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Financial

TEPHA, Inc. Announces Buy-Out of its Royalty Obligation to Metabolix, Inc.

October 11, 2016 OrthoSpineNews

LEXINGTON, Mass., Oct. 11, 2016 /PRNewswire/ — TEPHA Inc, the pioneer developer of implantable medical devices based on a resorbable polymer known as poly4hydroxybutyrate (P4HB), announced today that the Company has completed a buy-out of its royalty obligation to its former licensor and parent company, Metabolix, Inc.  Beginning in 2008, Tepha and its partners have commercialized implantable medical devices manufactured from P4HB in both the US and Europe. Tepha’s commercial partners include, C.R. Bard Inc., B Braun, Wright Medical Group NV, and Galatea Surgical, a wholly owned subsidiary of Tepha focused on the Aesthetic Plastic Surgery market.

Andrew Joiner, President and CEO of Tepha, commented:  “The buy-out of our royalty obligation in conjunction with Metabolix was financially advantageous for both companies. Specifically for Tepha, the cash flow from our savings will help finance the continued development of our core technology as well as pre-clinical and clinical testing of new applications.”

P4HB is a biologic polymer produced through a controlled fermentation process.  Compared to medical devices based on other commercially available resorbable polymers, P4HB constructed devices have been shown to be less inflammatory, less acidic, more flexible, less brittle, and stronger with implanted strength retention that is compatible with the body’s natural healing process. Tepha currently offers a range of P4HB-based fibers, mesh and other constructs. Tepha is continuing to expand its P4HB technology platform to include collagen and antibiotic coatings, high strength multi-filament fiber, and non-woven materials, all targeting new market and partnering opportunities.

About Tepha: Tepha Inc, founded in 1998 and headquartered in Lexington, MA, is a supplier of medical devices focused on the BioMaterials market.  Tepha’s products are designed and developed to elevate, support and reinforce areas of soft tissue weakness as well as to promote improved healing responses. To date Tepha and its partners have received 23 510(k) clearances for devices marketed in the US as well as five CE Marks for products sold in Europe. Commercial products based on Tepha’s resorbable P4HB polymer technology include:  high tensile strength sutures for orthopedic soft tissue repair; mesh constructs for ventral and inguinal hernia repair; monofilament sutures for abdominal wall closure and plastic surgery; patches for tendon and ligament repairs; and mesh constructs for face and breast lifts. To date, products made from P4HB have been successfully used in more than 1,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.

Contact:          John Hartnett
Executive Vice President and Chief Operating Officer, Tepha Inc.
781-357- 1772
Andy Joiner
President and Chief Executive Officer, Tepha Inc.
781-357-1770

 

SOURCE TEPHA, Inc.

Related Links

http://www.tepha.com

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FinancialRegulatory

State’s high court hears arguments in legal challenge to Medtronic-Covidien deal

October 11, 2016 OrthoSpineNews

By Star Tribune – October 5, 2016

Medical device maker Medtronic moved its legal headquarters to Ireland last year in a controversial $50 billion deal that forced about 20 percent of the people who owned its stock to shell out thousands of dollars each to cover capital gains taxes.

Now some shareholders want the company to cover those costs. First they will have to convince the Minnesota Supreme Court to agree with them that state law does not — or should not — prevent them from being able to bring their lawsuit at all. If they win at the high court, the plaintiffs would still have to prevail in a future trial or get a settlement to see any money.

In oral arguments Wednesday morning at the Supreme Court, the attorney representing Medtronic said the two-year-old class-action lawsuit should never have gotten to the state’s highest court. That is because long-standing Minnesota business law gives boards of directors legal protections so they can run a company without being second-guessed by litigious shareholders.

“The question before you this morning is whether you will abandon the rule of law that has been effectively applied for decades, and embrace a rule of law … that is inconsistent with your most recent statements of public policy,” said Medtronic’s attorney, Eric Magnuson, who was chief justice from 2008 to 2010.

