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Johnson & Johnson Reports 2018 First-Quarter Results

Posted On April 17, 2018 By OrthoSpineNews In Financial /  

NEW BRUNSWICK, N.J., April 17, 2018 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced sales of $20.0 billion for the first quarter of 2018, an increase of 12.6% as compared to the first quarter of 2017. Operational sales results increased 8.4% and the positive impact of currency was 4.2%. Domestic sales increased 6.1%. International sales increased 19.9%, reflecting operational growth of 10.9% and a positive currency impact of 9.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.3%, domestic sales increased 1.3% and international sales increased 7.6%.*

Net earnings and diluted earnings per share for the first quarter of 2018 were $4.4 billion and $1.60, respectively. First-quarter 2018 net earnings included after-tax intangible amortization expense of approximately $1.0 billion and a charge for after-tax special items of approximately $0.3 billion. First-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.4 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.6 billion and adjusted diluted earnings per share were $2.06, representing increases of 11.8% and 12.6%, respectively, as compared to the same period in 2017.* On an operational basis, adjusted diluted earnings per share also increased 5.5%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

“We are pleased with the strong and consistent performance delivered by our colleagues around the world, demonstrated by our sales and EPS growth in the first quarter,” said Alex Gorsky, Chairman and Chief Executive Officer. “Our Pharmaceutical business continues to deliver robust growth and we are pleased with the improvement in our Consumer business. In our Medical Devices businesses, we have areas of leadership and continue to make investments and portfolio choices to improve performance.”

Mr. Gorsky continued, “The U.S. tax legislation passed late last year is creating the opportunity for us to invest more than $30 billion in R&D and capital investments in the U.S. over the next four years, which is an increase of 15%.”

The Company increased its sales guidance for the full-year 2018 to a range of $81.0 to $81.8 billion, reflecting expected operational growth in the range of 4.0% to 5.0%. Additionally, the Company reaffirmed its adjusted earnings guidance for full-year 2018 to a range of $8.00 to $8.20 per share, reflecting expected operational growth in the range of 6.8% to 9.6%.

Segment Sales Performance
Worldwide Consumer sales of $3.4 billion for the first quarter 2018 represented an increase of 5.3% versus the prior year, consisting of an operational increase of 1.3% and a positive impact from currency of 4.0%. Domestic sales increased 1.6%, international sales increased 8.2%, which reflected an operational increase of 1.2% and a positive currency impact of 7.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 2.0%, domestic sales increased 1.6% and international sales increased 2.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by beauty products primarily NEUTROGENA, AVEENO, and Dr. Ci Labo, and international analgesics in over-the-counter products, partially offset by the negative impact of domestic baby care products.

Worldwide Pharmaceutical sales of $9.8 billion for the first quarter 2018 represented an increase of 19.4% versus the prior year with an operational increase of 15.1% and a positive impact from currency of 4.3%. Domestic sales increased 9.9%; international sales increased 33.1%, which reflected an operational increase of 22.5% and a positive currency impact of 10.6%. Sales included the impact of Actelion Ltd which contributed 7.6%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 7.5%, domestic sales increased 2.2% and international sales increased 15.3%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX (daratumumab), for the treatment of patients with multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer and TREMFYA (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis.  Additional contributors to operational sales growth included ZYTIGA  (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, STELARA (ustekinumab) and international SIMPONI/SIMPONI ARIA (golimumab), biologics for the treatment of  a number of immune-mediated inflammatory diseases, XARELTO (rivaroxaban), an oral anticoagulant, and INVEGA SUSTENNA/XEPLION/TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for ZYTIGA (abiraterone acetate), in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer and ERLEADA (apalutamide) an oral androgen receptor inhibitor for the treatment of patients with non-metastatic castration-resistant prostate cancer. In addition, the Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for JULUCA (rilpivirine and dolutegravir), the first, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 infection.

Also in the quarter, a marketing authorization application was submitted to the European Medicines Agency for apalutamide, an oral androgen receptor inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer.

Worldwide Medical Devices sales of $6.8 billion for the first quarter 2018 represented an increase of 7.5% versus the prior year consisting of an operational increase of 3.2% and a positive currency impact of 4.3%. Domestic sales increased 2.2%; international sales increased 12.7%, which reflected an operational increase of 4.2% and a positive currency impact of 8.5%. Sales included the partial quarter impact of the recently acquired surgical vision business  which contributed 3.1%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales decreased 0.2% and international sales increased 2.4%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by ACUVUE contact lenses in the Vision Care business; electrophysiology products in the Interventional Solutions business; endocutters in the Advanced Surgery business; and trauma products in the Orthopaedics business, partially offset by declines in the Diabetes Care business and spine products in the Orthopaedics business.

