Premia Spine Features TOPS™ System and ProMIS™ Fixation System at ISASS Cadaver Lab

Philadelphia, PA, April 6, 2018 — Premia Spine, Ltd. announced today that it will sponsor a hands-on cadaver lab for participants at the International Society for the Advancement of Spine Surgery in Toronto.  The event will take place on Thursday, April 12th and feature both the ProMIS™ Fixation System and the TOPS™ System.  This will be the first time that surgeons in North America will have the opportunity to try both technologies in an open cadaver lab setting.

“I am very pleased to offer surgeons the opportunity to experience the advantages of our One-Step, direct Skin-to-Screw technique,” stated Tom O’Hara, recently appointed President of Premia Spine, Inc. “We are the first company to launch this patented approach—a technique that reduces x-ray exposure and saves screw placement time.”  Surgeons will also gain hands-on experience with other unique features to the ProMIS™ Fixation System.

In addition, Premia Spine will be offering surgeons a chance to work with the TOPS™ System—a posterior motion preservation system for patients with degenerative lumbar spondylolisthesis and spinal stenosis.  The TOPS System is approved in Europe and Australia, and under investigation in the United States.

Premia Spine launched the US IDE study among leading centers in the United States, including the Cleveland Clinic, Mayo Clinic, UPenn, UPMC Harrisburg, Carolina Neurosurgery, Ascension Jacksonville, Allegheny Health Network, Florida Spine Institute, Johns Hopkins-Sibley, and Wisconsin Bone and Joint.

“We want to showcase our solution before leading surgeons from around the world.  In addition, we are offering US surgeons the opportunity to join our IDE study—which still has a few remaining slots,” said Ron Sacher, CEO of Premia Spine.

The new TOPS device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over 6 years.

The IDE study will take place in 30 institutions and enroll 330 subjects.  Patients will be randomized to either the TOPS™ System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.

Clinical sites will be measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control.  “Our goal is to establish the superiority of the TOPS™ System versus traditional lumbar spinal fusion,” explains Mr. Sacher.

About Premia Spine.  Premia Spine licensed the TOPS System technology in 2011 from Impliant, Ltd. Over $100 million has been invested to design, develop, and commercialize the TOPS System, with over 12 years of clinical use and 1,000 patients.

Contact:
Ron Sacher, CEO

ronsacher@premiaspine.com

SPRI to Host Vail International Shoulder Summit

Vail, Colorado, April 06, 2018 (GLOBE NEWSWIRE) — The latest and most up-to-date methods and technologies in shoulder surgery will be the primary topics of discussion at the Vail International Shoulder Summit on April 6th and 7th at the Sonnenalp Hotel in Vail. The Summit is sponsored by Steadman Philippon Research Institute (SPRI), with The Steadman Clinic’s own Peter Millett, MD, MSc serving as the primary host of the event.

The two-day session begins today, Friday, April 6th with SPRI clinical fellowship and International scholar alumni attending. The Summit continues Saturday the 7th and is open to all orthopaedic surgeons, athletic trainers, physical therapists and professionals in orthopaedics and sports medicine.

Dr. Millett – who is a shoulder, knee and elbow specialist at The Steadman Clinic and has practiced sports medicine there since 2005 – looks forward to the variety of topics that will be discussed at the weekend’s Summit.

“The meeting is truly an international one with surgeons coming from all over the world to speak and present on their areas of expertise,” said Millett. “One of the benefits of the meeting is that, by design, there is ample time for discussion and one-on-one interaction between the presenters and the audience. It’s more like a think tank, incubator type of meeting than a convention, and that’s by intent.”

While Millett and SPRI have played host to numerous national and international conferences over the years that have focused on shoulder surgery and injuries related to the shoulder, this marks just the second time that they have included a day solely for returning alumni.

“Since so many of us know each other so well,” continued Millett, “it creates more openness and frank dialogue. This format allows us to be less reserved, more candid, and therefore more likely to get real advancements. It leads to some great discussion and helps us all learn more about the latest innovations in shoulder care.

