Stryker announces definitive agreement to acquire NOVADAQ Technologies Inc.

Posted On June 19, 2017 By OrthoSpineNews In Financial, Top Stories /

By GlobeNewswire

Kalamazoo, Michigan – June 19, 2017- Stryker Corporation (NYSE:SYK) announced today a definitive agreement to acquire NOVADAQ Technologies Inc. (NASDAQ:NVDQ; TSX:NDQ) for US$11.75 per share, or US$701 million with a net purchase price of US$654 million, reflecting net cash of approximately US$47 million. NOVADAQ is a leading developer of fluorescence imaging technology that provides surgeons with visualization of blood flow in vessels, and related tissue perfusion in cardiac, cardiovascular, gastrointestinal, plastic, microsurgical, and reconstructive procedures. NOVADAQ was founded in 2000 and is headquartered in Mississauga, Canada.

“This acquisition aligns with Stryker’s focus on enabling our customers to see and do more by enhancing cross-specialty surgical visualization,” stated Timothy J. Scannell, Group President, MedSurg and NeuroTechnology. “NOVADAQ’S unique innovative technology complements Stryker’s advanced imaging portfolio and expands our product offerings into open and plastic reconstructive surgery. NOVADAQ’S innovative technology can reduce post-procedure complication rates and the cost of care for a broad variety of surgical treatments.”

“This transformative transaction recognizes the exceptional value we have built at NOVADAQ. Moreover, we believe it creates a strong opportunity for NOVADAQ, its customers, partners, shareholders, and employees,” said Rick Mangat, President and Chief Executive Officer of NOVADAQ. “I am proud of the impact our SPY and PINPOINT technology has made throughout the world in breast reconstruction and colorectal surgery, as well as other minimally invasive applications, and look forward to the additional progress we can make as part of Stryker’s organization.”

The transaction is structured as an arrangement under the Canada Business Corporations Act, subject to customary closing conditions, including approval by NOVADAQ’S shareholders and the Ontario Superior Court of Justice, the expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period and clearance under the Competition Act (Canada). The transaction is expected to close at the end of the third quarter and is expected to be dilutive to Stryker’s 2017 adjusted net earnings per diluted share by $0.03 – $0.05. There is no change to Stryker’s 2017 estimated adjusted net earnings per diluted share, which is in the range of $6.35 – $6.45. For 2018, this transaction is expected to be neutral to Stryker’s earnings and accretive thereafter.

Covington & Burling LLP and Osler, Hoskin & Harcourt LLP are serving as outside legal counsel for Stryker in connection with this transaction.

Forward-looking statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; potential supply disruptions; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions, including the acquisition of NOVADAQ; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Contacts

For investor inquiries please contact:

Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:

Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Stryker Corporation via Globenewswire

Bundled payments are gaining momentum in orthopedics, but can they work in other specialties?

Posted On June 16, 2017 By OrthoSpineNews In Financial /

By CHASE HENSEL, MedCity News – June 15, 2017

Despite pressure on hospitals to reduce readmissions and studies showing that patients who are supported after leaving the hospital are better equipped to self-manage, care continues to be disjointed, leading to poor outcomes for patients, and higher costs for hospitals.

Can bundled payments serve as a solution? For certain conditions, yes. Orthopedics is pioneering this new kind of payment model and if proven successful, other complex conditions and diseases could apply these best practices to improve health and reduce costs, too.

Bundled payments to initiate better coordinated care

The Bundled Payments for Care Improvement initiative (BPCI) was launched by Centers for Medicare & Medicaid Services (CMS) to support the transition to value-based care by developing a Medicare payment system that emphasizes quality instead of quantity. Essentially, this system links payments for a myriad of services patients receive during an episode of care, as opposed to making separate payments to providers for a single illness or courses of treatment.

Holding the provider financially accountable for patient outcomes leads to higher quality of service and increased collaboration between care teams. According to CMS, “Research has shown that bundled payments can align incentives for providers—hospitals, post-acute care providers, physicians, and other practitioners—allowing them to work closely together across all specialties and settings.” The hope is that this leads to lower spending, improved care and a better overall experience for patients.

As the transition to value-based care advances, bundled payments are gaining momentum, particularly in orthopedics where the CMS instituted the Comprehensive Care for Joint Replacement (CJR) initiative? A mandatory bundled payment program for total hip/knee replacements that is pioneering more innovative payment and healthcare delivery models. Risk-sharing models for example, which reimburse based on the success of treatment goals, provide an incentive for all stakeholders including the device manufacturer to work cohesively throughout the entire episode of care. Creating mutual accountability for benchmarks (such as reduced costs and improved patient outcomes) ensures all parties are working towards the same endgame.