During the quarter, the acquisition of Orthotaxy S.A.S., a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery was completed. In addition, the Company announced a binding offer from Platinum Equity, a private investment firm, to acquire its LifeScan business for approximately $2.1 billion, subject to customary adjustments.

Subsequent to the quarter, ACUVUE OASYS with Transitions received 510(k) clearance from the FDA and is indicated for vision correction and the attenuation of bright light.

Additionally, Johnson & Johnson plans to implement actions across its global supply chain that are intended to enable the company to focus resources and increase investments in critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio of the future, enhance agility and drive growth. The Company expects these supply chain actions will include expanding our use of strategic collaborations, and bolstering our initiatives to reduce complexity, improving cost-competitiveness, enhancing capabilities and optimizing our network.  Discussions regarding specific future actions are ongoing and are subject to all relevant consultation requirements before they are finalized.

In total, the Company expects these actions to generate approximately $0.6 to $0.8 billion in annual pre-tax cost savings that will be substantially delivered by 2022. The Company expects to record pre-tax restructuring charges of approximately $1.9 to $2.3 billion, which will be treated as a special item.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

* Operational sales growth excluding the net impact of acquisitions and divestitures, as well as adjusted net earnings, adjusted diluted earnings per share and operational adjusted diluted earnings per share excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company’s website at www.investor.jnj.com. Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Johnson & Johnson will conduct a conference call with investors to discuss this news release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website at www.investor.jnj.com. A replay and podcast will be available approximately two hours after the live webcast by visiting www.investor.jnj.com.

Copies of the financial schedules accompanying this press release are available at www.investor.jnj.com/historical-sales.cfm. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, a pharmaceutical pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can be found on the company’s website at www.investor.jnj.com.

NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

 

Johnson & Johnson and Subsidiaries

Supplementary Sales Data

(Unaudited; Dollars in Millions)

FIRST QUARTER

Percent Change

2018

2017

Total

Operations

Currency

Sales to customers by

segment of business

Consumer

    U.S.

$       1,436

1,414

1.6

%

1.6

–

    International

1,962

1,814

8.2

1.2

7.0

3,398

3,228

5.3

1.3

4.0

Pharmaceutical

    U.S.

5,354

4,872

9.9

9.9

–

    International

4,490

3,373

33.1

22.5

10.6

9,844

8,245

19.4

15.1

4.3

Medical Devices

    U.S.

3,161

3,092

2.2

2.2

–

    International

3,606

3,201

12.7

4.2

8.5

6,767

6,293

7.5

3.2

4.3

U.S.

9,951

9,378

6.1

6.1

–

International

10,058

8,388

19.9

10.9

9.0

Worldwide

$     20,009

17,766

12.6

%

8.4

4.2

 

 

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OrthoTrophix Will Present Data on Long-Term Clinical Benefit of TPX-100 in Mild to Severe Knee Osteoarthritis Patients at OARSI Annual Meeting 2018

Posted On April 17, 2018 By OrthoSpineNews In Biologics /  

OAKLAND, Calif., April 17, 2018 /PRNewswire/ — OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the company plans to report long-term clinical benefits in mild to severe knee osteoarthritis (OA) patients who were treated with TPX-100 at the 2018 OARSI annual meeting (Liverpool, U.K., 26-29 April 2018).

OrthoTrophix previously presented the results of a Phase 2 clinical study in which the company’s OA drug candidate, TPX-100 improved knee function and physical quality of life at 6 and 12 months after treatment compared with placebo (N=93). A follow-on protocol, TPX-100-4, assessed the same patient reported outcomes in subjects who participated in TPX-100-1. The average time from the initial TPX-100 treatment was 30 months, with a range of 28 – 35 months.  Exclusion criteria included knee surgery or investigational drugs for OA in the interim between TPX-100-1 and TPX-100-4.  Of the 93 subjects in TPX-100-1, 53 enrolled in TPX-100-4. Topline results of this follow-on study will be included in the poster session of the 2018 OARSI annual meeting under the abstract entitled “TPX-100 LEADS TO MARKED, SUSTAINED IMPROVEMENTS IN SUBJECTS WITH KNEE OSTEOARTHRITIS.”

The company’s Chief Medical Officer, Dawn McGuire, MD., FAAN stated, “The long-term follow-on study enrolled over half the TPX-100-1 subjects, despite being an observational study only. The sustained improvement in knee function for more than two years in knees injected with TPX-100  confirms our confidence in TPX-100 as a drug with the potential to modify the disease of knee osteoarthritis as patients actually experience it.”

About OrthoTrophix, Inc.

OrthoTrophix, Inc., based in Oakland, California, is a privately held biopharmaceutical company focused on the development and commercialization of revolutionary therapeutics for the treatment of diseases and conditions involving the hard tissues.  Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage in the knee and other joints with its novel proprietary compounds which promote formation of new cartilage and bone tissues and thereby repair the respective defects.  OrthoTrophix has received over $30 million from its preferred stock financing and research and development revenues since its inception.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix’ business.