“I think the venue in Vail really facilitates a lot of interaction, which no doubt creates a good cross-pollination of ideas,” added Millett. “Hopefully it not only serves as a forum where there is a lot of sharing of knowledge, but also spurs innovation.”

The Shoulder Summit begins Friday with presentations on the AC joint, bicep tendon, shoulder instability and rotator cuff tears. Saturday’s agenda includes segments on shoulder joint preservation and shoulder arthroplasty (total shoulder replacement surgery).

In addition to Millett, Burak Altintas, MD and Robert Boykin, MD will be serving as course directors for this year’s Shoulder Summit. Altintas, a German orthopaedic surgeon—originally from Turkey—is currently serving as an International scholar at SPRI, working closely with Millett and specializing in shoulder injuries and surgery. Boykin, who trained at Harvard, is a former sports medicine fellow at The Steadman Clinic and now practices as an orthopaedic surgeon in Asheville, N.C.

Other key presenters include The Steadman Clinic and SPRI’s own Matthew Provencher, MD and Johnny Huard, PhD. Provencher—a shoulder, knee and sports surgeon at The Steadman Clinic—will concentrate his talks on shoulder instability. Huard—Chief Scientific Officer and Director of the Center for Regenerative Sports Medicine at SPRI and recently named a recipient of the prestigious 2018 ORS (Orthopaedic Research Society) Kappa Delta Award—will talk about the use of biologics in the shoulder during Saturday morning’s discussion on shoulder preservation.

Attachment

Lynda Sampson
The Steadman Clinic 
970-479-1563
lsampson@sprivail.org

Anika Announces Plans to Showcase HYALOFAST Hyaluronic Acid-Based Scaffold at the 2018 World Congress of the International Cartilage Repair Society

April 06, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced plans to showcase HYALOFAST®, a biodegradable, HA-based cartilage repair scaffold, at the 14th World Congress of the of the International Cartilage Repair Society (ICRS). The ICRS World Congress, which is being held in Macau, China during April 9-12, 2018, is the world’s largest gathering of scientists, clinicians and industry participants focused on clinical cartilage repair and basic cartilage research.

“HYALOFAST represents a major advancement in the treatment of cartilage injuries and defects, evidenced by the positive reception it has received from physicians across 15 global markets,” said Joseph Darling, President and CEO, Anika Therapeutics. “The ICRS World Congress is the ideal venue to showcase the significant advantages HYALOFAST offers over invasive open surgical techniques and traditional scaffolds, to the largest gathering of cartilage repair specialists from around the world. At this year’s meeting, we’ve developed a robust educational agenda featuring world-renowned thought-leaders with HYALOFAST expertise sharing their technical know-how and providing hands-on, guided training sessions with our custom-built HYALOFAST Virtual Surgical Simulator. We believe that peer-to-peer education and technical training is central to prompting the HYALOFAST trial, which we hope will increase commercial adoption.”

HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used to successfully treat more than 14,000 patients internationally, and with strong five-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States and its FastTRACK Phase III trial is currently enrolling patients across the U.S. and Europe.

Company-Sponsored Lunch Symposium
Location: Room Almaty 3, Sheraton Grand Macau Hotel

Tuesday, April 10, 2018

  • 12:30 – 13:30 Almaty 3 Room, Lunch Symposium: HYALOFAST One-step Procedure: Best Practice and New Evidence in Cartilage Repair.
    Moderator: Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy
    Speakers: Dr. Bogusław Sadlik, St. Luke Hospital – Bielsko Biala – Poland, Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy, Prof. Stephan Nehrer, Danube University, Krems – Austria

Company-Sponsored Physician Education Availability
Location: Anika Booth #16, Sheraton Grand Macau Hotel

Monday, April 9, 2018

  • 15:15 – 16:15 Dr. Tho Kam San, Mount Alvernia and Gleneagles Hospitals – Singapore, will be available at the booth for guided training sessions with the HYALOFAST Virtual Surgical Simulator.

Tuesday, April 10, 2018

  • 11:00 – 12:00 Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy, will be available at the booth for guided training sessions with the HYALOFAST Virtual Simulator.

