Wednesday, April 27, 2016

News: Centric Medical™ Announces Full Market Release of TARSA-LINK™ Stand-Alone Wedge Fixation System for Foot and Ankle

HUNTLEY, Ill.--()--Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today the full market release of TARSA-LINK Stand-Alone Wedge Fixation System, for internal bone fixation of fractures, fusions and osteotomies in the foot and ankle. TARSA-LINK joins Centric Medical’s suite of innovative osteobiologic products.
“The TARSA-LINK wedge is a powerful device that can be used to correct flatfoot deformities. It truly allows for the optimal amount of correction needed for each patient’s unique anatomy”
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“The TARSA-LINK wedge is a powerful device that can be used to correct flatfoot deformities. It truly allows for the optimal amount of correction needed for each patient’s unique anatomy,” said Dr. Caronis, of Greenleaf Orthopaedics & Physical Therapy located in Libertyville, Illinois. “Because the implant is made from a PEEK material, it provides greater stability than an allograft, while eliminating the risk of donor graft rejection. The implant’s design facilitates the use of screws that can be placed through the wedge, locking in the correction while providing a stable environment for fusion.”
TARSA-LINK is the first stand-alone Osteotomy wedge with built-in fixation on the market. It is primarily utilized for procedures including Evans Osteotomy, Cottons Osteotomy, Bunionectomies, fractures, and fusions. This groundbreaking wedge boasts reduced procedure time owing to the incorporated screws, thereby eliminating the need for an additional plate.
About Centric Medical
Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois.

Contacts

for Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
847-884-6117

Published at BusinessWire

News: Lehigh Valley Medical Device Manufacturer Receives State Financing

A medical device manufacturer that relocated its corporate headquarters and manufacturing operation to the Lehigh Valley last year is now looking to grow even more thanks to a loan from the state.
Tyber Medical, a manufacturer of orthopedic and spinal implants based in Hanover Township, Northampton County, has been awarded a $362,500, 10-year loan at a 3.25 percent fixed rate, according to the state.
The loan will be used to purchase manufacturing equipment for in-house fabrication, a $725,000 project that will create 25 new jobs, according to thePennsylvania Department of Community and Economic Development (DCED).
“The funding provided through the PIDA loan program is another important milestone as we execute to our strategic plan,” said Jeff Tyber, President and CEO of Tyber Medical. “The PIDA funding will further empower our company to focus on building our customer’s private label brand while expanding our internal capabilities.”
The loan was awarded through the state’s Pennsylvania Industrial Development Authority (PIDA) program, which offers low-interest loans and lines of credit to eligible businesses that commit to creating and retaining full-time jobs.
In 2016 so far, PIDA has approved $15.2 million in low-interest loans that have resulted in $33.2 million in private investment across the state, supporting the creation and retention of 607 jobs, according to the state.
“In addition to the loans approved, the PIDA is offering extremely low interest rate options,” said DCED Secretary Dennis Davin. “The ability to offer lower rates, ensures that businesses have access to critical capital needed to support advancement and on-going success.”
In August, Davin announced that Tyber Medical was relocating its corporate headquarters and manufacturing operation to the Lehigh Valley from Morristown, N.J. At the time, the company announced it leased a 4,200 square-foot site and planned to invest $386,000 on the project.
“Tyber Medical’s decision to relocate to Pennsylvania and create more than two dozen, high-paying jobs is great news for the region and state,” Pennsylvania Gov. Tom Wolf said in August. “Medical device manufacturing is a thriving sector and will continue to create good-paying jobs through the significant reforms proposed my budget plan.”
In 2015, Tyber Medical was offered a funding proposal from the Governor’s Action Team, the economic development arm of the governor, which encouraged the company to apply for a low-interest loan through PIDA. The Lehigh Valley Economic Development Corporation (LVEDC) helped Tyber Medical with processing the loan application.
“The guidance from the Lehigh Valley Economic Development Corporation allowed Tyber Medical to efficiently navigate the process while maximizing both the state of Pennsylvania’s goal of job creation and Tyber Medical’s goal of internal enhancement,” Tyber said. “We look forward to putting the funds to use and creating additional jobs in the Lehigh Valley.”
John Kingsley, LVEDC Vice President of Finance, said: “We’re very pleased Tyber Medical has chosen the Lehigh Valley, and that they’re growing thanks to this PIDA loan. Health care is the region’s leading sector in terms of job creation, and Tyber Medical is a great company that makes an excellent addition to our medical device community.”
Tyber Medical’s loan was announced last week by the state as part of $3.9 million in low-interest loans awarded over the past month for five projects in Pennsylvania that will generate more than $10.8 million in total investments, Davin said.
PIDA, one of several financing programs LVEDC administers, is considered by the majority of lenders to be Pennsylvania’s flagship economic development lending program. It can finance up to $2.25 million with a term of up to 15 years.
PIDA funds can be used for land and building acquisitions, construction and renovation costs, machinery and equipment purchases, working capital and accounts receivable lines of credit, multi-tenant facility projects, or industrial park projects, according to the state.
PIDA loans are awarded through industrial development corporations. In this case, the Northampton County New Jobs Corporation was awarded the $362,500 loan on behalf of Tyber Medical, according to the state

