SI-BONE, Inc. Announces First-In-Patient Procedures with FDA Breakthrough Device for Pelvic Fracture Fixation
SI-BONE, a medical device company focused on sacropelvic disorders, announced the first-in-patient procedures with their FDA-designated breakthrough device, iFuse TORQ TNT™ Implant System (TNT). This innovative system, which received 510(k) clearance in August 2024, addresses the challenges of pelvic fragility fractures in patients with poor bone quality. The TNT implant features a pelvis-specific design for improved fixation and reduced screw backout risk, and it is the first 3D-printed transiliac-transsacral screw cleared for market use in the U.S. Surgeons praised its streamlined instrumentation and efficient implantation process, which minimizes operating time and enhances patient recovery. SI-BONE’s CEO, Laura Francis, highlighted the system's potential to meet the unmet clinical needs of complex pelvic fractures and expand their leadership in the sacropelvic space.
SI-BONE, un'azienda che sviluppa dispositivi medici focalizzati sui disturbi sacropelvici, ha annunciato le prime procedure sui pazienti con il proprio dispositivo innovativo designato come breakthrough dalla FDA, il sistema di impianto iFuse TORQ TNT™ (TNT). Questo sistema innovativo, che ha ricevuto l'approvazione 510(k) nell'agosto 2024, affronta le sfide delle fratture da fragilità pelvica in pazienti con scarsa qualità ossea. L'impianto TNT presenta un design specifico per il bacino, migliorando la fissazione e riducendo il rischio di allentamento delle viti, ed è il primo vite transiliaca-transsacrale stampata in 3D approvata per l'uso commerciale negli Stati Uniti. I chirurghi hanno lodato lo strumentario snello e il processo di impianto efficiente, che riduce i tempi di intervento e migliora il recupero dei pazienti. La CEO di SI-BONE, Laura Francis, ha evidenziato il potenziale del sistema di soddisfare le esigenze cliniche insoddisfatte delle fratture pelviche complesse e di espandere la loro leadership nel settore sacropelvico.
SI-BONE, una empresa de dispositivos médicos centrada en los trastornos sacropélvicos, anunció los primeros procedimientos en pacientes con su dispositivo designado como breakthrough por la FDA, el sistema de implante iFuse TORQ TNT™ (TNT). Este sistema innovador, que recibió la aprobación 510(k) en agosto de 2024, aborda los desafíos de las fracturas de fragilidad pélvica en pacientes con mala calidad ósea. El implante TNT cuenta con un diseño específico para la pelvis que mejora la fijación y reduce el riesgo de aflojamiento de los tornillos, y es el primer tornillo transilíaco-transsacro impreso en 3D aprobado para uso comercial en EE. UU. Los cirujanos elogiaron su instrumentación simplificada y el eficiente proceso de implantación, que minimiza el tiempo de operación y mejora la recuperación del paciente. Laura Francis, CEO de SI-BONE, destacó el potencial del sistema para satisfacer las necesidades clínicas no cubiertas de fracturas pélvicas complejas y expandir su liderazgo en el ámbito sacropélvico.
SI-BONE은 천골질환에 초점을 맞춘 의료기기 회사로, FDA에서 혁신적인 기기로 지정한 iFuse TORQ TNT™ 임플란트 시스템(TNT)으로 첫 번째 환자 수술을 발표했습니다. 이 혁신적인 시스템은 2024년 8월에 510(k) 승인을 받았으며, 뼈 질이 좋지 않은 환자에서의 골반의 취약성 골절 문제를 해결합니다. TNT 임플란트는 고정력을 개선하고 나사 이탈 위험을 줄이도록 설계된 골반 전용 디자인을 특징으로 하며, 미국에서 시장 사용을 위해 승인된 최초의 3D 프린트된 배면관-천골 나사입니다. 외과의사들은 효율적인 수술 도구와 임플란트 과정에 대해 찬사를 보였으며, 이는 수술 시간을 최소화하고 환자의 회복을 촉진합니다. SI-BONE의 CEO인 로라 프랜시스는 시스템이 복잡한 골반 골절의 충족되지 않은 임상 요구를 충족할 수 있는 잠재력과 함께 사골반 분야에서의 리더십을 확장할 수 있는 가능성을 강조했습니다.