Wednesday, April 11, 2018

  • 13:00 – 14:00 Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy, will be available at the booth for guided training sessions with the HYALOFAST Virtual Simulator.

About ICRS

The ICRS (International Cartilage Repair Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the second and third paragraphs of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to HYALOFAST’s impact and its regulatory trajectory. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, or timely file and receive FDA or other regulatory approvals or clearances of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (ii) the Company’s research and product development efforts, and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations and production planning; (iv) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (v) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (vi) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (vii) the Company’s ability to provide an adequate and timely supply of its products to its customers; (viii) the Company’s ability to continue to successfully manage Anika Therapeutics S.r.l.’s business; and (ix) the Company’s ability to achieve its growth targets.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

Medicrea Publishes 2017 Full Year Results and First Quarter 2018 Sales

April 05, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design and manufacturing with UNiD ASI™ (Adaptive Spine Intelligence) technology, publishes its 2017 IFRS annual results, as audited and approved by the Board of Directors on April 4, 2018, as well as its sales for the first quarter of 2018.

2017 ANNUAL RESULTS

(€ millions) 2016 2017

Sales

Gross margin (% of sales)

Operating income before amortization and provision (EBITDA)

Operating income / (loss) before non-recurring expenses

Other non-recurring expenses

Cost of net financial debt

Income / (loss) before tax

Net income / (loss)

29.4

76%

0.3

(4.5)

(2.4)

(0.7)

(7.8)

(7.6)

27.1

73%

(2.1)

(7.6)

(0.9)

(2.2)

(11.2)

(10.7)

Changes in exchange rates had no material impact on year to year comparison

Sales in 2017 amounted to €27.1 million, down 8% compared to 2016. Despite a 15% growth in sales on the French market, changes to the sales organization in the United States combined with the temporary absence of invoicing throughout 2017 in Brazil (the Group’s leading export market excluding distribution subsidiaries) weighed on the development of the overall business.

The gross margin stands at 73%, down 300 basis points compared to the previous year due to a less favorable geographic mix of sales and temporarily higher production costs following the transfer of the La Rochelle, France production site to the new combined ultra modern headquarters in Lyon. The gross margin rate, however, recovered in the second half of the year and the improvement is expected to continue through 2018.

The Group continued its investment in research and development as well as commercial efforts to develop its UNiD ASI™ (Adaptive Spine Intelligence) products and services for patient-specific spine operations. This strategic choice along with the commissioning of new property infrastructures in Lyon and New York led to an increase in operating expenses of €0.6 million compared to 2016.

Given these points, operating income before amortization and provisions (EBITDA) posted a loss of – €2.1 million for the year compared with + €0.3 million in 2016. After accounting for depreciation and provisions, the operating result for 2017 is negative at – €7.6 million.

Other non-recurring charges amounted to €0.9 million and mainly included exceptional legal and restructuring costs. The cost of financial debt increased by €1.5 million following full-year accounting of IFRS interest and adjustments related to the convertible bond issue in August 2016. The current result before tax is – €11.2 million compared to – €7.8 million, as of December 31, 2016.

At December 31, 2017, the Group held a cash position of €12 million.

2018 FIRST QUARTER SALES

(€ millions) Q1 2017 Q1 2018 Variation

Variation
at Constant
Exchange Rate

United States

Rest of the World

3.9

3.1

3.6

4.5

– 7 %

+45 %

+7 %

+45 %

Total Sales 7.0 8.2 +17 % + 25 %

Sales for the first quarter of 2018 totaled €8.2 million, up 25% at constant exchange rate compared with the first quarter of 2017.

In the United States, the reorganization of the sales force during 2017 is starting to bear fruit with a visible impact in the first quarter of 2018 on the evolution of the activity. In dollars, sales amounted to $4.4 million, an increase of +7% compared to the first quarter of 2017. Driven by the increase in the number of personalized surgeries (+60%), the revenue generated by the UNiD ASI™ technology platform increased by 40% compared to the first quarter of the previous year and now represents 55% of total sales.

