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February 2-4, 2017
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FinancialRoboticsTop Stories

Medtronic to Acquire Mazor Robotics

September 21, 2018 OrthoSpineNews

DUBLIN and CAESAREA, Israel – September 20, 2018 – Medtronic plc (NYSE:MDT), a global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR, TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today announced the companies have entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50 per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in cash, for a total of approximately $1.64 billion, or $1.34 billion net of Medtronic’s existing stake in Mazor and cash acquired. The boards of directors of both companies have unanimously approved the transaction.

Medtronic’s acquisition of Mazor strengthens Medtronic’s position as a global leader in enabling technologies for spine surgery, and drives Mazor Robotics’ vision to bring its core technology to the forefront of the global market. Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System (Renaissance), are transforming spinal surgery from freehand procedures to accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-leading spine implants, navigation, and intra-operative imaging technology with Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a fully-integrated procedural solution for surgical planning, execution and confirmation. The companies plan to showcase this technology integration at the upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.

“We believe robotic-assisted procedures are the future of spine surgery, enhancing surgeons’ abilities to perform complex procedures with greater precision, consistency and control. Medtronic is committed to accelerating the adoption of robotic-assisted surgery and transforming spine care through procedural solutions that integrate implants, biologics and enabling technologies,” said Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds robotic-assisted guidance systems to our expanding portfolio of enabling technologies, and we intend to further cultivate Mazor’s legacy of innovation in surgical robotics with the site and team in Israel as a base for future growth.”

This transaction builds on a relationship originated in May 2016 under a multi-phased strategic and equity investment agreement between Medtronic and Mazor. In August 2017, Medtronic expanded the partnership to become the exclusive worldwide distributor of the Mazor X system, leading to the successful installation of more than 80 Mazor X systems since launch. With today’s announcement bringing the two companies together, Medtronic aims to accelerate the advancement and adoption of RAS in spine to the benefit of patients, providers, and the healthcare system more broadly.

“Today is a historic day for spine surgery and a defining event in the market’s evolution, and I want to acknowledge and thank all of those whose contribution and faith have been so critical and impactful to our success,” said Ori Hadomi, CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration into Medtronic will maximize our impact globally through Medtronic’s channels, advance our systems’ leadership position in the marketplace, and drive the realization of our vision to heal through innovation.”

Financial Highlights
The acquisition is expected to close during Medtronic’s third fiscal quarter ending January 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders. The transaction is expected to be modestly dilutive to Medtronic’s fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic’s business, the company expects to absorb the dilution.

Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital (ROIC) by year four, with an increasing contribution thereafter.

Medtronic’s financial advisors for the transaction are Perella Weinberg Partners LP and Goldman Sachs & Co. LLC, with Meitar Liquornik Geva Leshem Tal and Ropes & Gray LLP acting as legal advisors. Mazor’s financial advisor is J.P. Morgan Securities LLC, Duff & Phelps LLC, with Kirkland & Ellis LLP and Luchtenstein Levy Wiseman Law office acting as legal advisor.

About Mazor Robotics
Mazor, founded in 2001, pioneered the application of robotics technology and guidance for use during spinal procedures, and is the market segment’s leader. In 2011, the Company introduced the Renaissance system and in 2016 launched the next generation Mazor X system. To date, more than 200 Mazor systems are in clinical use on four continents and have guided the placement of more than 250,000 implants during some 40,000 procedures, enabling minimally-invasive spine surgery to become standard procedure in many hospitals. Mazor’s core technology has received more than 15 U.S. Food and Drug Administration clearances and has been the subject of more than 60 publications, leading the spine robotics market on the evidence front. Mazor is the holder of more than fifty patents worldwide.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements, including, but not limited to, statements regarding the proposed transaction between Medtronic and Mazor, the expected timetable for completing the transaction, strategic and other potential benefits of the transaction, including meeting Medtronic’s long-term financial metrics for acquisitions, Mazor’s products and product candidates, and other statements about Medtronic or Mazor managements’ future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability and timing to satisfy conditions to closing including shareholder and regulatory approvals, the impact of the announcement of the transaction on the business, and other risks and uncertainties such as those described in Medtronic’s and Mazor’s reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic and Mazor caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic and Mazor undertake no obligation to update or revise any of these statements except to the extent required by law.