News: OS imaging Receives FDA Approval for spineEOS, its online 3D Planning Solution for Spine Surgery

FDA approval allows EOS to bring the first 3D surgical planning solution to the large and growing spine market in the United States

PARIS--()--Regulatory News:
EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that the U.S. Food and Drug Administration (FDA) has approved spineEOS, an online 3D planning software for spine surgery based on EOS stereo-radiographic 2D/3D imaging. The FDA approval of spineEOS allows EOS to expand its presence in the large and growing U.S. spine market, in particular the complex spine and thoraco-lumbar fusion surgery markets, which include approximately 400,000 patients per year and represent more than $3 billion in orthopedic implant value1.
The spineEOS online 3D planning software is intended for adults suffering from degenerative or deformative spine conditions, as well as for pediatric patients with Adolescent Idiopathic Scoliosis. It allows a surgeon to create a treatment plan to achieve optimal sagittal alignment from pelvic and vertebral 3D data obtained in the functional standing position from an EOS exam. The planned surgery and virtual post-correction 3D anatomy can be used to precisely plan for the 3D shape and length of the spinal implants. It can also be shared pre-operatively to engage the patient in the intended course of therapy, and is accessible in the operating room through a custom planning report.
Marie Meynadier, CEO of EOS imaging, said, “We believe that patients’ spines are complex 3D systems that need a personalized 3D planning of the intended surgery. We’re excited about the interest we’ve seen in our spineEOS planning software from surgeons inside and outside of our current installed base, as well as from our industry partners. We look forward to this next important step toward our broader goal of expanding our EOSapps planning software suite to better connect imaging to patient care.”
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

Next press release: 2015 Full-year results and 2016 First-quarter sales on April 28, 2016
About EOS imaging
EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan, China, and the European Union (EC). The Group posted 2015 revenues of €21.8 million and employs 107 people including an R&D team of 39 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

1 PiperJaffray Industry Note, January 4, 2016

Contacts

EOS imaging
Anne Renevot, Ph: +33 (0)1 55 25 61 24
CFO
or
NewCap
Financial communication and investor relations
Pierre Laurent, Ph: +33 (0)1 44 71 94 91
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, Ph: 646-536-7006

Published at BusinessWire

News: LISI MEDICAL, A SUBSIDIARY OF THE LISI GROUP, ANNOUNCES THE SIGNATURE OF A STOCK PURCHASE AGREEMENT WITH ALCOA TO ACQUIRE ITS REMMELE MEDICAL BUSINESS

LISI Group (Euronext Paris ISIN code FR0000050353 – FII) announced that it has signed a Stock Purchase Agreement with a subsidiary of Alcoa Inc. (NYSE:AA) to acquire its Remmele Medical Operations for USD 102 million (€90 million).

The transaction is expected to close in the second quarter of 2016, subject to regulatory approvals and other customary closing conditions.

Remmele Medical Operations, a unit of Alcoa Titanium & Engineered Products (ATEP) business unit, is a leading manufacturer of minimally invasive surgical components with strong positions in spine and other attractive healthcare end markets. With two manufacturing facilities totaling 100,000 square feet in Big Lake and Coon Rapids, MN, as well as a highly qualified staff of approximately 350, this acquisition will add complementary products and technologies and allow LISI MEDICAL to strengthen its position as a world-class contracting company specializing in medical device manufacturing. Remmele Medical Operations realized sales revenues of approximately USD 70 million in FY 2015. Once this acquisition is finalized, LISI MEDICAL will be among the leading contractors and manufacturers in the medical devices industry worldwide with more than USD 150 million in annualized sales revenues.

