Two Cincinnati hospitals among first in nation to perform new kind of robotic surgery

Posted On March 27, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

Mar 23, 2017 – By Barrett J. Brunsman, Staff reporter Cincinnati Business Courier

Surgeons at Mercy Health-Cincinnati’s Anderson Hospital and St. Elizabeth Healthcare in Edgewood are among the first in the nation to offer a total knee replacement using the Mako Robotic Arm-Assisted Surgery System.

Dr. Suresh Nayak performed Ohio’s first total knee replacement procedure using the robotic-arm-assisted technology together with the Stryker Triathlon Total Knee System at Anderson Hospital on March 7, according to Mercy Health.

Dr. Matthew Hummel of Commonwealth Orthopaedic Centers performed a similar total knee replacement surgery using the new robotic-arm-assisted technology at St. Elizabeth in Northern Kentucky on March 22.

The technology is available at only a handful of medical centers in the nation, a St. Elizabeth spokesman said. The U.S. Food & Drug Administration approved the robotic-arm-assisted technology for total knee replacement in August 2015, but the equipment won’t be available to most health systems until 2018.

The procedure is less invasive than traditional surgery, meaning patients often experience less pain after surgery, less hospitalization and more rapid recovery, according to St. Elizabeth. Patients also often feel better motion and a more natural-feeling knee after the surgery.

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Alphatec Completes its Senior Leadership Team with Appointment of Brian Snider, Executive Vice President, Strategic Marketing and Product Development

Posted On March 27, 2017 By OrthoSpineNews In Spine, Top Stories /

CARLSBAD, Calif., March 24, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today the addition of two new executives with proven track records in the spine industry, naming Brian Snider as Executive Vice President, Strategic Marketing and Product Development, and Chris Ryan as Area Vice President of Sales in the U.S. Central Region. Drawing on their deep commercial spine experience, Mr. Snider and Mr. Ryan will focus on building brand awareness with surgeon customers and driving market demand for Alphatec’s differentiated product solutions.

Brian Snider Named EVP Strategic Marketing and Product Development

“I am pleased to welcome Brian to the Alphatec Senior Leadership Team,” said Terry Rich, Alphatec Spine’s Chief Executive Officer. “Brian’s arrival completes our efforts over the past few months to restructure Alphatec leadership by adding individuals with significant spine and orthopedic experience. Brian brings an unquestioned track record of building strong surgeon relationships, product innovation, and commercialization, having brought to market over 30 innovative spine products and procedures. We look forward to leveraging his energy and expertise, as we launch our new products, including Battalion™ Lateral and Arsenal™ Deformity, deepen our engagement with surgeons, and aggressively build our brand. I look forward to partnering with Brian and believe his contributions will help take Alphatec to the next level of innovation and growth.”

As Alphatec’s Executive Vice President, Strategic Marketing and Product Development, Mr. Snider will lead all aspects of the Company’s go-to-market strategy, including product development, marketing, brand awareness and driving market adoption.

Mr. Snider has spent the past 11 years focused on marketing, brand and product development, and global product management in the spine and medical device industries. Prior to joining Alphatec Spine, Mr. Snider spent nine years at NuVasive, Inc., where he most recently served as the Business Lead of Thoracolumbar Anterior, and had substantial responsibility over the anterior column business, including XLIF® and Anterior Column Realignment (ACR®). Prior to NuVasive, Mr. Snider held marketing leadership roles at Alveolus, Inc., a medical device company focused on interventional stent technologies. He started his career at KPMG consulting in various business units, including Life Sciences.

Mr. Snider holds an MBA from the Fuqua School of Business at Duke University and a Bachelor’s degree in Business Administration from The George Washington University.

Chris Ryan Named AVP Sales, Central Region

“I’m excited to bring Chris onboard as the first of our new regional area sales vice presidents,” said Mr. Rich. “Given the recent launch of our three new products— Arsenal Deformity, Battalion Lateral and XYcor® Expandable Interbody—this is a perfect time for Chris to join the Alphatec team. Chris brings a combination of high-performing sales leadership and distribution channel transformation experience that will be crucial to leading our sales agent relationships and accelerating our growth. His reputation for high integrity, his deep understanding of the spine industry and his proven ability to drive significant revenue will make him an asset to our organization.”

