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February 2-4, 2017
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SpineTop Stories

SI-BONE, Inc. Announces Blue Cross and Blue Shield of Vermont Establishes Positive Coverage Policy for MIS Sacroiliac Joint Fusion

June 12, 2017 OrthoSpineNews

SAN JOSE, Calif., June 12, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross and Blue Shield of Vermont (BCBSVT), an independent, local, not-for-profit Vermont company, has established a written positive coverage policy for minimally invasive surgical (MIS) SI joint fusion.  The policy, available at the link below, will provide coverage for more than 200,000 BCBSVT health plan members and will become effective on July 1, 2017.  BCBSVT becomes the fourth BCBS insurer to cover MIS SI joint fusion joining the BCBS insurers HCSC (that includes BCBS of Illinois, Montana, New Mexico, Oklahoma and Texas), BCBS of Michigan and BCBS of Nebraska bringing the total number of people with BCBS insurance who have access to the procedure to over 18 million in eight states.

Craig Bartlett, MD of the University of Vermont Medical Group in Burlington, VT commented: “This is great news and I am delighted for our SI joint patients with Blue Cross Blue Shield of Vermont coverage.  I regularly see patients in my practice with chronic sacroiliac joint pain who could benefit from minimally invasive sacroiliac joint fusion with iFuse but I have been unable to perform the procedure due to coverage limitations.  Now, with this positive coverage decision, I will be able to provide iFuse as a treatment option to Blue Cross Blue Shield of Vermont patients who are properly diagnosed surgical candidates and meet the treatment criteria.”

“We are very pleased to learn that Blue Cross Blue Shield of Vermont has established a positive coverage policy based on the published peer-reviewed clinical evidence for patients with SI joint related low back or buttock pain who essentially meet the NASS coverage criteria for MIS SI joint fusion,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement at SI-BONE.

http://www.bcbsvt.com/wps/wcm/connect/50f5e2b1-b03e-4192-95e7-efb0f092e319/diagnosis-and-treatment-of-sacroiliac-joint-pain-medical-policy-2017.pdf?MOD=AJPERES

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse ImplantTMwas designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer reviewed publications including two level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9929.061217

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

 

SOURCE SI-BONE, Inc.

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Financial

ZipLine Medical closes $12m Series E to support Zip closure portfolio

June 9, 2017 OrthoSpineNews

By 

ZipLine Medical said today it closed a $12 million Series E round of financing, with funds slated to support commercialization of its Zip surgical skin closure portfolio and product development.

The round was led by newly invested growth equity fund HighCape Partners, and was joined by existing investor MVM Life Science Partners. As part of the financing round, HighCape Parnters operating partner Dean Tozer will join the company’s medical board of directors.

“ZipLine Medical has introduced a revolution in surgery – advanced wound closure that addresses inherent limitations with traditional, antiquated methods. The ZipLine team is developing and marketing disruptive products that minimize risk, improve clinical outcomes and address the constant pursuit of cost-effective healthcare,” = Tozer said in a prepared statement.

“We are excited to help propel the company to the next level of growth and commercial success,” HighCape Partners founder Matt Zuga said in a prepared release.

 

READ THE REST HERE

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Financial

CORRECTION – Amedica Releases 2016 Preliminary Unaudited Earnings Report and Business Update

June 9, 2017 OrthoSpineNews

SALT LAKE CITY, UT–(Marketwired – Jun 9, 2017) – In the news release, “Amedica Releases 2016 Preliminary Earnings Report and Business Update,” issued earlier today by Amedica Corporation (NASDAQ: AMDA), we are advised by the company that the this press release has been amended to reflect an increase in preliminary revenue, an increase in fourth quarter 2015 net loss per share, an adjustment to the decrease in cash and equivalents, and, to reflect that certain financial data in the Business Update and Related Developments section are unaudited. There have been numerous material changes to this release. Complete corrected text follows.

SALT LAKE CITY, UT — June 8, 2017 — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced its preliminary unaudited earnings report for the fourth quarter and fiscal year ended December 31, 2016 and provided a business update related to its business strategy and certain recent developments.

2016 PRELIMINARY EARNINGS REPORT — UNAUDITED

Amedica reported preliminary revenue of $3.7 million for the fourth quarter of 2016 and $15.2 million for the full year. Preliminary GAAP net loss for the fourth quarter of 2016 was $0.16 per share, compared to net loss of $0.57 per share in the fourth quarter of 2015. For the full year, the company reported preliminary GAAP net loss of $1.19 per share, compared to a net loss of $5.50 per share in 2015. The company’s cash and cash equivalents were $6.9 million at December 31, 2016, a decrease of $4.6 million from December 31, 2015.

