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Paragon 28 Announces the Launch of SMART 28℠ Portal and First Case Using SMART Bun-Yo-Matic℠

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Paragon 28 (NYSE: FNA) has launched the SMART28℠ Case Management Portal, a platform leveraging AI for coordinating patient-specific surgical plans. This marks the first major release in Paragon 28's SMART28℠ ecosystem, aimed at improving foot and ankle treatments through advanced technologies.

The portal's first module, SMART Bun-Yo-Matic℠, focuses on bunion correction. It offers unique features like 3D anatomy visualization from X-rays and AI-driven algorithms for tailored surgical plans. Dr. Cesar De Cesar Netto, an early user, praised the system's precision in Hallux Valgus surgery.

CEO Albert DaCosta emphasized the portal's significance for the future of foot and ankle surgery, highlighting its efficiency in 3D procedure planning and precise implementation. The SMART28℠ Case Management Portal is set to expand with additional modules for various foot and ankle conditions.

Paragon 28 (NYSE: FNA) ha lanciato il SMART28℠ Case Management Portal, una piattaforma che utilizza l'IA per coordinare piani chirurgici specifici per i pazienti. Questo segna la prima grande uscita nell'ecosistema SMART28℠ di Paragon 28, mirata a migliorare i trattamenti per il piede e la caviglia attraverso tecnologie avanzate.

Il primo modulo del portale, SMART Bun-Yo-Matic℠, si concentra sulla correzione del bunions. Offre caratteristiche uniche come la visualizzazione anatomica in 3D tramite raggi X e algoritmi basati su IA per piani chirurgici personalizzati. Il Dott. Cesar De Cesar Netto, un utente precoce, ha elogiato la precisione del sistema nella chirurgia dell'Hallux Valgus.

Il CEO Albert DaCosta ha sottolineato l'importanza del portale per il futuro della chirurgia del piede e della caviglia, evidenziando l'efficienza nella pianificazione delle procedure in 3D e nella loro implementazione precisa. Il SMART28℠ Case Management Portal è destinato ad espandersi con moduli aggiuntivi per varie condizioni del piede e della caviglia.

Paragon 28 (NYSE: FNA) ha lanzado el SMART28℠ Case Management Portal, una plataforma que utiliza IA para coordinar planes quirúrgicos específicos para pacientes. Este es el primer lanzamiento importante en el ecosistema SMART28℠ de Paragon 28, que tiene como objetivo mejorar los tratamientos del pie y el tobillo a través de tecnologías avanzadas.

El primer módulo del portal, SMART Bun-Yo-Matic℠, se centra en la corrección de juanetes. Ofrece características únicas como visualización anatómica en 3D a partir de rayos X y algoritmos impulsados por IA para planes quirúrgicos personalizados. El Dr. Cesar De Cesar Netto, un usuario temprano, elogió la precisión del sistema en la cirugía de Hallux Valgus.

El CEO Albert DaCosta destacó la importancia del portal para el futuro de la cirugía de pie y tobillo, subrayando su eficacia en la planificación de procedimientos en 3D y en la implementación precisa. El SMART28℠ Case Management Portal está preparado para expandirse con módulos adicionales para diversas condiciones del pie y tobillo.

Paragon 28 (NYSE: FNA)는 환자 맞춤형 수술 계획을 조정하기 위해 AI를 활용하는 플랫폼인 SMART28℠ Case Management Portal을 출시했습니다. 이는 Paragon 28의 SMART28℠ 생태계에서 처음으로 진행된 주요 출시로, 첨단 기술을 통해 발과 발목 치료를 개선하는 것을 목표로 하고 있습니다.

포털의 첫 번째 모듈인 SMART Bun-Yo-Matic℠는 방아쇠 수술에 초점을 맞추고 있습니다. 이 모듈은 엑스레이 기반의 3D 해부학 시각화 및 맞춤형 수술 계획을 위한 AI 기반 알고리즘과 같은 독특한 기능을 제공합니다. 초기 사용자인 세사르 데 세사르 네토 박사는 Hallux Valgus 수술에서 시스템의 정확성을 칭찬했습니다.

CEO 알버트 다코스타는 포털이 발과 발목 수술의 미래에 중요한 의미를 강조하며, 3D 절차 계획 및 정확한 실행에서의 효율성을 강조했습니다. SMART28℠ Case Management Portal은 다양한 발과 발목 상태에 대한 추가 모듈로 확장될 예정입니다.

Paragon 28 (NYSE: FNA) a lancé le SMART28℠ Case Management Portal, une plateforme utilisant l'IA pour coordonner des plans chirurgicaux spécifiques aux patients. Cela marque la première grande sortie de l'écosystème SMART28℠ de Paragon 28, visant à améliorer les traitements du pied et de la cheville grâce à des technologies avancées.

