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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.

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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

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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
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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

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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/

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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

Related Links

https://www.genesysspine.com

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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

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Carevature Medical’s Dreal™ Decompression System is Safer for Patients, Says Recent Article

Posted On September 10, 2018 By OrthoSpineNews In Spine /  

TEL AVIV, Israel, Sept. 5, 2018 /PRNewswire/ — According to a recent article in the International Journal of Spine Surgery, advanced decompression innovator Carevature’s Dreal™ device yields significantly better results in incidental dural tears, with 87% improvement compared to high-speed drills and Kerrison Rongeurs (0.4% vs. 2.91%; p<0.01); and 80% improvement compared to ultrasonic bone cutters (0.4% vs. 1.95%; p<0.01).

This data demonstrates the Dreal™’s marked advantages in reducing natural risk of neural element injury. The results are attributed to the device’s unique curved and shielded tip design, which requires only a very limited number of passes to remove the target pathology.[1]

“This confirms what my colleagues and I have been experiencing in our surgical practice,” says Dr. Ely Ashkenazi, MD, neurosurgeon and senior spine surgeon at Tel Aviv’s Israel Spine Center, where he and his team have used the Dreal™ in over 200 cervical, thoracic, and lumbar spine procedures.

“I’ve been deeply impressed with the design and function of these devices,” adds Scott C. Kutz, MD, neurosurgeon at the Texas Back Institute (Plano, TX). “I don’t believe any other device on the market can provide these results. Furthermore, it increases the efficiency and safety with which I can perform multiple, dissimilar spinal procedures. In particular, these devices are extremely helpful in minimally invasive spine surgery – a market segment that’s expanding relative to standard spine surgery. I expect that use of the Dreal™ system will grow exponentially over the next few years, in step with the demand for minimally invasive spinal techniques.”

Says Charlie Harrison, President of Carevature Medical, Inc. (Marietta, GA): “We’ve all been waiting for the new line of bayoneted designs, which truly raises the bar for decompression systems. Feedback from surgeons has been superb, and we’re confident that this overwhelmingly positive response will be a major step towards the Dreal™’s rapid expansion in US markets and beyond.”

ABOUT CAREVATURE

Carevature Medical Ltd., a privately-held medical device company headquartered in Rehovot, Israel, is dedicated to developing advanced orthopedic surgery solutions. Carevature is currently marketing its flagship line of products for spinal indications, Dreal™: the first and only curved device powerful enough to efficiently cut bone, and small enough for use in all sections of the spine. Over 800 patients worldwide have been treated with the Dreal™, with outstanding safety and recovery results.

www.carevature.com 

[1] Suitability of Administrative Databases for Durotomy Incidence Assessment: Comparison to the Incidence Associated With Bone-Removal Devices, Calculated Using a Systemic Literature Review and Clinical Data. Robert Pflugmacher, Angelo Franzini, Shaked Horovitz, Richard Guyer, Ely Ashkenazi. International Journal of Spine Surgery Aug 2018, 12 (4) 498-509; DOI: 10.14444/5061

Media contact:

Robert W. Cook, VP Marketing & Sales

Carevature Medical, Inc.

M: +1-260-417-1643

E: bob@carevature.com 

SOURCE Carevature Medical Ltd.

Related Links

http://www.carevature.com

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Top Joint Replacement Surgeon To Lead NYU Langone’s Adult Reconstructive Surgery Division

Posted On September 10, 2018 By OrthoSpineNews In Recon /  

NEW YORK, Sept. 10, 2018 /PRNewswire/ — William Macaulay, MD, an internationally renowned expert in hip and knee treatments and surgery, has been appointed Chief of the Division of Adult Reconstructive Surgery in the Department of Orthopedic Surgery at NYU Langone Health. The new appointment is effective August 23, 2018.

Dr. Macaulay first joined NYU Langone in January 2017 as its medical director for International Patient Services. In that role he oversaw an expansion of the health system’s program matching international patients with top physicians in a wide variety of medical and surgical disciplines. He will maintain this position as he assumes his new role.

