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Medical Device Makers Shut Out Of Value-Based Care Without Kickback Rule Change

Posted On October 30, 2018 By OrthoSpineNews In Financial, Top Stories /  

Oct 26, 2018 / Bruce Japsen Senior Contributor

The medical device industry is pushing for a change in the federal anti-kickback law to allow companies to fully participate in the shift away from fee-for-service medicine to value-based care.

The device industry wants changes known as “safe harbors” designed to prevent medical device makers from running afoul of healthcare fraud laws that impose penalties if individuals knowingly pay for or induce a sale or referral. Such rules are applied to medical care providers, insurers and other companies that have their services, products and devices covered by government health insurance.

The value-based care form of payment rewards medical care providers by compensating doctors and hospitals that achieve the best health outcomes. That is in contrast to the traditional fee-for-service form of payment that is based on volume of medical care delivered and is known to increase healthcare costs in the form of unnecessary tests and procedures.

But device makers are limited despite the role of medical technology and devices in healthcare advancements. Thus, the industry Friday submitted suggestions to the U.S. Department of Health and Human Services’ Office of Inspector General, which is seeking input on rule changes related to value-based care payments.

“Device makers cannot currently enter into certain value-based partnerships because federal rules prevent them from providing any incentives unless they fall within safe harbor or a waiver,” said Scott Whitaker, chief executive officer of The Advanced Medical Technology Association (AdvaMed). The trade group represents some of the world’s biggest medical device makers including Johnson & Johnson, Abbott Laboratories, Medtronic, Stryker and Baxter International.

“ The device industry wants clarity on how they can at least participate in a Medicare reimbursement structure that allows the company and the provider to share in savings should they create a system that led to a better outcome at a lower price,” Whitaker said. “The best way to accomplish this is through new value-based safe harbors for pricing arrangements, warranties, and risk-sharing arrangements.”

 

READ THE REST HERE

 

 

Photo Credit: Getty Royalty Free / Forbes

 

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Camber Spine Announces Hitting $1M Milestone With SPIRA™-C In Less Than 6 Months

Posted On October 25, 2018 By OrthoSpineNews In Spine, Top Stories /  

WAYNE, Pa., Oct. 25, 2018 /PRNewswire/ — Camber Spine today announced reaching the $1 million milestone with their recently launched SPIRA™-C in less than 6 months.

“The remarkable success and the early adoption of this revolutionary technology by so many surgeon users has attributed to this milestone,” commented CEO, Daniel Pontecorvo. “Camber Spine is now following through on its promise to be a leading innovator in the cervical interbody market segment. 2019 will see two more SPIRA™ devices in integrated fixation and stand-alone options.”

Spira™-C’s open architecture, arched design has large openings for significant graft packing. The proprietary Surface By Design™ roughened titanium surface promotes “mechanical fusion” bone in-growth for short-term stability, using trabecular, bone-like surface design, with an average pore diameter of 500µm. Newly-forming bone grows onto and through the multiple roughened titanium arches to achieve maximum stability and complete endplate-to-endplate arthrodesis.

Dr. Ira M. Garonzik, MD one of the surgeons who has been using SPIRA™-C since its launch, commented, “In review of our first 50 levels using Spira™-C, my partner James Conway, MD., PhD, and I have noticed excellent fusion rates, maintenance of lordotic correction and a decreased evidence of graft subsidence compared to previously used peek and allograft spacers. We attribute this to the open architecture concept of the Spira™ design which we feel accomplishes a true distribution of load across the vertebral endplates and is a full participant in the fusion process.”

Camber Spine has numerous studies underway designed to correlate the outstanding patient outcomes being reported by our surgeon customers with biomechanical, biologic, and clinical data. The ultimate goal is to show scientifically why SPIRA™ may be a superior implant as it relates to patients fusing and feeling pain free faster. Camber has assembled a team of top researchers and engineers who are all very excited about the design and performance of the SPIRA™ family of implants and are looking forward to reporting the results of these studies in the coming months.

For further information about Camber Spine or distribution opportunities please visit www.cambermedtech.com or call 484.427.7060.

