2017 – Page 99 – Selby Spine

IRVINE, Calif., April 12, 2017 /PRNewswire/ — United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration (FDA) cleared its E-XPE™ polyethylene knee insert. The knee insert is designed to provide patients with knee replacements with reduced risk of oxidation.¹

“Clearance of our E-XPE™ polyethylene knee insert represents an important milestone in our knee portfolio,” said Calvin Lin, President of United Orthopedic Corporation USA. “Oxidation continues to be a concern for surgeons. The E-XPE™ polyethylene is resistant to oxidation and performs extremely well with respect to abrasive wear resistance.”

The E-XPE™ is the new generation of highly cross-linked polyethylene blended with 0.1 percent (w/w) vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties.

UOC’s vertically integrated manufacturing process is unique, enabling the company to control the production cycle of their implants, from initial design to distribution in each of its manufacturing facilities. By doing so, UOC is capable of ensuring a stable, quality product supply and a remarkable level of customization to meet the needs of patients.

More than 600,000 knee replacements are performed each year in the United States.²

About United Orthopedic Corporation

United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. UOC’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact
Erich Sandoval
Lazar Partners Ltd.
Tel: +1 917-497-2867
Email: esandoval@lazarpartners.com

_________________________
¹ Bellare, A. et al. Journal of Applied Polymer Science (2016). Oxidation Resistance and Abrasive Wear Resistance of Vitamin E Stabilized Radiation Crosslinked Ultra-High Molecular Weight Polyethylene, DOI:10.1002/APP.44125.
² American Academy of Orthopedic Surgeons website. Beyond Surgery Day:
The Full Impact of Knee Replacement. Accessed April 10, 2017 from: http://www.anationinmotion.org/value/knee.

SOURCE United Orthopedic Corporation

Contacts

EOS imaging
Anne Renevot, +33 (0)1 55 25 61 24
CFO
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / 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

SAN DIEGO, April 12, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it will showcase the Company’s LessRay® software technology at the International Society for Advancement of Spine Surgery’s (ISASS) 17^th annual conference held April 12-14, 2017 in Boca Raton, Florida.

LessRay is a proprietary image enhancement technology that improves low-quality, low-radiation images to look more like conventional full-dose images without disrupting surgical workflow. The software is designed to be integrated into current surgeon workflow and utilizes an algorithm to drive image registration and enable management of radiation exposure, while maintaining high-quality, intra-operative images on existing C-Arm workflow without loss of visual accuracy.

NuVasive ISASS17 Participation Details

NuVasive will showcase its technologies at NuVasive Booth #400 on the ISASS exhibit floor.

The Company will host an industry lunch workshop featuring Robert Isaacs, M.D. and LessRay on April 12, 2017 from 12:00 p.m. to 1:30 p.m. at Room Royal 7.

Visit here for more details and the schedule of events.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. 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.

Contacts

Press Contact USA:
joimax^® Inc.
Melissa Brumley
001 949 859 3472
Melissa.brumley@joimaxusa.com

April 12, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic materials for extremities, hip and knee will release its first quarter 2017 financial results on Tuesday, April 25, 2017. A copy of the earnings release will be available at http://www.hawkassociates.com.

The company will hold a conference call with CEO David Petty and key members of the management team on Wednesday, April 26 at 10:00 a.m. Eastern Time. The call will cover Exactech’s first quarter 2017 results. Mr. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 877-874-1569 any time after 9:50 a.m. Eastern on April 26. International and local callers should dial 719-325-4888. A live webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm or http://public.viavid.com/index.php?id=123876.

This call will be archived for approximately 90 days.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech, Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Media contacts
Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

BY JOHN STARK for The Bellingham Herald

Thanks to advances in medical technology, many surgery patients who would once have faced a few nights in a hospital are now getting complex procedures done at outpatient clinics that can get them in and out in less than a day.

