Vertos Medical Announces MILD® Procedure Long-term Safety and Efficacy Data

Posted On September 11, 2018 By OrthoSpineNews In Spine /

ALISO VIEJO, Calif., Sept. 11, 2018 /PRNewswire/ — Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), today announced the publication of two-year data from a Centers for Medicare & Medicaid Services (CMS)-approved study, MiDAS ENCORE. The data affirms long-term safety and efficacy of the mild® lumbar decompression procedure, a clinically proven outpatient procedure that removes the cause of the stenosis through a portal the size of a baby aspirin and requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.

The mild procedure, which received broad coverage from CMS in 2016, has been performed on more than 20,0000 patients, and its safety and efficacy have been demonstrated in more than 13 clinical studies and 20 publications. The new long-term data, which appears in the September 7, 2018 issue of Regional Anesthesia and Pain Medicine, the official publication of the American Society of Regional Anesthesia and Pain Medicine, showed excellent long-term durability and revealed no evidence of spinal instability or fracture for patients who had the mild procedure. All outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through two-year follow-up. Additionally, the mild procedure had no device- or procedure-related serious adverse events, and a significantly lower rate of complications than other, more invasive spine interventions.

Authors of the journal article reporting the data, “Long-term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis with Neurogenic Claudication: Two-year Results of MiDAS ENCORE,” also noted that the mild procedure is an excellent early spinal decompression intervention choice for patients with thickened ligamentum flavum. Thickened ligamentum flavum causes narrowing of the spinal canal, resulting in pain and numbness of the lower back, legs and buttocks. The study further revealed that LSS patients having additional back conditions such as a bulging disc, facet hypertrophy and foraminal narrowing also achieved statistically significant pain relief and improvement in mobility, noting that the presence of these conditions should not exclude a patient from being considered for the mild procedure.

“Given the minimally invasive nature of this procedure, its safety profile, robust success rate, and durability of outcomes, mild is an optimal early intervention for patients suffering from lumbar spinal stenosis,” said Dr. Peter Staats, a principal investigator of the MiDAS ENCORE study, lead author of the journal article and founder of the Division of Pain Medicine at the Johns Hopkins School of Medicine. “These results are exciting, and further reinforce the mild procedure as a clinically validated, low-risk interventional pain treatment that directly removes the cause of stenosis, and provides long-term symptom relief.”

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include the mild instrumentation kit, which enables a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild treats this condition by restoring space in the spinal canal using specialized mild devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that the mild procedure can help LSS patients stand longer and walk farther with less pain¹, and no major device-related complications have been reported in any clinical trial.² Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how the mild procedure treats LSS, go to www.vertosmed.com/products/.

CONTACT:

Amy Scott

VP Marketing & Education

Vertos Medical

(949) 349-0008

SOURCE Vertos Medical

Nanovis Licenses Key Nanosurface Technology Patent from the University of Nevada, Reno

Posted On September 11, 2018 By OrthoSpineNews In Spine /

CARMEL, IND. (PRWEB) SEPTEMBER 11, 2018

Nanovis, a leader in nanomedicine for the spine, today announced a licensing agreement with the University of Nevada, Reno for a key nanosurface technology patent covering the use of ceramics on implants with nanopores.

This foundational patent allows development of ceramics for medical implants with nanosurfacing that enhances cell binding and drug delivery depending on the purpose of implantation.

The ceramic nanosurfacing technology dovetails with Nanovis’ technology, offering a range of spinal implant nanosurfaces designed to increase bone to implant growth. The addition of ceramic nanosurfacing allows Nanovis to extend its lead in the development of superior fixation technology for medical implants with greater strength, osseointegration and bactericidal properties.

“We are delighted to work with the University of Nevada, Reno on this nanotechnology,” says Matt Hedrick, Nanovis CEO. “Adding ceramics to nanopores provides important capabilities to influence cells attaching to the surface and for drug delivery. This technology used in combination with our nanotube surface will further bolster our portfolio of interbodies, screws and other implants as the superior fixation technology choice for surgeons to heal their patients and distributors to grow their business.”

