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Nanovis Expands the Range of Footprints for its Signature FortiCore Posterior Lumbar Interbody Fusion System

Posted On November 15, 2018 By OrthoSpineNews In Spine, Top Stories /

CARMEL, IND. (PRWEB) NOVEMBER 14, 2018

Nanovis, a leader in nanomedicine for the spine, today announced adding 22mm and 25mm lengths to its FortiCore® rotatable Posterior Lumbar Interbody Fusion (PLIF) devices.

With over 5,000 FortiCore interbodies now implanted, Nanovis plans to further accelerate its technology driven growth with the expansion of their FortiCore PLIF product line with the addition of 22 mm and 25 mm lengths that can be rotated in situ for optimal placement.

“Many of our customers asked for these new sizes so they could treat their lumbar patients after using FortiCore in the cervical spine. Our surgeon customers have converted from titanium, PEEK, plasma sprayed PEEK, and allograft for the benefit of a deeply porous interconnected titanium scaffold to secure the implant and the benefit of a PEEK core to visualize bridging bone. They’ve been very pleased with their patient’s results and are asking for more lumbar FortiCore options because of the difficulties in assessing and achieving the best outcomes with other interbody technologies.” said Matt Hedrick, CEO, Nanovis. FortiCore® interbody fusion devices are comprised of a deeply porous titanium scaffold designed to assist in securing the implant in the intervertebral space. The scaffold is intermolded with PEEK Optima® by InVibio to allow bridging bone visualization. This unique combination of technologies is designed to increase positive outcomes in spinal fusion procedures with the imaging capabilities preferred by surgeons. “These FortiCore sizes complete our lumbar TLIF and PLIF offering. Nanovis is growing quickly with the best technology portfolio for our distributors to build their revenue and their surgeon relationships. The science driven innovation and potential to help patients has helped achieve favorable hospital access as a technology product. Distributors interested in the best possible fixation technology should reach out to me at jeff.shepherd@nanovistechnology.com,” said Jeff Shepherd, VP of Sales, Nanovis. Nanovis’ technology driven growth strategy is based on its FortiCore, nanotube, and NanoPEEK fixation technology platform and it’s bactericidal nanotube and infection prevention and treatment technology platform. The FortiCore scaffold, sold in other orthopedic markets as the OsteoSync™ scaffold by the inventors of the technology, Sites Medical, shows positive results and attractive sales growth. Combined, these technologies provide exceptional fixation capability that supports years of spine and orthopedic implant upgrades, patient benefits, and technology driven sales growth. For more information about Nanovis, FortiCore or other proprietary Nanovis science-enhanced technologies, please visit us http://www.nanovisinc.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 nanotube surface; and a nanotube surface technology with anti-colonization and anti-microbial capabilities in pre-clinical studies.

HSS Receives Press Ganey Guardian of Excellence Award® for Sixth Consecutive Year

Posted On November 14, 2018 By OrthoSpineNews In Extremities, Top Stories /

NEW YORK, Nov. 13, 2018 /PRNewswire/ — Today, Press Ganey, a nationally recognized private company that measures patient experience, named Hospital for Special Surgery (HSS) a 2018 Press Ganey Guardian of Excellence Award® Winner. The Press Ganey Guardian of Excellence Award® was presented to HSS during their annual conference in Orlando, Florida.

“At HSS, we are committed to helping people move better so they can live better,” said Louis A. Shapiro, president and CEO at HSS. “As a world leader in musculoskeletal health, we put patients first and are honored to have earned this distinguished recognition for the sixth consecutive year.”

“We are proud to partner with HSS to support their mission to provide safe, high-quality, patient-centered care,” said Patrick T. Ryan, CEO of Press Ganey. “They are truly dedicated to delivering exceptional care in the communities they serve, and their commitment to capturing and acting on patient experience feedback is a very powerful demonstration of this.”

The Press Ganey Guardian of Excellence Award® is a nationally recognized achievement for those who have sustained performance in the top 5 percent for patient experience during the course of a year of data. HSS has been awarded this recognition for six consecutive years for outstanding inpatient and HCAHPS performance.

