Category: Knee deformation

LEWISVILLE, Texas, November 6, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full commercial launch in the U.S. of the WaveForm^® L Lateral lumbar interbody system. Designed for lateral lumbar interbody fusion (LLIF) procedures, the 3D printed WaveForm L features a porous structure that prioritizes strength and stability to provide a robust fusion environment.

“Designed to safely and reproducibly treat the spine via indirect decompression and sagittal alignment restoration, the WaveForm L features a large core opening for the placement of bone graft material to optimize bone fusion throughout the body,” said Dr. Donald Blaskiewicz, director of Spinal Malformation at St. Luke’s Boise Medical Center in Boise, Idaho, and faculty at UCSD in San Diego, CA. “The WaveForm L also has enhanced imaging properties to assist with radiographic visualization during intra- and postoperative imaging. These combined features make it one of the best 3D printed interbodies available.”

WaveForm interbodies are uniquely created with a primary focus on structure, surface and stability. Constructed from a repeating wave-like structure, WaveForm L is designed to efficiently distribute compressive loads and provide high porosity for optimized stiffness without compromising strength.^1,2 With an 80 percent body porosity, WaveForm L provides improved imaging properties and greater graft packability, while the optimized 65 percent endplate porosity of the wave-like structure provides bone ingrowth and early mechanical stability.^3,4,5

“We are committed to delivering a comprehensive portfolio of innovative, procedurally focused products that are strategically designed to work together to drive fusion,” said Kevin Kenny, president of Orthofix Global Spine. “WaveForm L represents the latest developments in patented spinal implant technology, which is designed to address the many nuances of spinal pathology to meet the individual needs of patients, providing both clinical and economic value to patients, surgeons and hospital systems.”

Lateral lumbar interbody fusion (LLIF) procedures represent approximately 20 percent of the interbody device market. The number of these procedures is expected to continue to increase based on the rapid growth of titanium-coated PEEK devices and 3D printed metal devices. According to 2022 data, the LLIF market in the US is estimated at over $350 million.⁶

1. Data available, TM-0043-22
2. Kelly, Cambre N., et al. “Design and structure-function characterization of 3D printed synthetic porous biomaterials for tissue engineering.” Advanced Healthcare Materials 7.7 (2018): 1701095.
3. Data available, TM-0071-23
4. Data available, D0006845
5. Kelly, C.N., Wang, T., Crowley, J., Wills, D., Pelletier, M.H., Westrick, E.R., Adams, S.B., Gall, K., & Walsh, W.R. (2021). High-strength, porous, additively manufactured implants with optimized mechanical osseointegration. Biomaterials, 279, 121206. https://doi.org/10.1016/j.biomaterials.2021.121206
6. Data on file. Market estimates based on iData 2022 US Market Report Suite for Spinal Impants and MIS.

About Orthofix

Orthofix and SeaSpine merged in January 2023 to form a leading global spine and orthopedics company with an extensive portfolio of biologics, innovative spine hardware, bone growth therapies, specialty orthopedic solutions and a leading surgical navigation system. The products are distributed in approximately 68 countries around the world.

The company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education and manufacturing, and corporate offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy. with an emphasis on product innovation, production and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France and São Paulo, Brazil. For more information, visit Orthofix.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects” , ‘intends’, ‘predicts’, ‘potential’, ‘continue’ or other similar terminology. Orthofix cautions you that statements in this press release that are not descriptions of historical facts are forward-looking statements based on the company’s current expectations and assumptions. Any forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including due to the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s annual report. on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6. , 2023. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Orthofix does not intend to revise or update any forward-looking statement contained in this press release to reflect events or circumstances occurring after the date of this press release, except as may be required by law.

Contacts

Media relations
Denise Landry
DeniseLandry@orthofix.com
214.937.2529

Investor Relations
Louisa Smith, Gilmartin Group
IR@orthofix.com

Annual guidance has been increased to $136 million – $137 million, implying annual growth of 28%-29%

SANTA CLARA, California, November 6, 2023 (GLOBE NEWSWIRE) – SI-BONE, Inc. (Nasdaq:SIBN), a medical device company committed to solving musculoskeletal disorders of the sacropelvic anatomy, today reported financial results for the quarter ended September 30, 2023.

Recent Financial Highlights

• Record global revenue of $34.0 million for the third quarter of 2023, representing approximately 29% growth over the corresponding period in 2022
• Record US revenue of $32.3 million for the third quarter of 2023, representing approximately 31% growth over the corresponding period in 2022
• Gross margin of approximately 79% for the third quarter of 2023
• More than 1,040 active surgeons in the US in the third quarter of 2023, representing approximately 30% growth over the corresponding period in 2022
• $166.8 million in cash and equivalents at the end of the third quarter; cash used of $2.7 million in the quarter

Recent operational highlights

• Patent received for triangular brooch instrument, a crucial technology to place triangular implants in the SI joint and provide protection until 2034
• International Journal of Spine Surgery published a meta-analysis of 57 studies involving more than 2,800 patients, reaffirming that the SI-BONE technique produces the highest improvement in pain and disability scores
• More than 90,000 procedures performed by more than 3,500 surgeons worldwide

“I am proud of the team’s performance as we defied industry seasonality and delivered another exceptional quarter with a 34% increase in US procedure volume, achieving the first time in the company’s history surpassed 1,000 active surgeons in the US in a quarter. In addition, we continued our progress toward profitability as record revenue in the quarter translated into significant operating leverage and lower cash consumption,” said Laura Francis, Chief Executive Officer. “As we close 2023 with strong momentum, our planned product portfolio expansions, combined with demand inflection in our large addressable market of nearly half a million annual procedures, give me confidence that we are in the early stages of growing demand to our solutions. In addition, we have the operational framework and strong balance sheet to deliver strong and sustainable revenue growth over the long term.”