The company’s technology already offers interbodies with the best combination of deeply porous bone interface scaffold and bridging bone visualization with a nanotube surface. Adding nanoscale ceramic technology further advances Nanovis’ surface technology lead and extends the company’s portfolio of implant offering the superior fixation technology choice.

“We can control the length, the height, the pore openings and the pore volumes within the ceramic nanosurface,” says Mano Misra, professor of materials science and engineering at the University of Nevada, Reno. “The sizes and shapes of the nanosurface pores can be changed so the ceramic coating releases drugs over a longer period of time, providing superior anti-infection properties.”

“Bringing discoveries into the marketplace is the way that university research benefits society,” says Ellen Purpus, University of Nevada, Reno assistant vice president for Enterprise & Innovation.

For more information about how to help patients, or better serve surgeons with Nanovis’ nanotechnologies, please visit us during the North American Spine Society (NASS) 2018 meeting September 26-29 in Los Angeles at Booth #2260 or call 1-317-507-1058.

For more information about distribution opportunities, please contact Jeff Shepherd, Vice President of Sales, at jeff.shepherd(at)nanovistechnology(dot)com.

About Nanovis
Nanovis’ mission is to develop science-enhanced, life-improving technologies. The Company’s patented and proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Focused on aggressive, sustainable growth across multiple markets, Nanovis is commercializing science-driven platforms: the deeply porous scaffold currently available with the FortiCore® line of interbody fusion devices; an advanced nano-surface technology in development; and a surface technology with anti-colonization and anti-microbial capabilities in pre-clinical studies.

About University of Nevada, Reno
Nevada’s land-grant university founded in 1874, the University of Nevada, Reno ranks in the top tier of best national universities by U.S. News and World Report and is steadily growing in enrollment, excellence and reputation. The University serves more than 22,000 students. Part of the Nevada System of Higher Education, the University is home to the University of Nevada, Reno School of Medicine and University of Nevada Cooperative Extension. Through a commitment to world-improving research, student success and outreach benefiting the communities and businesses of Nevada, the University has impact across the state and around the world. For more information, visit http://www.unr.edu.

CoreLink Surgical, LLC, Today Announced 510(k) Clearance to Market the M3™ Stand-Alone Anterior Lumbar (ALIF) System

Posted On September 11, 2018 By OrthoSpineNews In Regulatory, Spine /

September 11, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink Surgical, LLC, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the M3™ Stand-Alone Anterior Lumbar (ALIF) System.

Jay Bartling, CEO, said, “M3 is our first stand-alone interbody fusion device to feature 3D printing – I continue to be impressed by the ability of our design teams to rapidly turn direct feedback and market demand into commercially competitive products.”

The M3 system is a sterile packed, 3-screw, integrated fixation device for ALIF procedures, featuring a universal bi-directional design with a simple and intuitive locking mechanism. M3 was also developed utilizing CoreLink’s proprietary Mimetic Metal™ technology and features unique patent pending StrutSure™ technology, which creates a combination of load-sharing support structure and interconnected lattice minimizing material density for imaging.

With this new clearance, the CoreLink 3D printed ALIF portfolio, both Foundation 3D ALIF and M3™ ALIF, feature the largest footprint size available on the market, allowing for additional options to accommodate an ideal anatomical fit. “I’m always in pursuit of sizing cages to capture as much of the cortical ring that borders the endplates as possible. A larger cage option allows me a more appropriate fit for some patients. Additionally, a larger cage can be helpful for greater surface contact with the endplates, which can enhance stability for a higher likelihood for fusion,” said Neurosurgeon, Justin L. Owen, MD, FAANS (Slidell, LA).

“Our R & D team concentrated on creating a product that would feature our additive manufacturing capabilities, while also streamlining procedural efficiency. We’re extremely proud of the unique universal instruments offered with M3,” said David Castleman, VP of Research and Development for CoreLink.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where a full display of the Foundation 3D Products will be featured.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

www.corelinksurgical.com

(Photo: Business Wire)

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808

Captiva Spine Announces TowerLOX-EXT® MIS Extended Tab Pedicle Screw Receives Clearance

Posted On September 11, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

Jupiter, FL, September 2018 – Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine fusion solutions announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market TowerLOX-EXT® MIS Extended Tab Pedicle Screw complementing its TowerLOX® MIS Pedicle Screw System.

