Category: Knee deformation

With more than 100,000 implants worldwide, the M6-C and M6-L drives continue to demonstrate strong clinical performance, safety and patient benefits

The Orthofix M6-C™ artificial intervertebral disc is a next-generation artificial intervertebral disc designed to replace an intervertebral disc damaged by degeneration of the cervical intervertebral discs. The M6-C disc is designed to restore spinal motion and is an alternative to cervical fusion.

LEWISVILLE, Texas, November 29, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the release of the five-year results of its US clinical trial comparing the M6 ​​-C^™ artificial cervical disc with anterior cervical discectomy and fusion (ACDF). Published in The Spine diarypatients treated with the M6-C disc demonstrated superior clinical success at 60 months compared to ACDF patients. Secondary findings indicated significant improvements in neck and arm pain, function and quality of life. The M6-C patient group maintained flexion-extension and lateral bending motion as reported at previous time points. The release of these data coincides with the recognition that more than 100,000 implantations of the M6-C artificial cervical disc and the M6-L artificial lumbar disc (available outside the US only) have been performed worldwide since the product was first introduced in 2006.

“Publication of these data is important as it validates the strong clinical performance observed in the five-year data from the US IDE study,” said lead author Dr. Frank Phillips, professor of orthopedic surgery at Rush University Medical Center in Chicago and the director investigator for the FDA clinical trial. “Artificial intervertebral disc replacement is becoming the gold standard of care for indicated patients who might otherwise experience intervertebral disc fusion. Data from this study demonstrate that the M6-C artificial disc demonstrated superior clinical success over five years compared to ACDF controls. Furthermore, significantly more subjects in the M6-C group reported improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.”

A prospective, nonrandomized, concurrently controlled clinical trial, the M6-C IDE study, was conducted at 23 sites in the United States with a mean patient age of 44 years. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of symptomatic single-level cervical radiculopathy with or without umbilical cord compression. The overall success rate for the protocol-specified primary endpoint for the M6-C disk patients was 82.3 percent, compared to 67.0 percent in the control group. The rates of subsequent surgical intervention (SSI) on the M6-C drive were 3.1 percent, device or procedure related serious adverse events (SAE) were 3.1 percent and were comparable to ACDF rates of SSI of 5.3 percent and SAE failure of 4.8 percent. The M6-C drive received U.S. Food and Drug Administration (FDA) approval in February 2019 based on the two-year results of this study.

“To date, there have been more than 100,000 implants of M6 artificial disc technology in 20 countries around the world,” said Kevin Kenny, president of Orthofix Global Spine. “We are proud of this life-changing technology that has helped so many people enjoy their lives again.”

About the M6-C artificial cervical disc

The M6-C artificial cervical disc is designed to maintain the natural behavior of a functional spinal unit by replicating the biomechanical characteristics of the original disc and is indicated as an alternative to cervical fusion. The unique design of the M6-C disc features a compressible viscoelastic core core and annular structure construction that allows shock absorption at the implanted level, providing a controlled range of motion as the spine transitions into its combined complex movements.

Orthofix invites attendees of the Cervical Spine Research Society (CSRS) annual meeting in Las Vegas, November 29 through December 2, 2023, to visit booth #109 to learn more about the company’s full portfolio of cervical solutions .

About Orthofix

Orthofix is ​​a leading global spine and orthopedics company with a comprehensive 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

CARLSBAD, California, November 28, 2023–(BUSINESS WIRE)–Spinal Elements, a spine technology company, today announced the full commercial launch of their Ventana 3D printed Interbody portfolio: the Ventana C Anterior Cervical Interbody System, Ventana P/T Posterior Lumbar Interbody System and Ventana L Lateral Lumbar Interbody System. Developed by Spinal Elements, the Ventana portfolio is the latest innovation in its MIS Ultra^® platform of products and procedural solutions.

The Ventana portfolio features a uniquely designed implant architecture that maximizes bone graft volume and containment through a specialized 3D printing process, which also minimizes the amount of titanium used to enhance radiographic visualization.

