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Centinel Spine Completes Acquisition of Prodisc Assets

Posted On December 22, 2017 By OrthoSpineNews In Spine, Top Stories /

NEW YORK, Dec. 22, 2017 /PRNewswire/ — Centinel Spine, LLC (CS) is pleased to announce the acquisition of the worldwide assets of the prodisc® Total Disc Replacement portfolio from DePuy Synthes Products, Inc. The prodisc line of products are total disc replacement (TDR) products with the longest history of use globally. The prodisc® portfolio includes prodisc® C and prodisc® L in the United States and prodisc® VIVO, prodisc® NOVA, prodisc® C, prodisc® L, and prodisc® O, along with DISCOVER™ Cervical outside the United States.

This acquisition complements Centinel Spine’s existing spinal implant portfolio of leading technologies for anterior column support of the spine from cervical to lumbar. This includes the company’s standalone portfolio of STALIF C®, STALIF C-Ti™, MIDLINE II™, MIDLINE II-Ti™, and STALIF L™, as well as additional products ACTILIF™ Cervical Cage TRANSOM™ Plate, and ALTOS® PCT.

Centinel Spine, the pioneer of the No-Profile®, Integrated Interbody™ has a 30 year history of developing integrated interbody devices into a standard treatment for patients with degenerated disc disease. Centinel Spine will utilize the same clinical, regulatory, and development expertise to broaden acceptance and to increase carrier coverage and surgeon adoption of total discs worldwide.

“This transaction is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading company addressing spinal disease through anterior access to the spine with the widest breadth and depth of technology platforms,” said John J. Viscogliosi, Centinel Spine Chairman & CEO.

For background in understanding the acquisition, Viscogliosi Brothers, LLC, a lead investor in Centinel Spine, was the founder of Spine Solutions, Inc., the company that led the original IDE study to bring prodisc to the United States.

The company also completed debt and equity financing to close on the transaction and provide working capital. Piper Jaffray & Co. served as the sole placement agent for Centinel Spine.

About Centinel Spine, LLC.

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No- Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi	Wendy F. DiCicco
SVP, Corporate Finance & Strategic Planning	Chief Operating and Chief Financial Officer
Centinel Spine, LLC	Centinel Spine, LLC
900 Airport Road, Suite 3B	900 Airport Road, Suite 3B
West Chester, PA 19380	West Chester, PA 19380
Phone: 484-887-8871	Phone: 484-887-8837
Email: v.gandhi@centinelspine.com	Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, Inc.

Paragon 28® launches the Gorilla® Lateral Column Plating System designed to address the cuboid and lateral column in cases of Charcot deformity

Posted On December 22, 2017 By OrthoSpineNews In Extremities, Top Stories /

ENGLEWOOD, Colo., Dec. 22, 2017 /PRNewswire/ — Since its inception, Paragon 28® has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The Gorilla® Lateral Column Plating System was developed to offer surgeons a dedicated plating system designed to aid in the stabilization, fusion and fixation of the lateral column. This construct allows for strength, stability and compression throughout the lateral column which can help address certain cases of Charcot reconstruction where plantar subluxation of the cuboid may result in ulceration. This plate and screw construct consists of a dorsal plate placed on the 4^th metatarsal, 5^th metatarsal and cuboid that can accept a 5.5 mm Type II Anodized, non-locking, solid plate screw. This screw interfaces with the plate and is intended to span from the space between the 4^th and 5^th metatarsals, through the cuboid and into the posterior aspect of the calcaneus.

The Gorilla® Lateral Column Plating System contains system specific instrumentation to help facilitate insertion of the 5.5 mm solid plate screw as well as a unique templating system. This templating system not only aids in determining the correct size and location of the plate, but more importantly aids in the creation of a reamed space in a specific location between the 4^th and 5^th metatarsals. A Joint Finding Paddle is included and is intended to center the template allowing for equal reaming of the 4^th and 5^th metatarsals to allow room for the 5.5 mm solid plate screw to be placed and achieve optimal screw trajectory.

This addition to the Gorilla® R3CON Plating System family leverages all the benefits of the Gorilla System including the ability for all of the standard plate holes to accept either 2.7 mm, 3.5 mm or 4.2 mm locking and non-locking plate screws as well as a robust assortment of foot and ankle specific instrumentation.

Paragon 28® is grateful for the significant contributions Dr. Douglas Blacklidge, DPM has made as the surgeon designer of this system.