ADDITIONAL INFORMATION

In connection with the proposed transaction, Mazor intends to mail a proxy statement to its shareholders and furnish a copy of the proxy statement with the SEC on Form 6-K. Shareholders of Mazor are urged to read the proxy statement and the other relevant material when they become available because they will contain important information about Mazor, Medtronic, the proposed transaction and related matters. Shareholders are urged to carefully read the proxy statement and other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. The proxy statement (when available) may be obtained for free at the SEC’s website at www.sec.gov. In addition, the proxy statement will be available, without charge, at Mazor’s website at www.mazorrobotics.com.

-end-

Medtronic Contacts:
David T. Young
Public Relations
+1-774-284-2746

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Mazor Contacts:
Eran Gabay – Gelbart Kahana
Israel Public Relations
+972-54-246378

Michael Polyviou – EVC Group
U.S. Public Relations
+1-732-232-6914

 

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Spine

Stryker’s Spine Division To Showcase Tritanium® In-Growth Technology in Augmented Reality Experience at NASS 2018

September 21, 2018 OrthoSpineNews

September 20, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will feature its family of 3D-printed Tritanium interbody fusion cages and highlight its Tritanium In-Growth Technology1 in an augmented reality experience at the North American Spine Society Annual Meeting, Sept. 26–29, 2018, in Los Angeles (booth No. 1401).

The augmented reality “tour” combines objects in the real world with computer-augmented 3D animations. Using this augmented reality storyline, as well as a series of hands-on activities and scientific animations, the experience at the Stryker booth is designed to enhance understanding of the story behind Tritanium In-Growth Technology, as well as AMagine™, Stryker’s proprietary additive manufacturing (or 3D-printing) process, which assists in the creation of highly porous implants with a structure that is designed to mimic bone.

“Our augmented reality tour will demonstrate Tritanium’s characteristics, with the goal of helping surgeons better understand the differences of materials on the market,” said Michael Carter, vice president and general manager of Stryker’s Spine division. “Tritanium continues to receive terrific feedback as more surgeons become believers in the technology, validating our commitment to providing advanced and innovative products for our surgeon customers and their patients.”

Tritanium cages are inspired by the microstructure of cancellous bone1 and enabled by AMagine, Stryker’s proprietary approach to implant creation using additive manufacturing. The AMagine process allows the company to tackle previously difficult or impossible design complexities and address unmet surgeon needs with unique material characteristics. For example, Tritanium may be able to wick and retain fluid inside its porosity, compared to traditional titanium.1,2 Additionally, the unique porous structure of Tritanium Technology was designed to create a favorable environment for bone cells to attach and proliferate.3,4*

During the NASS conference, Stryker will also:

  • Feature results of a recent comparative animal study, which found significant differences in biomechanical and histologic performance among various interbody cage materials. The results showed that Tritanium cages achieved statistically significant increases in bone in-growth.4
  • Present a Solution Showcase titled “A Clinical Update on Tritanium—A Novel, Highly Porous Material Designed for Bone In-Growth and Biological Fixation,” by Scott Parker, M.D., assistant professor of neurological surgery, Vanderbilt University Medical Center, on Sept. 26, 2018, from 12–12:20 p.m. PT.
  • Preview its new Tritanium TL Curved Posterior Lumbar Cage, which received 510(k) clearance from the U.S. Food and Drug Administration in January 2018. Click here for the indications for use.

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 and www.builttofuse.com. Follow Stryker’s Spine division on Twitter @stryker_spine.

References

1. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials. 2005;26, 5475-5491.
2. RD0000053710: Tritanium cell infiltration and attachment experiment.
*No correlation to human clinical outcomes has been demonstrated or established.
3. RD0000050927: Tritanium material capillary evaluation.
4. McGilvray KC, Easley J, Seim HB, et al. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018;18(7):1250-1260.

CONTENT ID TRITA-PB-4

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Dr. Parker is a paid consultant of Stryker. His/her statements represent his/ her own opinions based on personal experience and are not necessarily those of Stryker. Individual results may vary.

