BoneSupport TM extends U.S. Distribution agreement for Cerament TM Bone Void Filler

Posted On March 14, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 14 March, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that it has extended the term of its U.S. distribution agreement with Zimmer Biomet. Under the agreement, Zimmer Biomet will continue to have exclusive rights for BONESUPPORT’s proprietary CERAMENT BONE VOID FILLER product line for Orthopedics, Trauma and Foot and Ankle indications in the United States.

“We are extremely pleased to extend our distribution agreement with Zimmer Biomet,” said Richard Davies, CEO of BONESUPPORT™. “The partnership has been very successful and has resulted in the current rapid growth of our flagship product, CERAMENT in the world’s largest bone graft substitute market. This rapid growth is building an important platform from which we can launch product extensions into the US.”

In addition to commercialization of CERAMENT BONE VOID FILLER in the U.S. market, BONESUPPORT is currently enrolling patients into the FORTIFY Clinical Study, an FDA approved IDE randomized control pivotal study for the Company’s anti-biotic eluting product CERAMENT G. CERAMENT G is currently approved and commercialized in the EU and other markets outside the United States.

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to improve the lives of patients suffering from bone disorders that cause bone voids, lead to injury, breakage, pain, and reduced quality of life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT and CERAMENT are registered trademarks.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

Implanet Strengthens Its Presence in Australia and New Zealand by Signing an Exclusive Distribution Partnership

Posted On March 14, 2017 By OrthoSpineNews In Spine, Top Stories /

March 14, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces the integration of Jazz Claw into the ARTG register. This integration is completing the JAZZ Range for the treatment of Pediatric and Adult Scoliosis. In conjunction, Implanet has signed an exclusive distribution partnership with Device Technologies for Australia and New Zealand. Implanet now markets in 17 countries across the globe, with this partnership significantly enhancing its sales potential in the Asia-Pacific region.

The entire range of Jazz® products will enable Implanet to address a vertebral fusion market estimated to be worth USD 120 million in Australia. Dr. John Choi, from Melbourne’s Spine Ortho Clinic, says: “The clinical benefit Jazz® provides compared with all-screw or screw-and-hook assemblies in the sagittal realignment of patients, as well as in their postoperative recovery, is undeniable. I am delighted to have access to the entire Jazz product range at the Spine Orthopedic Clinic and, more generally, across Australia.”

Implanet has signed an exclusive distribution partnership with Device Technologies, a company with more than 600 employees specializing in medical device distribution. Founded 25 years ago, the company is a pioneer in this sector in Australia, and covers the entire distribution chain from the sale of equipment to associated services. This agreement significantly strengthens Implanet’s geographical coverage through its partners’ various offices and sales agents across Australia and in New Zealand.

Michael Trevaskis, CEO of Device Technologies, concludes: “Jazz® represents truly innovative technology in the field of spine surgery. We are delighted and enthusiastic about the idea of making it available to all hospitals and patients throughout this country, notably for younger and older patients suffering from particularly debilitating deformities. Australian medical facilities are used to being among the world’s best equipped, and we are confident in our ability to provide them with one of the very best spine technologies.”

Ludovic Lastennet, CEO of Implanet, says: “The exclusive partnership with Device Technologies, a major player in Australia and New Zealand, represents a key milestone that opens the way for promising sales prospects for Implanet in the region. This milestone is fully in line with our expansion strategy in partnership with respected commercial partners.”

Next financial press release: 2016 annual results, on March 28, 2017

IMPLANET will participate in the following events:

AAOS (American Academy for Orthopedic Surgeons), San Diego CA, USA, March 15 to 17, 2017
Canaccord Genuity Musculoskeletal Conference, San Diego, CA, USA, March 14, 2017

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

OrthoSensor®(Booth #5823) At The 2017 AAOS Annual Meeting In San Diego

Posted On March 10, 2017 By OrthoSpineNews In Recon, Top Stories /

DANIA BEACH, Fla., March 9, 2017 /PRNewswire/ — OrthoSensor, Inc., a leader in sensor-assisted technology for total knee arthroplasty (TKA), will be on the main aisle at booth #5823 during the 2017 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting at the San Diego Convention Center from March 15-17. OrthoSensor will be releasing its three-year multicenter study results, as well as other new studies showing the clinical and economic advantages that may be gained with the use of VERASENSE, the leading intraoperative product for OrthoSensor. OrthoSensor will also host distinguished surgeon speakers at the booth.