Company Contact
Yoshi Kumagai
President and CEO
Tel:  (510) 488-3824

 

SOURCE OrthoTrophix, Inc.

Related Links

http://www.orthotrophix.com

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Zimmer Biomet Announces FDA Clearance and First Surgical Case of the Persona® Trabecular Metal™ Tibia

Posted On April 16, 2018 By OrthoSpineNews In Recon, Regulatory /  

WARSAW, Ind., April 16, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the completion of the first surgical case utilizing its Persona® Trabecular Metal™ (TM) Tibia by Dr. Richard Moore, Boise, Idaho on March 20, 2018. The Persona Trabecular Metal Tibia received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2018 and CE Mark approval in April 2018. The Persona TM Tibia is an integral component of the Company’s portfolio of cementless total knee arthroplasty (TKA) solutions.

“Combined with the Persona TM Femur and the TM Patella, clearance of the Persona TM Tibia allows us to provide a fully cementless total knee solution, furthering our long-standing commitment to enhancing patient experiences and outcomes,” said Dan Williamson, Zimmer Biomet’s Group President, Joint Reconstruction. “We believe this innovative product will position us to re-establish our leadership in the fully cementless primary knee market.”

Zimmer Biomet’s proprietary TM Material is a porous biomaterial made from elemental Tantalum with structural, functional and physiological properties similar to cancellous bone.1-3 With more than 20 years of clinical results, the Company’s TM Material has been used in over two million orthopaedic devices.

“The clearance of the Persona TM Tibia represents a significant step forward for those patients who can benefit from completely cementless total knee replacements that better integrate into the natural bone anatomy for durability, while possibly offering greater patient satisfaction,” said Dr. Moore.

The Persona TM Tibia features new drilling, sizing and insertion instrumentation that are unique to the Persona TM Tibia, while preserving all the anatomic benefits of the Persona Tibia design.4-8 The Persona TM Tibia is another example of how the Persona System continues to redefine personalization by combining Zimmer Biomet’s 20-year porous fixation expertise with the Persona Knee family. As the Company’s most comprehensive knee system, the Persona System offers more anatomically accurate components with finer increments to personalize patient fit and restore the unique identity of every knee.

“The TM tibial tray and pegs fit beautifully to the bone. I believe the instruments for trial prep and implant placement were a clear improvement and an advantage. I also appreciate the time efficiency of using cementless implants,” concluded Dr. Moore.

Zimmer Biomet plans a limited launch of the Persona TM Tibia in the first half of this year, followed by a full commercial launch in the second half of 2018.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

  1. Bobyn, et al., Characterization of a New Porous Tantalum Biomaterial for Reconstructive Orthopaedics. 66th Annual AAOS 1999.
  2. Zhang, et al., Interfacial Frictional Behavior: Cancellous Bone, Cortical Bone, and a Novel Porous Tantalum Biomaterial. Journal of Musculoskeletal Research. 3:4, 245-251, 1999.
  3. Karageorgiou and Kaplan. Porosity of Biomaterial Scaffolds and Osteogenesis. Biomaterials. 26: 5474-91, 2005.
  4. Dai, et al. Anatomical Tibial Component Design Can Increase Tibial Coverage and Rotational Alignment Accuracy: A Comparison of Six Contemporary Designs. Knee Surgery Sports Traumatology Arthroscopy 22:2911–2923; KSSTA 2014.
  5. Indelli, et al. Relationship between Tibial Baseplate Design and Rotational Alignment Landmarks in Primary Total Knee Arthroplasty. Hindawi Publishing Corporation Arthritis. Volume 2015, Article ID 189294.
  6. Jin, et al. How Much Does the Anatomical Tibial Component Improve the Bony Coverage in Total Knee Arthroplasty. Journal of Arthroplasty. pp. 1-5; 2017.
  7. Mizu-uchi, et al. Anatomical Shaped Tibial Baseplate Reduced Rotational Alignment Compromise in Total Knee Arthroplasty: Clinical Evaluation with Asian Knees. ORS 2017 Annual Meeting Paper No.0110. 21.Bandi, Marc, et al. Finer Femur and Insert Increments in Total Knee Arthroplasty Facilitate Accurate Balancing and Reduce the Need for Complex Techniques. Abstract number 850; ORS 2014.
  8. Stulberg and Goyal. Which Tibial Tray Design Achieves Maximum Coverage and Ideal Rotation: Anatomic, Symmetric, or Asymmetric? An MRI-based study. Journal of Arthroplasty.  30(10): 1839, 2015.