“The Ventana implant family features a 3D printed architecture that enables clear radiographic visualization during imaging. The implant windows allow a large amount of bone graft to be safely placed into the disc space to ensure contact with the end plates, which I believe is essential to the fusion process,” said Neel Anand, MD, Anand Spine Group, Los Angeles, CA.

Ventana’s minimalist radiolucent grid design maximizes the amount of bone graft captured within the device and improves visualization during and after the spinal fusion procedure. Ventana’s design also acts like a snowshoe, allowing the bone graft to come into contact with the endplates while providing a wide surface area to help prevent implant subsidence. The Ventana family of devices is available in different degrees of lordosis for restoring sagittal balance.

“The Spinal Elements team is committed to bringing innovative products to market that, when combined with our Orbit discectomy instrument set and our fixation systems, such as Karma^®Overwatch^® or Sapphire^®are successfully working together to achieve spinal fusion,” said Ron Lloyd, CEO of Spinal Elements. “Ventana represents another important milestone in our mission to redefine spine healthcare.”

The Ventana 3D printed interbody portfolio was developed organically by the Spinal Elements team with input and guidance from thought leaders in the field of spine surgery.

About Spinal Elements, Inc.

Spinal Elements is a technology-driven company headquartered in Carlsbad, California. As a leading designer, developer, manufacturer and marketer of innovative medical devices used in spine surgery, Spinal Elements combines leading medical device, biologic and instrumentation technologies to create positive surgical outcomes that exceed surgeons’ and patients’ expectations . Spinal Elements has built a reputation for delivering innovative and differentiated technologies that enable fundamental shifts in spine surgery solutions. The company markets a complete portfolio of advanced spinal implant technologies. For more information, please visit www.spinalelements.com.

About Kohlberg & Company, LLC

Kohlberg is a leading private equity firm based in Mount Kisco, New York. Since its founding in 1987, the company has organized nine private equity funds, raising $12 billion in committed equity capital. Over its 35-year history, Kohlberg has completed 91 platform investments and nearly 250 add-on acquisitions, with a total transaction value of approximately $40 billion. For more information, please visit www.kohlberg.com.

Contacts

For interviews or more information, please contact:
Laura Charlton (formerly Johnson) for Spinal Elements
laurajohnsonpr@yahoo.com (760) 450-7749 mobile

Value-building Medical Device Executive with 20 years of experience driving market-leading growth in orthopedics and spine companies

Global leader with extensive M&A expertise and commercial and operational experience in key Orthofix geographies

LEWISVILLE, Texas, November 28, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced that Massimo Calafiore has been named incoming President and Chief Executive Officer. Mr. Calafiore is currently Chief Executive Officer of LimaCorporate SpA, a global orthopedic company, and his appointment at Orthofix is ​​expected to become effective in early 2024, following the completion of the previously announced acquisition of LimaCorporate by Enovis Corporation (NYSE: ENOV). At that time, it is expected that Mr. Calafiore will also join the Orthofix Board of Directors.

“The Board of Directors has unanimously decided that Massimo is the right choice to lead Orthofix given his exceptional track record in delivering value creation and his extensive knowledge of the medical device industry, particularly within orthopedics and spine,” said Catherine Burzik, Chairman of the Board of Directors. of Board and Interim CEO of Orthofix. “Throughout his career, Massimo has demonstrated his ability to unlock value opportunities for multi-segment, global companies. He has successfully driven the sales and commercial activities to achieve both industry-leading profitability and growth. Importantly, he has proven experience in integrating companies and building high-performing teams.”

“Having worked in orthopedics and spine throughout my career, I know Orthofix well and have long admired the company and its talented team,” said Mr. Calafiore. “I was attracted to Orthofix because of the many growth opportunities created by its unique, broad portfolio and high-quality distributor relationships. I am also impressed by the innovative solutions Orthofix has developed to meet the needs of surgeons and the patients it serves. At this pivotal time for the company, I look forward to working with the Board and leadership team to leverage Orthofix’s significant profitable growth potential and enhance shareholder value.”

Mr. Calafiore is an experienced global business leader with an excellent track record at multiple companies in the orthopedics and spine industry. Throughout his career, he has demonstrated a commitment to operational excellence, ethical integrity and DE&I values.