Le premier module du portail, SMART Bun-Yo-Matic℠, se concentre sur la correction des hallux valgus. Il offre des fonctionnalités uniques telles que la visualisation anatomique en 3D à partir d'images radiographiques et des algorithmes dirigés par IA pour des plans chirurgicaux sur mesure. Le Dr Cesar De Cesar Netto, un utilisateur précoce, a salué la précision du système dans la chirurgie du Hallux Valgus.

Le PDG Albert DaCosta a souligné l'importance du portail pour l'avenir de la chirurgie du pied et de la cheville, en mettant en avant son efficacité dans la planification des procédures en 3D et sa mise en œuvre précise. Le SMART28℠ Case Management Portal est prévu pour s'étendre avec des modules supplémentaires pour diverses conditions des pieds et des chevilles.

Paragon 28 (NYSE: FNA) hat das SMART28℠ Case Management Portal gestartet, eine Plattform, die KI nutzt, um patientenspezifische Operationspläne zu koordinieren. Dies ist die erste bedeutende Veröffentlichung im SMART28℠-Ökosystem von Paragon 28, das darauf abzielt, die Behandlung von Fuß- und Sprunggelenksproblemen durch modernste Technologien zu verbessern.

Das erste Modul des Portals, SMART Bun-Yo-Matic℠, konzentriert sich auf die Korrektur von Hallux Valgus. Es bietet einzigartige Funktionen wie 3D-Anatomievisualisierung aus Röntgenbildern und KI-gesteuerte Algorithmen für maßgeschneiderte Operationspläne. Dr. Cesar De Cesar Netto, ein früher Nutzer, lobte die Präzision des Systems bei der Hallux Valgus-Operation.

CEO Albert DaCosta betonte die Bedeutung des Portals für die Zukunft der Fuß- und Sprunggelenkschirurgie und hob die Effizienz in der 3D-Verfahrensplanung und der präzisen Umsetzung hervor. Das SMART28℠ Case Management Portal soll mit zusätzlichen Modulen für verschiedene Fuß- und Sprunggelenkszustände erweitert werden.

Positive
  • Launch of SMART28℠ Case Management Portal, leveraging AI for surgical planning
  • Introduction of SMART Bun-Yo-Matic℠ module for bunion correction with 3D visualization capabilities
  • AI-driven algorithms create tailored surgical plans within 10 minutes
  • Potential for improved precision and outcomes in Hallux Valgus surgery
Negative
  • None.

Insights

Paragon 28's launch of the SMART28℠ Case Management Portal represents a significant advancement in foot and ankle surgery technology. The platform's integration of AI, 3D modeling and patient-specific algorithms for bunion correction is groundbreaking. Key innovations include:

  • 3D anatomy visualization from 2D X-rays, a first in the industry
  • AI-driven surgical planning completed in just 10 minutes
  • Real-time plan adjustments with immediate updates
  • Integration with the Bun-Yo-Matic Lapidus Clamp for precise intraoperative control

This technology has the potential to improve surgical outcomes and reduce procedure times. However, its success will depend on surgeon adoption and real-world performance data, which are yet to be seen.

The SMART Bun-Yo-Matic℠ system is a game-changer for hallux valgus correction. As an orthopedic surgeon, I see immense value in its ability to provide 3D planning from weight-bearing CT or X-rays. This allows for a comprehensive understanding of the deformity and optimal correction planning. The system's capacity to detect abnormal anatomy and allow real-time adjustments is particularly impressive. However, it's important to note that while this technology offers unprecedented precision, surgical skill and experience remain paramount. The true test will be in long-term patient outcomes and whether this technology can consistently improve results across a wide range of cases and surgeons.

Paragon 28's SMART28℠ ecosystem positions the company at the forefront of AI-driven orthopedic solutions. This launch could significantly impact the $5 billion global foot and ankle devices market. Key market implications include:

  • Potential increase in Paragon 28's market share
  • Pressure on competitors to develop similar AI-driven platforms
  • Possible boost in adoption of minimally invasive foot surgery techniques

While the technology is promising, market success will hinge on factors such as pricing strategy, training programs for surgeons and clinical evidence demonstrating improved patient outcomes. Investors should monitor adoption rates and any expansion of the SMART28℠ ecosystem to other foot and ankle conditions.

ENGLEWOOD, Colo.--(BUSINESS WIRE)-- Paragon 28, Inc. (NYSE: FNA), is proud to announce the launch of the SMART28℠ Case Management Portal, a cutting-edge platform that leverages AI and a seamless user experience to coordinate patient-specific surgical plans. It is the first major launch of Paragon 28’s SMART28℠ ecosystem, a portfolio of solutions and products that drive Paragon 28’s SMART28℠ initiative: to improve all aspects of foot and ankle treatments through the utilization of artificial intelligence, data analytics, patient specific algorithms, 3D modeling, and other enabling technologies.