Contacts

Stryker’s Spine Division
Jodie Morrow
Jodie.morrow@stryker.com
or
Sullivan & Associates
Andrea Sampson
asampson@sullivanpr.com, 714/374–6174

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ReconRegulatoryTop Stories

b-ONE Ortho Receives U.S. FDA 510(k) Clearance for Total Hip System

September 21, 2018 OrthoSpineNews

September 21, 2018

CEDAR KNOLLS, N.J.–(BUSINESS WIRE)–b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative healthcare solutions, today announced it has received 510(k) clearance for its first device, the b-ONETM Total Hip System, from the U.S. Food and Drug Administration (FDA).

The b-ONETM Total Hip System is a cementless total hip system with advanced coating technology and intuitive instrumentation, designed to optimize patient fit in the modern patient demographic. The system comprises the JuvenoTMFemoral Hip, a bone-conserving femoral prosthesis, and the b-ONE Primary Acetabular System, which are compatible with b-ONETM 12/14 Taper Femoral Heads.

“This milestone for the company will officially introduce b-ONE’s product line to the U.S. market,” said Dr. Mark Kester, the Chief Scientific Officer. “With our first U.S. surgery quickly approaching, we are eager to provide surgeons with a versatile system designed to accommodate the majority of today’s expanding patient demographic. In addition, with the support of Dr. Richard Rothman, a prolific designer and developer in the orthopedic industry, our strong R&D team will continue the development and expansion of our product portfolio with a focus on quality, affordability and speed to market.”

The b-ONETM Total Hip System will have a limited launch in the first half of 2019, followed by a full commercial release in the second half of 2019.

This news follows b-ONE Ortho Corp.’s recent US$20 million Series A financing led by Eight Roads Ventures and F-Prime Capital Partners. Proceeds are being used to fund the growth of b-ONE Ortho Corp.’s product portfolio and expansion into international markets.

About b-ONE Ortho Corp.

Based in Cedar Knolls, New Jersey, b-ONE Ortho Corp. is an emerging orthopedic technology company dedicated to the development of innovative orthopedic healthcare solutions that restore patient mobility and improve surgical outcomes. Every day we are committed to becoming the most credible choice for orthopedic products worldwide.
www.b1.co

About Eight Roads

Eight Roads Ventures is a global venture capital firm that backs entrepreneurs with aspirations for greatness. As the proprietary investment arm of Fidelity International Limited, Eight Roads is committed to building bold and meaningful businesses and together with its associated funds has invested almost US$6bn globally into growing companies in the past 10 years.

Eight Roads Ventures has led successful investments in China and across the world, including Wuxi PharmaTech, Hile, Innovent, Adagene, Hua Medicine, DeltaHealth, Denali, doctorlink, Laurus Labs, Alibaba, China PnR, AsiaInfo, iSoftStone, Wisers, GShopper, Rulai and PingPong. It launched a dedicated US$250m China Healthcare Fund in September 2017.
www.eightroads.com

About F-Prime Capital

F-Prime Capital Partners is a global venture capital firm investing in life sciences, healthcare, and technology. Since 1969, F-Prime has worked closely with entrepreneurs and academics to create innovative solutions to some of the world’s most significant challenges in healthcare and technology.
www.fprimecapital.com

Caution Concerning Forward-looking Statements

This press release may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding the Corporation’s expectations for future events. Such statements are based on currently available information and current expectations. If these assumptions prove incorrect or inaccurate, or known or unknown risks occur, actual results could differ materially from the expectations and projections of b-ONETM Ortho Corp. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

Contacts

For press enquiries, please contact:
b-ONE Ortho Corp.
Corinne Zappacosta
+1 (917) 733-8088
CZappacosta@b1.co
Related Links
www.b1.co

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Financial

Providence Medical Technology Secures $25 Million In Equity Financing

September 20, 2018 OrthoSpineNews

PLEASANTON, Calif., Sept. 20, 2018 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing surgical equipment and implants for cervical spine fusion surgery, today announced the closing of $25 million in new equity financing. Revelation Partners led the round with participation from the private equity investment team at BMO Global Asset Management (EMEA), MVM Life Science Partners, Medvest Capital, and Aphelion Capital. Inclusive of this new investment, Providence has raised a total of $53 million in equity financing since its 2008 inception.

The proceeds of the financing will be used to accelerate commercial expansion and clinical development of its DTRAX®line of cervical fusion instruments designed to help patients suffering from advanced cervical spine conditions.

