SpineGuard® Announces First Spinal Deformity Surgery in China with PediGuard® by Prof. Yong Qiu

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

April 18, 2018

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

SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, announced today that Professor Yong QIU performed the first spinal deformity surgery in China with the PediGuard® device.

Pr. Yong QIU is the Chairman of Orthopedic Surgery at Nanjing Drum Tower Hospital, President of the Chinese Scoliosis Research Society, and Vice-President of the Chinese Association of Orthopedic Surgeons and one of the leading scoliosis surgeons in China. His spine center is the largest scoliosis center in China, performing around 600 scoliosis surgeries per year, the majority of which are among the most complex cases in China.

This surgery case demonstrates the ability of XinRong Medical to quickly bring to market PediGuard enabled surgeries with the most preeminent surgeons in China, and highlights Xinrong’s ability to assist leading foreign brands in navigating the local tendering and hospital approval process.

“PediGuard increases safety for better screw placement, reduces surgical time by 15%, decreases X-ray exposure for patients, surgeons and staff and also helps train the young surgeons. It is a very useful and convenient device that is effective without any other supplementary equipment for complex spine surgery, especially for spinal deformity cases,” said Professor Yong Qiu, Chairman of Orthopedic Surgery of Nanjing Drum Tower Hospital.

“It is an immense honor for SpineGuard that Professor Yong Qiu performed the first spinal deformity surgery in China with the PediGuard device to secure pedicle screw placement. Professor Yong Qiu, who was trained in France, is the most experienced surgeon for spinal deformity in China with over 3,000 spinal deformity surgeries to his credit,” added Patricia Lempereur, International Director of Sales and Marketing at SpineGuard.

“We are honored by the use of PediGuard for spinal deformity cases at the Nanjing Drum Tower Hospital, one of the world most famous hospitals for spinal deformity with over 9,000 cases since their opening. We look forward to extending our collaboration with Pr. Yong Qiu with the use of PediGuard technology in training junior surgeons in China for pedicular screw placement. China market is growing rapidly, with spine surgery cases expected to grow around in the mid double digits in next 5 years. XinRong covers 2600 hospitals in China. We have great confidence that with the wide application PediGuard by Chinese surgeons will continue to dramatically enhance surgery case outcomes,” concluded Christine Zhang, XinRong Medical Group’s CEO.

The event was also reported by Chinese television news program, watch here.

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

Next financial press release: 2018 Half-year revenue: July 11, 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 60,000 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
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu

Two Data Presentations Highlight the Unique Potential of Spineology’s Duo™ Implant

Posted On April 16, 2018 By OrthoSpineNews In Spine, Top Stories /

April 16, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that two laboratory studies relating to the Spineology Duo™ Lumbar Interbody Fusion System were presented at the recent annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Toronto, Canada.

The Duo implant is the first to combine PEEK, titanium, and graft containment mesh elements. The unique hybrid design includes lateral PEEK supports integrated with an expandable porous mesh that serves to contain bone graft. The Duo implant, filled with bone graft after it is placed in the disc space, provides a large, endplate-conforming graft pack up to 30mm in width, to help maintain spinal alignment and support fusion. Due to the unique design of the implant, the Duo System requires minimal retraction for placement of the implant which may reduce direct and indirect injury to the neural elements and potentially decrease the postoperative complications commonly associated with the lateral decubitus transpsoas approach.

Pierce Nunley, M.D., Director of The Spine Institute of Louisiana and Lisa Ferrara, Ph.D., President of OrthoKinetic Technologies LLC, co-authored a study titled “Size Matters: A Novel Interbody Fusion Cage Design Increases Contact Area for Bone Exchange and Graft Incorporation.” A unique test methodology using pressure-sensitive contact film demonstrates that the Duo device design facilitates load-sharing contact between bone graft and endplates to support graft incorporation during fusion healing. Pressure profiles were generated during testing for the Duo implants and for monolithic PEEK interbody cages (Spineology Rampart™ L). The results showed that the expandable porous mesh of the Duo implant allows for direct contact between bone graft and the viscoelastic vertebral endplates, improving the endplate and graft interface mechanics.

