SHELTON, Conn., Sept. 17, 2018 (GLOBE NEWSWIRE) — Spine Wave is pleased to announce the commercial launch of the Paramount® Anterior Cervical Cage.  The Paramount® Anterior Cervical Cage is a titanium anterior cervical implant with integrated fixation blades.  The patented system offers controlled, less invasive blade deployment and maximized bone grafting.  The Paramount® Anterior Cervical Cage performed very well during its limited market release and is now fully launched and available, effective immediately.  The Paramount® Anterior Cervical Cage is Spine Wave’s second new cervical spine product since 2017 and its seventh major new product launch since 2016.

The Paramount® Anterior Cervical Cage is a titanium implant with a roughened endplate surface and integrated fixation blades.  The fixation blades deploy toward and behind the anterior vertebral cortex and away from the spinal cord using a unique threaded deployment mechanism.  Used in conjunction with the novel scoring trial, this mechanism gently positions the fixation blades in a controlled manner without force or impaction.  This unique design is less invasive because it does not require the exposure necessary to implant non-integrated blades or screws at challenging angles and trajectories.  Surgeons using the device can also completely fill the disc space with bone graft, endplate to endplate regardless of endplate anatomy, because of its innovative open face implant design and modular graft cap.  The Paramount® Anterior Cervical Cage was co-invented by Sandeep Kunwar, M.D., Medical Director, Bell Neuroscience Institute, Clinical Professor, UCSF Department of Neurological Surgery, San Francisco, California, and Bradley Jones, M.D., Director of the Joint and Spine Center, Dignity Health Medical Center, Redding, California.

“The Paramount® Anterior Cervical Cage is a novel and less invasive solution for anterior cervical interbody fusion,” said Dr. Kunwar. “The unique integrated blade design and in-line implant insertion approach make difficult cases safer and easier in my hands.  The procedure can be performed through a smaller insertion window without a struggle to accommodate challenging screw or blade insertion angles.”  Dr. Jones continued, “one major goal of our design effort was to eliminate forceful blade impaction from this procedure, and Spine Wave’s engineers did a phenomenal job delivering on that objective.  I am very pleased with the finished product.”

The Paramount® Anterior Cervical Cage is the latest example of creative surgeons partnering with our R&D team to develop and deliver a technology that is not only truly differentiated, but also addresses real surgical challenges,” said Spine Wave CEO, Mark LoGuidice. “Prior to 2018, Spine Wave had very little presence in the cervical market segment with the bulk of our revenues being generated by expandable and other MIS technologies designed for the lumbar spine. This launch of the Paramount® system, when combined with the recently launched Proficient® Posterior Cervical Spine System, provides the company with a very strong cervical portfolio and positions us as a full line company to both hospitals and distributors.”

About Spine Wave
Spine Wave is a leader in expandable fusion technologies and is committed to continually delivering highly differentiated products to enable improved and less invasive solutions for spine surgeons and their patients. In addition to the Paramount® Anterior Cervical Cage, Spine Wave also offers many highly differentiated spine technologies, including a full portfolio of expandable devices marketed under the StaXx®, Velocity® and Leva® brand names.  These expandable technologies comprise various materials, including PEEK, Titanium (and the combination of the two) that can be utilized in posterior, anterior and lateral surgical approaches.  Additionally, Spine Wave has a full suite of less invasive products including our two newest lines, the Proficient® Posterior Cervical Spine System and the GraftMag® Graft Delivery System.  The company is expanding rapidly and continues to recruit sales managers and independent distributors to fuel growth.  For more information on Spine Wave and its products, please visit www.spinewave.com.

Contact
Terry Brennan, Chief Financial Officer
tbrennan@spinewave.com
(203) 712-1810

SUNNYVALE, Calif., Sept. 17, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, announced today that an abstract for preliminary data from the Company’s 1-level Investigational Device Exemption (IDE) clinical trial has been selected as an Innovative Technology Presentation during the 2018 North American Spine Society (NASS) Annual Meeting, being held September 26-29 in Los Angeles, Calif.  Richard Guyer, M.D., Co-Principal Investigator for the study, will present the data at the session, and it will also be featured in a poster presentation.

David Hovda, CEO of Simplify Medical, commented, “We look forward to sharing initial results from a key site of our multi-center, prospective pivotal U.S. trial evaluating the Simplify Disc at one-level, for which we completed enrollment in February of this year. Our PEEK on ceramic Simplify Disc is engineered for durability, enhanced imaging with MRI, and with lower height options to better match patient anatomies.  We are encouraged by our early data. If FDA-approved, we believe the Simplify Disc will offer patients and physicians in the U.S. a meaningful alternative to cervical fusion surgery and other currently available discs.”