VERASENSE for TKA transmits quantitative data from a patient’s knee, enabling a surgeon to customize implant position and achieve better soft tissue balance. The newly released studies show:

Statistically significant improvement in patient-reported outcomes and satisfaction for TKA patients whose knees were balanced using VERASENSE sensors
Improved post-op physical therapy performance and short-term clinical outcomes
Reduced complications and costs over 90-day TKA episode of care (MUA rate)
Cost mitigation when used for revision TKA (implant preservation, improved rehabilitation and other ancillary benefits)

“We are excited to present a new study showing 88% of planned early stage total revisions changed to partial revisions when VERASENSE was used in revision TKA procedures. This reduction represents very meaningful clinical and financial benefits to both patients and providers. This is just one of many studies showing the significant clinical and economic advantages of VERASENSE that have been recently released,” said Ivan Delevic, President and Chief Executive Officer of OrthoSensor, Inc.

The distinguished presenters at the OrthoSensor Booth #5823 are as follows:

Wednesday, March 15, 2017
10:30 am – Gregory J. Golladay, MD – Virginia Commonwealth University
2:00 pm – Michael Mont, MD – Cleveland Clinic

Thursday, March 16, 2017
10:30 am – Jimmy Chow, MD – St. Luke’s Hospital
2:00 pm – Patrick Meere, MD – NYU Hospital for Joint Diseases

Friday, March 17, 2017
11:00 am – David Fabi, MD – Scripps Mercy Hospital San Diego

About OrthoSensor, Inc.

OrthoSensor, Inc., a leader in Sensor-Assisted Total Knee Arthroplasty develops and commercializes intelligent orthopedic devices and data services that provide quantitative feedback to surgeons and hospitals. The company’s intelligent orthopaedic devices utilize advanced proprietary sensor and communications technologies, coupled with the company’s innovative software products, to facilitate evidence-based decisions in orthopaedic surgery – with the goal of improving patient outcomes and potentially reducing the cost of treating musculoskeletal disease.

OrthoSensor^®, VERASENSE^™, and ORTHOLOGIQ^™ are trademarks of OrthoSensor, Inc.

Media Contact: Yvette Cuello, (954)666-0282, ycuello@orthosensor.com

SOURCE OrthoSensor, Inc.

Stryker’s Spine division to exhibit key technologies at AAOS 2017

Posted On March 10, 2017 By OrthoSpineNews In Spine, Top Stories /

March 09, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that it will demonstrate its Aero-C Cervical Stability System (Aero-C) and Xia 4.5 Cortical Trajectory implants and instruments (Xia CT) at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 15–18, 2017, in San Diego (booth No. 3133).

Aero-C, the only straight forward anterior cervical discectomy and fusion (ACDF) device that offers uniform compression across the interbody space, will be displayed at AAOS 2017, highlighting its full commercial launch. Using Aerofoil™ Compression Technology, Aero-C is designed to pull the vertebral bodies toward the implant as it is inserted, creating compressive forces at the implant-to-endplate interface.¹Aerofoil Compression Technology is also available for lateral and anterior lumbar interbody fusion procedures (LLIF and ALIF). Since the initial introduction to the market, over 600 cases have been completed.

Also to be demonstrated at AAOS is Xia CT, which includes implants and instruments used in less invasive LITe LIF posterior lumbar interbody fusion procedures for patients with degenerative disc disease, spondylolisthesis, and trauma. The cortical trajectory procedure facilitates a smaller midline incision to help achieve decompression, fixation, and fusion.² It also is intended to be more muscle sparing than standard open procedures that require lateral dissection, and its reduced incision may allow for more efficient exposure and closure time.² The launch of the Xia CT system occurred in 2016, with 575 cases completed to date.