He has been CEO of LimaCorporate since September 2022. During this time, Mr. Calafiore has strengthened and reimagined the company’s strategy and culture priorities, with a focus on nurturing, mentoring and retaining talent. His leadership resulted in consecutive quarter-over-quarter above-market growth; best-in-class EBITDA margins; and a substantial improvement in employee engagement and retention. On September 25, 2023, LimaCorporate announced its sale to Enovis Corporation for €800 million.

Before joining LimaCorporate, he was Executive Vice President and Chief Commercial Officer of NuVasive, Inc. and delivered consecutive quarter-over-quarter above-market growth across all core geographies, including US, APAC, EMEA and Japan, and successfully launched multiple products globally, becoming fundamental to NuVasive’s portfolio offering.

Early in his tenure at NuVasive, Mr. Calafiore served as President of NuVasive Specialized Orthopedics (formerly Ellipse Technologies). In this role, he helped further integrate the Ellipse business with NuVasive, delivering multiple quarters of accelerated revenue growth with above-average margin expansion. NuVasive Specialized Orthopedics is today a major player in complex trauma and limb reconstructions for adults and children, a market segment in which Orthofix is ​​also a recognized leader.

Earlier in his career, Mr. Calafiore worked for Waldemar Link GmbH & Co. KG and has held various leadership roles across multiple business segments, including orthopedics, lower extremity and spine. He oversaw the sales of the STAR Ankle to Small Bone Innovations and the PCM Cervical disc to NuVasive.

He has an M.Sc. in Mechanical Engineering from the University of Catania and an MBA from New York University.

The company also announced that Ms. Burzik has informed the Board of Directors that she has elected not to seek re-election as a member of the Board of Directors at the 2024 Annual Meeting.

Ms. Burzik said, “It is an honor to serve as interim CEO and work closely with the great employees at Orthofix. The organization is on solid foundations and I will be pleased to hand the business over to Massimo’s highly capable hands and plan to work closely with him in the coming months to ensure a seamless transition.”

The Board of Directors engaged Heidrick & Struggles, a leading global executive search firm, to assist in the search process.

About Orthofix

Orthofix is ​​a leading global spine and orthopedics company with a comprehensive 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 with 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, manufacturing 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 Sao Paulo, Brazil.

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

BETHLEHEM, Pa., Nov. 28, 2023 /PRNewswire/ — Tyber Medical has been selected to receive the Governor’s Award for Safety Excellence (GASE) – a highly competitive program that recognizes exceptional workplace safety and prevention initiatives, as well as the effective and successful management of these initiatives by its employees.

“Tyber Medical is committed to developing global products to help people recover from trauma and degenerative diseases. In order for our team to create these great products, the company must provide a safe, efficient workplace that keeps our ‘Work Hard, Play Hard’ mentality on track,” said Jeff Tyber, CEO and President of Tyber Medical . “The GASE Award recognizes that spirit and our commitment to maintaining an industry-leading approach to safety and performance.”

The eligibility criteria for the GASE is extensive, starting with a nomination process followed by an initial evaluation of each company by an assessment committee. To become a semifinalist, companies must undergo a multifaceted assessment of accident and illness rates, safety program innovation, and strategic safety policy development and approach. They are then compared to industry-wide rates and standards for those conditions.

Only after being approved by PA Labor & Industry Department officials will the semifinalists have the opportunity to host members of the GASE Review Committee for an on-site review. These reports help determine the finalists, who are then recommended to the Secretary of Labor and Industry for final review and decision-making.

Among the impressive factors noted by the review committee were Tyber Medical’s comprehensive safety policies and procedures, as well as their virtual reality training and online safety video reference – all accessible via a QR code. With these measures, employees have worked an outstanding total of 280,000 hours in 2021 and 2022 and 330,000 hours in 2022 without incident.

“I am so grateful to Tyber Medical, which puts employee well-being at the forefront of its mission. The team won this award by empowering its members to use creativity and technology in new ways to create the safest and most fun work environment I have ever been a part of,” said Toby Borcoman, Head of Culture and Vice President of Human Resources at Tyber. Medical. “Our culture promotes creativity and the implementation of new ideas. The company is willing to try out new ideas every day!”