Barbara Boyan, Ph.D., Dean of Engineering at Virginia Commonwealth University, presented the results of an in vitro cell culture model used to assess whether the Duo implant’s polyethylene terephthalate (PET) mesh would have an impact on migration of osteoprogenitor cells from vertebral endplates onto bone graft in interbody fusion, and to assess the biological response of these cells to the bone graft. The study, titled “Effect of PET Mesh on Mesenchymal Stem Cell Response to Bone Autograft”, indicated that the presence of the porous mesh does not negatively impact the ability of osteoblast lineage cells to attach to bone particles, nor does it impede the cells’ ability to proliferate or differentiate along an osteoblastic pathway.

“The graft containment mesh is a key component of the Duo implant design,” said John Booth, CEO, Spineology Inc. “Not only does it allow for the implant to be placed with minimal retraction and expand in width up to 30mm once filled in situ, it also provides improved graft loading properties compared to traditional monolithic PEEK cages and has a positive impact on osteoprogenitor cell activity, as demonstrated by the studies presented at ISASS.”

Spineology is currently conducting a prospective post-market lateral interbody fusion study with the Duo System. The primary study objectives are to gather data related to the new on-set of thigh symptoms, quality of life measures, and fusion outcomes. The company believes the minimal amount of retraction required to place the Duo implant will have a positive impact on post-operative thigh symptoms.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

Lumbar Artificial Disc Replacement with the activL® Artificial Disc to be More Effective at Delaying the Progression of Adjacent-Level Disease which Spinal Fusion has been Found to Accelerate

Posted On April 12, 2018 By OrthoSpineNews In Spine, Top Stories /

CENTER VALLEY, Pa., April 12, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the publication of “Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up” in Spine.¹ This is another significant milestone in Aesculap’s commitment to enhancing patient access to lumbar total disc replacement as a gold standard of care.

The post-hoc analysis, which used all available radiographic data from the activL^® Artificial Disc Investigative Device Exemption (IDE) study, examined the rate at which radiographic adjacent-level degeneration (ALD) occurred five years following lumbar total disc replacement (LTDR) with either the activL Artificial Disc (Aesculap AG, Tuttlingen, Germany) or the ProDisc-L (Centinel Spine, West Chester, PA) control arm. The authors found an extremely low incidence rate of radiographic adjacent level deterioration at five years (only 9.7% of patients) compared to previous reports of deterioration at levels superior to fusion (28% of patients) and an even lower rate of clinically-significant ALD that resulted in additional surgery (in just 2.29% of patients).

These newly published outcomes from the activL Study show that, in a select patient population, LTDR is more effective at slowing the adjacent segment degenerative cascade than fusion, which is consistent with previously reported LTDR ALD rates from both the U.S. and Europe (9.2%-10.7%).^2,3

As part of the analysis, the authors also sought to answer the question of whether patients with asymptomatic x-ray findings of adjacent level degeneration at the time of the index procedure experienced a clinically-relevant progression of this ALD at five years follow-up.

According to author Jack Zigler, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), “Spine surgeons who believe in motion preservation are often frustrated by U.S. payers whose medical policies state that the written reporting of even the smallest trace of anatomic deterioration at an adjacent but clinically-asymptomatic level will exclude their coverage of a lumbar TDR at the symptomatic level. Our analysis found that no patients who exhibited asymptomatic radiographic ALD changes at the time of preoperative assessment required any additional surgery at those levels at five years. In other words, even five years later, the implantation of a LTDR did not accelerate radiographic, non-pain-generating ALD to the point of requiring surgical treatment. This data shows how important it is to educate health plan decision makers about the medical necessity of allowing treatment with LTDR to treat single-level chronic degenerative disc disease.”

While the overall LTDR five-year rate of ALD was 9.7%, there was a statistically-significant difference in ALD rates between patient groups. The activL patients experienced an 8.8% ALD progression at five years, while ProDisc-L patients experienced a 19% progression (p=0.05).⁴ The authors hypothesized that these differences in progression rates between earlier versus later generation ProDisc-L discs may be related to the protective effect of improved of range of motion on ALD. The activL Disc, which has been shown to have a higher rate of motion preservation at five years than ProDisc-L (6.2° vs. 4.0°, p=0.004)⁵ also had a lower rate of ALD.