Details of the oral presentation follow:

Simplify Medical: Clinical Outcomes of the PEEK-on-Ceramic Simplify Disc: Preliminary Data from One Site Participating in the Single-Level Cervical FDA IDE Trial

In addition, during NASS, the Simplify Cervical Artificial Disc will be awarded as a winner in the 10^th Annual 2018 Spine Technology Awards, presented by RRY Publications and Orthopedics This Week. The Spine Technology Awards recognize the best new spine technologies, engineering teams and inventors for 2018 and, in the process, reward excellence in innovation.

To learn more about the Simplify Disc at one and two-levels, please visit Simplify Medical at Booth # 1911 in the Exhibit Hall.

About Simplify Disc
Simplify Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify™ Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

The Acquired Technology Will Complement Johnson & Johnson Medical Devices Companies’ Advanced Portfolio of Interbody Implants For Both Minimally Invasive and Open Spinal Fusion Surgery

NORDERSTEDT, Germany, Sept. 12, 2018 /PRNewswire/ — Johnson & Johnson Medical Devices Companies*, through its subsidiary Johnson & Johnson Medical GmbH, announced today the acquisition of Emerging Implant Technologies GmbH (EIT), a privately held manufacturer of 3D-printed titanium interbody implants for spinal fusion surgery, based in Wurmlingen, Germany. The products in this portfolio leverage EIT’s proprietary advanced cellular titanium, which consists of an open and interconnected porous structure designed to allow bone to grow into the implant. As an industry leader across the full range of orthopaedic and spine specialties, Johnson & Johnson Medical Devices Companies will leverage its global commercial infrastructure to bring EIT’s technologies to patients around the world.

This acquisition allows DePuy Synthes, the orthopaedics business of Johnson & Johnson, to enhance its comprehensive interbody implant portfolio that includes expandable interbody devices, titanium integrated PEEK technology and now 3D-printed cellular titanium, for both minimally invasive and open spinal surgery. The EIT technology complements DePuy Synthes’ investment in the interbody implant segment in spine, including the recent introductions of the CONCORDE LIFT Expandable Interbody Device, and in the U.S., the PROTI 360°™ Family of Titanium-Integrated Interbody Implants, designed to treat patients with degenerative disc disease.

“Our goal is to offer a complete portfolio of interbody solutions that provides surgeons with even more options for the treatment of their patients,” said Aldo Denti, Company Group Chairman of DePuy Synthes. “We are excited to welcome the skilled team at EIT, and together, we aspire to bring to market technologies that allow surgeons to perform spinal fusion procedures reliably and with consistent outcomes.”

This acquisition underscores the companies’ commitment to building an innovative portfolio of spine solutions to improve the standard of care for patients. Moving forward, DePuy Synthes will continue to focus on the spinal disease states with the most potential for surgeons and their patients – degenerative disc disease, deformity and complex cervical – and introduce technologies in the fastest-growing segments within these disease states; specifically, interbody implants, enabling technologies, minimally invasive spine (MIS), and biomaterials.

Financial terms of the transaction will not be disclosed.

About DePuy SynthesDePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

About the Johnson & Johnson Medical Devices CompaniesAs the world’s most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of healthcare. With unparalleled breadth, depth and reach in surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. Learn more about our latest innovations by visiting: https://www.jnjmedicaldevices.com.

Cautions Concerning Forward-Looking StatementsThis press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of EIT. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Medical GmbH, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the acquisition may not be realized or may take longer to realize than expected; challenges inherent in product research and development, especially at an early stage of the development program, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; competition, including technological advances, new products and patents attained by competitors; challenges to patents; and changes to applicable laws and regulations, including tax laws and global health care reforms. In addition, there are risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the technology, products, operations and employees of EIT, as well as the ability to ensure continued development, performance or market growth of EIT products. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.

*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, cardiovascular and specialty solutions businesses within Johnson & Johnson’s Medical Devices segment.

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SOURCE Johnson & Johnson Medical Devices Companies

Copyright (C) 2018 PR Newswire. All rights reserved

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

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

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

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

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

CONTACT:

Amy Scott

VP Marketing & Education

Vertos Medical

(949) 349-0008

SOURCE Vertos Medical

Related Links

http://www.vertosmed.com

CARMEL, IND. (PRWEB) SEPTEMBER 11, 2018

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

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

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

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

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

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

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

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

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

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

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