The aggrieved shareholders, however, argue that long-standing rule of law doesn’t address unique situations that can arise during corporate inversions like Medtronic’s.

An inversion happens when a U.S.-based company relocates its headquarters to a lower-tax jurisdiction through a corporate acquisition. In January 2015, Medtronic acquired health care supplier Covidien for $49.9 billion in cash and stock in a deal that put the combined company in Covidien’s old headquarters building in Dublin, Ireland. CEO Omar Ishrak continues to run the company from offices in Minnesota.

Medtronic’s board members knew the inversion would impose taxes on the minority of shareholders whose stock was not protected in a tax-deferred account like an IRA. The board members also knew Medtronic’s management strongly favored of the deal — so much so that the company agreed to cover $69 million in special excise taxes on company officers imposed by Congress to discourage inversions.

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ExtremitiesFinancial

Winning 3D printing startup rings the NASDAQ bell

October 11, 2016 OrthoSpineNews

October 10, 2016 – by

TriFusion Devices, winners of the Rice Business Plan Competition (RBPC) and manufacturers of custom 3D printed prosthetic devices, rang the NASDAQ opening bell earlier today.

This morning in New York, Blake Teipel, TriFusion Devices’ CEO, joined Brad Burke from the Rice Alliance for Technology and Entrepreneurship to announce the opening of the tech focused stock exchange for the first day of the week. Commenting on the event the CEO said, “We are grateful for the support, guidance, and encouragement that we’ve received from the Texas A&M University and Rice University programs. The experience and coaching we have received as we’ve launched our venture have proven immensely valuable to our success.”

Texas based TriFusion Devices beat 41 rival companies to take the RBPC prize earlier this year in April. The young company aims to revolutionize “the health care and sports-equipment industries in powerful and profitable ways” by using 3D printing to create tailored solutions for “amputees and prosthetists”.

The Super Bowl of Business Plan Competitions

In the U.S. alone, approximately two million people manage with the loss of a limb: a group currently growing at a rate of 185,000 each year.

TriFusion Devices emerged as the 2016 RBPC winner after review by 275 judges and was awarded prizes and cash valued at approximately $400,000. The total prize pool for this year’s competition was reported at over $1.7 million.

 

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Extremities

Novastep Enhances its Nexis® Headless Screws Portfolio

October 11, 2016 OrthoSpineNews

Orangeburg, New York, Oct. 07, 2016 (GLOBE NEWSWIRE) — Novastep, Inc., and its affiliates (“Novastep” or the “Company”), a global medical technologies company specializing in the foot and ankle, has further expanded its coverage of midfoot and rearfoot indications with the addition of a full range of Nexis® 5.0 and 7.0mm headless, cannulated compression screws.

The implants feature all of the hallmark design attributes inherent to the Company’s Nexis® brand, including helical thread flutes that are self-drilling, self-tapping and reverse-cutting; Torx drive recess interfaces for optimal force distribution and tapered, self-penetrating compression cones.  Loïc Girod, Novastep’s Vice President of Research and Development, noted that “The Nexis® system provides surgeons with a complete and versatile selection of sterile packaged, low-profile, cannulated screws that are designed to address a broad spectrum of midfoot and hindfoot pathologies.”

The system is likewise supported with a robust instrumentation platform that is neatly stored in a versatile, light-weight, space-saving tray to combine the Nexis® 5.0 and 7.0mm instruments with interchangeable Nexis® 4.0mm headless screw or Arcad 18/20/25mm nitinol compression clip instrument modules that serve to further enhance its versatility.  “Operating room efficiency and cost reduction are prime areas of focus for Novastep” said Joseph Larsen, DPM of ProHealthCare Foot & Ankle in New York; adding that “Novastep’s implant and cleanSTART® deployment technologies provide a systematized logistics platform that is easily customizable to fit virtually anyone’s needs and substantially reduces inventory requirements and sterile field volumes.”

