Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System

Posted On September 28, 2018 By OrthoSpineNews In Regulatory, Top Stories /

REDLANDS, Calif. and AUSTIN, Texas, Sept. 26, 2018 /PRNewswire/ — Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System.

Tesera X is the latest product to utilize Renovis’ proprietary 3D-printed porous architecture, which is made using additively manufactured titanium alloy, and features a low modulus, load-sharing design with a randomized pore structure to mimic cancellous bone. A 550-micron average pore size and 68% porosity combined with micro-surface roughness within the structure makes for an ideal environment for bone ongrowth and ingrowth.

Tesera X completes Renovis’ 3D-printed titanium interbody product portfolio, which also includes implants for ALIF, TLIF, PLIF, ACDF, and standalones. The company is hoping to take advantage of the recent consolidations in the spine market.

For more information on the Tesera porous structure, visit www.teseratrabeculartechnology.com, or visit the company website to learn about our systems for spine, total joint replacement and trauma applications at www.renovis-surgical.com.

About Renovis Surgical

Renovis Surgical Technologies, Inc. was founded in 2009 with the mission to be a leading manufacturer of advanced medical devices, striving to continuously exceed customer expectations in service, quality, reliability, and value. The company is headquartered in Redlands, California, with engineering & manufacturing operations in Austin, Texas.

For additional information on the Company, please visit www.renovis-surgical.com.

Media Contact: sales@renovis-surgical.com, 1 (800) RENOVIS

SOURCE Renovis Surgical Technologies, Inc.

North Carolina Physicians’ Whistleblower Lawsuit Leads to Second Multi-Million-Dollar Recovery in Ground-Breaking Emergency Room Fraud Case

Posted On September 27, 2018 By OrthoSpineNews In Regulatory, Top Stories /

September 27, 2018

CHARLOTTE, N.C.–(BUSINESS WIRE)–The United States Department of Justice and the United States Attorney’s Office for the Western District of North Carolina announced that HEALTH MANAGEMENT ASSOCIATES, INC. (“HMA”), now known as Health Management Associates, LLC, and its parent, will pay over $260 million to resolve false hospital billing and kickback allegations. This settlement includes civil payments by HMA of more than $74 million plus interest to the federal government and participating Medicaid states to settle six whistleblower lawsuits filed under federal and state False Claims Acts (FCAs) related to HMA’s emergency room fraud.

One of these cases, filed by Drs. Thomas Mason and Steven Folstad, and their emergency medicine practice, Mid-Atlantic Emergency Medical Associates, PA (“MEMA”)(“collectively, “the MEMA Relators”), alleges a nationwide scheme by HMA’s corporate, division, and hospital executives to defraud federal and state healthcare programs by submitting false claims related to patients treated in HMA’s emergency rooms. MEMA alleged that HMA’s fraud caused two types of false claims to be submitted. First, HMA caused patients to be admitted from their emergency room without regard for medical necessity. In other words, patients were hospitalized when they did not need to be. Second, when HMA did bill for outpatient emergency room care, they padded the charges by manipulating the acuity points used to justify their billing.

The MEMA Relators also allege that HMA and its affiliates acted in concert with a national emergency physician staffing company, Emergency Medical Services Corporation, Inc. (“EmCare”), and its affiliated entities, to defraud government healthcare programs and retaliate against MEMA for refusing to participate in the HMA and EmCare defendants’ emergency room fraud. The settlement includes false claims HMA submitted for both unnecessary admissions (false inpatient charges) and inflated patient acuity to support upcoded outpatient emergency room charges.

Drs. Mason and Folstad and MEMA have been represented for longer than eight years by Marc S. Raspanti, Pamela Coyle Brecht, and Michael A. Morse of the Pennsylvania law firm, Pietragallo Gordon Alfano Bosick & Raspanti, LLP. They pursued this case on behalf of the MEMA Relators and the American taxpayers with co-counsel, James F. Wyatt, III and Robert Blake of the Charlotte, North Carolina law firm Wyatt & Blake, LLP.