Amedica continues to consider any potential impairment in relation to certain of its long-lived assets. Once this exercise is completed, the Company will promptly complete its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and file it with the SEC. Upon filing of the annual report the Company also expects to promptly file its quarterly report on Form 10-Q for the first quarter ended March 31, 2017.

BUSINESS UPDATE AND RELATED DEVELOPMENTS

Unaudited Financial Update

The company has reduced its total debt to approximately $4 million, down from $24.3 million in July 2015 and from $36 million in late 2014. All debt will retire by January 2018, or sooner. Absent new financing, Amedica expects to be compliant with its debt covenants under the Hercules loan through July 2017. The company’s monthly cash burn rate has decreased from $2.8 million in 2014 to $1.3 million per month. Exclusive of principal and interest payments on the debt, the monthly operating cash burn rate is approximately $500,000. Staff count is now 35, compared to 56 last year, and greater than 100 in late 2014, as the company continues to focus on cost controls in-line with its October 2016 reorganization.

Commercialization Report

The Alpha launch of Amedica’s Taurus™ Pedicle Screw System, a spine fixation product line that received FDA clearance in November 2016, has completed over 60 surgeries, generating a total of $450,000 in new revenue (unaudited) with 10 new surgeons trialing the system for the first time. The company expects the Beta launch in mid-summer as additional instrument sets become available for new surgeon users.

Amedica continues to promote its Valeo ® line of silicon nitride spine implants with the addition of new surgeon users and distributors. With solid material science data supporting its silicon nitride, the company is now focused on clinical studies. The company has been successful in entering purchasing agreements for its products with multiple national and regional hospital groups. These purchasing agreements should lead to increased usage of the company’s products at those hospitals, resulting in increased revenue.

Other commercialization highlights include:

  • 12% increase in surgeons users since the end of 2016.
  • 10% increase in sales agents representing our products versus end of 2016, with a focus on improved management leading to increased productivity.
  • Multi-center clinical study initiated with long-term surgeon users of silicon nitride to examine results in a retrospective cohort of more than 1,000 patients.
  • Two new spine industry executives hired for Area Vice President and Vice President of Market Development positions; both with 20+ years of experience in the U.S. spine market.

Research and Development

Recent Research and Development Highlights:

  • Since the beginning of 2017, Amedica’s R&D group has published 10 peer-reviewed journal articles and 7 scientific proceedings on various aspects of silicon nitride. 7 additional manuscripts are in preparation or are at various stages of submission and peer review.
  • 4 additional patents awarded related to silicon nitride and other ceramic materials processes since 2015.
  • Already this year there have been 13 presentations made at scientific conferences including the American Academy of Orthopaedic Surgeons (AAOS), the Orthopedic Research Society (ORS), the Society for Biomaterials (SFB), and the Association of Bone and Joint Surgeons (ABJS), among others.
  • A recently-completed University of Rochester study re-confirmed that silicon nitride is resistant to bacteria, and has osteogenic properties.
  • As previously announced, Amedica completed five million cycle (Mc) wear testing of silicon nitride femoral heads in comparison to the industry-standard zirconia-toughened alumina (ZTA). Silicon nitride produced less wear, and less oxidative damage to the polyethylene than ZTA. Testing is continuing through 12 million cycles. Additional testing of the corrosion resistance of silicon nitride femoral heads is in progress toward a regulatory filing.
  • The company is testing the friction and wear behavior of polished silicon nitride against native cartilage. If successful, this project will open hemi-arthroplasty applications in several anatomic joint reconstructions, where native cartilage is partially preserved.
  • In large-animal testing, 12-week data have shown greater bone formation within porous silicon nitride than porous titanium. A separate large-animal spine fusion model with Amedica’s silicon nitride spacers showed greater bone formation than PEEK at the six-month study end-point.
  • The company entered a multi-year agreement with Texas A&M University’s School of Dentistry to evaluate silicon nitride in maxillofacial surgery, where osteogenic and antimicrobial properties are highly desirable. This partnership is expected to yield funding from the U.S. National Institute of Health (NIH) and the Small Business Innovative Research (SBIR) programs to continue support for Amedica’s R&D efforts.