Macaulay also serves as professor of orthopedic surgery in the Division of Adult Reconstructive Surgery, performing his surgical procedures at NYU Langone Orthopedic Hospital in Manhattan. In addition, he consults with patients at several of NYU Langone’s state-of-the-art outpatient facilities, including the Preston Robert Tisch Center for Men’s Health in Manhattan and NYU Langone Orthopedics—Westchester.

“We are thrilled to have Dr. Macaulay’s vast orthopedic expertise and renowned leadership spearheading NYU Langone’s adult reconstructive surgery division,” says Joseph D. Zuckerman, MD, the Walter A. L. Thompson Professor of Orthopedic Surgery and chair of the Department of Orthopedic Surgery. “Dr. Macaulay enjoys international acclaim, and will apply his experience to continue to elevate our division, which is recognized for its extensive clinical, educational and academic activities.”

About Dr. Macaulay: A Leader in Hip and Knee Care

Dr. Macaulay specializes in orthopedic procedures including primary and revision total knee and total hip replacement, partial knee replacement, hip resurfacing, hip fracture repair and knee arthroscopy. For the most complex cases, he utilizes new technologies, including robotics and computer-assisted navigation, to ensure optimal outcomes.

Prior to joining NYU Langone, Dr. Macaulay served as chief of the Division of Hip and Knee Surgery and director of the Center for Hip and Knee Replacement at NewYork-Presbyterian (NYP) at Columbia. He also served as the director of Orthopedic Surgery at NYP/Lawrence Hospital in Westchester County, and had been a member of the faculty at Columbia University Medical Center for 17 years, acting as Advisory Dean at The College of Physicians and Surgeons for 7 years. He was also the founder and director of their hip and knee replacement fellowship program. Dr. Macaulay earned his medical degree from Columbia University College of Physicians and Surgeons, and completed his surgery internship and orthopedic surgery residency at University of Pittsburgh Medical Center. He also completed a postdoctoral arthroplasty fellowship at the Hospital for Special Surgery in New York.

An accomplished researcher and clinician, Dr. Macaulay has received more than a dozen awards and honors for his work in hip and knee orthopedic care. He was named one of the “25 Best U.S. Knee Surgeons” by Becker’s ASC Review. He is also a member of several prestigious medical societies, including The Hip Society, The Knee Society, and the American Association of Hip and Knee Surgeons, the latter of which presented him with the Lawrence D. Dorr Surgical Techniques and Technologies Award in 2007. For the last two decades, Dr. Macaulay’s research has focused on advances in hip and knee reconstructive surgery, such as surgical recovery enhancement and outcomes of hip and knee replacement surgery, including partial knee replacement and hip resurfacing. He has served as a site investigator, principal investigator, and steering committee member of several prominent randomized clinical trials.

“It’s a true honor to be selected to oversee one of the largest and most renowned adult reconstructive surgery divisions in the United States, whose faculty is lauded for pushing the envelope in cutting-edge treatments and new research to provide top orthopedic care,” says Macaulay.

Why Choose NYU Langone for Joint Replacements

The Adult Reconstructive Surgery Division at NYU Langone is one of the largest in the country, with 36 surgeons who performed more than 4,500 procedures last year. Our total joint replacement surgeons are experienced in minimally invasive joint replacement techniques and work with the latest technology and equipment in specialized orthopedic operating rooms. They use their expertise in planning, as well as during, all surgical procedure to address their patient’s joint problems and ensure the best possible outcomes.

NYU Langone ranks No. 8 in the nation in Orthopedics, according to U.S. News & World Report‘s “Best Hospitals 2018-2019 Honor Roll.” It also ranks No. 2 in New York State and number two in the New York metro area. Equally noteworthy, NYU Langone is the only hospital in New York to receive top 10 rankings for all three musculoskeletal specialty disciplines: orthopedics, rheumatology, and rehabilitation.

Patients who choose to travel from outside of the United States can find expert assistance at NYU Langone, where care coordinators match patients with the appropriate doctors and treatment options. The team also helps arrange travel and local accommodations for accompanying family members, and ensures patients have medical interpreters during all phases of care, including via telephone, video, or face-to-face consultations.