CONTACT:
Jim Edson
Director of Product Management and Marketing
jedson@paragon28.com

SOURCE Paragon 28

Histogenics Corporation and MEDINET Co., Ltd Enter Into Licensing Agreement for Development and Commercialization of NeoCart for the Japanese Market

Posted On December 22, 2017 By OrthoSpineNews In Biologics, Top Stories /

WALTHAM, Mass., Dec. 21, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that it has entered into an agreement with MEDINET Co., Ltd. (MEDINET), a pioneering leader in the development and commercialization of cancer immuno-cell therapy technologies, for the development and commercialization of NeoCart^® for the Japanese market.

“This transformative collaboration for Histogenics is a clear validation of the value NeoCart potentially provides to the physicians and patients who suffer from painful cartilage defects and related loss of function. MEDINET is one of the leaders of the burgeoning regenerative medicine sector in Japan, with strong capabilities in development and manufacturing of cell therapy products. We believe their recent initiatives to further develop their therapeutic capabilities with the addition of innovative products such as NeoCart will provide a rapid entry into the Japanese market,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “Our ability to leverage our long clinical and translational medicine history in the U.S. in markets such as Japan was a first step in bringing NeoCart to other regions, and we look forward to expanding our global presence more broadly in 2018 into other potential territories in Asia and Europe.”

Histogenics’ formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) concluded in the second quarter of 2017 and the positive conclusion of those consultations played an integral role in enabling this collaboration. Formal feedback from the PMDA regarding the development and approval pathway for NeoCart in Japan included:

A 30-patient, one-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan in conjunction with data from Histogenics’ fully enrolled U.S. Phase 3 clinical trial.
NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and Histogenics can supply the confirmatory clinical trial from the U.S. using the current good manufacturing process (cGMP) for NeoCart.

“I am excited about the potential to bring this exciting therapy to Japanese patients and physicians through this new partnership,” stated Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School, in whose laboratory the underlying technology for NeoCart was discovered.

Japanese Cartilage Repair Market

The Japanese cartilage repair market is estimated to be the second largest market in the world after the U.S. and it is estimated that there may be at least 10,000 NeoCart treatments per year. If left untreated, cartilage defects may result in Osteoarthritis (OA) and ultimately, total knee replacements. Market forecasts predict that the number of OA patients in Japan aged 40 and older amounts to more than 25 million and is expected to accelerate as the population ages.

In the first half of 2017, Histogenics conducted market research in Japan with approximately 80 leading surgeons with the findings summarized below:

Approximately 60% of patients with knee cartilage defects are either not treated, or treated solely for temporary pain relief.
Approximately 60-70% of patients with knee cartilage defects that are left untreated will likely progress to OA in the knee.
Cartilage defects are believed to have caused OA in 15-20% of patients suffering from knee OA.
More than 85% of orthopedic surgeons are not satisfied with the current options to treat knee cartilage defects.
Approximately 80% of orthopedic surgeons consider early improvement in pain and function to be important and more than half of the surgeons feel they would prescribe NeoCart based on published data.

“This licensing deal has been realized based on our longtime close relationship with Histogenics. I am excited about and proud of, the big challenge to enter into the regenerative medical product market with NeoCart in collaboration with the excellent team of Histogenics,” stated Yoshiji Kimura, Chief Executive Officer of MEDINET. “We believe this restorative cell therapy will contribute to better treatment by the physicians and quality life, of the patients with knee cartilage defects in Japan.”

Locust Walk served as transaction advisor to Histogenics.

Conference Call and Webcast Information

Histogenics’ management will host a conference call on Thursday, December 21, 2017 at 9:00 a.m. ET. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial 877-930-8064 (domestic) or 253-336-8040 (international) and provide the conference ID: 5982636 five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the “Investor Relations” page of the Histogenics website, www.histogenics.com, or by clicking here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

About MEDINET Co., Ltd.

MEDINET is a pioneering leader in the development and commercialization of cancer immuno-cell therapies. MEDINET is also rigorously preparing to enter into the regenerative medical product market to leverage its long clinical and translational medicine history responding to the expected aging of the population. MEDINET went public in October, 2003 on the MOTHERS, Tokyo Stock Exchange. For more information, visit http://www.medinet-inc.co.jp/english/.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Medical device maker says savings from new tax law to fuel innovation and growth

Posted On December 21, 2017 By OrthoSpineNews In Regulatory, Spine /

By DBJ Staff/Dec 21, 2017

Medical device maker NuVasive Inc. says savings from President Donald Trump‘s new tax reform will help it to fuel innovation and growth in its business, which could be a boon to local operations that are already experiencing growth.

