LinkSPINE Promotes Dennis Farrell to President and CEO

October 24, 2017

COLUMBIA, Md.–(BUSINESS WIRE)–LinkSPINE™, a medical device company focused on the development of less invasive techniques for spine surgery, has promoted Dennis Farrell to President and Chief Executive Officer.

Farrell has been with LinkSPINE since 2011, serving as President since 2015, and previously leading the company’s Sales, Marketing, and Product Development initiatives.

“We are very pleased to announce the promotion of Dennis Farrell to Chief Executive Officer of LinkSPINE, Inc.,” stated Helmut D Link, Chairman of the LINK family of companies. “Dennis started with the company nearly six years ago and has advanced through progressive development of our MidlineChoice™ Platform as a member of our Executive Management Team. With his experience, expertise and knowledge as well as his communication skills and surgeon relationships, he has provided an invaluable resource to the company.”

“As CEO, Dennis will be responsible for the oversight of day to day corporate operations, human resource management as well as quality assurance and all reporting,” added Link. “We are excited about his new role at the company and look very much forward to a bright future of LinkSPINE under his leadership.”

“I am excited about and grateful for the opportunity to continue working with LinkSPINE’s exceptional team,” said Farrell. “We remain committed to developing innovative solutions that are designed for placement with minimal fluoro and shorter learning curves than tubular MIS techniques, offering the potential for reduced surgical morbidity. It is particularly rewarding to be able to offer, through LinkSPINE’s MidlineChoice, a platform designed specifically to provide surgeons enhanced flexibility. With our technology, the surgeon community can intra-operatively customize the fusion construct based upon patient anatomy, pathology, and preference. Novel, cross-linked two screw constructs are available in addition to cortical and pedicle screws, ensuring the desired implant options are available on game day even if the game plan changes according to intra-operative discovery.”

‘MidlineChoice’ 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. The system is specifically designed for the Ambulatory Surgery Center setting, or to reduce length of hospital stay in a conventional facility.

LinkSPINE will be exhibiting the company’s novel technology in Booth 434 at the North American Spine Society Meeting in Orlando, from October 25-28, 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.

Contacts

for LinkSPINE
Paul Williams
310/569-0023
paul@medialinecommunications.com

VEXIM to be Acquired by Stryker Corporation

October 24, 2017

BALMA, France–(BUSINESS WIRE)–Regulatory News:

Stryker Corporation, a global leading medical technology company, acquired on October 24th, 2017 a majority of the share capital and voting rights of VEXIM, a medical device company specializing in the minimally invasive treatment of vertebral fractures listed on Euronext Growth (FR0011072602 – ALVXM).

Stryker Corporation (NYSE:SYK) has indirectly acquired 4,115,151 VEXIM shares, representing 50.7% of the share capital and 50.3% of the voting rights of the Company for a cash price of EUR 20.00 per share, and 170,745 listed warrants (“BSAAR”), representing 37.1% of outstanding BSAARs for a cash price of EUR 3.91 per BSAAR. The selling shareholders comprised funds managed by Truffle Capital, Bpifrance and Kreaxi, as well as managers of VEXIM.

The purchase price of EUR 20.00 per share represents a premium of 29.4% to the closing share price on October 23rd, 2017 of EUR 15.46, and of 34.4% and 57.6% to the volume-weighted average share prices over 6 months and 12 months, respectively (EUR 14.89 and EUR 12.69). This price represents an aggregated equity value of VEXIM on a fully diluted basis of approximatively EUR 183 million, which corresponds to an enterprise value of approximatively EUR 162 million.