All Novastep implants are packaged sterile in quickSTACK™ containers or quickTUBE™ nested cylinders, depending on the size and configuration of the product. The STACKS and TUBES are housed and organized in the cleanSTART® Implant Dispenser console, which may be uniquely tailored to address individual surgeon preferences.

Nexis® and other key elements of Novastep’s portfolio will be featured at the Desert Foot 2016 meeting on October 19–22 in Phoenix, AZ and the upcoming 2016 Global Foot and Ankle Symposium in New York City on December 2–3.

About Novastep

Novastep is a global medical device company specializing in the design, development and commercialization of advanced technologies that treat conditions affecting the foot and ankle. The Company is focused on optimizing clinical efficiencies, inventory management and healthcare economics by transforming the way foot and ankle products are deployed and utilized in the surgical environment. Novastep has allied itself with a strategic network of key international opinion leaders to deliver breakthrough technologies, innovative services and compelling medical education programs to the foot and ankle community. Novastep’s portfolio, services and distribution platforms are uniquely positioned to address foot and ankle trauma, deformity corrections and Charcot fracture management.

For further information concerning this announcement and/or Novastep, Inc., send all inquiries to info@novasteportho.com or call 877.287.0795.

Related Links

For general information visit:  novastep-us.com

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FinancialRobotics

Titan Medical Board of Directors Initiates Leadership Changes

October 11, 2016 OrthoSpineNews

TORONTO, ON–(Marketwired – October 11, 2016) – Titan Medical Inc. (TSX: TMD) (OTCQX: TITXF) today reported that the Company’s Board of Directors has initiated a leadership change strategy in order to expedite the development of the SPORT™ Surgical System. The initial steps of the strategy include the resignation of John Hargrove as Titan’s Chief Executive Officer, the appointment of Martin Bernholtz as Chairman of the Board of Directors, and a revised focus of the previously announced executive search plan.

Mr. Hargrove’s resignation as Chief Executive Officer is effective immediately. He is succeeded as interim C.E.O. by John E. Barker, a member of the Titan Medical Board of Directors since 2009. Mr. Barker’s primary responsibilities will include working with the Board to recruit a permanent C.E.O. on a timely basis. Mr. Barker is a finance professional with general management experience who previously served as the Senior Vice President of Finance, Chief Financial Officer and in other senior executive positions at Zenon Environmental Inc., a Toronto Stock Exchange (TSX) listed Company. During his career Mr. Barker has lead organizations of up to 1200 employees and has lead several operational turnarounds. Mr. Barker currently sits as a director and Chairman of the Audit Committee of Ecosynthetix Inc., a TSX listed Company and is a Fellow of the Chartered Professional Accountants of Canada and holds the FCMA designation.

“Our Board and management team are fully committed to advancing the SPORT™ Surgical System’s development program in an effective and efficient manner,” said Mr. Barker. “While we are aggressively pursuing plans to advance the program, we have also revised our previously announced executive search effort to focus on recruiting to the Company a permanent CEO with a proven leadership and capital markets track record. At the same time, we are examining our cost structure with an eye on focusing resources on the SPORT’s development. The Board thanks John for his service to Titan Medical during the past seven years and also appreciates Mr. Bernholtz’ assumption of the Chairman’s duties as we execute our plan. We look forward to reporting on our progress as developments merit.”

Mr. Bernholtz, BBA, CPA, CA has been the Chief Financial Officer of Kerbel Group Inc., since 1987, an integrated Construction and Land Development Company, and a member of the Titan Board since 2008.

About Titan Medical Inc.

Titan Medical Inc. is a Canadian public company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (“MIS”). The Company’s SPORT™ Surgical System, currently under development, includes a surgeon-controlled robotic platform that incorporates a 3D high-definition vision system and multi-articulating instruments for performing MIS procedures through a single incision. The surgical system also includes a surgeon workstation that provides a surgeon with an advanced ergonomic interface to the robotic platform for controlling the instruments and provides a 3D high-definition endoscopic view of inside a patient’s body. The SPORT™ Surgical System is designed to enable surgeons to perform a broad set of surgical procedures for general abdominal, gynecologic, and urologic indications. For more information, visit the Company’s website at www.titanmedicalinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the Company’s Annual Information Form dated March 30, 2016 (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.

