Trice Medical Achieves CE Mark and Health Canada Approval for Mi-Eye 2™, Performs First Cases in Toronto and the UK

U.S. based, Trice Medical, announced today the completion of its first successful case performed in the United Kingdom, after receiving CE (Conformité Européenne) Mark of approval in Europe for the mi-eye 2™, as well as entry into Health Canada.

Today’s case was performed by Mr. Tony Andrade, a Consultant Orthopaedic Surgeon at Circle Reading Hospital. “This is a fantastic opportunity to be able to show patients what’s going on inside their joints and talk them through it live as you see the pathology. This is something that’s been needed for a long time to aid patient’s understanding of their condition. It’s useful not just for diagnostic purposes, but it allows for the delivery of injections into the appropriate targeted area.” said Mr. Andrade.

The early success of Trice Medical’s mi-eye 2, which was launched in the U.S. in 2017, has captured the attention of medical professionals who are embracing the technology as a new diagnostic modality. After the first year of commercial launch, the mi-eye is currently being used by over 200 institutions across the states. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries right in their clinic, and provide their patients with immediate answers to the cause of their pain.

“Truly disruptive technology always provides value by enhancing care and lowering cost. This approach to diagnosis is such a proposition.” Stated Jon J.P. Warner, MD. Chief, MGH Shoulder Service and Professor of Orthopaedic Surgery at Harvard Medical School, regarding the mi-eye 2 technology.

“Trice is proud and excited to be commercializing the mi-eye 2 into Europe and Canada. MRI and Ultrasound will always be good options for patients with sports injuries. We are thrilled to add disposable in-clinic arthroscopy to the list of available tools physicians have to be able to assess joint injuries. In many countries, the mi-eye 2 has a chance to save weeks to months of the treatment pathway to surgery AND provide a dynamic image of the joint. The is truly an example of innovation in the new world of value-based medicine,” said Mark Foster, Chief Commercialization Officer and VP of Worldwide Sales at Trice Medical.

Additionally, Dr. Anthony Miniaci of the Cleveland Clinic Canada has completed the first cases performed by a surgeon in Toronto, ON. The advent of this technology in the Canadian market has the potential to provide patients with a dramatic amount of time saved in their overall continuum of care per injury.

Today’s patient had this to say about her experience, “I had an operation back in December but was still having some knee problems. I didn’t want to go through another general anesthetic operation so Mr. Andrade recommended the mi-eye procedure would be a good option…The experience overall was fantastic, and I didn’t feel any pulling, tugging or pressure. Mr. Andrade has now identified what we need to do next for my treatment. I would definitely recommend it to others.”

About the mi-eye 2™:

Trice Medical’s mi-eye 2, is a handheld, single-use, and disposable direct visualization tool. The mi-eye 2 was specifically designed for use in the clinic setting, consisting of a single stick percutaneous, and self-blunting design which deploys an integrated camera and a light source. The procedure is performed with local anesthetic and provides patients with an alternative to traditional diagnostic modalities, such as time-consuming and often inaccurate MRIs. The mi-eye is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. mi-eye 2 is available for prescription use only.

About Trice Medical:

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, and the physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2, that provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

Contact Trice Medical:

+1 (610) 989-8080

Source: Trice Medical

Histogenics Corporation Announces Financial and Operating Results for the Fourth Quarter and Year Ended December 31, 2017

WALTHAM, Mass., March 15, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, announced its financial and operational results for the quarter and year ended December 31, 2017.

“We achieved multiple, significant milestones in our global development strategy for NeoCart in 2017, providing a strong foundation for additional value creation in 2018. With the completion of enrollment in the NeoCart Phase 3 clinical trial in the first half of 2017, we are on track to report top-line data from this trial and potentially submit a Biologics License Application for this novel restorative cell therapy in the third quarter of 2018. In parallel we are initiating pre-commercialization activities for the U.S. market in advance of a potential launch of NeoCart in fourth quarter of 2019, and we continue to hear positive anecdotal feedback from our investigators regarding NeoCart patients,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “We also made significant progress on the international expansion of the NeoCart platform by completing formal discussions with the Japan Pharmaceuticals and Medical Devices Agency on the development and regulatory pathway for NeoCart in Japan.  Our robust historical data packages and the PMDA conclusions were instrumental in our ability to complete the licensing agreement with MEDINET for the rights to develop and commercialize NeoCart in Japan.”