“Since their introduction last year, Aero-C and Xia CT have been well received by our surgeon customers and have achieved rapid adoption in the marketplace,” said Bradley Paddock, President of Stryker’s Spine division. “These unique products reflect our strong commitment to advancing spine health and helping to enhance outcomes for patients by providing physicians with innovative and differentiated technology.”

Aero-C and Xia CT offer advancements that highlight the Spine division’s leadership in pioneering innovative technologies for traditional and minimally invasive surgical techniques. The company offers one of the most comprehensive and diverse product portfolios for the treatment of degenerative and complex spinal disorders. Its suite of leading-edge products includes implants, instruments, and biologics for the cervical, thoracic, and lumbar spine.

About Stryker

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

References

PROJ0000050417 Aero-C Anchor Induced Compression Testing Design Iteration Memo
Lee GW, Son JH, Ahn MW, Kim HJ, Yeom JS. (2015) The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion: a prospective randomized noninferiority trial. The Spine Journal 15, 1519-1526.

Indications for Use

The AERO-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. The AERO-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The Xia CT implants and instruments are intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.

Content ID: CVAER-PR-2_13458

Contacts

Barbara Sullivan, Sullivan & Associates
bsullivan@sullivanpr.com, 714/374-6174

Study Finds Wide Use of Computed Tomography (CT) for Post-Operative Assessment of Spine Surgery, Despite Radiation Risks for Patients

Posted On March 9, 2017 By OrthoSpineNews In Spine, Top Stories /

March 08, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical, Inc., maker of the Simplify® cervical artificial disc designed to be clearly viewed on MRI with minimal artifact, announced findings from a new study published in BMC Musculoskeletal Disorders that is the first to estimate the magnitude of computed tomography (CT) imaging for post-operative assessment of spine surgery, which exposes patients to high doses of radiation. The Simplify Disc is considered an investigational device in the U.S.

The study found that CT prevalence following complex spine surgery increased more than two-fold from six months to five years, with patients averaging two scans over that period. Each CT scan has been estimated to deliver the equivalent radiation of 400 to 550 chest X-rays to the patient. The retrospective study utilized data drawn from a Humana database covering eight consecutive years from 2007 through 2014 and comprising adjudicated claims for more than 130,000 complex spine procedures.

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, surgeons often switch to CT post-operatively because spinal implants usually include metal components. The metal creates artifacts in the MRI image, making the implants difficult to view and affecting visualization of the facets and adjacent levels.

The study authors state, “We detected a high frequency of CT utilization following complex spine surgery. There is emerging evidence of an increased cancer risk due to ionizing radiation exposure with CT. Thus, in the setting of complex spine surgery, actions to mitigate this risk should be considered…(including) adopting non-ferromagnetic implant biomaterials that facilitate MRI post-operatively.”

One device that may minimize the need for post-surgical CT scans is the Simplify Disc, a cervical artificial disc designed to be clearly viewed on MRI without artifact. Composed of PEEK-on-ceramic materials, the Simplify Disc is intended to minimize patient exposure to high-dose ionizing radiation from CT and its associated risks. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. The Simplify Disc is anatomically designed with low height implant options for patients with smaller cervical disc spaces for whom larger implants are not optimal.

The Simplify Disc is currently enrolling patients in a non-randomized pivotal clinical trial in the U.S. – where all patients will receive the device – comparing one-level cervical implantation of the disc between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. More information about the clinical trial is available at www.SimplifyTrial.com.

The Simplify Disc has received the CE Mark and has been used to treat 600 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores after treatment.

The Simplify Disc is designed to comply with two principles developed by the International Committee on Radiological Protection and endorsed by the U.S. Food and Drug Administration (FDA), which mandate that exams using ionizing radiation – such as CT – be performed only when medically necessary, and that patients should be exposed to the lowest possible radiation.