CONTACT INFORMATION

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Regulatory

Spineology Interbody Devices Now FDA Approved with Allograft Bone

October 10, 2016 OrthoSpineNews

October 10, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc. announced today that it has obtained FDA clearance for the use of allograft bone with its Rampart™ Interbody Fusion Devices.

“This approval and our recent partnership expansion with Musculoskeletal Transplant Foundation (MTF) provides us the ability to pair MTF allografts with the Rampart family of interbody devices,” says John Booth, CEO of Spineology. “In addition to reducing patient morbidity and enhancing surgical efficiency we expect this approval will provide Spineology with an excellent platform for delivery of our new Incite™ Cortical Fibers.”

Incite Cortical Fibers are a unique and versatile bone grafting solution. The fibers offer an osteoconductive and inductive matrix, excellent handling properties, in-situ expansion and placement options via a variety of delivery methods.

The Rampart Interbody fusion devices incorporate large graft windows to facilitate healing and a recently enhanced instrumentation system. Additionally, devices are now available sterile packed, eliminating the need for continual reprocessing, which reduces costs for our customers.

About Spineology Inc.

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

Contacts

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

SPINEOLOGY INC.

Release Summary

Spineology Inc. received FDA approval for Musculoskeletal Transplant Foundation allografts with Rampart Interbody Fusion Devices, which facilitates healing time and reduces costs for patients.

Release Versions

Contacts

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

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Extremities

EOS imaging Announces the Opening of a New EOS Installation at the Prestigious Charité Hospital in Berlin

October 10, 2016 OrthoSpineNews

October 10, 2016

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that the hospital Charité – Universitätsmedizin Berlin in Germany has started to provide patient exams with its new EOS® imaging system. Charité is a leading hospital in Germany with 17 different Charité Centers in the Berlin area.

Established over 300 years ago, Charité is one of the largest university hospitals in Europe. It employs 13,200 employees and handles 142,000 inpatient and 663,000 outpatient cases every year. A leading research institution, Charité lays claim to more than half of all German Nobel Prize winners in Physiology or Medicine.

Professor Dr. Carsten Perka, Medical Director of the Center for Musculoskeletal Surgery at Charité, commented, “The newly-acquired EOS system provides very accurate 3D imaging data for treatment planning. Of particular importance is that the EOS system provides a full-body exam in a functional position while conventional imaging examination positions are often unsuitable for evaluating the musculoskeletal system.”

Marie Meynadier, CEO of EOS imaging, said, “Charité is an internationally-recognized institution with a history of providing excellent care. The EOS installation there, adding to earlier installations in key private centers of the country, speaks to the growing recognition in Germany of our technology.”

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States, Japan, China, and the European Union. The Group posted 2015 revenues of €21.8 million and employs 122 people. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Anne Renevot
CFO
+33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Valentine Brouchot
+33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
646-536-7006
jzimmerman@theruthgroup.com

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Spine

NFL players get back in the game after upper spine surgery

October 10, 2016 OrthoSpineNews

October 4, 2016 – Wolters Kluwer Health: Lippincott Williams and Wilkins

The majority of U.S. National Football League (NFL) players who undergo surgery for a herniated disc in the upper (cervical) spine are able to resume their careers and perform at a high level, suggests a study in Spine, published by Wolters Kluwer.

Even players with “upper-level” cervical disc herniation (CDH) have a high return rate and can return to play with similar performance outcomes compared to their “lower-level” counterparts, according to the analysis by Dr. Harry T. Mai of the Department of Orthopaedic surgery at the Northwestern Feinberg School of Medicine, Chicago, and colleagues. The results may help guide decisions about surgery and the likelihood of returning to competition for players with these career-threatening injuries.