TowerLOX-EXT MIS Extended Tab Pedicle Screw

TowerLOX-EXT MIS Extended Tab Pedicle Screws provide the narrow insertion of an extended tab pedicle screw and the versatility, reliability, and security of a tower-based MIS pedicle screw. TowerLOX-EXT’s narrow insertion path coupled with TowerLOX’s patented articulating rod delivery/reduction options expand the capabilities of the system. Most notably, TowerLOX-EXT allows percutaneous tower attachment after the extended tabs have been removed, establishing a new standard for MIS pedicle screw systems. This is especially important intraoperatively, or for use when extending the fusion at a later date.

Dale Mitchell, President of Captiva Spine, stated “The design rationale and goals developed with our surgeon collaborators guided the creation of TowerLOX-EXT Extended Tab Pedicle Screw. Our intent was to reduce insertion pathway, eliminate counter-torque wound expansion, and retain the versatility provided by TowerLOX’s unique instrumentation for rod delivery, rod reduction, and spondylolisthesis reduction.”

TowerLOX® MIS Pedicle Screw System already supports MIS, mini-open, and open cases with simple and less invasive rod insertion (using patented Pivotec® Technology) and efficient internal/external rod reduction. TowerLOX-EXT screws provide 15mm of controlled built-in rod reduction above the break-off and in-situ tower attachment capabilities provide a MIS rescue/revision option not available with other extended tab systems.

Captiva Spine’s TowerLOX-EXT MIS Extended Tab Pedicle Screw is one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angeles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality. They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

SEE MORE ABOUT TOWERLOX-EXT

This Press Release can be found at PRWeb.com and is also featured on other industry sites.

Invuity Announces Definitive Agreement to Be Acquired by Stryker Corporation for $7.40 Per Share in Cash

Posted On September 11, 2018 By OrthoSpineNews In Financial /

SAN FRANCISCO, Sept. 11, 2018 (GLOBE NEWSWIRE) — Invuity, Inc. (NASDAQ: IVTY), a leading medical technology company focused on advanced surgical devices to enable better visualization, today announced it has entered into a definitive agreement with Stryker Corporation (NYSE:SYK), pursuant to which Stryker will acquire all of the outstanding shares of Invuity for $7.40 per share in cash, implying a total equity value of approximately $190 million.

“The combination of Stryker’s established leadership in minimal access surgery paired with Invuity’s suite of enabling visualization and surgical devices should facilitate better patient outcomes and operating room efficiencies in women’s health, general surgery, electrophysiology and orthopedics,” said Scott Flora, Invuity’s Interim Chief Executive Officer. “It is with this in mind that Invuity’s Board of Directors voted to recommend this transaction to Invuity’s stockholders.”

“Invuity’s innovative products in the single-use lighted instrumentation and hybrid energy markets provide best in class illumination and help make surgery safer,” stated Spencer S. Stiles, Group President, Neurotechnology, Instruments and Spine. “I look forward to the work we will do together to advance Stryker’s mission of making healthcare better.”

Under the terms of the definitive transaction agreement, a subsidiary of Stryker Corporation will commence a tender offer to purchase all outstanding shares of Invuity, Inc. common stock in exchange for $7.40 per share in cash. The completion of the tender offer is subject to customary terms and closing conditions, including a requirement that a majority of Invuity, Inc.’s outstanding shares are tendered in the offer and receipt of certain regulatory approvals. The agreement provides that immediately following the successful completion of the tender offer, the subsidiary of Stryker Corporation making the offer will merge with and into Invuity, Inc. and all remaining outstanding shares of Invuity, Inc. common stock that were not tendered in the offer will receive the same consideration paid in respect of those shares that were tendered. Stryker Corporation intends to fund the transaction with cash on hand.

The Invuity, Inc. Board of Directors has approved entering into the agreement and recommends that Invuity, Inc.’s stockholders tender their shares in the upcoming tender offer. All directors and executive officers of Invuity, Inc. have entered into a tender and support agreement providing that they will tender their shares in the offer.

Following the completion of the transaction, Invuity, Inc. shares will be delisted from NASDAQ. The tender offer is expected to be completed in the fourth quarter of 2018, subject to the satisfaction or waiver of the transaction conditions.