As Alphatec’s Area Vice President, Sales, Central, Mr. Ryan will be responsible for expanding the Company’s presence in the Central United States, including building dedicated sales agent relationships, targeting new customer and market opportunities, as well as providing service and support for existing surgeon customers.

Mr. Ryan brings more than 20 years of progressive spine sales leadership experience to Alphatec. Prior to joining Alphatec, Mr. Ryan held multiple sales leadership roles over a six-year period with Zimmer Biomet Spine, including as its Vice President of U.S. Sales and a member of the Zimmer Spine Leadership Team. Under Mr. Ryan’s leadership, Zimmer’s U.S. Spine Sales channel underwent a substantial, strategic change in distribution, yielding significant annual revenue growth. Prior to Zimmer, Mr. Ryan served in a number of leadership capacities during his 14-year career at Medtronic, including Regional Vice President of Medtronic Spinal and Biologics business unit, responsible for Medtronic’s Central Region.

Mr. Ryan holds a Bachelor of Science in Economics from Western Michigan University.

Inducement Awards Granted

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on March 16, 2017, the Compensation Committee of the Board of Directors approved the following inducement awards:

Mr. Snider: 75,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 75,000 shares of common stock.
Mr. Ryan: 25,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan. Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the first date of employment, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (March 20, 2017). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company markets products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the Company’s ability to launch new products, deepen surgeon engagement, build brand awareness and accelerate growth. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in launching new products and developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; the Company’s ability to compete with other competing products and with emerging new technologies; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer 
Investor Relations 
Alphatec Spine, Inc. 
(760) 494-6610 
czedelmayer@alphatecspine.com

InVivo to Initiate Cervical Spinal Cord Injury Study

Posted On March 24, 2017 By OrthoSpineNews In Neuro, Top Stories /

March 23, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold™ in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs). InVivo currently is in late stage conversation with several site Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.

“This approval is an important step towards our goal of redefining the life of the spinal cord injury patient,” said Mark Perrin, InVivo’s CEO and Chairman. “We are dedicated to helping as many SCI patients as we can, and this approval helps us to evaluate our investigational product in the most severe spinal cord injury cases, with neurologically complete cervical injuries involving impairment of the arms, hands, trunk, and legs. As I explain further in my CEO’s Perspective, moving into the cervical spinal cord is exciting, since each level of the cervical spinal cord has a substantial functional impact. If the Neuro-Spinal Scaffold were able to preserve, remyelinate and/or regenerate just a small area of spinal cord, we believe this could have significant functional consequences. We look forward to bringing sites onboard in Canada to commence enrollment and ultimately to expanding our study of cervical patients to the United Kingdom and the United States.”

A new CEO’s Perspective discussing the differences between thoracic and cervical spinal cord injuries can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the ability of the company to open a site in Canada or enroll patients in Canada, and the ability to expand the trial to the United Kingdom and the United States. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the impact of achieving the OPC on the FDA approval process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most

Posted On March 23, 2017 By OrthoSpineNews In Regulatory, Top Stories /

March 20, 2017 by Stewart Eisenhart

EMERGO SUMMARY OF KEY POINTS:

The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018.
Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted.
Smaller manufacturers make up the vast majority of the US medical device industry, and would be most substantially affected by higher FDA fees.

US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry.

President Trump’s recently released budget blueprint for 2018 would adjust FDA user fees for 2018 to more than $2 billion, “approximately $1 billion over the 2017 annualized…level, and replaces the need for new budget authority to cover pre-market review costs.” These increases would be offset by administrative initiatives to boost regulatory efficiencies and speed up market authorization timeframes, according to the text of the proposed budget.

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Dr. Price Brakes Bundled Payments Expansion

Posted On March 22, 2017 By OrthoSpineNews In Regulatory, Top Stories /

Walter Eisner • Tue, March 21st, 2017

Our orthopedic surgeon and Health and Human Services Secretary, Tom Price, M.D., has said he is no fan of bundled payments.