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

SOURCE Camber Spine

Related Links

http://www.cambermedtech.com

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SpinalCyte Announces Positive 12 Month Pain Data From Phase 1/Phase 2 Clinical Trial for Degenerative Disc Disease

Posted On October 25, 2018 By OrthoSpineNews In Spine, Top Stories /  

October 25, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs), today announced 12-month endpoint data from its Phase 1/Phase 2 clinical trial for treatment of degenerative disc disease (DDD). The analysis showed that patients who received intradiscal injections of the HDF product CybroCell™ had sustained improvement in pain relief and increased back mobility after 12 months. The sustained pain relief suggests that there is a regenerative process stimulated by its cell-based therapy, CybroCell. CybroCell is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.

The landmark Phase 1/Phase 2 clinical trial included 24 patients with chronic lower back pain caused by DDD. The patients’ pain levels were measured using the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS) at 6 and 12-months post-treatment. At the 12-month endpoint, more than 90% of the treatment group had over a 10-point reduction in ODI and 100% had improvement in VAS. On average, treatment group patients showed a 61% improvement over baseline ODI scores, compared to 29% improvement in the placebo group. Patients received intradiscal injections in one to three spinal discs and were randomly assigned to treatment groups which received: a saline injection, an injection of 10 million HDFs or an injection of 10 million HDFs in combination with platelet-rich plasma (PRP).

Previous MRI data from the 6-month endpoint demonstrated superior outcomes in the treatment versus the control group. Of the treatment group, 83% demonstrated increased disc height or no change in one or more discs compared to 66% of control patients. More than half 52% of CybroCell-treated discs showed either increased disc height or no change versus only 38% of control discs. Preclinical animal studies have demonstrated that an intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn regenerate the disc nucleus.

“We are encouraged by the significant pain reduction of the CybroCell patients over the control patients,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “CybroCell has demonstrated clinically relevant outcomes in the area of pain reduction for those patients who received treatment injections. The data suggests CybroCell possesses tangible pain reduction benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical improvement in the degenerated disc.”

“We are excited about the sustained pain reduction we witnessed in the treatment arm patients from 6 months to 12 months,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “This study provides evidence of long-term reduction in pain and quality of life improvement for treated patients. This will ultimately lead to a reduction or elimination in need for opioids for chronic back pain patients and address the critical opioid epidemic in the U.S.”

SpinalCyte’s Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts which would otherwise be disposed of, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

Russo Partners LLC
David Schull, 858-717-2310
david.schull@russopartnersllc.com
or
Ned Berkowitz, 646-942-5629
ned.berkowitz@russopartnersllc.com
or
SpinalCyte, LLC
info@spinalcyte.com

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Clinical Study Shows DJO’s “Dual-Pivot” Knee Replacement Technology Reduces Patient Dissatisfaction, Improves Function and Activity Levels

Posted On October 23, 2018 By OrthoSpineNews In Recon, Top Stories /  

October 23, 2018

AUSTIN, Texas–(BUSINESS WIRE)–DJO (“DJO” or the “Company”), a leading provider of medical technologies designed to get and keep people moving, released a new clinical study to show that EMPOWR 3D Knee technology reduces patient dissatisfaction, and improves function and activity levels. Based on a multitude of studies on the biomechanics and kinematics of the knee joint, and more than 10 years of clinical heritage with DJO’s 3D Knee™, the EMPOWR 3D Knee® is the industry’s first “dual-pivot” technology, a breakthrough concept that is designed to better replicate the natural motion and feeling of the healthy knee.

With nearly 700,000 procedures performed in the U.S. each year, total knee replacement surgery (TKR) is one of the most widely accepted and effective treatments for relieving degenerative osteoarthritis pain and suffering. Unfortunately, nearly 20 percent of all patients – approximately 140,000 Americans each year1 – report they are not satisfied after their procedure, often claiming that their knee replacement “does not feel normal.”