In connection with this transaction, Moelis & Company LLC is acting as financial advisor and Wilson Sonsini Goodrich & Rosati P.C. is acting as legal advisor to Invuity, Inc.

About Invuity, Inc. (Nasdaq: IVTY):

Invuity, Inc., is a leading medical technology company focused on developing and marketing advanced surgical devices to improve the surgeon’s ability to perform minimal access surgery through smaller and hidden incisions. The Company’s patented Intelligent Photonics® technology delivers enhanced visualization, which facilitates surgical precision, efficiency and safety. Clinical applications include women’s health, encompassing breast cancer and breast reconstruction surgery, gynecology and thyroid surgery. Additional applications include procedures for general surgery, electrophysiology, spine and orthopedics. Invuity, Inc. is headquartered in San Francisco, CA. For more information, visit www.invuity.com

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, statements related to expectations, goals, plans, objectives and future events. In some cases, forward-looking statements can be identified by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “outlook,” “guidance” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking information and statements are or may be based on a series of projections and estimates and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. These risks and uncertainties include such factors as: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the transaction agreement or delay the closing of the transaction, (2) uncertainties as to how many shares will be tendered in the tender offer, (3) the possibility that various closing conditions for the tender offer or the merger may not be satisfied or waived; (4) risks related to disruption of management’s attention from Invuity, Inc.’s ongoing business operations due to the transaction and (5) the effect of the announcement or completion of the transaction on the ability of Invuity, Inc. to retain and hire key personnel and maintain relationships with its customers, suppliers and others with whom it does business, or on its operating results and business generally. Additional risks are described in Invuity, Inc.’s periodic filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Invuity, Inc.’s annual report on Form 10-K for the year ended December 31, 2017 and subsequent reports on Form 10-Q. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. Invuity, Inc. does not undertake any obligation to release any revisions to these forward-looking statements publicly to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

Additional Information and Where to Find It

The tender offer for the outstanding shares of Invuity, Inc. referenced in this document has not yet commenced. This press release is for informational purposes only and is not an offer to purchase, a solicitation of an offer to sell, or a recommendation to sell shares of Invuity, nor is it a substitute for the tender offer materials that Stryker Corporation and its subsidiary will file with the Securities and Exchange Commission (“SEC”). At the time the tender offer is commenced, Stryker Corporation and its subsidiary will file tender offer materials on Schedule TO, and thereafter Invuity, Inc. will file a Solicitation/Recommendation Statement on Schedule 14D-9, with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION. HOLDERS OF SHARES OF INVUITY, INC. COMMON STOCK ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF SHARES OF INVUITY, INC. COMMON STOCK SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES. The Offer to Purchase, the related Letter of Transmittal and other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Invuity, Inc. common stock at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov. Additional copies of the tender offer materials may be obtained for free by contacting Invuity, Inc. at 444 De Haro St., San Francisco, CA 94107, Attention: Investor Relations or the investor relations department of Stryker Corporation at katherine.owen@stryker.com. In addition to the Offer to Purchase, the related Letter of Transmittal and other tender offer documents, as well as the Solicitation/Recommendation Statement, Stryker Corporation and Invuity, Inc. file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Stryker Corporation or Invuity, Inc. at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Stryker Corporation’s and Invuity, Inc.’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

James Mackaness
Chief Financial Officer
Invuity, Inc.
415-655-2100

Westwicke Partners
Mark Klausner
443-213-0500

Amedica Corporation to Host Conference Call to Discuss Recent Sale of Spine Implant Business and Transition to Biomaterials Company

Posted On September 11, 2018 By OrthoSpineNews In Spine /

SALT LAKE CITY, Sept. 11, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, announced today that it will host a conference call with Dr. Sonny Bal, Chairman and CEO of Amedica Corporation, to discuss the recently announced sale of its spine implant business to CTL Medical and its transition to a biomaterials company.

Details related to this call are as follows:

Date: Thursday, September 13, 2018

Time: 11:00 a.m., Eastern Time

Dial-in: Toll-free 877-524-8416
International 412-902-1028

Questions: Questions will not be taken during the call. Investors may submit questions prior to the call via email to IR@amedica.com. Questions will be accepted through 10:00 p.m. Mountain time on Tuesday, September 11, 2018.