Third Financial results quarter 2023

Global revenue for the third quarter of 2023 was $34.0 million, up 29% from $26.4 million in the corresponding period in 2022. U.S. revenue for the third quarter of 2023 was $32.3 million, a increase of 31% from $24.6 million in the corresponding period in 2022. International revenue growth for the third quarter of 2023 was $1.7 million, compared to $1.8 million in the corresponding period in 2022.

Gross margin was 79% for the third quarter of 2023, compared to 84% in the corresponding period in 2022. The gross margin in the third quarter of 2023 was influenced by procedure and product mix, given the higher total costs of iFuse-TORQ and iFuse Bedrock Granite . Gross margin also includes the impact of increased depreciation on instrument trays to support business growth and depreciation related to our second facility in Santa Clara.

Operating expenses increased 6% to $38.1 million in the third quarter of 2023, compared to $35.8 million in the corresponding period in 2022. The change in operating expenses was primarily driven by increases in commissions related to revenue growth, research investments and development and commercial expenses. activities to support the turnover and active growth of surgeons.

Operating loss improved 18% to $11.2 million in the third quarter of 2023, compared to an operating loss of $13.6 million in the corresponding period in 2022.

Net loss improved 29% to $10.0 million, or $0.25 per diluted share for the third quarter of 2023, compared to a net loss of $14.2 million, or $0.41 per diluted share in the corresponding period in 2022. Net loss per diluted share for the third quarter of 2023 includes the impact of the increase in the number of shares outstanding resulting from a follow-on issuance of common shares in May 2023.

Adjusted EBITDA loss improved approximately 44% to negative $3.9 million in the third quarter of 2023, compared to an adjusted EBITDA loss of negative $6.9 million in the corresponding period in 2022.

Cash and marketable securities at September 30, 2023 were $166.8 million and borrowings were $36.0 million.

2023 Updated financial guidelines

Based on the strength of the company’s year-to-date performance and momentum exiting the third quarter of 2023, SI-BONE increases its 2023 global revenue guidance to a range of $136 million to $137 million compared to prior expectations from the company. $132 million to $134 million. The updated guidance translates to growth of approximately 28% to 29% compared to fiscal 2022, versus previous revenue growth of approximately 24% to 26%.

Webcast information

SI-BONE will host a conference call to discuss its third quarter 2023 financial results after the market closes on Monday, November 6, 2023 at 4:30 PM Eastern Time. The conference call can be accessed live via webcast at https://edge.media-server.com/mmc/p/jw54nzhx. Live audio of the webcast will be available on the “Investors” section of the company’s website: www.si-bone.com. The webcast will be archived and available for replay for at least 90 days after the event.

About SI-BONE, Inc.

SI-BONE (NASDAQ: SIBN) is a global leader in technology for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Since pioneering minimally invasive SI joint surgery in 2009, SI-BONE has supported more than 3,500 surgeons performing a total of more than 90,000 sacropelvic procedures. A unique body of clinical evidence supports the use of SI-BONE’s technologies, including two randomized controlled trials and more than 120 peer-reviewed publications. SI-BONE has leveraged its leadership in minimally invasive SI joint fusion to commercialize new solutions for adjacent markets including adult deformity, spinopelvic fixation and pelvic trauma.

For additional information about the company or its products, including risks and benefits, please visit www.si-bone.com.

iFuse Bedrock Granite, iFuse-TORQ and SI-BONE are registered trademarks of SI-BONE, Inc. ©2023 SI-BONE, Inc. All rights reserved.

Forward-Looking Statements

The statements in this press release regarding expectations of future events or results, including SI-BONE’s expectations regarding continued revenue and procedural growth and financial prospects, contained in this press release are “forward-looking” statements. These forward-looking statements are based on SI-BONE’s current expectations and inherently involve significant risks and uncertainties. These risks include SI-BONE’s ability to introduce and commercialize new products and indications, SI-BONE’s ability to maintain favorable reimbursement for procedures using its products, the impact of any future economic weakness on patients’ ability and desire to undergo elective procedures, including those affecting the use of SI-BONE’s devices, SI-BONE’s ability to manage risks to its supply chain, future capital requirements resulting from new surgical systems requiring investment in instrument trays, and the pace of re-normalization of the healthcare work environment, including the ability and desire of patients and physicians to undergo and perform procedures using SI-‘s devices BONE. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these and other risks and uncertainties, many of which are described in the Company’s most recent filings on Form 10-K and Form 10- Q, and the company’s other filings with the Securities and Exchange Commission (SEC), available on the SEC’s Internet site (www.sec.gov), particularly under the heading “Risk Factors.” SI-BONE undertakes no obligation to update any forward-looking statements and expressly disclaims any obligation or undertaking to publicly release any updates or revisions to any forward-looking statements contained herein, except as required by law.