The BMC Musculoskeletal Disorders article was authored by Vikas Patel, MD, of the University of Colorado Hospital, Denver; Gunnar Andersson, MD, of Rush University Medical Center, Chicago; Steven Garfin, MD, and Donald Resnick, MD, both with the University of California, San Diego; and Jon Block, Ph.D.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit www.simplifymedical.com.

Caution: The Simplify Disc is an Investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications
Michelle McAdam, 949-545-6654
michelle@chronic-comm.com

Bio2 Technologies, Inc. to Present Results from Ovine Spinal Fusion Study

Posted On March 9, 2017 By OrthoSpineNews In Biologics, Spine, Top Stories /

WOBURN, Mass., March 8, 2017 /PRNewswire/ — Bio2 Technologies will present a poster at the Annual Meeting of the Orthopaedic Research Society (http://www.ors.org) in San Diego, CA on March 22, 2017 reporting the results from an ovine interbody fusion study conducted at Colorado State University comparing Bio2’s Vitrium device to an implant of similar design constructed from PEEK polymer. Autograft bone was placed in the central lumen of both devices.

Vitrium is an advanced orthobiomaterial with structural properties similar to cortical bone. It is composed of bioactive glass, a material with well-established osteostimulative properties. Bio2 has developed a proprietary manufacturing process to produce a strong, three-dimensional structure featuring interconnected pores facilitating the propagation of new bone.

The biomechanical tests (performed by mdevdev, San Francisco, CA) evaluated Vitrium’s ability to exhibit the ideal characteristics of a spinal fusion product, prospectively defined as: a) an effective, safe resorption/bone formation profile, b) stimulation of new bone formation to increase fusion rates, and c) sufficient strength to bear/share physiologic loads. Janet Krevolin, Ph.D., Bio2’s Chief Technical Officer and co-author of the poster, stated “the test results clearly demonstrated that Vitrium achieved these objectives. All subjects demonstrated a reduction in motion at 26 weeks indicating a fusion taking place for both the Vitrium and PEEK implants. Of note, in axial compressive load to failure testing the Vitrium fusion exhibited strength in excess of the adjoining vertebral bodies, whereas the PEEK fusion failed at the fusion site. The test data show the Vitrium devices exhibited the ideal characteristics of an interbody fusion product.”

Additional information on Vitrium and the ovine spinal fusion study may be found at: http://www.bio2tech.com

SOURCE Bio2 Technologies, Inc.

Vertos Medical’s mild® Procedure Receives Broad Coverage From Centers For Medicare & Medicaid Services

Posted On March 8, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ALISO VIEJO, Calif., March 7, 2017 /PRNewswire/ — Vertos Medical, a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has received national coverage for its mild^® Procedure through a recently approved study under the Centers for Medicare & Medicaid Services’ (CMS) Coverage with Evidence Development (CED) Program. A clinically proven outpatient procedure performed through a portal the size of a baby aspirin, mild requires no stitches, no general anesthesia, no implants, and no overnight hospital stay.

Broad access to the mild procedure has been granted for Medicare patients via a CMS-approved claims-analysis study that will passively collect and analyze real-world data to demonstrate the role of the therapy in the continuum of care for LSS. CMS’s recent decision to expand access follows the successful completion of the company’s CMS-approved randomized controlled study, MiDAS ENCORE.¹

“Patient and physician demand for the mild procedure has grown a great deal, and I’m excited to hear that my patients and fellow practitioners will now have access to this effective, proven method for relieving pain and getting people back to doing the things that make life enjoyable,” said Nagy Mekhail, M.D., Ph.D., Director of Evidence Based Pain Medicine Research and Education at Cleveland Clinic, who is an investigator of previous clinical studies of mild and has been performing the procedure since 2010. “Neurogenic claudication related to lumbar spinal stenosis can be extremely life limiting; this first-line treatment stands to benefit the many patients currently being treated for LSS in the United States, who have no viable treatment options.”

It is estimated that roughly 10% of Americans have lumbar spinal stenosis, and that by 2021 some 2.4 million will be experiencing considerable pain as a result of the condition.

“This is great news for the thousands of people who suffer from the debilitating symptoms related to their lumbar spinal stenosis with neurogenic claudication, who have struggled to find a safe, effective, low-cost solution,” said Eric Wichems, President and CEO of Vertos Medical.