San Diego-based NuVasive (NASDAQ: NUVA) announced today the potential implications to its business based on the recent passage by Republicans in the U.S. Congress and soon-to-occur signing by President Trump of the tax bill. The new bill will reduce the U.S. corporate tax rate from 35 percent to approximately 21 percent. This is the largest tax overhaul in 30 years and will significantly reduce the future corporate tax rate for NuVasive, which prior to the enactment of the tax overhaul was expected to be approximately 33 percent on a non-GAAP basis in 2018, the company said.

While the Company will be undertaking a thorough analysis over the coming weeks, early analysis indicates that the NuVasive non-GAAP tax rate will drop into the low 20 percent range in 2018 and in future periods converge to a 20 percent non-GAAP tax rate.

“The savings from this landmark decision are expected to boost forward-looking free cash flow and non-GAAP EPS well in excess of 10 percent per year beginning in 2018, delivering incredible incremental value-generating opportunities for our shareholders,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Innovation requires fuel, and this surplus can support increased investments in R&D to provide solutions that empower spine surgeons to change the lives of their patients. This is a tremendous opportunity for the medical device industry, and a major spark in our ability to continue to invest in life-changing innovations.”

READ THE REST HERE

FH Orthopedics announces more than 6,000 spinal disc prostheses sold

Posted On December 21, 2017 By OrthoSpineNews In Spine /

(PR NewsChannel) / December 20, 2017 / HEIMSBRUNN, France

FH Orthopedics is proud to announce that sales of its Cervical Prosthesis (CP-ESP®) and Lumbar Prosthesis (LP-ESP®) has exceeded 6,000 units. Designed to replace damaged discs in the cervical (neck) or lumbar (lower back) regions of the spine, CP-ESP and LP-ESP prostheses mimics the function and range of movement of a natural disc and allows the spine to behave naturally.

Widespread interest in both of the ESP disc prosthesis, and their swift acceptance by orthopedic and neuro surgeons and their patients, highlights the strong desire for products that can restore quality of health and life. “Most patients for disc replacement surgery are up to forty or fifty years old and wish to maintain their mobility,” says Dr. Biren Desai, a specialist in orthopedic general and trauma surgery. “This type of surgery has been standardized now for many years and is performed quite routinely.”

ESP discs combine two titanium end plates with an elastomeric cushion made of polycarbonate urethane. This structure imitates the natural disc, in which bony segments are connected by a spongy disc that provides flexibility while withstanding the pressures of compression and torsion. Specific features of the end plates — short spikes, a rough outer surface, and a coating of hydroxyapatite (HA), which is proven to enhance bone ingrowth — help to ensure stability and bony fixation of the implant over time.

This design provides a number of benefits for orthopedic surgeons and their patients:

Adaptive center of rotation
Shock absorbing
Improved stability
No surface bearing for increased lifetime
Designed to fit and restore patient lordosis (spinal curvature)
Range of sizes to fit different patients
Minimally invasive surgical technique and shorter hospital stay

The CP-ESP prosthesis — indicated for use in cases of symptomatic cervical discopathy that have not responded to other medical treatments for at least six months — offers 7 degrees of flexion/extension, 5 degrees of lateral flexion, and 4.5 degrees of axial rotation.

The LP-ESP prosthesis — indicated for use in cases of lumbar disc disease, typically related to disc herniation, that have not responded satisfactorily to other treatments — offers 6 degrees of flexion/extension, lateral flexion, and axial rotation.

The quality and efficacy of ESP spinal implants, which has been demonstrated through years of clinical results, is frequently echoed in the sentiments of physicians who have used these implants with their own patients.

“The LP-ESP prosthesis has the advantage, compared to other prostheses, that it is similar to a natural disc,” says Andreas Schmitz, a specialist in neurosurgery. “The prosthesis mimics the natural disc. It absorbs the pressure from above and maintains mobility. It is made of two titanium plates covered with titanium porous coating which improves bone ingrowth. After three weeks, the prosthesis is tightly fixed to the spine.”

Schmitz goes on to say, “The LP-ESP prosthetic discs made by FH Orthopedics allow patients to rapidly return to work and to their daily activities.”

———————————————

For more than 50 years, FH Orthopedics S.A.S. has demonstrated passionate dedication to creating innovative implants, evaluating them, and following them clinically. The company promotes original products and techniques designed in collaboration with expert surgeons, distributes products worldwide from its ISO 9001/13485-certified distribution site, and provides unparalleled service that guarantees the confidence and loyalty of healthcare facilities.