READ THE REST HERE

Image Stream Medical and Olympus introduce MedPresence™, the first Virtual Medical Presence Solution for the Hospital Enterprise

Posted On June 16, 2017 By OrthoSpineNews In Financial, Top Stories /

CENTER VALLEY, Pa. and LITTLETON, Mass., June 12, 2017 /PRNewswire/ — Olympus Corporation of the Americas (OCA) and Image Stream Medical, Inc. today announced the medical industry’s first enterprise virtual presence solution, MedPresence™. The system enables surgical and interventional clinicians to virtually connect and collaborate in ways that have not been possible, practical, or cost-effective before.

Specifically designed to help improve the delivery of patient care, MedPresence™ provides real-time sharing of procedural imagery, applications, and in-room frame of reference to create a context-rich, immersive experience. The system is intended to empower surgical and care teams to quickly and securely connect to clinical specialists, technicians, trainers, or manufacturer’s representatives from across the organization or around the world, and at any time – virtually.

“Our mission at Image Stream Medical is about innovating to create simple ways for clinicians to connect with each other and sources of visual insight. Our flagship EasySuite® product helps improve the workflows of in-room clinicians by connecting them with imaging sources and patient information. MedPresence™ is the next step in care team efficiency improvement, allowing hospitals to assemble teams of experts, no matter where they are located,” said Eddie Mitchell, Image Stream Medical CEO. “Leveraging virtual experts elevates care team expertise, and protects the patient care environment by reducing room crowding, eliminating security and access concerns, and lowering a patient’s infection risk. And we’ve taken a great deal of care to ensure that all MedPresence™ participants can interact and communicate naturally with one another in the same kinds of ways that they would with an in-room colleague. We know that supporting natural ways of interacting is key to improving teamwork and efficiency.”

The release of MedPresence™ follows the June 1 acquisition of Image Stream Medical, Inc. by Olympus Corporation of the Americas. The completion of this acquisition, along with the release of MedPresence™, marks the start of new collaborations from the two companies.

“Directly on the heels of Image Stream Medical joining the Olympus family, the release of MedPresence™ is a testament to the strength of their innovation. We believe MedPresence™ has the potential to dramatically improve the efficiency and level of expertise of surgical teams by enabling hospitals to assemble highly collaborative teams with virtual experts to support a host of clinical and operational scenarios such as remote clinical consultations, tele-mentoring, care standardization programs, in-case application support, and new equipment training,” said Todd Usen, president, Olympus Medical Systems Group, United States. “We are delighted to have Image Stream Medical on board and look forward to continuing to improve both hospital efficiency and patient care through technologies like MedPresence™.”

Validated by an independent, nationally recognized security firm, MedPresence™ protects the integrity of sensitive information, featuring a fully encrypted, end-to-end security architecture. The patent-pending technology offers innovative features like automated masking of PHI, “on air” indicators, and one-button privacy mode enables real-time collaboration, while safeguarding patient and clinician privacy, as well as ensuring HIPAA compliance.

MedPresence™ and applications for advanced integration in procedure room environments will be on display in the Image Stream Medical booth #415 at the OR Manager Conference on October 2-4 in Orlando, FL.

About Image Stream Medical
Image Stream Medical is a leader in clinical visual collaboration solutions and focused on a single mission: to improve healthcare by connecting providers with the visual information and collaborative insight they need to deliver exceptional patient care. Since its founding in 1999, Image Stream Medical has achieved that goal by innovating healthcare environment integration solutions that make powerful capabilities easy to use. The result is a clinical workflow experience that is more intuitive, natural and efficient. Image Stream Medical, Inc. is a wholly owned subsidiary of Olympus Corporation of the Americas.

For more information, visit Image Stream Medical at www.imagestreammedical.com.

About Olympus Corporation of the Americas
Olympus Corporation of the Americas is a precision technology leader, designing and delivering innovative solutions in Medical and Surgical Products; Scientific Solutions; and Cameras and Audio Recorders. Our expertise in optical, digital and precision technologies provides the foundation for our innovations which look inside the human body to help prevent, diagnose and treat illness; further scientific research; and capture images of the world. Throughout our nearly 100-year history, Olympus has been recognized as a pioneer and innovator focused on contributing to society by making people’s lives healthier, safer and more fulfilling. Olympus Corporation of the Americas —a wholly owned subsidiary of Olympus Corporation in Tokyo, Japan—is headquartered in Center Valley, Pennsylvania and employs more than 5,000 employees throughout locations in North and South America.