“After 24 years of practicing emergency room medicine at the highest level, it saddens me that we needed to file a federal lawsuit with all the effort that it has taken to stop these fraudulent practices. It is my hope that our efforts over these many years will make a difference for emergency room patients all over the United States,” said Thomas L. Mason, M.D., FACEP, Senior Member –Mid-Atlantic Emergency Medical Associates.

“Our efforts should embolden other emergency medicine practitioners to stand up against corporate pressure to put profits before patient care. Perhaps others will not have to resort to taking the extraordinary measures that our group was forced to do to stop this type of illegal behavior,” said Steven G. Folstad, M.D., FACEP, Senior Member, Mid-Atlantic Emergency Medical Associates.

Marc S. Raspanti, of Pietragallo Gordon Alfano Bosick & Raspanti, LLP, lead counsel said, “It has been a privilege to represent our clients through this long and stressful ordeal. They remain true healthcare professionals who chose to place their patients before corporate pressures. At the end of the day, only sick patients should be hospitalized. Billing for unnecessary hospital stays wastes precious government funds and endangers the viability of the Medicare Trust Fund.”

Pamela Coyle Brecht, a partner with Pietragallo Gordon Alfano Bosick & Raspanti, LLP, who has also represented the MEMA Relators since 2010, added, “As a result of the fortitude of Drs. Mason and Folstad and their practice, and their willingness to stand up for their patients against two national behemoths, unsuspecting emergency room patients are no longer subject to this fraud. The taxpayers – both federal and state – have recovered tens of millions of dollars through the MEMA Relators’ efforts.

“In recognition of the harsh reality that those who stand up against fraud often suffer retaliation and all of its related harm, the federal False Claims Act and the laws of North Carolina provide remedies for persons who, like the MEMA Relators, have been victimized by fraudsters,” said James F. Wyatt, III, the whistleblowers’ Charlotte-based counsel.

The lawsuit is captioned United States et. al. ex rel. Mason, Folstad and MEMA v. Health Management Associates, Inc., et. al., No. 3:10CV472 (W.D.N.C.). The matter is assigned to the Honorable Graham C. Mullen. The plaintiffs’ private causes of action, which are still pending against HMA and EmCare, will be remanded to the U.S. District Court for the Western District of North Carolina for litigation on the Whistleblowers’ private causes of action.

About Pietragallo Gordon Alfano Bosick & Raspanti LLP

Pietragallo Gordon Alfano Bosick & Raspanti, LLP, a litigation and business law firm with a national client base, is one of the largest and most experienced whistleblower law firms in the United States. Lawyers in its nationwide whistleblower practice have served for 30 years as lead counsel in qui tam cases that have recovered over $2 billion for federal and state taxpayers. In addition to its Pittsburgh and Philadelphia offices, the firm has offices in Sharon, Pennsylvania; Steubenville, Ohio; and Weirton, West Virginia. For more information, visit our website at www.PIETRAGALLO.com.

Contacts

Pietragallo Gordon Alfano Bosick & Raspanti, LLP
Pamela Coyle Brecht, Esquire
PCB@Pietragallo.com
or
Marc S. Raspanti, Esquire
MSR@Pietragallo.com
or
Micaela A. Famiglietti
Public Relations Coordinator
MAF@Pietragallo.com
(215) 320-6200

tirbolox-c-titanium-cervical-cage-3D-printed-interbody-12bto-1.jpg

Captiva Spine Adds TirboLOX-C Titanium Cervical Cage to 3D Printed Dual Layer Lattice Structure Offering

Posted On September 26, 2018 By OrthoSpineNews In Spine, Top Stories /

September 20, 2018/by Captiva Spine

Jupiter, FL – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-C 3D Printed Titanium Cervical Cages.

TirboLOX-C Titanium Cervical Cages

TirboLOX-C Titanium Cervical Cages were created following the principles of biomimicry. The titanium alloy interbody fusion devices with a dual layer organic lattice structure are formed using advanced 3D printing technologies. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture. Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony on growth, in growth and vascularization. TirboLOX-C’s open architecture is designed to reduce radiographic presence for clear imaging. TirboLOX-C’s high coefficient of friction creates immediate bidirectional fixation.