Use of Non-GAAP Financial Measures

SI-BONE uses adjusted EBITDA, a non-GAAP financial measure that excludes the effects of interest income, interest expense, depreciation and amortization and stock-based compensation from net loss. SI-BONE believes that the presentation of Adjusted EBITDA is useful to management because it allows management to more consistently analyze financial performance from period to period and provides meaningful additional information regarding the core operating activities used to drive performance of management to evaluate. SI-BONE also believes that the presentation of Adjusted EBITDA is useful to investors and other interested persons because it allows these persons to use this additional information to assess the company’s performance by using this additional measure that management uses to assess company performance.

Adjusted EBITDA should be considered a supplement to, and not a substitute for, financial information prepared in accordance with GAAP. Because Adjusted EBITDA excludes the effect of items that increase or decrease SI-BONE’s reported results of operations, management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety when they become available. The Company’s definition of adjusted EBITDA may differ from similar measures used by others.

Contact person for investors

Saqib Iqbal
Sr. Director, FP&A and Investor Relations
investors@SI-BONE.com

SEE FINANCES HERE

WARSAW, Ind., November 6, 2023 (GLOBE NEWSWIRE) — Orthopediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company solely focused on advancing the field of pediatric orthopedics, today announced that the company has entered into an exclusive distribution agreement with Montreal-based Ora Medical to market Ora’s gait trainer. Medical, The Levity, a device designed for children with mobility problems.

The Levity supports a child with an innovative partial weight bearing mechanism. This allows the child to interact with the world using his arms, unlocking countless possibilities. Thanks to the unique design, each child can receive personalized treatment. The Levity comes with versatile features to meet a wide range of needs: body weight support, harness, speed and direction of the device are adjustable, and the foldable design offers easy transportation. The Levity is suitable for most children between the ages of 3 and 12.

The Levity supports a child at the waist, allowing for a unique hands-free experience that strengthens the muscles most important for optimal walking rehabilitation. This opens up a whole new experience for children and therapists, as the latter can now fully concentrate on patient engagement.

Joe Hauser, president of Trauma and Deformity Correction at OrthoPediatrics, added: “Our new partnership with the team at Ora Medical is an exciting step in our non-surgical business. By partnering with great organizations with world-class technology, we can help more children with orthopedic conditions worldwide. The Levity running trainer will be a great addition to our portfolio of mobility solutions under the Specialty Bracing brand.”

Sarah Lambert, CEO and co-founder of Ora Medical, said: “As we begin to expand beyond Canadian borders, our partnership with OrthoPediatrics is perfectly timed. Their established market presence and expertise will facilitate the distribution of our device, furthering our mission to improve the mobility of children worldwide.”

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering for the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products serving three of the largest categories within the pediatric orthopedic market. This product offering includes trauma and deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization focuses exclusively on pediatric orthopedics and distributes its products in the United States and more than 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.

Contact person for investors
Philip Trip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406

Dr. Hartl is the Hansen-MacDonald Professor of Neurological Surgery and director of Spinal Surgery at the Weill Cornell Brain and Spine Center in New York, and co-director of New York-Presbyterian Och Spine.

Dr. Hartl becomes Aclarion’s 2^NL KOL to gain access to an MRI center authorized to perform Nociscans, adding NYC to Denver as the second active KOL location.

Aclarion will report on year-to-date Nociscan volumes before year-end and add this key metric to quarterly reporting starting in 2024.

BROOMFIELD, CO, November 6, 2023 (GLOBE NEWSWIRE) – via NewMediaWire — Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that uses biomarkers and proprietary enhanced intelligence algorithms to help physicians identify the location of chronic low back pain, today announced that Roger Hartl, MD, Hansen-MacDonald Professor of Neurological Surgery and director of Spinal Surgery at Weill Cornell Brain and Spine Center in New York, as well as New York-Presbyterian co-director Och Spine, will advise the company nationally as a key thought leader (KOL).

The practice of Dr. Hartl emphasizes an interdisciplinary approach to disease processes, and he works very closely with other specialists to personalize patients’ treatments. “My clinical interests focus on simple and complex spine surgery for degenerative conditions, as well as biological approaches for intervertebral disc repair and regeneration,” said Dr. Hartl. “Aclarion’s technology addresses a major gap in the current diagnosis of discogenic low back pain. I expect that Nociscan will provide valuable, objective information for our interdisciplinary approach to the treatment of degenerative intervertebral discs. Furthermore, I believe Nociscan will be equally valuable in our efforts to better understand less invasive surgical and biological treatment strategies for degenerative diseases of the spine.”

Chronic low back pain (cLBP) is a leading cause of opioid addiction in the US and the most expensive diagnosis in the United States. Aclarion’s Nociscan solution is the first science-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful intervertebral discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies.