FH Orthopedics is part of GROUP FH ORTHO, which designs, manufactures, and distributes high-quality orthopedic implants and instruments in France and further afield. Operating two companies in France and three subsidiaries in the UK, US, and Poland, GROUP FH ORTHO and its partners work together to offer services and products that guarantee the health and safety of its end customer: the patient.

———————————————

For more information, contact:

Eric Hermann
Spine Business Unit Director
FH Orthopedics
e.hermann@fhorthopedics.com
+33 6 14 28 82 30
contact@esp-disc.com

Direct link: https://www.prnewschannel.com/2017/12/20/fh-orthopedics-announces-more-than-6000-spinal-disc-prostheses-sold/SOURCE: FH Orthopedics S.A.S.

This press release is distributed by PR NewsChannel. Your News. Everywhere.

Fuse Medical, Inc. Signs Definitive Purchase Agreement to Acquire CPM Medical Consultants, LLC

Posted On December 21, 2017 By OrthoSpineNews In Biologics, Extremities, Recon, Spine /

December 19, 2017

RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc., (OTC: FZMD), (“Fuse” or the “Company”), announced today that it signed a definitive purchase agreement to acquire CPM Medical Consultants, LLC (“CPM”), a privately-owned nationwide distributor of medical device implants and biologics.

CPM is a stocking distributor with an extensive portfolio of orthopedic implants for total joint reconstruction, sports medicine, internal and external fixation products for extremities, and full spinal implants and instrumentation. CPM also offers an extensive assortment of biologics, which include human allograft with cell based products, regenerative tissue, and amniotic fluids to augment all types of surgical procedures.

Fuse expects the transaction to be accretive to 2018, and it anticipates the 2018 consolidated company revenues generated from its product sales and distribution to be at approximately $35 million. The transaction is subject to customary conditions of closing, which is expected to occur by December 31, 2017. Following the transaction, CPM will be a wholly-owned subsidiary of Fuse.

Management Commentary on Acquisition

Christopher C. Reeg, Chief Executive Officer of Fuse, said, “We are thrilled to have the CPM family join the Fuse team, and look forward to welcoming new business associates to Fuse. We are confident that the consolidated Fuse and CPM organizations will provide the necessary platform to achieve our numerous growth and expansion goals.”

“The acquisition of CPM is an ideal complement to our strategic objectives as it brings an experienced and proven distribution organization consisting of direct sales employees, independent sales agents, and sub-distributors who are focused in specific surgical areas. In developing our strategies in this market sector, we believe this new sales channel will provide us with an opportune pipeline for the expansion of national distribution and the launch of new product offerings, both internally developed and acquired,” added Mr. Reeg.

Mark W. Brooks, CPM Founder and Owner, stated, “We are excited with the expected benefits both organizations will gain from this transaction. CPM brings the ideal combination of broad product assortment, sales and distribution, and employee talents in a strategic market sector with outstanding growth potential. We expect our extensive product portfolio to strengthen and complement Fuse.”

“The prospect of combining the collective Fuse and CPM product portfolios is synergistic to both organizations,” commented Mr. Brooks.

About Fuse Medical, Inc.

Fuse provides a broad portfolio of orthopedic implants including internal and external fixation products; upper and lower extremity plating; total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; full spinal implants for trauma, degenerative disc disease, and deformity indications; human allografts, substitute bone materials, and tendons; and regenerative tissues and fluids to augment orthopedic surgeries and wound care. For more information about Fuse, please visit: www.fusemedical.com.

Forward-Looking Statements

Certain statements in this press release, including those related to an anticipated purchase of all of the outstanding membership units and plans for the consolidated company, constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based only on information available to the Company as of the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the Securities and Exchange Commission; the failure of the Company to close the transaction; and integration issues with the consolidated company. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events, or otherwise, except as required by law.

Contacts

Fuse Medical, Inc.
Devon Peddie, 469-862-3030
Investor Relations Analyst
Facsimile 469-862-3035
info@Fusemedical.com

K2M Introduces World’s First 3D-Printed Expandable Corpectomy Cage with Cervical Spine Indications Following CE Mark of CAPRI® Cervical 3D Expandable Featuring Lamellar 3D Titanium Technology™

Posted On December 21, 2017 By OrthoSpineNews In Spine, Top Stories /

LEESBURG, Va., Dec. 20, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc.(NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced that it received a CE Mark for its CAPRI^® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case. CAPRI Cervical 3D Expandable is the world’s first and only 3D-printed expandable device on the market to facilitate continuous in-situ height expansion and endplate angulation in the cervical spine. K2M was the first leading spine company to introduce a 3D-printed spinal implant and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.