2017 and Recent Milestones

NeoCart Clinical, Regulatory and Commercialization

  • Completed enrollment for NeoCart Phase 3 clinical trial: In June 2017, Histogenics enrolled the final patient for its 249-patient Phase 3 randomized, controlled clinical trial conducted against the current standard of care, microfracture. The trial is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration (the FDA).
  • Executed licensing agreement for the development and commercialization of NeoCart in Japan with MEDINET Co., Ltd. (MEDINET): In December 2017, Histogenics entered into an agreement with 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.  The agreement included a $10 million up-front payment, potential total payments of up to $87 million in total milestones and tiered royalties on sales. MEDINET intends to initiate NeoCart clinical development in Japan in the second half of 2018, and may enter the Japanese market in 2021, if approved.
  • Completed formal discussions with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) to establish the development/regulatory pathway for NeoCart in Japan: Histogenics successfully concluded formal discussions with the PMDA in the second quarter of 2017. Feedback from the PMDA was positive and included the determination that a 30-patient, one-year confirmatory clinical trial with 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. Additionally, the PMDA agreed that NeoCart would be regulated as a Regenerative Medicine Product, as covered by the recently enacted laws in Japan, and that Histogenics may supply the confirmatory clinical trial from the U.S. using the current good manufacturing processes (cGMP) for NeoCart.
  • Confirmed significant unmet need in cartilage repair through U.S. and Japan NeoCart market research: Histogenics conducted primary market research in the U.S. and Japan with approximately 200 orthopedic and sports medicine surgeons across both markets. The findings provide support for Histogenics’ assumptions regarding the size of each market, the lack of satisfactory solutions, and confirm the need for a novel cartilage repair therapy. Surgeons noted a strong desire for a safe and effective alternative to microfracture that may potentially offer patients a more rapid recovery from pain and return to function as well as a durable treatment response.

NeoCart Data Publications and Presentations

  • Generated additional peer-reviewed data that may support the upcoming NeoCart regulatory submissions and highlight the potential of Histogenics’ RCT platform: The published results included analyses of the compressive properties of engineered cartilage tissue grown with chondrocytes seeded in a porous scaffold in a study titled “In Vitro Culture Increases Mechanical Stability of Human Tissue Engineered Cartilage Constructs by Prevention of Microscale Scaffold Buckling,” which appeared in the peer-reviewed Journal of Biomechanics. In addition, a study appearing in the Journal of Orthopaedic Research entitled “Mechanical Properties and Structure-Function Relationships of Human Chondrocyte-Seeded Cartilage Constructs After In Vitro Culture” evaluated 3-D bioprinting of collagen and chondrocytes. These studies may support both process optimization and a potential Biologics License Application (BLA) filing for NeoCart, as well as the future development of additional product candidates based on the RCT technology platform.
  • Podium and poster presentations at Orthopedic Research Society (ORS) Annual Meeting:  Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital (BWH), and Harvard Medical School, delivered a podium presentation on NeoCart and Histogenics’ RCT technology platform at the ORS Annual Meeting on March 10, 2018.  In addition, three additional poster presentations on NeoCart were presented during the meeting.  Data presented on these posters are available here.


  • Enhanced executive team ahead of potential approval and commercialization of NeoCart:In October 2017, Histogenics promoted Stephen Kennedy from Chief Technology Officer to Executive Vice President & Chief Operating Officer. In June 2017, Donald Haut was appointed Chief Business Officer. Both individuals possess strong professional experience that will be instrumental as Histogenics prepares for potential NeoCart commercial manufacturing and launch.
  • Completed registered direct financing: In January 2018, Histogenics raised net proceeds of $5.9 million dollars from a registered direct offering of its common stock. The proceeds from the offering provided an important source of additional funding and flexibility in advance of a potential NeoCart BLA filing.

2018 Corporate Objectives

  • Report NeoCart top-line Phase 3 data and submit BLA: Assuming positive results from the report of top-line superiority data from the NeoCart Phase 3 clinical trial in the third quarter of 2018, Histogenics remains positioned to submit a BLA with the FDA thereafter in the third quarter of 2018.
  • Continue advancement of NeoCart U.S. commercialization strategy: In advance of potential FDA approval of NeoCart, Histogenics intends to continue to prepare for a potential NeoCart launch in the U.S., including the assembly of a leading Clinical Advisory Board, the further development of marketing and reimbursement strategies and the initial development of sales and medical science liaison territories.
  • Leverage collaborations to generate and publish additional data to support BLA and foreign regulatory filings and potential U.S. commercialization of NeoCart: Histogenics expects to continue to generate data from its collaborations with BWH, Cornell University (Cornell) and Intrexon Corporation (Intrexon).  Anticipated presentations and publications in 2018 include additional biomechanical and three-dimensional printing data from the collaboration with Cornell, the use of chondrocytes to develop new products to treat additional soft-tissue and musculoskeletal-related disorders from the collaboration with BWH and proof-of-concept data from studies combining Intrexon’s induced Pluripotent Stem Cell (iPSC) technology and Histogenics’ NeoCart platform to manufacture next generation, NeoCart restorative cell therapies using iPSC-derived chondrocytes.
  • Secure additional manufacturing capacity: Subject to positive top-line data from the NeoCart Phase 3 clinical trial, Histogenics intends to initiate the design and buildout of additional space to support expected increased commercial manufacturing requirements in future years following the initial launch of NeoCart.
  • Support MEDINETS’ Japan clinical trial and regulatory activities: Histogenics is working closely with MEDINET on the development of NeoCart for the Japanese market. Specifically, the companies intend to work on the preparation of a clinical trial notification to support the planned NeoCart Phase 3 clinical trial in Japan in the second half of 2018. In addition, Histogenics intends to continue to explore additional licensing opportunities for NeoCart outside of North America.