Tyber Medical received the award from representatives of the Department of Labor and Industry at the Governor’s Occupational Safety and Health (GOSH) Conference last October, and the safety practices used at Tyber Medical facilities are now shared across the state as a model for reference for companies within the industry.

“Building a safe work environment is not a one-person endeavor,” Tyber noted in response to the recognition. “It will take a team of leaders, such as our safety officers and champions, and a corporate commitment not only to implement this policy, but also to train our people on the policy and ensure everyone can benefit from its positive impacts .”

About Tyber Medical LLC

Tyber Medical LLC is a leading orthopedic device manufacturer providing rapid access to FDA-cleared and CE-marked private label, portfolio-expanding, regulatory-approved orthopedic implants for the spine, limb and trauma markets. Tyber Medical offers customers a fast and seamless path to market. Since its founding in 2012, the company has introduced more than 50 spine, extremity and trauma systems. Tyber Medical strives to develop and utilize differentiated technologies to create advanced orthopedic implants.

Contact person: Toby Borcoman, Tyber Medical
Email: tborcoman@tybermed.com

SOURCE Tyber Medical

BETHLEHEM, Pa., Nov. 28, 2023 /PRNewswire/ — Tyber Medical has been selected to receive the Governor’s Award for Safety Excellence (GASE) – a highly competitive program that recognizes exceptional workplace safety and prevention initiatives, as well as the effective and successful management of these initiatives by its employees.

“Tyber Medical is committed to developing global products to help people recover from trauma and degenerative diseases. In order for our team to create these great products, the company must provide a safe, efficient workplace that keeps our ‘Work Hard, Play Hard’ mentality on track,” said Jeff Tyber, CEO and President of Tyber Medical . “The GASE Award recognizes that spirit and our commitment to maintaining an industry-leading approach to safety and performance.”

The eligibility criteria for the GASE is extensive, starting with a nomination process followed by an initial evaluation of each company by an assessment committee. To become a semifinalist, companies must undergo a multifaceted assessment of accident and illness rates, safety program innovation, and strategic safety policy development and approach. They are then compared to industry-wide rates and standards for those conditions.

Only after being approved by PA Labor & Industry Department officials will the semifinalists have the opportunity to host members of the GASE Review Committee for an on-site review. These reports help determine the finalists, who are then recommended to the Secretary of Labor and Industry for final review and decision-making.

Among the impressive factors noted by the review committee were Tyber Medical’s comprehensive safety policies and procedures, as well as their virtual reality training and online safety video reference – all accessible via a QR code. With these measures, employees have worked an outstanding total of 280,000 hours in 2021 and 2022 and 330,000 hours in 2022 without incident.

“I am so grateful to Tyber Medical, which puts employee well-being at the forefront of its mission. The team won this award by empowering its members to use creativity and technology in new ways to create the safest and most fun work environment I have ever been a part of,” said Toby Borcoman, Head of Culture and Vice President of Human Resources at Tyber. Medical. “Our culture promotes creativity and the implementation of new ideas. The company is willing to try out new ideas every day!”

Tyber Medical received the award from representatives of the Department of Labor and Industry at the Governor’s Occupational Safety and Health (GOSH) Conference last October, and the safety practices used at Tyber Medical facilities are now shared across the state as a model for reference for companies within the industry.

“Building a safe work environment is not a one-person endeavor,” Tyber noted in response to the recognition. “It will take a team of leaders, such as our safety officers and champions, and a corporate commitment not only to implement this policy, but also to train our people on the policy and ensure everyone can benefit from its positive impacts .”

About Tyber Medical LLC

Tyber Medical LLC is a leading orthopedic device manufacturer providing rapid access to FDA-cleared and CE-marked private label, portfolio-expanding, regulatory-approved orthopedic implants for the spine, limb and trauma markets. Tyber Medical offers customers a fast and seamless path to market. Since its founding in 2012, the company has introduced more than 50 spine, extremity and trauma systems. Tyber Medical strives to develop and utilize differentiated technologies to create advanced orthopedic implants.

