SpineSource Enters Long Term Agreement with Kisco International

Posted On February 2, 2017 By OrthoSpineNews In Spine /

February 02, 2017

CHESTERFIELD, Mo.–(EON: Enhanced Online News)–SpineSource, Inc. has entered into a long term exclusive distribution agreement with Kisco International to market, sell and distribute Kisco’s L-Varlock^® Expandable Lumbar Cage for vertebral interbody fusion in the United States.

The L-Varlock^® Expandable Lumbar Cage provides spine surgeons a device which can be expanded from any range of zero to 24.5° of angle, and from zero to 7.1 mm of expansion within the disc space. Made of titanium alloy, it provides a preferred material for bony osteointegration and a wide open framework for bony in-growth.

“Bone-healing principles never change and the simplicity of this device provides surgeons the ability to follow the fundamental principles of sagittal balance, re-establishment of disc height, and the provision of a large fusion bed within and around the implanted cage,” said Tom Mitchell, President and CEO of SpineSource. “With the adjunct of supplemental fixation, the L-Varlock® Expandable Cage puts the odds in favor of the surgeon and patient to achieve the goal of segmental stability, proper angles, and fusion.”

“What we have seen from our initial launch in 2016 is that surgeons like the simplicity of the expansion, a tactile feel while expanding, and the ability to pack copious amounts of autograft before and after expansion,” added Mr. Mitchell.

SpineSource will market and distribute the L-Varlock® Expandable Cage through its independent sales force which exceeds more than 750 independent professional spinal implant sales professionals nationwide.

SpineSource was founded in 2004, becoming the exclusive distributor for Ulrich Medical GmbH and then was a founder of Ulrich Medical USA in 2007, still based in St. Louis County. In 2008, SpineSource launched expandable PEEK cages from Advanced Medical Technologies, AG which was acquired by Medtronic in 2012.

The Mission of SpineSource is to provide the highest level of quality service based upon clinical and industry expertise and ethics while delivering intelligent technology promoting the well-being of patients with spinal disorders.

L-Varlock^®is patented and trademarked by Kisco International.

Contacts

SpineSource, Inc.
Kristin Menefee, 636-532-9300
info@spinesource.com

Senate Finance Committee OKs Tom Price, MD, for HHS Chief

Posted On February 2, 2017 By OrthoSpineNews In Regulatory /

February 01, 2017 – Medscape Medical News – Robert Lowes

The Senate Finance Committee today approved the nomination of Rep. Tom Price, MD, (R-Ga), to head the Department of Health and Human Services (HHS) and serve as President Donald Trump’s point person in repealing and replacing the Affordable Care Act (ACA).

The 14 to 0 vote reflected the partisan tumult engulfing the nation’s capital during Trump’s first few weeks in office. All the votes came from Republican members of the committee because, for a second day in a row, the 12 Democratic members boycotted executive sessions to confirm both Dr Price and Steven Mnuchin, the president’s nominee for Treasury secretary. Ranking member Sen. Ron Wyden (D-Ore) said the committee should not move forward on the nominations until it addresses “unanswered questions and misleading statements” by both men. Democrats contend that Dr Price has not come clean about alleged conflicts of interest regarding his investments in healthcare companies, which he has denied.

The committee normally needs at least one member from each party present to fulfill its quorum requirement, but Republicans suspended that rule so they could proceed to a vote.

Dr Price’s nomination now goes before the full Republican-controlled Senate for a vote. Because the Senate changed its rules when Democrats were in power to exempt cabinet-level appointments from a filibuster, Dr Price needs only a simple majority, or 51 votes, for confirmation. Republicans hold 52 seats.