EMPOWR 3D Knee® is one of the most functionally accurate prostheses ever created.1 EMPOWR 3D Knee®more closely recreates the natural dual-pivot motion pattern of the healthy knee throughout the entire range of motion, from early to deep flexion, creating a more natural feeling knee for the patient.1

Short term clinical results recently presented at the International Congress for Joint Reconstruction Hip and Knee Course in June 2018, demonstrate that the unique dual-pivot design of the EMPOWR 3D Knee® may offer far more natural motion for total knee arthroplasty (TKA) patients by more closely recreating the kinematics of a healthy human knee.2

The most significant clinical benefits of the EMPOWR 3D Knee® identified in the study include2:

  • Patient dissatisfaction is reduced by 50% compared to a competitive implant
  • Patient’s “knee feels normal” ~25% more often than with a competitive implant
  • Patients are over ~2X more active following surgery with the EMPOWR 3D Knee® versus a competitive knee implant

“Initial clinical results have been very encouraging for the EMPOWR 3D Knee®,” said presenter Dr. Michael Meneghini, MD, Associate Professor of Orthopedic Surgery at Indiana University School of Medicine. “Patients with the EMPOWR 3D dual-pivot knee implant are experiencing improved knee function and showing a greater likelihood of a normal feeling knee.”2

Dr. Scott Banks, PhD, Professor of Orthopedic and Joint Mechanics at the University of Florida, and Dr. Meneghini recently published an article in the journal Techniques in Orthopedics comparing the EMPOWR 3D Knee® implant to traditional knee implant designs. They concluded that contemporary dual-pivot design and kinematics of the EMPOWR 3D Knee® may contribute to improved function and satisfaction after TKR.1

“Clinical studies over the past decade have shown that healthy knees have a much more complex front-to-back and side-to-side motion than previously believed,” said Banks. “As a result, we now better understand why traditional knee arthroplasty designs have failed to accurately replicate normal knee activity and results in many patients feeling dissatisfied with their knee implant.”

“EMPOWR 3D Knee® patients tell us, ‘this knee just feels like my own,’ and that’s the whole point,” said Jeffery A. McCaulley, Global President of DJO Surgical®. “EMPOWR 3D Knee® goes beyond clinical effectiveness to deliver one of the most functionally accurate knee implants based on our novel dual-pivot design that helps to improve patient outcomes and patient satisfaction.”

For more information on the EMPOWR 3D Knee®, please visit: www.djoglobal.com/empowr.

1. Banks, Scott A., and Robert M. Meneghini. “Achieving More Natural Motion, Stability, and Function With a Dual-Pivot ACL-substituting Total Knee Arthroplasty Design.” Techniques in Orthopaedics 33, no. 1 (2018): 48-51.

2. “Replicating Native Knee Dual-Pivot Kinematics Improves Outcomes After Total Knee Arthroplasty” R. Michael Meneghini MD – ICJR South Presentation June 2018.

R. Michael Meneghini, MD is a consultant for DJO Global®.

Scott A. Banks, MD is a consultant for DJO Global®.

About DJO®

DJO® is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals.

In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga®, CMF™, Compex®, DonJoy®, ProCare®, DJO Surgical®, Dr. Comfort® and Exos®. For additional information on the Company, please visit www.DJOGlobal.com.

Contacts

DJO Media Contact:
Ashley Brown
Marketing Communications Manager
512.348.9098
ashley.brown@djoglobal.com
or
DJO Investor Contact:
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
IR@djoglobal.com

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BONESUPPORT starts selling CERAMENT® BONE VOID FILLER Direct in the US via its own New Distributor Network

Posted On October 22, 2018 By OrthoSpineNews In Biologics, Top Stories /  

Lund, Sweden, 08:00 CET, 22 October 2018 –BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, announces that it has started selling CERAMENT® BVF direct via its own US distributor network.

Emil Billbäck, BONESUPPORT’s CEO said “The launch of our own US distribution network is a key strategic milestone as we work towards our goal of becoming a global orthobiologics leader focused on the treatment of bone voids. Gaining control of our destiny in the US delivers multiple significant benefits that we are confident will allow us to build a much stronger BONESUPPORT business and deliver significant value to all of our stakeholders.”

