Russo Partners Teams with Medovex to Highlight Medical Technology Innovation with DenerveX System

NEW YORKNov. 13, 2017 /PRNewswire/ — Russo Partners LLC and Medovex Corp. (NASDAQ: MDVX) have teamed to call attention to the need for new treatments for chronic back pain and the Company’s innovative solution known as the DenerveX® System. Currently approved for use outside of the U.S., DenerveX is a new device designed to enable doctors to provide patients with enduring relief of back pain caused by Facet Joint Syndrome.

The Medovex public relations initiatives include an extensive video campaign featuring spine surgeons worldwide. Wilcots, an NFL broadcaster, former professional football player and leader of Russo Partners’ Sports-Health Alliance, recently interviewed doctors at the EUROSPINE 2017 annual meeting in Dublin and the North American Spine Society (NASS) conference in Orlando, where he also taped a demonstration of the DenerveX System in use in a surgical cadaver lab. Russo Partners and Medovex will integrate the content into ongoing social and traditional media initiatives this quarter as Medovex continues its country-by-country roll-out of the medical technology.

“Solomon has the natural ability to bring professionals together and craft medical stories in a natural and impactful manner,” said Patrick Kullmann, president and COO of Medovex. “We look forward to using the output of his work to increase the visibility and awareness of what we are doing at Medovex to transform how surgeons and pain management physicians treat a common source of chronic back pain. This is a meaningful change with our DenerveX system that is focused on long-term relief.”

Wilcots added, “Chronic back pain, including that caused by Facet Joint Syndrome, is common among former professional athletes. The opportunity presented by the DenerveX System is one of giving people back quality of life without reliance on prescriptive pain relief medicines. This is exciting technology about which physicians were eager to speak with me and share their perspectives on how it will change their practices and patients’ lives. We will continue with these initiatives throughout 2018.”

The DenerveX System is a non-addictive opioid drug alternative capable of restoring a patient to a more normal and active lifestyle. It was designed by medical professionals for medical professionals to enhance a patient’s quality of life. Using highly differentiated technology, the DenerveX System denervates and removes capsular tissue from the facet joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and radio frequency ablation treatment on the facet joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint. To learn more about the DenerveX System, visit http://medovex.com/us/denervex-system/.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in countries worldwide, including the U.S. and countries in the EU. This condition affects millions of people each year, and current treatment options are generally temporary with no proven long-lasting option.

About Medovex

Medovex Corp. was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with Facet Joint Syndrome at significantly less cost over time than currently available options. To learn more about Medovex, visit www.medovex.com.

About Russo Partners’ Sports-Health Alliance

The Sports-Health Alliance is an award-winning public relations service at the intersection of health, medicine and sports. Launched by Russo Partners in 2017, this offering leverages the agency’s inside access to athletes, broadcasters and sports business leaders who have a shared passion with their clients for a disease or treatment. The Alliance was cultivated over a two-year span and involves Russo Partners’ Team Leader Solomon Wilcots. Visit https://russopartnersllc.com/services/sports-health-alliance/ for more information.

About Russo Partners

Since 1988, Russo Partners, formerly Noonan/Russo Communications, has provided public and investor relations and corporate communications services to both emerging and established healthcare and technology-centric companies worldwide. The agency’s staff is comprised of senior executives with extensive backgrounds in science, medicine, finance and communications. Visit www.russopartnersllc.com for more information.

CONTACT INFORMATION

Medovex Corp.
Jason Assad
470-505-9905
Jassad@medovex.com

GLOBAL MEDIA CONTACTS

David Schull
Russo Partners LLC
212-845-4271 (office)
858-717-2310 (mobile)
David.schull@russopartnersllc.com

Caroline Cunningham
Russo Partners LLC
212-845-4292 (office)
203-969-4308 (mobile)
Caroline.cunningham@russopartnersllc.com

SOURCE Russo Partners, LLC

Related Links

http://www.russopartnersllc.com

SpineGuard and XingRong Medical launch PediGuard® in China

November 13, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today that XinRong Medical Group will officially launch the Classic PediGuard product range in China during the Chinese Orthopedic Association (COA) annual meeting being held in Zhuhai, China from November 15-18.

The COA meeting is the largest and most influential Orthopedic Surgery Society in China with 14 sub-specialties such as spine surgery. This annual meeting is widely attended by Chinese surgeons (over 21,000 attendees in 2016) and is a unique opportunity to launch the PediGuard®. Over recent years, the Chinese orthopedic market has become the second largest in the world, after the USA.

On November 16th, XinRong Medical Group will offer a PediGuard® workshop at their booth #3A11 with Prof. Chen Zhong Quing (China), Prof. Wong Hee Kit (Singapore) and Prof. Liang Yu (China) as faculty.