Good Chance of Continuing NFL Career after CDH Surgery

The researchers identified 53 NFL players who underwent surgery for a herniated disc in the cervical spine between 1979 and 2013. Forty players had confirmed data on the level of the disc injury: 15 had “upper level” CDH (involving the uppermost vertebrae of the neck) while 25 had “lower level” injuries. Forty-five percent of the players were defensive backs and linebackers.

Rates of successful return to play after CDH surgery were analyzed. Most players — 67 percent of those with upper-level CDH and 72 percent with lower-level injuries — were able to return to play after surgery and rehabilitation, with no significant differences between the two groups. In both groups, recovery time was about nine months. On average, players continued playing for about 44 games and three years after CDH surgery.

To get an idea of how well each athlete played after returning from surgery, the researchers used a “Performance Score” based on NFL game statistics. Scores were not significantly different between groups, suggesting that athletes with upper-level CDH performed as well as those with lower-level injuries.

In 34 players, surgery consisted of spinal fusion (a procedure called anterior cervical discectomy and fusion, or ACDF). Four players developed degenerative disease at an adjacent vertebral level, requiring additional surgery. While this is a serious complication, it appeared to be no more frequent than in non-athletes undergoing ACDF.

The other six players underwent a less invasive procedure called foraminotomy which attempts to take pressure off the spinal nerves by decompression. Half of these patients later required additional ACDF surgery — a higher rate than observed in non-athletes. “It is possible that the rigors and activity required by a professional athlete, specifically axial collision forces, make them poor candidates for a non-fusion procedure,” Dr. Mai comments.

Cervical disc herniation is common among NFL and other elite athletes in contact sports and appears to be more common in upper level discs than the general population. While CDH also occurs in non-athletes, it is typically diagnosed in middle age and usually is not related to traumatic injury. For football players, the expected outcomes after CDH surgery — including the player’s ability to continue to compete at a high level — are unclear. That’s especially true for patients with upper-level CDH injuries.

The results suggest that most NFL players who undergo cervical spinal surgeries for CDH are able to resume their careers. Return to play, and level of performance after returning to competition, appear similar for players with upper-level versus lower-level cervical injuries. The authors note some important limitations of the study data, including potential “selection bias toward more prominent athletes.”

Gaining a better understanding of cervical spine injuries in elite athletes may help in developing better-tailored treatment approaches for this unique group of patients, Dr. Mai and colleagues believe. They conclude, “Further study is required to help surgeons definitively determine the individualized course of treatment for an NFL player dependent on pathology, position, and patient wishes.”

Story Source:

Materials provided by Wolters Kluwer Health: Lippincott Williams and Wilkins. Note: Content may be edited for style and length.

Journal Reference:

  1. Harry T. Mai, Robert J. Burgmeier, Sean M. Mitchell, Andrew C. Hecht, Joseph C. Maroon, Gordon W. Nuber, Wellington K. Hsu. Does the Level of Cervical Disc Herniation Surgery Affect Performance-Based Outcomes in National Football League Athletes? SPINE, 2016; 1 DOI:10.1097/BRS.0000000000001868

  2. Cite This Page:

    Wolters Kluwer Health: Lippincott Williams and Wilkins. “NFL players get back in the game after upper spine surgery.” ScienceDaily. ScienceDaily, 4 October 2016. <www.sciencedaily.com/releases/2016/10/161004111655.htm>.
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Financial

Kessler Foundation receives Spinal Cord Injury Model System Grant from NIDILRR

October 10, 2016 OrthoSpineNews

October 7, 2016 – Source: Kessler Foundation

Kessler Foundation has been awarded a Spinal Cord Injury Model System (SCIMS) grant valued at $2,300,000 over 5 years (2016-2021) from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). This federal grant, one of only 14 awarded to centers across the U.S. this year, continues funding for the Northern New Jersey SCI System (NNJSCIS).