READ THE REST HERE

Medtronic, Intuitive Surgical Lead Japan Surgical Navigation and Robotics Systems Market Driven by Changes in Regulatory Policy

Posted On February 2, 2017 By OrthoSpineNews In Regulatory, Robotics /

VANCOUVER, BC–(Marketwired – February 01, 2017) – According to a new series of reports on the Japanese robotics and surgical navigation market by iData Research (www.idataresearch.com), the market in the region is still in its infancy. While several systems have regular sales and a growing installed-base, a number of companies are planning to enter the market in the next several years, particularly due to recent changes in regulatory policy. The largest segment in the Japanese surgical navigation market is represented by navigation systems with orthopedic applications, accounting for nearly 50% of the total market value. As orthopedic navigation systems gain market share from competing technologies such as patient-specific cutting blocks, they will continue to make up the largest navigation segment. However, these systems will face increased competition from newer technologies, like orthopedic robotics systems.

Many orthopedic surgical navigation systems are leased; however, the growth of the orthopedic navigation systems market is driven by sales to new facilities. Market growth is expected to be fueled as applications in total knee and total hip arthroplasty increases, and partial knee arthroplasty procedures begin to use navigation technology.

“As the installed-base expands, companies will be able to increase revenues from service and maintenance,” explains Dr. Kamran Zamanian, CEO of iData. “Also, the entrance of new companies who are looking to provide navigation systems at more budget-friendly prices will expand the market to smaller facilities who, in the past, could not afford the top-of-the-line systems.”

The overall average selling price (ASP) is expected to remain stable due to newer systems entering the market both on the higher and lower ends of the price spectrum, which will stabilize the ASP as institutions upgrade. For example, ENT departments often have lower budgets for navigation systems than their high-priced neurosurgical or spinal counterparts, and the Japanese market is seeing growth in both of these segments. The spinal navigation system segment is projected to exhibit the fastest growth. Image guided systems (ISG) with spine surgery capabilities have a similar ASP to neurosurgery IGS systems as the majority of systems that can be used for neurosurgery can also be used for spine surgery, and vice versa.

Medtronic leads the Japan surgical navigation systems market. The company has established itself through brand recognition and by making systems compatible with their implant products. Medtronic competes with a number of other navigation and implant companies in Japan. Other leading competitors in the Japanese surgical navigation market include Brainlab and Stryker. Intuitive Surgical leads the Japan surgical robotics market. It remains the dominant competitor in Japan with a focus on laparoscopic approaches for a variety of procedures. As regulatory policies shift to encourage investment in this area, companies are expected to expand robotic options in other procedural areas. The surgical robotic systems market is expected to see growth on the part of Accuray and other companies.

For Further Information

More on the surgical navigation and robotics systems market in Japan can be found in a series of reports published by iData Research entitled the Japan Market Report Suite for Surgical Navigation and Robotic Systems. The report covers over 600 pages of market and business analysis on this market in Japan. The suite covers reports on the following markets: surgical navigation systems for neurosurgery, spinal surgery, ENT (ear/nose/throat), and orthopedic hip and knee applications. The segmentation for surgical robotics systems includes spinal, neurosurgery, minimally invasive surgery (MIS), radiosurgery, catheter and orthopedic robotically assisted systems.

The iData report series on robotics and surgical navigation covers the U.S., Japan, China, India, Australia, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about robotics and surgical navigation market data or procedure data, register online or email us at info@idataresearch.netfor a Japan Market Report Suite for Surgical Navigation and Robotic Systems brochure and synopsis.

About iData Research

iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.

CONTACT INFORMATION

Contact Info
Marvin Cidamon
Marketing Coordinator
iData Research Inc.
604-266-6933 Ext. 205
marvinc@idataresearch.net

Minimally invasive spine market will surpass $842 million by 2023 as technology swiftly develops: GlobalData

Posted On February 2, 2017 By OrthoSpineNews In Financial, Spine /

February 1, 2017 — The minimally invasive spine (MIS) surgery market, which covers 39 markets, will rise from $512.6 million in 2016 to just over $842 million, representing a compound annual growth rate of 7.4%, according to research and consulting firm GlobalData.