Financial Results for the Year Ended December 31, 2017

Histogenics’ loss from operations was $(25.0) million for the year ended December 31, 2017, compared to $(30.3) million for the year ended December 31, 2016. The decrease in operating loss was driven by a reduction in research and development expenses and partially offset by an increase in general and administrative expenses.

Research and development expenses were $15.6 million for the year ended December 31, 2017, compared to $21.6 million for the year ended December 31, 2016. The decrease was primarily due to decreases in collaboration, consulting and temporary labor expenses, clinical trial-related costs, personnel-related expenses and repairs and maintenance costs concurrent with the wind up of enrollment in our NeoCart Phase 3 clinical trial. General and administrative expenses were $9.4 million for the year ended December 31, 2017, compared to $8.5 million for the year ended December 31, 2016. The increase was primarily due to increased activities related to potential commercialization of NeoCart and was driven by increases in personnel-related costs, professional fees and facility-related and stock-based compensation expenses.

Basic net loss attributable to common stockholders was $(22.5) million for the year ended December 31, 2017, or $(0.99) per share, compared to $(13.9) million, or $(0.97) per share, for the year ended December 31, 2016. The increase in basic net loss attributable to common stockholders is attributable to the conversion into common stock in 2017 of a significant portion of the convertible preferred stock issued in connection with the 2016 private placement and changes in the fair value of the warrants issued in connection with the 2016 private placement, both of which were offset by a reduction in operating expenses in 2017 relative to 2016. Diluted net loss attributable to common stockholders was $(22.5) million for the year ended December 31, 2017, or $(0.99) per share, compared to $(31.4) million, or $(2.18) per share, for the year ended December 31, 2016. The difference in diluted net loss per share is primarily due to a reduction in operating expenses.

At December 31, 2017, Histogenics had cash, cash equivalents and marketable securities of $8.0 million, compared to $31.9 million at December 31, 2016. Cash at December 31, 2017 excludes approximately $9.0 million net of expenses received in January 2018 in connection with the licensing agreement entered into with MEDINET in December 2017 and $5.9 in net proceeds from the registered direct offering completed in January 2018.

Histogenics expects total operating expenses of between $29 million and $31 million for the year ending December 31, 2018 and believes its current cash position will be sufficient to fund its operations into the fourth quarter of 2018.

Conference Call and Webcast Information

Histogenics management will host a conference call on Thursday, March 15, 2018 at 8:30 a.m. EDT.  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 “7394538” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of the Histogenics website, please click 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

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; MEDINET’s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; the scope, progress, timing, 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 SEC and available on the SEC’s website at Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017, to be filed with the SEC in the first quarter of 2018.  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.

(in thousands, except share and per share data)

Three Months Ended
December 31,
Year Ended
December 31,
2017 2016 2017 2016
Revenue $   ‒ $   ‒ $   ‒ $   ‒
Operating expenses:
Research and development   3,366   5,317   15,566   21,577
General and administrative   2,667   2,389    9,384    8,530
Impairment of intangible asset    ‒    200    –    200
Total operating expenses   6,033   7,906   24,950   30,307
Loss from operations   (6,033 )   (7,906 )   (24,950 )   (30,307 )
Other income (expense):
Interest income (expense), net   20   (5 )    134    (60 )
Other income (expense), net    25    50    (116 )    (248 )
Warrant expense   –    (44 )   –    (3,100 )
Change in fair value of warrant liability    (808 )   16,968    (1,482 )   17,507
Total other income (expense), net    (763 )   16,969    (1,464 )   14,099
Net Income (loss) $   (6,796 ) $   9,063 $    (26,414 ) $   (16,208 )
Net Income (loss) attributable to common stockholders
Basic: $   (6,129 ) $   5,844 $    (22,499 ) $    (13,863 )
Diluted: $    (6,129 ) $    (11,125 ) $    (22,499 ) $    (31,370 )
Net Income (loss) per common share:
Basic: $   (0.26 ) $    0.34 $   (0.99 ) $   (0.97 )
Diluted: $   (0.26 ) $    (0.63 ) $   (0.99 ) $   (2.18 )
Weighted-average shares used to compute earnings (loss) per common share:
Basic:   24,005,598   17,143,121   22,669,819   14,256,954
Diluted:   24,005,598   17,508,120   22,669,819   14,389,192

(in thousands, except share and per share data)