Dale Mitchell, President and Founder of Captiva Spine said, “Our design development, incorporating substantial surgeon design input, including dual layer porous 3D printed titanium cages, dates back several years. The timing for commercialization is excellent, as surgeons’ apparent growing preference for porous 3D printed titanium cages is substantial. In addition, the recently announced industry acquisitions, that include 3D cage technology, may limit independent distributors’ access to this critical growth technology. Likewise, we are pleased to make our complete line of TirboLOX 3D printed titanium cages available to support their surgeons’ needs.” Captiva Spine is able to deliver TirboLOX Cervical’s unique dual layer organic lattice structure with numerous geometries and sizes satisfying a wide range of surgeon preferences.

Captiva Spine’s TirboLOX-C Titanium Cervical Cages are one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angeles, September 26-28, 2018.

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

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

About Captiva Spine, Inc.

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

SEE MORE ABOUT TIRBOLOX-C

This Press Release can be found at PRWeb.com

Medtronic Launches the Infinity(TM) OCT Spinal System

Posted On September 25, 2018 By OrthoSpineNews In Spine, Top Stories /

DUBLIN and LOS ANGELES – September 25, 2018 – Medtronic plc (NYSE:MDT) today announced the U.S. launch of the Infinity(TM) Occipitocervical-Upper Thoracic (OCT) System designed to simplify posterior cervical spine surgery. The Infinity OCT System is a complete procedural solution that integrates navigation and biologics with Medtronic’s comprehensive devices and instrumentation to create efficiency in fusion procedure workflows for the upper back and neck. The announcement was made during the North American Spine Society meeting taking place from September 26th – 29th in Los Angeles where Medtronic is exhibiting at Booth #1201.

“For more than 35 years, Medtronic has partnered with leading spine surgeons to advance new technologies with the goal of improving patient outcomes,” said Doug King, senior vice president and president of the Medtronic’s Spine division, which is part of the Restorative Therapies Group. “We engineered every component of the Infinity OCT System to perform efficiently during the most complex spine procedures, as well as to integrate seamlessly with our market-leading imaging and navigation technologies.”

The Infinity OCT System is used to immobilize and stabilize the spine while it fuses. The system features several innovative components – including a multi-axial screw with 60 degrees of angulation in any direction, a set screw (locking cap) with a quick-start thread to minimize cross threading, and 3.0mm and 5.5mm diameter screws for expanded patient demographics and clinical applications. The system has a full spectrum of implant materials and sizes – and when paired with the O-arm(TM) Imaging System and StealthStation(TM) Navigation System – provides a fully-enabled procedural solution designed to bring efficiency and simplicity to even the most complex posterior cervical procedures.

The Infinity OCT System is indicated for certain conditions including degenerative disc disease, instability or deformity, tumors, and traumatic spinal fractures or traumatic dislocations. Spine trauma can sometimes result in a spinal cord injury. September is Spinal Cord Injury Awareness Month and according to the National Spinal Cord Injury Statistical Center, the 2016 annual incidence of spinal cord injuries in the U.S. was approximately 54 cases per million people, or about 17,000 cases per year.¹

“Some of our posterior cervical patients arrive in critical condition and their lives depend on our surgical skills and the performance of the tools we use to treat them,” said Dr. Greg Trost, neurosurgeon at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin. “With Infinity, I can focus on delivering the best patient care during complex procedures knowing that every component was precisely-designed with modularity and versatility in mind. And an integrated procedural solution with Stealth navigation and Infinity was game-changing as a 3D-view of the anatomy allows me the precision to place pedicle screws with confidence and accuracy.”

The Infinity OCT System is now available in the U.S. The system will be released in geographies around the world in 2018 and 2019.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

¹ Grand View Research. Spinal Implants & Devices Market Size, Share & Trends Analysis Report By Product (Fusion Devices, Spinal Biologics), By Technology, By Surgery Type, By Procedure Type, And Segment Forecasts, 2018 – 2024. April 2018. Available at: https://www.grandviewresearch.com/industry-analysis/spinal-implants-spinal-devices-market

Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Biedermann Motech to launch iMAS 360™ procedure at NASS

Posted On September 24, 2018 By OrthoSpineNews In Spine, Top Stories /

Miami, FL – September 24, 2018 / Business Wire / – Biedermann Motech will launch the iMAS 360™ procedure at NASS 2018 in Los Angeles, September 26-28, 2018.