Clinical and Regulatory

Results from Amedica’s CASCADE clinical trial showing effective spine fusion with porous silicon nitride without added bone graft are now published in the European Spine Journal. A similar trial (SNAP) compared silicon nitride to PEEK in lumbar fusion; preliminary data from the SNAP trial are consistent with previous observations that silicon nitride shows enhanced and earlier spine fusion than PEEK.

In December 2016, Amedica re-filed an application with the FDA with a modified porous (cancellous structured ceramic) cervical implant. After a 510(k) pre-submission meeting, the company is using FDA feedback to prepare a 510k submission to be filed in October 2017.

In 2017, Amedica’s Quality and Regulatory systems were audited exhaustively by the U.S. FDA and ANVISA – Brazil’s equivalent to the FDA — and the company is fully compliant with these regulatory bodies.

Strategic Direction

“Going forward, we are focused on growing spine sales, first and foremost, while pursuing a robust R&D program with academic and industry leaders, to assure leadership in medical ceramic technology,” said Dr. Bal, Chairman and CEO of Amedica. In addition to adding new U.S. surgeons, Amedica is aggressively targeting revenue opportunities in Brazil, Europe, and Australia, all markets where its silicon nitride implants are approved for sale. With recent submission of favorable clinical data to the Japan PMDA, the company expects approval in that market as well.

In addition to the ceramic femoral head development for the hip replacement market, Amedica has fabricated and tested a silicon nitride dental implant with FDA pre-submission, and expects FDA feedback in June 2017. A metal-ceramic brazing project with a global ceramics manufacturer is underway, targeting the total knee market, and composite devices in the spine market.

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements, which include statements regarding preliminary unaudited financial results, anticipated future revenues, FDA clearance of our products, addition of new surgeon users, and, results of clinical studies are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

CONTACT INFORMATION

 Correction, Amended 2016 Preliminary
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FinancialRobotics

Global $6.8 Billion Medical Robotics and Computer-Assisted Surgery Market, 2021 – Research and Markets

June 9, 2017 OrthoSpineNews

DUBLIN, June 9, 2017 /PRNewswire/ —

Research and Markets has announced the addition of the “Medical Robotics and Computer-assisted Surgery: The Global Market” report to their offering.

The Global Surgical Robotics and Computer-Assisted Surgery Market is Expected to Increase from $4.0 Billion in 2016 to $6.8 Billion in 2021 at a CAGR of 11.3%

The scope of this report is broad and covers different types of MRCAS, and the applications for surgical robots and computer-assisted surgery for different kinds of treatment.

The market is broken down by types of medical robotics, types of computer-assisted surgery, applications and regional markets. Revenue forecasts from 2016 to 2021 are given for each major type of medical robotics, computer-assisted surgery, application and regional market, and the estimated values are derived from the manufacturers’ total revenues.

The report also includes a discussion of the major players across each of the regional MRCAS market; it explains the major market drivers of the global MRCAS industry, current trends within the industry, major applications and the regional dynamics of the global MRCAS market.

The report concludes with a special focus on the vendor landscape, which includes detailed profiles of the major vendors in the global MRCAS industry.

Report Includes

– An overview of the global market for medical robotics and computer-assisted surgery (MRCAS).
– Analyses of global market trends, with data from 2015 and 2016, and projections of CAGRs through 2021.
– Examination of the historical and current value of each of the product segments in specified applications and geographical markets.
– Evaluation of the impact of demographic, economic, and other factors that will drive future demand for MRCAS devices.
– Identification of promising new surgical procedures and products still in the development and testing stages, and the probability that they will be commercialized successfully within the next five years.
– Profiles of major players in the industry.

Key Topics Covered:

1: Introduction

2: Summary and Highlights

3: Overview

– Medical Robotics
– Evolution of Medical Robotics
– Advantages and Disadvantages
– Types of Medical Robotics
– Applications of Surgical Robotics and Computer Assisted Surgery
– Types of Computer-Aided Surgery

4: Global Medical Robotics and Computer-assisted Surgery Market

– Global Medical Robotics Market by Type
– Global Surgical Robotics and Computer-assisted Surgery Market by Type
– Global Surgical Robotics and Computer-assisted Surgery Market by Applications
– Global Surgical Robotics and Computer-assisted Surgery Market by Region
– Global Surgical Robotics and Computer-assisted Surgery Market by Region
– Global Surgical Navigation System Market by Component Technology
– Global Intelligent Operating Room Market by Mode of Delivery
– Global Surgical Simulators and Planners Market by Type
– Global Surgical Robotics and Computer-assisted Application Market by Region
– Global Surgical Robotics and Computer-assisted Surgery Application Market by Type