The trend toward replacing lengthy hospital stays with an outpatient approach began in the 1970s, grew steadily and still appears to be gaining momentum. There is much more at stake than patient convenience: Outpatient surgery is far less costly to patients, insurers and the government programs that pay medical bills for millions of people.

That’s because hospitals must charge enough to cover their extensive overhead costs, which are far less in an outpatient clinic.

Pam Novotny, administrator at Bellingham Ambulatory Surgery Center at 2075 Barkley Boulevard, provided some examples:

▪ For cataract surgery, Medicare reimburses a hospital about $1,800. An ambulatory surgery center gets less about $1,100.

▪ For inguinal hernia repair, a hospital gets about $2,900, while a surgery center gets about $1,700.

▪ A breast lumpectomy costs Medicare about $2,500 in a hospital, compared to about $1,200 at a surgery center.

Gary Richberg is administrator at Pacific Rim Outpatient Surgery Center, 3009 Squalicum Parkway next to Peace Health St. Joseph Medical Center. Richberg said Pacific Rim is Bellingham’s largest surgery center, with about 5,000 surgeries performed there each year.

Richberg estimated that about 35 percent of procedures at Pacific Rim are knee and hip surgeries, including full joint replacements that once involved costly hospital stays of three to four days. Medical and professional journals report that an increasing number of such surgeries are being done at surgical centers instead of in hospitals, mostly because the cost is thousands of dollars less.

READ THE REST HERE

OR AKIVA, Israel, April 12, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that clinical experience with the FLXfit™, world’s first articulating and lordotic expandable cage, which will be presented by two distinguished surgeons at the International Society for the Advancement of Spine Surgery (ISASS) Meeting in Boca Raton, FL.

Dr. Marc Weinstein, from the Center for Spinal Disorders at the Florida Orthopaedic Institute in Tampa, will have a podium presentation “Use of a Novel 3-D Titanium Alloy Lordotic Expandable Cage Improves Segmental Lordosis after TLIF Greater than with a Static Lordotic Cage. Dr. Weinstein commented, “The FLXfit enables a unique, in-situ lordosis correction allowing to dial in the lordosis angle and to fit it to the patient’s anatomy.” Moreover, “The FLXfit^TM cage effectively allows for larger cage in the interbody space once expanded.” Dr. Weinstein added, “Our study has shown significantly improved segmental lordosis was achieved using FLXfit^TM with TLIF when compared to a static cage. He concludes, “We are in the midst of a clinical study which will provide a more thorough investigation of this unique device and demonstrate its clinical value for our patients.”

Dr. Raphael Roybal, from the Spine Institute at Chatham Orthopaedics, Savannah, GA., will have a poster presentation “Improvement in Sagittal Alignment and ODI Scores in Patients Treated with MIS TLIF Using a Lordotic Expandable Cage versus a Fixed Lordotic cage”. He noted, “The use of the FLXfit™ expandable cage demonstrated increased correction of the sagittal alignment post-operatively compared to a fixed angle banana cage.” Dr. Roybal added, “The combination of a large footprint device, controlled lordotic expansion and an easy to use instrumentation makes it an optimal solution for my patients.”

Mr. Ofer Bokobza, CEO of Expanding Orthopedics, said that “We are excited to present at this important ISSAS event with two renowned surgeons as Dr. Roybal and Dr. Weinstein. This continues to reinforce the clinical benefits of this novel device and its potential contribution to sagittal alignment.” Mr. Bokobza stated that, “We are excited about the momentum and growth of the FLXfit^TMin the US and are continuing to monitor and collect clinical data in more US centers.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The company is led by a seasoned management team, and is backed by prominent spine surgeons. EOI owns a broad patent portfolio of anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:
David Elkaïm
Vice President
Sales and Marketing
E-mail: david@xortho.com
Phone: +1(347)3219683

SOURCE Expanding Orthopedics Inc. (EOI)

April 12, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical, Inc., maker of the Simplify® cervical artificial disc, today announced that the first patient has been treated in the device’s pivotal clinical trial studying its use in two adjacent levels of the spine as a treatment for cervical degenerative disc disease. The Simplify Disc is designed to be clearly viewed on magnetic resonance imaging (MRI) without the artifact that can result from metal used in typical spine implants, potentially protecting patients from radiation associated with computed tomography (CT) scans.