Biedermann Motech, the developer of the world’s first polyaxial pedicle screw (MOSS System) and pioneer in the spinal market for more than 30 years, announced today the launch of the iMAS 360™ procedure at the North American Spine Society (NASS) meeting in Los Angeles, September 26-28, 2018.

The iMAS 360 is a mini-open, microsurgical 360 fusion procedure for the lumbar spine developed by spinal surgeon Robert L. Masson, M.D., Orlando. It incorporates many of the traditional fusion techniques combined with advanced implants and instruments to create a less invasive muscle sparing procedural solution. The key takeaway of the iMAS 360 is the ability to treat any level of the lumbar spine between L2 and S1 with one small posterior midline skin incision.

“iMAS 360 is a lumbar fusion technique that is tissue sparing, has an optimized surgical field, allows for bilateral direct decompression and restoration of lordosis. The MOSS 100™ modular pedicle screw system and the TELIX K™ steerable interbody system have been specifically designed with the iMAS 360 procedure in mind,” says Ray Oktavec, Biedermann Motech’s Director of US Sales & Marketing, Spine.

Robert L. Masson, M.D., said, “The iMAS 360 evolved over time to optimize accuracy, strategy, sequence and ultimately systems. It is an advanced procedural solution integrating technologically sophisticated equipment and techniques focusing on a specific 3D reconstructive plan…”

There will be presentations for surgeons discussing the clinical value of the iMAS 360 procedure at the Biedermann Motech booth # 2435 all three days during NASS with Robert L. Masson, M.D., Tim Keenen, M.D., Syed Aftab, FRCS, and PD Dr. med. Ali Reza Fathi.

More information is available at www.biedermann.com or call 866-622-6082.

About Biedermann Motech

Biedermann Motech is a mid-sized, family owned group of companies with headquarters in Germany (Villingen-Schwenningen) and the USA (Miami). Since 1916 we have been working in synergy with world-class surgeons to solve significant clinical challenges through the development of next-generation technology. Our core competence is the development, production, and distribution of innovative implants and instruments for spinal and extremity surgery. We research, develop, manufacture and distribute high-quality implant systems in collaboration with healthcare professionals, technology partners, scientific institutions and specialized companies with the goal of achieving improved clinical outcomes.

Contact: Serina Prado

305-722-5310 x132

sprado@biedermann.com

Biedermann Motech, Inc – USA

7620 NW 25^th Street, Unit 3 & 4

Miami, FL 33122

Biedermann Motech GmbH & Co. KG
Bertha-von-Suttner-Str. 23
78054 Villingen-Schwenningen

Germany

Medtronic to Acquire Mazor Robotics

Posted On September 21, 2018 By OrthoSpineNews In Financial, Robotics, Top Stories /

DUBLIN and CAESAREA, Israel – September 20, 2018 – Medtronic plc (NYSE:MDT), a global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR, TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today announced the companies have entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50 per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in cash, for a total of approximately $1.64 billion, or $1.34 billion net of Medtronic’s existing stake in Mazor and cash acquired. The boards of directors of both companies have unanimously approved the transaction.

Medtronic’s acquisition of Mazor strengthens Medtronic’s position as a global leader in enabling technologies for spine surgery, and drives Mazor Robotics’ vision to bring its core technology to the forefront of the global market. Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System (Renaissance), are transforming spinal surgery from freehand procedures to accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-leading spine implants, navigation, and intra-operative imaging technology with Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a fully-integrated procedural solution for surgical planning, execution and confirmation. The companies plan to showcase this technology integration at the upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.

“We believe robotic-assisted procedures are the future of spine surgery, enhancing surgeons’ abilities to perform complex procedures with greater precision, consistency and control. Medtronic is committed to accelerating the adoption of robotic-assisted surgery and transforming spine care through procedural solutions that integrate implants, biologics and enabling technologies,” said Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds robotic-assisted guidance systems to our expanding portfolio of enabling technologies, and we intend to further cultivate Mazor’s legacy of innovation in surgical robotics with the site and team in Israel as a base for future growth.”