5: Drivers and Challenges

– Growth in Laproscopic Surgery
– Growth in Cardiac Surgery

6: Supplier and Landscape Company Profiles

– 4Navitec GMBH
– Aesculap, Inc.
– Biobot Surgical Pte Ltd.
– Boulder Innovation Group, Inc.
– Brainlab AG
– CAE Healthcare
– Corindus Vascular Robotics Inc.
– Hansen Medical
– Hitachi Ltd.
– Hocoma AG
– Honda Motor Co., Ltd.
– Imris, Deerfield Imaging
– Intuitive Surgical, Inc.
– Karl Storz Gmbh & Co. KG
– Kinamed Incorporated
– Kinova Robotics
– Kirby Lester
– Maxon Motor AG
– Mazor Robotics Ltd.
– Medrobotics Corp.
– Medtech Global Ltd.
– Mentice AB
– Omni Life Science, Inc.
– Panasonic Corporation
– Schaerer Medical Usa, Inc.
– Siemens AG
– Simbionix Ltd.
– Simquest
– Simsurgery AS
– Smith & Nephew Plc
– Sonowand AS
– Stryker Corporation
– Surgical Science Sweden AB
– Swisslog Holding AG
– Think Surgical, Inc.
– Titan Medical Inc.
– Touch Bionics
– Virtamed AG
– Voxel-Man
– Zimmer Biomet Holding, Inc.

For more information about this report visit http://www.researchandmarkets.com/research/xz8tv4/medical_robotics

Media Contact:

Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

 

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ExtremitiesSports MedicineTop Stories

Spring Loaded Technology Officially Launches LevitationTM, the World’s First Compact Bionic Knee Brace, with support from Government of Canada

June 9, 2017 OrthoSpineNews

HALIFAX, NS – June 9, 2017 – Spring Loaded Technology announces the official launch of its LevitationTM bionic knee brace for consumer sales across North America, and is now welcoming commercial partnerships with clinics, distributors, and brace retailers across Canada. The product launch takes place as the Government of Canada announces a $2.46-million investment through the Atlantic Canada Opportunities Agency’s Atlantic Innovation Fund (AIF).

Spring Loaded Technology CEO Chris Cowper-Smith describes the announcement as “The next chapter in our journey to change and improve lives in a big way.” COO Dawn Umlah added, “With the support of ACOA, combined with our research and development efforts and leading-edge product development, it’s a game changer. We’re proud to be able to put the world’s first and only compact, bionic knee brace into the hands of consumers on a large scale.”

As the world’s first bionic knee brace, Levitation™ uniquely enhances knee strength, mobility, and endurance by storing energy as the leg bends and then returning that energy as the leg straightens. Current users range from performance athletes, to manual laborers, to people with osteoarthritis. Levitation has proven useful for most knee injuries and conditions.

“The team at Spring Loaded Technology is transforming the versatility of assistive devices,” says

Darren Fisher, Member of Parliament for Dartmouth-Cole Harbour. “They represent a broader

life sciences community working on research that brings solutions to the marketplace. Targeted

investments such as these are helping us grow beyond our borders in line with our Atlantic

Growth Strategy.”

After successfully securing USD $208,000 through an Indiegogo crowdfunding campaign, delivering a $1-million contract for the Canadian forces, and fulfilling hundreds of consumer pre-orders, the Nova Scotia company is entering what they call real-time production. With bolstered manufacturing capacity, product improvements, and increased demand, Spring Loaded Technology is positioned to deliver Levitation across North America, to help people do more of what they love.

To learn more about Levitation™ and Spring Loaded Technology, or to inquire about partnership opportunities, visit www. springloadedtechnology.com.

About Spring Loaded Technology

Spring Loaded Technology is an award-winning company based in Halifax, Nova Scotia, which has designed an entirely new knee bracing technology to enhance the strength and power of the leg muscles. By increasing leg strength, their technology can be used in a wide range of applications including: mobility assistance, fatigue reduction, injury prevention/rehabilitation, and performance enhancement. The company was founded in 2012.