“We are really excited by this transaction and enthusiastic about our future integration into Stryker’s Interventional Spine business, which we view as highly complementary to VEXIM. Stryker will significantly help us achieve our objective to become a global spine trauma leader, through consolidation of our European presence and expansion of our international footprint. We will benefit from Stryker’s broad customer base and commercial platform in back trauma surgery, enabling further acceleration in the adoption of the SpineJack® technology. Stryker is the ideal partner to lay the ground for VEXIM business on the promising US market. VEXIM’s US FDA trial is progressing well and is in line with a 510(k) filing in 2018. This landmark transaction is the recognition of our outstanding sales growth over the past five years, with net sales CAGR of 73% between 2011 and 2016, and of the strong implication and expertize of all of VEXIM employees. For the first 9 months of 2017, sales performance continued to be robust. VEXIM generated €5.4m in revenue in Q3 and we still expect a strong performance in Q4. We are reiterating our objective to reach full-year profitability on the back of a FY 2017 sales growth which remains very significant at 25%. This transaction is really beneficial to all VEXIM stakeholders: our customers, employees and shareholders. As VEXIM enters its next chapter of growth as part of Stryker Corporation, I would like to warmly thank our reference shareholders Truffle Capital, which co-founded the Company, Bpifrance and Kreaxi, all of which steadily supported VEXIM over the years,“ said Vincent Gardès, VEXIM’s CEO.

“This transaction further illustrates the power of medtech radical innovation in France,” added Philippe Pouletty, MD, CEO of Truffle Capital.

As required by applicable regulations, Stryker France MM Holdings SAS, an indirect wholly-owned French subsidiary of Stryker Corporation, will file on October 25th, 2017 a simplified all-cash tender offer (OPA simplifiée) with the Autorité des Marchés Financiers(AMF) for all VEXIM shares and BSAARs it does not already own, at the same prices per share and per BSAAR as the prices paid for the controlling blocks (the “Offer”). Following the Offer, Stryker intends to pursue a squeeze-out (retrait obligatoire) if the appropriate ownership thresholds are reached at the closing of the Offer.

The Board of Directors of VEXIM has unanimously and unreservedly approved the Offer which it considers being in the best interest of the Company, its shareholders, employees and stakeholders and recommends that all shareholders and holders of BSAAR tender their securities to the Offer.

In accordance with applicable regulations, VEXIM will file a draft response note (projet de note en réponse) which will include the reasoned opinion of the Board of Directors and the report of Associés en Finance, the independent expert appointed by VEXIM in accordance with AMF General Regulation (articles 261-1 I and II) opining on the fairness of the financial terms and conditions of the simplified tender offer and potential squeeze-out. The transaction is expected to close in the fourth quarter of 2017.

Documentation relating to the Offer will be available on the websites of the AMF (www.amf-france.org) and the Investor Relations page of VEXIM’s website (www.vexim.com).

Goldman Sachs acted as financial advisor and Dechert LLP acted as legal advisor to VEXIM on this transaction. BNP Paribas is acting as financial advisor and presenting bank and Skadden, Arps, Slate, Meagher & Flom LLP is acting as outside legal counsel to Stryker.

Update on the US FDA trial:

The VEXIM FDA trial (European, prospective and randomized multicenter study aiming to compare safety and efficacy of the SpineJack® vs balloon kyphoplasty) is intended to provide clinical data to support a 510(k) submission in the US. The FDA trial is progressing well and is in line with a 510(k) filing in 2018.

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. VEXIM has been listed on Euronext Growth Paris since May 3rd2012. For further information, please visit www.vexim.com

SpineJack®, an innovative implant for treating Vertebral Compression Fractures

The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

About STRYKER

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
investisseur@vexim.com
Tél. : +33 5 61 48 48 38
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
vexim@alizerp.com
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94

Sites Medical Licenses its OsteoSync™ Ti Technology to Integrity Implants for Incorporation into their FlareHawk™ Family of Expandable Implants

October 24, 2017

COLUMBIA CITY, Ind.–(BUSINESS WIRE)–Sites Medical, a firm specializing in value-driven innovation in orthopedics, today announced it has entered into a licensing agreement with Integrity Implants, to incorporate its proprietary OsteoSync™ Ti technology into Integrity’s novel multi-dimensional expandable interbody devices.

“We are thrilled to be partnering with Integrity Implants, a company with a high degree of innovation in the spine field and an accomplished leadership team,” said Greg Stalcup, President/CEO of Sites Medical. “We look forward to working with the Integrity team to combine our respective technologies to deliver a new generation of high performance, high value products to the market.”

