative rate (undected fractures) on x-rays by 29%. Additionally, X-ray reading time was reduced by 15% on exams specifically selected for their difficulty. Upon FDA 510(k) clearance in March, BoneView had analyzed more than three million images around the world and was deployed in more than 13 countries across Europe, the Middle East, Asia-Pacific and North America.