 

Media Contacts:

Kaleigh DeHart

Uproar PR for Spring Loaded Technology

Office: 321.236.0102

Email: kdehart@uproarpr.com

 

Alex Smith

Director of Communications and Outreach, Atlantic Canada Opportunities Agency

Cell: (902) 830-3839
Office: (902) 426-9417
E-mail: alex.smith@canada.ca

 

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Financial

Global Orthopedic Device Industry to Reach $62.6 Billion by 2022 – Research and Markets

June 9, 2017 OrthoSpineNews

June 09, 2017

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Growth Opportunities in the Global Orthopedic Device Industry” report to their offering.

The global orthopedic device industry looks attractive with opportunities in public and private hospitals. The global orthopedic device industry is expected to reach an estimated $62.6 billion by 2022 and is forecast to grow at a CAGR of 5.5% from 2017 to 2022. The major drivers for the growth of this market are the increasing aging population, increasing adoption of advancements in medical technologies, and growing healthcare expenditure and awareness.

Emerging trends, which have a direct impact on the dynamics of the orthopedic device industry, include the increasing demand for smart implants, the widening use of nanotechnologies, and the adoption of robotic surgery to increase mechanical performance and accuracy.

Orthopedic device companies profiled in this industry include DePuy Synthes, Zimmer Biomet Holding Inc., Stryker Corporation, Smith and Nephew PLC, and Medtronic are among the major manufacturers of orthopedic devices. Some of these companies are also pursuing mergers and acquisitions as strategic initiatives for driving growth.

Within the global orthopedic device industry, orthopedic reconstruction is expected to remain the largest segment by device type. With the rise of orthopedic disorders and increasing aging population are the major driving forces that will spur growth for this segment over the forecast period.

Companies Mentioned

  • Arthrex Inc.
  • DJO Global Inc.
  • Globus Medical Inc.
  • Johnson and Johnson (DePuy Synthes)
  • Medtronic
  • Smith & Nephew PLC
  • Stryker Corporation
  • Zimmer Biomet Holding Inc.

Key Topics Covered:

1. Executive Summary

2. Market Background and Classifications

3. Market Trends and Forecast Analysis from 2011 to 2022

4. Market Trends and Forecast Analysis by Region

5. Competitor Analysis

6. Cost Structure Analysis

7. Growth Opportunities and Strategic Analysis

8. Company Profiles of Leading Players

For more information about this report visit http://www.researchandmarkets.com/research/6lfb7t/growth

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Orthopedic Devices

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SpineTop Stories

Camber Spine Technologies Appoints Two New Area Sales Directors

June 9, 2017 OrthoSpineNews

WAYNE, Pa., June 9, 2017 /PRNewswire/ — Camber Spine Technologies, a medical device company focused on designing, developing and commercializing innovative and proprietary musculoskeletal implant systems, announced the appointment of two new Area Sales Directors to its sales team, Gant Newsom and Doug Wyciskalla. As part of Camber Spine’s commitment to expanding its sales efforts across the country these new positions have been created for these two very talented spine device sales veterans.

“It is an extreme pleasure to welcome both Gant and Doug to our fast-paced organization,” said Dan Lawson, Camber Spine’s East Coast Area Sales Director. “I have worked with both of them in the past and have witnessed firsthand the level of success, leadership and extreme professionalism that they brought to their organizations.”

Doug Wyciskalla joins Camber Spine as the Midwest Area Sales Director bringing 14 years of sales leadership experience to the Camber Spine organization.  Most recently he worked with LDR and Spineart in sales leadership roles. Doug started his career in spine with Kyphon, where his region was always amongst the top in performance.  He also spent several years as an area sales director for Paradigm Spine, where he built the sales team across the western U.S.  Doug has consistently led teams to exceed sales goals and has been one of the top performers at each of the companies where he has worked.

Gant Newsom, who joins Camber Spine as the Southwest Area Sales Director, has an impressive background with over 10 years of experience in the spine business, having worked with brands such as Globus Medical, Aesculap and most recently LDR and Zimmer Biomet. He, too, was consistently amongst the top performing regions in the U.S. across all product lines and was named MVP of SC Area for 2 years running while working for LDR. Gant lives in Tulsa, Oklahoma with his wife and two daughters and is a graduate of Oklahoma State University.

“With the addition of Gant and Doug along with some newly added sales representatives we are now poised for an extremely aggressive and productive 2017,” said Camber Spine’s Vice President of New Business Development, Seth Anderson. “In addition to having several new exclusive technologies for planned launches over the next two quarters we now have varsity level sales management leading us into new markets across America.”