We believe the COA annual meeting is the best congress with the right timing to launch the PediGuard® in China. The workshop given by XinRong Medical Group will be the opportunity for the Chinese spine surgeons who have been waiting for SpineGuard’s DSG™ technology since its clearance by CFDA, to learn more about the products from experienced key opinion leader surgeons and facilitate first use. We are delighted by the collaboration with our very dynamic partner XinRong and are looking forward to supporting our common success in China with PediGuard®” said Stéphane Bette, CEO and co-founder of SpineGuard.

“We are very excited to hold the official PediGuard® China Launch Meeting during COA supported by top key opinion leaders in spine surgery in China. PediGuard® can alert surgeons of potential pedicular or vertebral breaches and provides real-time feedback through audio and visual signals. With the introduction of this device, we could help Chinese surgeons reduce the risk of pedicle screw misplacement and dramatically improve outcomes for patients. Moreover and looking forward, SpineGuard has received the patent for its smart screw concept integrating its DSG™ sensor into the implantable pedicle screw through imbedding electronics into the screwdriver handle, opening new opportunities for further collaborations.”, added Christine Zhang, XinRong Medical Group’s CEO.

More information on the DSG™ technology and surgeons’ testimonials here.

Next financial press release: 2017 full year revenue, January 4, 2018

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About XinRong Medical Group
XinRong Medical Group, a leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solutions for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopedic surgery, neurosurgery, reconstructive surgery, and minimally invasive therapy. Established in 2000 in Jiangsu Province, China, XinRong Medical was one of the first companies in China cleared by CFDA to manufacture Orthopedic Implants. In 2014, the Company received a strategic investment from The Blackstone Group (NYSE: BX). For additional information about XinRong Medical, please refer to our website www.XRBest.Com, or contact us directly at +86-512-58100828 or info@xrmed.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette
Chief Executive Officer
Tel: +33 (0) 1 45 18 45 19
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
Tel: +33 (0)1 45 18 45 19
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr

OrthoPediatrics Corp. to Start Distributing Bioretec Devices via Private Label

WARSAW, Ind., Nov. 13, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, and Bioretec Ltd. (“Bioretec”), announced today that they have amended their existing distribution agreement in order for OrthoPediatrics to market and sell Bioretec’s unique, bioresorbable orthopaedic bone and soft-tissue fixation implants under the OrthoPediatrics brand, TorqLoc™. Bioretec’s bioresorbable implants are ideal for repairing musculoskeletal defects of children and young people. Treatment of musculoskeletal defects and trauma related bone and soft-tissue injuries are steadily increasing, as well as the need for surgeries related to treating such conditions. Bioretec’s fully bioresorbable implants have shown excellent results in repairing the growing bones of children and young people.

“We are excited to start OrthoPediatrics’ private label collaboration, whose enthusiasm towards developing and improving surgical care for children, we admire.  Our products are ideal for surgeries of children, since the bioresorption of our implants eliminates the need for secondary removal operation after the healing of musculoskeletal tissues. This is especially important with children, for whom the risks and inconveniences associated with surgical procedures are much higher,” commented Tomi Numminen, CEO of Bioretec.

OrthoPediatrics’ Vice President for Trauma & Deformity Correction, Joe Hauser, added, “This evolving strategic partnership and collaboration with Bioretec represents another area for tremendous growth within OrthoPediatrics’ portfolio.  The TorqLoc™ screw portfolio will provide a truly innovative option for many unmet pediatric orthopedic sports and tissue repair surgical needs.  In addition to OrthoPediatrics’ all epiphyseal ACL system, we now can help our surgeon partners with MPFL, foot, shoulder, and hand solutions by providing this new generation bioabsorbable implant offering.”

About Bioretec
Bioretec Ltd. is a Finnish material technology company focused on the development, manufacturing and marketing of bioabsorbable, bioactive and drug-releasing surgical implants for orthopedic, trauma and sport medicine surgeries. Bioretec implants, designed and manufactured in Finland, have been used in 33 countries, including United States, China, Russia, UK, Germany, Italy and Spain.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

TransEnterix Announces Senhance US Sale Agreement With Florida Hospital

November 13, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that Florida Hospital entered into an agreement to purchase the Company’s Senhance Surgical Robotic System.

The Florida Hospital Orlando campus will be home to the first commercial unit of the Senhance Surgical System to be installed in the United States.

Now available in the United States, the recently FDA-cleared Senhance Surgical System represents an innovative technology designed to assist surgeons in performing minimally invasive surgery. The system features multiple robotic arms that are controlled by a surgeon seated comfortably at a console. The surgeon controls small surgical instruments with robotic precision while at the same time moving a small scope that tracks the eye movement of the surgeon. The Senhance is the first surgical robotic system to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue. The Senhance represents a new era of digital laparoscopy designed to support responsible economics for the hospital, patient and today’s value-based healthcare system.