Outside of the United States, revenue jumped by 45%, supported by continued gains in market share in France where Medicrea has become a leading player, and the launch of a new distribution subsidiary in Belgium in February 2018, which enabled the Group to begin directly invoicing hospitals within the country. As a result, sales in Belgium increased fivefold compared to the first quarter of 2017. The new subsidiary was created through a joint venture agreement with its historic distributor in this market, in which Medicrea holds 51%.

By type of activity, the consolidated Group turnover in the first quarter of 2018 has evolved as follows:

(€ millions) Q1 2017 Q1 2018 Variation

Variation
at Constant
Exchange Rate

Patient-specific sales activity with UNiD ASI™

Traditional sales activity with historic products

1.9

5.1

2.4

5.8

+21 %

+9 %

+37 %

+9 %

Total Sales 7.0 8.2 +17 % + 25 %

“After completing major steps in 2017 toward the Group’s restructuring, including the consolidation of the French entities to a new site in the Lyon area, the reorganization of the sales force in the United States and the FDA clearance of new products, sales are growing again, and signs indicate a strong positive outlook for the coming months. We are developing our business by opening new markets, both through new distribution agreements and the launch of newly-formed marketing subsidiaries. In this vein, we announce the creation of Medicrea Australia, formed through a joint venture similar to that successfully introduced in Belgium. With this, Medicrea enters a robust and growing market that is among the most profitable in the world. We expect this subsidiary to contribute to the Group’s revenues in the second quarter of 2018,” stated Denys Sournac, President and CEO of Medicrea.

“As a pioneer and worldwide leader in cutting-edge technologies for the design and manufacturing of personalized implants, we are continuing to develop our service offering thanks to the extensive data we have collected during the more than 2,200 UNiD ASI™ surgeries performed to date. We recently launched the commercialization of our in-house 3D printed titanium cages in the United States and will be offering new personalized devices and related services in 2018 to optimize the selection and number of implants used in spinal surgeries,” Mr. Sournac concluded.

Next publication : Sales for the First Half of 2018 : Thursday, July 12, 2018, after-market.

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea 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 175 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: Medicrea.com.

Connect with Medicrea:

FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

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

Contacts

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

CTL Wins FDA Approval for Seurat Universal Pedicle Screw

DALLAS, TX / ACCESSWIRE / March 29, 2018 / CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has recently secured clearance and approval from the Food and Drug Administration to market its new SEURAT Universal Pedicle Screw System for the practice of spine fusion surgery. This is the second FDA clearance for the company in the first quarter of 2018. CTL Medical’s in-house research and development team designed the SEURAT Universal Pedicle Screw System after working closely with surgeons to determine the most comprehensive, adaptable, and advanced features for use in the surgical operative environment.

“The FDA approval of the SEURAT Universal Pedicle Screw System enables us to offer very versatile intraoperative hardware options for surgeons and the surgical spine industry as a whole,” stated Danny Chon, CEO for CTL Medical Corporation. “As the general population continues to age and the reported degenerative spine cases increase, it is inevitable that the pedicle screw market and related instrumentation challenges will continue to grow, ultimately demanding a one-stop solution. As an answer to this need, we designed the SEURAT Universal Pedicle Screw System to be a truly comprehensive pedicle screw offering unlike any other in the market today.”

The SEURAT Universal Pedicle Screws are medically classified as bone screws, designed for direct implantation into a vertebral pedicle. This system is a compilation and consolidation of the best features from each of CTL Medical’s already cleared pedicle screw systems, boasting the addition of true intraoperative versatility. The modular housing assembly option enables surgeons to intraoperatively build the most appropriate implant for the present indication, and the option to select a standard or reinforced-ring locking set screw ensures the SEURAT Universal Pedicle Screw System will accommodate a broader range of anatomical challenges and usage preferences. This comprehensive single system includes polyaxial and monoaxial; open and MIS; single and dual thread profile; solid and cannulated; and hex and hexalobe screws of all diameters and lengths.

CTL Medical expects to launch the SEURAT Universal Pedicle Screw System in the second half of 2018.