The activL Artificial Disc and ProDisc-L are currently the only commercially available lumbar artificial disc devices that have undergone the rigor of biomechanical and clinical studies to satisfy the safety and efficacy requirements for Food and Drug Administration approval and the only devices that have been evaluated for ALD rates. The activL Disc was approved in 2015.

In the interest of improving the evidence base for LTDR, Aesculap has sponsored Open Access to this landmark publication. The full text can be found on the Spine website. https://journals.lww.com/spinejournal/Abstract/publishahead/Progression _of_Adjacent_level_
Degeneration_After.95075.aspx

“It is evidence like this that will hopefully move the needle with health plans in favor of a procedure that is less costly in the short- and long-term,” said coauthor Scott Blumenthal, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), who performed the first lumbar disc replacement eighteen years ago. “It is time we acknowledge the strength of the current evidence base for this life-improving procedure.”

Over the last eighteen months, U.S. commercial payers have begun to adopt coverage of lumbar total disc replacement due largely in part to the availability of long-term evidence such as the data presented in this publication.

Last year, major health care insurance carriers such as Humana, BlueCross BlueShield of Louisiana and Highmark BlueCross BlueShield established positive coverage policies for LTDR. Aesculap offers a patient advocacy platform, the Patient Assistance Line, to patients who are candidates for single-level LTDR with the activL disc to help them overcome commercial payer hurdles for those plans still denying access to this proven procedure.

In 2017, a panel of surgeons at the North American Spine Society Annual Meeting (Orlando, FL) concluded that the evidence now supports that lumbar artificial disc replacement is a standard of care for a subset of degenerative disc disease patients.

The full dataset of five-year safety and efficacy outcomes from the activL Artificial Disc IDE study are currently in submission to Spine.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

Zigler JE, Blumenthal SL, Guyer RD, Ohnmeiss DD, Patel L. Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up. Spine 2018: published online ahead of print, March 21, 2018.
Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. Journal of Neurosurgery. Spine 2012;17:504-11.
Aghayev E, Etter C, Barlocher C, et al. Five-year results of lumbar disc prostheses in the SWISSspine registry.
Eur Spine J 2014;23:2114-26.
Blumenthal, SL et al. Adjacent Segment Degeneration After Lumbar Total Disc Replacement: 5-Year Results of a Multicenter, Prospective, Randomized Study with Independent Radiographic Assessment. In NASS 32^nd Annual Meeting Proceedings NASS, The Spine Journal 17 (2017) S111–S165.
Yue JJ, Garcia R, Jr. Five-Year Results of a Randomized Controlled Trial for Lumbar Artificial
Discs in Single-Level Degenerative Disc Disease. Spine; in submission.

SOURCE Aesculap Implant Systems, LLC

CoreLink Announces Full Commercial Launch of Foundation™ 3D Printed Titanium Interbody Cage Systems

Posted On April 11, 2018 By OrthoSpineNews In Spine, Top Stories /

April 11, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a fast growing, vertically integrated designer and manufacturer of spinal implant systems, announced the full commercial release of its Foundation 3D Interbody Cage Systems for cervical and lumbar fusions.

The titanium devices utilize additive manufacturing to create Mimetic Metal™ technology that mimics key characteristics of natural bone, featuring 100% open-pore architecture and micro roughened porosity with significant hydro-wicking properties.

The lumbar devices incorporate patent pending StrutSure™ technology featuring an asymmetric load sharing support structure with an interconnected lattice that is designed to provide the optimal balance between strength, stiffness, and stability. This unique to market support structure minimizes overall implant density, providing for good imaging characteristics. Internal testing shows the center of the Straight Foundation 3D Lumbar interbody has a modulus of elasticity less than PEEK which may reduce stress shielding and enable the benefits of Wolff’s Law in three key areas: the interface with the vertebral endplates, the central graft column, and inside the walls of the device itself.