“We are pleased to announce our first US sale of the Senhance Surgical System,” said Todd M. Pope, President and CEO at TransEnterix. “Florida Hospital is a global leader in the application of next generation technologies to care for patients. It’s fitting that Florida Hospital will be the first in the United States to adopt this technology for patient care.”

“The digital operating room of the future has arrived, and our surgeons will continue to be leaders in applying robotic technology, like the Senhance, to benefit our patients across a full range of procedures and specialties,” said Dr. Steve Eubanks, surgeon and Executive Medical Director for the Institute for Surgical Advancement at Florida Hospital. “Our team of clinicians selected the Senhance Surgical System to further our minimally invasive offerings. We believe this robotic system will support our surgeons in maximizing their precision and control during procedures while minimizing costs.”

About Florida Hospital

Florida Hospital is a member of Adventist Health System, which operates 45 hospitals in 9 states, making it one of the largest not-for-profit healthcare systems in the United States, caring for more than 5 million patients annually. Florida Hospital continues to be at the forefront of health-care innovation. In addition to the Florida Hospital Institute for Surgical Advancement, it’s also home to the Florida Hospital Nicholson Center, a facility specializing in training surgeons from around the globe on the latest surgical technology and techniques, and the Global Robotics Institute, a world leader in the robotic-assisted treatment of prostate cancer.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The company is focused on the commercialization of the Senhance Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. For more information, visit the TransEnterix website at www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance Surgical Robotic System will benefit Florida Hospital’s patients and whether the Senhance Surgical Robotic System will support Florida Hospital’s surgeons in maximizing their precision and control during procedures while minimizing costs. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact:
Joanna Rice, + 1 951-751-1858
joanna@greymattermarketing.com

Trump picks Alex Azar to lead the Health and Human Services Department

 / November 13, 2017

President Trump has selected Alex Azar, a former pharmaceutical executive and a top health official during the George W. Bush administration, to lead the Health and Human Services Department.

The decision to enlist the 50-year-old Azar — who served as president of Lilly USA, the biggest affiliate of Eli Lilly and Co., before stepping down in January to work as a health-care consultant — represents a pragmatic pick. An establishment figure with a reputation as a conservative thinker and methodical lawyer, Azar would be expected to use his experience as HHS general counsel and deputy secretary to pursue Trump’s goals through executive action.

In announcing the nomination Monday morning, Trump tweeted that Azar “will be a star for better healthcare and lower drug prices!” He has a close rapport with the department’s top political appointees as well as Vice President Pence.

Azar has been highly critical of the Affordable Care Act, telling Fox Business in May that the law was “certainly circling the drain” and saying in a speech two months ago that many of its problems “were entirely predictable as a matter of economic and individual behavior.”

In a June interview on Bloomberg Television, Azar made it clear he thought the administration could shift the ACA in a more conservative direction even if congressional Republicans failed to repeal much of it. “I’m not one to say many good things about Obamacare, but one of the nice things in it is it does give tremendous amount of authority to the secretary of HHS,” he said.

He also supports converting Medicaid from an entitlement program covering everyone who is eligible into block grants, a long-standing GOP goal that has sparked opposition from Democrats as well as some centrist Republicans. He has opposed expanding the program under the ACA to people with slightly higher incomes.

The nominee boasts sterling conservative credentials, clerking for the late Supreme Court Justice Antonin Scalia before working under special counsel Kenneth Starr to investigate Bill Clinton’s failed Whitewater real estate investments. Still, administration officials think he could work more deftly with competing health-care interests and politicians than his predecessor, Tom Price.

 

READ THE REST HERE

Smith & Nephew’s NAVIO™ Surgical System launches the first robotics-assisted bi-cruciate retaining total knee replacement

13 November 2017

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announces completion of the world’s first robotics-assisted bi-cruciate retaining total knee replacement procedures.

The NAVIO robotics-assisted surgical system aids in implanting the JOURNEY™ II XR (bi-cruciate retaining total knee system) which is one of the only total knee designs allowing retention of the ACL, and is designed to improve patient satisfaction. 1

With this launch, NAVIO now offers both partial and total knee options that include the first and only robotics-assisted bi-cruciate retaining knee procedure, commercially available today.

Drs. Vivek Neginhal (WV), David Rovinsky(HI), and David Fabi (CA) recently performed the first cases. “I believe that the NAVIO is able to provide critical elements of success for the JOURNEY II XR, such as accuracy of tibia component placement and a streamlined surgical technique.” Dr. Neginhal further commented: “I was amazed at how fluid the knee motion was on the first postop day. My patients have expressed great satisfaction so far. I believe that NAVIO’s accuracy and flexibility of use combined with JOURNEY II XR’s retention of the patient’s cruciate ligaments and physiological design will truly increase patients’ function and satisfaction.”