“Dr. Hartl is a world-renowned neurosurgeon who continues to make advances in the diagnosis and treatment of low back pain,” said Brent Ness, CEO of Aclarion. “With immediate access to a Nociscan-activated MRI on Park Avenue in New York City, Dr. Hartl is already using Nociscan and will continue to gain clinical insights into the condition of his patients well into the future.”

Over the past 18 months, Aclarion has built a leading consortium of 10 KOL surgeons. Dr. Hartl represents the 10^e and latest KOL addition to Aclarion’s panel. The company is now in the critical phase of activating MRIs for each of its KOLs so they can begin using the technology, track clinical outcomes, and advocate for payer coverage decisions to expand access to Nociscan for all expand patients. The company will announce additional MRI activations for the remaining KOLs as they become available and will begin reporting on scan volumes as Nociscan usage increases with these MRI activations.

For information about using Nociscan in New York City, please contact Aclarion at info@aclarion.com.

About Aclarion, Inc.

Aclarion is a healthcare technology company that uses magnetic resonance spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers and enhanced intelligence algorithms to optimize clinical treatments. The company is entering the chronic low back pain market for the first time with Nociscan, the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies. For more information please visit www.aclarion.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These forward-looking statements are based on management’s current plans and expectations and are subject to a number of uncertainties and risks that could materially affect the company’s current plans and expectations, as well as its future results of operations and financial condition. These and other risks and uncertainties are discussed in more detail in our filings with the Securities and Exchange Commission. Readers are encouraged to read the section entitled “Risk Factors” in the Company’s April 21, 2022 Prospectus as filed with the Securities and Exchange Commission on April 25, 2022 under Rule 424(b)(4), as well as other disclosures. included in the Prospectus and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor contacts:
Kirin M. Smith
PCG Advice, Inc.
646.823.8656
ksmith@pcgadvisory.com

Media contacts:
Jodi Lamberti
SPRIG advice
612.812.7477
jodi@sprigconsulting.com

The report provides a snapshot of the current state of hip and knee arthroplasty practices in the United States

ROSEMONT, Ill., Nov. 3, 2023 /PRNewswire/ — The American Joint Replacement Registry (AJRR), the cornerstone of the American Academy of Orthopedic Surgeons (AAOS) Registry Program, has released its 2023 Annual Report on Procedural Trends in Hip and Knee Arthroplasties and patient outcomes today. Marking the 10^e anniversary edition of the report, the data represents more than 3.1 million primary and revision hip and knee arthroplasty procedures performed between 2012 and 2022. This is a 23% growth in procedural cases compared to the previous report.

Click here to view the full AJRR annual report.

“This year’s AJRR Annual Report provides a look at the past decade of data through 2022 and provides clinical insights, national trends, and risk-stratified outcome analyzes related to Medicare patients undergoing hip and knee arthroplasty procedures,” said James I. Huddleston, III, MD, FAAOS, AJRR Steering Committee Chairman. “This linkage provides a more complete picture of our patient population and associated comorbidities and outcomes, including longitudinal outcomes of patients receiving care at non-AJRR participating sites. The information in this year’s annual report provides the most comprehensive picture yet of practice patterns and outcomes of hip and knee arthroplasty in the US.”

Harnessing the power of registry data to improve patient care
By collecting and reporting U.S. hip and knee arthroplasty data, the report aims to provide valuable information to orthopedic surgeons, hospitals, ambulatory surgical centers (ASCs), private practices, device manufacturers, payers and, most importantly, patients. The analytics can help physicians change practice and improve patient outcomes.

The AJRR is the largest orthopedic registry based on annual number of procedures. Some notable findings in the 2023 Annual Report include:

• Patient-reported outcome measures (PROMs) are increasingly used to evaluate the success of a hip or knee arthroplasty procedure. Through continued support of the RegistryInsights® PROM platform and partnerships with third-party vendors, AJRR has experienced substantial growth in PROM capture. By the end of 2022, 496 participating sites had submitted PROMs, which is a 24% increase from the previous year. Collection of PROMs data via de KOOS, JR. The score showed that 86% of patients achieved meaningful improvement after total knee arthroplasty (TKA).
• Ambulatory surgical centers (ASCs) continue to play an increasingly important role in the delivery of total joint arthroplasty care in the U.S. There are now 42,228 procedural cases reported by ASCs, an increase of 84% since 2022.
• Hospital discharges to home versus a skilled nursing facility are trending upward – Approximately 93% of patients are now discharged home after elective primary total hip arthroplasty (THA), with many fewer patients (8%) being discharged to skilled nursing facilities compared to just a few years ago. The percentage of patients discharged to skilled nursing after primary TKA also continues to decline and now represents less than 6% of all discharges. These data demonstrate surgeons’ continued commitment to safely returning patients to their home environments, as well as their interest in preoperative patient optimization and care coordination.
• The use of technology to assist in elective primary total hip arthroplasty has increased significantly – Over the past six years, the use of robotics in TKA has increased more than sixfold and is now reported in over 13% of procedures, while the use of computer navigation has remained relatively stable. According to Dr. Huddleston, the continued collection and analysis of robotic data will ultimately allow surgeons to assess the value proposition of these technologies.
• New analyzes offer new perspectives on patient outcomes – Additional analyzes included for the first time in the 2023 AJRR Annual Report, including comparisons of hip and knee survival rates between pre- and post-COVID-19 emergency declarations, revision outcomes after revision THA between dual mobility and standard designs, and survival rates among fracture patients treated with THA versus hemiarthroplasty. These new analyzes provide critical insights into the impact of COVID-19 on patients and shed light on the performance of new technologies and treatment paradigms.
• Peer-reviewed publications and presentations based on registry data remain an important focus of AJRR.

