Mortise Medical Receives FDA Clearance for SyndesMetrics Syndesmosis Repair System

LOGAN, Utah, November 14, 2017 – Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative SyndesMetricsÔ Syndesmosis Repair System.

The Mortise Medical SyndesMetricsÔ Syndesmosis Repair System was developed to address three clinical needs for syndesmotic disruption injuries: predictable and repeatable anatomic reduction, restoration of physiological motion, and restoration of ankle stability.  Anatomic reduction is achieved using the SyndesMetricsÔ Reduction Clamp, which features: anatomic referencing clamp points; precision, surgeon controlled, calibrated clamping force; and an integrated drill guide to prepare the bone for the SyndesMetricsÔ  implant system.  Both the SyndesMetricsÔ Reduction Clamp and implant system are compatible with distal fibula plating systems.  Also, the SyndesMetricsÔ implant system features minimal hardware prominence, no suture prominence and a reversible locking mechanism for securing the high strength suture tape that connects the tibial and fibular implant components.

Based on biomechanical testing on matched pair human cadaveric ankle specimens at the University of Iowa, the SyndesMetricsÔ implant system was found to more closely reproduce normal physiological ankle motion when compared to a 4.5mm cortical screw or a suture button construct.1  Additionally, mechanical testing conducted by a third party medical device testing company demonstrated that SyndesMetricsÔ repair constructs had higher static strength and higher fatigue strength than 3.5mm cortical screw or suture button repair constructs.2

“Surgeons will find this innovative system more intuitive to use and more reproducible for positioning and tensioning the distal tibiofibular syndesmosis than anything we now have available,” states Dr. Charles L. Saltzman, Professor and Chairman of Orthopaedics at the University of Utah and immediate past President of the International Federation of Foot and Ankle Societies.

Mortise Medical is a medical device company incubated and operated by Surgical Frontiers.

1 Goetz JE, et al., Annual Meeting of the American Society of Biomechanics, 2017

2 Data on file

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

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

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.

Arthrex Announces Plans for Expansion of Global Headquarters

NAPLES, FL – November 9, 2017 – Arthrex announced details of its planned expansion for its North Naples global headquarters on Thursday in an event with Florida Governor Rick Scott and other state and local elected officials.

Construction is scheduled to begin next month with completion by the end of 2019.

“As Arthrex continues to experience unprecedented growth around the world, we remain committed to expanding in Southwest Florida,” said President and Founder Reinhold Schmieding. “This project was designed to accommodate our growth into the next decade, while maintaining the beautiful aesthetic of the Naples community.”

The project will demolish the Arthrex Manufacturing Inc. North building, located at 1250 Creekside Way, just east of the post office. Two grey office buildings located along Goodlette Road will also be demolished for the project.

Arthrex will construct three facilities for the project. The Arthrex Event and Administration Building will be a six-story, 300,000-square-foot modern office building with meeting space and will include a 15,000-square-foot cafeteria, a six-story parking garage with space for 1,400 vehicles and an outdoor terrace area overlooking a one-acre lake.

The INNovation Hotel, which will be located on the corner of Goodlette Road and Creekside Boulevard, will accommodate Arthrex guests and business travelers. The four-story, 170,000-square-foot full-service hotel will have approximately 160 rooms.

The third building, the Arthrex Wellness and Medical Center, will be located on the current site of the two office buildings along Goodlette Road. The two-story, 38,000-square-foot building will have a fitness center for employees with state-of-the-art equipment and group classes such as spinning and yoga. The building will also have a juice bar and lounge, a retail shop with Arthrex apparel and merchandise, and will be home to the Arthrex Medical Center, which provides free medical care to Arthrex employees and their families.

The campus expansion also includes a road project that will close the mid-section of Creekside Boulevard to create a university-style campus with abundant green space, interconnected walking and bicycle paths, a three-acre outdoor park area with a 1,000-square-foot pavilion for outdoor events and other activities.

Arthrex Boulevard, which is the street that runs between the post office and the Naples Daily News, will become the main entrance to Arthrex’s global headquarters and will undergo a renovation to expand the two-way street to include a median.

The expansion project is expected to create 560 jobs by 2021 and approximately 1,200 construction-related jobs through 2019.