The company’s latest report states that this relatively strong growth will be driven by a global shift towards healthcare treatments performed in outpatient facilities, heightened surgeon interest in incorporating MIS surgical approaches in their practices, and a growing interest in surgical navigation and robotics technologies.

Jennifer Ryan, GlobalData’s Analyst covering Medical Devices, explains: “These factors, coupled with the rising prevalence of degenerative spine diseases and advancements in complementary technologies, is propelling the market forward.”

The global MIS market is controlled by three large multinationals with strong brand name recognition: Medtronic, DePuy, and NuVasive. Other top players include Stryker, Globus Medical, and Zimmer Biomet. These six market leaders boast strong overall spine portfolios and wide-ranging distribution networks, and most offer a full orthopedics platform beyond spine and biologics.

READ THE REST HERE

First Mazor X™ System Utilized in Mid-Atlantic for Advanced Spine Surgery Procedure

Posted On February 2, 2017 By OrthoSpineNews In Robotics /

RESTON, VA–(Marketwired – February 02, 2017) – The award-winning spine surgeons at Virginia Spine Institute are the first in the Mid-Atlantic region to utilize the Mazor X™ System, a transformative robotic platform for spine surgery. Dr. Christopher Good, Dr. Thomas Schuler and Dr. Colin Haines teamed up to perform a spinal fusion with the new Mazor X™ System which utilizes enhanced analytical tools, precision guidance, optical tracking, and intra-operative verification to make spine surgery safer and less invasive. This latest advancement in spinal surgery was developed at Reston Hospital Center.

“I am very excited to offer the new Mazor X™ System’s robotic technology to our patients,” says Dr. Christopher R. Good, Spine Surgeon and Director of Research at Virginia Spine Institute. “We are proud to have performed the first and the most advanced robotic spine surgery in the Mid-Atlantic region and to be able to offer robotic surgery to our patients both for minimally invasive spine surgery and scoliosis reconstruction. Our research is already showing that robotic surgery can decrease intra-operative radiation to patients in the operating room, as well as improve accuracy of surgery and decrease patient complications. The new Mazor X™ System represents the future of robotic spine surgery and will lead to many future breakthroughs by combining robotic surgery with intra-operative spinal navigation and increase the number and types of surgeries we can perform with robot guidance.”

The new Mazor X™ System, manufactured by Mazor Robotics Ltd., represents a breakthrough and improvement from the original Renaissance^® system. Mazor commercially launched the FDA-cleared platform during the North American Spine Society annual meeting in October 2016.

Through their leadership and vast experience, Virginia Spine Institute is reshaping the future of spine surgery by improving patient safety and reducing recovery time. Virginia Spine Institute continues to pioneer alternate methods of utilizing technology to more efficiently perform complex spinal procedures. With the latest release of the Mazor X™ System comes improved surgical accuracy while incorporating a combination of robotics and live intra-operative navigation.

About Virginia Spine Institute: Virginia Spine Institute is an award-winning medical practice in the Washington, DC metro area solely dedicated to spinal health care. For 25 years they have improved the lives of over 80,000 patients suffering from back or neck pain conditions. This comprehensive spine center provides convenience of specialty care with the top experts from multiple specialties of spinal health care under one roof. Custom treatment options include non operative care, pain management, physical therapy, and when necessary surgical intervention, including minimally invasive, laser and robot-guided procedures. For more information about Virginia Spine Institute visit SpineMD.com.