  December 31,   December 31,
  2017   2016
Cash, cash equivalents and marketable securities $     7,981 $   31,908
Prepaid expenses and other current assets     194     173
Property and equipment, net   2,723   3,860
Other assets, net     137     137
  Total assets $   11,035 $   36,078
Current liabilities $     3,805 $     5,171
Warrant and other non-current liabilities   18,498   17,340
Total stockholders’ equity (deficit)   (11,268 )   13,567
  Total liabilities and stockholders’ equity (deficit) $   11,035 $   36,078


Green Sun Medical Wins SXSW Pediatric Device Competition Held in Austin, Texas

Fort Collins, CO, March 14, 2018 (GLOBE NEWSWIRE) — On March 13, 2018, medical device company Green Sun Medical won first place at the South by Southwest (SXSW) Impact Pediatric Health Pitch Competition in Austin, Texas.

Green Sun Medical is developing a dynamic scoliosis brace that applies continuous corrective pressure to the spine and allows physicians to monitor remotely the performance of the brace. Current treatments for scoliosis include spinal fusion surgeries, and braces developed over 40 years ago.  The company has raised over $2.5 million in equity and awards.

The competition was part of the annual conference to foster innovation that will advance pediatric healthcare and address the unmet surgical and medical device needs for children. The Impact Pediatric Health competition judges were from eight leading children’s hospitals including Boston, LA, Seattle, Atlanta, Cincinnati, Stanford, Philadelphia and Texas.

During the competition, ten finalists had three minutes to present their proposal to the judging panel, followed by a seven-minute question and answer session. This competition was created to foster innovation in the pediatric device sector.  The pediatric device sector continues to lag behind adult device development and creates a host of challenges for doctors when treating children.

“We are honored to have our dynamic scoliosis brace recognized by executives from these leading children’s hospitals,” said Jamie Haggard, CEO of Green Sun Medical. “These hospitals have opened up expansion potential after we complete a pilot study with the dynamic scoliosis brace.” The study will begin this spring at the National Scoliosis Center.

The award has culminated an impressive 18 month run of winning awards including the 2017 pediatric device competition sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children’s National Health System.  In October of 2016, 3000 medtech executives selected Green Sun Medical as the grand champion for best innovation at the Medtech Innovator Competition.  The company was also awarded a two-year grant to establish a residence at the Johnson & Johnson JLABS in South San Francisco.

Green Sun Medical is a graduate client company of Innosphere, Colorado’s leading technology incubator accelerating the success of high-impact science, engineering and technology startup and scaleup companies.

Green Sun Medical also completed its $2M Series-A round for development of its dynamic scoliosis brace with a $500k investment from the AngelMD Catalyst Fund.

To learn more about Green Sun Medical visit

About Green Sun Medical:
Green Sun Medical has a team of the world’s finest scoliosis thought leaders dedicated to transforming the treatment of Adolescent Idiopathic Scoliosis. They are developing a comfortable, dynamic brace that applies continuous corrective pressure and allows the physicians to track the performance of the brace in real time.


A photo accompanying this announcement is available at

A photo accompanying this announcement is available at

Jamie Haggard
Green Sun Medical 

Orthofix Announces Agreement to Acquire Spinal Kinetics

March 15, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced that it has entered into a definitive agreement to acquire Spinal Kinetics Inc., a privately held developer and manufacturer of artificial cervical and lumbar discs. Terms of the agreement include $45 million in cash closing consideration plus up to $60 million in contingent milestone payments related to U.S. Food and Drug Administration approval of the M6-C cervical disc and the achievement of trailing twelve-month sales targets of $30 million and $50 million.

“The Spinal Kinetics M6 artificial discs will further strengthen Orthofix’s product portfolio by filling a strategic gap in our Spine Fixation product line. This technology is a significant advancement in mimicking the natural motion of the spine, which we believe will be very beneficial to patients and well received by our surgeon customers,” said Orthofix President and Chief Executive Officer, Brad Mason. “This acquisition is very well aligned with our value creation strategy of accelerating topline growth by investing in faster growing market segments in our core businesses. In addition, we expect this news will energize our sales force and be attractive to potential new sales talent.”

Spinal Kinetics manufactures and distributes the M6-C cervical and M6-L lumbar artificial discs for patients suffering from degenerative disc disease (DDD) of the spine. These unique discs are designed to mimic the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus. This allows for six degrees of motion, similar to a natural disc.

“Artificial disc replacement is increasingly being indicated as the superior surgical solution to the traditional spinal fusion because it maintains normal motion of the spine and in many cases lessens the chance of future surgery. However, the designs of the first-generation artificial discs, much like total hip replacement, were based on the ball-and-socket concept which does not take into account the natural compression of the native disc,” said Dr. Richard D. Guyer, orthopedic spine surgeon and Chairman of the Texas Back Institute Research Foundation in Dallas and an investigator in the “Restore” U.S. clinical trial sponsored by Spinal Kinetics. “The M6 disc is designed out of materials to mimic the biomechanics of a normal disc including axial compression, flexion-extension, lateral bending, translation and axial rotation in order to provide patients with a more natural range of motion.”