The CAPRI Cervical 3D Expandable Cage System* stabilizes the cervical spine in cases of vertebral body resections resulting from trauma or tumor. Offered in various footprint options, its continuous in-situ adjustment capabilities allow surgeons to lock the cage with set screws at desired heights and lordotic angles within the expansion range of the implant. The system also allows for fixed endplate angulation of 0°, 5°, and 10° to accommodate surgeon preference and vertebral anatomy.

“Never before has a cervical corpectomy cage combined the capabilities of 3D printing with the functionality of continuous in-situ height and lordotic adjustment,” said Lars Valentin, MD, of Rigshospitalet in Denmark. “Using the CAPRI Cervical 3D Expandable Corpectomy Cage,” explained Martin Gehrchen, MD, PhD, chief of spine surgery at Rigshospitalet in Denmark, “we were able to dial in a precise height and lordotic angle in-situ while also utilizing a 3D-printed device designed to allow for bony integration.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CAPRI Cervical 3D Expandable Corpectomy Cages are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the cage.

K2M Chairman, President, and CEO Eric Major said, “We are pleased to receive a CE Mark for our CAPRI Cervical 3D Expandable Cage System*, which reinforces our commitment to excellence in 3D-printed spinal innovation and the further integration of expandable technologies across our comprehensive complex spine, minimally invasive, and degenerative product portfolios. We look forward to further strengthening our market-leading portfolio of 3D-printed spinal devices that, when supported by our comprehensive Balance ACS platform, help surgeons facilitate three-dimensional spinal balance in their patients.”

Balance ACS^® or (BACS^®) is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions to help surgeons achieve balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information on the CAPRI Cervical 3D Expandable Corpectomy Cage System* and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

*This product is intended for export and is not sold or offered for sale in the United States.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

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 such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “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 in the future; our ability to demonstrate to spine surgeons the merits of our products and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; 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 and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; 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 and our Quarterly Report filed with the SEC on August 2, 2017, 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. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

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Life Spine Announces Initial Cases and Multiple Surgeries with the SIMPACT™ Tri-Fin Sacroiliac Joint Fusion System

Posted On December 20, 2017 By OrthoSpineNews In Spine /

December 20, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today the initial cases and multiple surgeries performed with SIMPACT Tri-Fin Sacroiliac Joint Fusion System.

“My first surgery with SIMPACT Tri-Fin was seamless and incredibly simple. The procedure was complete in less than twenty minutes, the patient lost almost no blood and there was no bruising,” said Dr. Ali Mesiwala of the Southern California Center for Neuroscience and Spine. “The system is unique in that the screw is aggressive enough to self-drill and tap, reducing or eliminating the need for multiple steps, and allows you to reduce Sacroiliac Joint Diastasis. Additionally, the anti-rotational sleeve protects against back-out and the fenestrations and cannulation of the screw self-harvest bone as it is implanted. Separately, these features are excellent, but combined, they allow for a procedure that is safe, effective and reproducible.”

SIMPACT Tri-Fin, which features OSSEO-LOC™ surface technology, launched November of 2017 and joins Life Spine’s broad portfolio of full procedural solutions.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Physicians, patients should be aware of benefits, risks associated with biologic treatments for osteoarthritis according to new AAOS position statement

Posted On December 20, 2017 By OrthoSpineNews In Biologics /

ROSEMONT, Ill., Dec. 20, 2017 /PRNewswire-USNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved a new “Use of Emerging Biologic Therapies” position statement urging orthopaedic surgeons and patients to be fully aware of the risks and benefits of stem cell and other biologic treatments for musculoskeletal joint conditions.

The development and use of biologics has expanded within orthopaedics over the past decade with some products reaching the market without extensive research or data. Biologics are treatments isolated or derived from natural sources—human or animal stem cells or tissues, or other microorganisms—through innovative technologies. Common biologic treatments include the injection of platelet rich plasma, a patient’s or donor’s blood heavily concentrated with platelets, into an osteoarthritis infected joint. Biologics also are used to repair damaged cartilage. Through a process called autologous chondrocyte implantation, healthy cartilage cells are removed from a patient, altered in a lab, and then implanted into a patient’s damaged cartilage to help spur regrowth.