Image Available: http://www.marketwire.com/library/MwGo/2017/2/2/11G129207/Images/VSI_MAZOR_2-c3bbfffa5e479f76bb217178ecb78a5e.JPG
Image Available: http://www.marketwire.com/library/MwGo/2017/2/2/11G129207/Images/MAZOR_X-a1980a153591a5eda1ef1b217dc8e1f0.JPG

CONTACT INFORMATION

Contact:
Erin Orr
Communications Director
Virginia Spine Institute
Tel: 703.709.1114 x 180
Email: Email contact

SpineMD.com

GMP-compliance-improving-based-on-expert-s-analysis-of-483-issues-inspection-outcomes.jpg

“SERIOUS“ FDA OBSERVATION AT ZIMMER BIOMET WARSAW PLANT

Posted On February 2, 2017 By OrthoSpineNews In Regulatory /

Walter Eisner – Wed, February 1st, 2017

Zimmer Biomet Holdings, Inc. has a lot of ‘splaining to do to the FDA after an inspection of the company’s Warsaw, Indiana, plant resulted in one the “longest and most serious” 483s ever encountered by a legal expert quoted by Wells Fargo Analyst, Larry Biegelsen.

FDA 483s are “Inspectional Observations,” used by the FDA to document and communicate concerns discovered during inspections. They do not represent a final determination regarding a company’s compliance.

Over the course of three one-week blocks, the agency conducted an inspection at the company and issued a 60-page heavily redacted Form 483 in November.

North Campus Concerns

Prior to the FDA inspection the company completed internal audits of its North Campus in the first half of 2016. According to a January 30, 2017 analyst report by RBC’s Glenn Novarro, these audits identified several compliance-related issues, and a remediation program was established in July 2016. This program identified 7 of the 14 Form-483 observations and 6 of the 15 discussion points prior to the start of the FDA’s inspection.

Biegelsen wrote in mid-December that the 60 heavily redacted pages of the 483 appears to be “severe”, but is unlikely to have a material impact on the business in the near-term because the issues found by the FDA do not impact product approvals and are unlikely to lead to an injunction.

READ THE REST HERE

VEXIM Strengthens Its Intellectual Property Protection for the SpineJack® in Asia: Two Patents Granted in China and Japan

Posted On February 2, 2017 By OrthoSpineNews In Regulatory /

February 02, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME eligible), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces the expansion of its SpineJack® patent portfolio in Asia.

The issuance of new patents in Japan and China further confirms the highly innovative nature of VEXIM’s technology. The SpineJack® has undergone almost 47 patents applications gathered in three patent families. The technology is protected by international patents, namely in VEXIM’s strategic markets in Europe, in the United States, in China, Brazil, South Korea, Australia and in South Africa.

Alongside with the protection of its intellectual property in China, VEXIM is about to initiate, with a Chinese laboratory, the first biological and mechanical qualifying tests required for the registration of its products by the China Food and Drug Administration (CFDA).

“Our investments to reinforce our intellectual property and its protection are key features of VEXIM’s Innovation Management. Our patent portfolio continues to expand internationally and further demonstrates the value of the technology underlying the SpineJack® implant. This makes us particularly confident that our products will achieve commercial success. Furthermore, the incoming launch of a regulatory procedure in China will give us new opportunities for long-term growth in this region”, commented Vincent Gardès, CEO of VEXIM.

Financial reporting schedule:
2016 Full-Year Results: March 22^nd, 2017¹

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital² and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors.
VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® ³, a revolutionary implant for treating Vertebral Fractures
The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

Masterflow^TM ², a high-performance orthopedic cement delivery system
The Masterflow^TM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the Masterflow^TM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The Masterflow^TM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

Name : VEXIM
ISIN code : FR0011072602
Ticker : ALVXM

¹ Indicative date, subject to changes.
² Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
³ This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
investisseur@vexim.com
Tél. : +33 5 61 48 48 38
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
vexim@alizerp.com
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94

Zimmer Biomet Announces FDA Approval of Expanded 26-week Efficacy Claim for Gel-One® Cross-Linked Hyaluronate for Treatment of Pain Associated with Knee Osteoarthritis

Posted On February 2, 2017 By OrthoSpineNews In Regulatory /

WARSAW, Ind., Feb. 1, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded 26-week efficacy claim for its single-injection viscosupplement Gel-One^® Cross-linked Hyaluronate for the treatment of knee pain associated with osteoarthritis. Gel-One Cross-linked Hyaluronate may be administered in the physician office setting and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen¹.