OsteoSync™ Ti technology is a highly porous titanium scaffold designed to meet the needs of today’s patients from both clinical and economic standpoints. Its high friction coefficient ensures high initial implant stability and its open pore geometry and micro-texturing facilitate superior bone ingrowth. Preclinical testing has demonstrated bone attachment strength nearly twice that of titanium plasma spray and approximately seven times that of PEEK material at the 5-week follow up period, a performance differential that can impact clinical outcomes, especially in spinal fusion patients. OsteoSync™ Ti technology has also been engineered to reduce the potential for abrasion during implant insertion and associated debris-related inflammation, offering an additional measure of safety for the patient. The material is manufactured using highly innovative methods and offers substantial value in today’s cost-conscious healthcare environment.

“We are very excited to work with Sites Medical,” said Wyatt Geist, President & CTO of Integrity Implants. “As the market begins to recognize the need for implants that promote better short- and long-term stability, the Sites Medical OsteoSync™ Ti technology offers us an opportunity to provide proven bone ingrowth capability at cost-effective levels. Together with our unique expandable technology, our devices will offer state-of-the-art capabilities for surgeons to help promote better clinical outcomes. We look forward to showing our first devices featuring this unique technology at NASS.”

About Sites Medical

Sites Medical has recognized the shift in healthcare reimbursement paradigms and is entirely focused on Value-Driven Innovation in orthopedics. With its suite of proprietary orthopedic implant technologies and manufacturing process improvements, Sites aims to deliver improved clinical outcomes and reduced cost to all stakeholders. Additional information about the company can be found at www.sitesmedical.com.

About Integrity Implants

Founded in 2016, Integrity Implants focuses on unique expandable interbody technology. The FlareHawk family of expandable interbodies are the world’s first to expand in height, width and lordosis. Additional information about the company and product can be found at www.integrityimplants.com.

Contacts

Sites Medical
Greg Stalcup
gstalcup@sitesmedical.com
www.sitesmedical.com
or
Integrity Implants
Brad Sutika
bsutika@integrityimplants.com
www.integrityimplants.com

Implanet Presents JAZZ® Results at NASS Annual Meeting, Addressing Unmet Clinical Needs in Complex Spine Surgery

October 24, 2017

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

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces the first presentation of JAZZ® clinical US study data in adult spinal deformity surgery at the NASS Annual Meeting on October 26th, 2017.

Technical advances have enabled spinal deformity surgeons to correct severe spinal mal-alignment. However, proximal adjacent segment pathology, such as proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) remain serious issues. About 65% of surgeons use a PJK prevention strategy in over 40% of patients1. The diversity of strategies employed by surgeons to prevent PJK/PJF illustrates i) the desire to address the problem, and ii) the lack of effective options available to surgeons.

Dr. H. Francis Farhadi, The Ohio State University Wexner Medical Center, will present findings from his prospective study at the NASS Annual Meeting, on Thursday October 26th in Orlando. ‘Prospective Assessment of Early Clinical and Radiologic Outcomes Following Sublaminar Band Placement for Proximal Junctional Kyphosis Prophylaxis in Adult Spinal Deformity Surgery.’ The presentation P114 will take place as part of Poster Grand Rounds, The Learning Place, Exhibition Hall Entrance, Green Theater, Thursday, October 26th at 3:10PM.

Dr. Farhadi commented: “We have seen encouraging results so far at one-year follow-up. Proximal junctional sublaminar banding appears safe and does not increase proximal junctional kyphosis following long-segment adult spinal deformity surgeries. We have not seen any cases of proximal junctional failure to date in over 60 patients enrolled. Longer term follow-up in a larger cohort of patients will be needed before we can make any definite conclusions on prevention of proximal junctional kyphosis.”

Ludovic Lastennet, CEO of Implanet, adds: “Implanet is a clinical solutions driven company, developing novel technology JAZZ® for the spine surgery community. This is an important first step in addressing with JAZZ® an unmet clinical need in complex spine surgery, aUS $200 Million market2. We are actively recruiting patients in multiple prospective studies to both strengthen and document the clinical evidence for the JAZZ platform as the option in the prevention of PJK.

About The Ohio State University Wexner Medical Center and Dr H.F. Farhadi

Ohio State University Wexner Medical Center is one of America’s top-ranked academic medical centers, with more than 900 beds. Their mission is to improve people’s lives in Ohio and across the world through innovation in research, education and patient care.

Dr H. Francis Farhadi, MD, PhD, FRCSC is Chief of the Degenerative and Deformity Spine Division, Director of the Spinal Surgery Fellowship Program, Department of Neurological Surgery.