The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials, and has been performed on more than 20,000 patients. Peer-reviewed clinical data has demonstrated that mild helps patients suffering from LSS stand longer and walk further with less pain.²

¹Benyamin, R., et al. (2016). mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician, 19: 229-242. ISSN 1533-3159.

² Mekhail, Nagy, et al. (2012). Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x.

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

SOURCE Vertos Medical

VTI Expands with 3 New International Distribution Partners

Posted On March 8, 2017 By OrthoSpineNews In Spine, Top Stories /

(March 7, 2017) VTI – Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has strengthened its distribution in Northern Europe to better serve its international customers. During this process VTI has appointed three new distributors with a strong focus on the spine market. This improved territory coverage will help increase awareness and give surgeons access to VTI’s InterFuse® modular spinal implants.

The three new distribution channels VTI will be partnering with are: Joline GmbH & Co KG, based in Hechingen, Germany: Articular, based in Helsinki, Finland and Anatomica, headquartered in Gothenburg, Sweden. All three distributors have a strong presence in all major hospitals within their respective countries.

Vice President of International Sales Ben Wasscher states “We believe that we have significantly upgraded the quality of our distribution network in Northern Europe, enabling VTI to better serve its existing surgeon customers as well as significantly expanding on this existing user base. This will bring the benefits of the InterFuse® modular interbodies to a larger patient population.”

“Anatomica’s sales force is very enthusiastic about the InterFuse® system!” says CEO Sverker Stomberg of Anatomica.

When asked about how surgeons react when seeing the InterFuse® product, Peter Kohlbecher Director of Sales & Marketing at Joline GmbH & Co KG said, “They like the fact that a large surface implant can be inserted from posterior; no need to flip the patient; no need to work with general surgeons to get access to the spine from the anterior”.

ABOUT VERTEBRAL TECHNOLOGIES, INC.

Vertebral Technologies, Inc. (VTI) is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells InterFuse® modular interbody fusion devices worldwide.

For more information visit, http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or +1.877-912-5401

AAEAAQAAAAAAAAJWAAAAJGI2MWI1YmU0LTljYzItNDdmOS1hZDJhLTI4YWNlYWNkZmM4OA.png

LinkSPINE Names Tom McLeer Vice President of Sales and Marketing

Posted On March 7, 2017 By OrthoSpineNews In Spine, Top Stories /

Rockaway, NJ — March 7, 2017 — LinkSPINE, a medical device company focused on the development of less invasive techniques for spine surgery, has named Tom McLeer Vice President of Sales and Marketing.

McLeer is an established medical device executive leader who has made a name in the industry by exponentially boosting sales for existing companies and leading startups through clinical approval and into full commercialization. He most recently served as Senior Vice President of US Commercial Operations for Alphatec Spine. Previously, he was CMO and General Manager of Spinal Operations for Pioneer Surgical Technology and VP of Sales and Marketing for Archus Orthopedics. Earlier in his career, McLeer was VP of Marketing and Business Development for Spinal Concepts and VP of Marketing for Interpore Cross International.

“We are excited to welcome Tom McLeer to the LinkSPINE team to lead our Sales and Marketing efforts,” sad LinkSPINE President, Dennis Farrell. “Tom’s deep leadership experience in spine and familiarity with novel technologies will be invaluable to us as we as we continue to expand our less invasive Midline Choice product portfolio.”

Farrell added that LinkSPINE remains committed to developing innovative solutions which reduce surgical morbidity and which are designed for placement with minimal fluoro and shorter learning curves than tubular MIS techniques; and that McLeer is ideally suited to help bring those solutions to the surgical community.

‘Midline Choice’ is LinkSPINE’s comprehensive midline fusion portfolio, which includes CorticaLINK and FacetLINK. A single kit houses a complete array of screws and devices, offering the surgeon the ability to intra-operatively create a less invasive fusion construct based upon each patient.

