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

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

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

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

 

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

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

 

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

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

Camber Spine Technologies Appoints Two New Area Sales Directors

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

Amedica Releases 2016 Preliminary Earnings Report and Business Update

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.

CONTACT INFORMATION

joimax® Elevates Its Presence across Europe and Asia

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

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

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

Juvent Names Scott D. Boden, MD as Chief Medical Advisor

RIVIERA BEACH, FL–(Marketwired – June 07, 2017) – Juvent (www.juvent.com) a leader in orthopaedic regenerative therapies for bone and musculoskeletal health announced today the engagement of Scott D. Boden, MD as Chief Medical Advisor. Dr. Boden is a tenured Professor of Orthopaedic Surgery at the Emory University School of Medicine and serves as the Director of the Emory Orthopeadics & Spine Center, Vice Chair of Orthopaedics, CMO/CQO of The Emory University Orthopaedics & Spine Hospital, and Emory Healthcare Physician Director of Strategy and Development for Orthopaedics & Spine Programs.

Dr. Boden has received numerous awards for his work and is the author of more than 175 peer-reviewed articles on spine and basic science topics; as well as 30 chapters and seven textbooks. He is co-editor of Seminars in Spine Surgery, a deputy editor of SPINE, and a reviewer for the Journal of Bone and Joint Surgery, the Journal of Bone and Mineral Research, and the European Spine Journal.

“Dr. Boden brings in-depth experience and perspective to our group and has a unique blend of medicine, science, and business skills,” said Rush Simonson, Chairman & CEO of Regenerative Technologies Corporation. “His reputation and expertise will help us in our quest to expand the clinical value of the Juvent technology.”

In 2013, Dr. Boden served as President of the American Orthopaedic Association. He received his B.A. and M.D. from the University of Pennsylvania and completed an Orthopaedic Residency at The George Washington University Medical Center, followed by a Spine Fellowship at Case Western Reserve University Hospitals.

Additionally, Dr. Boden, Emory Orthopaedics and Spine are also pioneering a sports team and academic health-care partnership with the Atlanta Hawks and P3 (Peak Performance Project) in a soon to open 90,000-square foot, $50 million-dollar facility. Juvent is playing an ever-increasing role in professional sports as their device helps to rehab athletes and speed recovery time after training. Olympic gold medal tennis champion, Mike Bryan, uses Juvent daily as well as many other national football players, such as Eric Wood, Center with the Buffalo Bills.

Juvent’s presence in physical therapy centers continues to grow with one leading therapy franchise putting over 80% of their patients on Juvent at each visit. “Dr. Boden’s experience and expertise in bone health is widely recognized and he will help drive Juvent’s product development and clinical applications,” said Juvent President, Peter Simonson.

“We are just before entering our next round of funding to complete development and production of a low-cost consumer unit to meet the demand of a broader consumer market. Over 50 million people who suffer from osteoarthritis in the U.S. could benefit from this safe, non-invasive technology,” said Chairman & CEO Rush Simonson.

Juvent’s Micro-Impact Platform® is registered as a FDA Class I medical exercise and rehabilitation device. Juvent uses a unique, patented resonant wave technology to deliver thousands of low-magnitude and high-frequency micro-impacts that enter through the heels of the feet and move up the entire body. These micro-impacts safely stimulate the body’s muscles and bones to rebuild. Users stand on the Juvent for as little as 10 minutes per day and many begin to feel joint pain relief within days. Juvent’s platform is recommended and used by world-renowned trainers, doctors, physical therapists, and chiropractors. Juvent holds over 26 patents worldwide on its technology.

Juvent’s platform is also used in the athletic world for recovery and healing by leading organizations such as The David Leadbetter Golf Academy, NFL Alumni Association (NFLA), and Hospital for Special Surgery’s, Pete Draovitch, PT, MS, ATC, CSCS. Some of the champion athletes using Juvent in their daily training regimens include; Olympic Tennis Champion Mike Bryan, former NFL legend, Ray Lewis, Eric Wood, with the Buffalo Bills and tennis legend Mats Wilander.

Juvent is a Corporate Advisory Roundtable Member of the National Osteoporosis Foundation (NOF).