“I love how these cages image, both intraoperative and post op, without the typical hardware-associated artifacts we are used to with metal cages,” commented Justin Owen M.D., neurosurgeon in Slidell, LA, on his experience with the Foundation 3D Cervical cages. “I appreciate the possibility of the endplates growing around the porous metal surfaces, which would seem to provide faster stabilization towards fusion before growing across the entire disc space. This is a great system, for me and my patients.”

After a limited initial launch, CoreLink has now released full commercial quantities of all three devices: Cervical, Straight Lumbar, and Curved Lumbar. They are individually prepacked sterile and available in variety of footprints and lengths.

“We are excited about F3D, because of the significant improvement in patient care expected, but also because it establishes CoreLink as a leader in additive manufacturing,” said Jay Bartling, CoreLink’s CEO.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering the performance of its surgeons and the improvement of the lives of their patients.

Be a part of something at The Source.

www.corelinksurgical.com

Contacts

CoreLink, LLC
Matthew Linhardt, 888-349-7808
m.linhardt@corelinksurgical.com

OrthoSpineNews Interview with Mark Foster, President and Chief Commercialization Officer at Trice Medical

Posted On April 10, 2018 By OrthoSpineNews In Extremities, Top Stories /

Good afternoon Mark, thank you so much for talking with us today. We really appreciate you taking the time. Would you mind giving us a brief introduction and sharing a bit about your background?

Sure thing. I am the President and Chief Commercialization Officer here at Trice. I have been here for a little under two years and before that was at Smith & Nephew for 8 years. My last role at Smith & Nephew was Vice President of U.S. for their Sports Division. Before that I was at Boston Scientific for 8 years, and I graduated from the University of Richmond.

Mark, we’ve seen a lot of buzz around the mi-Eye 2 lately. What originally prompted the creation of this innovative technology?

As you may know, there have been some other technologies that took a swing, if you will, at in office arthroscopy. Unfortunately, they may have been a little ahead of their time. They basically tried to miniaturize a traditional arthroscopy tower, which still leaves you with a high capital cost, reusable components and multiple steps to set up; all of which make it hard to adopt in a busy office setting. So, the mi-eye was founded by asking the question- “Can we take a needle and put optics on it?” We started with a totally different view of the market compared to what had already been tried. Essentially, we took a 14-gauge needle and put optics through it, allowing us to deliver a high-quality image in a fully disposable product, that can be used readily and quickly in an office setting.

The mi-eye 2 is actually our 3^rd generation camera that has hit the market. As you know, the chips have gotten better and better, as well as more cost effective. We have come to a point where you can finally get an operating room type image, in a disposable needle, at a cost-effective price. This image gives patients instant answers because it is used by the physician in the office.What do you see as the biggest value of the mi-eye 2 to the various stakeholders involved?

Well, it is the first product I’ve been around that can bring major value to the three main stakeholders involved in the healthcare environment.

Patients: Consider yourself a patient with a torn meniscus or labrum, most physicians know from your physical exam that you’ve got some pathology. Yet in today’s world, you still have to go get that MRI. So, you have to take another day off of work, add an additional office visit, and so on which gets expensive and time consuming. Because the mi-eye was designed to be used in the clinical setting, it saves the patient a tremendous amount of time and money. Or, imagine you are the patient that has had a negative MRI and still has lingering knee pain. I have been in those cases and seen the relief on a patient’s face when the surgeon shows them cartlidge damage on the tablet and let’s them know that they “weren’t crazy.” They can then confidently move forward with treatment.

Physicians: Our surgeons use the mi-eye 2 not only because of the value to the system. They love the fact that they can get a dynamic view inside of the joint by using the camera in the office. The MRI’s are a wonderful tool, but they are a static image of the body at one point in time. The mi- eye allows the physicians to literally have their eye inside of the patient to achieve dynamic diagnostics. Additionally, they can confidently deliver biologics under direct visualization through the lumen of the needle.

Providers: Often times, something that is great for patients might be very expensive. Or if it’s great for the system, maybe it doesn’t fit a clinical need of the physician. In this case, we have peer-reviewed data supporting the fact that for intra-articular pathology, the mi-eye performed on the initial patient visit is the most cost-effective way to manage their imaging needs.

To that point, how does the mi-eye compare with the other options that are on the market?