For more information, visit Olympus at www.olympusamerica.com.

SOURCE Olympus Corporation of the Americas

Acelity Names Tracy Jokinen as Chief Financial Officer

Posted On June 16, 2017 By OrthoSpineNews In Financial /

June 12, 2017

SAN ANTONIO–(BUSINESS WIRE)–Acelity L.P. Inc., a leading global advanced wound care company, today announced the appointment of Tracy Jokinen as Executive Vice President and Chief Financial Officer.

Jokinen has 25 years of financial accounting, reporting, planning and analysis experience. She is the former CFO of G&K Services, a leading provider of uniform and facility services that was acquired by Cintas earlier this year. Prior to her role at G&K, Jokinen spent more than 20 years at Valspar Corporation where she held a number of leadership roles within the global finance organization.

“Tracy has a dynamic combination of skill and experience that is uniquely suited to the needs of Acelity and the next stage of growth for the company,” said R. Andrew Eckert, President and CEO of Acelity. “She brings a strategic mindset and fresh perspective that will help accelerate our objectives, not only on behalf of Acelity, but also the many patients around the world that we serve.”

Jokinen holds a bachelor’s degree in accounting from St. Cloud State University in St. Cloud, Minn. Interim CFO Todd Wyatt will transition into a new leadership role as part of the Acelity senior management team. Acelity wishes to acknowledge Todd’s indispensable leadership and service as Interim CFO.

About Acelity

Acelity L.P. Inc. and its subsidiaries are a global advanced wound care company that leverages the strengths of Kinetic Concepts, Inc. and Systagenix Wound Management, Limited. Available in approximately 90 countries, the innovative and complementary ACELITY™ product portfolio delivers value through solutions that speed healing and lead the industry in quality, safety and customer experience. Headquartered in San Antonio, Texas, Acelity employs nearly 4,800 people around the world.

Contacts

Acelity L.P. Inc.
Cheston Turbyfill, +1-210-515-7757
Corporate Communications
cheston.turbyfill@acelity.com
or
Investor Relations
Caleb Moore, +1-210-255-6433
caleb.moore@acelity.com

Cretex Companies Acquires Leading Medical Packaging Services Provider

Posted On June 15, 2017 By OrthoSpineNews In Financial, Top Stories /

ELK RIVER, MN, June 13, 2017— Cretex Companies (www.cretex.com) today announced it has acquired Quality Tech Services (QTS), a supplier of outsourced packaging services to the medical device industry.

We are extremely pleased to have QTS join our Cretex Medical group of companies,” said Lynn Schuler, Chief Executive Officer of Cretex Companies, Inc. “QTS is widely recognized as a leading provider of validated assembly, kitting, and packaging solutions. Their experienced team, including packaging engineers and microbiologists, are experts in the end‐of‐line, critical processes that most companies don’t understand or do well. By adding QTS’s capabilities, we’ve made Cretex Medical an even better outsource partner for medical device companies.”

Located in Bloomington, MN, QTS specializes in cleanroom assembly, packaging and labeling, sterilization management, process development and validations, and material sourcing and supply chain management. They serve a broad set of Original Equipment Manufacturers (OEMs) in the orthopedic, neurology, pulmonary, dental, and other medical device markets.

Doug Wilder, President of QTS, said, “We’re very excited to become part of the Cretex Medical group. Medical device OEMs are increasingly looking for providers who bring end‐to‐end solutions. They are actively pruning their supplier base and rewarding those who can do more. Combining Cretex and QTS creates significant upside for our customers. Equally important, the combination will be great for our employees. The cultures of the two companies are very similar. Customer service, quality, and providing a positive work environment are values that we share. We’re anxious to get started.”

Terms of the acquisition were not disclosed.

About Cretex Companies, Inc.

Cretex, established in 1917, is a privately held, diversified manufacturing company headquartered in Elk River, Minnesota serving four major markets: medical, aerospace & defense, industrial, and infrastructure. Under the Cretex Medical brand, the company’s subsidiaries rms, rms Surgical, Meier, Spectralytics, JunoPacific, and QTS provide contract manufacturing and outsourcing services to medical device manufacturers (OEMs). Cretex Medical provides a full suite of capabilities, including precision machining, metal stamping and fabrication, laser processing, plastic injection molding, medical device assembly and cleanroom packaging. Cretex Companies employs about 2,000 people in 14 locations in Minnesota, California, Tennessee, and Wisconsin.