“Gel-One Hyaluronate is a vital component in the continuum of treatments for knee osteoarthritis, offering millions of patients the potential for up to six months of pain relief with a single injection,” said David Nolan, Zimmer Biomet Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office Based Technologies and Zimmer Biomet Signature Solutions. “The expanded efficacy claim not only strengthens our competitive positioning, but reinforces our commitment to alleviating pain and restoring mobility for patients at every stage in the continuum of musculoskeletal care, including conservative and non-surgical options.”

Gel-One Cross-Linked Hyaluronate is the first low-volume viscosupplement available in a single-injection formulation for the treatment of osteoarthritis of the knee. Hyaluronic acid (HA) products such as Gel-One Cross-linked Hyaluronate may supplement the natural HA of the knee, which provides cushioning and lubrication to the joint. Gel-One Cross-linked Hyaluronate requires only a single 3 mL injection to complete the treatment course.

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

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

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

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

¹Important Safety Information

Important Safety Information

Before using Gel-One Hyaluronate, tell your doctor if you are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry. Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. You should not receive Gel-One Hyaluronate injection if you have a skin disease or infection around the area where the injection will be given. Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA. Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. You should tell your doctor if you think you are pregnant or if you are nursing a child. Talk to your doctor before resuming strenuous or prolonged weight-bearing activities after treatment. The effectiveness of repeat treatment cycles of Gel-One Hyaluronate has not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate in the clinical trial were knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. Other conditions, including but not limited to skin redness and rash, knee stiffness, knee muscular weakness and dizziness, were also reported. If any of these symptoms or signs appear after you are given Gel-One Hyaluronate or if you have any other problems, you should call your doctor. Ask your surgeon if you are a candidate and discuss potential risks. For additional information, call 1-800-348-2759, or visit www.zimmerbiomet.com.

This material is intended for US patients and US Health Care Professionals.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/zimmer-biomet-announces-fda-approval-of-expanded-26-week-efficacy-claim-for-gel-one-cross-linked-hyaluronate-for-treatment-of-pain-associated-with-knee-osteoarthritis-300399479.html

SOURCE Zimmer Biomet Holdings, Inc.

News Provided by Acquire Media

Stryker’s Marc Esformes Discusses Future of Medical Implants at LAM 2017

Posted On February 2, 2017 By OrthoSpineNews In Spine /

ORLANDO, FL (PRWEB) JANUARY 31, 2017

The additive manufacturing revolution is in full swing. With more industries adopting 3D printing capabilities for their parts development, 3D printed materials are here to stay. At the Laser Institute of America 2017 Laser Additive Manufacturing Workshop (LAM®), researchers and industry leaders alike will discuss the state of additive manufacturing, as well as present ongoing developments within the various industries they serve.

Presenting on Day One, during Session One: Trends in Laser Additive Manufacturing, is Marc Esformes of Stryker Corporation, discussing “Additive Manufacturing of Medical Implants.” Stryker Corporation is among the pioneering companies to use additive manufacturing technology to develop medical devices and tools, and recently announced the expansion of their 3D printing capabilities by developing a brand new, multi-million-dollar facility. Their exciting new solution for spinal surgical implants has garnered ample attention, not just in the world of additive manufacturing, but in fields like orthopedics, neurosurgery and general surgery.

Stryker Corporation began as the medical practice of Dr. Homer Stryker. The practice was incorporated as an orthopedic frame company in 1946, before becoming Stryker Corporation following Dr. Stryker’s retirement in 1964. In recent years, Stryker Corporation has become one of the leading companies using additive manufacturing technology to develop parts for the medical field. Unlike other industries, the parts and implants created in the medical industry must go through numerous comprehensive trials and tests for biocompatibility, long before they are used for their intended purpose.