Contact person: Toby Borcoman, Tyber Medical
Email: tborcoman@tybermed.com

SOURCE Tyber Medical

– First sale to major global distributor represents major revenue milestone and paves way for broader commercialization –

AUSTIN, TX / ACCESS WIRE / November 28, 2023 / Monogram Orthopedics Inc. (NASDAQ:MGRM) (“Monogram” or the “Company”), a medical technology company focused on reconstructive joint procedures and surgical robotics, has delivered its first surgical robot to one of the world’s largest global robotics distributors.

“Delivering our first robot and achieving our first commercial revenues validates our technology and represents a critical milestone for our strategic roadmap,” said Ben Sexson, Chief Executive Officer of Monogram Orthopedics. “Our system performs at an extremely high level. We now look forward to seeing how our robot competes and scales in the real world. We hope that the mBôs robot will contribute to improving the standard of care for orthopedic patients worldwide.”

Monogram aims to improve the standard of care in orthopedic joint replacement surgery with advanced, next-generation active surgical robotics. About 88% of knee replacement surgeries (the company’s first target group) are still performed manually. The mBôs robot aims to combine safety, ease of use, streamlined costs, novel implant design, broad clinical functionality and speed to help drive the next wave of robot adoption in orthopedics.

About Monogram Orthopedics

Monogram Orthopedics (NASDAQ: MGRM) is developing a product solution architecture with the long-term goal of enabling patient-optimized orthopedic implants at scale by coupling 3D printing and robotics with advanced pre-operative imaging. The company has a robot prototype that can autonomously perform optimized paths for high-precision insertion of implants into synthetic bone specimens. Monogram plans to manufacture and market robotic surgical equipment and related software, orthopedic implants, tissue ablation devices, navigation consumables and other miscellaneous instruments required for reconstructive joint replacement procedures. The company has not yet filed a 510(k) premarket notification or obtained 510(k) approvals for its robotic products. Marketing these products requires FDA approval, and the Company has not obtained FDA approval for any of its robotic products, and it cannot estimate the timing or guarantee the ability to obtain such approvals.

Monogram Orthopedics is working to improve the way orthopedic surgery is performed. Our system is being developed to combine personalized knee implants with precision robotic surgical assistants to hopefully provide patients with a more appropriate knee replacement with minimally invasive surgery. One hundred thousand knee replacements that fail each year in a $19.4 billion market represent a huge opportunity for us.

For more information, visit www.monogramorthopedics.com.

Forward-Looking Statements

This press release may contain “forward-looking statements.” To the extent that the information presented in this presentation discusses financial projections, information or expectations about Monogram Orthopedics Inc.’s business plans, results of operations, products or markets, or otherwise makes statements regarding future events, such statements are forward-looking. . Such forward-looking statements can be identified by the use of words such as “should”, “may”, “intend”, “anticipate”, “believe”, “estimate”, “project”, “predict”, “expect” , ”planning” and ”making proposals”.

Although Monogram Orthopedics Inc. believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider all cautionary statements and other disclosures, including the statements under the heading “Risk Factors” and elsewhere in the offering statement filed with the SEC. Forward-looking statements speak only as of the date of the document in which they appear, and Monogram Orthopedics Inc. assumes no obligation to update any forward-looking statements, except as may be required by law.

Investor Relations

Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us

SOURCE: MONOGRAM ORTHOPEDICS INC

Reduces time to weight bearing to two weeks from the current six to eight weeks

ATLANTA , Nov. 28, 2023 /PRNewswire/ — Shotel Medical today announced its Shotel™ Ankle Arthrodesis Nail System, which utilizes a novel device design for the treatment of end-stage ankle arthritis. It was used for the first time in Florida last month during a procedure in Delray Beach. Two weeks postoperatively, the patient was weight-bearing with the use of a CAM walking shoe, a significant improvement over the six- to eight-week time to weight-bearing offered by traditional ankle arthrodesis systems.