For those who are not available to listen to the call, a digital replay will be archived on the investor relations section of the Amedica website under Events & Presentations.

About Amedica Corporation

Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

Contacts:
Amedica IR 
801-839-3502
IR@amedica.com

Amplitude Surgical: 1st Arthroplasty Performed With an ANATOMIC® Total Knee Prosthesis in the United States

Posted On September 10, 2018 By OrthoSpineNews In Recon /

September 10, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, announces the first arthroplasty performed with an ANATOMIC® knee prosthesis in the United States, the world’s largest market, at a hospital in Champaign, Illinois.

The operation was performed by Dr. Sartawi, orthopedic surgeon, Director of Orthopedics at the Christie Clinic, Director of the OSF Heart of Mary Joint Care Center of Excellence and a Professor at the University of Illinois School of Medicine. At the same time, two total knee replacements using the ANATOMIC® system have been carried out by a surgeon in Florida, with very satisfactory results for both patients.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “The implantation of a first ANATOMIC® knee prosthesis in the United States, the world’s largest market for lower-limb prosthetic reconstruction, represents a major milestone for Amplitude and the first step in our development on this market. The operation was a success, with the patient doing very well and able to get around without a walking stick just a week after her surgery, and I would like to thank Dr. Sartawi for his trust. Our Anatomic® knee system is proving to be a real success, with more than 50,000 prostheses already fitted worldwide, and we are proud to be able to make our innovative and reliable products and technologies available to American practitioners and patients to their great satisfaction”.

Next financial press release: 2017-18 annual results, on Wednesday October 17, 2018, after market.

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2018, Amplitude Surgical had a workforce of nearly 400 employees and recorded sales of over 100 million euros.

Contacts

Amplitude Surgical
Philippe Garcia
CFO
finances@amplitude-surgical.com
+33 (0)4 75 41 87 41
or
NewCap
Investor Relations
Marc Willaume
amplitude@newcap.eu
+33 (0)1 44 71 00 13
or
NewCap
Media Relations
Nicolas Merigeau
amplitude@newcap.eu
+33 (0)1 44 71 98 55

Orthopedic Implants Market: Sales in Knee Reconstruction Pre-eminent, Hip Reconstruction to Gain Steady Momentum, slates Fact.MR

Posted On September 10, 2018 By OrthoSpineNews In Recon /

Rockville, MD, Aug. 08, 2018 (GLOBE NEWSWIRE) — The orthopedic implants market continues to be a promising avenue in the global medical technology space. Emergence of advanced technologies coupled with rise in orthopedic disorders are major growth determinants for the orthopedic implants market. A recent report by Fact.MR envisions the orthopedic implants market to record an august 6.5% CAGR over the forecast period 2018 to 2027. Although surgeries of orthopedic implants incorporating robotics offer reproducible precision and are less invasive, expensiveness of the technology coupled with the requirement for robust, evidence-based studies continues to impede its adoption in orthopedic surgeries.

The report opines that knee reconstruction will continue to hold major revenue shares of the orthopedic implants market, trailed by hip reconstruction. Governments across the globe are taking efforts to reduce prices of orthopedic implants used in knee reconstruction surgeries. For example, the National Pharmaceutical Pricing Authority (NPPA) has announced price caps on the orthopedic implants employed in knee reconstruction surgeries, bringing the basic models’ price down by 65%.

Request For Report Sample – https://www.factmr.com/connectus/sample?flag=S&rep_id=990

Additionally, the NPPA has also passed off most of the margins in trade, thereby alleviating concerns regarding impact of the orthopedic implants’ reduced prices on research & innovation. Such efforts from the government will further underpin growth of the orthopedic implants market in the near future. Orthopedic implant sales for knee reconstruction are envisaged to increase at 6.3% CAGR through 2027, according to Fact.MR study. In case of hip reconstruction surgeries, dislocation of orthopedic implants has prevailed as a prominent concern among patients and healthcare professionals alike.