“It is rewarding to be part of a medical staff that is devoted to researching the latest advancements in treatment for all musculoskeletal conditions,” said Todd J. Albert, MD, surgeon-in-chief and medical director at HSS. “From motion analysis to virtual reality, HSS physicians implement the best practices in all initiatives to improve patient care and elevate patient satisfaction.”

“Getting patients back to how they want to live their lives is our utmost priority,” said Chao Wu, chief patient experience officer at HSS. “Guided by committed leadership, systematic feedback and a dedicated team of physicians and staff, we are able to continuously evolve our model of care to best treat each patient.”

About Press Ganey
Press Ganey pioneered the health care performance improvement movement more than 30 years ago. Today, Press Ganey offers an integrated suite of solutions that enable enterprise transformation across the patient journey. Delivered through a cutting-edge digital platform built on a foundation of data security, Press Ganey solutions address safety, clinical excellence, patient experience and workforce engagement. The company works with more than 33,000 health care facilities in its mission to reduce patient suffering and enhance caregiver resilience to improve the overall safety, quality and experience of care.

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic of musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

Posted On November 13, 2018 By OrthoSpineNews In Regulatory, Top Stories /

SILVER SPRING, Md., Nov. 13, 2018 /PRNewswire/ — The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.

“The potential health benefits of regenerative medicine have spurred major progress in stem-cell biology over the past several decades. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments; when instead these stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products. This is putting patients’ health at risk. It’s also putting at risk the long-term viability of the industry and of effective products, when other operators are misleading consumers by marketing unproven therapies using claims of safety and benefit,” said FDA Commissioner Scott Gottlieb, M.D. “We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the efficient approval of regenerative medicine products. At the same time, we’ll continue to take enforcement actions against companies that abuse the trust of patients and endanger their health with uncontrolled manufacturing conditions or by promoting so-called ‘treatments’ that haven’t been proven safe or effective for any use.”

The FDA recently inspected the StemGenex facility and found the company was processing adipose tissue (body fat) into stromal vascular fraction (SVF, a cellular product derived from body fat) for administration in a variety of ways, including intravenously, by inhalation, and directly into the spinal canal. StemGenex illegally markets the SVF product to treat a variety of serious diseases and life-threatening conditions, including Alzheimer’s disease, Crohn’s disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, peripheral neuropathy and rheumatoid arthritis. StemGenex’s SVF product, which involves more than minimal manipulation of a patient’s adipose tissue, is regulated as both a drug and biological product. To lawfully market its SVF product, a valid biologics license must be in effect. While in the development stage, the firm’s SVF product may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or approvals exist for StemGenex’s product, and the firm does not have an IND in effect.

During the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice requirements in the manufacture of the SVF product; including unvalidated manufacturing processes, an uncontrolled environment, lack of control over the components used in production, and the lack of sufficient and validated product testing.

The FDA has requested a response from StemGenex, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction, or prosecution.

Health care professionals and consumers should report any adverse events related to treatments with the StemGenex product to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

For more information:

FDA: Comprehensive Regenerative Medicine Policy
FDA: FDA Warns About Stem Cell Claims
FDA: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, stephanie.caccomo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA, ocod@fda.hhs.gov

SOURCE U.S. Food and Drug Administration

CartiHeal Performs First Agili-C™ Implant Case on the East Coast

Posted On November 12, 2018 By OrthoSpineNews In Sports Medicine, Top Stories /

NEW YORK and KFAR SABA, Israel, Nov. 12, 2018 /PRNewswire/ — CartiHeal, developer of Agili-C, a proprietary implant for the treatment of joint surface lesions, announced today the successful enrollment of the first patient in the Agili-C Investigational Device Exemption (IDE) pivotal study on the East Coast.

The surgery was performed by site Principal Investigator Eric J. Strauss, MD, an orthopedic surgeon at NYU Langone Health’s Sports Medicine Center in New York City. NYU Langoprnewne is one of 15 U.S. sites in the new Food and Drug Administration (FDA) IDE trial and will enroll 20 patients with major knee cartilage injuries.