About the North American Spine Society (NASS)

The North American Spine Society (NASS) is a medical society for health care professionals who specialize in spine care. Founded in 1985, it is the largest society in America. The organization’s goal is the promotion of evidence-based and ethical spine care. NASS does this with policies and actions aimed at promoting education, research and advocacy in health care fields related to the spine. NASS membership consists of about 8,000 health care professionals; such as orthopedic surgeons, neurosurgeons, physiatrists, anesthesiologists, researchers and other related practitioners. NASS publishes two major publications, the Spine Journal and SpineLine. The Spine Journal is the official peer-reviewed journal of the North American Spine Society, and was launched in 2001. SpineLine is a bimonthly clinical and news publication for spine care professionals; it is published both in print and in digital editions.

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 Euronext™ Growth market in Paris.

Disclaimer
This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

1 Results of the 2014 SRS survey on PJK/PJF give valuable insight into PJK/PJF management (SPINE Volume 40, Number 11, pp 829 – 840).
2 Health Advance study & company data.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
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

Mazor Robotics to Report Third Quarter Financial Results on November 7, 2017

Oct. 24, 2017

CAESAREA, Israel–(BUSINESS WIRE)– Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic guidance systems, announced today that it will report financial results for the third quarter ended September 30, 2017, before the U.S. markets open on Tuesday, November 7, 2017.

The company will host a conference call to discuss these results on Tuesday, November 7, 2017, at 8:30 AM ET (3:30 PM IST). Investors within the United States interested in participating are invited to call 800-298-0498. Participants in Israel can use the toll-free dial-in number 1 80 924 6042. All other international participants can use the dial-in number 719-457-2654. For all callers, refer to Conference ID 5718138.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 5718138. All international callers can dial +1 719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a precise manner. For more information, please visit http://www.MazorRobotics.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171024005310/en/

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 415-652-9100
dsherk@evcgroup.com

 

Source: Mazor Robotics Ltd.

Ortho Sales Partners Announces the Addition of Matt Stuttle as Senior Vice President

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is excited to announce the addition of Matt Stuttle as Senior Vice President. This addition continues the momentum of Ortho Sales Partners in assisting clients by providing access to some of the industry’s top talent. Mr. Stuttle will instantly bring immense value to our clients from around the globe.

Matt has been in the medical industry for over 18 years. He began his career in sales and management with Forest Pharmaceuticals prior to transitioning to medical devices in 2003. Since then he’s held roles of increasing responsibility and executive management positions at Kyphon (acquired by Medtronic in 2008 for $4.3B), Paradigm Spine, Spine Wave and most recently Spineart.

Throughout his career Matt has lead sales organizations through enormous revenue growth in both private and public sectors. Prior to joining Ortho Sales Partners Matt was U.S. Vice President for Spineart, a global spine implant company based in Switzerland. During his tenure at Spineart he was instrumental in developing the US infrastructure, commercialization, distribution, product launch and market development strategies while providing necessary operational guidance. Under his leadership the organization received FDA approval for several new technologies subsequently introduced into the U.S. market while doubling U.S. sales.

Matt was also previously U.S. Vice President for Paradigm Spine where he built and scaled the initial U.S. sales and distribution infrastructure. Matt led the organization though key product launches while also assisting in management of the IDE clinical trial for Coflex, now FDA approved and market leading technology worldwide. Under his leadership the company grew from $0 to over $13M.

“It’s an honor to join such a tremendous group of experienced professionals with such a vast breadth of expertise. Ortho Sales Partners is well positioned to assist a broad scope of clients throughout various stages of growth and scale. Whether a startup company or well-established organization, OSP has the knowledge, resources and team to assist in providing real tangible value while mitigating unnecessary operational risk,” said Matt Stuttle.

“I have had the pleasure of knowing and working with Matt for the past 12 years and I am thrilled to have someone of his caliber join Ortho Sales Partners,” said Josh Sandberg President, Ortho Sales Partners. “We have been able to create a disruptive change to the supply chain in orthopedics over the past couple of years and with this addition, we are able to further advance the initiatives that we have been working on. We welcome Matt as a core member of our team and look forward to the contributions he will add to our team.”