Well we don’t really have true, comparable competitors in the market at this time. Our real cost competitor is the MRI. Looking at our device in a single day setting, compared to the amount of time, office visits, MRI costs, and MRI reads, we are really in a great spot. As I mentioned earlier, the mi-eye provides incredible value to all parties involved. However, the MRI and Ultrasound will never and should never go away. They are wonderful tools and will always have a place. The mi-eye is just another great diagnostic option for today’s busy surgeon.

What are some of the other things you are excited about as you look at what’s ahead for Trice?

We are really excited about getting the CE mark two weeks ago and getting Health Canada approval. In many countries around the world, it can take weeks or months to get MRI’s so we really have a great value proposition outside of the U.S.

We are also excited about the expansion of indications. We’ve seen recon physicians using mi-eye to determine partial vs total knee candidates. We’ve seen trauma physicians using it to confirm fracture reduction. And most recently, we launched our hip camera and the ability to get additional information inside of the hip while delivering an injection, or potentially removing the need for fluoro, is really quite powerful.

Well Mark we really appreciate you spending some time with us and giving us some keen insights into the mi-eye 2. Congratulations on all of the success and we are looking forward to what lies ahead!

Thanks guys, hope you have a great rest of your day.

More Information:

Trice Medical

Ortho Sales Partners Announces the Addition of Chris Lyons as Vice President of Exit Strategy

Posted On April 9, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce a tremendous addition to the executive team. In an effort to serve clients from inception through exit, Ortho Sales Partners has recruited Chris Lyons to serve as its Vice President of Exit Strategy. Mr. Lyons will be a vital component of any client’s project as he will help create and guide the overall strategy and work on client’s behalf during possible transaction discussions.

Mr. Lyons career began at Smith and Nephew in 1989. While at SNN, he held numerous marketing roles, driving product launches, engaging surgeons, and creating intellectual property predominantly in the companies Knee and Hip product lines. Additionally, he spent two years in the Smith and Nephew Sales Force to learn the underpinnings of what made the organization successful.

In 2005, Chris joined Medtronic Spine and Biologics, with the first three years being focused on driving growth of the International biologics business of Medtronic. The opportunity presented itself to move into the realm of Business Development where he served the past 10 years. During this time, Mr. Lyons worked with all of the executive and cross functional leadership to transact various acquisitions, minority investments, as well as license and distribution agreements. Chris was also selected to join the Board of the Southeast Medical Device Association (SEMDA) of which he remains a contributor, also serving as Chairman of the board for SEMDA for 2016.

With a highly driven, passionate, and entrepreneurial spirit, Chris is excited to be joining the ranks of Ortho Sales Partners as Vice President of Exit Strategy to assist this growing team of industry experts to influence positive commercialization and exit outcomes for Med Tech and Device companies. Chris will work closely with Venture Capital, Private Equity and other companies focused on successfully exiting. Chris can provide Strategic Guidance, Gap Analysis, M&A consultation and will help implement general strategies that help the shareholders to maximize their return during due diligence and negotiations.

About his new role, Chris Lyons said: “The power of Ortho Sales Partners is their leadership. They have developed a game changing business based on integrity to positively influence better outcomes for medical device companies, which in turn has the possibility to influence greater innovation and healthcare delivery to the market in a timely manner. I am excited to be part of this team of industry experts.”

“Chris Lyons is extremely well respected and we are thrilled that he has chosen to join our team of the industries most talented and experienced leaders. Ortho Sales Partners continues to demonstrate its commitment to excellence and our team has just gotten demonstrably stronger. We are now able to help companies successfully navigate from early commercialization through exit.” Said Kevin McGann, CEO of Ortho Sales Partners.

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

Premia Spine Features TOPS™ System and ProMIS™ Fixation System at ISASS Cadaver Lab

Posted On April 6, 2018 By OrthoSpineNews In Spine, Top Stories /

Philadelphia, PA, April 6, 2018 — Premia Spine, Ltd. announced today that it will sponsor a hands-on cadaver lab for participants at the International Society for the Advancement of Spine Surgery in Toronto. The event will take place on Thursday, April 12^th and feature both the ProMIS™ Fixation System and the TOPS™ System. This will be the first time that surgeons in North America will have the opportunity to try both technologies in an open cadaver lab setting.