A collaboration of Kessler Foundation, Kessler Institute for Rehabilitation, and University Hospital in Newark, the NNJSCIS has been supported by NIDILRR since 1990. Kessler is also a federally funded Traumatic Brain Injury Model System, and is one of only nine centers in the U.S. to hold both grants.

The SCIMS grants fund Model Systems across the nation that provide a multidisciplinary system of rehabilitative care specifically designed to meet the needs of individuals with SCI, encompassing acute care and extending through rehabilitation, reintegration to the community and the workplace, and aging with SCI.

“Research is the cornerstone of the SCIMS,” noted Trevor Dyson-Hudson, MD, director of SCI Research at Kessler Foundation. “Each model system enrolls newly injured patients and collects data that are contributed to the National SCIMS Statistical Center, the world’s largest and longest database for SCI research. This database helps us identify medical complications that occur after SCI and to focus our research efforts on what individuals need to live full and productive lives after their injury. Through the NNJSCIS, we have contributed to improved care for respiratory complications, for example, and we are continuing to study the effects of a medication combined with therapy that may help restore mobility.”

“The renewal of this grant has real implications for the community we serve,” said Steven Kirshblum, MD, of Kessler Institute for Rehabilitation, where he is medical director and director of SCI Services. “Each year, we treat more than 120 newly injured persons and more than 300 individuals with spinal cord dysfunction, and we provide followup care to more than 1500 persons with chronic spinal cord injury. In addition to current projects, this new grant will enable us to explore pharmacologic approaches to managing bladder dysfunction, a complication that adversely affects quality of life for many individuals living with SCI.”

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Robotics

Mazor Robotics Receives First Pre-Launch Orders for Mazor X System; Reports Record System Purchase Orders During Third Quarter

October 10, 2016 OrthoSpineNews

October 10, 2016

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced that it received purchase orders for 25 systems during the third quarter ended September 30, 2016 including pre-launch orders for the recently unveiled Mazor X, a transformative guidance platform for spine surgeries. The Mazor X will be commercially launched at the North American Spine Society (NASS) annual meeting in Boston, MA October 26-29.

“The market’s response to the Mazor X is exceptional, exceeding our early expectations,” commented Ori Hadomi, Chief Executive Officer. “Customers who first experience the Mazor X at our training centers are quickly realizing the increased benefits of the system and they have already placed pre-launch orders. Mazor’s expanded portfolio of products, which now includes both the Mazor X and Renaissance systems, is responsible for the record number of purchase orders we received in the third quarter. As we move into the fourth quarter, we expect to build our momentum in the market as the Mazor X is launched, maximize our presence at NASS and our strategic partnership with Medtronic continues to be implemented.”

The 25 system purchase orders during the quarter included:

  • Three Mazor X pre-orders that the Company expects to deliver to U.S. customers by the end of the 2017 first quarter.
  • Four Renaissance systems ordered by U.S. customers were delivered during Q3 2016.
  • Three Renaissance systems ordered by distribution partners in the International Market.
  • 15 Mazor X systems ordered by strategic partner Medtronic, four of which were delivered in the 2016 third quarter.

During the third quarter, Mazor delivered a previously ordered Renaissance system to a distribution partner in the international market.

As previously reported, the Company recently implemented a policy enabling new Renaissance system customers to exchange to the Mazor X following the launch. Therefore, revenue from system sales with exchange option will be deferred until the Mazor X orders are supplied or the exchange option expires. The Company expects total third quarter revenue, including system sales and recurring revenues, to be approximately $7.5 million.

Mazor Robotics ended the third quarter with an installed base of 131 Renaissance systems globally, including 79 in the U.S., the Company’s primary growth market. The Company currently intends to report its complete financial results for the third quarter ended September 30, 2016 in November and will issue a press release with the date, time and dial in and webcast details.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the market’s response to Mazor X, the benefits of Mazor X, Mazor’s expectations about market momentum, the expected delivery of Mazor’s systems, expected revenue for the third quarter and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary 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 more accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Contacts

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

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