BONESUPPORT created its own network of highly motivated distributors and expanded its US commercial organization to:

  •   Access a much larger market opportunity for CERAMENT BVF
  •  Increase its ability to drive end-user sales
  •  Deliver higher net margins
  •  Expand its US product offering
  •  Raise brand awareness ahead of the CERAMENT G launch

BONESUPPORT ‘s US network currently consists of 25 high quality distributors, that cover all key areas of the US bone void filler market that the Company is targeting. Together these distributors employ a total of 512 sales reps.

  • their close relationships to the leading orthopedic surgeons in their region,
  •  a track record of sales success, and
  •  dynamic sales reps who spend significant time in the operating theatre with the surgeons who are the key target customers for CERAMENT BVF

BONESUPPORT’S own US commercial organization of 21 employees is, in parallel, approaching key national purchasing organizations to ensure that CERAMENT BVF will have access to a growing number of hospitals.

This strengthened US commercial platform will launch new products from its recent agreements with Collagen Matrix Inc. and MTF Biologics, which are complementary to CERAMENT BVF, in the first half of 2019.

Patrick O’Donnell, General Manager & Executive Vice President of Commercial Operations North America, said “We are extremely pleased with the strength and reach of the US network of independent distributors that we now have in place. Their highly motivated reps will start selling CERAMENT BVF today targeting orthopedic surgeons, focused on trauma, total joint arthroplasty, foot & ankle, and orthopedic oncology. I am very confident that our new enlarged commercial platform will drive significant US sales growth in 2019 and beyond.”

BONESUPPORT terminated its exclusive distribution agreement for CERAMENT BVF with Zimmer Biomet (ZB) for the US market in May 2018. Under the terms of this agreement, ZB’s exclusivity expired on 20 October 2018. ZB will continue to be a non-exclusive distributor of CERAMENT BVF until 21 April 2019. 

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

David Dible, Shabnam Bashir, Pip Batty

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

 BONESUPPORT is an innovative commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology and foot and ankle.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

BONESUPPORT is currently conducting two important clinical trials to generate data demonstrating the clinical and health economic benefits its products deliver. The first trial, CERTiFy, is comparing CERAMENT BVF with autograft, the most widely used approach for managing bone voids. Top line results from this study are due to be announced at the end of 2018. The FORTIFY study is assessing CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and a reduction in the number of secondary procedures intended to promote fracture union. Data from this study will be used for a planned Premarket approval filing with FDA in 2020.

The Company’s research and development is focused on extending the use of its CERAMENT technology into further indications via the incorporation of additional drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is also preparing to expand its product offering in the US and has entered into strategic agreements with Collagen Matrix Inc. and MTF Biologics to gain access to products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.

CERAMENT V: Not available in the United States.

BONESUPPORT® and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on 22 October 2018.

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OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System

Posted On October 19, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

WARSAW, Ind., Oct. 19, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis.  The system represents the Company’s 26th surgical system and is expected to launch in the fourth quarter of 2018.

The RESPONSE 4.5/5.0mm System was designed in collaboration with pediatric orthopedic surgeons focused on additional solutions for treating complex pediatric scoliosis patients. It expands the Company’s RESPONSE platform to treat smaller stature children and builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System. The RESPONSE 4.5/5.0mm System offers a hybrid implant technology allowing the option of either a 4.5mm rod in CoCr or 5.0mm rod in titanium or cobalt chromium/chrome material, multiple implant connector options, and innovative, new instrumentation.

OrthoPediatrics’ Executive Vice President, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our 4.5/5.0mm system, which allows physicians to better treat smaller statures and patients at a younger age. Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring their innovative vision to life with another surgical solution for treating complex pediatric scoliosis.  The addition of the new system to our scoliosis platform continues to demonstrate OrthoPediatrics’ focus and commitment to providing solutions for children with complex spinal disorders.”