“I am very pleased to offer surgeons the opportunity to experience the advantages of our One-Step, direct Skin-to-Screw technique,” stated Tom O’Hara, recently appointed President of Premia Spine, Inc. “We are the first company to launch this patented approach—a technique that reduces x-ray exposure and saves screw placement time.” Surgeons will also gain hands-on experience with other unique features to the ProMIS™ Fixation System.

In addition, Premia Spine will be offering surgeons a chance to work with the TOPS™ System—a posterior motion preservation system for patients with degenerative lumbar spondylolisthesis and spinal stenosis. The TOPS System is approved in Europe and Australia, and under investigation in the United States.

Premia Spine launched the US IDE study among leading centers in the United States, including the Cleveland Clinic, Mayo Clinic, UPenn, UPMC Harrisburg, Carolina Neurosurgery, Ascension Jacksonville, Allegheny Health Network, Florida Spine Institute, Johns Hopkins-Sibley, and Wisconsin Bone and Joint.

“We want to showcase our solution before leading surgeons from around the world. In addition, we are offering US surgeons the opportunity to join our IDE study—which still has a few remaining slots,” said Ron Sacher, CEO of Premia Spine.

The new TOPS device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over 6 years.

The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS™ System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.

Clinical sites will be measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. “Our goal is to establish the superiority of the TOPS™ System versus traditional lumbar spinal fusion,” explains Mr. Sacher.

About Premia Spine. Premia Spine licensed the TOPS System technology in 2011 from Impliant, Ltd. Over $100 million has been invested to design, develop, and commercialize the TOPS System, with over 12 years of clinical use and 1,000 patients.

Contact:
Ron Sacher, CEO

ronsacher@premiaspine.com

Globus Medical Announces Launch of ELSA® Expandable Lateral Spacer System

Posted On April 5, 2018 By OrthoSpineNews In Spine, Top Stories /

AUDUBON, Pa., April 05, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the launch of two innovative lateral expandable interbody spacers with integrated screw fixation, ELSA® AL and ELSA®-ATP, the latest additions to Globus’ unmatched expandable solutions. These next generation expandable implants provide an optimized fit for the patient, allowing for restoration of sagittal balance and enhanced structural fixation.

Globus Medical is the market leader in expandable interbody spacers with over 20 expandable implant solutions supported by 15 years of clinical experience. Globus Medical’s full line of expandable products has enabled surgeons to treat over 130,000 levels.

“ELSA® AL is the alternative to RISE®-L for selected cases in which maximizing segmental lordosis is indicated,” said Dr. Paul K. Kim, neurosurgeon at Carolina Neurosurgery & Spine Associates. “In conjunction with the ALL (anterior longitudinal ligament) release technique, ELSA® AL has the potential to provide the most amount of segmental lordosis of any device on the market.”

Adjustable Lordosis Technology with ELSA® AL

ELSA® AL’s in situ adjustability and integrated screw fixation are designed to help correct sagittal balance and improve stability. The implant features exclusive adjustable lordotic technology that allows up to 30° of lordosis while maintaining a minimally invasive surgical corridor. With less disruption compared to traditional static spacers, ELSA® AL provides maximum correction and additional fixation for increased segmental stability.

First Expandable Spacer for a Customized ATP Approach

ELSA®-ATP is the only expandable spacer designed to avoid nerve complications associated with the direct lateral technique by using an anterior-to-psoas approach.

The Lateral Lumbar Interbody Fusion (LLIF) technique approaches the spine from the side of the patient, which allows for placement of a larger implant footprint and less disruption of the lower back muscles. The anterior-to-psoas approach is a modified LLIF procedure that avoids the psoas, a large muscle responsible for movement and flexion of the leg. Avoiding this muscle and its integrated nerves may help reduce post-operative complications such as thigh pain.

ELSA®-ATP features angled integrated screws for direct fixation to the adjacent vertebrae. The spacer can be inserted at a minimal height and expanded in situ to minimize tissue disruption and maximize indirect decompression. A full suite of anterolateral access and insertion instruments makes ELSA®-ATP the most comprehensive system on the market.