This transaction builds on a relationship originated in May 2016 under a multi-phased strategic and equity investment agreement between Medtronic and Mazor. In August 2017, Medtronic expanded the partnership to become the exclusive worldwide distributor of the Mazor X system, leading to the successful installation of more than 80 Mazor X systems since launch. With today’s announcement bringing the two companies together, Medtronic aims to accelerate the advancement and adoption of RAS in spine to the benefit of patients, providers, and the healthcare system more broadly.

“Today is a historic day for spine surgery and a defining event in the market’s evolution, and I want to acknowledge and thank all of those whose contribution and faith have been so critical and impactful to our success,” said Ori Hadomi, CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration into Medtronic will maximize our impact globally through Medtronic’s channels, advance our systems’ leadership position in the marketplace, and drive the realization of our vision to heal through innovation.”

Financial Highlights
The acquisition is expected to close during Medtronic’s third fiscal quarter ending January 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders. The transaction is expected to be modestly dilutive to Medtronic’s fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic’s business, the company expects to absorb the dilution.

Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital (ROIC) by year four, with an increasing contribution thereafter.

Medtronic’s financial advisors for the transaction are Perella Weinberg Partners LP and Goldman Sachs & Co. LLC, with Meitar Liquornik Geva Leshem Tal and Ropes & Gray LLP acting as legal advisors. Mazor’s financial advisor is J.P. Morgan Securities LLC, Duff & Phelps LLC, with Kirkland & Ellis LLP and Luchtenstein Levy Wiseman Law office acting as legal advisor.

About Mazor Robotics
Mazor, founded in 2001, pioneered the application of robotics technology and guidance for use during spinal procedures, and is the market segment’s leader. In 2011, the Company introduced the Renaissance system and in 2016 launched the next generation Mazor X system. To date, more than 200 Mazor systems are in clinical use on four continents and have guided the placement of more than 250,000 implants during some 40,000 procedures, enabling minimally-invasive spine surgery to become standard procedure in many hospitals. Mazor’s core technology has received more than 15 U.S. Food and Drug Administration clearances and has been the subject of more than 60 publications, leading the spine robotics market on the evidence front. Mazor is the holder of more than fifty patents worldwide.

Any forward-looking statements, including, but not limited to, statements regarding the proposed transaction between Medtronic and Mazor, the expected timetable for completing the transaction, strategic and other potential benefits of the transaction, including meeting Medtronic’s long-term financial metrics for acquisitions, Mazor’s products and product candidates, and other statements about Medtronic or Mazor managements’ future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability and timing to satisfy conditions to closing including shareholder and regulatory approvals, the impact of the announcement of the transaction on the business, and other risks and uncertainties such as those described in Medtronic’s and Mazor’s reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic and Mazor caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic and Mazor undertake no obligation to update or revise any of these statements except to the extent required by law.

ADDITIONAL INFORMATION

In connection with the proposed transaction, Mazor intends to mail a proxy statement to its shareholders and furnish a copy of the proxy statement with the SEC on Form 6-K. Shareholders of Mazor are urged to read the proxy statement and the other relevant material when they become available because they will contain important information about Mazor, Medtronic, the proposed transaction and related matters. Shareholders are urged to carefully read the proxy statement and other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. The proxy statement (when available) may be obtained for free at the SEC’s website at www.sec.gov. In addition, the proxy statement will be available, without charge, at Mazor’s website at www.mazorrobotics.com.

-end-

Medtronic Contacts:
David T. Young
Public Relations
+1-774-284-2746

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Mazor Contacts:
Eran Gabay – Gelbart Kahana
Israel Public Relations
+972-54-246378

Michael Polyviou – EVC Group
U.S. Public Relations
+1-732-232-6914

b-ONE Ortho Receives U.S. FDA 510(k) Clearance for Total Hip System

Posted On September 21, 2018 By OrthoSpineNews In Recon, Regulatory, Top Stories /

September 21, 2018

CEDAR KNOLLS, N.J.–(BUSINESS WIRE)–b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative healthcare solutions, today announced it has received 510(k) clearance for its first device, the b-ONE^TM Total Hip System, from the U.S. Food and Drug Administration (FDA).

