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Artoss Announces Completion of $1 Million Funding Round

Posted On July 13, 2018 By OrthoSpineNews In Financial /  1

Press Release – July 13, 2018

Artoss, Inc. is pleased to announce the successful completion of its recent funding round of Unsecured Convertible Notes. The round, which began in 2017 with a target of raising $500,000, was oversubscribed to twice that amount or a total of $1 million.

James J. Cassidy, Ph.D., Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone® Bone Graft in orthopaedic surgery, said, “We have been overwhelmed by the interest shown in our second round of angel funding. We are especially grateful to those investors who participated in our 2016 funding round and chose to increase their investment in this round as well as to our new investors for their support of Artoss.”

Paul Byerley, Managing Director of Artoss, Inc. said, “We are very pleased with our commercial success to-date and appreciate the support of our investors. Surgeon feedback on the clinical performance of NanoBone SBX Putty and QD remains extremely positive. We look forward to expanding our distribution network to put our superior bone grafting solution in the hands of more surgeons.”

Artoss, Inc. is using the proceeds of this funding to support the development of additional NanoBone Bone Graft products for the US market, for costs associated with regulatory requirements, and for commercialization activities.

 

For further information, please contact:

Artoss, Inc.

425 E Saint Germain St., Suite 106

Saint Cloud, MN 56304-0752

320-259-4321

info@artossinc.com

 

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Power T Handle Announces Completion of First Spinal Surgery Procedures Performed With Innovative Power Device

Posted On July 13, 2018 By OrthoSpineNews In Spine /  

WILMINGTON, NC (PRWEB) JULY 12, 2018

Power T Handle, LLC, a surgeon-driven, innovative company, announced today the successful completion of the first spinal surgical cases using the Power T Handle, an instrument designed to merge power and tactile feel in spinal and other surgical procedures.

The Power T Handle is the first surgical power solution that seamlessly integrates power while preserving the manual capabilities of traditional T-handles that attach to orthopedic instruments, such as screw taps and screwdrivers. This revolutionary, cordless device is the first of its kind that transforms from a manual handle to a low-speed, high-torque power driver with the press of a button. The low profile and sleek design preserves the tactile feel of traditional T-handles and is compatible with existing 1/4” square attachment instruments. This low-cost, single-use device is provided in a sterile package for immediate use.

The Power T Handle overcomes the limitations of pre-existing power tools by eliminating cumbersome surgical drills, custom instrument attachments, and power cords. This device is also cost efficient, as there is no investment in capital equipment, no reprocessing, no maintenance costs and no batteries to recharge.

Andrew Rhea, MD, Florence Neurosurgery and Spine Center, Florence, SC performed the first procedures with the Power T Handle. “I decided to use the Power T Handle in these spinal fusion procedures to allow for easier and quicker insertion of the tap and pedicle screws without loss of tactile feedback,” stated Dr. Rhea. “The Power T Handle fits my existing surgical technique. It is simple to attach, increased my surgical efficiency, and provided the natural feel of using a traditional T-handle. It also fit well in the surgical field without having to move the C-Arm or struggle with a power cable.”

Kevin Cahill, MD, PhD, President of Power T Handle LLC, said of the device, “We developed the Power T Handle to offer surgeons a better power tool. This device truly delivers power without compromise.” Dr. Cahill continued, “The Power T Handle solves many of the challenges facing surgeons and the surgical team today trying to incorporate power technologies. It offers an easy to attach and use device that increases OR efficiencies, reduces surgeon fatigue and preserves the tactile feedback of traditional instrumentation. We are eager to see what the future holds for the Power T Handle as we continue to evolve and provide better power solutions for surgeons.”

About Power T Handle, LLC 
The Power T Handle LLC was founded by Dr Cahill and a team of experienced medical device engineers with the goal of developing better power solutions for surgeons. The Power T Handle was designed to overcome the substantial limitations of existing surgical power instruments. The Power T Handle provides surgeons with the power, precision, and feedback necessary to perform surgery without the fatigue, hassle and cost of traditional instrumentation.