“With this acquisition LISI MEDICAL will be ideally positioned to serve customers worldwide, as well as to provide our growing customer base with our unique concept of Manufacturing Excellence for Life Technologies” said Mr. Olivier Le Bars, Chief Executive Officer of LISI MEDICAL.

Monday, April 18, 2016

News:RTI Surgical® Announces Launch of Streamline® TL Spinal Fixation System – Deformity Instrumentation

ALACHUA, Fla.--()--RTI Surgical® Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, is pleased to announce the launch of the Streamline TL Spinal Fixation System – Deformity Instrumentation for complex adult deformities or curvatures. With a focus on versatility, ease-of-use and surgeon comfort, the Streamline TL deformity instruments bring another level of functionality to RTI Surgical’s advanced pedicle screw system.
RTI Surgical® Announces Launch of Streamline® TL Spinal Fixation System – Deformity Instrumentation
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The Streamline TL Spinal Fixation System allows a rigid construct to be created in the thoracolumbar spine using pedicle screws, set screws, rods and crosslinks. RTI has continued to expand on the system’s offerings since the initial launch of the system in 2011, adding innovative solutions to address various patient pathologies. The newest addition to the system, the deformity instrumentation, provides surgeons with the resources necessary to perform challenging adult deformity cases.
“Expanding our Streamline TL Spinal Fixation System with these innovative and versatile deformity instruments enhances our ability to compete in the complex deformity market,” said Brian K. Hutchison, president and CEO of RTI Surgical. “With this addition to our spine portfolio we are very excited to be able to cover an even broader range of surgeon and patient needs.”
About RTI Surgical Inc.
RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.
Forward Looking Statement
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management's beliefs and certain assumptions made by our management. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company's SEC filings may be obtained by contacting the company or the SEC or by visiting RTI's website at www.rtix.com or the SEC's website at www.sec.gov.

Contacts

RTI Surgical Inc.
Ryan Gerds, APR, CPRC, 386-418-8888
Director, Marketing Communications

Published at BusinessWire

News: Stryker Acquires SafeWire Product Portfolio for Use in Minimally-Invasive (MIS) Spine Procedures

Technology Used with Stryker’s Percutaneous ES2 Spinal Fixation System & LITe (Less Invasive Technologies) Procedural Solutions

ALLENDALE, N.J.--()--Stryker’s Spine division today announced the acquisition of the SafeWire product portfolio, including the Y-Wire guidewire and Tiger Jamshidi Needle Family for use in minimally invasive spine surgery. The acquisition is highly complementary to Stryker’s current spine product portfolio and is aligned with the Spine division’s strategy of expanding its product offering for minimally-invasive spine surgery.
“This acquisition increases our competitive advantage as we broaden our product line and extend our customer base among teaching facilities, competitive accounts, and existing SafeWire customers.”
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Acquired from SafeWire, the Y-Wire features a patented feature that is designed to mitigate potential wire-based complications, such as inadvertent advancement of the guidewire through bone, accidental pullout, kinking, or wire migration. In addition, with reduced surgical steps and technical ease, the Y-Wire helps to optimize workflow for minimally invasive spine cases, and to significantly reduce patient and surgeon exposure to fluoroscopy.1
Brad Paddock, president of Stryker’s Spine division, said the introduction of the SafeWire portfolio reflects Stryker’s ongoing commitment to patient safety and to providing surgeons with innovative technology needed to treat patients undergoing minimally-invasive spine surgery. “We are excited to bring this important complementary technology into the Stryker family,” Paddock said. “This acquisition increases our competitive advantage as we broaden our product line and extend our customer base among teaching facilities, competitive accounts, and existing SafeWire customers.”
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.
1. MITLF-JA-2 Significant reduction in fluoroscopy time and radiation dosage utilizing an innovative guide wire in the placement of percutaneous MIS pedicle screws, Zavatsky JM, Waddell B.
Content ID MITLF-PR-1

Contacts

Sullivan & Associates
Barbara Sullivan, 714-374–6174

Published at BusinessWire

News: MEDICREA: 2015 Annual Results and Q1 2016 Sales

Solid sales growth in Q1 2016: +20% | More than 600 surgeries carried out with UNiD customized rods | 4 million euros of investments in new industrial equipment in 2015