Scott Luhmann, M.D., Chief of Staff at Shriners Hospital for Children-St. Louis and Associate Professor in the Department of Orthopedic Surgery and Fellowship Director of Pediatric Orthopedic Surgery at Washington University School of Medicine, commented, “The new Response 4.5/5.0mm System brings OrthoPediatrics’ expertise and passion for musculoskeletal care of pediatric patients to the area of spinal deformity. This surgeon-centric system is focused on surgical efficacy and efficiency with an elegant rod reduction tool that significantly cuts down laborious task time in the effort to provide optimal patient outcome.”

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat the distinct needs of pediatric patients with spinal deformities. The system features advanced instrument & implant technology including 1) innovative, low profile screw design including a proprietary set screw thread design for improved fixation and reduced potential for cross threading, and 2) unique pedicle screw head accepts a 5.5mm or 6.0mm rod in both cobalt chrome and titanium. Additionally, the system has versatile reduction & de-rotation capabilities with rod reducer instrument designed for easy snap on and off 2-in-1 rod reduction instrument enables each surgeon to perform reduction and de-rotation technique of choice and serves as a rod reducer and de-rotator in one.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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TransEnterix CEO, Todd Pope Named One of TIME Magazine’s 50 Most Influential People in Health Care 2018

Posted On October 18, 2018 By OrthoSpineNews In Robotics, Top Stories /  

October 18, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, congratulates its President and Chief Executive Officer, Todd M. Pope, for being named to TIME Magazine’s 50 Most Influential People in Health Care for 2018. In this inaugural list, Pope is highlighted for his role as one of those leaders whose work right now is transforming health care.

“Being named one of TIME Magazine’s 50 Most Influential People in Health Care for 2018 is a tremendous honor,” said Todd M. Pope, TransEnterix president and CEO. “It’s humbling to be recognized alongside other talented, boundary-pushing individuals across the spectrum of health care. This recognition reflects the efforts of our global team at TransEnterix who work every day to deliver innovative solutions that help surgeons achieve better outcomes for their patients.”

As Chief Executive Officer, Mr. Pope sets the company’s strategic vision and oversees its continuing growth. Mr. Pope has spent more than 25 years working in key leadership positions within the medical-device industry. Prior to joining TransEnterix, Mr. Pope served as worldwide president of Cordis, a multi-billion-dollar division within Johnson & Johnson’s medical-device sector. He previously held a number of senior leadership positions within Johnson & Johnson and Boston Scientific.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient 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 System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance Surgical 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 delivery of TransEnterix’s innovative solutions help surgeons achieve better outcomes for their patients. 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 8, 2018, 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

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

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Biedermann Motech to Launch MDS Injection Screw for its Polyaxial Humerus Plating Systems

Posted On October 17, 2018 By OrthoSpineNews In Extremities, Top Stories /  

Miami, FL – October 17, 2018 / Business Wire / – Biedermann Motech, the leading innovator of polyaxial screw technologies, announced today the launch of the first injection screw that can be used through, and in combination with, its polyaxial locking plate systems at the 2018 Orthopaedic Trauma Association (OTA) Annual Meeting in Kissimmee (Orlando), October 17-20, 2018.

The MDS Injection Screw can be utilized to deliver injectable bone void fillers to a surgical site and is compatible with MDS humerus plating systems. It was developed as an innovative option for the systems to offer stable fixation in osteoporotic and complex fractures.

The current MDS plating systems utilize Next Generation Polyaxial Locking TechnologyTM, which includes 40-degree polyaxial locking for optimal plate and screw placement, a strong and consistent locking mechanism at every screw angle and a low profile construct. By adding the MDS Injection Screw to the system, surgeons will have additional options in the treatment of complex humeral fractures. Biedermann Motech is the first company to offer such a technology for extremity surgery.

“Biedermann Motech first introduced the combination of fenestrated augmentable polyaxial screws for complex spine reconstructions more than 15 years ago,” said Markku Biedermann, Chairman of Biedermann Motech, Inc., “and we are very excited to now introduce this sophisticated technology for the fixation of bone fractures and bone reconstructions of the humerus.”

Biedermann Motech will showcase the MDS Injection Screw Technology Platform at the up-coming 2018 Orthopaedic Trauma Association (OTA) Annual Meeting in Kissimmee (Orlando), October 17-20, 2018 at booth number 1015.