SI-BONE, une entreprise de dispositifs médicaux axée sur les troubles sacropelviens, a annoncé les premières procédures chez des patients avec leur dispositif innovant désigné comme breakthrough par la FDA, le système d'implant iFuse TORQ TNT™ (TNT). Ce système innovant, qui a reçu l'approbation 510(k) en août 2024, répond aux défis des fractures pelviennes de fragilité chez les patients ayant une mauvaise qualité osseuse. L'implant TNT présente un design spécifique pour le pelvis, améliorant la fixation et réduisant le risque de dévissage, et c'est la première vis transiliaco-transsacrale imprimée en 3D approuvée pour une utilisation sur le marché aux États-Unis. Les chirurgiens ont salué son instrumentation rationalisée et son processus d'implantation efficace, qui minimise le temps opératoire et améliore la récupération des patients. Laura Francis, PDG de SI-BONE, a souligné le potentiel du système à répondre aux besoins cliniques non satisfaits des fractures pelviennes compliquées et à étendre leur leadership dans le domaine sacropelvien.
SI-BONE, ein Unternehmen für medizinische Geräte, das sich auf sakropelvine Störungen konzentriert, hat die ersten Eingriffe bei Patienten mit seinem von der FDA als bahnbrechend eingestuften Gerät, dem iFuse TORQ TNT™ Implantatsystem (TNT), angekündigt. Dieses innovative System, das im August 2024 die 510(k)-Genehmigung erhielt, adressiert die Herausforderungen von pelviner Fragilitätsfrakturen bei Patienten mit schlechter Knochenqualität. Das TNT-Implantat verfügt über ein becken-spezifisches Design für eine verbesserte Fixierung und ein reduziertes Risiko des Herausfallens von Schrauben und ist die erste 3D-gedruckte transiliakale-transsakrale Schraube, die in den USA für den Markt zugelassen ist. Chirurgen lobten die optimierte Instrumentierung und den effizienten Implantationsprozess, der die Operationszeit minimiert und die Genesung der Patienten verbessert. Laura Francis, CEO von SI-BONE, hob das Potenzial des Systems hervor, unbefriedigte klinische Bedürfnisse bei komplexen Beckenfrakturen zu decken und ihre Führungsposition im sakropelvinen Bereich auszubauen.
- First-in-patient procedures completed with iFuse TORQ TNT™ Implant System.
- TNT received 510(k) clearance in August 2024.
- FDA Breakthrough Device Designation awarded to TNT.
- First 3D-printed transiliac-transsacral screw cleared for market use in the U.S.
- Improved fixation and reduced risk of screw backout.
- Streamlined instrumentation and efficient implantation process.
- None.
Insights
The introduction of the iFuse TORQ TNT™ Implant System represents a significant advancement in pelvic fracture fixation. As the first 3D-printed transiliac-transsacral screw cleared for use in the U.S., it addresses critical challenges in treating pelvic fragility fractures, especially in patients with poor bone quality.
Key features of TNT include:
- Pelvis-specific design for improved initial fixation
- Reduced risk of screw backout
- 3D-printed porous surface to facilitate osseointegration
- Streamlined instrumentation for efficient implantation
The FDA Breakthrough Device Designation underscores the potential impact of this technology. Early adopter feedback suggests improved surgical efficiency and potentially better long-term outcomes for osteoporotic patients. This innovation could significantly enhance SI-BONE's market position in the sacropelvic space and address an important unmet clinical need.