The NAVIO is a next generation handheld robotics platform designed to aid surgeons with implant alignment, ligament balancing and bone preparation – key factors that can drive implant survivorship.2,3 The small footprint of NAVIO allows for set up and portability. Furthermore, the NAVIO robotics-assisted system does not require a preoperative image, such as a CT scan. This allows patients to receive the benefits of robotics-assistance without the extra steps, costs, and radiation associated with additional preoperative imaging.4

“The JOURNEY II XR bi-cruciate retaining knee has the potential to deliver the best possible outcome for the surgeon and patient through the preservation of important anatomical structures such as the ACL. The NAVIO robotics-assisted surgical system enables accurate tibial implant placement to deliver a more reproducible surgical technique. We are proud to be the only company to offer the unique combination of NAVIO robotics-assistance and the JOURNEY II XR Knee System,” said Mike Donoghue, Senior Vice President of Global Marketing, Orthopaedics at Smith & Nephew.

References

  1. Moro-Oka, Taka-Aki, Marc Muenchinger, Jean Pierre Canciani, and Scott A. Banks.“Comparing in Vivo
    Kinematics of Anterior Cruciate-retaining and Posterior Cruciate-retaining Total Knee Arthroplasty.” Knee
    Surgery, Sports Traumatology, Arthroscopy 15.1 (200&): 93:99. Web.
  2. Sharkey, P., et al. “Why Are Total Knee Arthroplasties Failing Today?” Clinical Orthopaedics and Related Research. 2002 Nov;404:7-13.
  3. Siddique, N., Ahmad, Z. “Revision of Unicondylar to Total Knee Arthroplasty: A Systematic Review” The Open Orthopaedics Journal 2012;6; (Suppl 2: M2) 268-275
  4. Sg2 Healthcare Intelligence. Technology Guide: Orthopedic Surgical Robotics. 2014.25. Readmissions Reduction Program (HRRP). CMS.gov. Page last Modified: 04/18/2016 5:08 PM.

Enquiries

Media  
Charles Reynolds +44 (0) 1923 477314
Smith & Nephew
Dave Snyder +1 (978) 749-1440
Smith & Nephew
Simon Conway / Debbie Scott +44 (0) 20 3727 1000
FTI Consulting

 

Investors  
Ingeborg Øie +44 (0) 20 7960 2285
Smith & Nephew

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic ReconstructionAdvanced Wound ManagementSports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.comfollow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

 Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

Extremity Reconstruction Market is evolving at fast pace

11-13-20017 / Health & Medicine, Press Release from: TMR Research

Extremity reconstruction implies the restoration of limbs and limb functions to patients who have suffered the removal of limbs due to trauma or medical removal after cancer or other issues. This also includes limb removal after vascular diseases, metabolic diseases, infections, or rheumatoid arthritis. Lower extremity reconstruction involves three key segments based on the location of the wound, into knees, feet, and the tibia bone. Extremity reconstruction can allow for a high level of restoration of mobility and lifestyle to patients. Owing to the increasing counts of patients suffering from cancers, chronic diseases, and accident related injuries that result in the removal of extremities, it is becoming increasingly important for developments in this field to take up greater investments from the healthcare industry.

Request a sample copy of the Report @ www.tmrresearch.com/sample/sample?flag=B&rep_id=1175

Plastic surgeons can also make use of flaps or skin grafts to hide the wounds on extremities, giving patients a significantly faster recovery rate into daily life and a normal lifestyle. Nearly all types of extremity reconstruction surgeries will require the use of general anesthesia. Additional care is also needed from the patient’s side post-surgery. For example, they are expected to follow s stricter diet for the speedy recovery of limbs. Smokers are especially encouraged to quit in order to prevent deterioration of wound and to normalize the overall healing rate.

Global Extremity Reconstruction Market : Snapshot

The global market for extremity reconstruction is expected to witness a high level of growth in the next few years. The rising number of cases of abnormalities and injuries in the lower and upper extremity of the human body is one of the vital factors estimated to encourage the growth of the global market in the coming years. In addition, several advancements in the healthcare infrastructure are anticipated to accelerate the development of the market in the near future. The implant devices for different parts of the human body comprises the extremity reconstruction market in the coming years.

A tremendous rise in the geriatric population and the rising incidences of obesity and diabetes are some of the major factors that are estimated to fuel the development of the global extremity reconstruction market in the near future. Moreover, the increasing cases of osteoarthritis and rheumatoid are likely to accelerate the growth of the market in the coming years. The rising awareness regarding the benefits of small joint reconstruction implants among patients is predicted to encourage the growth of the global extremity reconstruction market in the next few years.

Request TOC of the report @ www.tmrresearch.com/sample/sample?flag=T&rep_id=1175

Technological advancements and the availability of required infrastructure are projected to augment extremity reconstruction market in North America market in the next few years. The leading players operating in the extremity reconstruction market across the globe are emphasizing on introducing innovative implants in order to attract a large number of consumers and attain a leading position in the market. Additionally, the rising level of competition is predicted to expand the product portfolio and benefit the patients in the coming years.