LYON, France & NEW YORK--()--The MEDICREA group (Paris:ALMED) (Alternext Paris: FR0004178572 - ALMED), PEA-PME eligible, which specializes in the development and manufacturing of innovative implantable solutions for the surgical treatment of spinal pathologies, and world leader in solutions customized for each patient, announces its audited 2015 IFRS annual results, as approved by the Board on April 4, and its sales for the first quarter of 2016.
2015 annual results:
€ millions  2014  2015
Sales
Gross margin
Gross margin (% of sales)
Operating profit before amortization and provisions (EBITDA)
Operating profit before share-based payments
Current pre-tax profit
Net profit
  24.2
19.6
81%
2.5
(0.2)
(0.7)
(1.0)
  27.8
21.8
79%
1.9
(1.5)
(1.8)
(1.5)
Variations in currency rates between 2014 and 2015 had a positive impact of €0.6 million on 2015 net profit.
In 2015, sales were up +15% on the previous year. The Group is confirming that it is now a leading player in France with sales growth of +23% in this country compared with 2014. Sales generated by the United States, the Group’s main and priority market, accounted for 60% of total sales.
The gross margin improved by €2.2 million compared with 2014. Investments in new industrial equipment and the deployment of the UNiD™ platform, not yet offset by further productivity gains and the anticipated increase in sales volumes, are the reason for the temporary decrease in gross margin as a percentage of sales, which remains one of the highest in the sector.
We strengthened our organization in 2015 by recruiting 12 staff, mainly in our R&D and marketing departments. The arrival of Greg Rhinehart as Vice-President US Sales is a major milestone and should allow us to move to the next level in the US market in 2016. We also opened a new distribution subsidiary in Germany, Europe’s largest spine surgery market”, says Denys SOURNAC, Chairman and CEO of MEDICREA.
At the same time, we renewed and supplemented our production tool by integrating a new additive manufacturing center using titanium 3D printing, a comprehensive prototyping unit and latest-generation digital control machines. These investments will enable us to be more responsive in meeting surgeons’ requirements. For the sixth year in a row, we have posted positive EBITDA, highlighting our ability to control the Group’s development”, Denys SOURNAC continues.
Q1 2016 sales:
In the 1st quarter of 2016, sales totaled €7 million, up 20% on the same period of 2015. The Group’s two main markets recorded solid growth: the United States saw sales grow by 27% at constant currency and France recorded sales growth of 20%.
The strengthening of the sales teams in the United States, the marketing of new products and the ramping up of the British and German subsidiaries will bolster the growth in coming quarters.
Outlook:
We have recorded an encouraging start to 2016. The rate of adoption of our UNiD™ technology offering customized osteosynthesis rods and a platform of associated patient analysis and pre-op planning services is accelerating. The number of surgical operations carried out using our technology surpassed 600 in early March, and we are now engaged in more than 60 planned surgical interventions a month. UNiD™ is a wonderful growth driver for the Group thanks to its particularly innovative service-focused approach. MEDICREA is actively working to expand its range of customized implants and will, in 2016, industrialize interbody cages and corpectomy implants manufactured via titanium 3D printing. We are convinced that computer-assisted customized surgery is the most appropriate response to spinal pathologies, and this is being confirmed by the growing interest shown by surgeons and also patients in our solutions”, Denys SOURNAC explains.
Next publication:
Sales for the 1st half of 2016: July 7, after market.

About MEDICREA (www.medicrea.com)
The MEDICREA Group specializes in the design, manufacture, and distribution of innovative proprietary technologies devoted exclusively to spinal surgery. Operating in a $10 billion market, MEDICREA is a small to medium-sized business with 140 employees, including 40 at its MEDICREA USA Corp. subsidiary based in New York City.
The Company enjoys an excellent and ever-improving reputation, and develops unique scientific partnerships with some of the most visionary and creative spine surgeons in France, the UK, and the USA. The products developed and patented by MEDICREA provide neurosurgeons and orthopedic surgeons specializing in the spine with new and less-invasive surgical solutions that are faster and easier to implement than traditional techniques.
MEDICREA has also become a pioneer and global leader in the manufacturing of customized implants for personalized spinal surgery with the development of a comprehensive process incorporating the software analysis of each patient, the pre-surgical planning of the surgical strategy, and the production of customized spinal osteosynthesis rods (UNiD™ rod) and lumbar interbody osteosynthesis cages (UNiD™ ALIF cage) that are made to measure by a 3D printer.
The Group’s headquarters are based near Lyon, France. It also has an implant and surgical instrument manufacturing facility located in La Rochelle, France, as well as four distribution subsidiaries in the USA, the UK, France and Germany.
MEDICREA is listed on ALTERNEXT Paris
ISIN: FR 0004178572 – Ticker: ALMED