About Juvent:

Juvent is a part of Regenerative Technologies Corporation, a privately held, Florida based company who manufactures the Juvent Micro-Impact Platform® here in the U.S. The platform provides non-invasive, micro-impact pulses to support bone health, lymphatic drainage, relieve joint and back pain, and enhance balance. The Class I medical exercise and rehabilitation device is the result of more than 20 years and $45 million in R&D, with many peer-reviewed journals articles and 6 human clinical studies (completed or current) with backing from the National Institutes of Health (NIH), NASA, and the U.S. Army. Used by world-renowned medical doctors, trainers, physical therapists, and chiropractors, for more information, visit www.juvent.com or follow us on Twitter @JuventHealth, Facebook Juvent Health and, Facebook Juvent Sports

In the U.S., the Juvent 1000N device is considered investigational for the treatment of osteoporosis or improvement/maintenance of bone mineral density (BMD).

Image Available: http://www.marketwire.com/library/MwGo/2017/6/6/11G140561/Images/Scott_D._Boden,_MD_2017-629ecab0215885c7bb1a88ab05d2c83d.jpg

CONTACT INFORMATION

Bioventus Surgical Expands Portfolio Offering with Premier

June 07, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced that, effective June 1, 2017, its full surgical orthobiologics portfolio is available through Premier, Inc. Premier is a health care improvement company comprised of 3,750 US hospitals and more than 130,000 other provider organizations throughout the country. Bioventus Surgical has numerous offerings for bone healing and spine fusion including allograft bone, synthetic bone graft substitutes and cell and marrow extraction needles.

OSTEOAMP®, an allograft fusion solution, has been available through Premier since 2012. Additional products in the new agreement include: SIGNAFUSE, a bioactive bone graft substitute, EXPONENT demineralized bone matrix, PUREBONE® demineralized cancellous bone and cancellous chips, INTERFACE bioactive bone graft, OSTEOMATRIX® biphasic mineral/collagen bone graft, OSTEOPLUS® biphasic mineral bone graft, CELLXTRACT®, an autologous cell and marrow extraction device, and EXTRACTOR autologous cell and marrow extraction device.

“The Bioventus Surgical portfolio is designed to meet the needs of surgeons and their patients, across a broad range of clinical situations, procedures, and costs,” said Henry Tung, MD, Senior Vice President, Bioventus and President, Bioventus Surgical. “We expect the Premier alliance of hospitals and healthcare providers to benefit greatly from our clinically supported and cost-effective orthobiologic solutions.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, CELLXTRACT, OSTEOAMP, OSTEOMATRIX, OSTEOPLUS, PUREBONE and EXOGEN are registered trademarks, and EXPONENT, EXTRACTOR and SIGNAFUSE are trademarks of Bioventus LLC.

Summary of Indications for Use

Please see Instructions for Use for complete lists of indications, contraindications, warnings, and precautions on the product labels, at www.BioventusSurgical.com, or by calling 1-800-637-4391.

CELLXTRACT is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

EXPONENT Demineralized Bone Matrix is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

EXTRACTOR is intended for the purpose of harvesting bone marrow.

INTERFACE Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. INTERFACE Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), and in the posterolateral spine when mixed with autograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

OSTEOAMP may be used in situations where an autograft is appropriate. It should be restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects.

OSTEOMATRIX is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

OSTEOPLUS is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g., extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. OSTEOPLUS can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

PUREBONE Demineralized Cancellous Tissue is restricted to use by a licensed physician. PUREBONE Demineralized Cancellous Tissue can be used in orthopedic, neurosurgical and reconstructive bone grafting procedures for homologous use for the repair, replacement, or reconstruction of musculoskeletal defects. It can be used by itself as a bone graft or in conjunction with autologous bone and other forms of allograft bone. PUREBONE Demineralized Cancellous Tissue has been tested for sterility and is ready for use. Do not subject the product to additional disinfection or sterilization procedures. PUREBONE Demineralized Cancellous Tissue is intended for single patient use only. In order to prevent contamination of the graft, any open and unused PUREBONE Demineralized Cancellous Tissue must be discarded and not used in other patients.

SIGNAFUSE is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). SIGNAFUSE can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

Contacts

Bioventus LLC
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com