The first patient enrolled at NYU Langone was a 53 year-old female with a history of two failed surgeries on her left knee, who had a very symptomatic cartilage lesion, with significant bone marrow edema affecting her lateral femoral condyle. “The patient was randomized to the Agili-C arm and treated with a single implant in a procedure that went smoothly and led to an immediate increase in blood flow to the affected region,” according to Dr. Strauss.

“My colleagues and I are looking forward to building upon this first successful case and contributing to the study on treating these difficult-to-manage injuries. This investigational implant has great potential to provide an off-the shelf solution for a large spectrum of cartilage lesions.”

Nir Altschuler, CartiHeal’s founder & CEO said: “Enrolling the first US East Coast patient is an important milestone for our study. We are honored that this important case was performed in the good hands of Dr. Eric Strauss, and look forward to his research team continuing to enroll patients.” Altschuler also added that the IDE study, with over 100 enrolled patients, is currently ongoing in the US, EU and Israel, and aiming for an FDA premarket approval application.

CartiHeal’s cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of trials conducted in leading centers in Europe and Israel. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

About CartiHeal
CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C implant is not available for sale – it is an investigational device limited for use in the IDE study.

info@cartiheal.com
www.cartiheal.com

SOURCE CartiHeal

Spinal Elements® Announces FDA Clearance of Ti-Bond® Titanium Coating as a Macro-, Micro-, and Nano-Surface

Posted On November 7, 2018 By OrthoSpineNews In Spine, Top Stories /

November 07, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a Carlsbad, CA-based spine technology company, today announced FDA clearance for claims related to the macro-, micro-, and nano-surface structure of its Ti-Bond® surface coating technology. Highlighting Spinal Elements’ portfolio are a number of products featuring Ti-Bond, including the most recently introduced Lucent® XP height- and lordosis- expandable interbody device.

Interbody fusion products featuring Ti-Bond technology are comprised of a PEEK body which provides the favorable modulus and imaging characteristics surgeons have come to trust while the multi-structured Ti-Bond-coated surfaces are designed to provide a favorable environment at the vertebral endplate. Since its initial introduction in 2012, products featuring the Ti-Bond surface coating technology have benefitted tens of thousands of patients.

“Spinal Elements has had a long, successful experience with the clinical application of Ti-Bond technology in the spine,” stated Jason Blain, President and CEO of Spinal Elements. “This FDA clearance represents an important scientific element of the overall Ti-Bond story – one that will expand even more as the platform continues to flourish, and we provide an increasing number of technology-based solutions to improve patient outcomes.”

Ti-Bond was one of the many innovations introduced to the spine fusion market by Spinal Elements. Since its introduction, other technologies have emerged, each with their own compromises when considered for fusion. Ti-Bond allows the spine surgeon to have the latest, proven technology without compromising imaging characteristics, spinal loading conditions, or long-term performance. This clearance further demonstrates the complex surface environment provided by Ti-Bond coating adjacent to boney structures.

Spinal Elements is a technology-driven company headquartered in Carlsbad, CA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.spinalelements.com.

Contacts

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

Rapid Company Growth Prompts joimax® Inc. to Move Its US Headquarters to a New, Larger State-of-the-Art Facility

Posted On November 5, 2018 By OrthoSpineNews In Spine, Top Stories /

November 05, 2018

IRVINE, Calif.–(BUSINESS WIRE)–joimax^®, the Germany-based market leader of technologies and training methods for full-endoscopic minimally invasive spinal surgery, announces the move of its US headquarters to a new 26,000-square-foot facility in Irvine, California, beginning November 5, 2018.

“With the move to the new building, the steadily growing need for endoscopic procedures among patients and physician communities can now be efficiently met,” states Wolfgang Ries, Founder and CEO of the joimax^® Group. “Growth requires space — the continued demand in the US market creates a major opportunity which joimax^® Inc. is addressing with the expansion of its US organization.”

The new office is located at 140 Technology Drive, Suite 150 in the city of Irvine and includes a brand new training and education center. The center offers a demonstration and wet lab training room displaying all joimax^®systems and products, as well as a big audience room for didactics presentations. The first workshop will be held at the center November 30– December 1, 2018.