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 such as:

  •     A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
  •     OUS companies looking to establish or enhance their presence in the United States.
  •     Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
  •     Established companies looking for sales and marketing horsepower to properly launch a new product.

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)

FzioMed Receives FDA Approval for Small Confirmatory Study of Oxiplex® in Patients Undergoing Lumbar Surgery for Disc Herniation

October 23, 2017

SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc., a biomaterials company celebrating 21 years in business, has received approval from FDA to conduct a small confirmatory study of Oxiplex® in the United States.

Oxiplex® is an absorbable, synthetic viscoelastic gel that is applied following partial discectomy, with the intent to reduce postoperative leg pain, back pain and neurologic symptoms.

“We have been working with FDA for many years to bring this technology to the US,” said John Krelle, President and CEO of FzioMed, “and we are confident that a new level of cooperation with FDA will finally enable patients in this country to experience the benefits of Oxiplex following the large number of lumbar surgeries performed here.”

Multiple US and OUS studies have already demonstrated the benefits of Oxiplex® and this study will target patients with higher levels of back and leg pain who do not always experience the level of pain relief offered by surgery alone.

FzioMed is pleased to be working with Musculoskeletal Clinical Regulatory Advisers (MCRA) as both regulatory advisor and CRO on this study, which will be posted on Clinicaltrials.gov when open for enrollment.

About FzioMed, Inc.

FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable surgical biomaterials based on its patented scientific technology. For more information, please contact John Krelle at jkrelle@fziomed.com. You can also visit www.fziomed.com or contact investorrelations@fziomed.com.

FzioMed®, Oxiplex®,Oxiplex/AP®, Laresse® and Dynavisc® are registered trademarks of FzioMed, Inc.

Contacts

FzioMed, Inc.
John Krelle
jkrelle@fziomed.com

Esaote Launches Q-Spine

FISHERS, Ind.Oct. 23, 2017 /PRNewswire/ — Q-Spine, a technology that provides biometrics of the spine, will be launched at North America Spine Society (NASS), October 25th – 28thQ-Spine is a software tool to assist spine surgeon, orthopedists and chiropractors in their planning therapy and surgical procedures by means of visualization and quantification of relative biomechanical changes between weight-bearing and recumbent MRI lumbar spine examination.

In addition to being showcased in Esaote North America booth #1337, luminary Orthopedic Spine Surgeon, Dr. D. Guyer, M.D. from Texas Back Institute will be presenting an Abstract on Q-Spine during the Innovative Technology Presentations Q-Spine: New MRI-Based Quantification Method for L-Spine Analysis (Non-CME) Room: W230CD, Wednesday, October 25, 20171:00 PM – 2:00 PM.

Clinical Benefits of Q-Spine:

  • Facilitates and simplifies the analysis of weight-bearing versus recumbent MRI by semi-automatic segmentation of the Lumbar-spine
  • Provides a numerical quantification of the relative changes
  • Reliable and coherent measures by taking out the “human factor”
  • Provides ability to evaluate patient follow-up with numerical evidence
  • Generates a PDF report to be attached to the medical report

Dr. Guyer states, “We are excited to present the Q spine software, which is a semi-automated software analysis used with the Esaote weight-bearing Brio G MRI scanner which reliably calculates spinal canal area, dural diameter, lumbar lordosis and sacral angles.  We believe this will demonstrate nerve compression which may not be diagnosed with supine MRI scanners and help surgeons manage sagittal alignment in their patients.”

Q-Spine is available on Esaote’s G-Scan Brio a dedicated MRI system featuring a comprehensive set of coils and sequences to provide complete MSK MRI, from spine to extremities — plus the ability to perform unique weight-bearing studies.

About Esaote: With a consolidated turnover of EUR 270 million in 2016, the Esaote Group is a leader in the biomedical equipment sector, the areas of ultrasound, dedicated MRI and software for managing the diagnostic process. The Group currently employs 1,200 people. With its own production and research units in Italy and the Netherlands, Esaote is recognized as one of the top 10 diagnostic imaging companies in the world. Information on Esaote and its products is available at www.esaote.com.