“The publication of the 10^e edition of the AJRR Annual Report further affirms the commitment of healthcare organizations, physicians and patients to improve the quality of musculoskeletal care,” said James A. Browne, MD, FAAOS, chairman of the AJRR Publications Subcommittee and editor of the AJRR -annual report. “The ever-increasing submission and compilation of data is driving new insights and fueling our desire to improve the value of care for our patients.”

For slides with numbers and data tables shown in the report, please email media@aaos.org.

AAOS Registry Program
The mission of the AAOS Registry Program is to improve orthopedic care by collecting, analyzing and reporting actionable data. The American Joint Replacement Registry (AJRR), the Academy’s hip and knee replacement registry, is the cornerstone of the AAOS Registry Program and the world’s largest national registry of hip and knee joint replacement data based on annual procedural counts, with more than 3 million procedures included in its database. Additional registries include the Fracture & Trauma Registry (FTR), the Musculoskeletal Tumor Registry (MsTR), the Shoulder & Elbow Registry (SER), and the American Spine Registry (ASR), a partnership between the American Association of Neurological Surgeons (AANS ) and the AAOS.

About the AAOS
With more than 39,000 members, the American Academy of Orthopedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in promoting musculoskeletal health. It provides the highest quality and most comprehensive training to help orthopedic surgeons and paramedics at all career levels best treat patients in their daily practice. The AAOS is the source for information about bone and joint disorders, treatments and related issues in musculoskeletal health care; and it guides the healthcare discussion on promoting quality.

Follow the AAOS on Facebook, TweetLinkedIn and Instagram.

SOURCE American Academy of Orthopedic Surgeons

MIAMI, Nov. 3, 2023 /PRNewswire/ — POLARIS^AR is pleased to announce today that their STELLAR knee has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). STELLAR Knee is the first approval for POLARIS^ARa company focused on creating a new category in surgical guidance in Mixed Reality.

POLARIS^AR and STELLAR Knee are building the intersection of physical surgery and virtual surgical guidance, creating a unique digital operating room environment. This digital OR environment uses Mixed Reality displays to provide surgeons with real-time access to intraoperative anatomical data used to measure, plan and guide total knee arthroplasty procedures. Using a unique combination of proprietary optical tracking algorithms and spatial computing software, STELLAR Knee measures and records clinically meaningful hard and soft tissue anatomical data, enabling sub-millimetric intraoperative planning and providing precise resection accuracy and guidance.

“This is an important moment for orthopedic surgery,” said Dr. John Cooper, associate professor of orthopedic surgery, Columbia University Irving Medical Center. “Before STELLAR Knee, I had to rely on the inaccuracy of conventional instruments, or on complex technologies such as robotics to improve surgical precision. While these technologies provide important data that can be used to personalize surgery for each patient, they require a large footprint in my OR and a significant financial commitment from my institution. Now I can wear an unobtrusive digital assistant that provides real-time measurements and calculations I can trust, validating surgical decisions.”

With no footprint in the operating room other than a Mixed Reality headset that acts as a three-dimensional spatial computing tool, STELLAR Knee dynamically acquires patient-specific anatomical data and digitizes that information into holographic displays. By capturing the surgeon’s field of view, STELLAR Knee creates a real-time digital data exchange between the surgeon and the technology that supports clinical decisions. Surgeons have full interactive capabilities with the highly customizable and intuitive user interface, allowing them to make quick assessments and micro-adjustments to the surgical plan.

With minimal physical installation, a simple integration process and competitive pricing compared to traditional surgical guidance systems, STELLAR Knee has the ability to shift the standard of care. The STELLAR Knee workflow is open and available for use in all total knee replacement implant systems. POLARIS^AR and STELLAR Knee are creating a new category in surgical guidance software that leverages the latest visual display technology.

“One of the most important aspects of new technology entering the operating room is the impact it makes and the footprint it requires,” said Dr. Francis Gonzales, professor of orthopedic surgery, University of California, San Diego. “Technological progress does not always correlate with improvements within the OR. STELLAR Knee is an exception. Because it has no footprint outside the headset, no computers or stalls, it does exactly what it was designed to do: it allows me to focus on what matters most: the operation, and to have confidence in the decisions I make. take.”

“Our software has the power to usher in the next generation of surgical advancements,” said Paul Mikus, Chief Executive Officer of POLARIS^AR. “This is a new day for orthopedics and surgery as a whole, as the promise of Augmented Reality is now being fulfilled. STELLAR Knee is pioneering a new class of surgical software that leverages best-in-class spatial computing and optimizes operating room workflow. STELLAR Knee not only impacts the surgeon and the patient, but also empowers healthcare providers to change the standard of care.”