The M6 artificial discs currently have CE Mark approval for distribution in the European Union and other international geographies. They are not available for commercial distribution in the U.S. Spinal Kinetics has submitted a PMA to the U.S. Food and Drug Administration in order to gain U.S. market approval for the M6-C cervical disc to treat single level cervical DDD. Internationally, there have been more than 54,000 implants of the M6-C and M6-L since the products were first launched in 2006.

“We look forward to becoming a part of the Orthofix team,” said Tom Afzal, President and CEO of Spinal Kinetics. “Joining forces gives us the opportunity to bring together Spinal Kinetics’ proven innovative technology with Orthofix’s regulatory, market development, distribution and commercial expertise as we work to broaden the availability of these devices and ultimately prepare for U.S. commercialization.”

Orthofix estimates the artificial disc market in 2017 to be over $325 million worldwide and $200 million in the U.S., with double-digit growth expected for many years. Also, Orthofix anticipates that the momentum created from the addition of the M6 disc to the Orthofix spine fixation portfolio will generate pull-through revenue of other Orthofix products and position the company for market share gains in the $5.4 billion U.S. spine hardware market.

The transaction is anticipated to close in the second quarter of 2018, subject to customary closing conditions. Orthofix expects the acquisition to not only add revenue in 2018, but also increase its organic revenue growth rate in 2019 and beyond. The company also expects the deal to be slightly accretive to the Company’s non-GAAP diluted earnings per share and adjusted EBITDA within 12 months of PMA approval in the U.S. and further accretive thereafter.

In connection with the transaction, Canaccord Genuity is acting as a financial advisor to Spinal Kinetics.

Orthofix Conference Call

Orthofix will conduct a conference call on Thursday, March 15 at 4:00 p.m. Central time (5:00 p.m. Eastern time). An overview of the transaction will be provided during the call. The investor presentation is viewable on Orthofix’s U.S. corporate home page or Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 7493218. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 7493218.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit

About Spinal Kinetics Inc.

Founded in 2003, Spinal Kinetics is a privately held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to the unique biomechanical properties that replicate the motion of a natural disc and the positive clinical outcomes for patients. The company is located in Sunnyvale, California. For more information about Spinal Kinetics or the M6 Artificial Disc, please visit

Forward Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the estimates, projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, Spinal Kinetics and their respective companies’ product portfolios, are based on Orthofix management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks, including the possibility that the deal might not close, difficulties commercializing Spinal Kinetics’ products and integrating their product lines into Orthofix’s business, inaccuracies in Orthofix’s estimates and projections of future product sales, including the current and future size of the worldwide and U.S. artificial disc market, FDA and regulatory approval risks, and other risks described in the “Risk Factors” section of our 2017 Annual Report on Form 10-K, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.


Orthofix International N.V.
Investor Relations
Mark Quick, 214-937-2924
Media Relations
Denise Landry, 214-937-2529

Laser Spine Institute Welcomes Board-Certified Orthopedic Spine Surgeon

March 13, 2018 (TAMPA, Fla.)  – Laser Spine Institute, the leader in minimally invasive spine surgery, is proud to welcome board-certified Orthopedic Spine Surgeon, Brett G. Menmuir, M.D. In his role, Dr. Menmuir will serve patients out of Laser Spine Institute’s Scottsdale, Ariz. facility, helping patients find lasting relief from chronic neck and back pain.

“We’re incredibly pleased to have Dr. Menmuir join our Laser Spine Institute team as the newest Orthopedic Spine Surgeon,” said Roger Cary, President and Chief Executive Officer, Laser Spine Institute. “Dr. Menmuir is an accomplished surgeon, and he has devoted his career to providing the best possible care for his patients, making him a perfect fit for the surgical team.”

From an early age, Dr. Menmuir knew his career would involve working with his hands to help those suffering from chronic pain. His focus and determination would eventually lead him to a career in orthopedic spine surgery, allowing him to use his skills to heal those in need.

After earning his degree in science from Georgetown University, Dr. Menmuir went on to earn his medical degree from Georgetown University’s School of Medicine. He then attended Louisiana State University to complete his residency in orthopedic spine surgery followed by a fellowship at Twin Cities Spine Center in Minneapolis.

Before joining Laser Spine Institute’s surgical team, Dr. Menmuir spent more than a decade at Reno Orthopedic Clinic where he was the Spine Team Leader. While there, he specialized in minimally invasive techniques for spine and sacroiliac joint fusions, motion preservation surgery, pain management and orthopedic procedures.

Dr. Menmuir is also a member of various professional associations, including American Academy of Orthopedic Surgeons, Nevada Orthopedic Society, Society of Lateral Access Surgery and AO Spine.