Following the first case at Texas Back Institute, Simplify Disc IDE study investigator John Peloza, MD said, “Disc implantation went smoothly and the patient is doing quite well.” Dr. Peloza, medical director of the Center for Spine Care, continued, “I look forward to studying the use of the Simplify Disc at two levels, in collaboration with the Texas Back Institute team. I believe the Simplify Disc’s anatomic design with lower heights can help minimize overdistraction, which may improve outcomes in multi-level procedures.”

Richard Guyer, MD, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, said, “We are excited to start the Simplify Disc Two-Level IDE study. The device is made of materials designed to optimize its viewing and viewing of the adjacent spinal canal on MRI without artifact. This may eliminate or minimize the use of post-operative CT scans and reduce the risk of the associated radiation to the patient.”

The prospective, randomized controlled Simplify Disc pivotal trial will encompass up to 215 patients at up to 15 centers and will compare cervical implantation of two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The composite primary endpoint includes functional improvement, pain relief and safety. The national co-principal investigators are Domagoj Coric, MD, chief of the department of neurosurgery, Carolinas Medical Center, and Dr. Guyer. For information about eligibility or enrollment in the two-level pivotal trial, please visit http://www.simplifytrial.com/.

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a simple, three-step procedure. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

“We have designed the Simplify Disc to be responsive to surgeons’ needs, providing them with the potential to improve patient outcomes,” said David Hovda, Simplify Medical Chief Executive Officer. “We are enthusiastic about moving forward with the pivotal trial.”

The Simplify Disc is also enrolling patients in a second pivotal trial comparing one-level cervical implantation of the disc between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. More information about the one-level clinical trial is available at www.SimplifyTrial.com.

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

ABOUT SIMPLIFY MEDICAL

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

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

Contacts

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

April 12, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR)(NASDAQGM: MZOR), a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Los Angeles, CA, April 22-26.

Mazor X Align leverages Mazor Robotics’ extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of different imaging modalities. It is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.

According to Ori Hadomi, CEO of Mazor Robotics, “Mazor X Align is the product of Mazor’s development program and represents our innovative pipeline and visionary team experience. We are dedicated to pushing the envelope bringing to the market advanced products and applications in order to benefit an increasing number of patients suffering from difficult conditions and supporting the medical professionals serving them.”

Mazor X Align will be released to a selection of Mazor X customers in early May. This early release will be followed by a widespread release during the second half of 2017.

During AANS, Mazor Robotics will be hosting the following special presentations at booth #1423:

Presentation: Clinical Experience with Mazor Robotics Guidance Systems
Presenter: Dr. Jae Y. Lim
Date: Monday, April 24
Time: 1:00 – 2:00 pm

Presentation: Initial Case Series with Mazor Robotics’ Next Gen System: Mazor X™
Presenter: Dr. Donald M. Whiting
Date: Monday, April 24
Time: 3:30 – 4:00 pm

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 an accurate and secure manner. For more information, please visit MazorRobotics.com.

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 benefits of the Company’s products, the timing of release of Mazor X Align, 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.

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

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€ millions	Q1 2017	Q1 2016
Equipment sales	5.47	4.09
As a % of total revenues	77%	77%
Sales of maintenance	1.40	0.99
As a % of total revenues	19%	18%
Sales of consumables and services	0.26	0.24
As a % of total revenues	4%	5%
Total revenues	7.13	5.33
Unaudited data


€ millions	Q1 2017	Q1 2016
EMEA	3.21	2.45
North America	2.48	2.85
Asia-Pacific	1.44	0.03
Total revenues	7.13	5.33
Unaudited data

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