For more information on CTL Medical Corporation, visit www.ctlmed.com.

About CTL Medical Corporation

CTL Medical Corporation is a fully integrated, innovative, industry-leading, global medical device design, development and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talents, positioning it to be a leader in medical device design and manufacturing. For more information, visit www.ctlmed.com.

Media Contact:

Jeff Cheatham
TrizCom PR
O: 972-247-1369
C: 972-961-6171
jeffc@trizcom.com

SOURCE: CTL Medical Corporation

Globus Medical Announces Launch of ELSA® Expandable Lateral Spacer System

AUDUBON, Pa., April 05, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the launch of two innovative lateral expandable interbody spacers with integrated screw fixation, ELSA® AL and ELSA®-ATP, the latest additions to Globus’ unmatched expandable solutions. These next generation expandable implants provide an optimized fit for the patient, allowing for restoration of sagittal balance and enhanced structural fixation.

Globus Medical is the market leader in expandable interbody spacers with over 20 expandable implant solutions supported by 15 years of clinical experience. Globus Medical’s full line of expandable products has enabled surgeons to treat over 130,000 levels.

“ELSA® AL is the alternative to RISE®-L for selected cases in which maximizing segmental lordosis is indicated,” said Dr. Paul K. Kim, neurosurgeon at Carolina Neurosurgery & Spine Associates. “In conjunction with the ALL (anterior longitudinal ligament) release technique, ELSA® AL has the potential to provide the most amount of segmental lordosis of any device on the market.”

Adjustable Lordosis Technology with ELSA® AL

ELSA® AL’s in situ adjustability and integrated screw fixation are designed to help correct sagittal balance and improve stability. The implant features exclusive adjustable lordotic technology that allows up to 30° of lordosis while maintaining a minimally invasive surgical corridor. With less disruption compared to traditional static spacers, ELSA® AL provides maximum correction and additional fixation for increased segmental stability.

First Expandable Spacer for a Customized ATP Approach

ELSA®-ATP is the only expandable spacer designed to avoid nerve complications associated with the direct lateral technique by using an anterior-to-psoas approach.

The Lateral Lumbar Interbody Fusion (LLIF) technique approaches the spine from the side of the patient, which allows for placement of a larger implant footprint and less disruption of the lower back muscles. The anterior-to-psoas approach is a modified LLIF procedure that avoids the psoas, a large muscle responsible for movement and flexion of the leg. Avoiding this muscle and its integrated nerves may help reduce post-operative complications such as thigh pain.

ELSA®-ATP features angled integrated screws for direct fixation to the adjacent vertebrae. The spacer can be inserted at a minimal height and expanded in situ to minimize tissue disruption and maximize indirect decompression. A full suite of anterolateral access and insertion instruments makes ELSA®-ATP the most comprehensive system on the market.

“Our product development team’s continued commitment to innovation has enabled us to design expandable interbody technology for nearly every surgical approach.  The addition of these two unique ELSA® spacers to our expandable lateral portfolio demonstrates our commitment to listening and responding to our customers’ needs through continuous product innovation,” said Andrew Iott, Senior Vice President of Global Product Development. “The use of an expandable spacer for the ATP approach may help reduce complications associated with the lateral procedure.  With restoration of alignment being of critical importance, these implants were developed as a tool to help surgeons address sagittal imbalance, with the goal of maximizing lordotic correction.”

Learn more about ELSA® and Globus Medical’s full line of expandable interbody spacers at www.GlobusMedical.com/Expandables.

Indications

The ELSA® Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

About Globus Medical, Inc.

Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements

All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

NuVasive Sponsors ISASS 2018, Hosts Workshops And Presentations

SAN DIEGOApril 5, 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 the Company is a sponsor of the International Society for the Advancement of Spine Surgery, 18th Annual Conference (ISASS) being held April 11-13, 2018, in Toronto, at the Metro Toronto Convention Centre. NuVasive will host a hands-on workshop featuring the latest advances in Lateral Single-Position solutions, as well as a number of podium presentations at ISASS 2018.