Contacts

MEDICREA
Denys Sournac
Founder, Chairman and CEO
Fabrice Kilfiger, Tel: +33 (0)4 72 01 87 87
Chief Financial Officer
or
NewCap.
Investor & Media Relations & Strategic Communications
Tristan Roquet Montégon, Tel: +33 (0)1 44 71 00 16

Published at BusinessWire

News: Bodycad Introduces Bodycad OnCall Custom Orthopaedic Restorations

QUEBEC CITYApril 7, 2016 /PRNewswire/ -- Bodycad has announced the introduction of Bodycad OnCall, its personalized, individually manufactured orthopaedic restorations for complex cases.

Bodycad OnCall gives surgeons unprecedented flexibility in design and manufacturing of a fully personalized restoration. It is ideal for oncology, revision and osteotomy.

"With complex cases, anatomy can be compromised in an endless number of ways which makes off-the-shelf implants a sub-optimal solution," says Dr. Brian HamlinAssociate Director of the Bone and Joint Center of Magee-Womens Hospital ofUniversity of Pittsburgh Medical Center. "Bodycad OnCall allows us to customize the restoration with the goal of achieving better outcomes for the patient," says Hamlin.

The Personalized Restoration Evaluation Process (PREP) is guided by Bodycad PREP Techs, who collaborate with surgeons to achieve an anatomical fit for every patient. PREP Techs offer consultation and support on load bearing, joint articulation and orthopaedic correction.

"At Bodycad, we are changing the paradigm of joint restoration," says Jean Robichaud, founder and CEO of Bodycad. "A direct relationship between the surgeon and the prosthesis designer must be established, and mutual trust must be created, in order for a customized approach to deliver optimal results. Bodycad is pioneering this relationship."

Bodycad OnCall uses state-of-the-art additive manufacturing (3D printing). The process involves applying successive layers of material in a precise configuration guided by the model created with Bodycad Personalized Restoration Software. 
Bodycad maintains its own manufacturing facility, enabling it to control costs while continually upgrading its capabilities. With its background in personalized oral implantology, the Bodycad team has the knowledge and expertise to make mass orthopaedic personalization possible.
About Bodycad
Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedics. Its personalized restorations offer patients a high level of conformity to their unique anatomy, providing comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.
Contact
Andy McLeod
111 West Illinois Street
Chicago, IL 60654 USA
(418) 527.1388

Published at PR NewsWire

News: K2M’s MESA® Mini and DENALI® Mini Spinal Systems Receive Additional FDA Clearance for Posterior Cervical Spine Fixation

New Clearance Expands the Use of K2M’s Mini Systems in the Complex and Degenerative Markets by Offering Surgeons New Capabilities to Treat the Cervical Spine

LEESBURG, Va., April 06, 2016 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of its MESA® Mini Spinal System and DENALI® Mini Spinal System.

The MESA Mini and DENALI Mini Spinal Systems function as adjuncts to fusion, providing stabilization of the posterior cervical and thoracic spine. Both systems were previously cleared for use in the posterior thoracic spine, from T1-T3. The new clearance now allows for the systems to be used in the posterior cervical spine, from C1-C7, in addition to the thoracic spine.

“With this FDA clearance, we are excited to provide surgeons treating the cervico-thoracic regions of the spine with expanded use of our MESA Mini and DENALI Mini Spinal Systems,” stated Eric Major, K2M's President and CEO. “This new clearance reinforces the clinical effectiveness of posterior cervical screws, differentiates K2M from our competitors in the complex spine cervical markets that currently lack this important regulatory indication, and clears the path for our future development of innovative technologies to treat spinal conditions in the posterior cervical spine.”