For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and www.zimmerbiomet.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

ZB-Corp

CONTACT:  Media –  Monica Kendrick, 574-372-4989, monica.kendrick@zimmerbiomet.com; Investors – Derek Davis, 574-372-4250, derek.davis@zimmerbiomet.com, or Barbara Goslee, 574-371-9449, barb.goslee@zimmerbiomet.com

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Global Knee Replacement Market Analysis 2018-2024: Key Players are Zimmer Biomet, Stryker, Smith & Nephew, Johnson & Johnson – ResearchAndMarkets.com

Posted On April 16, 2018 By OrthoSpineNews In Recon /  

April 16, 2018

DUBLIN–(BUSINESS WIRE)–The “Knee Replacement Market, Global Analysis, by Products, by Regions and Companies” report has been added to ResearchAndMarkets.com’s offering.

Knee Replacement Market Globally is anticipated to exceed US$ 13 Billion by the year 2024, experiencing a significant growth over the forecast period.

Knee Replacement consists of tools or system which is used for the diagnosis and treatment of knee fracture and other knee diseases. Knee Reconstruction Devices market is expected to witness substantial growth due to increasing number of Osteoarthritis patients, Rising Geriatric Population, Rising Pool of Knee Fractures, favorable reimbursement, and technological advancements further boosts the demand for the industry over the forecast period.

Zimmer Biomet Holding Inc., Stryker Corporation, Smith & Nephew, Johnson & Johnson (Depuy Synthes), and are some of the top companies operating in the global knee replacement market; which has been studied thoroughly in the report.

Key Topics Covered:

1. Executive Summary

2. Global Knee Replacement Market

3. Market Share – Global Knee Replacement (2011 – 2024)

4. Companies Share – Knee Replacement

5. By Product – Global Knee Replacement Market

6. By Region – Global Knee Replacement Market

7. Zimmer Biomet Holdings Inc. – Companies Analysis

8. Stryker Corporation – Company Analysis

9. Smith & Nephew PLC – Company Analysis

10. Johnson & Johnson – Company Analysis

11. Growth Drivers of Knee Replacement Market

12. Challenges faced by Knee Replacement Market

For more information about this report visit https://www.researchandmarkets.com/research/bvh2l6/global_knee?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Orthopedic Devices

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Ceterix Orthopaedics Announces FDA Clearance of the NovoStitch Pro Meniscal Repair System

Posted On April 16, 2018 By OrthoSpineNews In Regulatory /  

April 16, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced U.S. Food and Drug Administration (FDA) clearance of the company’s NovoStitch® Pro Meniscal Repair System. This next-generation meniscal repair system is a significant product evolution, offering enhanced technical features to improve the ease of use and workflow for the surgeon.

Ceterix’s NovoStitch systems enable surgeons to place stitches arthroscopically in tight joint compartments, allowing them to address complex meniscal tears that have not been amenable to repair in the past. Enhancements in the newly FDA-cleared NovoStitch Pro system include an ergonomic and intuitive handle design, the addition of well-defined visual cues for precise stitch placement, and improved control and stability from upper jaw texturing.

“The new NovoStitch Pro meniscal repair system represents a significant improvement to one of the most innovative technologies developed for arthroscopic knee repair,” said Dr. Peter Kurzweil, president of Memorial Orthopaedic Surgical Group in Long Beach, Calif. “The technological enhancements incorporated into the new system offer the potential to repair tear types that were previously considered difficult or impossible to sew, with improved control and access for the surgeon. I look forward to incorporating it into my practice.”

The meniscus is a crescent of soft cartilage resting between the femur and tibia that cushions the knee and provides stability to the joint. Meniscal tears are one of the most frequently occurring knee injuries and are most often treated by a procedure called a meniscectomy, in which a surgeon removes the torn tissue. Meniscectomy has been shown to increase a patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life. A 2015 health economics study determined that effective meniscal repair can result in long-term cost savings vs. meniscectomy due to the reduced risk of requiring costly future interventions1.

“This FDA clearance is another important milestone in our mission to reduce the number of meniscectomies and to save the meniscus,” said John McCutcheon, Ceterix’s president and CEO. “Ceterix continues to be the leader in meniscal repair by providing innovations that preserve tissue and sustain the natural biomechanics of the knee joint.”

Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats a damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually2,3.

About Ceterix® Orthopaedics

Ceterix® Orthopaedics develops surgical tools that fill unmet clinical needs for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch® Pro Meniscal Repair System has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif., and is backed by investors Versant Ventures, 5AM Ventures, and CRG. For more information, please visit www.ceterix.com and follow us at @ceterix on Twitter.

1 Feeley, B. et. al. The Cost-Effectiveness of Meniscal Repair versus Partial Meniscectomy: A Model-based Projection of Clinical Outcomes and Costs in the United States Healthcare System. ISPOR Annual Meeting 2015.
2 Brinker MR, O’Connor DP, Pierce P, Woods GW, Elliott MN. Utilization of orthopaedic services in a capitated population. J Bone Joint Surg Am. 2002 Nov; 84-A (11):1926-32.
3 New Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care System; 2006.