A recent study carried out by a well-known research director, Geoffrey Westrich, unveiled that patients receiving newer implants, referred to “dual mobility,” has zero dislocation tendency in hip reconstruction and replacement. Researchers have found out dual-mobility orthopedic implants to have no dislocations post three-year follow-up of patients.

Results of the study are considered encouraging to meet active, high demand for orthopedic implants among patients, and are likely to lessen concerns apropos of dislocation. Such novel revelations and discoveries will continue to propel demand for orthopedic implants associated with hip reconstruction. Revenues from sales of orthopedic implants for hip reconstructed exceeded US$ 16,800 Mn in 2017.

North America’s preeminent in the orthopedic implants market will continue to prevail, states Fact.MR study. According to American Joint Replacement Registry (AJRR), over 7 million America have been associated with knee and hip reconstruction surgeries collectively. Over half revenue share of the market will be accounted by orthopedic implants sales in North America by 2027-end.

To know the Latest Trends in Orthopedic Implants Market, Visit – https://www.factmr.com/report/990/orthopedic-implants-market

The U.S. Food and Drug Administration (FDA) has approved a slew of robotic surgery systems for orthopedic implants, with the da Vinci Surgical System being the first one. More companies have been investing in the technology for providing a better navigation during the procedure, and obtain 3D scans to aid designing of customized joints.

Acquisitions and mergers continue to be key strategic expansion methods adopted by companies operating in the orthopedic implants market. Acquisition of Mako Surgical Corp. by Stryker – for total hip and knee construction robotic products for orthopedic implants, and Blue Belt Holdings by Smith & Nephew for robot-assisted orthopedic implant surgery product for partial knee replacements are prime instances of such strategic expansions.

Continues advancements in orthopedics have resulted in the development of new, novel implants, with several of them being employed in clinical practices with none or little evidence on their effectiveness and safety. Appropriate staging of new orthopedic implants implementation is therefore gaining emphasis in the market, to eliminate relevant adverse effects on patients. Methodologies for evaluation of new orthopedic implants are now being used as a base for contemplating their success and resolving observed drawbacks.

To Buy Orthopedic Implants Market Report, Check the page- https://www.factmr.com/checkout/990/S

About Fact.MR

Fact.MR is a fast-growing market research firm that offers the most comprehensive suite of syndicated and customized market research reports. We believe transformative intelligence can educate and inspire businesses to make smarter decisions. We know the limitations of the one-size-fits-all approach; that’s why we publish multi-industry global, regional, and country-specific research reports.

Contact Us

Rohit Bhisey

Fact.MR

11140 Rockville Pike

Suite 400

Rockville, MD 20852

United States

Email: sales@factmr.com

Web: https://www.factmr.com/

Genesys Spine releases AIS-C Stand-Alone System

Posted On September 10, 2018 By OrthoSpineNews In Spine, Top Stories /

AUSTIN, Texas, Sept. 10, 2018 /PRNewswire/ — Genesys Spine is pleased to announce the FDA clearance of our latest product line, the AIS-C Stand-Alone System.

The AIS-C Stand-Alone system is a first of its kind, non-screw based, zero-profile, direct-anterior stand-alone interbody system for the cervical spine. It was designed to provide the greatest ease of use to the surgeon at every step of the procedure.

Advantages of the AIS-C Stand-Alone System include:

Direct anterior approach – Allows for a smaller, mid-line incision.
Non-screw-based fixation.
Quick, simple, non-impacting anchor insertion – Does not need an awl or drill.
Zero-step locking mechanism – Contains a locking feature that provides visual confirmation of engagement, but allows for anchor removal when desired.
Easily revised or removed – Use of the removal instruments allows the locking mechanism to be defeated so the anchor can be extracted. No drilling is required.

Dr. Matthew Philips, board-certified neurosurgeon and Director of the Brain and Spine Center at SouthCoast Health in Massachusetts says, “The ease of application of the AIS-C Stand-Alone will reduce both my surgical times and the morbidity associated with plate and screw constructs. This advantageous technique has made this my implant of choice for ACDFs.”

“The most significant aspect of the AIS-C design is its simplicity to implant. From a surgeon’s perspective, there’s only one extra step compared to a standard cervical fusion. Once everything is loaded, they simply squeeze the trigger of the inserter and detach from the implant.” -J. Landon Gilkey, Senior Principal Design Engineer, Genesys Spine.