The MESA Mini and the DENALI Mini Spinal Systems are comprehensive, 3.5 mm diameter rod systems that offer all-inclusive answers for rigid posterior fixation of the cervico-thoracic regions of the spine. The systems feature multiple hook and rod options, and innovative instrument technology to facilitate more efficient intraoperative use of the systems.

Developed using K2M’s revolutionary MESA Technology, MESA Mini features low-profile, 90° range of motion cervical and thoracic screws and Zero-Torque Technology®, which offers surgeons the ability to one-step lock without applying torsional stress to the spine. The DENALI Mini implants feature top-loading, 50° polyaxial range of motion cervical and thoracic pedicle screws that incorporate a low-volume design and offer off-axis height adjustment. 

For more information on the MESA Mini Spinal System, the DENALI Mini Spinal System, and K2M's complete product portfolio, visit www.K2M.com.

About K2M
K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.

Forward-Looking Statements
This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarters facility; or an ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions, voluntary corrective actions or agency enforcement actions; a recall of our products, withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations may fluctuate over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC. We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.
We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward looking statements and you should not place undue reliance on our forward-looking statements.
Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Marcie Kohenak, 202-965-7811
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Marcie.Kohenak@ZenoGroup.com Investor Contact:
Mike Piccinino, CFA, 443-213-0500

Published at Nasdaq GlobeNewswire

News: OrtoWay extends usage of its hydraulic OrtoWell® Distractor tool to include spinal tumor or trauma surgery

Device offers unique fixation and access for surgeons, facilitating accurate positioning of implants.

LogoSTOCKHOLM--()--OrtoWay AB, a medical technology company based in Stockholm, Sweden, says that its OrtoWell® Distractor instrument for spinal surgery can now be used by surgeons in connection with spinal tumor removal or trauma. Following tests on animals and cadavers, it was shown that the device may offer time-saving possibilities for surgeons, giving them freer access and resulting in more accurate implant positioning. The instrument fixates the vertebra in a unique way which allows safer and less complicated insertion of implants and can be used with any prosthesis.
“This new development is in line with our goal of making anterior-approach surgeries simpler and more accurate, which has the potential to enable better outcomes of such procedures”
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Approvals in US and Europe 
Already approved in Europe (CE Mark) and the US (Class 1 medical device), the OrtoWell® Distractor is a hydraulically powered system that separates and holds apart vertebral bodies in the spinal column during anterior surgery. It consists of some non-disposable parts (distractor unit, spanner unit, retractors and frame, tools) as well as disposable components (tube unit, gauge, hooks, bone screws). The use of gentle, yet powerful incremental hydraulic force to prevent the vertebrae from collapsing or moving during operations is beneficial to surgeons since it facilitates correct positioning of spinal prosthesis such as disc implants, ALIF cages and during corpectomies.
Longer space enabled
The novel technology, which is mainly intended for disc prosthesis and ALIF cages, can also be used during spinal tumor surgeries or trauma where the removal of vertebra is clinically required. This is made possible through a solution that allows for longer space when inserting hydraulic implants during such surgery.
Easier, more accurate
“The availability of this solution makes access during reconstructive process much easier and allows for more accurate positioning of such prosthesis,” says Dr. Staffan Bowald, Spine Center, Stockholm, Sweden one of the inventors of this technology.
“This new development is in line with our goal of making anterior-approach surgeries simpler and more accurate, which has the potential to enable better outcomes of such procedures,” says Stan Mikulowski, CEO of OrtoWay AB.
About OrtoWay AB
OrtoWay AB was founded in 2006 by a group of experts in biomaterials, spinal surgery and medical technology who were looking for ways to improve anterior surgery and implantation of spinal prosthesis in the lumbar region. The developer behind the OrtoWell® Distractor system is today a Swedish privately held medical technology company that is seeking partners for commercialization. The OrtoWell® instrument has CE marking for medical devices in Europe and is approved for usage as a Class 1 medical device in the USA. The product will be made available through OrtoWay LLC, an independent company based near Philadelphia, Pennsylvania, USA.
OrtoWay has received patents for this invention in Europe, the USA and in Australia.
OrtoWell® is a registered trademark in the USA, EU and Australia.
Currently OrtoWay is looking for partners to commercialize this invention.
US patent number 8,152,811, CE Marked
OrtoWell® Distractor
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Contacts

OrtoWay
Stan Mikulowski, CEO
Cell phone: +46 708 769 991
From the US; 011 708 769 991

Published at BusinessWire