“DTRAX is an important innovation in cervical spine treatment that addresses a large market with significant unmet clinical need,” said Zack Scott, Managing Partner of Revelation Partners. “We are pleased to back the Providence team during this pivotal stage of the Company’s growth.”

“We welcome Revelation Partners and BMO to our dedicated team of investors,” said Jeff Smith, CEO of Providence. “We are committed to improving the lives of patients suffering from cervical spine disorders. This funding enables Providence to increase our investment in clinical evidence development and bring our unique cervical fusion technology to more patients and surgeons. I am grateful for the new and continued support from our venture partners.”

Over 300,000 Americans receive cervical spine fusion annually for debilitating neck and arm pain. While many have successful results, roughly 20% of two-level anterior fusions fail.1,2 Additionally, 22% of patients are predicted to require reoperation for adjacent segment disease within ten years after surgery.3 Providence has developed a unique tissue-sparing approach to cervical fusion that is designed to address this unmet need. The company’s flagship DTRAX Spinal System was recently cleared by the FDA for use in posterior cervical fusion in patients with cervical degenerative disc disease and has been approved at over 1,800 hospitals in the United States.

About DTRAX Spinal System
The DTRAX Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion in patients with cervical degenerative disc disease. The system allows surgeons to perform posterior cervical fusion using a variety of surgical techniques including a tissue-sparing technique that reduces the dissection and stripping of muscles.4

About Providence
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative surgical solutions for cervical spine surgery. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market.

The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, ALLY® bone and facet screws, and ENTRUS™ Allograft Bone. All products are sterile-packaged and single-use to maximize perioperative efficiency and ensure consistent quality and performance.

For more information, please visit www.providencemt.com.

MKT-PMT-308 Rev 0

References
1. Davis RJ, et al. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6. PubMed PMID: 24010901.

2. Fraser JF, et al. Anterior approaches to fusion of the cervical spine: a meta analysis of fusion rates. J Neurosurg Spine. 2007 Apr;6(4):298-303. PubMed PMID: 17436916.

3. Lee JC, et al. Adjacent segment pathology requiring reoperation after anterior cervical arthrodesis: the influence of smoking, sex, and number of operated levels. Spine (Phila Pa 1976). 2015 May 15;40(10):E571-7. doi: 10.1097/BRS.0000000000000846. PubMed PMID: 25705959.

4. McCormack BM, et al. Novel instrumentation and technique for tissue sparing posterior cervical fusion. J Clin Neurosci. 2016 Dec;34:299-302. doi: 10.1016/j.jocn.2016.08.008. Epub 2016 Aug 31. PubMed PMID: 27590864.

SOURCE Providence Medical Technology, Inc.

Related Links

http://www.providencemt.com

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Financial

Ortho Regenerative Technologies Inc. Appoints Accomplished Life Science Executive, Luc Mainville, as CFO

September 20, 2018 OrthoSpineNews

KIRKLAND, Quebec, Sept. 19, 2018 (GLOBE NEWSWIRE) — Ortho Regenerative Technologies Inc. (“Ortho RTi” or the “Corporation”) (CSE: ORTH) today announced the appointment of Luc Mainville as Senior Vice President and Chief Financial Officer, with overall responsibility for operational finance, financial reporting, budgeting and strategic planning, as well as helping to manage the Corporation’s relationships and interactions with the investment community. Mr. Mainville succeeds Ortho RTi’s interim CFO, Benedek Simo, who will remain as Corporate Controller.

“We are delighted to have Luc join Ortho RTi at this important time in its corporate and clinical development,” said Brent Norton, President and CEO, Ortho RTi.  “Being able to attract someone of Luc’s caliber to this role is a clear testament to the quality of our science and the potential market opportunity for our products under development.  His significant operational experience will be a particularly valuable asset as we implement the last phase of our pre-IND program and pursue joint development initiatives with interested industry players for our lead product, Ortho-R.”

Mr. Mainville has an accomplished history of financial and operational leadership successes within the life science industry.  In an executive management career that spans more than 20 years, he has led or been integrally involved in four go-public transactions, completed more than 20 public financings, and managed more than 50 licensing, merger and acquisition, and sale transactions.  Mr. Mainville also serves as Senior Vice President and CFO for Valeo Pharma. His earlier experience includes senior management and financial roles at various life science companies, including Acerus Pharma, Cardiome Pharma Corp., Neopharm Labs Inc. and LAB Research Inc.  Prior to launching his career in the life science industry, Mr. Mainville was a Partner at KPMG LLP.  Mr. Mainville has served as Vice-Chairman of BIOTECanada and holds an MBA from McGill University.