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New Biomechanical Study Finds Acutrak® Headless Compression Screw Potentially Favorable for Medial Malleolus Fractures

Posted On July 13, 2018 By OrthoSpineNews In Extremities /  

PORTLAND, ORE. (PRWEB) JULY 12, 2018

A recent study published in the Journal of Clinical Biomechanics examined a comparison of Acutrak 2®–4.7 mm fully threaded headless compression screws and 4.0 mm partially threaded cancellous screws and found Acutrak was the potentially favorable option for the fixation of medial malleolus fractures.

The investigator-initiated biomechanical study was led by Robin Z. Cheng of the University of California Davis Medical Center. Additional contributors were from UC Davis and the Stanford University School of Medicine. The work was funded in part by Acumed.

The study utilized 18 synthetic tibiae, each cut 18 cm from the tibial plafond, to simulate medial malleolar fractures. Each tibia was then randomly assigned fixation with either two Synthes parallel, partially threaded, unicortical 4.0 mm cancellous screws or two parallel, fully threaded Acutrak 2–4.7 mm headless compression screws, with nine tibiae in each group. To simulate tensile force on the fracture fragment, a single steel slotted spring pin was inserted through the fragment and attached to a steel cable hooked to a test machine actuator. Force was applied with an initial 50N then pulled at a rate of 10 mm per minute. Distal and lateral movement was measured to failure via spherical markers placed on the anterior portion of the medial malleolus and monitored with a CCD camera. Clinical failure was defined as 2 mm of intrarticular fragment displacement, with construct stiffness measured in both distal and lateral directions.

All tests resulted in both distal and lateral displacement of the medial malleolar fragment. Construct stiffness results for Acutrak 2–4.7 mm screws were significantly greater than the 4.0 mm cancellous screws, with mean stiffness results at:

Proximal–Distal:
4.0 mm Cancellous Screws: 668 N/mm
Acutrak 2–4.7 mm Screws: 1,699 N/mm

Medial–Lateral:
4.0 mm Cancellous Screws: 281 N/mm
Acutrak 2–4.7 mm Screws: 604 N/mm

It is important to note that synthetic tibiae were used in this study rather than cadaveric bone. The Acutrak 2 screws, however, were noted by the authors as having a larger diameter than the 4.0 mm screws, which would engage more bone and potentially result in lower bone and screw stress.

Additionally, artificially simulated axial loading in a single loading mode was observed in this study as a means to demonstrate the force exerted by the deltoid ligament on the medial malleolus without taking other soft tissue structures into account. And the tensile stress was modeled as a singular force, rather than cyclical loading, which would model stress over time.

Key findings of the Cheng et al study were in favor of using Acutrak 2–4.7 mm screws in medial malleolar fractures:

“When subjected to a single load to failure, the headless compression screw construct provides over two times greater stiffness in both the proximal-distal and medial-lateral directions. Additionally, the headless compression screw construct sustains higher forces prior [to] reaching 2 mm lateral displacement, with 2 mm of displacement defined as clinical failure.”1

“…our findings suggest that a headless compression screw construct provides a stiffer construct than a parallel unicortical cancellous screw construct. The headless compression construct sustains higher load prior to reaching clinical failure in the lateral direction.”1

“The increased resistance to both axial and shear loading, greater interfragmentary compression, and low-profile design of the Acutrak 2 headless compression screw may decrease the rate of clinical failure and reduce the need for revision surgeries, thus being a potentially improved option for fixation of horizontal medial malleolus fractures.”1

About Acumed 

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With 30 years of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. Acumed was founded in 1988 by Randy and Mary Huebner and became a member of the Colson Associates group of companies in 1999. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported worldwide.

1. Cheng RZ, Wegner AM, Behn AW, Amanatullah DF. Headless compression screw for horizontal medial malleolus fractures. Clin Biomech. 2018;55:1–6.

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WishBone Medical, Inc. announces Sanford S. Kunkel, M.D. joins Board of Advisors

Posted On July 12, 2018 By OrthoSpineNews In Extremities, Sports Medicine /  

WARSAW, Ind., July 12, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc. is pleased to announce that Sanford Kunkel, M.D. joins the WishBone Medical Board of Advisors. Dr. Kunkel has been a Consulting Surgeon for WishBone Medical helping to develop several new products and will continue in this role.  As a member of the Board of Advisors, he will be a part of an elite group of business people from around the World to provide strategic expertise and guidance for WishBone Medical. He is considered an expert in his field and was a team physician for the Indiana Pacers, Indiana Fever, USA Basketball, Depauw University and Brebeuf Jesuit Preparatory school.