Contacts

for Ceterix Orthopaedics, Inc.
Krysta Pellegrino
Krysta@healthandcommerce.com

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Two Data Presentations Highlight the Unique Potential of Spineology’s Duo™ Implant

Posted On April 16, 2018 By OrthoSpineNews In Spine, Top Stories /  

April 16, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that two laboratory studies relating to the Spineology Duo™ Lumbar Interbody Fusion System were presented at the recent annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Toronto, Canada.

The Duo implant is the first to combine PEEK, titanium, and graft containment mesh elements. The unique hybrid design includes lateral PEEK supports integrated with an expandable porous mesh that serves to contain bone graft. The Duo implant, filled with bone graft after it is placed in the disc space, provides a large, endplate-conforming graft pack up to 30mm in width, to help maintain spinal alignment and support fusion. Due to the unique design of the implant, the Duo System requires minimal retraction for placement of the implant which may reduce direct and indirect injury to the neural elements and potentially decrease the postoperative complications commonly associated with the lateral decubitus transpsoas approach.

Pierce Nunley, M.D., Director of The Spine Institute of Louisiana and Lisa Ferrara, Ph.D., President of OrthoKinetic Technologies LLC, co-authored a study titled “Size Matters: A Novel Interbody Fusion Cage Design Increases Contact Area for Bone Exchange and Graft Incorporation.” A unique test methodology using pressure-sensitive contact film demonstrates that the Duo device design facilitates load-sharing contact between bone graft and endplates to support graft incorporation during fusion healing. Pressure profiles were generated during testing for the Duo implants and for monolithic PEEK interbody cages (Spineology Rampart™ L). The results showed that the expandable porous mesh of the Duo implant allows for direct contact between bone graft and the viscoelastic vertebral endplates, improving the endplate and graft interface mechanics.

Barbara Boyan, Ph.D., Dean of Engineering at Virginia Commonwealth University, presented the results of an in vitro cell culture model used to assess whether the Duo implant’s polyethylene terephthalate (PET) mesh would have an impact on migration of osteoprogenitor cells from vertebral endplates onto bone graft in interbody fusion, and to assess the biological response of these cells to the bone graft. The study, titled “Effect of PET Mesh on Mesenchymal Stem Cell Response to Bone Autograft”, indicated that the presence of the porous mesh does not negatively impact the ability of osteoblast lineage cells to attach to bone particles, nor does it impede the cells’ ability to proliferate or differentiate along an osteoblastic pathway.

“The graft containment mesh is a key component of the Duo implant design,” said John Booth, CEO, Spineology Inc. “Not only does it allow for the implant to be placed with minimal retraction and expand in width up to 30mm once filled in situ, it also provides improved graft loading properties compared to traditional monolithic PEEK cages and has a positive impact on osteoprogenitor cell activity, as demonstrated by the studies presented at ISASS.”

Spineology is currently conducting a prospective post-market lateral interbody fusion study with the Duo System. The primary study objectives are to gather data related to the new on-set of thigh symptoms, quality of life measures, and fusion outcomes. The company believes the minimal amount of retraction required to place the Duo implant will have a positive impact on post-operative thigh symptoms.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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K2M Group Holdings, Inc. to Release First Quarter of Fiscal Year 2018 Financial Results on May 1, 2018

Posted On April 13, 2018 By OrthoSpineNews In Financial /  

LEESBURG, Va., April 13, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that first quarter of fiscal year 2018 financial results will be released after the market close on May 1, 2018.

Management will host a conference call at 5:30 p.m. Eastern Time on May 1, 2018 to discuss the results of the first quarter, and to host a question and answer session. Those who would like to participate may dial 866-393-4306 (734-385-2616 for international callers) and provide access code 8395568 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 855-859-2056 (404-537-3406 for international callers); access code 8395568. The webcast will be archived on the investor relations section of the Company’s website.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS®, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. 

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

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Conventus Orthopaedics Appoints Jonathan Isenburg as Chief Financial Officer

Posted On April 13, 2018 By OrthoSpineNews In Extremities /  

MINNEAPOLIS, April 12, 2018 /PRNewswire/ — Conventus Orthopaedics, a medical device company revolutionizing fracture repair surgery, today announced the appointment of Jonathan Isenburg as its new Chief Financial Officer.  Mr. Isenburg brings corporate finance and executive experience to Conventus spanning both entrepreneurial and public company settings. Since April 2015, Mr. Isenburg served as CFO at Infraredx, Inc., where he led the cardiovascular imaging start-up through a dual-track IPO and M&A process that culminated in a sale to a publically traded strategic buyer.