About Ortho Regenerative technologies Inc.

Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage. The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. Further information about Ortho RTi is available on the Company’s website at www.orthorti.com and on SEDAR at www.sedar.com.

Caution regarding forward-looking statements

This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

For further Information, please contact:

Stephen Kilmer
Investor & Media Relations
647.872.4849
kilmer@orthorti.com

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Spine

Green Sun Medical Celebrates Spine Technology Award, Scoliosis Brace Company Continues Helping Kids

September 20, 2018 OrthoSpineNews

Fort Collins, CO., 9/20/18  –  Green Sun Medical LLC., a medical device company specializing in scoliosis bracing, announced that it has been selected to receive Orthopedics This Week’s Spine Technology Award during the 2018 National Association of Spine Surgeons (NASS) Meeting in Los Angeles, CA. Green Sun Medical has developed a comfortable, dynamic brace which applies continuous corrective pressure to the spine of adolescent patients with scoliosis. The brace will provide physicians and patients with real-time performance metrics utilizing a cloud-based health platform developed by Mindset Medical LLC.

Commenting on the company’s latest award, CEO Jamie Haggard said, “Winning the Spine Technology Award is the dream of every entrepreneur who works in the spine industry. Our goal is to provide a transformative scoliosis treatment experience for children. Creating a better quality of life and clinical outcome is now one step closer for adolescents who are coping with this disease.”

To meet our goal, Green Sun Medical has assembled a team of the world’s thought leaders in scoliosis treatment. The company is executing a carefully planned clinical study beginning at the National Scoliosis Center and continuing at the Shriner’s Hospital for Children in Sacramento, CA.

About Green Sun Medical:

Green Sun Medical is based in Fort Collins, CO. Founded in 2015, the company has developed a connected dynamic scoliosis brace. It has won numerous prestigious awards including; the FDA sponsored Pediatric Device Symposium, SXSW Pediatrics Device Competition and a $200,000 prize for best medtech innovation from the Medtech Innovator.  www.greensunmedical.com

Attachments

Jamie Haggard
Green Sun Medical 
970-215-3291
jamie@greensunmedical.com
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Spine

NuVasive To Showcase Spine Precision Surgery Leading To Smarter, More Predictable Clinical Outcomes At NASS 2018

September 20, 2018 OrthoSpineNews

SAN DIEGO, Sept. 20, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ :NUVA ), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it will highlight the Company’s latest disruptive spine technology at the North American Spine Society (NASS) Annual Meeting held September 26-29, 2018 in Los Angeles, California, at the Los Angeles Convention Center.

“Now more than ever, NuVasive is expanding its portfolio with innovative launches covering spine’s leading procedures, materials and systems,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “NuVasive is fully committed to furthering its R&D investment and bringing disruptive technology to market to meet the needs of our surgeon partners to provide better and more predictable outcomes for patients.”

At the annual meeting, NuVasive will highlight its commitment in developing spine precision surgery advancements in key focus areas:

  • Surgical Intelligence™ is an ecosystem of integrated, modular technologies to deliver safer, faster and smarter surgery. A key part of this ecosystem is LessRay®, a stand-alone proprietary technology that enhances low-dose, low-radiation fluoroscopy (or x-ray) images to have similar diagnostic capabilities as conventional full-dose fluoroscopy images. With the evolution of Surgical Intelligence, LessRay will integrate into the Pulse™ surgical automation platform, a first-of-its-kind integrated spine system addressing a broad range of clinical challenges, with enhanced utility and intuitive workflow. This platform introduces 2D- and 3D-navigation and smart imaging capabilities along with the Company’s leading neuromonitoring, NuvaMap® O.R. surgical planning, radiation reduction and patient-specific rod-bending technologies. Both systems will be available for live demonstrations at the meeting.
  • Lateral Single-Position Solutions are intended to decrease the amount of time a patient is under anesthesia and increase operating room efficiency by reducing the need for patient repositioning. This is built on the foundation of the Company’s XLIF® procedure and is supported by extensive clinical evidence with more than 400 peer-reviewed, XLIF-specific publications. NuVasive’s proprietary instrumentation and fixation expand the benefits of lateral surgery to more spinal levels from T6-S1, compared to traditional lateral procedures, by providing direct access to the L5-S1 level from a lateral position.
  • Advanced Materials Science™ (AMS) Interbody Portfolio is designed to deliver enhanced osseointegration and biomechanics through innovative implant design and superior surface, structure and imaging characteristics. The Company’s recently launched TLX® 20 degree expandable spinal interbody implant with a first-of-its-kind oblique profile designed for transforaminal lumbar interbody fusion (TLIF) procedures will be on display, and demonstrates the Company’s commitment for further development of a full suite of expandable cage technologies. NuVasive is the only company to offer four specific materials for spinal interbodies: traditional PEEK (polyetheretherketone), propriety porous PEEK, titanium and 3D-printed porous titanium.
  • Intraoperative Neuromonitoring (IONM) For the first time, the NASS Annual Meeting will include an IONM symposium where surgeons can learn more about the utility, evidence and value of neuromonitoring in spine surgery, along with moderated abstract presentations. NuVasive’s clinical services division is the nation’s largest provider of outsourced IONM services, and the Company will demonstrate its neuromonitoring capabilities through its Pulse platform.

NuVasive 2018 NASS Annual Meeting Participation Details 
NuVasive will showcase its innovation in Booth #2301 at the NASS Annual Meeting, as well as host several clinical workshops and participate in numerous podium presentations demonstrating the Company’s commitment to high-quality studies to advance the full application of its spinal solutions.

About NuVasive
NuVasive, Inc. (NASDAQ :NUVA ) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Financial

Implanet Publishes Its Interim 2018 Results

September 19, 2018 OrthoSpineNews

September 19, 2018

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

Implanet (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY) (Paris:ALIMP) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee surgery implants, has announced its interim results for the six-month period ended June 30, 2018, as approved by the Board of Directors on September 18, 2018.

Ludovic Lastennet, Implanet’s Chief Executive Officer, commented: “Through our unrelenting focus on costs containment we were able to improve our operating performance in spite of a revenue contraction in the first half of 2018. Jazz® continued to deliver healthy sales growth, particularly in France (sales up 10%) and in the US (sales up 14% at constant exchange rates). We have already begun to replicate this direct sales model by opening a branch in the United Kingdom and a subsidiary in Germany. We have also extended the Jazz® range by introducing Jazz Evo® for the adult degenerative spinal disease market. Finally, we have obtained additional funds by arranging a €5 million1 convertible bond line. The implementation of these actions should continue in the coming months to lift our operating performance that has already begun to improve.”

In thousands of euros – IFRS* H1 2018 H1 2017 Change (%)
Revenue 3,632 4,119 -12%
Cost of sales -1,609 -2,014 -20%
Gross profit 2,023 2,105 -4%
Gross margin 55.7% 51.1% +4 pts
Operating costs -4,772 -5,189 -8%
Operating income/(loss) before non-recurring items -2,750 -3,084 +11%
Other non-recurring operating income/(expense) 0 -456 –
Operating income/(loss) -2,750 -3,540 +22%
Financial income/(loss) -22 -150 +85%
Net income/(loss) -2,772 -3,690 +25%

*Unaudited data

Jazz® revenue up 10% in France and up 14% in the United States (at constant exchange rates)

Implanet’s sales declined 12% to €3.6 million and fell 9% at constant exchange rates in the first half of 2018. Lower sales performance in the rest of the world segment was the main factor. The strong growth trajectory in Jazz® sales continued, especially in markets in which Implanet has a direct presence: +10% in France to €0.9 million and +14% (at constant exchange rates) to €1.1 million in the United States. Jazz®’s contribution to overall revenue continues to grow. It now stands at 61% of total revenue (vs. 58% in H1 2017).

Significant improvement in gross margin and operating performance

During the first half of 2018, Implanet’s gross margin improved by 4 points to 55.7% (vs. 51.1% in H1 2017). The main factor at work here was the shift in the product mix following the shutdown of the Arthroscopy business.

Implanet has kept a very tight grip on its operating costs, which continues to pay off handsomely quarter after quarter. Overhead declined 8% (or €0.4 million) over the period helping Implanet to cut its operating loss before non-recurring items by 11% and its operating loss by 22% to €2.7 million from €3.5 million in the first half of 2017.