“The AIS-C Stand-Alone system works great from insertion to removal and I think it will remain one of Genesys’ flagship products for years to come.” –Benjamin Keller, Product Development Engineer, Genesys Spine.

Media inquiries please contact:

marketing@genesysspine.com

www.genesysspine.com

About Genesys Spine:

Founded in 2009, Genesys Spine is a privately held company focused on the design, development and marketing of an array of medical implants and instruments with novel characteristics. These devices, with their award winning proprietary features, all remain within existing parameters for today’s current reimbursement codes.

SOURCE Genesys Spine

Integra LifeSciences Selected for Healogics iSupply℠ Program

Posted On September 10, 2018 By OrthoSpineNews In Biologics /

PLAINSBORO, N.J., Sept. 10, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, today announced it has been selected as a primary provider for cellular-based tissue products within Healogics^® Inc. new iSupply program. This program is exclusively available to Healogics’ hospital partners and is focused on ensuring hospitals and patients receive the best value from wound care products commonly used in Wound Care Centers^® and other sites of care.

Under Healogics new iSupply program, Integra will be a lead provider for cellular-based tissue products – AmnioExcel^® Amniotic Allograft Membrane, AMNIOMATRIX^® Amniotic Allograft Suspension, PriMatrix^® Dermal Repair Scaffold, PriMatrix^® Ag Antimicrobial Dermal Repair Scaffold for the treatment of acute and chronic complex wounds, and Omnigraft^® Dermal Regeneration Matrix for the treatment of diabetic foot ulcers. Cellular-based tissue products or skin substitutes are a group of FDA-regulated products that are designed to repair, restore or replace dermal and epidermal tissue architecture through different mechanisms of action. Integra’s comprehensive suite of evidence-based product solutions are designed to support the body’s natural restorative healing process. In addition, Integra’s market leading total contact casting system, TCC-EZ^® for offloading and protection of wounds, will also be available under the iSupply program.

“We are excited to be a primary provider of cellular-based tissue products for the iSupply program,” said Robert T. Davis, Jr., corporate vice president and president, Orthopedics and Tissue Technologies. “Integra’s products were selected through a rigorous analysis of published data and reviewed by Healogics’ value analysis committee of leading wound care clinicians. This partnership with Healogics reinforces Integra’s commitment to broader access to our advanced wound care products and improving outcomes for patients with chronic wounds.”

“I have used Integra’s line of advanced wound care products and believe they are a vital part of our iSupply Program,” said Dr. Scott Covington, executive vice president of Provider Education at Healogics. “Through this program, we are able to offer high quality, cost-effective products to clinicians, who can confidently use these products to care for their patients.”

About Integra
Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel^®, Bactiseal^®, Cadence^®, Certas™, Codman^®, CUSA^®, DuraGen^®, DuraSeal^®, ICP Express^®, Integra^®, MediHoney^®, MicroFrance^®, PriMatrix^®, Salto Talaris^®, SurgiMend^®, TCC-EZ^®, Titan™ and VersaTru™. For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

About Healogics
Headquartered in Jacksonville, Fla., Healogics is the nation’s wound healing expert. Last year over 330,000 patients received advanced wound care through a nationwide network of 700 Wound Care Centers^®. The Healogics team is made up of nearly 3,000 employees, 4,000 affiliated physicians and a Healogics Specialty Physician practice group of almost 300. In addition to the company’s network of outpatient Centers, Healogics partners with over 300 skilled nursing facilities to care for patients with chronic wounds, and provides inpatient consults at 85 partner hospitals. As the industry leader, Healogics has the largest repository of chronic wound-specific patient data in the country. The Healogics Wound Science Initiative, an effort launched in 2017 to provide peer-reviewed research, recognizes the value and relevance of big data and advanced analytics to drive continuous, collaborative learning towards a better understanding of how to efficiently utilize healthcare resources for patients with wounds. For additional information, please visit Healogics.com.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Sravan Emany
(609) 936-2488
sravan.emany@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984
laurene.isip@integralife.com

Healogics Media Contact
Leslie Niblock
904-524-2695
leslie.niblock@healogics.com

Author: OrthoSpineNews

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