After just taking office in February, he’s already putting on the brakes to the payment model with the March 20, 2017 announcement that the expansion of hip and knee replacement bundled payment programs (Comprehensive Care for Joint Replacement – CJR) from the Centers for Medicare and Medicaid Services’ (CMS) Innovation Center will be delayed.

Last fall, then Congressman Price, said in a letter to the Obama administration that CMS had overstepped its authority, upsetting the balance between the executive and legislative branches and failing to engage stakeholders when creating the programs. He also wrote, “these mandatory models overhaul major payment systems, commandeer clinical decisionmaking and dramatically alter the delivery of care.”

According to a March 20 notice in the Federal Register, the CJR program was scheduled to expand on the 20th, but those expansions will now be delayed until May 20, 2017 to “allow time for additional review, to ensure that the agency has adequate time to undertake notice and comment [on] rulemaking to modify the policy if policy modifications are warranted,” and to make sure its participants understand the rules and how to comply with them.

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Spinal Elements® Announces Initial Procedures with Lucent® XP Expandable Interbody Implant

Posted On March 20, 2017 By OrthoSpineNews In Spine, Top Stories /

March 20, 2017

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that the first procedures with its Lucent XP expandable interbody implant have been successfully completed.

The Lucent XP System is an interbody device that can expand in height and increase in lordotic angle after it has been surgically implanted. The height expansion helps restore the height of the spinal disc space and the lordotic angling helps correct the curvature of the spine. With the Lucent XP device, surgeons can achieve up to 15 degrees of lordotic angle, helping restore sagittal balance for the patient.

The Lucent XP system is made primary of polyetheretherketone (PEEK), a radiolucent material with a lower modulus of elasticity than titanium, the primary material of many competitive systems. The PEEK mechanical properties along with the design of the device allow for a more load-sharing construct. The radiolucency allows for post-operative evaluation of the fusion progression. Additionally, the device is coated with Spinal Elements’ Ti-Bond® porous titanium coating. Ti-Bond is a hydrophilic coating applied at the bone-contacting endplates of the implant.

Hyun Bae, MD, a leading spine surgeon who practices at The Spine Institute in Los Angeles, California, had this to say about his experience with the Lucent XP System: “The ease of use of this system and the ability of the device to expand in height and restore lordotic angle are exactly what I need to address the challenges spinal fusion surgery for my patients.

Paul Kim, MD, of the Spine Institute of San Diego, added, “The clinical importance of height restoration and spinal curvature cannot be understated. Spinal Elements’ system provides these features without making sacrifices relative to construct rigidity or post-operative ability to monitor the progress of a fusion. Furthermore, I was able deploy the system safely and efficiently with a minimally invasive surgical approach.”

Spinal Elements will be more widely launching the Lucent XP expandable interbody device in the summer of 2017. The company has seen over 20% growth of the past year in its core technologies, fueled by demand for its advanced technologies including Ti-Bond coated implants.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

Contacts

For Spinal Elements
Laura Charlton (formerly Johnson)
760.450.7749
laurajohnsonpr@yahoo.com

Soft Tissue Regeneration Raises Series C Financing and Rebrands to Biorez

Posted On March 16, 2017 By OrthoSpineNews In Biologics, Top Stories /

NEW HAVEN, CONN. (PRWEB) MARCH 14, 2017

Biorez, Inc., formerly known as Soft Tissue Regeneration, Inc., today announced the close of a $1.5 million investment following preliminary results of the first in-human study of its novel implant for anterior cruciate ligament (ACL) reconstruction.

The breakthrough approach makes use of a proprietary tissue-engineered scaffold that stabilizes the knee, facilitates the body to regrow new ACL tissue, and then fully resorbs, leaving only new, functional tissue.

Connecticut Innovations, Connecticut’s leading source of financing and ongoing support for Connecticut’s innovative, growing companies, led the investment round. Vertical Group and KLP Ventures, an affiliate of Launch Capital, also participated in the round.

“Biorez has learned a great deal through their early stages of development and testing,” said Dan Wagner, managing director at Connecticut Innovations, and a Biorez board member. “With a new CEO at the helm and a new path ahead, we look forward to supporting the progress of this company and technology in the future.”