More information is available at www.biedermann.com or call 866-622-6082. Follow us on LinkedIn https://www.linkedin.com/company/biedermann-motech/

About Biedermann Motech

Biedermann Motech is a mid-sized, family owned group of companies with headquarters in Germany (Villingen-Schwenningen) and the USA (Miami). Since 1916 we have been working in synergy with world-class surgeons to solve significant clinical challenges through the development of next-generation technology. Our core competency is the development, production, and distribution of innovative implants and instruments for spinal and extremity surgery. We research, develop, manufacture and distribute high-quality implant systems in collaboration with healthcare professionals, technology partners, scientific institutions and specialized companies with the goal of achieving improved clinical outcomes.

Contact: Serina Prado sprado@biedermann.com

Biedermann Motech, Inc – USA

7620 NW 25th Street, Unit 3 & 4

Miami, FL 33122

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HSS Receives Landmark $10 Million Grant from Stavros Niarchos Foundation for Complex Joint Reconstruction Center

Posted On October 16, 2018 By OrthoSpineNews In Recon, Top Stories /  

NEW YORK, Oct. 16, 2018 /PRNewswire/ — An unprecedented $10 million grant from the Stavros Niarchos Foundation (SNF) has been given to Hospital for Special Surgery (HSS) to name the Complex Joint Reconstruction Center (CJRC). This new commitment will support the endowment of the CJRC for the operation and expansion of its clinical, research and educational programs.

According to the American Joint Replacement Registry, there are over 7 million Americans living with replaced hip and knee joints and, should they fail, treatment is complex and requires specialized management.

“This generous gift will improve the lives of countless patients who suffer from debilitating complications or need revision surgery due to failed implants,” said Thomas P. Sculco, MD, surgeon-in-chief emeritus and director of the CJRC at HSS. “We are deeply honored by the visionary leadership of the SNF in supporting our endeavor to lessen implant failure, restore function, and relieve pain for patients who need specialized joint reconstructions.”

As the first of its kind, the Stavros Niarchos Foundation Complex Joint Reconstruction Center provides the best in diagnosis and treatment for patients with the most challenging conditions in joint reconstructions, regardless of their financial circumstances, and conducts cutting-edge basic and clinical research on the causes and prevention of implant failure.

“Having partnered with HSS for over a decade, the SNF has witnessed first-hand the deep commitment of the people of HSS to excellence and progress in orthopedic care,” said Andreas Dracopoulos, Co-President of the SNF. “We are especially proud to support Dr. Sculco’s vision to improve the lives of patients with the most complex cases of joint reconstruction, and to seek solutions to issues that impact the field at large.”

“HSS is uniquely positioned to develop new techniques and improvements in implant design that will significantly impact global care for these complex problems.” said Dr. Sculco. “People are living longer and leading more active lives thus making the need for progress in our knowledge and treatment of these failed implants more critical than ever.”

Dr. Sculco is internationally recognized as a leader in hip and knee replacement surgery, having pioneered minimally invasive surgical techniques. Now, he is leading efforts to improve the success and longevity of implants to benefit millions of patients worldwide.

Over the past year, the CJRC has expanded its surgical team to 16 experienced orthopedic surgeons and successfully launched a patient registry with over 800 surgical cases already recorded. This registry is the first in the world solely dedicated to capturing vital clinical and outcomes data from patients undergoing joint reconstruction and complex primary joint replacement surgery. This data creates a platform for clinical trials, translational research and innovations in treatment that will lead to improved standards of care. In 2017, the CJRC performed 534 surgeries on patients with complex joint reconstructions.

The Stavros Niarchos Foundation is one of the world’s leading private international philanthropic organizations, making grants in the areas of health and sports, arts and culture, education, and social welfare. The SNF supports projects that aim to achieve a broad, lasting and positive impact on society.