For more information about POLARIS, visit the link below^AR and STELLAR Knee, and to connect to a sales or POLARIS^AR team representative: https://www.thinkpolaris.com/

ABOUT POLARIS^AR

POLARIS^AR is a Miami-based startup whose mission is to develop a new class of Mixed Reality surgical technology. Their goal is to optimize intraoperative workflows and improve patient outcomes using advanced, three-dimensional spatial computing algorithms – going beyond traditional navigation, patient-specific instrumentation, robotics and first-generation augmented reality.

The US Food and Drug Administration has approved STELLAR Knee in 2023. The company was founded in 2020 and is headquartered in Miami, Florida.

For more information about POLARIS^ARvisit: https://www.thinkpolaris.com/

For any further information please contact:
Media
Ethan Metelenis
Ethan.Metelenis@precisionvh.com
917.882.9038

SOURCE PolarisAR

The formation of the board comes at a pivotal time for Nanovis as they continue their ongoing mission to leverage nanotechnology for improved patient care.

COLUMBIA CITY, Ind., Nov. 2, 2023 /PRNewswire-PRWeb/ — Nanovis, a leader in nanotechnology surface solutions for orthopedic, spinal and dental applications, announces the formation of its Scientific Advisory Board (SAB). The board will consist of Dr. C. Lowry Barnes, Dr. Douglas W. Pahl, Dr. Brent Ponce and Dr. Thomas J. Webster. This team is a multidisciplinary, multidisciplinary scientific advisory board composed of leaders from the musculoskeletal specialties. Nanovis will continue to fill their SAB with other specialties such as dentistry, trauma, foot and ankle, and infectious diseases in the coming months.

Brian More, CEO of Nanovis, said: “The creation of the SAB marks a pivotal moment for Nanovis in our ongoing mission to leverage nanotechnology for improved patient care. The board’s collective expertise will be critical in advancing claims and indications for nanoVIS Ti Surface Technology, our FDA-designated nanotechnology surface that has been approved for seven product systems and has been successfully implanted in thousands of patients.”

In addition to technological advancements, the SAB will play a critical role in guiding Nanovis’ approach to clinical data collection and analysis. Their expertise will help strategically collect clinical data, ensure its thorough research and help present the benefits of Nanovis’ technologies at conferences and in academic journals. This initiative aims to validate the clinical efficacy of the company’s surface technology portfolio, drive innovation, discover new product applications and identify potential new markets.

Brian More added: “With the guidance of the SAB, we are well positioned to break new ground in orthopedic implant technology, ensuring that our scientific breakthroughs translate into real benefits for surgeons and patients.”

Board members:

Dr. C. Lowry Barnes

Orthopedic surgeon

University of Arkansas, Little Rock, Chairman of the Department of Orthopedic Surgery, Hip & Knee Specialty

Dr. Douglas W. Pahl

Orthopedic surgeon

Hughston Spine and the Hughston Clinic Spine specialty

Dr. Brent Ponce

Orthopedic surgeon

Hughston Clinic, Columbus, Georgia

Chair, Hughston Foundation Research Shoulder and Sports Medicine Specialty

Dr. Thomas J. Webster

Professor

Brown University

Department of Pre-college and Undergraduate Studies

Nanovis will exhibit its FDA-designated nanotechnology surface at the American Association of Hip and Knee Surgeons in Dallas, Texas, November 2-5, 2023. In conjunction with the AAHKS meeting, Scientific Advisory Board Member Dr. C. Lowry Barnes to host a Nanovis-sponsored educational event on nanotechnology in total joint arthroplasty.

About Nanovis

Nanovis is a technology-driven company committed to discovering unmet clinical needs, developing innovative and enabling solutions, and validating new technologies for clinical and market acceptance. The company, through its subsidiary Nanovis Spine, has successfully commercialized its proprietary nanoVIS Ti Surface Technology^™ for a range of spinal implants, including the nano FortiFix^™ Pedicle screws and Nano FortiCore^™ PEEK Titanium Hybrid Interbodies, the latter being enriched with OsteoSync^™ technology licensed from Site Medical.

In particular, the nanoVIS Ti Surface technology^™ platform shows in preclinical studies its potential to evolve into an antimicrobial surface in select markets, while Nanovis simultaneously innovates a next-generation antimicrobial technology aimed at combating localized infections in various applications including skin, transcutaneous devices and orthopedic implants .

Ready to learn more about the science behind nanoVIS Ti Surface Technology™? Join us on LinkedIn.

Media contact

Guillaume Viallaneix, Nanovis, 1 (407) 960-2994, guillaume@medtechmomentum.com, MedTechMomentum.com

SOURCE Nanovis

Spine surgeons and distributors are welcome

DALLAS, November 3, 2023 / OrthoSpineNews/ – On November 4, CTL Amedica will introduce surgeons and distributors to the new MONDRIAN™ Anterior Lumbar Interbody Fusion (ALIF) System during a special hands-on laboratory. The laboratory will be held in the Minimally Invasive Surgical Training and Education Center, located in the Rosenstiel Building at the University of Miami.

This will be the spine industry’s first official, hands-on look at the MONDRIAN™ ALIF System. The FDA-cleared implant system is an integrated plate-and-cage construction made of titanium and featuring CTL Amedica’s patented TiCRO™ surface technology, which enhances the interlocking properties of bones.