He has been a practicing physician at OrthoIndy for over 30 years. OrthoIndy is one of the largest orthopedic practices in the world.  Dr. Kunkel consults for several healthcare companies and has developed several successful products.

Dr. Kunkel earned his Bachelor’s Degree from Indiana University and his Medical Degree from the Indiana University School of Medicine. He did his Internship at St. Mary’s Hospital in Grand Rapids, MI. and his Residency at Grand Rapids Orthopedic Surgery and Blodgett Memorial Medical Center. His fellowship was in Sports Medicine at the University of Toronto and at the University of Western Ontario in London, Ontario. He is certified by the American Board of Orthopaedics.

Nick Deeter, Chairman of the Board and CEO at WishBone Medical, said, “Dr. Kunkel brings his surgeon skills and entrepreneurial background to the WishBone Medical Board of Advisors. We look forward to working with Dr. Kunkel to not only develop successful pediatric products but also to help strategically guide WishBone Medical. Mr. Deeter added, “With his extensive background and experience, he will contribute to our mission of helping children globally with orthopedic issues.”

About WishBone Medical, Inc.

WishBone Medical is a Global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing.

For further information, visit www.WishBoneMedical.com or call Andrew Miclot, Vice-Chairman and President at 574-306-4006.

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SPINEWAY: Revenue for the first half of 2018

Posted On July 12, 2018 By OrthoSpineNews In Financial /  

Ecully, 11 July 2018

Revenue for the first half of 2018

  In thousands of euros 2017 2018*
1st quarter 3 091 1 834
2nd quarter 2 925 1 517
HY1 revenue 6 016 3 351

  * Not audited

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), closed the first half of 2018 with revenue of €3.4M compared with €6M the previous year. It is no surprise that the Group’s sales followed the trend of the first quarter of 2018 and confirmed the Group’s strategic redirection. Thus, excluding the United States, the Group posted half-year revenue of €3.2M in the rest of the world, up 7%.

The Middle-East/Africa region continued its upswing and posted half-year revenue of €497K, representing a 40% improvement compared with HY1 2017. Europe generated €569K in revenue, representing a slight decline in activity due, in particular, to a challenging base effect in France, which had shown a 35% increase in revenue for HY1 2017.

Sales in Asia amounted to €432K at the end of June, benefitting from the delivery of the first instrument kits for the Tinavi robotic equipment. Approval of Spineway’s products by the Chinese FDA (C-FDA), expected at the end of the year, should allow the Group to increase its sales in China starting in 2019.

Latin America represents 51% of the Group’s revenue and continues to be a very dynamic region with its half-year sales reaching €1.7M at the end of June, up 18% compared with HY1 2017.

Over the last six months, the Group has prepared and announced a new strategic plan aiming to reposition Spineway on its markets and has begun to implement the plan, with the signature of a financing package for the issuance of OCEANE (bonds convertible into new or existing shares) representing a maximum amount of €14.5M.

Thanks to a reinforced financial structure, Spineway will be able to carry out its new strategy to refocus its activities on the most profitable regions and reorganize its US subsidiary in order to benefit once again from the growth in said country.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication: Half-year results for 2018 – 24 October 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW

Contacts:

Investor relations
David Siegrist – Directeur Financier
Phone: +33 (0)4 72 77 01 52
finance.dsg@spineway.com		   Financial communication
Jérôme Gacoin / Solène Kennis
Phone: +33 (0)1 75 77 54 68
skennis@aelium.fr

 

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Spinal Implants Market 2023 to Obtain Double Digit CAGR | Increasing Chronic Back Problems will Boost the Market By Top Global Prominent Players

Posted On July 12, 2018 By OrthoSpineNews In Financial /  

07-12-2018 – Press Release from: Market Research Future

Market Research Future has a half cooked research report about Global Spinal Implants Market which is currently growing tremendously and is expected to reach USD of 14 billion by the end of 2022.

The Global Spinal Implants Market has been evaluated to be rapidly growing market and is expected to grow tremendously in the near future. Spinal implants are devices used by surgeons during surgery to treats deformities, stabilizes and provides strength to the spine and to expedite the fusion process. Spinal implants are used to treat spine related disorders including degenerative disc disease, scoliosis, kyphosis, fracture and spondylolisthesis.