In addition, the new facility will handle all corporate and business functions. Over the next year, joimax^® Inc. will add more clinical support, marketing, and sales personnel in order to face the fast growing demand for endoscopic spine procedures.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for full-endoscopic and minimally invasive spinal surgery. With the Endoscopic Surgical Systems TESSYS^®(transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, MultiZYTE^®for facet and sacroiliac joint pain treatment and EndoLIF^® and Percusys^® for minimally invasive endoscopically assisted stabilizations, established systems are provided, addressing a whole range of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^®technologies to operate through small incisions under local or full anesthesia, via tissue and muscle-sparing corridors and through natural openings in the spinal canal, e.g. the intervertebral foramen, the so called “Kambin triangle.”

Contacts

Press Contact Germany:
joimax^® GmbH
Sabine Jarosch
sabine.jarosch@joimax.com
0049 721 25514 0
or
Press Contact USA :
joimax^® Inc.
Melissa Brumley
melissa.brumley@joimaxusa.com
001 949 859 3472

(Photo: Business Wire)

DJO® Unveils Two Additional Products, Further Expanding the Breadth of the EMPOWR Knee System®

Posted On November 1, 2018 By OrthoSpineNews In Recon, Top Stories /

November 01, 2018

DALLAS–(BUSINESS WIRE)–DJO, a leading provider of medical technologies designed to get and keep people moving, introduced the EMPOWR Porous™ Knee System and EMPOWR™ Complex Primary Knee System at the 2018 Annual Meeting of the American Association of Hip and Knee Surgeons (AAHKS) today (Booth # 510). These new additions to the EMPOWR™ Knee Platform expand one of the industry’s most modern total knee replacement systems, which now offers primary, cementless primary, complex primary, and tibial revision solutions for surgeons and patients.

EMPOWR Porous Knee System is based on two decades of clinical experience and highly porous materials designed to enhance early implant fixation, while creating an ideal environment for both immediate and long-term biologic fixation.¹ DJO’s industry leading surface coating technologies, including DJO’s proprietary, highly porous coating, P^2™ aids in bone apposition for superior in-growth performance.¹ EMPOWR Porous’ bladed keel has a bone sparing geometry optimized for cementless application.² The bladed keel of the asymmetric baseplate was developed to provide robust fixation, while the cruciform pegs provide initial component fixation and durable rotational stability.²

EMPOWR Complex Primary Knee System, with the EMPOWR Universal Tibial Baseplate and EMPOWR Varus Valgus Constraint (VVC) Tibial Insert expand the utility of the EMPOWR Knee Platform and provide a wider range of solutions for complex primary and revision knee arthroplasty. These new implant technologies are designed to provide an efficient and seamless transition from standard primary to revision knee procedures, with a minimal number of additional instruments and trays. The EMPOWR Universal Tibial baseplate maintains the EMPOWR System’s characteristic asymmetric footprint which maximizes cortical coverage and prevents component overhang to ensure long-term fixation without tissue irritation⁴. This baseplate also provides the ability to stem and augment when more supplementary fixation is required. The VVC insert is offered in e+™ polyethene, formulated to reduce long-term wear³, while the insert is designed to provide the necessary support and stability in knees with supportive soft tissue deficiencies.

“DJO has a proven record of bringing high quality products to market with incredible cadence – faster than any other implant company today,” said Dr. Eugene S. Krauss, orthopedic surgeon with Northwell Health. “In 2018 alone, the EMPOWR Porous Knee and EMPOWR Complex Primary Knee launches have significantly expanded our ability to treat a wide variety of patients in our practices.”

“The efficiency of DJO’s instrument trays and the streamlined instrumentation enables my surgical team and I to perform up to 12 knee replacements in a single day, making the system well-suited for both hospital and ambulatory surgery center environments,” said Dr. Krauss.

Over the past decade, the science of highly porous metals, including DJO’s P^2, has significantly advanced, helping to improve implant longevity and ultimately patient outcomes. These scientific advancements coupled with a younger, healthier patient population, have resulted in a resurgence of cementless knee arthroplasty. Therefore, the contemporary design of the EMPOWR Porous Knee, is certain to have a meaningful impact on the market.