Esaote@NASS2017:  Esaote will be exhibiting at NASS  2017, Orlando, FL October 25th – 29th, 2017

LOCATION: Booth #1337

Dr. D. Guyer, M.D. from Texas Back Institute will be presenting an Abstract on Q-Spine during the Innovative Technology Presentations – Q-Spine: New MRI-Based Quantification Method for L-Spine Analysis (Non-CME) Room: Room W230CD
Wednesday, October 25, 20171:00 PM – 2:00 PM

Information about the Esaote Group and its products is available at www.esaote.com

© Copyright Esaote 2017. Technology and features are system/configuration dependent. Specifications are subject to change without notice. Information might refer to products or modalities not yet approved in all countries. For further details, please contact your Esaote sales representative.

Contact ljoos@esaoteusa.com

SOURCE Esaote North America

Related Links

http://www.esaote.com

Astura Medical Receives FDA 510(k) Clearance For BRIDALVEIL OCT Stabilization System

CARLSBAD, CA – October 19, 2017 – Astura Medical, a high growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System.

“The FDA 510(k) clearance of our BRIDALVEIL OCT System, demonstrates the power of our innovation engine at Astura Medical and represents our best system released to date. We are excited for the opportunity to provide our rapidly expanding group of surgeon partners the most complete OCT technology offering on the market today, to further enhance their ability to provide the best in patient care,” said Thomas Purcell, Vice President.

Designed with the most complex and demanding cases in mind, BRIDALVEIL OCT provides a comprehensive offering of screw options (single-lead, dual-lead, high-top, and smooth shank) ranging from 3.5mm to 5.5mm in diameter that are compatible with either a 3.5mm or 4.0mm rod in titanium or cobalt chrome. The system also provides an extensive line of connectors, transition rods, and instrumentation options to allow surgeons the ability to seamlessly transition across multiple segments of the spine.

The launch of BRIDALVEIL OCT represents the 11th system launched since the company was founded in 2014. The company anticipates high demand for BRIDALVEIL OCT in addition to the robust growth seen in its current line of products.

Astura Medical will be showcasing BRIDALVEIL OCT, along with the Company’s other systems at Exhibit 565 during the 32nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27th.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, mulit-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

 

Media Contact:

Steve Haayen

Astura Medical

858.472.8825

steve@asturamedical.com

SI-BONE’s New iFuse-Navigation™ Set* and iFuse-3D™ Fenestrated SI Joint Fusion Implant to be Featured at NASS 2017

SAN JOSE, Calif.Oct. 23, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced its new iFuse-Navigation Set* and proprietary 3D printed iFuse-3D fenestrated triangular titanium implant, will be featured at this year’s North American Spine Society (NASS) annual meeting in Orlando, FL.  The new iFuse-Navigation Set was designed to allow surgeons using the O-armTMimaging system and StealthStationTM navigation system to perform the iFuse procedure for MIS SI joint fusion.

In addition to the new iFuse-Navigation Set, the company will also showcase its new iFuse-3D Implant. This novel implant combines the patented triangular shape of the iFuse ImplantTM with a proprietary 3D-printed porous trabecular surface and unique patented fenestrated design which is intended to enhance bony ongrowth, ingrowth, through growth and intra-articular fusion.

The company will also be hosting Dr. David Polly**, Chief of Spine Surgery at the University of Minnesota, on Thursday, October 26th from 3:10 pm to 3:40 pm at its booth (#1518) in the NASS exhibit hall.  Dr. Polly will present and discuss his experience utilizing navigation with the iFuse Procedure as well as his clinical experience with the new iFuse-3D Implant.

“We are excited to have Dr. Polly join us at our booth and we’re grateful that he has offered to take time to share his clinical experience with the iFuse Implant System® and navigation as well as provide his initial perspective on the new iFuse-3D Implant,” said Tony Recupero, Chief Commercial Officer at SI-BONE.  “We have made great progress this past year toward advancing the diagnosis and treatment of SI joint disorders and we look forward to this year’s NASS meeting to help build on that progress and create even greater awareness about the condition and access to our procedure.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse ImplantTM was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

*Pending 510(k), not available for sale in USA.
**Dr. Polly was an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse-Navigation and iFuse-3D are trademarks of SI-BONE, Inc.  ©2017 SI-BONE, Inc. All Rights Reserved.  All other trademarks are property of their respective owners.

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  1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com