“The MONDRIAN™ ALIF System is designed to provide anterior column stabilization and supplemental fixation while accommodating a wide range of patient anatomies and surgical preferences,” said Daniel Chon, CEO of CTL Amedica. “It is a unique implant that we believe will be very useful to surgeons and their patients, and we are excited to demonstrate this important technology this coming weekend at the University of Miami.”

Named after the influential, early 20s^e century artist Piet Mondrian, the MONDRIAN™ ALIF System features a smooth, tapered leading edge for easy insertion, a large central chamber for maximum biological graft volume, a proprietary screw locking mechanism and an additional screw blocking plate for additional reinforcement.

Additionally, the MONDRIAN™ ALIF System features hyperlordotic cages for complex corrections, multiple screw plate configurations for greater operational versatility, and CTL Amedica’s patented and precision machined TiCRO™ surface technology, which provides a larger surface area than predicates, increasing contact with the bony endplates is significantly increased. .

The educational laboratory is open to all surgeons and distributors, but participation space is limited. For more information, contact info@ctlamedica.com or call 1-800-713-9489.

CTL Amedica is a progressive medical device design, development and manufacturing company. CTL Amedica has a Texas-based headquarters and its own manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. CTL Amedica is a leader in medical device and biomaterials technology, offering a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, it is the world’s exclusive supplier of silicon nitride backbone products, which demonstrate greater protein absorption and increased osseointegration, promote better bone growth, improve osteogenic response and accelerate fusion. For more information, visit https://www.ctlamedica.com/.

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Contact:
Joy Mazza
CTL America Corporation
443-422-5653
Jmazza@ctlmed.com

• Third Quarter 2023 US prodisk^® Total Disc Replacement (TDR) sales reached nearly $14 million in sales – a new record – surpassing the second quarter of 2023, the company’s previous best quarter.
• Third quarter 2023 worldwide proDisc TDR remained strong by product segment, with global lumbar TDR growing 43% – a new sales record – and global cervical TDR growing 75%.
• Year-to-date worldwide proDisc TDR revenues of $49 million in the third quarter are up 55% year-over-year.
• Strong global revenue growth and operating performance resulted in Centinel Spine’s second consecutive EBITDA positive quarter.

WEST CHESTER, Pa., Nov. 2, 2023 /PRNewswire/ — Centinel Spine^®LLC, (“the Company”), the leading global medical device company addressing cervical and lumbar spine diseases with the world’s most clinically proven total disc replacement (TDR) technology platform (prodisk^®), today announced record third quarter 2023 prodisk TDR financial results. Strong operating performance combined with global revenue growth of 61% year-on-year in Q3 2023 saw the company achieve its second consecutive EBITDA-positive quarter. Centinel Spine’s strong quarterly results were driven by record numbers of professionalsdisk surgeon users, as well as accelerated procedure volume and user acceptance of the company’s new professionaldrive C I’m alive and prodisk C SK cervical TDR system.

According to one of the early adopters of the new prodisk cervical system neurosurgeon John S. Shiau, MD, of Maplewood, NJ and Manhattan, NY: “I believe in the benefits of cervical disc replacement over fusion in my patients. The functional recovery and long-term results are fantastic. I am very pleased with the various disc replacements available from Centinel Spine. I can choose the implant that best achieves my surgical goals of functional stabilization. In addition, I can choose the implant that fits the anatomy, instead of matching the anatomy to the implant. This maximizes the chance of successful results in my patients. For these reasons, depending on the clinical setting, I continue to use both the original prodisk C implant and the professionaldrive C I’m alive implant. For example, if the superior end plate is flat, then the prodisk C fits the anatomy better; if the end plate is concave, I choose the domed prodrive C I’m alive. The proffesionaldrive C I’m alive implant is an improvement in terms of ease of insertion.”

Centinel Spine CEO Steve Murray said: “We are pleased with the progress Centinel Spine is making in the overall disc replacement market this year. The company is exclusively and completely focused on becoming the unrivaled leader in TDR and expanding the market as we grow. In both cervical and lumbar disc replacement, surgeons see the benefit of our Match-the-Disc family of anatomic discs. The clinical benefits of total disc replacement are clearly and impeccably reported in the many studies examining its safety and effectiveness – and patients are increasingly seeking treatment options that preserve motion and reduce the likelihood of future surgery. We will continue to do our utmost to improve patient care in everything we do.”

Highlights third quarter 2023

Q3 2023 worldwide prodisk Franchise sales exceeded $17 million, up 61% from last year, with prodisk cervical growth 75% and prodisk lumbar increase by 43% compared to 2022.

American profdisk turnover grew by 71% in the third quarter compared to last year. Quarterly revenue reached a record $14 million, thanks to the continued success of the new professionaldrive C I’m alive and prodisk C SK cervical TDR system and almost 40% year-over-year prodisk lumbar growth. American profdisk Cervical cancer revenue grew by more than 100% in the third quarter of 2023 compared to last year.

The American Profdisk Surgeon user base grew more than 50% year-over-year, including 70% growth in prodisk cervical users. New professionaldisk the number of users has more than tripled from the third quarter of 2022. Additionally, the total number of US healthcare facilities that prodisk TDR products exceeded 465, up 45% year-over-year, and the number of distributors selling pro productsdisk almost 30% growth compared to the third quarter of 2022.