Global Extremity Reconstruction Market: Overview

The increasing incidence of injuries, abnormalities, and congenital defects in the upper or lower extremity of human body has fuelled the demand for reconstructive surgical procedures. Implant devices for the shoulder, wrist, ankle joints, digits, elbow, and foot are part of the extremity reconstruction market.

The primary driver of the global extremity reconstruction market is the large pool of geriatric population. According to the Centers of Disease Control and Prevention, with a rise in the geriatric population in the U.S., by the year 2040, the number of patients affected by arthritis is expected to increase to 78 million. Since aged people are more prone to injuries, growth in geriatric population is expected to fuel the demand for reconstructive surgical procedures.

Global Extremity Reconstruction Market: Key Trends

The rising incidence of joint disorders such as rheumatoid and osteoarthritis arthritis, coupled with the globally increasing incidence of diabetes and obesity, and rising geriatric population are driving the global extremity reconstruction market. Moreover, growing awareness among patients about the advantages of small joint reconstruction implants and enhanced technology such as development of reverse shoulder implants, stem less shoulder implants, and ankle reconstruction implants, which aid in recovering ankle mobility are projected to boost the market. The zest to get back to the active lifestyle, post-injury or trauma will supplement the demand for extremity reconstruction surgeries.

Read Comprehensive Overview of Report @ www.tmrresearch.com/extremity-reconstruction-market

On the downside, complications associated with extremity reconstruction surgeries and unfavorable reimbursement scenario will pose as threat to the global extremity reconstruction market.

Global Extremity Reconstruction Market: Market Potential

The global market for extremity reconstruction surgeries is evolving at fast pace. 3D implants are fast gaining traction among arthritis patients. It helps in better motion, it is less painful, and results in quick recovery. Various market giants have largely invested in this technology, to hold their position over the forecast period.

In February 2016, Zimmer Biomet received the US FDA approval for its 3D printed ankle fusion system. Similarly, in 2015 Stryker added 3D printed patellas and tibial baseplates to their Triathlon Tritanium Cone Augments and Triathlon Tritanium Knee System, which are used in knee surgeries. The company also has plans to build 3D manufacturing facility with investment of around US$ 400 mn.

Recently, a shoulder hemiarthroplasty or a shoulder replacement surgery was successfully carried out in Gandhi Hospital. This is a first-of-its-kind surgery performed by the doctors of the state-run hospital. Shoulder arthroplasty is a fast evolving field of orthopedics concentrated on treating specific, painful ailments of the gleno humeral articulation.

Global Extremity Reconstruction Market: Regional Outlook

The region to hold a leading share of the market is North America, and is expected to grow at a strong rate during the forecast period. Increased awareness regarding the benefits of extremity reconstruction devices, rise in occurrence of joint disorders, coupled with escalating geriatric population, encouraging reimbursement rates, presence of innovative technologies, and quest for better quality of life are the factors fuelling the demand for reconstruction procedures in this region.

During the forecast period, Asia Pacific is forecast to emerge as a lucrative market for extremity reconstruction. The rate of growth can be attributed to increase in acceptance of advanced technologies, presence of ample growth opportunities for the treatment of small joint disorders, and rise in awareness about the advantages of extremity reconstruction surgeries.

Global Extremity Reconstruction Market: Competitive Analysis

Some of the leading players operating in the global extremity reconstruction market are Arthrex, Inc., DePuy Synthes, Integra Lifesciences Holdings Corporation, Acumed, Inc., CONMED Corporation, Stryker Corporation, Zimmer Biomet Holdings, Inc., Wright Medical Group N.V., Smith & Nephew plc, and Skeletal Dynamics LLC.

The key market participants are bringing out innovative implants, which are wear and corrosion resistant to gain a stronghold in the market. Established players to boost clinical outcomes are making improvements in reconstruction procedures.

About Us:
TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in today’s supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients’ conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

Contact Us:
Rohit Bhisey
Head Internet Marketing
Tel: +1-415-520-1050
Email: sales@tmrresearch.com

This release was published on openPR.

Alphatec Holdings, Inc. Reports Third Quarter 2017 Financial Results

CARLSBAD, Calif., Nov. 09, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, announced today financial results for its third quarter ended September 30, 2017 and recent corporate highlights.

Third Quarter 2017 Financial Highlights

  • Total revenue of $23.1 million; U.S. commercial revenue of $20.7 million;
  • Cash burn improved to $3.7 million from $6.4 million sequentially;
  • Operating expenses improved $0.7 million sequentially; non-GAAP operating expenses improved $1.2 million sequentially.