The successful launch of the iFuse TORQ TNT™ Implant System is a positive development for SI-BONE (NASDAQ: SIBN). This breakthrough device has several potential financial implications:
- Expanded market opportunity in the growing field of pelvic fragility fractures
- Potential for increased revenue through premium pricing for advanced technology
- Improved competitive positioning in the sacropelvic disorders market
- Possible acceleration of market adoption due to FDA Breakthrough Device Designation
While specific financial projections are not provided, the innovative nature of TNT and positive initial surgeon feedback suggest strong potential for market penetration. Investors should monitor future earnings reports for indications of TNT's impact on revenue growth and market share. The company's ability to capitalize on this innovation could be a key driver of future financial performance.
SANTA CLARA, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, today announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT™ Implant System (TNT). Designed to address the anatomic and biomechanical challenges of pelvic fragility fractures, particularly in patients with poor bone quality, TNT offers a significant advancement over traditional cannulated screws.
TNT, which received 510(k) clearance in August 2024 and was awarded Breakthrough Device Designation by the FDA, is the first 3D-printed transiliac-transsacral screw cleared for market use in the U.S. It features a pelvis-specific design to improve initial fixation and reduce the risk of screw backout. Among the first surgeons to perform procedures with TNT were Edward Westrick, MD, at Allegheny General Hospital in Pittsburgh, PA, Reza Firoozabadi, MD, at Harborview Medical Center in Seattle, WA, J.D. Black, MD, at Kadlec Regional Medical Center in Richland, WA, and Brian Cunningham, MD, at Methodist Hospital – HealthPartners in St. Louis Park, MN.
“TNT went beyond my expectations,” said Dr. Black. “The streamlined instrumentation and implant design not only provided excellent fixation but also allowed for quick, precise implantation. This efficiency is critical when treating patients with fragile bones, as it reduces operating time, minimizes risks, and leads to faster recovery.”
“TNT’s 3D-printed porous surface facilitates osseointegration, which I believe will lead to better long-term outcomes for my older, osteoporotic patients,” said Dr. Cunningham, Vice Chair and Director of Orthopedics at Methodist Hospital – HealthPartners.
“We are thrilled with the successful completion of these initial procedures using our iFuse TORQ TNT system,” said Laura Francis, Chief Executive Officer of SI-BONE. “This breakthrough technology marks a significant step forward in addressing the unmet clinical needs of complex pelvic fragility fractures. By providing a solution that improves both surgical efficiency and patient recovery, we are further expanding our leadership in the sacropelvic space.”
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a global leader in technology for the surgical treatment of sacropelvic disorders. Since pioneering minimally invasive surgery of the SI joint in 2009, SI-BONE has supported over 3,900 surgeons in performing more than 100,000 sacropelvic procedures. A unique body of clinical evidence supports the use of SI-BONE’s technologies, including two randomized controlled trials and over 135 peer-reviewed publications. SI-BONE has leveraged its leadership in minimally invasive SI joint fusion to commercialize novel solutions for adjacent markets, including adult deformity, spinopelvic fixation, and pelvic trauma.
For additional information on the company or its products, including risks and benefits, please visit www.si-bone.com.
iFuse TORQ, iFuse Bedrock Granite, and SI-BONE are registered trademarks; iFuse TORQ TNT is a trademark of SI-BONE, Inc. ©2024 SI-BONE, Inc. All Rights Reserved. Edward Westrick, MD, Reza Firoozabadi, MD, and J.D. Black, MD, are paid consultants for SI-BONE, Inc. Brian Cunningham, MD, is not a paid consultant for SI-BONE, Inc.
Investor Contact: Saqib Iqbal investors@si-bone.com
FAQ
What is the iFuse TORQ TNT™ Implant System?
When did the iFuse TORQ TNT™ receive 510(k) clearance?
What is the significance of the FDA Breakthrough Device Designation for TNT?
Which surgeons performed the first procedures with the iFuse TORQ TNT™?
What are the benefits of the iFuse TORQ TNT™ Implant System?