Contact Info

Katie Welch Len

612‐720‐9374

Email: katiep@newsworthycommunications.com

Spinal Implants Market Is Predicted to Reach USD 14 Billion by 2022

Posted On June 14, 2017 By OrthoSpineNews In Financial /

Pune, India — (SBWIRE) — 06/14/2017 — Market Highlight

The global spinal implants market has been evaluated to be rapidly growing market and is expected to grow tremendously in the near future. Spinal implants are devices used by surgeons during surgery to treats deformities, stabilize and provide strength to the spine and to expedite the fusion process.

Spinal implants are used to treat spine related disorders including degenerative disc disease, scoliosis, kyphosis, fracture and spondylolisthesis. Global spinal implants market which is currently growing tremendously and is expected to reach USD 14 billion by the end of 2022.

Major Key Players

-Alphatec Spine Inc,
-Amedica Corporation,
-Depuy Synthes Inc. (Johnson & Johnson),
-Exactech Inc.,
-Globus Medical Inc.,
-Integra LifeSciences,
-K2M Inc.,
-LDR Holding Corporation,
-Medtronic plc,
-NuVasive Inc.,
-Orthofix Holdings, Inc.,
-RTI Surgical Inc.,
-Stryker Corporation,
-Quandary Medical LLC,
-Zimmer Biomet

READ THE REST HERE

Vertos Medical Secures $28 Million In Latest Round Of Funding

Posted On June 12, 2017 By OrthoSpineNews In Financial, Spine /

ALISO VIEJO, Calif., June 12, 2017 /PRNewswire/ — Vertos Medical Inc., a leader in the minimally invasive treatment of lumbar spinal stenosis (LSS), announced today it has completed a $28 million financing round. New investor, MVM Life Science Partners LLP, led the round with participation from existing investors Leerink Revelation Partners, Pitango Venture Capital, ONSET Ventures, and Aweida Venture Partners. Proceeds of the financing will be used to expand commercialization of the company’s proprietary mild® procedure, a clinically proven outpatient procedure that removes the cause of the stenosis through a portal the size of a baby aspirin and requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.

In December 2016, Vertos Medical received broad coverage from the Centers for Medicare & Medicaid Services (CMS) for mild. Vertos Medical will use the latest round of funding to help meet the strong demand for the procedure from providers and patients. Funding will also be used to support physician training and education designed to expand access to the novel treatment for appropriate patients.

“There are millions of patients currently suffering from the debilitating effects of lumbar spinal stenosis who are looking for new treatment options that are safe, effective, and treat the underlying cause of stenosis,” said Eric Wichems, President and CEO of Vertos Medical. “We are pleased that we are able to expand access to the mild procedure with the help of MVM and our current investors.”

In addition to leading this latest round, MVM partner Hugo Harrod will join the board of directors of Vertos Medical. Harrod, who has been with MVM since 2005, has extensive board-level experience at pharmaceutical and device companies.

“The proven, low-cost, and safe mild solution stands to benefit the more than 2.4 million Americans who are expected to suffer from LSS by 2021,” Harrod said. “MVM is excited to join with Vertos Medical in extending access to this unique clinical solution for patients living with the debilitating symptoms associated with LSS.”

The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials and has been performed on more than 20,000 patients. Peer-reviewed clinical data has proven the procedure’s strong safety profile and demonstrated that mild helps patients suffering from LSS stand longer and walk farther with less pain. ¹

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild^®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. The mild^®procedure treats this condition by restoring space in the spinal canal using specialized mild^® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that mild^® can help LSS patients stand longer and walk farther with less pain¹, and no major device-related complications have been reported in any clinical trial.² Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how mild^® treats LSS click here.

MVM Life Science Partners LLP, founded in 1997, is a healthcare investment firm with offices in London and Boston. MVM is currently investing from its fourth fund, which has $233M in commitments and broad interests across drugs, devices, and diagnostics.

SOURCE Vertos Medical

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

Posted On June 9, 2017 By OrthoSpineNews In Financial /

June 6, 2017 – By FINK DENSFORD

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

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

Posted On June 9, 2017 By OrthoSpineNews In Financial /

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

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

Correction, Amended 2016 Preliminary

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

Posted On June 9, 2017 By OrthoSpineNews In Financial, Robotics /

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

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