About Camber Spine Technologies

Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market.  Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

If you would like more information about this topic, please contact Mindy Elgart, Marketing Director at 484.420.4671 or email at melgart@cambermedtech.com

SOURCE Camber Spine Technologies

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Financial

Amedica Releases 2016 Preliminary Earnings Report and Business Update

June 8, 2017 OrthoSpineNews

SALT LAKE CITY, UT–(Marketwired – Jun 8, 2017) – Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced its preliminary earnings report for the fourth quarter and fiscal year ended December 31, 2016 and provided a business update related to its business strategy and certain recent developments.

2016 PRELIMINARY EARNINGS REPORT

Amedica reported preliminary revenue of $3.6 million for the fourth quarter of 2016 and $15.2 million for the full year. Preliminary GAAP net loss for the fourth quarter of 2016 was $0.16 per share, compared to net loss of $0.57 per share in the fourth quarter of 2015. For the full year, the company reported preliminary GAAP net loss of $1.19 per share, compared to a net loss of $5.50 per share in 2015. The company’s cash and cash equivalents were $6.9 million at December 31, 2016, a decrease of $4.5 million from December 31, 2015.

In collaboration with its auditors, Amedica continues to consider any potential impairment in relation to certain of its long-lived assets. Once this exercise is completed, the Company will promptly complete its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and file it with the SEC. Upon filing of the annual report the Company also expects to promptly file its quarterly report on Form 10-Q for the first quarter ended March 31, 2017.

BUSINESS UPDATE AND RELATED DEVELOPMENTS

Financial Update

The company has reduced its total debt to approximately $4 million, down from $24.3 million in July 2015 and from $36 million in late 2014. All debt will retire by January 2018, or sooner. Absent new financing, Amedica expects to be compliant with its debt covenants under the Hercules loan through July 2017. The company’s monthly cash burn rate has decreased from $2.8 million in 2014 to $1.3 million per month. Exclusive of principal and interest payments on the debt, the monthly operating cash burn rate is approximately $500,000. Staff count is now 35, compared to 56 last year, and greater than 100 in late 2014, as the company continues to focus on cost controls in-line with its October 2016 reorganization.

Commercialization Report

The Alpha launch of Amedica’s Taurus™ Pedicle Screw System, a spine fixation product line that received FDA clearance in November 2016, has completed over 60 surgeries, generating a total of $450,000 in new revenue with 10 new surgeons trialing the system for the first time. The company expects the Beta launch in mid-summer as additional instrument sets become available for new surgeon users.

Amedica continues to promote its Valeo ® line of silicon nitride spine implants with the addition of new surgeon users and distributors. With solid material science data supporting its silicon nitride, the company is now focused on clinical studies. The company has been successful in entering purchasing agreements for its products with multiple national and regional hospital groups. These purchasing agreements should lead to increased usage of the company’s products at those hospitals, resulting in increased revenue.

Other commercialization highlights include:

  • 12% increase in surgeons users since the end of 2016.
  • 10% increase in sales agents representing our products versus end of 2016, with a focus on improved management leading to increased productivity.
  • Multi-center clinical study initiated with long-term surgeon users of silicon nitride to examine results in a retrospective cohort of more than 1,000 patients.
  • Two new spine industry executives hired for Area Vice President and Vice President of Market Development positions; both with 20+ years of experience in the U.S. spine market.

Research and Development

Recent Research and Development Highlights:

  • Since the beginning of 2017, Amedica’s R&D group has published 10 peer-reviewed journal articles and 7 scientific proceedings on various aspects of silicon nitride. 7 additional manuscripts are in preparation or are at various stages of submission and peer review.
  • 4 additional patents awarded related to silicon nitride and other ceramic materials processes since 2015.
  • Already this year there have been 13 presentations made at scientific conferences including the American Academy of Orthopaedic Surgeons (AAOS), the Orthopedic Research Society (ORS), the Society for Biomaterials (SFB), and the Association of Bone and Joint Surgeons (ABJS), among others.
  • A recently-completed University of Rochester study re-confirmed that silicon nitride is resistant to bacteria, and has osteogenic properties.
  • As previously announced, Amedica completed five million cycle (Mc) wear testing of silicon nitride femoral heads in comparison to the industry-standard zirconia-toughened alumina (ZTA). Silicon nitride produced less wear, and less oxidative damage to the polyethylene than ZTA. Testing is continuing through 12 million cycles. Additional testing of the corrosion resistance of silicon nitride femoral heads is in progress toward a regulatory filing.
  • The company is testing the friction and wear behavior of polished silicon nitride against native cartilage. If successful, this project will open hemi-arthroplasty applications in several anatomic joint reconstructions, where native cartilage is partially preserved.
  • In large-animal testing, 12-week data have shown greater bone formation within porous silicon nitride than porous titanium. A separate large-animal spine fusion model with Amedica’s silicon nitride spacers showed greater bone formation than PEEK at the six-month study end-point.
  • The company entered a multi-year agreement with Texas A&M University’s School of Dentistry to evaluate silicon nitride in maxillofacial surgery, where osteogenic and antimicrobial properties are highly desirable. This partnership is expected to yield funding from the U.S. National Institute of Health (NIH) and the Small Business Innovative Research (SBIR) programs to continue support for Amedica’s R&D efforts.