“Our product development team’s continued commitment to innovation has enabled us to design expandable interbody technology for nearly every surgical approach. The addition of these two unique ELSA® spacers to our expandable lateral portfolio demonstrates our commitment to listening and responding to our customers’ needs through continuous product innovation,” said Andrew Iott, Senior Vice President of Global Product Development. “The use of an expandable spacer for the ATP approach may help reduce complications associated with the lateral procedure. With restoration of alignment being of critical importance, these implants were developed as a tool to help surgeons address sagittal imbalance, with the goal of maximizing lordotic correction.”

Learn more about ELSA® and Globus Medical’s full line of expandable interbody spacers at www.GlobusMedical.com/Expandables.

Indications

The ELSA® Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

About Globus Medical, Inc.

Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements

All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

Namal Nawana appointed Chief Executive Officer of Smith & Nephew

Posted On April 4, 2018 By OrthoSpineNews In Recon, Top Stories /

4 April 2018

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces the appointment of Namal Nawana as Chief Executive Officer. He will join the Company and be appointed to the Board as an Executive Director on 7 May 2018.

Most recently, Namal was Chief Executive Officer of medical diagnostics company Alere Inc, where he led the successful turnaround of this global business and oversaw its $5.3 billion acquisition by Abbott in 2017. He joined Alere as Chief Operating Officer in December 2012.

Prior to Alere, Namal spent more than 15 years at Johnson & Johnson, primarily in its Medical Devices & Diagnostics segment, in a number of progressively senior commercial leadership roles across markets including in the USA, Asia and Europe. In 2011 he became Worldwide President of DePuy Synthes Spine, where he oversaw a transformation programme including substantial margin improvement and the integration of Synthes following its acquisition in 2012.

Namal will succeed Olivier Bohuon, who will step down from the Board on 7 May. During his notice period, Olivier will be available in an advisory capacity to provide advice and assistance to Namal in his new role, to help ensure a smooth transition.

Roberto Quarta, Chairman of Smith & Nephew, commented:

“In Namal I am delighted that we have secured an exceptional new chief executive with a proven record within the medical device industry. He has the experience as a CEO of a major listed company in the healthcare sector, and has demonstrated that he can energise businesses to deliver better performance and greater value to shareholders. We are looking forward to him joining our Board and driving Smith & Nephew to the next level of success.”

“I would also like to thank Olivier for his service. In his seven years as chief executive, Smith & Nephew has undergone important and necessary change and he has significantly strengthened the foundations of our Company. This has delivered strong value to shareholders, almost doubling the share price and materially outperforming the FTSE100, whilst also increasing the dividend distribution by more than 100%. On behalf of the Board and all of Smith & Nephew I wish him a happy retirement and all the best for the future.”

Namal Nawana commented:

“I am passionate about the medical devices industry where I have worked all my life and it is an honour to become the new Chief Executive of Smith & Nephew, a company I greatly admire. I am most excited by its portfolio of innovation which I believe gives an excellent platform from which to drive the business forward into its next exciting chapter.”

Mr Nawana is an independent member of the Board of Hologic, Inc. No further disclosure obligations arise under paragraphs (1) to (6) of LR 9.6.13 R of the UK Listing Authority’s Listing Rules in respect of this appointment.

Remuneration

Mr Nawana will be paid in accordance with the Remuneration Policy approved by shareholders on 6 April 2017, as set out in the Annual Report:

He will be employed on our standard US executive contract.
He will receive a base salary of $1,540,000 per annum (£1,100,000 converted using average exchange rates for Q1 2018) and will be paid at that dollar amount going forward.
He will participate in the Annual Incentive Plan (cash and equity) and the Performance Share Plan. Awards for 2018 will be pro-rated to reflect time served during the year.
He will be eligible to join those US defined contribution pension plans available to our US executives: Executive Plus Plan, 401k and 401k plus savings. Collectively, the Company contributions to these plans total 21.47% of salary.
He will receive standard US Executive benefits, which are not materially different in nature or value relative to the incumbent CEO.
His notice period will be six months, with the Company required to provide 12 months.
Mr Nawana will receive no sign-on or buy-out award associated with joining the Company.