The b-ONE^TM Total Hip System is a cementless total hip system with advanced coating technology and intuitive instrumentation, designed to optimize patient fit in the modern patient demographic. The system comprises the Juveno^TMFemoral Hip, a bone-conserving femoral prosthesis, and the b-ONE Primary Acetabular System, which are compatible with b-ONE^TM 12/14 Taper Femoral Heads.

“This milestone for the company will officially introduce b-ONE’s product line to the U.S. market,” said Dr. Mark Kester, the Chief Scientific Officer. “With our first U.S. surgery quickly approaching, we are eager to provide surgeons with a versatile system designed to accommodate the majority of today’s expanding patient demographic. In addition, with the support of Dr. Richard Rothman, a prolific designer and developer in the orthopedic industry, our strong R&D team will continue the development and expansion of our product portfolio with a focus on quality, affordability and speed to market.”

The b-ONE^TMTotal Hip System will have a limited launch in the first half of 2019, followed by a full commercial release in the second half of 2019.

This news follows b-ONE Ortho Corp.’s recent US$20 million Series A financing led by Eight Roads Ventures and F-Prime Capital Partners. Proceeds are being used to fund the growth of b-ONE Ortho Corp.’s product portfolio and expansion into international markets.

About b-ONE Ortho Corp.

Based in Cedar Knolls, New Jersey, b-ONE Ortho Corp. is an emerging orthopedic technology company dedicated to the development of innovative orthopedic healthcare solutions that restore patient mobility and improve surgical outcomes. Every day we are committed to becoming the most credible choice for orthopedic products worldwide.
www.b1.co

About Eight Roads

Eight Roads Ventures is a global venture capital firm that backs entrepreneurs with aspirations for greatness. As the proprietary investment arm of Fidelity International Limited, Eight Roads is committed to building bold and meaningful businesses and together with its associated funds has invested almost US$6bn globally into growing companies in the past 10 years.

Eight Roads Ventures has led successful investments in China and across the world, including Wuxi PharmaTech, Hile, Innovent, Adagene, Hua Medicine, DeltaHealth, Denali, doctorlink, Laurus Labs, Alibaba, China PnR, AsiaInfo, iSoftStone, Wisers, GShopper, Rulai and PingPong. It launched a dedicated US$250m China Healthcare Fund in September 2017.
www.eightroads.com

About F-Prime Capital

F-Prime Capital Partners is a global venture capital firm investing in life sciences, healthcare, and technology. Since 1969, F-Prime has worked closely with entrepreneurs and academics to create innovative solutions to some of the world’s most significant challenges in healthcare and technology.
www.fprimecapital.com

Caution Concerning Forward-looking Statements

This press release may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding the Corporation’s expectations for future events. Such statements are based on currently available information and current expectations. If these assumptions prove incorrect or inaccurate, or known or unknown risks occur, actual results could differ materially from the expectations and projections of b-ONE^TMOrtho Corp. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

Contacts

For press enquiries, please contact:
b-ONE Ortho Corp.
Corinne Zappacosta
+1 (917) 733-8088
CZappacosta@b1.co
Related Links
www.b1.co

Meditech Spine Receives FDA Clearance for its Cure™ Opel-C Plating System

Posted On September 18, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, Sept. 18, 2018 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the Cure™ Opel-C Plate System, an add-on technology to its already cleared CURE™ ACP System and Talos®-C (HA) Interbody Systems. With this approval, Meditech will now offer two additional CURE™ ACP plating options with its Talos® line of cervical interbodies made with the osteoconductive PEEK-OPTIMA® HA Enhanced material. Since Meditech’s introduction of the CURE™ ACP System in late 2016, its adoption and usage have seen double-digit growth. By adding the Opel™-C plating options to the CURE™ ACP product line, surgeons now have two modular snap-on plate styles providing rigid fixation while minimizing adjacent level impact. The Cure™ Opel-C Plate System incorporates the same unique, patented, one-step locking mechanism of the CURE™ ACP System preventing screws from backing out when anchored in the vertebral body. Meditech will be demonstrating the newly approved system at the North American Spine Society (NASS) meeting held in Los Angeles, CA from September 26-28 along with its proprietary Talos® HA Peek Interbody Systems in booth 1757.

