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

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

Medicrea to Attend the 9th Annual Craig-Hallum Alpha Select Conference

November 05, 2018

LYON & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572-ALMED ; OTCQX Best Market – MRNTY & MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, announced today that the company will host one-on-one investor meetings during the 9th Annual Craig-Hallum Alpha Select Conference at the Sheraton New York Times Square Hotel on Thursday, November 15, 2018.

For more information on the conference or to schedule a one-on-one meeting, please contact your Craig-Hallum representative.

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 200 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D- printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Medicrea is traded on
OTCQX Best Market
Tickers: MRNTY & MRNTF

Contacts

Medicrea
Denys SOURNAC
Founder, Chairman and CEO
dsournac@medicrea.com
Fabrice KILFIGER
Chief Financial Officer
fkilfiger@medicrea.com
Tel: +33 (0)4 72 01 87 87

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

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)

Innovasive™ Granted FDA Clearance for DualX™ Expanding Interbody Spinal Device

Innovasive, a privately-held spinal device company, focuses on developing and commercializing minimally-invasive, innovative spinal technologies. Today, Innovasive announced that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their DualX technology, a titanium, dual expanding, interbody device for spinal fusion procedures in the lumbar spine.

“DualX is a unique expandable interbody that expands in two independent directions,” explained Andy Choi, Chief Executive Officer, Innovasive, Inc. “First, it expands laterally to provide a wide base for stability and spinal support. DualX then expands vertically with lordosis to aide in the restoration of sagittal alignment of the lumbar spine.”

The DualX technology is comprised of a family of titanium expandable interbody devices designed to be used in transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF) and lateral lumbar interbody fusion (LLIF) spinal procedures. The product portfolio contains varying footprints, heights and degrees of lordosis with post-expansion bone grafting to provide a customized anatomical fit for a clinically successful fusion environment.

“The ability of DualX to provide expansion in two planes is essential for achieving a successful surgical outcome. DualX accomplishes the goals of creating a biomechanically stable environment for spinal fusion, as well as supporting normal sagittal and coronal alignment; both of which are essential factors for restoring optimal spinal balance. These critical factors will help spine surgeons achieve the primary goals of performing surgeries that lead to successful, minimally invasive spinal fusion procedures.” said, Jeffrey Roh, MD, MBA, MSc, Director of Minimally Invasive Spine Surgery at the Swedish Neuroscience Institute in Seattle, WA.

“We are excited to receive FDA clearance and look forward to a successful product launch in the near future,” said Mr. Choi. DualX will be available for implantation in spinal fusion procedures before the end of this year.

About Innovasive 

Innovasive, Inc. is a privately-held spinal device company located in Mission Viejo, CA. The Company focuses on developing and commercializing innovative, minimally-invasive technologies for spine surgery. Innovasive is a portfolio company of IntuitiveX, a life science innovation incubator.

Alphatec Announces Participation at Stifel 2018 Healthcare Conference

CARLSBAD, Calif., Oct. 31, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced it will present at the Stifel 2018 Healthcare Conference on November 14, 2018, at 2:00 P.M. EST at the Lotte New York Palace Hotel.

Terry Rich, ATEC’s President and Chief Operating Officer, will provide a business overview of the during the live presentation. Management will also be available to participate in one-on-one meetings with investors who are registered to attend the conference.

A copy of the presentation will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com. The conference will be webcast live. To access the webcast, please visit http://wsw.com/webcast/stifel14/atec/. The webcast replay will remain available for 90 days following the live presentation.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.atecspine.com

Forward-Looking Statements

Statements made in this press release and made during the investor events referenced herein may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the ATEC brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the OrthoTec, LLC settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. ATEC disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:

Tina Jacobsen
ir@atecspine.com
(760) 494-6790

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
ir@atecspine.com

EOS imaging Announces Installations of First EOS® Systems in Spain and Portugal

October 30, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), a pioneer in 2D/3D orthopedic medical imaging, today announced the first two installations in Barcelona at Clavel’s Instituto, a spine center of Hospital Quiron, and the HM Delfos Hospital. In addition, the first installation in Portugal is planned in Lisbon by the end of the year. All three facilities are part of private hospital groups.

“We are delighted with these first installations in two of the best private spine surgery centers in Spain as well as the upcoming installation in Portugal. Our solutions, already widely adopted within academic hospitals in Europe and around the world, are increasingly becoming valued by private orthopedic centers and private hospitals. We are happy and proud to see our technology accessible to more patients, as a large traction of osteoarticular care and orthopedic surgeries are taking place outside of academic hospital settings,” concluded Marie Meynadier, Chief Executive Officer of EOS imaging.

ABOUT EOS IMAGING

EOS imaging is listed on Compartment C of Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 33 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 280 installed EOS® platforms representing more than one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017. For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com
or
Press Relations (US)
Kirsten Thomas
The Ruth Group Ph: 508-280-6592
kthomas@theruthgroup.com

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

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

TORONTOOct. 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

Related Links

http://www.7Dsurgical.com

Camber Spine Announces Hitting $1M Milestone With SPIRA™-C In Less Than 6 Months

Aurora Spine Announces European Patent Related To ZIP Minimally Invasive Spinal Implant

CARLSBAD, Calif., Oct. 25, 2018 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSXV:ASG) (“Aurora Spine” or the “Company”) announced today the grant by the European Patent Office (the “EPO”) of Aurora’s first European patent related to the ZIP®, minimally invasive spinal implant. The patent is titled “Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation System”, and covers Aurora’s family of ZIP® interspinous devices, including its ZIP Ultra®, ZIP 51™, ZIP LP™ and Dyna-ZIP™ among others.  The EPO has reported that no oppositions have been filed against the European patent.

“The recent European ZIP® Interspinous patent allowance is another milestone in Aurora Spine’s history. This newly issued patent features our patented ONE-STEP™ locking mechanism that eliminates the use of a set screw in Aurora’s Screwless Procedure™ surgeries,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine and Co-Inventor of the ZIP. “The ZIP technology provides Aurora Spine with opportunities to market, license and develop its products and screwless, minimally invasive implant technology further. We are very proud of the progress that we have made over the past couple of years in spinal surgery and the remarkable value that Aurora Spine`s intellectual property has added to our company`s growth.”

“Aurora is changing spine surgery, and we are thrilled that our newest patent has been issued by the EPO. This patent further validates the modern advancements of our Screwless technology and it maintains our commitment to introduce advanced minimally invasive spine surgery technologies,” said Trent Northcutt, President and CEO of Aurora Spine.

This is Aurora Spine’s first European patent. Aurora Spine has several U.S. and international patent applications pending directed to the ZIP system and its future technologies.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies.  Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the Offering and the proposed use of proceeds of the Offering. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

For more information, please contact:

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com