During the first half, Implanet’s financial expenses improved significantly owing to the Company’s lower borrowing costs.

As a result of these factors, Implanet’s net loss narrowed to €2.8 million in the first half of 2018 (vs. €3.7 million in H1 2017).

Cash and cash equivalents

At June 30, 2018, Implanet held €2.0 million in cash and cash equivalents (vs. €4.0 million at December 31, 2017).

In August, Implanet also raised €0.5 million by issuing another tranche of its convertible bonds to the European Select Growth Fund. Implanet can also request the subscription of an additional 350 convertible bonds subject to certain conditions, which would enable it to raise €3.5 million to support Jazz®’s international development.

Significant advances and highlights

Business development: replication of the direct sales model in France and the United States to conquer the principal European markets

  • 155 surgeons using Jazz® technology in France and the United States (vs. 137 at June 30, 2017)
  • finalization of the strategic alliance with L&K Biomed (signature of the cross-distribution agreements covering respective products in Asia and Europe)
  • opening of Implanet’s branch in the United Kingdom
  • establishment of Implanet subsidiary in Germany, the largest market in Europe, to develop a mixed sales network (direct sales staff and exclusive sales agents).

Clinical development, innovation and regulatory affairs: compelling clinical results and strong increases in the uptake of Jazz®

  • encouraging results from the first surgeries carried out in Brazil using Jazz Lock®
  • publication of the results of the clinical in the form of a prospective assessment of Jazz®2 in vertebral column deformity surgery in the American Association of Neurological Surgeons’ Journal of Neurosurgery, supporting the use of the Jazz® platform as a promising alternative in the prevention of proximal junctional kyphosis
  • launch of Jazz Evo® dedicated to treat vertebral fusion indications in adults following CE mark and 510(K) authorization from FDA.

Next press release: 3rd quarter 2018 revenue on October 9, 2018 before the market opens.

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 46 staff and recorded 2017 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. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

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 16, 2018 under number D.18-0337 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 Conditions detailed in the press released of March 8, 2018
2 Clinical study by Dr. H. Francis Farhadi of the Ohio State University Medical Center (USA).

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
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

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Financial

SPINEWAY : Early redemption of 44 ORNANE Notes End of bond financing by ORNANE

September 19, 2018 OrthoSpineNews

 Ecully, 19 September 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces the early redemption of 44 notes redeemable in cash and/or convertible into new and/or existing shares (the “Notes”) and the end of the financing via issuance of Notes set up on 28 July 2017 with the YA II PN, LTD investment fund.

The diversification of Spineway’s financing methods implemented as part of its strategic plan with the issuance of bonds convertible into new or existing shares (OCEANE) representing a maximum of €14.50M, resulted in the early redemption of the 44 Notes still in YA II PN, LTD’s possession, for a total of 440 000 euros.

To this end, today Spineway redeemed 50% of the 44 Notes still in YA II PN, LTD’s possession, i.e., €220 000. The remainder shall be paid end of October/early November 2018.

The early redemption of the Notes also results in the early termination of this agreement and therefore cancels the option for Spineway to trigger the final tranche of 100 Notes.

Finally, in order to protect the bearers of the 267 379 Warrants issued pursuant to the issuance of Notes with attached Warrants, the exercise ratio for said Warrants shall be adjusted as provided in the agreement.

This early redemption allows Spineway to clarify its financing methods and limit, in part, dilution. Thanks to solid financing via the issuance of OCEANE, Spineway will be able to implement its strategic plan and reorganize its US subsidiary and reposition its offer on its global markets.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication: Half-year results for 2018 – 24 October 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW

Contacts:

Investor relations
David Siegrist – CFO
Phone: +33 (0)4 72 77 01 52
finance.dsg@spineway.com		   Financial communication
Jérôme Gacoin / Solène Kennis
Phone: +33 (0)1 75 77 54 68
skennis@aelium.fr

Attachment

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Financial

Medicrea Reports First Half 2018 Results

September 19, 2018 OrthoSpineNews

September 19, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED, PEA-PME eligible, and OTCQX: MNRTY and MNRTF), pioneering the transformation of spinal surgeries through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) technology, has today published its unaudited results for the first half of 2018, as approved by the Board of Directors on September 12, 2018.