“I’m excited to be part of such a great team and I look forward to working with my existing contacts to help advance this minimally invasive procedure to a wide patient population,” said McLeer. “I was drawn to LinkSPINE’s dedicated focus on improving patient outcomes — and it’s innovative portfolio of powerful, yet simple solutions for less invasive surgery. The devices are novel, elegant and intuitive and fulfill a desire for a simple, less invasive approach to lumbar surgery, adding true value for surgeons who are tiring of long learning curves. It will be rewarding to be part of the company’s growth and success.”

McLeer and his new LINKSpine colleagues will be exhibiting the company’s technology in Booth 907 at the Spine Summit 2017 AANS/CNS Meeting in Las Vegas, from March 8-11, 2017.

LinkSPINE is a privately held medical device company focused on the development of less invasive techniques for spine surgery. LinkSPINE is a sister company of Waldemar Link GmbH of Hamburg Germany, a worldwide leader in Reconstructive Orthopedics.

Media: Interviews and photos are available upon request. Please contact Paul Williams at 310/569-0023 or via paul@medialinecommunications.com.

Paul Williams

President

MediaLine Communications

310/569-0023

Safe Orthopaedics expands into Germany and appoints Jochen Esser as Head of Sales Germany

Posted On March 6, 2017 By OrthoSpineNews In Spine, Top Stories /

Eragny-sur-Oise, France, March 6, 2017, 6pm (CET) – SAFE ORTHOPAEDICS (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, is today announcing that it is expanding into Germany and has appointed Jochen Esser as Head of Sales Germany.

Jochen has over 25 years’ sales development and sales force leadership experience in the spinal surgery sector, both in Germany and in international markets. Before joining Safe Orthopaedics, Jochen held various sales positions with Zimmer, and DePuy Synthes, the Johnson & Johnson group subsidiary specialized in medical devices, where he was awarded for his sales performance on several occasions. In 2010, he joined K2M, a leader in minimally invasive techniques for back surgery, as head of the Germany, Austria and Switzerland region where he built a team of seven sales representatives and more than tripled the sales base. Since 2015, Jochen has been head of sales Germany at Joimax, a specialist in endoscopic solutions for minimally invasive back surgeries. In this role, he also built up the company’s sales in Austria and Switzerland.

“We are delighted to welcome Jochen to Safe Orthopaedics. His knowledge of the German market and many years of experience in the spinal surgery sector will be invaluable to our development in Germany where we intend to replicate the success we have had in France with direct sales of our products”, said Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics. “2017 is shaping up to be a strategically important year for the Group, with the progressive strengthening of our sales force in regions experiencing the most rapid growth. Following on from the appointment of Dr. Franke, a highly renowned German surgeon, to our Scientific Advisory Board, the addition of Jochen as our Head of Sales represents another step forward establishing us in this very important market.”

The German market, Europe’s largest, is also growing most rapidly. Sales of spinal implants totaled €443 million in 2015, and a CAGR in sales of 4.7% has been forecast for the period to 2024. By comparison, sales in the French market totaled €64.7 million in the same year. Germany is also a very large market for traumatology, a segment estimated to be worth €50 million. It has around 600 centers specialized in trauma surgery, compared with around a hundred in France.

Jochen Esser, Safe Orthopaedics’ Head of Sales Germany, added: “I’m very excited to be joining Safe Orthopaedics’ team and to be contributing to its development, following on from its solid performance in 2016. With its steadily growing international footprint and its unrelenting commitment to innovation, Safe Orthopaedics is a breakthrough force in back surgery. Its single-use technology is particularly well-suited for minimally-invasive techniques and for trauma surgeries. With this in mind, I will initially focus on traumatology to establish our sales base in Germany in this key segment before building a larger sales team and catering to the degenerative condition segment.”

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally‑invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpine^TM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

CONTACTS

Safe Orthopaedics

Thierry Lambert
CFO

Tel. : +33 (0)1 34 21 50 00
investors@safeorthopaedics.com

NewCap

Julien Perez/Valentine Brouchot
Investor Relations

Nicolas Merigeau
Press Relations

Tel. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

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