As age increases bone density declines which leads to chronic back problems which is common in old age people. This elevates spinal cord damage risk. Recently there have been amazing innovations in implantable devices allowing enhancement of the same the result of which is their use have increased in spinal and orthopedic surgeries. Advanced spinal implantable devices are widely accepted globally as maximum people are willing to spend on spinal surgeries which includes use of these devices. The demand for minimally invasive surgical procedures is more as it provides benefits like less blood loss, less recovery time, reduce risk of medical complication, infections, pain and muscle damage. Minimally invasive spinal surgeries are done more which has boosted the market of spinal implants.

Get Sample PDF Illustration @ www.marketresearchfuture.com/sample_request/2050

There are some other factors which have substantial impact on the spinal implant market. Rise in number of vehicular accidents, increased spinal injuries and disorders, increasing geriatric and obese population, lack of proper nutrition and exercise which are consequently increasing chronic back problems. All these are some of the factors which are responsible for the growth of the global spinal implants market. However, high cost of the spinal implants, spinal surgical procedures and unstable reimbursement policies put immense pressure on developing nations and the low income economies causing hindrance to the growth of the spinal implants market.

Key Players for Global Spinal Implants Market

Some major players in the Global Spinal Implants Market include Medtronic, plc (Ireland), Depuy Synthes Inc. (Johnson & Johnson) (U.S.), Stryker Corporation (U.S.), NuVasive, Inc. (U.S.), Zimmer Biomet Holdings, Inc. (U.S.), Globus Medical, Inc. (U.S.), Alphatec Holdings, Inc. (U.S.), Orthofix International N.V. (Netherlands), K2M Group Holdings, Inc. (U.S.), RTI Surgical, Inc. (U.S.), Amedica Corporation (U.S.), Exactech Inc. (U.S.), Integra LifeSciences (U.S.), LDR Holding Corporation (U.S.), Quandary Medical LLC (U.S.), AESCULAP (U.S.), Alliance Spine (U.S.), Apollo Spine (U.S.), Premia Spine (Israel), Ascendx Spine (U.S.), A-Spine (Taiwan), Back 2 Basics Spine (Canada), Accel Spine (U.S.), SI-BONE (U.S.), Captiva Spine Inc. (U.S.), Centinel Spine (U.S.), Life Spine (U.S.), SpineGuard (France), NLT Spine (U.S.), Paradigm Spine LLC (U.S.), Precision Spine (U.S.), Reliance Medical Systems (U.S.), Spinal Solutions Inc. (U.S.), Spine Frontier (U.S.), Spineart Geneva SA (Switzerland), and others

Segments for Global Spinal Implants Market

The Global Spinal Implants Market consists of four regions, namely, America, Europe, Asia Pacific, and the Middle East and Africa.

Americas dominated the global spinal implants market owing to the technological innovation, advancement in manufacturing processes, and contribution of nanotechnology to the pharmaceutical packaging market.

Get Prime Discount on Report @ www.marketresearchfuture.com/check-discount/2050

The European region is the second largest market owing to the increase in geriatric population and the increasing demand for spinal implants and devices for the treatment of spinal disorders. Asia Pacific is the emerging market in the global spinal implants market owing to the rising obesity cases, increasing healthcare expenditure in developing nations, increasing government funding, the presence of a large patient population, and growing awareness about novel spine treatment techniques.

Some Brief Table of Contents of Report

Chapter 1. Report Prologue

Chapter 2. Market Introduction

2.1 Definition

2.2 Scope Of The Study

2.2.1 Research Objective

2.2.2 Assumptions

2.2.3 Limitations

Chapter 3. Research Methodology

3.1 Introduction

3.2 Primary Research

3.3 Secondary Research

3.4 Market Size Estimation

Chapter 4. Market Dynamics

4.1 Drivers

4.2 Restrains

4.3 Opportunities

4.4 Challenges

4.5 Macroeconomic Indicators

4.6 Technology Trends & Assessment

Chapter 5. Market Factor Analysis

5.1 Porters Five Forces Analysis

5.1.1 Bargaining Power Of Suppliers

TOC Continued…

Do You Have Specific Requirement? Ask To Our Experts@ www.marketresearchfuture.com/enquiry/2050

About Market Research Future:

At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Statistical Report, Continuous-Feed Research (CFR), and Market Research & Consulting Services.