Laser Spine Institute’s locations are recognized as providers of the highest level of patient care by the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC).

For more information, visit

Media Contact: Maura Devetski, Edelman

Phone: 404-832-6788


About Laser Spine Institute
Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven regional surgery centers across the country, in Tampa, Fla.; Scottsdale, Ariz.; Philadelphia; Oklahoma City; Cleveland, St. Louis and Cincinnati. Laser Spine Institute has helped more than 75,000 patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Patients often refer a friend or family member to have surgery at Laser Spine Institute; we have a patient recommendation score of 97 out of 100. Additionally, Laser Spine Institute has been repeatedly recognized for outstanding patient satisfaction and reports an enterprise patient satisfaction score of more than 96.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, and okc.BIZ and a Most Admired Company by BestCompaniesAZ. Opening in Tampa in 2005 with one operating room and nine employees, Laser Spine Institute now has nearly 1,000 corporate and health care professionals across the country.


SpineGuard Reports Full-Year 2017 Financial Results

March 15, 2018


SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, reported today its full-year 2017 financial results as approved by the Board of Directors on March 14, 2017.

€ thousands – IFRS audited Dec 31, 2017 Dec 31, 2016
Revenue 8 174 7 463
Gross Margin 6 952 6 354
Gross margin (% of revenue) 85,1 % 85,1 %
Sales, distribution & marketing 6 116 6 643
Administrative costs 2 116 2 049
Research & Development 1 267 1 295
Operating profit / (loss) -2 547 -3 633
Non recurring operating costs -415 0
Financial Result -1 163 -545
Income Tax 0 0
Net profit / (loss) -4 125 -4 178

Stephane Bette, CEO of SpineGuard said: « The full-year results demonstrate that we can achieve our goal of operational profitability by the end of 2018. We generated solid growth while launching our innovative technology platform. In 2017 SpineGuard signed 2 major strategic partnerships: for distribution in China with XinRong Medical; and an exclusive worldwide DSG™ licensing to Adin for dental implant surgery. Furthermore, the early commercial success of the DSG screw with our partner Zavation in 2017 bodes well for 2018.”

Solid growth of revenue and strong improvement of the operating profit

Full year revenue was € 8,174k, growing 10% (12% cc). The United States represented 61% of the 8,764 DSG™-enabled devices sold by Dec. 31, 2017 and 81.5% of the revenue. Sales grew in the US by 14% (cc).

Gross margin remains stable at 85.1% and grew by € 598k. This was the result of a combination of stable OUS prices, ASP increases in the USA and improvements in manufacturing costs (despite unfavorable exchange rates).

Operating expenses decreased by € 488k (4.9%) thanks to the company reorganization initiated in the second half of 2017 and to rigorous control of operational expenses.

As expected, SpineGuard greatly reduced its operating loss to € -2,547k (vs. € -3,633k), i.e. an improvement of € +1 087k (close to +30%) for the full-year with a progress of € +505k in the second half of 2017.

Non-recurring operating costs related to the reorganization amount to € 415k.

Net loss was € -4,125k (vs. € -4,178k) after taking into account the financial result impacted by the unrealized exchange rate losses and by the concurrent increase of the paid interest related to contracted loans.

Working capital requirement decreased by € 249k as the result of a reduction of the inventory dedicated to late 2016 new product launch.

At Dec. 31, 2017, cash and cash equivalents were € 1.2M, plus the secured € 2.0M of convertible bonds (OCAPI) for a total of € 3.2M.

2017: SpineGuard reached the following key milestones

In the United States, SpineGuard’s leading market, the company continued its solid progress supported by the following events:

  • The FDA cleared the DSG™ integration module for the smart screw in January. The subsequent pre-launch period enabled SpineGuard to collect the positive clinical experiences of 100 surgeries.
  • In October, Zavation and SpineGuard officially launched the Z-Direct smart screw at the annual congress of the North American Spine Society (NASS) to great acclaim.
  • Penetration of university hospitals continues to grow, with 38 centers using PediGuard® in their training process by year-end.

In the rest of the world, the company focused its marketing and training support activities toward major commercial partners and signed a major distribution agreement with XinRong Medical for China, Hong-Kong and Macao.

SpineGuard broadened the scope of its DSG™ technology platform beyond Spine with the completion of an exclusive license deal in dental implantology with the Israeli Group Adin Dental Systems, a high growth potential market.

In an area of strong interest, SpineGuard obtained the world’s first experimental validation with the laboratory Institut des Systèmes Intelligents et de Robotique of the Paris Sorbonne University that demonstrated how DSG™ technology can stop a surgical robot automatically when an impending bone breach is detected.

Promising perspectives in 2018:

  • Growing adoption by physicians and various orthopedic industry players of DSG™-enabled devices (industry partnerships, distributors, universities).
  • The commercial launch of the Z-Direct smart screw with Zavation in the USA and additional partnerships for DSG™ screw expansion.
  • A broadening of the scope of DSG™ applications: robotics, visualization module and non-spine.
  • Reaching operating profitability by the end of 2018.