“DJO Surgical’s strong growth over the past few years is a reflection of our commitment to developing products and solutions that help improve clinical outcomes and enhance patient experience,” said Jeffery A. McCaulley, Global President of DJO Surgical^®. “Our continued expansion of the EMPOWR Platform reflects the overwhelmingly positive reaction we’ve received from surgeons and patients since the first EMPOWR Knee System was launched here at AAHKS in 2015.”

The complete line of products in the EMPOWR Platform include:

EMPOWR 3D Knee^®System
EMPOWR PS Knee^® System
EMPOWR CR Knee^® System
EMPOWR Porous™ KneeSystem
EMPOWR™ Complex Primary Knee System

For more information about the EMPOWR Porous Knee System, the EMPOWR Complex Primary Knee System or the entire EMPOWR Knee Platform, visit https://www.djoglobal.com/empowr or at AAHKS Booth # 510.

Dr. Eugene S. Krauss is a paid consultant for DJO^® Global.

		1.		P^2™Testing Summary 0020327-001 Rev A 10/14
		2.		Bhimji, Safia, and R. Michael Meneghini. “Micromotion of cementless tibial baseplates: keels with adjuvant pegs offer more stability than pegs alone.” The Journal of arthroplasty 29, no. 7 (2014): 1503-1506.
		3.		e+^™ Surgeon Testing Summary 0011110-004
		4.		Dai, Yifei, Giles R. Scuderi, Jeffrey E. Bischoff, Kim Bertin, Samih Tarabichi, and Ashok Rajgopal. “Anatomic tibial component design can increase tibial coverage and rotational alignment accuracy: a comparison of six contemporary designs.” Knee Surgery, Sports Traumatology, Arthroscopy 22, no. 12 (2014): 2911-2923.

About DJO^®

DJO^®is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals.

In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga®, CMF™, Compex®, DonJoy®, ProCare®, DJO Surgical^®, Dr. Comfort^® and Exos^®. For additional information on the Company, please visit www.DJOGlobal.com.

Contacts

DJO
Ashley Brown
Marketing Communications Manager
512.348.9098
ashley.brown@djoglobal.com

Amedica Announces Corporate Name Change to SINTX Technologies, Inc.

Posted On October 31, 2018 By OrthoSpineNews In Biologics, Top Stories /

SALT LAKE CITY, Oct. 31, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, announced that it has changed its corporate name to SINTX Technologies, Inc. in order to better reflect its focus on silicon nitride science and technologies and robust pipeline of silicon nitride based products in various biomedical applications. The company expects to change its trading symbol on the NASDAQ Capital Market to “SINT” in approximately 10 days. In the meantime, shares will continue to trade under the symbol “AMDA.”

“The previous name, i.e., Amedica, has transferred to CTL Medical, which is now CTL-Amedica. Our new corporate brand reflects both our core competence in the science and production of silicon nitride ceramics, as well as encouraging prospects for the future, as an OEM supplier of spine implants to CTL-Amedica, and several opportunities outside of spine,” said Dr. B. Sonny Bal, Chairman and CEO of SINTX Technologies. “As SINTX Technologies, we will focus on developing silicon nitride in terms of product design, and future biomaterial formulations, for a variety of OEM customers.”

SINTX Technologies is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including the spine, dental, oral maxillofacial, podiatry, and arthroplasty markets.

In connection with its name change, the new CUSIP number for the Company’s shares of common stock is 829392109.

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. 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 Sintx’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 Sintx’s other filings with the SEC. SINTX disclaims any obligation to update any forward-looking statements. Sintx 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:
SINTX IR
801-839-3502
IR@SINTX.com

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Life Spine Announces First Clinical Cases of PROLIFT® Post Pack Expandable TLIF/PLIF Spacer System

Posted On October 30, 2018 By OrthoSpineNews In Spine, Top Stories /

October 30, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders today announced the first clinical cases of PROLIFT Post Pack Expandable Interbody System with Dr. Richard Weiner of Dallas, Texas and Dr. Bryan Barnes of Athens, Georgia.