“I am pleased to welcome Jonathan to the Conventus team.  We will benefit from his expertise and leadership as we continue to grow commercial operations and accelerate development to bring the CAGE platform technology to additional types of fractures,” said Matthew Jewett, Chief Executive Officer of Conventus.  “Jonathan is an experienced medical device industry executive who has excelled in corporate finance, strategy, business development and operations.  He has a proven track record of success and we look forward to utilizing his many talents.”

Mr. Isenburg said, “It is with much enthusiasm that I join the outstanding Conventus team who has developed true game-changing technology for the treatment of simple and complex fractures throughout the anatomy.  I look forward to working with them to grow the business and bring this innovative and less invasive surgical solution to more patients.”

Prior to his most recent role as CFO of Infraredx, Inc., Mr. Isenburg served as a Manager in Financial Advisory Services at RSM from 2008 to 2013. Mr. Isenburg was a CPA who began his career as an auditor at PricewaterhouseCoopers.  He earned his Bachelor’s degree in Accounting from UMASS—Amherst and a graduate degree in Finance from Boston University.

About Conventus Orthopaedics, Inc.

Conventus Orthopaedics, Inc. was founded by a team of medical device professionals and physicians with the sole purpose of improving patient care by creating a 3-dimensional platform technology with less invasive solutions to a broad range of challenging periarticular fractures. Taking its name from the Latin word for coming together or union, Conventus Orthopaedics is focused on creating less invasive solutions to fractures in and around the joints. The company is dedicated to working with surgeons to improve healing and enable their patients’ return to normal activities.

 

SOURCE Conventus Orthopaedics, Inc.

Related Links

http://www.conventusortho.com

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EOS imaging Reports 1st Quarter 2018 Revenue Growth of 34% and Full Year 2017 Results

Posted On April 12, 2018 By OrthoSpineNews In Financial /  

April 11, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer of orthopedic medical imaging 2D / 3D, today announces its first quarter 2018 consolidated sales revenue and consolidated results for the full year ended December 31, 2017, as adopted by the Board of Directors on April 11, 2018.

FIRST QUARTER 2018 & FULL YEAR 2017 HIGHLIGHTS

  • Q1 2018 sales increased 34% to €9.5 million, driven by 54% growth in the North American region
    (76% exluding forex impact) coupled with an increase in average selling price (ASP) despite an unfavorable forex effect
  • 2017 revenue up 21% to €37.1 million taking the 5-year CAGR to 32% (2012-2017)
  • Gross margin temporarily impacted during the reorganization in North America during 2017
  • Robust control of operating expenses
  • Cash position of €6.9 million as of December 31, 2017, strengthened in January 2018 by drawing a fourth tranche of €4.9 million on the bond issue

Marie Meynadier, CEO of EOS imaging, commented: “2017 was a year rich in corporate achievements for EOS imaging. We successfully completed an in-depth remodeling of our North American operations in record time to support our development in this key market, while maintaining strong growth of 54% on the combination of the EMEA and APAC markets. The strong momentum in North America evidenced by Q1 2018 sales growth supports our confidence about the effectiveness of this new organization.

Sales growth, driven by the contribution of the North American zone and significant improvement in selling prices, will contribute positively to the increase in the gross margin in 2018. This combined with continued cost control of operating expenses will allow to significantly reduce operating losses over the coming year.

The company is further strengthened and well-positioned to respond effectively to the strong acceleration of the adoption of the EOS® system and continue to provide healthcare professionals and patients with innovative solutions tailored to their needs.”

REVENUE UP 34% IN FIRST QUARTER 2018, DRIVEN BY NORTH AMERICA

€ millions Q1 2018 Q1 2017 Var
Equipment sales 7.56 5.47 38%
As a % of total revenues 79% 77%
Sales of maintenance 1.73 1.40 24%
As a % of total revenues 18% 19%
Sales of consumables and services 0.26 0.26 0%
As a % of total revenues 3% 4%
Total revenues 9.54 7.13 34%
NB. Unaudited data

Equipment sales increased 38% compared to the first quarter of 2017 to €7.56 million, following the sales of 19 EOS® systems, compared to the 14 systems sold in first quarter 2017. Average selling price reached €398 thousand, including currency effects, compared with €391 thousand in 2017.

Sales of maintenance contracts increased 24% to €1.7 million. This reflects the continued increase in the installed base of EOS® systems and an associated high contract subscription rate after warranty.

Sales of consumables and services were stable at €0.3 million.

€ millions Q1 2018 Q1 2017 Var
EMEA 3.53 3.21 10%
North America 3.81 2.48 54%
Asia-Pacific 2.21 1.44 53%
Total revenues 9.54 7.13 34%
NB. Unaudited data

Sales in the North American market grew at a historic level of 54% to €3.8 million (76% growth at constant exchange rate). The strong dynamics observed in the first quarter in the region confirms the trend observed in the fourth quarter of 2017 and abodes for solid growth in coming quarters. ASP in USD in North America was 10% above that of the first quarter of 2017.