The patented Shotel Nail System, manufactured and distributed by BioPro Implants, differs from traditional ankle arthrodesis devices because its unique curved design allows for a minimally invasive approach with very small incisions. It is designed to achieve fusion at the tibiotalar joint while allowing unrestricted motion at all other joints. This benefits the patient with faster healing, faster recovery and faster loading. End-stage ankle arthritis is becoming increasingly common and can lead to significant physical disability. There are an estimated 50,000 new cases of ankle arthritis in the US each year¹

“We designed our ankle fusion nail system so that patients have smaller incisions, allowing them to heal faster and function much earlier, giving them a better quality of life. The improvement in time to weight bearing for the patient is meaningful,” said Christopher Weathers, Chief Commercial Officer. “We are pleased to see our Shotel nailing system gaining traction among surgeons across the country. So far, 24 operations have been performed with it.”

Kevin Palmer, DPM, dual board certified podiatrist from Boca Raton and Delray Beach, FL, who performed the procedure, said, “The patient presented with progressively worsening ankle disease and pre-existing structurally compromised hardware. The new design of the Shotel Nail System gave me confidence that it would be stable and would hold up over the long term. During the procedure, after I removed the patient’s current hardware, the Shotel Nail System was inserted smoothly, with a smaller incision and a much less invasive approach than traditional ankle fusion systems. I also like that it provides multiple layers of compression, which is needed at the fusion site to speed healing.

“I cannot emphasize enough how important it is that the patient started walking with a CAM walking shoe within two weeks,” added Dr. Palmer added. “This will be a game changer – and life changing – for many patients in the future.”

For more information about the Shotel™ Ankle Arthrodesis Nailing System or for surgical training, visit www.shotelmedical.com.

About Shotel Medical
Shotel Medical is the developer of the Shotel™ Ankle Arthrodesis Nail System, an entirely new device that has the potential to transform patient care and have a significant impact on the healthcare landscape. Developed in collaboration with a team of biomechanical engineers, orthopedic surgeons and industry thought leaders, the device addresses the needs of patients with end-stage ankle arthritis. The unique design allows patients to heal faster, function sooner and improve quality of life compared to current treatment options. Founded in 2017, the company has offices in New Orleans and Atlanta.

About BioPro
For more than three decades, BioPro has been at the forefront of orthopedic innovation, focused on improving the lives of patients suffering from orthopedic conditions. The company is committed to developing advanced implants and surgical devices that reduce pain and restore function, providing patients and surgeons with a diverse portfolio of established solutions and emerging technology. For more information, visit https://bioproimplants.com/.

Media contact:
Barbara Bikkel
305-215-2121
369140@email4pr.com

___________________________________
¹ Smyth, Niall A. MD; Dawkins, Brody J.BA; Goldstein, Joshua P.B.S.; Kaplan, Jonathan R. MD; Schon, Lew C. MD; Aiyer, Amiethab A. MD. Consumer prices for surgical treatment of ankle arthritis: limited availability and high variability. JAAOS: Global Research and Reviews 3(7):p e011, July 2019. | DOI: 10.5435/JAAOSGlobal-D-19-00011

SOURCE Shotel Medical

Drs. Ali H. Mesiwala and Grant D. Shifflett participate in the pivotal two-level study of the safety and effectiveness of the Orthofix M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion.

NEWPORT BEACH, Calif., Nov. 28, 2023 /PRNewswire/ – DISC Surgery Center of Newport Beach (“DISC”), committed to supporting research vital to the field of spine care, has announced its participation in a clinical trial to artificial disc replacement and is now enrolling qualified patients. Candidates may include patients between the ages of 18 and 75 who have been told they need cervical (neck) surgery at two consecutive levels (among other requirements).

Drs. Ali H. Mesiwala and Grant D. Shifflett – both board-certified, fellowship-trained spine surgeons at DISC – join other experts at approximately 30 clinical sites participating in this study across the country. The primary objective of the study is to evaluate the safety and effectiveness of the Orthofix M6-C™ artificial cervical disc (already FDA-approved for single-level surgery) in patients with contiguous symptomatic bilevel cervical radiculopathy, with or without umbilical cord compression. The results will then be compared with those in patients undergoing anterior cervical discectomy and fusion (ACDF).

Artificial disc replacement surgery is very similar to ACDF surgery. Both procedures remove the damaged disk. However, when the damaged disc is removed to replace the disc, the space between the vertebrae is filled with a specialized implant called an artificial disc, instead of a bone graft. The artificial disc is designed to restore the distance between the vertebrae while still allowing some movement.