PROLIFT Post Pack allows for in-situ disc height restoration, for minimally invasive PLIF, TLIF and oblique approaches, as well as a systematic method for the introduction of additional graft material in-situ within the device. PROLIFT Post Pack, which incorporates the proprietary surface technology OSSEO-LOC, provides the surgeon the ability to restore normal spinal pelvic parameters with the multiple lordotic options, while continuing to build upon the patented expandable technologies at Life Spine.

“Expandable technology, such as PROLIFT Post Pack, continues the innovation process for challenges associated with complex spine procedures, as well as providing the means to enhance patient outcomes. Restoration of normal spinal alignment, as well as lowering iatrogenic impact to the patient’s anatomy can all be achieved with the technology developed by Life Spine,” noted Richard L. Weiner M.D. of Dallas Neurosurgical and Spine at Texas Institute for Surgery.

Minimally Invasive Surgery (MIS) is one of the fastest growing segments in the spinal implant market. Trends and market research have noted that in 2011 MIS surgical solutions made up 20% of all surgical procedures, and that by the year 2021, this paradigm with have expanded to almost 80%¹. Development of MIS technologies such as the ProLift, and complementary fixation systems such as the AVATAR^® Percutaneous Screw System and CENTERLINE^® Cortical Bone Fixation Systems allow Life Spine to provide surgeons the tools to support these important surgical procedure advancements and trends. In addition, the advancement of MIS access products like CENTRIC^®-T Pedicle-Based Retractor System and CALYPSO^® Midline Retractor System, enhance Life Spine’s goal of offering full MIS procedural solutions.

“One of the cornerstones for successful spinal fusion surgery is providing an environment to enhance the fusion process. Facilitating in-situ delivery of bone grafting material after placement increases the volume within and around the device required for a successful fusion,” noted Bryan B. Barnes, MD of the Georgia Neurological Surgery & Georgia Comprehensive Spine in Athens, Georgia.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

1: 2015 iData Reports

Life Spine is a registered trademark

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

South Denver Surgery Center First to Deploy 7D Surgical’s Machine-Vision Image Guided Surgery (MvIGS) Platform in Colorado

Posted On October 30, 2018 By OrthoSpineNews In Spine, Top Stories /

TORONTO, Oct. 29, 2018 /PRNewswire/ — As providers around the world look for new and innovative ways to improve surgical outcomes and patient safety, the South Denver Surgery Center has taken a leap into the future with the installation of the 7D Surgical System for spinal procedures. This system virtually replaces standard fluoroscopy, providing the surgical team with a fast, accurate and radiation-free tool for the placement of spinal implants.

“7D Surgical’s technology makes perfect sense in the ASC setting where speed, safety, ease of use and cost are critical factors,” said Beau Standish, Chief Executive Officer of 7D Surgical. “We will expand our presence in the ASC market while continuing to build on our hospital based installations.”

The 7D Surgical System is the first and only Machine-Vision Image Guided Surgery (MvIGS) platform. For the first-time, spine surgeons can guide their tools to the critical anatomy using sophisticated camera technology linked to a computer in the operating theater. The underlying technology is similar to what is used in the latest self-driving automobiles. Unlike time-consuming, conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new MvIGS platform can achieve an incredibly fast surgical workflow for spine procedures, reducing operative time for patients.

“We’re excited to be the first to have the new 7D Surgical navigation system in the western United States. We feel this technology offers groundbreaking workflow efficiency to optimize patient outcomes and patient safety,” said Dr. David Vansickle, neurosurgeon with Neurosurgery One.

Dr. J. Adair Prall, also with Neurosurgery One, agrees. “This system puts us right where we want to be in the outpatient environment – fast, accurate, safe and cost-effective. This technology is the future of spine surgery.”

If you are a surgeon or facility administrator and interested in learning more about 7D Surgical, please visit www.7Dsurgical.com or contact our team at 203933@email4pr.com.

About 7D Surgical

7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada approved MvIGS system delivers profound improvement to surgical workflows in spine and cranial surgery. The underlying technology provides the promise of similar future advancements for other surgical specialties.

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
203933@email4pr.com

SOURCE 7D Surgical

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