International Q3 2023 prodisk TDR’s revenue grew 30% from Q3 2022, driven by 85% growth in prodisk lumbar sales.

Highlights on new cervical prodisc TDR system One year after US launch

Acceptance by the American market of the new professionaldrive C I’m alive and prodisk S.K system remains strong, with nearly 380 surgeons now using the system – a sequential user growth of nearly 30% in the second quarter of 2023. The company reached the milestone of 2,500 procedures with the new prodrive C I’m alive and prodisk c S.K system in September, just five months after hitting 1,000^e The case was announced in April 2023. In the third quarter of 2023, almost 900 procedures were completed with the new system, a volume growth of 15% over the second quarter of 2023.

The average monthly user base of US surgeons for the new professionaldrive C I’m alive and prodisk c S.K the system continued to grow in the third quarter of 2023, with an increase of almost 10% compared to the previous quarter. The proffesionaldrive C I’m alive and prodisk C S.K The surgeon user base also remains committed to the new system, with the majority being competitive conversions and returning users.

2023 performance to date

Year-to-date September 2023 worldwide prodisk TDR revenue of $49 million represents a 55% year-over-year increase. Record sales across all geographic segments were also strong through the first nine months of 2023, with year-over-year gains in the US.disk turnover is growing by 61% and international turnover is growing by 36%. The growth in the number of new surgeons has been driven by the company’s medical education programs, which have trained more than 750 surgeons to date.

Year-to-date Q3 US prodisk TDR’s revenue approached $38 million, driven by a rapidly growing user base of surgeons and repeat use within its existing customer base. Until the third quarter, the American prodisk The user base of TDR surgeons has increased by more than 50% year over year.

The year-over-year growth of the US prodisk The cervical surgeon base was particularly strong, growing over 65% through the end of the third quarter of 2023. Finally, more than 85% of the pro grewdisk The TDR cervical surgeon user base has seen repeated use since the beginning of the year compared to the same period in 2022.

Year-to-date Q3 International prodisk TDR revenues are up 36% in 2022, driven by 55% prodisk lumbar growth and prodisk sales growth of cervical products by 30% by 2022.

Outlook for the full year 2023

Looking ahead to full year 2023, the company has increased its projection and anticipates its global benefitsdisk TDR business will exceed 50% year-on-year, significantly exceeding expected market growth of 11% (source: Artificial Drives Market Insights, Competitive Landscape and Market Forecast-2027, DelveInsight Business Research LLP, 2022). The full year growth will come from the prosdisk global lumbar activities and continued expansion of the recently launched prodrive C I’m alive and prodisk c S.K cervical system.

About Centinel Spine, LLC

Centinel spine^®LLC is the leading global medical device company addressing cervical and lumbar spine diseases with the world’s most clinically proven total disc replacement (TDR) technology platform (prodisk^®). The company’s prodisk technology is the most studied and clinically proven TDR system in the world, validated by more than 540 published articles and more than 250,000 implantations worldwide.

Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst for change in the spine industry and change the way spine surgery is experienced. The proffesionaldisk platform remains the only technology with multiple motion preservation solutions for both cervical and lumbar anterior column reconstruction.

For more information, please visit the company’s website at www.CentinelSpine.com or contact:

Varun Gandhi
Finance Director
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

SOURCE Centinel Spine, LLC

CHICAGO , Nov. 2, 2023 /PRNewswire/ — A record 15 Midwest Orthopedics physicians at RUSH (MOR) were named to Chicago Magazine’s “Top Docs” list. The “Top Docs” list, compiled by Castle Connelly, a physician-led healthcare research and information company, features Chicago-area physicians selected by their peers.

The MOR physicians on this list are Drs. Charles Bush Joseph, Brian Forsythe, Grant Garrigues, Eduard Goudberg, Joshua Jacobs, Dennis Name, Shane Nho, Frank Phillips, Nikhil VermaAnd Adam Cut (orthopedic surgery category); Drs. Mark Cohen, John Fernandez, And Robert Wysocki (hand surgery category); Dr. Joshua Blomgren (sports medicine category); And Dr. Leda Ghannad (physical medicine and rehabilitation category).

This is the highest number of MOR physicians named to this honor since the popular list began published in Chicago Magazine.

About Midwest Orthopedics at RUSH

MOR is an international leader in musculoskeletal health and is ranked among the top ten in the country American news and world report. MOR consists of renowned orthopedic and spine surgeons who pioneer the latest developments in surgical techniques and non-surgical care. MOR physicians are the designated team care providers for several organizations, including the Chicago Bulls, Chicago White Sox, Chicago Red Stars and Joffrey Ballet. MOR has seven full-service locations in Chicago, Joliet, Naperville, Oak Brook, Oak Park, Westchester and Munster, IN. The group also operates nine standalone physical therapy clinics in Bensenville, Chicago’s South Loop, Geneva, Lincoln Park, Lockport, Orland Park, River Grove, Park Ridge and Munster, IN. Visit www.rushortho.com for more information.

SOURCE Midwest Orthopedics at RUSH