With its track record as a national leader in outpatient spine and its team’s extensive experience performing advanced motion maintenance techniques, DISC is ideally positioned to participate in such research.

“The DISC Surgery Center in Newport Beach has placed more than 3,000 cervical discs since 2018 and we are well versed in the motion-preserving qualities of the surgery,” said Dr. Mesiwala. “I think it is important to stay actively involved in research to improve patient care, so I wanted to be part of a study that will improve our learnings and discoveries.”

Dr. Shifflett added, “As pioneers in minimally invasive spine surgery and techniques, we always welcome the opportunity to advance the field while informing the treatment options available to patients.”

Patients who would like to know if they are eligible for this study can visit https://www.discmdgroup.com/adr-clinical-study/.

About DISC Surgery Center in Newport Beach
DISC Surgery Center in Newport Beach is a purpose-built outpatient clinic focused on providing patients with the safest, most advanced minimally invasive spine surgery, orthopedic sports medicine, total joint replacement and pain management. DISC is a subsidiary of TriasMD, a portfolio company of Chicago Pacific Founders, and also an official partner of Red Bull Athlete Performance Center. For more information, call 949-988-7800, visit www.discmdgroup.com or follow @DISCMD on Instagram.

Media contact:
Kristien Brada-Thompson
760-274-6393
369218@email4pr.com

SOURCE DISC Sports and Spine Center

Nociscan orders accelerated 2.5x for the last 250 scans compared to the first 250 scans

Further acceleration in scan volumes is expected as MRIs are activated for the recently completed panel of 10 Key Opinion Leader (KOL) surgeons

All commercial Nociscans to date have been completed on Siemens MRI scanners, with additional acceleration in volumes expected as Philips scanners come on board

BROOMFIELD, CO, November 27, 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 it has completed 1,000 commercial Nociscan studies.

“This milestone in itself is significant, but the pace of our commercial adoption is the most exciting aspect of reaching 1,000 commercial scans,” said Brent Ness, CEO of Aclarion. “For context, 36% of these 1,000 studies were conducted in the last twelve months, demonstrating the adoption our strategy has delivered on our journey to a standard of care. As more imaging locations are added and KOLs continue to access Nociscan, we expect to reach the 2,000 scans milestone even faster.”

“This achievement reinforces Aclarion’s clear leadership in the evolving field of augmented intelligence and the renaissance in MR spectroscopy,” said Ryan Bond, Chief Strategy Officer at Aclarion. “Nociscan is the first of its kind, evidence-based SaaS platform that turns volumes of complex data into a clear, streamlined report that efficiently communicates individualized biomarker data to help physicians optimize treatment strategies for patients suffering from chronic low back pain. This is an important commercial milestone for our physician customers, their patients and our team.”

Worldwide, 266 million people suffer from degenerative spinal disorders and lower back pain¹. Conventional imaging and diagnostics provide valuable structural information but struggle to identify the source of the pathogenic pain. Low surgical success rates (41-57%)^2.3 especially for patients suffering from discogenic chronic low back pain (DCLP). Of all disease conditions, low back and neck pain are responsible for the highest healthcare expenditures in the US¹.

Aclarion’s disruptive innovation, Nociscan, emerged over a decade of development. Aclarion’s patent portfolio includes 22 U.S. patents, 17 international patents, 6 pending U.S. patent applications and 7 pending international patent applications, including patents and patent applications exclusively licensed by Regents of the University of California.

Nociscan is currently available from imaging facilities using select models of Siemens 1.5T and 3T magnetic resonance spectroscopy. For more information please contact 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 Annual Report on Form 10-K for the year ended December 31, 2022, as well as other disclosures 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.