Market Research Future

Hadapsar, Pune – 411028

Maharashtra, India

Phone: +1 646 845 9312

Email: sales@marketresearchfuture.com

This release was published on openPR.

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NuVasive Announces Conference Call And Webcast Of Second Quarter 2018 Results

Posted On July 12, 2018 By OrthoSpineNews In Financial /  

SAN DIEGO, July 11, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company will release its second quarter 2018 earnings results on Tuesday, July 31, 2018 after the close of the market.

NuVasive will hold a conference call on Tuesday, July 31, 2018 at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the second quarter 2018. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website through August 28, 2018. In addition, a telephone replay of the call will be available until August 7, 2018. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13681479.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, but are not limited to, the risk that NuVasive’s revenue or earnings projections may turn out to be inaccurate because of the preliminary nature of the forecasts; the risk of further adjustment to financial results or future financial expectations; unanticipated difficulty in selling products, generating revenue or producing expected profitability; and those other risks and uncertainties more fully described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Ceterix Orthopaedics Awarded New Patent for Circumferential Suturing Method in Meniscus Repair

Posted On July 12, 2018 By OrthoSpineNews In Regulatory, Top Stories /  

July 12, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced the issuance of U.S. Patent No. 10,004,492 related to the company’s method of placing a suture around a tear to repair a damaged meniscus, adding to the company’s already expansive intellectual property portfolio.

Ceterix’s new patent further protects the company’s technology enabling surgeons to arthroscopically repair soft tissue injuries in the knee using minimally invasive techniques. This is the second set of method claims describing Ceterix’s proprietary Circumferential Compression Stitch (CCS), a suture method that provides uniform, anatomic compression of meniscus tears that was not possible to do previously given the tight constraints of the knee.

“Whether you are setting a broken bone or suturing a laceration, injuries heal best when the tissue edges are perfectly lined up and repaired without gaps,” says Dr. Justin Saliman, founder and chief medical officer of Ceterix. “For the first time, orthopaedic surgeons can now apply this principle to meniscus tears with NovoStitch® Meniscal Repair Systems. We believe that by enabling simultaneous compression of the femoral and tibial sides of meniscus tears, the Ceterix technology can provide surgeons with greater confidence to repair tears that would have previously been considered non-repairable.”[i],[ii]

“The invention of delivering a Circumferential Compression Stitch within the tight constraints of the knee may be the biggest innovation in meniscal repair in the last 15 years,” says John McCutcheon, president and CEO of Ceterix. “We are committed to expanding options for surgeons to preserve the meniscus and protect normal knee function in their patients.”

The meniscus is a crescent of soft cartilage resting between the femur and tibia that cushions the knee and is surrounded by critical nerves, arteries and cartilage. Ceterix’s NovoStitch Meniscal Repair Systems enable surgeons to work within this tight compartment to place a stabilizing circumferential compression stitch around a meniscus tear. The circumferential compression stitch is the only meniscus repair technique that treats the femoral and tibial sides of a tear simultaneously, enabling the repair of injuries that may previously have required partial or complete removal of this important structure.

Arthroscopic surgery is a minimally invasive procedure in which an orthopaedic surgeon treats the damaged joint through small incisions using specialized tools and guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.[iii],[iv]

About Ceterix Orthopaedics

Ceterix Orthopaedics develops surgical tools that fill unmet clinical needs for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch® Pro Meniscal Repair System has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif., and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com and follow us at @ceterix on Twitter

[i] Brooks KR. Arthroscopy Techniques. 2017 Oct; 6(5):e1767-e1773.
[ii] Woodmass et al. Arthroscopy Techniques. 2017 Aug; 6(4):e1329-e1333
[iii] Brinker MR. O’Connor DP, Pierce P, Woods GW, Elliott MN. Utilization of orthopaedic services in a capitated population. JBJS. 2002 Nov; 84-A (11): 1926-1932
[iv] New Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care System; 2006

Contacts

for Ceterix Orthopaedics, Inc.
Krysta Pellegrino
krysta@healthandcommerce.com

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Cutting Edge Spine Announces FDA 510(K) Clearance of its New HA Enhanced PEEK Interbody for the Cervical Spine, the EVOL ha-C

Posted On July 11, 2018 By OrthoSpineNews In Regulatory, Spine /  

WAXHAW, N.C. (PRWEB) JULY 11, 2018

Cutting Edge Spine (http://www.CuttingEdgeSpine.com), a US leader in the development and commercialization of bio-active technologies for the spine, today announced the 510(k) clearance and commercial launch of it’s latest innovation, the EVOL ha-C cervical inter-body system.