This year, Stryker Corporation developed a 3D printed Tritanium (the brand name of Stryker’s alloy material, used in their powder bed laser sintering process) Posterior Lumbar Cage Spinal Implant. The implant was showcased at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting. Using virtual reality technology, the presentation showed viewers the evolution of Stryker’s manufacturing before giving a virtual tour of the Stryker facility, including a close-up look at the implant. Expanding upon existing implant technology, and over a decade worth of research, the spinal implant is porous, and resembles bone tissue. Given its flexible, permeable state, early trials suggest that the implant may encourage natural bone growth, leading to a longer-lasting, more functional implant, that behaves like natural bone.

Don’t miss your chance to explore the latest advancements in medical additive manufacturing when Marc Esformes of Stryker Corporation presents at LAM 2017. LAM will take place February 21-22, 2017, in Houston, Texas. For more information, and to register, please visit https://www.lia.org/conferences/lam.

The Laser Institute of America (LIA) is the international society for laser applications and safety. Our mission is to foster lasers, laser applications, and laser safety worldwide. http://www.lia.org.

SeaSpine® Announces Full Commercial Launch of Vu a∙POD™ Prime NanoMetalene® System

Posted On February 2, 2017 By OrthoSpineNews In Spine /

CARLSBAD, Calif., Jan. 31, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of its Vu a•POD Prime NanoMetalene System.

The Vu a•POD Prime NanoMetalene System features a zero-profile, standalone anterior lumbar interbody device that can be configured in a variety of footprint and lordosis combinations to accommodate an individual patient’s pathology. The Vu a•POD Prime NanoMetalene System offers multiple fixation options for maximum versatility and adds to SeaSpine’s growing portfolio of offerings featuring proprietary NanoMetalene technology.

“The new lordosis options enable me to better recreate the patient’s natural alignment. These features, particularly when combined with the NanoMetalene technology, should speed the healing process and improve long-term outcomes,” stated Dr. Nilesh Patel, an orthopedic surgeon practicing at Beaumont Hospital in Dearborn, MI.

NanoMetalene interbody implants are designed to provide the benefits of a titanium surface while retaining the benefits associated with traditional PEEK devices, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging. NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO®. It is applied in a proprietary, high-energy, low-temperature process that differs from other coating applications and maximizes implant surface area with titanium nanotopography.

Additionally, Vu a•POD Prime NanoMetalene implants are delivered individually sterile-packaged and ready-to-use. This packaging solution is designed to facilitate configurations tailored to address individual surgeon preferences, while simplifying hospital processing requirements and inventory management.

NanoMetalene, SeaSpine and the SeaSpine logo are registered trademarks of SeaSpine Orthopedics Corporation or its subsidiaries in the United States and other countries. Vu a•POD Prime is a trademark of SeaSpine Orthopedics Corporation or its subsidiaries. PEEK-OPTIMA is a registered trademark of Invibio and is used by SeaSpine under license.

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal fusion hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes and cellular grafts that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal fusion hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development allows SeaSpine to offer our surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the versatility of the Vu a•POD Prime NanoMetalene System; its ability to better recreate patient anatomy; the benefits of NanoMetalene technology and products; the benefits of sterile-packaged products; and whether new lordosis options, alone or when combined with NanoMetalene, will speed the healing process and improve long-term outcomes. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products; the ability of newly launched products, including the Vu a•POD Prime NanoMetalene System, to perform as designed and to meet clinical needs when implanted in patients; the lack of clinical validation of newly launched products, including the Vu a•POD Prime NanoMetalene System; the Company’s ability to invest adequately in the commercialization of its products, including new products such as the Vu a•POD Prime NanoMetalene System, and the risk of excess inventory in the event demand for new products is less than the Company’s expectations; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; other difficulties and delays in launching new products; the inability to apply NanoMetalene technology consistently and reproducibly; the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing, including in ongoing and future studies, the outcomes of which inherently are uncertain; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact 
Lynn Pieper
(415) 513-1281
ir@seaspine.com

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