The NuVasive Industry Lunch Workshop, Leading. Expanding. Advancing. Insights to Lateral Procedural Solutions, by J. Alex Thomas, M.D., will take place on Thursday, April 12 from 12:00-1:30 p.m. in Room 802A / 802B. For more information, visit http://www.isass.org/education/conferences/isass18-scientific-program/.

“We encourage attendees to participate in the workshop to see firsthand how surgeons are already incorporating Lateral Single-Position solutions to help their patients,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “This equates to increased OR efficiency by reducing the number of times a patient has to be repositioned and expanding the benefits of lateral surgery to more spinal levels. Since its launch in October 2017, the Lateral Single-Position solution is fully integrated into our portfolio, and we have received extremely positive feedback from early adopters who are seeing great results as they take XLIF® to the next level to create a better and more streamlined surgical experience for both surgeon and patient.”

Additionally, NuVasive will present on podium during ISASS 2018, touching on topics ranging from advanced implant materials such as Porous PEEK™ to biologics:

  • April 1111:14 a.m. Efficacy of a Novel Microstructured Calcium Phosphate-Collagen Bone Graft in a Rabbit Posterolateral Spine Fusion Model. Speaker: Greg M. Williams, Ph.D.
  • April 13, 8:00 a.m. Comparing the Osseointegration of Seven Spinal Interbody Device Materials in an Ovine Bone Implantation Model. Speaker: Greg M. Williams, Ph.D.
  • April 139:00 a.m. PEEK, HA PEEK and Porous PEEK science. Speaker: Prof. Ken Gall

Conference attendees can visit NuVasive Booth #201 to experience the latest innovative spine solutions and systems firsthand from the NuVasive team of experts and also view research posters in the exhibit hall.

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

Orthopaedic Surgeons Offer Laser Therapy For Pain Management And Find Great Success

 

Episurf Medical’s knee products approved for marketing and sale in Spain

TUE, APR 03, 2018

Episurf Medical (NASDAQ: EPIS B) today announces that the Spanish authority AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) has approved the Episealer® knee implant for marketing and sale in Spain. The approval follows a review process and Episurf Medical will now continue the process of establishment on the Spanish market.

“We are happy for this approval which follows our strategy. Spain is a market of significant size with a large number of knee replacements annually. Knee osteoarthritis is a global disease and the global markets are homogenous when it comes to prevalence. We look forward to taking the next steps in Spain shortly”, says Pål Ryfors, CEO Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 14.00 CEST on 3 April 2018.

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AlloSource and Stryker Launch ProChondrix CR Cryopreserved Osteochondral Allograft

CENTENNIAL, Colo.April 4, 2018 /PRNewswire-USNewswire/ — AlloSource and Stryker today announced the launch of ProChondrix® CR, a cryopreserved osteochondral allograft. ProChondrix CR is a single-stage, natural solution for patients in need of articular cartilage repair.

ProChondrix CR is designed to match biomechanical and biochemical properties of normal hyaline cartilage, restore a smooth articular cartilage surface, help relieve patient symptoms, and improve function. AlloSource launched ProChondrix in 2016 and developed a cryopreserved version to provide a longer shelf-life, while maintaining the high cellular viability of the product1.

“ProChondrix CR demonstrates our commitment to innovation and our surgeon customers,” said Kerr Holbrook, AlloSource Chief Commercial Officer. “This cryopreserved allograft provides opportunities for more surgeons to use ProChondrix CR to help restore patient health. We are proud to work with Stryker on the distribution of this product and look forward to more opportunities to serve surgeons and their patients.”

Stryker will distribute ProChondrix CR across multiple treatment areas to help expand access for patients.

About AlloSource
AlloSource is dedicated to advancing the science and use of transplantable allogeneic cells and tissue through pioneering research in regenerative therapies. The organization offers life-saving and life-enhancing solutions in orthopedic, spine, burn and wound procedures to help restore patient health and mobility. As a world leader in cell-based products, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource’s products bridge the proven science of allografts with the advanced technology of cells. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org.

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.

1Data on file at AlloSource

CONTACT: Megan Duggan, 720-382-2766, mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org