Spanning over a decade, HSS and SNF’s longstanding relationship has spurred programs such as the Stavros Niarchos Foundation-Thomas P. Sculco, MD International Orthopaedic Fellowship Program, HSS Stavros Niarchos Foundation Orthopaedic Seminar and Academic Visitor Program to educate Greek orthopedic surgeons on ways to improve treatment and outcomes in joint replacement.

Since 2006, HSS has hosted Greek surgeons for the annual HSS Stavros Niarchos Foundation Orthopaedic Seminar Program, which teaches the latest techniques and innovations in complex and primary total hip and knee replacement with the ultimate goal of improving healthcare in Greece.

This year, the seminar will take place on November 27-28, 2018 with two days of didactic sessions, case consultations, roundtable discussions, hands-on workshops and operating room observation at operations at HSS. The following three days will include attendance at the 30th Annual HSS Holiday Knee & Hip Course, a CME-accredited professional education course.

The program immerses visiting Greek surgeons, typically those early in their careers, in the high-volume joint replacement environment at HSS.

SNF also previously granted HSS $1 million to fund the Thomas P. Sculco, Chair in Orthopedic Surgery, which played an instrumental role in the creation of the CJRC.

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

About the Stavros Niarchos Foundation
The Stavros Niarchos Foundation [(SNF) (www.SNF.org)] is one of the world’s leading private, international philanthropic organizations, making grants in the areas of arts and culture, education, health and sports, and social welfare. Since 1996, the Foundation has committed more than $2.6 billion, through more than 4,000 grants to nonprofit organizations in 124 nations around the world.

The SNF funds organizations and projects, worldwide, that aim to achieve a broad, lasting and positive impact, for society at large, and exhibit strong leadership and sound management. The Foundation also supports projects that facilitate the formation of public-private partnerships as an effective means for serving public welfare.

SOURCE Hospital for Special Surgery

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TDM USA Enters Domestic Extremity Market, Launches Six Product Systems at OTA

Posted On October 15, 2018 By OrthoSpineNews In Extremities, Top Stories /  

TDM USA, based in Salt Lake City, Utah, is pleased to announce its entry into the rapidly expanding US extremity market with the launch of six new product systems at the 2018 Annual Meeting of the Orthopaedic Trauma Association (OTA) in Kissimmee, Florida from October 17-20.

Bringing true value to facilities, surgeons and patients requires going beyond the standard. TDM USA is setting new standards by partnering with medical professionals to define and deliver value-generating solutions for complex healthcare challenges. TDM USA brings a new focus on flexibility to the industry, through its collaborative approach to the unique individual needs of Acute Care Hospitals and Ambulatory Surgery Centers.

The APIS (Advanced Principle Implant System) product group offers surgical solutions for Foot and Ankle, Hand and Wrist, and Shoulder and Elbow. The currently available product offering includes: 2.0mm Locking Plate and Screw System; 2.7mm Locking Plate and Screw System; Proximal Humerus Locking Plate and Screw System; Variable Locking Elbow Plate and Screw System; Variable Locking Foot Plate and Screw System; and Trifix Small Locking Plate and Screw System, a curated product set with a wide variety of plates/screws to address multiple anatomies and procedures in one offering.

“We are excited and humbled by the opportunity to positively impact the US healthcare market by providing high-quality, high-value products for fracture care and extremity reconstruction that have a demonstrated track record around the world,” said Clay Smith, President and General Manager of TDM USA. “In today’s value-driven healthcare environment, our mission is to help achieve clinically equivalent outcomes while reducing costs for providers and patients.”

To learn more about the broad and expanding product portfolio of TDM USA, and its philosophy of value-generating solutions in extremity fixation, please visit www.tdm-usa.com and booth 624 during the OTA meeting.

About TDM USA

TDM USA has a management team with over 60 years of combined Commercial and Operations experience in the US healthcare sector. TDM USA is a wholly owned subsidiary of TDM Co., Ltd., a global medical device manufacturer headquartered in Gwangju, Korea. TDM Co., Ltd. entered the orthopedic market in 2007 and currently distributes over 40 unique product systems in 15 countries. All available on-market TDM USA products are FDA 510(k) cleared and manufactured to ISO 13485 standards.

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