Organizational, Commercial, and Product Highlights

  • Enhanced senior leadership team with the appointment of Patrick Miles, a globally recognized spine visionary, to the position of Executive Chairman;
  • Expanded the Board of Directors with the appointments of seasoned medical device executive, Quentin Blackford, and capital markets expert, Ward Woods;
  • Continued to drive momentum in transition of sales organization from non-exclusive to dedicated with third quarter sales from dedicated sales agents and distributors of over 30%, up significantly from just over 18% last quarter;
  • Commercially launched the Alphatec SquadronTM Lateral Retractor, a key component of the Battalion® Lateral System, in October.

“I am pleased with the execution of our team during the third quarter. Our financial results were in line with our pre-announced ranges.  In spite of the revenue challenges presented by weather and the sequential loss of two selling days in the quarter, we successfully managed operating expenses and improved cash burn,” said Terry Rich, CEO.   “We also drove momentum in the transition of our sales channel and made excellent progress on the initiatives that remain priorities as we reimagine Alphatec, keeping us on track to grow revenue sequentially in the fourth quarter.”

“I am especially excited to welcome Pat Miles, one of the spine industry’s most respected leaders, to our team,” added Rich. “Under his leadership, and with his passionate contribution to Alphatec’s product development, marketing, and surgeon engagement, we will lead the industry in terms of spine experience, driving innovation that improves the surgical experience and patient outcomes.  We are exceptionally well-positioned to take market share in U.S. spine.”

Comparison of Financial Results for the Third Quarter 2017 to Second Quarter 2017

Following is a table, comparing key third quarter 2017 results to second quarter 2017 results.  At this time, the Company believes that sequential results are the best indicators of performance. These are the comparisons management uses in its own evaluation of continuing operating performance given the re-focus of the Company’s strategy under a new leadership team.

Three Months Ended Change
September 30, 2017   June 30, 2017 $000’s   %
(unaudited)
U.S. commercial revenue $ 20,662 $ 21,877 $ (1,215 ) (5.6 %)
U.S gross profit 14,280 15,521 (1,241 ) (8.0 %)
U.S. gross margin 69.1 % 70.9 %
Operating Expenses
Research and development $ 1,044 $ 990 $ 54 5.5 %
Sales and marketing 10,015 10,298 (283 ) (2.8 %)
General and administrative 4,403 5,351 (948 ) (17.7 %)
Amortization of intangible assets 172 172
Restructuring expenses 139 528 (389 ) (73.7 %)
Gain on sale of assets (856 ) 856
Total operating expenses $ 15,773 16,483 $ (710 ) (4.3 %)
Operating loss $ (1,261 ) $ (735 ) $ (526 ) (71.6 %)
Loss from continuing operations $ (3,076 ) $ (2,629 ) $ (447 ) (17.0 %)
Non-GAAP Adjusted EBITDA $ 1,126 $ 1,218 $ (92 ) (7.6 %)

U.S. commercial revenue for the third quarter of 2017 was $20.7 million, down $1.2 million compared to $21.9 million in the second quarter of 2017.  The sequential decline was driven primarily by the impact of two less surgery days in the third quarter, weather-related impacts, and deliberate decisions to discontinue non-strategic relationships.

U.S. gross profit and gross margin for the third quarter of 2017 were $14.3 million and 69.1%, respectively, compared to $15.5 million and 70.9%, respectively, for the second quarter of 2017. The decrease in gross margin was due to lower sales volume, changes in product mix, and the impact of variations in inventory write-offs as the Company continues to optimize its supply chain.

Total operating expenses for the third quarter of 2017 were $15.8 million, reflecting a decrease of $0.7 million compared to $16.5 million in the second quarter of 2017.  On a non-GAAP basis, excluding restructuring charges and a gain on sale of assets, total operating expenses in the third quarter improved by $1.2 million compared to the second quarter of 2017. The improvements reflected the execution of operational improvement initiatives, including workforce reductions, facilities consolidation, and the success of ongoing efforts to reduce expenses.

GAAP loss from continuing operations for the third quarter of 2017 was $3.1 million, compared to a loss of $2.6 million for the second quarter of 2017.

Non-GAAP Adjusted EBITDA in the third quarter of 2017 was $1.1 million, compared to $1.2 million in the second quarter of 2017.  For more detailed information, please refer to the table, ”Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures,” that follows.

Current and long-term debt includes $33.0 million in term debt and $9.2 million outstanding under the Company’s revolving credit facility at September 30, 2017. This compares to $33.6 million in term debt and $8.9 million outstanding under the Company’s revolving credit facility at June 30, 2017.

Cash and cash equivalents were $15.4 million at September 30, 2017, compared to $19.1 million reported at June 30, 2017.  In October 2017, the Company secured a commitment for additional equity investments of $3.5 million to $4.0 million, payable on or before January 1, 2018, and generated cash proceeds of $1.7 million from the exercise of warrants.