Sales rose 54% in the Asia-Pacific region to €2.2 million, boosted by a strong Australian market and new milestones in China.

In the EMEA region, the company observed continued momentum on all key markets, with sales growth of 10% at €3.5 million.

A FULL YEAR OF STRONG ACHIEVEMENTS IN 2017

  • Revenue growth of 21% to €37.1 million

EOS imaging reported full year 2017 revenue of €37.1 million, an increase of 21% compared to the prior year.

Equipment sales grew by 20% to €30.0 million. Recurring revenues were €7.1 million, up 24% compared to 2016. Recurring revenues included sales of maintenance of €5.9 million and sales of consumables and services of €1.2 million.

In addition, EOS imaging received €1.7 million in public grants in 2017 to support ongoing innovation, including a research tax credit recognized in “Other income”.

  • Gross margin temporarily impacted at 45.3%

Gross margin for the full year 2017 was 45.3%, a decrease compared to the prior year mainly due to a reduction in average selling price which was partially compensated by reductions in average cost of sales.

Average selling price was impacted by (1) the remodeling of the US organization, leading to a lower North American contribution to global revenue as well as a decrease in ASP in the first half of the year, and (2) a forex effect.

  • Solid control of operating expenses

Operating expenses excluding cost of share-based payments for the full year 2017 totaled €23.4 million, up 11% compared to the prior year. Global operating expenses were 24.3 million and included a €0.4 million increase in the cost of share-based payments.

Operating loss for the full year 2017 was €5.8 million compared with an operating loss of €4.6 million in 2016.

Net financial expense for the full year 2017 totaled €2.0 million, compared to €1.6 million in 2016, reflecting interest expense on the Company’s €15.0 million debt financing

Net loss for the full year 2016 was €7.8 million compared with a net loss of €6.2 million in the previous year.

  • Summarized Income statement
In millions of euros 2017 2016
Revenue 37.09 30.77
Other income 1.72 2.33
Total income 38.81 33.10
Direct cost of sales (20.29) (16.20)
Gross margin 16.81 14.58
as a % of revenue 45.3% 47.4%
Indirect cost of production and services (4.12) (3.83)
Research & development (4.10) (3.89)
Sales & marketing (9.81) (8.66)
Regulatory expenses (0.74) (0.70)
Administrative costs (4.61) (3.91)
Total operating expenses excluding cost of goods and share-based payments (23.38) (20.99)
Share-based payments (0.91) (0.48)
Total operating expenses (24.29) (21.46)
Operating income/(loss) (5.77) (4.56)
Net financial income/(expense) (2.01) (1.61)
Net income/(loss) (7.78) (6.17)
NB. Unaudited data
  • Net cash at December 31, 2017: €6.9 million

As of December 31, 2017, EOS imaging’s net cash totaled €6.9 million, compared with €14.9 million at December 31, 2016. A fraction of the first tranche of the IPF debt was reimbursed in 2017, and a rescheduling and drafting of a €4.9 million fourth tranche concluded in early 2018.

Consolidated equity stood at €23.2 million at December 31, 2017, compared with €22.8 million at December 31, 2016.

ABOUT EOS imaging

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopaedics combining equipment and services targeting a $2M per year market opportunity. EOS imaging is currently present in 27 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through approximately 250 EOS® installed representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Next press release: Release of Q2 2018 sales in July 17, 2018

Contacts

EOS imaging
Marie Meynadier, CEO, +33 1 55256060
investors@eos-imaging.com
or
Press Relations (US)
The Ruth Group
Joanna Zimmerman, +1 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
The Ruth Group
Matt Picciano / Emma Poalillo
Ph: +1 646-536-7008 / 7024
eos-imaging@theruthgroup.com

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Lumbar Artificial Disc Replacement with the activL® Artificial Disc to be More Effective at Delaying the Progression of Adjacent-Level Disease which Spinal Fusion has been Found to Accelerate

Posted On April 12, 2018 By OrthoSpineNews In Spine, Top Stories /  

CENTER VALLEY, Pa., April 12, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the publication of “Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up” in Spine.1 This is another significant milestone in Aesculap’s commitment to enhancing patient access to lumbar total disc replacement as a gold standard of care.

The post-hoc analysis, which used all available radiographic data from the activL® Artificial Disc Investigative Device Exemption (IDE) study, examined the rate at which radiographic adjacent-level degeneration (ALD) occurred five years following lumbar total disc replacement (LTDR) with either the activL Artificial Disc (Aesculap AG, Tuttlingen, Germany) or the ProDisc-L (Centinel Spine, West Chester, PA) control arm. The authors found an extremely low incidence rate of radiographic adjacent level deterioration at five years (only 9.7% of patients) compared to previous reports of deterioration at levels superior to fusion (28% of patients) and an even lower rate of clinically-significant ALD that resulted in additional surgery (in just 2.29% of patients).