Figure 1: Smart Bun-Yo-Matic Case Management and Workflow (Graphic: Paragon 28)

Figure 1: Smart Bun-Yo-Matic Case Management and Workflow (Graphic: Paragon 28)

The SMART28℠ Case Management Portal gives surgeons the ability to plan cases, coordinate surgery dates, and submit patient imaging. It will also serve as a direct line of communication with the Paragon 28 engineering and sales teams for real-time support, status updates, and surgical planning insights. The first module to launch within the Case Management Portal is SMART Bun-Yo-Matic℠ for bunion correction.

SMART Bun-Yo-Matic℠ has imaging optionality to input either patient weight-bearing X-rays or weight-bearing CT (“WBCT”) scans. It is the first foot and ankle orthopedic device on the market that allows the user to see the foot as 3D anatomy from two X-ray images. If a surgeon uses WBCT, they have access to “see inside the joint,” allowing the user to assess the joint distance distribution specific to their patient and compare it to normal joint alignment.

SMART Bun-Yo-Matic℠ revolutionizes preoperative planning and correction for hallux valgus by creating plans tailored to the individual patient. AI-driven algorithms and statistical shape modeling integrate with surgeon input, and within 10 minutes, export a surgical plan for correction, notifying the user if abnormal anatomy is detected. SMART BYM℠ allows the surgeon to adjust the plan in real time and exports a new surgical plan incorporating their recommended changes, if desired. The final surgical plan provides the surgeon user specific reference points that allow for additional reproducibility when paired with The Bun-Yo-Matic Lapidus Clamp, which can be used to identify, measure, and hold the planned corrections in place during the procedure.

Dr. Cesar De Cesar Netto, surgeon designer and one of the first users of the SMART Bun-Yo-Matic℠, says of the portal: “The ability to 3D plan your Hallux Valgus correction is crucial for understanding this complex deformity and optimizing multiplanar correction. Even more revolutionary is the capability to apply, control, and achieve the planned correction with the use of the Clamp. Precision down to the millimeter matters, the SMART Bun-Yo-Matic℠ system represents a significant advancement in improving precision and outcomes in Hallux Valgus surgery.”

Paragon 28’s CEO, Albert DaCosta, commented, “We could not be more excited about the launch of our SMART 28 Case Management Portal and SMART Bun-Yo-Matic cleared for weight-bearing CT and X-ray. This marks a tremendous step forward for Paragon 28 and we expect it will make a big impact on the future of foot and ankle surgery. With the SMART Bun-Yo-Matic℠, surgeons are able to efficiently plan a procedure in 3D and have the ability to precisely implement the plan with full intraoperative control.”

The SMART28℠ Case Management Portal is a foundational tool for future modules to span many additional foot and ankle conditions. With the introduction of SMART Bun-Yo-Matic℠, Paragon 28 has taken a giant leap forward in paving the way for surgeons to utilize artificial intelligence to optimize surgical outcomes for their patients.

For more information regarding the SMART 28℠ ecosystem and modules please visit: https://smart.paragon28.com/

About Paragon 28, Inc.

Based in Englewood, CO., Paragon 28, is a leading medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that cover a wide range of foot and ankle ailments including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, Charcot foot and orthobiologics. The company designs products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedures simpler, consistent, and reproducible.

Forward Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Paragon 28’s business in general, see Paragon 28’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023 and its Quarterly Reports on Form 10-Q, as updated periodically with its other lings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could di er from those projected in the forward-looking statements, except as required by law.

Disclaimer

Dr. Cesar De Cesar Netto may report consulting and royalty fees from Paragon 28 in connection with the provision of product development services to Paragon 28.

Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.

Investor Contact

Matthew Brinkman

Senior Vice President, Strategy and Investor Relations

mbrinkman@paragon28.com

Source: Paragon 28, Inc.

FAQ

What is the SMART28℠ Case Management Portal launched by Paragon 28 (FNA)?

The SMART28℠ Case Management Portal is a platform that uses AI to coordinate patient-specific surgical plans for foot and ankle treatments. It allows surgeons to plan cases, coordinate surgery dates, submit patient imaging, and communicate with Paragon 28's engineering and sales teams.

What features does the SMART Bun-Yo-Matic℠ module offer for bunion correction?

SMART Bun-Yo-Matic℠ offers 3D anatomy visualization from X-rays or weight-bearing CT scans, AI-driven algorithms for tailored surgical plans, real-time plan adjustments, and integration with The Bun-Yo-Matic Lapidus Clamp for precise correction during surgery.

How long does it take for SMART Bun-Yo-Matic℠ to create a surgical plan?

SMART Bun-Yo-Matic℠ can create a tailored surgical plan within 10 minutes using AI-driven algorithms and statistical shape modeling integrated with surgeon input.

What does Paragon 28 (FNA) CEO Albert DaCosta say about the SMART28℠ Case Management Portal?

CEO Albert DaCosta stated that the launch of the SMART28℠ Case Management Portal and SMART Bun-Yo-Matic℠ is a significant step forward for Paragon 28 and is expected to have a big impact on the future of foot and ankle surgery.

Paragon 28, Inc.

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