Comparison of Financial Results for the Three and Nine Months Ended September 30, 2017 and 2016

Revenue decreased on a year-over-year basis as a result of the Company’s execution of its sales organization transition and the impact of lost revenue related to the financial and operational challenges the Company faced in 2016 prior to the sale of its international business.  The year-over-year improvement in operating expenses is the result of a comprehensive initiative to reduce costs and drive operational efficiencies.  For additional information, please reference the following financial statement tables and the Company’s Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission on November 10, 2017.

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, and other non-recurring income or expense items, such as sale of assets, impairments, restructuring expenses, severance expenses and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures. The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Investor Conference Call

Alphatec will hold a conference today at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 4698936. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

About Alphatec Holdings, Inc.

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

Additional information can be found at www.atecspine.com.

Forward Looking Statements 

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

Investor/Media Contact:

Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
ir@atecspine.com

 

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited) 
Three Months Ended Nine Months Ended
September 30,  September 30, 
2017 2016 2017 2016
Revenues $ 23,099 $ 26,711 $ 75,456 $ 93,158
Cost of revenues 8,587 10,849 28,417 31,651
Gross profit 14,512 15,862 47,039 61,507
Operating expenses:
Research and development 1,044 1,087 3,483 6,799
Sales and marketing 10,015 11,764 31,416 39,498
General and administrative 4,403 4,136 15,977 19,416
Amortization of intangible assets 172 83 516 593
Restructuring expenses 139 1,605 1,898 1,736
Goodwill and intangible asset impairment 1,736 1,778
Gain on sale of assets (856 )
Total operating expenses 15,773 20,411 52,434 69,820
Operating loss (1,261 ) (4,549 ) (5,395 ) (8,313 )
Interest and other expense, net (1,822 ) (10,511 ) (5,677 ) (12,869 )
Loss from continuing operations before taxes (3,083 ) (15,060 ) (11,072 ) (21,182 )
Income tax provision (7 ) (4,997 ) 57 (4,962 )
Loss from continuing operations (3,076 ) (10,063 ) (11,129 ) (16,220 )
Loss from discontinued operations (61 ) (3,658 ) (220 ) (9,351 )
Net loss $ (3,137 ) $ (13,721 ) $ (11,349 ) $ (25,571 )
Net loss per share continuing operations $ (0.22 ) $ (1.17 ) $ (0.98 ) $ (1.91 )
Net loss per share discontinued operations (0.01 ) (0.43 ) (0.02 ) (1.10 )
Net loss per share  – basic and diluted $ (0.23 ) $ (1.60 ) $ (1.00 ) $ (3.01 )
Weighted-average shares – basic and diluted 13,938 8,560 11,349 8,505
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands) 
September 30, December 31,
2017 2016
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 15,437 $ 19,593
Accounts receivable, net 13,303 18,512
Inventories, net 29,747 30,093
Prepaid expenses and other current assets 2,019 4,262
Current assets of discontinued operations 236 364
Total current assets 60,742 72,824
Property and equipment, net 13,275 15,076
Intangibles, net 5,482 5,711
Other assets 222 516
Noncurrent assets of discontinued operations 52 61
Total assets $ 79,773 $ 94,188
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 2,865 $ 8,701
Accrued expenses 22,606 27,589
Current portion of long-term debt 3,037 3,113
Current liabilities of discontinued operations 283 732
Total current liabilities 28,791 40,135
Total long term liabilities 60,894 71,954
Redeemable preferred stock 23,603 23,603
Stockholders’ deficit (33,515 ) (41,504 )
Total liabilities and stockholders’ deficit $ 79,773 $ 94,188

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands – unaudited) 
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Operating loss, as reported $ (1,261 ) $ (4,549 ) $ (5,395 ) $ (8,313 )
Add back:
Depreciation 1,564 1,623 4,834 5,652
Amortization of intangible assets 234 306 702 915
Total EBITDA 537 (2,620 ) 141 (1,746 )
Add back significant items:
Stock-based compensation and stock price guarantee 450 (12 ) 1,669 1,510
Restructuring and other charges 139 1,605 1,898 1,778
Goodwill and intangible asset impairment 1,736 1,736
Gain on sale of assets (856 )
Adjusted EBITDA $ 1,126 $ 709 $ 2,852 $ 3,278

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF GEOGRAPHIC SEGMENT REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited) 
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Revenues by source
U.S. commercial revenue $ 20,662 $ 25,189 $ 65,976 $ 82,445
Other 2,437 1,522 9,480 10,713
Total revenues $ 23,099 $ 26,711 $ 75,456 $ 93,158
Gross profit by source
U.S. $ 14,280 $ 15,209 $ 46,070 $ 56,430
Other 232 653 969 5,077
Total gross profit $ 14,512 $ 15,862 $ 47,039 $ 61,507
Gross profit margin by source
U.S. 69.1 % 60.4 % 69.8 % 68.4 %
Other 9.5 % 42.9 % 10.2 % 47.4 %
Total gross profit margin 62.8 % 59.4 % 62.3 % 66.0 %