About Arthrex

Arthrex Inc., headquartered in Naples, FL, is a global leader in orthopedic product development and medical education for orthopedic surgeons. More than 11,000 products for arthroscopic and minimally invasive orthopedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.Arthrex.com.

SpineGuard Demonstrates the Unique Potential of its DSG™ Technology in Surgical Robotics

November 09, 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 the successful completion of an experimental feasibility study in collaboration with the Institut des Systèmes Intelligents et de Robotique (UPMC /CNRS), Paris, France.

The study demonstrates how DSG™ technology can stop a robot automatically when an impending bone breach is detected and thus can prevent serious surgical complications. Practically, during a vertebral drilling, a DSG™ drill bit mounted on a robot transmits in real time an alert signal to the control unit of the robot.

Olivier Frézal, VP Technical Operations at SpineGuard declared: “We are very satisfied by this result which confirms the potential of our DSG™ technology in surgical robotics thanks to its ability to measure tissue electrical conductivity locally and in real time. A technology breakthrough is now possible, because the robot will be able to automatically drill into the human skeleton, and allow the direct insertion of DSG™ sensing “smart” implants.” I am also delighted by our collaboration with UPMC which again underlines French research excellence.”

Guillaume Morel, ISIR, Professor, Director of the team AGATHE at INSERM: “For years it has been apparent that a sensing technology that could provide robots with a feedback loop would be an indispensable component of the progress of automation of surgical procedures. When SpineGuard contacted us about this research project and presented their DSG technology, we were immediately committed to a collaboration that revealed fruitful.”

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.

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, Tel: +33 (0) 1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi, Tel: +33 (0)1 45 18 45 19
Chief Financial Officer
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

Patients sue B. Braun alleging defect in replacement knees

By Peter Hall of The Morning Call / November 7, 2017

Medical device maker B. Braun concealed from regulators problems with its line of ceramic-coated artificial knees and promoted the products to surgeons despite knowing they were prone to fail, a lawsuit filed in a California court alleges.

The Bethlehem-based company’s Aesculap Implant Systems subsidiary marketed the “advanced surface” ceramic coated knees as superior to standard bare metal implants, claiming they would last longer, the lawsuit says. But the ceramic joints were defective, the suit alleges, because they didn’t adhere properly to cement used to bond them with the patients’ bones.

As a result, the 25 knee replacement patients who are suing B. Braun and Aesculap in a California court were or will be required to undergo additional surgeries to correct problems with the joints or implant different devices, the suit says.

A spokesman for B. Braun, a German company with U.S. headquarters in Bethlehem, did not respond to messages Tuesday.

The lawsuit was filed last month in Los Angeles Superior Court by attorneys Christopher K. Johnston of Guaynabo, Puerto Rico, and Anthony Buzbee of Houston on behalf of the patients, who are from Louisiana, Florida and 10 other states.

According to the lawsuit, Aesculap sought and received permission from the U.S. Food and Drug Administration to sell its advanced surface replacement knees by demonstrating that the devices were as safe and effective as devices that had already been approved. The process is less rigorous than the FDA’s standard medical device approval process, the suit says.

 

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AlloSource Announces Bob Lay As Chief Operating Officer

CENTENNIAL, Colo.Nov. 7, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced the appointment of Bob Lay as Chief Operating Officer.

With over 20 years of experience in both finance and operations, Bob has a broad-based understanding of how each department within an organization impacts another. He has an extensive background working with businesses and medical device companies to conduct operational audits, improve processes and systems, and balance the needs of many departments to drive company growth and success.

“The Chief Operating Officer role at AlloSource is critical to creating the cellular and tissue products surgeons need to help restore mobility in more patients,” said Thomas Cycyota, AlloSource President and Chief Executive Officer. “Bob’s background, as well as his open-minded approach to driving improvements, will help us identify new opportunities to advance the work we do.”

In addition to his role as Chief Operating Officer, Bob also served AlloSource as the Director of Cost Accounting and Vice President, Operations. Prior to his time at AlloSource, he held leadership roles at both startups and large companies. Bob received his Bachelor’s and Master’s degrees in Accounting from the University of Denver.

“I am honored to lead the dedicated and passionate Operations team at AlloSource,” said Lay. “AlloSource’s commitment to donors and patients inspires me every day, and I look forward to contributing to the organization’s continued growth.”

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

 

SOURCE AlloSource