Clinical and Regulatory

Results from Amedica’s CASCADE clinical trial showing effective spine fusion with porous silicon nitride without added bone graft are now published in the European Spine Journal. A similar trial (SNAP) compared silicon nitride to PEEK in lumbar fusion; preliminary data from the SNAP trial are consistent with previous observations that silicon nitride shows enhanced and earlier spine fusion than PEEK.

In December 2016, Amedica re-filed an application with the FDA with a modified porous (cancellous structured ceramic) cervical implant. After a 510(k) pre-submission meeting, the company is using FDA feedback to prepare a 510k submission to be filed in October 2017.

In 2017, Amedica’s Quality and Regulatory systems were audited exhaustively by the U.S. FDA and ANVISA — Brazil’s equivalent to the FDA — and the company is fully compliant with these regulatory bodies.

Strategic Direction

“Going forward, we are focused on growing spine sales, first and foremost, while pursuing a robust R&D program with academic and industry leaders, to assure leadership in medical ceramic technology,” said Dr. Bal, Chairman and CEO of Amedica. In addition to adding new U.S. surgeons, Amedica is aggressively targeting revenue opportunities in Brazil, Europe, and Australia, all markets where its silicon nitride implants are approved for sale. With recent submission of favorable clinical data to the Japan PMDA, the company expects approval in that market as well.

In addition to the ceramic femoral head development for the hip replacement market, Amedica has fabricated and tested a silicon nitride dental implant with FDA pre-submission, and expects FDA feedback in June 2017. A metal-ceramic brazing project with a global ceramics manufacturer is underway, targeting the total knee market, and composite devices in the spine market.

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements, which include statements regarding anticipated future revenues, FDA clearance of our products, addition of new surgeon users, and, results of clinical studies are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

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SpineTop Stories

joimax® Elevates Its Presence across Europe and Asia

June 8, 2017 OrthoSpineNews

June 08, 2017

IRVINE, Calif.–(BUSINESS WIRE)–Over the last few weeks, joimax® participated in numerous scientific meetings, held across Europe and Asia. During these meetings, the German-based company reiterated its position as market leader for endoscopic minimally invasive spine surgery.

Starting in early May, joimax® exhibited at this year’s Global Spine Congress (GSC, http://www.gsc2017.org) in Milan, Italy, including a Meet-the-Expert Session at its booth and at the Intermediate Meeting of the World Congress of Minimally Invasive Spine Surgery and Techniques (WCMISST) in Paris, France. Numerous joimax® faculty members presented the latest results in endoscopic spine surgery.

From May 11 to 14, joimax® participated in the 10th Conference of the Chinese Association of Orthopedic Surgeons, held in cooperation with the North American Spine Society (CAOS/NASS) in Guangzhou, China. The conference was combined with a highly attended workshop on principles and techniques of complex spine surgery. This session was video transmitted to 20,000 hubs.

During the annual meeting of the German Society of Neurosurgery (DGNC) in Magdeburg, Germany, from May 14 to 17, joimax®exhibited its complete product range. The lunch symposium, covering the treatment options in endoscopic decompression and pain therapy, was presented by the well-recognized joimax® faculty members Drs. Erik Traupe, Guntram Krzok and Ralf Wagner.

From May 18 to 20, joimax® participated in the first International Spine Conference at the KCM clinic in Jelenia Gora, Poland, highlighting the achievements of modern endoscopic minimally invasive spine surgery. In live surgeries various endoscopic techniques in cervical and lumbar cases were performed. The session was coupled with a simultaneous discussion between surgeons and participants.