“While gaining in popularity, and providing relief for some patients, biologic treatments may lack the demonstrated safety and efficacy of many traditional orthopaedic therapeutics,” said J. Tracy Watson, MD, chair of the AAOS Biologics Committee. “The Academy wants to make sure that doctors and patients are making informed treatment decisions, based on the most current research and product indications.”

The AAOS “believes that surgeons should be cognizant of the risks, benefits, regulatory status and labeled indications of the products they use,” according to the new statement. Two additional Academy guidelines are reference in the new statement: Orthopaedic Surgical Consent and Standards of Professionalism (LINK), which reinforces the role of the orthopaedic surgeons in fully informing patients of the risks and benefits of various treatments, including biologics, and securing patient consent before moving forward with a particular modality.

Finally, the new statement recommends that orthopaedic surgeons and their affiliated hospitals and clinics/organizations participate in orthopaedic registries and other data collection systems to provide much-needed data on the efficacy of biologic treatments.

More Information about the AAOS
With more than 38,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS, at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Facebook.org/AAOS1
Twitter.com/AAOS1
Instagram.com/AAOS_1

SOURCE American Academy of Orthopaedic Surgeons

LivaNova Names ECA Medical Instruments 2017 Supplier of the Year Award Winner

Posted On December 20, 2017 By OrthoSpineNews In Spine, Top Stories /

December 20, 2018

Thousand Oaks, CA. — ECA Medical Instruments, the leading global designer and manufacturer of single-procedure torque-limiting instruments and procedural kits for the medical industry, was named LivaNova 2017 Supplier of the Year Award winner. ECA was one of just 3 strategic partner firms out of 300 LivaNova suppliers worldwide to win the prestigious award.

“We have the pleasure to recognize ECA Medical Instruments as the LivaNova 2017 Supplier of the Year,” said Pascal Chaussepied, Purchasing Director, CRM and Neuro. “This award honors ECA’s overall performance in areas including quality, logistics, cost and customer service and support. Supplier performance is fundamental to LivaNova’s success to remain competitive within the challenging CRM market and global environment. We congratulate the ECA team and its management for the continuous outstanding level of performance,” he said.

ECA designs and manufactures a variety of precision single-use torque-limiting instruments used by surgeons to secure delicate electrodes and leads that connect LivaNova pacemakers and defibrillators to the heart. ECA’s instruments also secure electrodes to LivaNova’s Vagus Nerve neuromodulation devices used to treat people affected by treatment-resistant epilepsy, depression, heart failure and other disorders. ECA’s instruments are single-use meaning a pristine instrument is used for each mission critical implant and for each patient.

“This is a tremendous honor for ECA and our global team of medical device employees, who are dedicated to providing LivaNova with pristine single-procedure instrumentation. ECA has been successfully supporting LivaNova across multiple life sustaining product lines for many years,” said Lane Hale, President and CEO of ECA Medical Instruments.

“Winning the LivaNova 2017 Supplier of the Year Award underscores our commitment to providing single-procedure instrumentation that offers clinical and economic value. We are always striving with our customers and partners to jointly improve the quality of people’s lives—one instrument, one patient at a time,” he said.

Single-procedure torque-limiting instruments and procedural kits provide surgeons and patients alike with a pristine set of surgery ready instruments for addressing a wide range of procedures. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection, and reduction in hospital and outpatient surgery center inventory management.

ECA is a one-stop shop OEM instrument company providing medical device implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments
ECA Medical Instruments®, headquartered in Thousand Oaks, CA., is the industry leader in designing and manufacturing precision single-procedure torque-limiting instruments and surgical fixation kits. Founded in 1979, the company has delivered over 35 million torque limiting instruments and procedural kits to the world’s leading cardio, neuromodulation, orthopaedic and spine implant companies. Every 15 seconds of every day an ECA torque
instrument or procedural kit is used to secure a medical implant—One Instrument, One Patient at a Time™. ECA, a LongueVue Capital Partners company, is an ISO 13485, CE Mark certified and FDA registered firm and was named Business of the Year 2017 by LivaNova and earned the LivaNova 2017 Supplier Excellence Award. www.ecamedical.com

About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more
than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively. For more information, please visit www.livanova.com.

Media Contact: James Schultz, EVP Sales & Marketing Phone: +1 805-990-6177 Email: jschultz@ecamedical.com

Author: OrthoSpineNews

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