These newly published outcomes from the activL Study show that, in a select patient population, LTDR is more effective at slowing the adjacent segment degenerative cascade than fusion, which is consistent with previously reported LTDR ALD rates from both the U.S. and Europe (9.2%-10.7%).2,3

As part of the analysis, the authors also sought to answer the question of whether patients with asymptomatic x-ray findings of adjacent level degeneration at the time of the index procedure experienced a clinically-relevant progression of this ALD at five years follow-up.

According to author Jack Zigler, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), “Spine surgeons who believe in motion preservation are often frustrated by U.S. payers whose medical policies state that the written reporting of even the smallest trace of anatomic deterioration at an adjacent but clinically-asymptomatic level will exclude their coverage of a lumbar TDR at the symptomatic level. Our analysis found that no patients who exhibited asymptomatic radiographic ALD changes at the time of preoperative assessment required any additional surgery at those levels at five years. In other words, even five years later, the implantation of a LTDR did not accelerate radiographic, non-pain-generating ALD to the point of requiring surgical treatment. This data shows how important it is to educate health plan decision makers about the medical necessity of allowing treatment with LTDR to treat single-level chronic degenerative disc disease.”

While the overall LTDR five-year rate of ALD was 9.7%, there was a statistically-significant difference in ALD rates between patient groups. The activL patients experienced an 8.8% ALD progression at five years, while ProDisc-L patients experienced a 19% progression (p=0.05).4 The authors hypothesized that these differences in progression rates between earlier versus later generation ProDisc-L discs may be related to the protective effect of improved of range of motion on ALD. The activL Disc, which has been shown to have a higher rate of motion preservation at five years than ProDisc-L (6.2° vs. 4.0°, p=0.004)5 also had a lower rate of ALD.

The activL Artificial Disc and ProDisc-L are currently the only commercially available lumbar artificial disc devices that have undergone the rigor of biomechanical and clinical studies to satisfy the safety and efficacy requirements for Food and Drug Administration approval and the only devices that have been evaluated for ALD rates. The activL Disc was approved in 2015.

In the interest of improving the evidence base for LTDR, Aesculap has sponsored Open Access to this landmark publication. The full text can be found on the Spine website. https://journals.lww.com/spinejournal/Abstract/publishahead/Progression _of_Adjacent_level_
Degeneration_After.95075.aspx

“It is evidence like this that will hopefully move the needle with health plans in favor of a procedure that is less costly in the short- and long-term,” said coauthor Scott Blumenthal, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), who performed the first lumbar disc replacement eighteen years ago. “It is time we acknowledge the strength of the current evidence base for this life-improving procedure.”

Over the last eighteen months, U.S. commercial payers have begun to adopt coverage of lumbar total disc replacement due largely in part to the availability of long-term evidence such as the data presented in this publication.

Last year, major health care insurance carriers such as Humana, BlueCross BlueShield of Louisiana and Highmark BlueCross BlueShield established positive coverage policies for LTDR. Aesculap offers a patient advocacy platform, the Patient Assistance Line, to patients who are candidates for single-level LTDR with the activL disc to help them overcome commercial payer hurdles for those plans still denying access to this proven procedure.

In 2017, a panel of surgeons at the North American Spine Society Annual Meeting (Orlando, FL) concluded that the evidence now supports that lumbar artificial disc replacement is a standard of care for a subset of degenerative disc disease patients.

The full dataset of five-year safety and efficacy outcomes from the activL Artificial Disc IDE study are currently in submission to Spine.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

  1. Zigler JE, Blumenthal SL, Guyer RD, Ohnmeiss DD, Patel L. Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up. Spine 2018: published online ahead of print, March 21, 2018.
  2. Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. Journal of Neurosurgery. Spine 2012;17:504-11.
  3. Aghayev E, Etter C, Barlocher C, et al. Five-year results of lumbar disc prostheses in the SWISSspine registry.
    Eur Spine J 2014;23:2114-26.
  4. Blumenthal, SL et al. Adjacent Segment Degeneration After Lumbar Total Disc Replacement: 5-Year Results of a Multicenter, Prospective, Randomized Study with Independent Radiographic Assessment. In NASS 32nd Annual Meeting Proceedings NASS, The Spine Journal 17 (2017) S111–S165.
  5. Yue JJ, Garcia R, Jr. Five-Year Results of a Randomized Controlled Trial for Lumbar Artificial
    Discs in Single-Level Degenerative Disc Disease. Spine; in submission.

SOURCE Aesculap Implant Systems, LLC

Related Links

https://www.aesculapimplantsystems.com

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