The EVOL ha-C system is made of PEEK-OPTIMA HA Enhanced material supplied by Invibio Biomaterial Solutions (“Invibio”). Cutting Edge Spine implants made from the material have demonstrated early onset bone formation and apposition to it’s implants; as presented at NASS 2016, NASS 2017, Selby Spine Society 2017, and Becker’s Spine Symposium. The EVOL ha-C system leverages Cutting Edge Spine’s acuity relative to developing systems made from the material in order to offer superior inter-body options to Surgeons looking for superior and early onset new bone formation and bony apposition to the implant during the fusion process.

“The EVOL ha-C cervical inter-body system demonstrates the strong confidence we have in our ability to deliver improved clinical outcomes,” said Randy Roof, President and Co-Founder. “The EVOL ha-C cervical system is our second HA Enhanced PEEK-OPTIMA system to be 510(K) cleared this year; and with an ALIF, DLIF and OLIF system forthcoming in 2018 Cutting Edge Spine, arguably, will be offering the world’s largest Bio-Active interbody portfolio.”

“The EVOL ha-C system combines Invibio’s leadership in PEEK and Cutting Edge Spine’s second to none clinical experience and engineering expertise in HA enhanced PEEK Interbodies,” said Kyle Kuntz, Manager of Research & Development at Cutting Edge Spine. “Our growing and compelling body of work demonstrates improved clinical outcomes with HA enhanced PEEK. We are proud to have the opportunity to make it available to patients and surgeons.”

Cutting Edge Spine is currently in the process of launching the technology nationwide. The leadership team will be attending NASS in Los Angeles, September 26-29, 2018 and looks forward to meeting anyone looking to make a difference.

(1)    Comparative Study Finds Performance Advantages with PEEK-OPTIMA® _HA Enhanced Polymer

About Cutting Edge Spine

Founded in 2009, Cutting Edge Spine (CES) is a privately owned medical device organization, headquartered in Waxhaw, North Carolina, dedicated to developing and distributing new generation spinal technologies focused upon inter-body fusion. The company was built on the conviction that patients, payers and healthcare providers deserve more value from the technologies that they select. CES is future ready, providing the market with highly differentiated implant systems that meet the clinical and economic demands of today’s marketplace. As a testimony to its founding principles, CES developed the EVOS-ha system, the first HA enhanced PEEK Lumbar Inter-body system approved in the United States; affording the Company clinical experience that the competition does not have. The company possesses four FDA cleared proprietary technologies at present with many more coming in 2018. For more information, please visit http://www.CuttingEdgeSpine.com.

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Safe Orthopaedics Announces Revenue for First Half of 2018

Posted On July 11, 2018 By OrthoSpineNews In Financial /  

July 10, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

Safe Orthopaedics (Paris:SAFOR) (FR0012452746 – SAFOR), a company specialized in the design and marketing of single-use implants and instruments improving the minimally invasive treatment of spinal fracture conditions, today announces its revenue for the six months to June 30, 2018.

“Following a series of structural changes – the acquisition of a new sales force in the UK, the signature of a strategic partnership in Japan and the success of our capital increase – sales at Safe Orthopaedics are stable. Double-digit growth in France, triple-digit growth in Germany and our new ambitions in the UK all made it necessary to recruit a Global Sales Director. Sjors Hermans has all the qualities and experience in European markets, particularly Germany, needed to support our growth plans. Most recently, he has demonstrated his ability to launch a range of products for use in spinal surgery, reaching sales of €10 million,” noted Pierre Dumouchel, Chief Executive Officer and co-founder of Safe Orthopaedics. “Having refocused on the vertebral fracture segment over the past two years, we are launching our SteriSpine VA vertebral augmentation balloon at the beginning of this second half of the year. On a global level, we are the only manufacturer of single-use, minimally invasive technologies that allow treatment of all vertebral fractures. This will help drive our sales in the second half and enable us to generate growth in 2018 similar to that seen in 2017.”