“Typically, a torn ACL is surgically reconstructed using a tissue graft harvested from the patient or a cadaver,” said Kevin Rocco, CEO of Biorez. “Neither option is ideal for patients, but both biologic grafts remodel into new functional tissue over time. We have developed an off-the-shelf, synthetic scaffold constructed from biocompatible polymers that harnesses the same regenerative remodeling process.”

Biorez will be sharing the detailed results of the human trial in private meetings with key partners, surgeons, and researchers during the American Association of Orthopedic Surgeons (AAOS) meeting in San Diego, from March 14 through March 18, 2017. Biorez is the first company to clinically investigate a tissue-engineered scaffold for ACL reconstruction in a human trial.

“The clinical study has validated our unique approach, and given us a first-mover advantage to further optimize our technology,” said Rocco. “We look forward to publishing our results.”

About Biorez, Inc.
Biorez, Inc. is a privately-held, early-stage regenerative medicine company engaged in developing bioresorbable scaffold implants to regenerate functional tissue in vivo. Its lead product candidate is an off-the-shelf implant for ACL reconstruction that spares harvesting of patient donor-tissue, and provides a better alternative to cadaver-based materials. The company plans to commercialize its lead ACL technology, as well as expand its platform to develop new and innovative clinical solutions. To learn more, visit http://www.biorez.com.

Smith & Nephew previews NAVIO™ Robotics-assisted Total Knee Application at AAOS ahead of full market release in Q2 2017

Posted On March 16, 2017 By OrthoSpineNews In Recon, Top Stories /

LONDON, March 14, 2017 /PRNewswire/ — Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, today announces the upcoming full market release of its NAVIO hand-held robotics-assisted total knee arthroplasty (TKA) system. Smith & Nephew will be hosting live hands-on demonstrations for surgeons at the 2017 Annual American Academy of Orthopaedic Surgeons meeting in San Diego, CA, March 15-17 (booth # 5133).

The NAVIO Surgical System total knee application is expected to enter full market release in the second quarter of 2017, 510(k) pending, with Smith & Nephew’s JOURNEY II, LEGION and GENESIS II Total Knee Systems.

The NAVIO robotic-assisted total knee application is designed to deliver consistent and accurate results through the utilization of a surgeon controlled robotics-assisted hand piece, coupled with NAVIO specific cut guides. This unique combination yields an intuitive and efficient workflow for the entire surgical team. In addition, the versatile NAVIO planning software enables precise implant alignment and ligament balance, without the need for a pre-operative CT scan. Eliminating the dependency on pre-operative imaging allows the surgeon to seamlessly plan for either a unicompartmental or total knee procedure at the time of surgery.

“I have experience with several robotic systems and my experience with the NAVIO Surgical System has been phenomenal. Both NAVIO UKA and TKA applications allow me freedom as a surgeon, unlike other robotic options, because it is imageless. I can easily plan and correct for significant deformities and retained hardware with confidence. I love the direct interface with the system itself, putting me back in control.

Additionally, the cost of the system including the capital investment, lack of advanced imaging and its portability make it affordable for both hospitals and ASCs” says Jimmy Chow, M.D, Director of Orthopaedics: Hip & Joint, Phoenix St. Luke’s Medical Center.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew

Stryker launches expensive Mako robot for knee replacement in cost-conscious era

Posted On March 15, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

By ARUNDHATI PARMAR – MedCity News

As value-based care and bundled payments begin to take hold in the orthopedics industry and healthcare overall, Kalamazoo, Michigan-based Stryker is doing something counterintuitive.

It is launching an expensive piece of equipment. Coinciding with the first day of the annual meeting of the American Academy of Orthopaedics Surgeons (AAOS) in San Diego, the orthopedics company announced Tuesday that the MAKO robot is now officially launched in the U.S. to perform total knee replacements. (MAKO has been available to perform total hip knee replacements and partial knees in the U.S. up until now.)

Why introduce a reportedly million-dollar piece of new technology at a time when hospitals and orthopedics practices are racing to reduce the cost of hip and knee replacements?

In a phone interview, Stuart Simpson, vice president and general manager, Stryker, shared his confidence that the Mako robot with the total knee application would have both clinical and economic benefits that hospitals would find compelling.