“The International Spine Conference in Poland marks the successful kick-off for the cooperation with our new partner to start extensive market activities in this country,” says Wolfgang Ries, Founder and CEO of joimax®. “Both, training and education, which also started in Poland, now are the key to success to further deepen the endoscopic knowledge of spine surgeons.”

In early June, the annual meeting of the International Society for the Study of the Lumbar Spine (ISSLS) took place in Athens, Greece, followed by the annual congress of the French Society of Spinal Surgery (Societé Francaise de Chirurgie Rachidienne, SFCR) in Lille, France. Both meetings attracted many spine specialists and generated good traffic at the joimax® booths.

Since its inception, joimax® participates in the European Course for Minimally Invasive Spinal Surgery (EUCMISS, http://www.eucmiss.com). This year’s 5th Course in Madrid, Spain, was held on June 1 and 2. It was a special course of globally leading experts in minimally invasive spine, exchanging the practical and scientific experience in presentation and multidisciplinary cadaver courses.

joimax® will continue its activities by exhibiting at the NSpine Main Conference in London, UK, from June 12 to 15 and then they head back to Asia to attend the 6th Asian Conference of Minimally Invasive Spine Surgery Techniques (ACMISST) in Bangkok, Thailand between June 29 and July 2 with a faculty presentation and a booth presence.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® RT (e.g. for rhizotomy) and with MultiZYTE® SI for SI-Joint therapy or with EndoLIF® and Percusys® for endoscopic minimally invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety 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 anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

joimax® Inc.
Melissa Brumley
001 949 859 3472
Melissa.brumley@joimaxusa.com

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Financial

Trice Medical Closes $19.3 Million Series C Financing To Address Increased Demand For Mi-Eye

June 8, 2017 OrthoSpineNews

KING OF PRUSSIA, Pa., June 6, 2017 /PRNewswire/ — Trice Medical announced today that it closed a $19.3 million Series C financing and will use the proceeds to accelerate and expand the company’s U.S. market penetration for mi-eye2™, R&D, sales, marketing and key international regulatory approvals. Smith & Nephew (LSE:SN, NYSE: SNN), a global medical technology business dedicated to helping healthcare professionals improve people’s lives, has taken a minority stake joining a consortium of current investors including Safeguard Scientifics (NYSE: SFE), HealthQuest Capital, BioStar Ventures and others in this latest funding round. To-date, Trice Medical has raised $40.9 million.

“This is a significant milestone for Trice Medical as we looking to expand our sales, marketing and commercialization efforts and bolster our workforce,” said Jeffrey O’Donnell, Sr., President and CEO at Trice Medical. “We’re proud to add Smith & Nephew to our list of investors and look forward to being able to leverage their global experience as we roll out additional mi-eye products in the future.”

The early success of Trice Medical’s mi-eye2™, which received FDA 510(K) clearance during the fourth quarter of 2016, has captured the attention of medical professionals who are embracing the technology as a replacement to the MRI. After the first few months of commercial launch, the mi-eye is currently being used by nearly 100 physician practices across 25 states. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries from the office. The scope’s improved vision quality and non-invasive technique provides patients with a more complete diagnosis. As the competitive landscape continues to evolve, Trice Medical will allocate resources to research and development of the technology’s third generation.

Dr. Sean McMillan, Chief of Orthopedics at Our Lady of Lourdes, is a physician who has successfully integrated the mi-eye into his practice. “I am extremely excited to have the ability to offer safe, cutting edge technology to my patients,” said Dr. McMillan. “By using the mi-eye, my patients are able to obtain the answer to their cause of pain immediately and start their road to recovery 2 to 3 weeks quicker than if they had an MRI. The most exciting part about using the mi-eye is the increasing number of patients who are calling up and specifically asking for the procedure. Our patients are seeking out innovative technology that is both fast, convenient, and cost effective.”

O’Donnell continued, “This financial support from our existing and new investors gives us the runway we need to fulfill our mission – to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system. We can now attract the talent we need to scale to make mi-eye the standard of care in diagnostic imaging.”

About Trice Medical
Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, physician, and payor by providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2, which provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system. Trice Medical’s major investors include BioStar Ventures, HealthQuest Capital, Smith & Nephew and Safeguard Scientifics (NYSE: SFE). For more information, visit www.tricemedical.com; follow us on Twitter, LinkedIn and Facebook; or call 844.643.9300.

SOURCE Trice Medical

Related Links

http://www.tricemedical.com

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