Nomination of Pierre Jerome as successor of Alan Olsen as Chairman of the Board

The Board of Directors accepted Alan Olsen’s resignation from his role of Chairman of the Board during its March 14th meeting. Alan served as Chairman of the Board of SpineGuard since 2010 and will remain a Director until the term of his mandate expires on May 17, 2018. The Board of Directors sincerely thanks Alan for his unwavering support over the last nine years.

Maurice Bourlion, SpineGuard Board Director and co-inventor of DSG® technology says: “On behalf of all Board members, I sincerely thank Alan Olsen for his major contribution to SpineGuard’s progress. Since 2010, he has organized and managed the governance of the company, while also sharing his great experience with the company. Today Pierre Jerome, co-founder of the company, takes over as Chairman. With Pierre, we will be able to pursue our growth strategy and our path towards profitability”.

During the same meeting, the Board of Directors named Pierre Jérôme – co-founder of SpineGuard – as new Chairman of the board.

« I would like to warmly thank the board of directors for their vote of confidence in giving me this new responsibility, as well as Alan Olsen for his contribution to the development of SpineGuard since his nomination in 2010; I wish him all the best. The company under the leadership of Stéphane is now well on track toward profitability while continuing to demonstrate the strong potential of its DSG™ technology through sustained growth and innovation. The Chinese market, the smart pedicle screw, dental implantology and the robotic applications are now as many tangible opportunities that I will strive, along with the other board members, to help Stéphane and his team fully materialize so that our shareholders can harvest the fruit of their investment” concludes Pierre Jérôme.

Next financial press release: First Quarter 2018 revenue on April 5, 2018.

About SpineGuard®
Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit


Stéphane Bette
Chief Executive Officer
Tél. : +33 (0)1 45 18 45 19
Manuel Lanfossi
Chief Financial Officer
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tél. : +33 (0)1 44 71 94 94

Stryker Spine Division’s Tritanium® C Anterior Cervical Cage Gains Momentum With Surgeons

March 15, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Tritanium® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has been implanted by 311 surgeons in more than 1,770 procedures across the U.S. since its introduction in late October. The company has sold more than 3,188 Tritanium C implants to date.

The Tritanium C Anterior Cervical Cage is the newest addition to Stryker’s expanding line of spinal implants constructed from its proprietary Tritanium Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study,2* and the Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.3

“As more spine surgeons gain experience using Tritanium cages, they are becoming believers in Tritanium Technology, which is designed to mimic the porosity of cancellous bone,” said Bradley Paddock, president of Stryker’s Spine division. “We are thrilled by the positive feedback the Tritanium C Anterior Cervical Cage is receiving from our surgeon customers.”

“The Tritanium C Anterior Cervical Cage is another great product by Stryker that brings revolutionary technology to the operating room,” said Dr. Lance Smith, Orthopedic Surgeon at McBride Orthopedic Hospital, Oklahoma City. “With many product sizes and lordosis options, I feel like I can match the anatomy and needs of the patient with the implant. I look forward to using the Tritanium C Cage product in more spinal surgeries.”

“I was intrigued by Tritanium because of the idea of bone in-growth as opposed to the on-growth of competitive products,” said Dr. Scott Kutz, Texas Back Institute, Plano, Texas. “I found the large graft window and imaging characteristics of Tritanium to be favorable versus other metal implants I’ve used.”

Tritanium Technology allows for the creation of porous structures designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.4 This “precise randomization”4 of fully interconnected pores differs from other technologies featuring longitudinal channels and traverse windows that create a uniform lattice structure, as well as cages offering porosity that is only present on the surface. Tritanium Cages feature an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment.

The Tritanium C Anterior Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration in September 2017 and was introduced to surgeons during the North American Spine Society conference Oct. 25–28, 2017. Full commercial launch occurred on Dec. 10, 2017. For Indications for Use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

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 and Follow Stryker’s Spine division on Twitter @stryker_spine.


1. PROJ43909 Tritanium technology claim support memo
2. RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
3. RD0000050927: Tritanium material capillary evaluation
4. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491

Drs. Smith and Kutz are paid consultants of Stryker. Their statements represent their own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Content ID: TRICC-PR-3_16579


Sullivan & Associates
Barbara Sullivan, 714/374–6174

New European patent approval for Episurf Medical

MAR 14, 2018

The European patent office EPO has announced its intention to grant another European patent for Episurf Medical (NASDAQ: EPIS B). The patent, entitled “Method and node for manufacturing a surgical kit for cartilage repair, covers the medical image segmentation process used for joint damage visualisation as well as for manufacturing of Episurf Medical’s patient-specific joint implants and surgical instruments.