To step back a bit, Stryker made a bold acquisition of Mako for nearly $1.65 billion in 2013. Bold because none of the larger ortho players had envisioned joint replacement procedures to be done by a robot. The company has also bucked the consolidation trend in the marketplace – think Zimmer buying Biomet; Wright Medical buying Tornier – although there leaked reports showed that it was exploring a merger with Smith & Nephew. The bet was new, innovative technology backed by proper clinical and economic validation would win the future.

Mako’s total knee application — where the Mako robot would implant Stryker’s Triathlon knee — won FDA approval back in August 2015. But Kevin Lobo, the company’s CEO made the rather atypical decision to delay a wide sales roll out nationwide until 2017. [ I reported on that decision for a different publication last year].

In that two years, Mako’s total knee application has been used on a limited basis in 65 hospitals in the U.S., U.K., Japan and Germany, Simpson said and more than 1,400 cases have been performed.

Now it’s ready for full launch and the hope is that the clinical benefits noticed in the partial knee application by using the Mako robot will extend to the total knee as well.

READ THE REST HERE

Nearly one-third of osteoarthritis-related costs incurred the year prior to knee replacement surgery are for non-recommended treatments

Posted On March 14, 2017 By OrthoSpineNews In Recon, Top Stories /

SAN DIEGO, March 14, 2017 /PRNewswire-USNewswire/ — In the year prior to total knee replacement (TKR) surgery, almost one-third of the costs for treatment of arthritis symptoms went toward strategies not recommended by the American Academy of Orthopaedic Surgeons (AAOS), according to new research presented today at the 2017 AAOS Annual Meeting. Costs could decrease by an estimated 30 percent if treatments that are not recommended are no longer utilized.

“As we transition to an era of value based health care, it will be important to consider both the quality of our interventions as well as the cost associated with that care,” said study author Nicholas Bedard, MD, an orthopaedic surgeon at the University of Iowa Hospitals & Clinics.

Researchers reviewed Humana Inc. insurance information (both private and Medicare Advantage plans) from 2007 through 2015 on more than 86,000 patients diagnosed with osteoarthritis of the knee, who went on to have TKR within one year. The costs were specifically related to reimbursement for hyaluronic acid (HA) or corticosteroid (CS) injections, physical therapy (PT), braces and wedge insoles, pain medication and non-steroidal anti-inflammatory drugs (NSAIDs). Only three of these treatments—physical therapy, NSAIDs, and the drug tramadol (short-term for severe pain)—are recommended in the AAOS clinical practice guideline (CPG): “Non-arthroplasty Treatment of Osteoarthritis of the Knee.”

The total costs associated with outpatient knee osteoarthritis was $43,582,648. Among the other findings:

65.8 percent of the patients (56,960) underwent at least one of the analyzed treatments in the year prior to their TKR.
The top three most costly treatments were HA injections, CS injections and PT, accounting for 52.6 percent of expenses (excluding hospital or inpatient), total costs of knee osteoarthritis in the year prior to TKR.
The AAOS recommended treatments—PT, NSAIDs and Tramadol—represented just 11 percent of the total costs; in contrast, 29 percent of the costs were for interventions with strong or moderate recommendations against their use in the AAOS knee CPG.

“We hope that research such as this highlights the high prevalence of low-value interventions in the management of knee osteoarthritis and helps to motivate a transition to higher value care,” said Dr. Bedard.

Study abstract

2017 AAOS Annual Meeting Disclosure Statements

The American Academy of Orthopaedic Surgeons
With more than 39,000 members, the American Academy of Orthopaedic Surgeons (AAOS) is the world’s largest association of musculoskeletal specialists. The AAOS provides education programs for orthopaedic surgeons and allied health professionals, champions and advances the highest musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments, and related issues.

Visit AAOS at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
Facebook.com/AAOS1
Twitter.com/AAOS1

CONTACT: Sheryl Cash, 847-384-4032, 847-804-7486, scash@aaos.org; or Lauren Pearson Riley, 847-384-4031, 708-227-1773, pearson@aaos.org
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Walter Eisner • Tue, March 21st, 2017

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