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[1] Ravindra VM, Global Spine Journal (2018) 8(8): 784-794
[2] Wei J, Song Y, et al. Comparison of artificial total disc replacement versus fusion for lumbar disc disease: a meta-analysis of randomized controlled trials. Int Orthop. 2013; 37(7):1315-1325
[3] Ibrahim T, Tieyjeh IM, et al. Surgical versus nonsurgical treatment of chronic low back pain: a meta-analysis of randomized trials. Int Orthop. 2008; 32(1):107-113

CHICAGO, Nov. 27, 2023 /PRNewswire/ — Stronger quadriceps muscles, compared to the hamstrings, may lower the risk of total knee replacement, according to research presented today at the annual meeting of the Radiological Society of North America (RSNA). Researchers said the findings could inform strength training programs for people with advanced knee arthritis.

Advanced knee osteoarthritis is a leading cause of pain and disability worldwide. In the US alone, 14 million adults have symptomatic knee osteoarthritis, and more than half of diagnosed patients are expected to eventually undergo total knee replacement surgery.

Although stronger muscle groups are generally thought to be associated with a lower rate of total knee replacements, their relative importance is not well established. Of particular importance is the relationship between the extensors and the hamstrings, the two main muscle groups in the knee.

The extensors, the muscles at the front of the thigh, commonly called the quadriceps, are the strongest muscle group in the body and have a vital influence on walking, other activities and biomechanics. The muscles around the back of the thigh, known as the hamstrings, are responsible for the extension of the hip and flexion of the knee, making them equally essential for physical activity.

“The two muscle groups act as opposing forces, and the balance between them allows for a wide range of activities while protecting the knee joint,” says lead study author Upasana Upadhyay Bharadwaj, MD, of the University of California, San Francisco (UCSF). “An imbalance, among other factors, leads to a change in biomechanics, resulting in the progression of osteoarthritis.”

Dr. Upadhyay Bharadwaj and colleagues evaluated thigh muscle volume in 134 participants in the Osteoarthritis Initiative, a nationwide study sponsored by the National Institutes of Health. They compared 67 patients who underwent total knee replacement of one knee with 67 control participants who did not undergo knee replacement. The cases and controls were matched on variables such as age and gender.

The researchers obtained 3T MRI of the thigh at the time of surgery. They also evaluated MRI findings two years and four years before surgery. They used a previously trained deep learning model to segment and calculate the volumes of the muscles of the thigh – measurements that are difficult to calculate manually.

When comparing patients who had undergone total knee replacement with the control group, a higher ratio of quadriceps to hamstring volume was significantly associated with a lower likelihood of total knee replacement. Higher hamstring and gracilis volumes, a long, thin muscle on the inside of the thigh, were also associated with a lower likelihood of total knee replacement.

“Our research shows that in addition to strong individual muscles, larger extensor muscle groups – compared to hamstring muscle groups – are significantly associated with a lower likelihood of total knee replacement surgery within two to four years,” said Dr. Upadhyay Bharadwaj.

The study results have implications for both the interpretation of imaging studies and clinical management. The results suggest that training programs that strengthen the quadriceps in relation to the hamstrings may be beneficial.

“Although we assume that total muscle volume is important as a surrogate marker of muscle strength, the relationship, and therefore balance, between the extensor and hamstring muscles may be more important and significantly associated with a lower likelihood of total knee replacement,” Dr. Upadhyay Bharadwaj said.

Although the study focused on people with arthritis, the findings could also help inform strength training for a broader segment of the population.

“While these results are essential for targeted therapy in a population at risk for osteoarthritis, even the general public can benefit from our results by preventively incorporating appropriate strengthening exercises,” said Dr. Upadhyay Bharadwaj.

Co-authors are John A. Lynch, Ph.D., Gabby B. Joseph, Ph.D., and Thomas M. Link, MD, Ph.D.

Note: Copies of RSNA 2023 news releases and electronic images will be available online at RSNA.org/press23.

RSNA is an association of radiologists, radiation oncologists, medical physicists and related scientists who promote excellence in patient care and health care through education, research and technological innovation. The association is located in Oak Brook, Illinois. (RSNA.org)

Editor’s note: The data in these publications may differ from the data in the published abstract and the data actually presented at the meeting, as researchers continue to update their data up until the meeting. To ensure you are using the most current information, please call the RSNA Newsroom at 1-312-791-6610.

For patient-friendly information about musculoskeletal imaging, please visit RadiologyInfo.org.

SOURCE Radiological Society of North America (RSNA)