Amedica Announces Reverse Stock Split

SALT LAKE CITY, Nov. 10, 2017 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company that develops and manufactures silicon nitride as a platform for biomedical applications, today announced a 1-for-12 reverse stock split of its issued and outstanding common stock. The Company’s common stock will open for trading on a split-adjusted basis on Friday, November 10, 2017 (the “Effective Time”).  The split-adjusted shares of Amedica’s common stock will continue trading on the Nasdaq Capital Market under the Company’s existing symbol “AMDA.”  A new CUSIP number of 023435407 has been assigned to the Company’s common stock as a result of the reverse split.

The reverse stock split will reduce the number of shares of common stock outstanding from approximately 36,264,881 million to approximately 3,022,073 million upon commencement of trading on the Effective Time.  The reverse stock split affects all issued and outstanding shares of the Company’s common stock immediately prior to the Effective Time of the reverse stock split. The number of authorized shares of the Company’s common stock will remain unchanged.

American Stock Transfer and Trust Company, Amedica’s transfer agent, will instruct certificate shareholders on the exchange process once the reverse stock split takes effect.  Shareholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split.  Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.  No fractional shares will be issued.  Stockholders who otherwise would be entitled to receive fractional shares because they hold a number of shares not evenly divisible by 12, will automatically receive one whole share of common stock in lieu of the fractional share. No stockholders will receive cash in lieu of fractional shares.

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 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 September 20, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

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

Solvay helps DiFusion Technologies innovate new ZFUZE osteoconductive PEEK composite for spinal implants

Alpharetta, Ga., Nov. 9, 2017 —Solvay, a leading global supplier of specialty polymers, announced that medical device-maker DiFusion Technologies chose Zeniva® ZA-500 polyetheretherketone (PEEK) as the base polymer for its ZFUZE osteoconductive PEEK composite for spinal implants. The new compound exhibited large areas of new bone formation on all bone implant surfaces in recent testing by DiFusion, who shared its results at the recent NASS 2017 event in Orlando.

PEEK is an attractive alternative to titanium for spinal implants because it shares similar modulus to bone, and its radio transparency allows for easy visualization in X-rays. The polymer is also inert, which means it does not interact with human tissue. While this quality supports biocompatibility, it means that PEEK does not naturally lend itself to bone growth. DiFusion solved this problem by compounding negatively charged zeolites into Solvay’s Zeniva® PEEK polymer.
“It was sort of a penicillin moment,”said Derrick Johns, CEO of DiFusion Technologies. “We started out engineering anti-microbial polymers by first loading zeolite particles with silver before compounding them. But we discovered if we took the silver cations out of the zeolite, they imbued PEEK with a negative charge. Osteoblast cells are attracted to the negatively charged surface at a far higher rate than titanium, and yet we were able to preserve the polymer’s outstanding visualization, modulus and strength benefits.”
Solvay was an early collaborator in the development of DiFusion’s patented ZFUZE composite, combining industry-leading materials expertise with technical and regulatory support for medical devices. Zeniva® ZA-500 PEEK was of particular interest to DiFusion due to the polymer’s higher flow, which facilitates both the compounding process and the extrusion of osteoconductive implants.
“In addition to our materials expertise, Solvay’s open innovation business model was instrumental to the successful innovation of DiFusion’s ZFUZE osteoconductive composite,”said Jeff Hrivnak, global business manager for Healthcare at Solvay’s Specialty Polymers Business Unit. “Our uniquely collaborative approach to customer projects differentiates us from other PEEK suppliers in this industry, and it allowed us to pool our respective capabilities and resources with DiFusion to solve this demanding challenge.”
DiFusion’s ZFUZE composite technology is in the final stages of its 510K approval process with the U.S. Food and Drug Administration. It is expected to be commercially available in the U.S. early next year.
® Zeniva is a registered trademark of Solvay

Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra-high performance polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay is a multi-specialty chemical company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers in diverse global end markets. Its products and solutions are used in planes, cars, smart and medical devices, batteries, in mineral and oil extraction, among many other applications promoting sustainability. Its lightweighting materials enhance cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 58 countries. Net sales were € 10.9 billion in 2016, with 90% from activities where Solvay ranks among the world’s top 3 leaders. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Founded in 2008 in Austin, Tex., DiFusion Technologies, Inc. is a medical device company focused on reducing the rising incidence of surgical site infections in orthopedic and spine surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants. Initially focusing on the multi-billion dollar spinal implant market, the company has developed a technology with applicability across a variety of orthopedic segments using well characterized implants with benefits for the patient, surgeon, hospital and payer. For more information about DiFusion Technologies, visit www.difusiontech.com.

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