International patients seeking care can contact NYU Langone’s International Patient Services Program at (212) 263-3588, or by email at internationalservices@nyulangone.org. Please include your name, country of origin, preferred contact method, and preferred language. Documents can also be faxed to 646-501-5296.

Media Inquiries:

Ryan Jaslow

Phone: 212-404-3511

ryan.jaslow@nyulangone.org

SOURCE NYU Langone Health

Photo: (PRNewsfoto/NYU Langone Health)

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Amedica Announces Filing of Key Patent Application Relating to the Anti-Viral Effect of its Silicon Nitride

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

SALT LAKE CITY, Sept. 10, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced the filing of a U.S. patent application for breakthrough research findings that have identified a new property of its proprietary silicon nitride.

Amedica investigators led by Dr. Giuseppe Pezzotti, a professor at the Kyoto Institute of Technology (Japan) and consultant to Amedica Corporation, have developed micromeritic silicon nitride powders as well as bulk surfaces that are effective against several strains of commonly prevalent viruses – including Influenza A virus (H1N1), the virus responsible for the 2009 flu pandemic. The research has also identified the surface chemical properties of silicon nitride that contribute to the observed virucidal effect.

The mechanism, known as alkaline transesterification, is known to cause genomic cleavage in active viruses leading to their inactivation and lysis. The investigation employed a commonly accepted assay of measuring mammalian cell viability in the presence of high concentrations of virus particles. In the case of Influenza A virus, a 5-minute exposure to Amedica’s silicon nitride either at room temperature or at 4oC was enough to result in complete virus lysis and inactivation such that 100% of the exposed cells survived. In an identical parallel test conducted without silicon nitride, the virus remained intact and was able to infect and destroy exposed cells. Silicon nitride proved to be an effective disinfectant of the virus thus providing a protective effect to cells exposed to the virus.

“These unexpected results are of course entirely welcome, and the remarkable discovery opens new frontiers in our evolving understanding of silicon nitride as a biomaterial and in practical applications of it,” said Dr. B. Sonny Bal, Chairman and CEO of Amedica Corporation. “The discovery is particularly timely given our recent divestment of the retail spine business to CTL Medical and our transition to an OEM manufacturer and biomaterials company.”

“From the standpoint of spine surgery, the antiviral properties of silicon nitride implants probably have little consequence since viral infections of implanted biomaterials are not a practical problem. On the other hand, systemic viral infections and their spread through contaminated surfaces are a global concern. Drug treatments of established Influenza A infections, such as Tamiflu, are effective only in controlling symptoms by reducing viral load and the virus can still mutate to newly resistant, dangerous strains. The control of viral propagation by surface sanitization is therefore of worldwide interest; witness the hand sanitizers and other protections used commonly during the flu season. Surface sanitization destroys the virus itself, and commonly-used methods rely on ammonia, alcohol, silicon nanoparticles, and certain pH conditions to inactivate virus particles.”

“The latest findings show the above-surface conditions for viral disinfection are already manifest on Amedica’s silicon nitride whether the material is studied in bulk form or as a micron-layer coating on other surfaces. This property is a powerful advantage toward safe and reliable methods for viral inactivation and elimination. This fortuitous, intrinsic anti-viral effect of Amedica’s silicon nitride has broad applications in health care, from medical therapies to various medical devices and equipment such as examination tables, clothing, filters, masks, gloves, catheters, endoscopic instruments, and well beyond.”

“Previous data, supported by clinical studies, have established that Amedica’s silicon nitride enhances osteogenesis while resisting bacterial adhesion; both highly desirable properties in spinal fusion implants. Now, the material appears to be equally effective against the world’s most common pathogens, i.e., viruses that are responsible for a number of diseases and their global spread. Going forward, we will seek commercial applications and partnerships that can leverage the unique antiviral behavior of silicon nitride, a property that, to our knowledge, is not present in any other biomaterial known in the world today.”

Further to today’s announcement, Amedica will host a conference call on September 13, 2018 to discuss the agreement with CTL Medical and to provide a business update. Details related to this call will be provided at a later date.

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

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties, including without limitation the risks associated with generating data to support the patent application for the technology and of obtaining a patent that provides commercially significant protection for this technology; the risk that the technology may infringe the proprietary rights of third parties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

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

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