(€ millions) H1 2017 H1 2018
Sales 14.7 16.9
Gross margin (% of sales) 73% 68%
Operating income/(loss) before amortization and provision (EBITDA) (1.0) (1.6)
Operating income/(loss) after amortization and provision (EBIT) (3.6) (4.6)
Other non-recurring expenses (0.2) (0.4)
Cost of net financial debt (1.4) (1.1)
Income/(loss) before tax (5.5) (6.5)
Net income/(loss) (5.1) (6.5)

 

First Half 2018 Results

Sales for the first half of 2018 amounted to €16.9 million, marked by two quarters of record invoicing in 2018 resulting in growth of 15% in comparison with the first half of 2017 and 22% at constant exchange rates. The 50% increase in personalized UNiD ASI™ surgery in the United States, the recovery of sales in Brazil, the strengthening of market share in France and the opening of new subsidiaries (Belgium and Australia) are behind this performance.

Gross margin, down in comparison with the first half of 2017, was impacted by a number of one-off factors: the unfavorable currency effect of the dollar/euro conversion, a different mix of sales in comparison with the same period of 2017 and some exceptional inventory discrepancies. The decrease in sub-contracting expected during the second half of the year should have a favorable impact on the gross margin rate.

Operating expenses increased by €1.8 million as a result of Research & Development investments to complete the range of UNiD ASI™ products and services, and the integration of the marketing and administrative expenses of the newly-created subsidiaries.

The operating loss for the first half-year stood at €4.6 million and the loss before tax, after taking into account the cost of net financial debt, was €6.5 million.

Cash at June 30, 2018 amounted to €5.1 million, strengthened by the €3.1 million equity raise which took place beginning of July.

Outlook

Net loss for the first half of 2018 reflects the significant and necessary investments made by the Group to gain recognition for its position as a leading and strategic player in the field of personalized spine surgery.

The spinal market has entered a period of consolidation with 12 merger-acquisition transactions over the last 12 months, including two major deals announced very recently with the purchase in the United States of K2M by Stryker, and of Surgimap, a surgical planning software developer, by Globus Medical.

This trend reflects the growing interest of leading market players in planning tools solutions for the treatment of spinal pathologies. Medicrea has established itself as the worldwide leader and has set the industry standard in the segment by being the only company to date to use cutting-edge analysis tools based on artificial intelligence and predictive modeling to offer customized implants to treat each patient’s individual pathologies.

Medicrea’s UNiD ASI™ technology is therefore becoming increasingly popular with surgeons who are incorporating it into their day-to-day practice: to date, more than 2,800 patients have been operated on using personalized implants, and the number of UNiD ASI™ procedures performed in the United States has grown by 60% in relation to 2017.

“The approach we have developed is specific and tailored to each patient. It will become a standard of care and replace the traditional approach of spinal surgery, which has used commoditized implants for many years,” said Denys Sournac, Chairman and CEO of Medicrea.

Medicrea continues to consolidate its presence and visibility on the US territory

In July 2018, 4 US-based international institutional investors participated in a capital increase worth €3.1 million through the issue of ordinary shares with warrants attached (€4.8 million in the event of all the warrants being exercised).

Since August 28, 2018, Company’s securities are traded on the US OTCQX Best Market (“OTCQX”). In addition to trading on the Euronext-Growth market, this listing will give Medicrea the opportunity to increase its visibility within the US and grow its investor base.

Medicrea will be attending the 33rd annual meeting of the North American Spine Society (“NASS”) which will be held between September 26 and 29, 2018 in Los Angeles, California. During this major conference, the Company will present the latest innovations from its proprietary UNiD ASI™ (Adaptive Spine Intelligence) patient-specific technology for personalized spine surgery to leading orthopedic surgeons.

Next publication: Sales for the 3rd quarter of 2018: October 11, 2018, after market.

About Medicrea ( www.medicrea.com )

Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 200 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: www.medicrea.com

Connect with Medicrea
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on 
EURONEXT Growth Paris 
ISIN: FR 0004178572 
Ticker: ALMED 
LEI: 969500BR1CPTYMTJBA37

Medicrea is traded on 
OTCQX Best Market 
Tickers: MNRTY & MRNTF

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@medicrea.com

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