In the six months to June 30, 2018, Safe Orthopaedics generated stable revenue of €1,657,000, from €1,644,000 in the corresponding period of 2017.

Direct distribution in France continued its steady growth in the first half of 2018, reaching €904,000, from €802,000 in 2017, an increase of 13%.

International sales fell by 11% in the first half of 2018: sales continued to grow in Germany, but sales in the United Kingdom temporarily fell to zero purely as the result of a transfer. It should be remembered that Safe Orthopaedics announced in June 2018 the acquisition of the sales force of its distributor, QSpine, which resulted in the cessation of orders between the two companies during the negotiation period. Sales in the rest of the world were hampered by difficulties experienced in the Middle East and Southern Europe.

Thousands of euros H1 2018 H1 2017 Change
France 904 802 +13%
Rest of the World 753 842 -11%
Total revenue 1,657 1,644 +1%

In the second quarter of 2018, Safe Orthopaedics’ revenue from the rest of the world was €307,000, a fall of €118,000 (after restating UK sales in 2017), due to the negative contribution from the Middle East and Southern Europe.

On January 15, 2018, Safe Orthopaedics announced that it was facing difficult conditions in the Middle East and was taking action to restore growth in the region. The company has been audited by inspectors from the GCC tender team and is ready to relaunch in the second half, working with new distributors.

Meanwhile, Safe Orthopaedics, seeking to optimize its cash requirements, has decided to strengthen the financial solidity criteria for its distributors, which resulted in the agreement with one of its existing distributors in Southern Europe being put out for competition.

Thousands of euros Q2 2018 Q2 2017 Change
France 419 382 +10%
Rest of the World 307 499 -39%
Total revenue 726 881 -18%

Key developments

Signature of a strategic partnership agreement in Japan

As announced on June 12, 2018, Safe Orthopaedics has signed a strategic partnership agreement with a group in Japan, the third largest market in the world.

Extension of the dedicated spinal fracture product range

The company has completed its product range with the launch of its kyphoplasty range, from July in countries where it distributes directly, and then in all markets. This so-called ‘balloon cement injection’ method will enable Safe Orthopaedics to offer a full range for emergency fracture treatment, thus increasing the penetration of its products with surgeons as well as enhancing margins.

Strengthening the global sales and marketing teams

Sjors Hermans joined Safe Orthopaedics as Global Sales Director in early July, and has also been appointed to the Executive Committee. An engineer by training, Sjors began his career in 1997 in the field of medical implants, particularly for the spine. His career began with Medtronic, before he joined a start-up company, then Zimmer Spine as Business Director for Germany and Switzerland.

In 2011, Sjors joined Medacta with responsibility for expanding its spinal products business in Europe and the Asia-Pacific region. He contributed to growing this business to around €10 million per year by adapting the product portfolio, managing the approval process for new products and building up highly-effective sales teams in Germany and other countries.

Sven Claes has worked for Safe Orthopaedics for one year, and has now been promoted to Marketing Director. Sven has 10 years’ experience in Marketing and Business Development in an international context in the spinal medical equipment industry. Before joining Safe Orthopaedics he was VP International Business Development at Aurora Spine.

Cash Position

At June 30, 2018, Safe Orthopaedics had cash of €500,000, from €995,000 at the end of June 2017. It should be noted that this does not include the €6.95 million raised at the beginning of July 2018 to allow Safe Orthopaedics to further accelerate the group’s development in the spinal fracture market, notably by strengthening its sales teams in France, Germany and the UK.

Next financial publication: First half 2018 results, September 28, (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
François-Henri Reynaud, +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
Relations Investisseurs
NewCap
Julien Perez / Valentine Brouchot
+33 (0)1 44 71 94 94
SafeOrtho@newcap.eu
or
Relations Presse
Ulysse Communication
Bruno Arabian, +33 (0)6 87 88 47 26
barabian@ulysse-communication.com
or
Nicolas Daniels, +33 (0)6 63 66 59 22
ndaniels@ulysse-communication.com

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