“A comprehensive patent portfolio supporting various aspects of our technology has for a long time been a prioritised area, and this patent forms an important part thereof. This grant follows previous approvals for this patent family in China and Australia”, comments Pål Ryfors, CEO, Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69


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:

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 11.30 CET on 14 March 2018.


 About Us

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:

K2M Launches Next-Generation YUKON™ OCT Spinal System at AANS/CNS 2018

LEESBURG, Va., March 14, 2018 (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 the commercial launch of the YUKON™ OCT Spinal System at the 34th Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS), occurring March 14-17 in Orlando, FL (Booth #200). At the meeting, the Company will also showcase Balance ACS® or (BACS®), a comprehensive platform that applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes for spine patients.

The YUKON OCT Spinal System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in September 2017, was developed to help surgeons restore cervical sagittal balance through posterior fixation in the occipito-cervico-thoracic regions of the spine. It features a newly designed top-loading polyaxial screw with high angulation and the ability to accommodate rods in two diameters. The screw provides 60 degrees of angulation for 60 degrees of coronal swing “60 for 60” to aid in screw placement, providing up to 105 degrees of polyaxial angulation.

“We are pleased to launch our next-generation YUKON OCT Spinal System, an important addition to our growing complex spine portfolio, at this year’s AANS/CNS meeting,” said K2M Chairman, President, and CEO Eric Major. “K2M is committed to realizing the theme of this year’s meeting—restoring alignment in an era of global change—as evidenced by this latest commercial milestone and through our comprehensive Balance ACS platform.”

YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium to accommodate construct rigidity based on degenerative or deformity corrections. The system’s advanced, streamlined reduction instruments allow for intraoperative flexibility and ease of use. A Pistol Grip Rod Reducer provides up to 20 mm of reduction, while the Sequential Reducers deliver up to 15 mm of controlled reduction and correction.

BACS provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the YUKON OCT Spinal System and K2M’s complete product portfolio, visit For more information on Balance ACS, visit

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 and connect with us on FacebookTwitterInstagramLinkedIn 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 payers; 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; 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, 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  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

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

Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery

WESTMINSTER, Colo.March 14, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced the company received approval from the U.S. Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of P-15L Peptide Enhanced Bone Graft compared to autograft in transforaminal lumbar interbody fusion (TLIF) surgery for degenerative disk disease.

Spinal fusion procedures such as TLIF involve joining and stabilizing one or more vertebrae to reduce pain and nerve irritation. A bone graft, which has historically been obtained from the patient’s pelvis, is placed in the interbody space to promote fusion. P-15L Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation, and is designed to be used as a substitute for autologous bone.

“With regulatory approval to begin a new IDE study of P-15L Bone Graft in TLIF procedures, we are now in position to collect additional Level 1 human clinical data on our next-generation advanced drug-device combination bone graft,” said Glen Kashuba, chief executive officer of Cerapedics. “Several hundred thousand people in the U.S. need surgery for degenerative disk disease every year, and it is our goal to offer surgeons a safe and effective alternative to a patient’s own bone as well as address the evidence gap around commercial bone grafts often used in these procedures.”

The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include 364 patients with degenerative disk disease at up to 30 clinical trial sites across the U.S. Patients will be assessed prior to surgery and six weeks, three months, 12 months, and 24 months post-surgery. The primary endpoint for the study is composite clinical success at 24 months based on several factors including the achievement of radiographic fusion (assessed by CT), at least a 15-point improvement in the Oswestry Disability Index (ODI), no new or worsening persistent neurological deficit, and no subsequent surgical intervention at the index level. Clinical investigators are permitted to use any FDA cleared static PEEK interbody device and any FDA cleared pedicle fixation system delivered through either an open or minimally invasive TLIF technique.

“We are very pleased to be on the verge of initiating this milestone study,” said Jeffrey G. Marx, PhD, president and chief operating officer of Cerapedics. “We believe the FDA approved study design should allow for rapid enrollment and clear evaluation of the safety and efficacy of P-15L Bone Graft versus local autograft. We’re assembling an outstanding team of surgeon investigators whom we are excited to collaborate with.”

“Prior research of this proprietary P-15 technology has demonstrated potential benefits in fusion rates, neurological outcomes and safety in cervical and lumbar fusions,” said Paul M. Arnold, MD, neurosurgeon and vice chair of research in the Department of Neurosurgery at the University of Kansas Medical Center and principal investigator of the IDE study. “We are pleased to participate in a new study evaluating whether similar results can be achieved in a wider range of patients with degenerative disk disease utilizing the next generation P-15L product.”

In November 2015, Cerapedics received Premarket Approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures, becoming only the second PMA-approved bone graft in the spine. The company is initiating enrollment in the newly approved TLIF IDE study with the expectation that the results from the study will support a PMA application.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at

Media contact:
Adam Daley
Berry & Company Public Relations

SOURCE Cerapedics

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