Up until his retirement from the Company on 6 November 2018, Mr Bohuon will be paid in accordance with the Company’s Remuneration Policy and the terms of his service agreement:

He will continue to receive his salary, benefits and a payment in lieu of pension during his notice period.
He will also participate in the 2018 Annual Incentive Plan for the period up until his retirement. Any Annual Incentive Plan payment, which is dependent on performance, will be determined by the Remuneration Committee in February 2019.
In accordance with the Plan Rules, on his retirement from the Company all unvested Equity Incentive Awards will vest in their entirety.
Also in accordance with the Plan Rules, the outstanding Performance Share Plan awards granted will be pro-rated for service and will, subject to the performance conditions being satisfactorily met at the end of the three-year performance period, vest on the original vesting dates on the third anniversary of the respective dates of grant. He will be required to retain any vested shares, net of tax, in relation to the 2017 award for a further two-year period after the vesting date. In light of his anticipated retirement, no Performance Share Plan award was made in 2018.

Enquiries

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

Media
Charles Reynolds	+44 (0) 20 7401 7646
Smith & Nephew
Ben Atwell / Debbie Scott	+44 (0) 20 3727 1000
FTI Consulting

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 Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 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.com, follow @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.}

SpinalCyte Announces MRI Evidence of Disc Regeneration Following Phase 1/Phase 2 Clinical Trial of CybroCell™ Dermal Fibroblasts

Posted On April 3, 2018 By OrthoSpineNews In Biologics, Top Stories /

April 03, 2018

HOUSTON–(BUSINESS WIRE)–MRI analysis of patients who received intradiscal injections of human dermal fibroblasts (HDFs) shows significant improvement in disc height after six months. This is the latest evidence from SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using HDFs. This suggests there is a quantifiable regenerative process stimulated by its new cell-based therapy, CybroCell, which is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.

The landmark Phase 1/Phase 2 clinical trial, which is still enrolling, includes 24 patients with chronic lower back pain caused by degenerative disc disease. The patients are randomly assigned to one of three groups and receive intradiscal injections from one to three discs. The first group receives placebo in the form of saline only; the second group receives 10 million HDFs and the third group receives 10 million HDFs in combination with platelet-rich plasma (PRP).

Preliminary six-month MRI data on 18 patients has been completed with an independent radiological expert providing MRI analysis. Patients who received CybroCell or CybroCell with PRP demonstrated superior outcomes versus the control group. Of patients treated with CybroCell, 83 percent demonstrated increased disc height or no change in one or more discs compared to only 66 percent of control patients. More than half (52 percent) of CybroCell-treated discs showed either increased disc height or no change (a clinically relevant outcome) versus only 38 percent of control discs.

“We are encouraged by the superior radiographic analysis of the CybroCell patients over the control patients,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “We have demonstrated clinically relevant outcomes which include increased disc height for those patients who received treatment injections.”

This data suggests CybroCell possesses tangible benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical alteration in the degenerated disc.

Over 50 percent of patients treated with CybroCell in the trial reported significant therapeutic improvement. Preclinical animal studies demonstrated that 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 generate the jelly-like material (disc nucleus) that provides cushioning for the spine.

“MRI evidence of disc regeneration is the most important clinical validation to explain the reduction in pain of our study patients,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “This study provides real evidence of pain reduction and disc regeneration at only six months. The CybroCell product has the ability to change the quality of life for these chronically diseased patients and eliminate the need for opioid use in patients suffering from chronic back pain. CybroCell can address an urgent public need and impact the national opioid crisis 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 that would otherwise be disposed of, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

Photo available for download: https://www.dpkpr.com/files/701/

Photo credit: Dr. Torsten Wittmann/Science Photo Library/Getty Images

SpinalCyte Youtube Channel: https://www.youtube.com/channel/UC0MaC2QPyqAsFJ-JGoStSAA

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and international issued patents and has filed for an additional 48 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in biologics. Visit www.spinalcyte.com.

Contacts

SpinalCyte, LLC
Investor Contact:
281.461.6211
info@spinalcyte.com
or
Media Contact:
Dan Keeney, APR, 832.467.2904
dan@dpkpr.com

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