Meditech is excited to continue its relationship with CURE International, the namesake of the CURE™ ACP, an organization serving children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate helps CURE International treat patients in need of surgical care.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a growing spinal implant company that partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best technologies available. Meditech’s belief in the spinal marketplace is to value and honor their partners and all who are touched by their interactions in the development and distribution process so that each experience leaves a positive impact upon those they serve.

CONTACT

Meditech Spine, LLC
(678) 974-5287
support@meditechspine.com

Caption & Copyright:

SOURCE Meditech Spine, LLC

Photo: (PRNewsfoto/Meditech Spine, LLC)

SpineVision® Receives CE Mark for Next-Gen P.L.U.S.® Deformity-Correction Spinal System

Posted On September 18, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received CE mark for its next-generation Pivot Link Universal System (P.L.U.S.) spine deformity-correction system. SpineVision will introduce the next-generation P.L.U.S. to spine surgeons at “EuroSpine 2018” (Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29).

Deformity of the spine includes any abnormality of the formation, alignment, or shape of the vertebral column. Diagnoses that are associated with spine deformity include scoliosis, spina bifida, Becker and Duchenne muscular dystrophy, kyphosis, and spondylolisthesis, among others. Spine stabilization surgery is recommended in cases where there is severe pain, neurological problems, or curvature greater than 50 degrees. The goal of surgery is to straighten and hold the spine straight. Several surgical techniques can be used, including spinal fusion and the use of implants such as the P.L.U.S. to secure the fusion.

“The introduction of our Pivot Link Universal System (P.L.U.S.) extends our successful track record of commercializing cutting-edge products encompassing all spine pathologies,” said Arnaud Brisard, CEO of SpineVision. “We believe that this next generation of an already successful product will be enthusiastically embraced by orthopedic surgeons, because the P.L.U.S. is designed to make every step of spine deformity surgery more facile for the orthopedic surgeon—especially correction maneuvers before final locking.”

CLICK HERE FOR THE COMPLETE VERSION OF THIS NEWS RELEASE.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1 508-816-6730
rtrahan@ronaldtrahan.com

SpineVision® Receives FDA Clearance and CE Mark for Next-Gen Titanium 3D-Printed HEXANIUM TLIF Cage

Posted On September 17, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

September 17, 2018

ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received FDA clearance and CE mark for its next-generation titanium 3D laser-printed HEXANIUM TLIF (Transforaminal Lumbar Interbody Fusion) cage for back surgery. SpineVision will introduce its new product to spine surgeons at “EuroSpine 2018”(Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29).

Spine fusion surgery is often necessary to stop the motion of a painful segment in the spine by fusing two vertebrae with a TLIF cage. Conditions that may be treated with a spine fusion include tumors, spinal stenosis, herniated discs, and degenerative disc disease. The HEXANIUM TLIF cage combines a roughened titanium surface designed for fast osseointegration along with a honeycomb-like structure that features large windows for maximizing bone in-growth and on-growth from endplate to endplate.

“While TLIF back surgery is successful at relieving patients’ pain in about 60 to 70 percent of cases, there is room for improvement,” said Arnaud Brisard, CEO of SpineVision. “In particular, our HEXANIUM TLIF cage is designed to reduce the risk of subsidence in disc height in the post-operative period. HEXANIUM represents a continuation of our substantial achievements in developing cutting-edge products for all spine pathologies. HEXANIUM TLIF is the first of a complete range of 3D-printed implants SpineVision will be introducing.”

“Hexanium TLIF is an advance for spine fusion surgery,” said Neurosurgeon Gary P. Colon, M.D., NCH Healthcare System, Naples, Fla. (Click here for an interview with Dr. Colon.) “I am able now to deploy the TLIF cage exactly where my intent is when I start the approach. And that’s been a big move forward compared to prior products that I used.”

Click here for the complete news release.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1 508-816-6730
rtrahan@ronaldtrahan.com