Author: OrthoSpineNews

OrthAlign, Inc. Announces Full Commercial Launch of UniAlign™

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with precision tools, announced the full commercial launch of UniAlign™, the world’s first handheld navigation device for unicompartmental knee arthroplasty (UKA).

UniAlign provides surgeons with OrthAlign’s clinically-proven handheld navigation technology, along with instruments uniquely designed to address the demanding requirements for precision of UKA procedures. To date, OrthAlign technology has successfully been used in approximately 60,000 joint arthroplasty cases, worldwide.

“UniAlign has become an invaluable tool for my practice,” said Sridhar M. Durbhakula, MD of the Washington Joint Institute in Bethesda, MD. “It delivers a more efficient operation with precise bone cuts, no CT/MRI, minimal pin site morbidity, and it gives me real-time data so that I always know exactly what I’m doing. Patients will get home more quickly because UniAlign allows for a minimally invasive surgical approach that promotes faster patient recuperation. UniAlign is the ideal way to cost-effectively offer computer assisted surgery in the outpatient setting.”

UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The system has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth. This accuracy has been validated with at least 90% confidence.

“The introduction of UniAlign is just the beginning of OrthAlign’s new product rollout for 2017,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “As OrthAlign’s biggest focus for this year is in expanding our customer reach and application pipeline, we will continue providing orthopedic surgeons and healthcare facilities with our clinically beneficial and economically friendly portfolio of products, staying true to our core design principles of ease of use, precision, and cost effectiveness.”

OrthAlign will be showcasing its full portfolio of products, including the recently launched UniAlign and Direct Anterior HipAlign® technologies at this year’s AAOS meeting in San Diego, CA, March 15-18, 2017 at booth #5615.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical navigation products for precise alignment and positioning. We believe that our technology will raise the standard of care in Joint Arthroplasty surgeries by making consistent and measurable results accessible and affordable to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precision-driven solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Corbion full year 2016 results

Corbion reported sales of € 911.3 million in 2016, a decrease of 0.8%. Organic sales growth was -1.2%. EBITDA excluding one-off items grew by 13.2% in 2016. In Q4 2016 sales were € 226.1 million, a decrease of 1.9%. Q4 2016 EBITDA excluding one-off items increased by 6.3%. The company proposes to distribute a regular dividend of € 0.56 per share, an additional cash dividend of € 0.44 per share, and a new share buyback of € 25 million.

“In 2016 we continued to make good progress in executing our strategy and we are well on track to deliver on our 2015-2018 targets. In the past year we have made strategic choices involving our customer and product portfolios. These choices resulted in a significant margin improvement, but at the same time had an adverse, albeit temporary, impact on our top-line growth in the year. For 2017, we are confident top-line growth will return to our guidance range. A notable highlight in the second half of the year was the announcement of the PLA joint venture together with Total, a market leader with technical and marketing expertise and a leading position in polymers,” commented Tjerk de Ruiter, CEO.

Key financial highlights FY 2016

  • Net sales organic growth was -1.2%; volume growth was -1.2%
  • EBITDA excluding one-off items was € 170.1 million, an organic increase of 13.8%
  • EBITDA margin excluding one-off items was 18.7%, up from 16.4%
  • “Streamline” contributed € 20 million to EBITDA (2015: € 15 million)
  • One-off items at EBITDA level of € -3.2 million in 2016, mostly in connection with the closure of our Kansas powder blending plant, partly offset by the sale of the Breddo-Likwifier activities
  • Operating result was € 126.9 million, an organic increase of 17.5%
  • Free cash flow was € 72.1 million (2015: € 55.2 million)
  • Net debt/EBITDA at year-end was 0.6x (2015: 0.4x)
  • Our € 50 million share-buyback program was finalized on 28 October 2016.

 Key figures

€ million FY 2016 FY 2015 Total growth Organic growth
Net sales 911.3 918.3 -0.8% -1.2%
EBITDA excluding one-off items 170.1 150.3 13.2% 13.8%
EBITDA margin excluding one-off items 18.7% 16.4%
Operating result 126.9 108.6 16.9% 17.5%
ROCE 20.6% 19.2%

 

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/919ed3c2-7b2b-4d86-94fe-bd6dbbbedfb8

 

Bone Therapeutics Strengthens Clinical Development Leadership with Appointment of Dr. Miguel Forte as Chief Medical Officer

March 06, 2017

GOSSELIES, Belgium–(BUSINESS WIRE)–Regulatory News:

BONE THERAPEUTICS (Brussels:BOTHE) (Paris:BOTHE) (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces the appointment of Miguel Forte, MD, PhD as Chief Medical Officer (CMO).

Dr. Forte has significant regenerative medicine and cell therapy industry experience, most recently as Chief Operating and Medical Officer at TxCell, a French biotechnology company specializing in immune cell therapy, and as Chief Commercialization Officer and Chair of the Commercialization Committee at the International Society of Cellular Therapy (ISCT). With over 20 years’ industry experience, Dr. Forte has gained broad expertise in medical and regulatory affairs, ranging from leading early and late stage clinical trials to market authorization and the launch of new biologic products for various indications.

At Bone Therapeutics, Dr. Forte will be responsible for the Company’s clinical development strategy and advancing its products to market. He will also play a key role in increasing the visibility of the Company throughout the medical community.

At TxCell, Dr. Forte was instrumental in defining the company’s regulatory strategy, design and implementation of clinical studies and completed a positive first-in-man Phase I/II study with an antigen specific T-cell therapy. Prior to TxCell, Dr. Forte held several senior positions in large pharmaceutical companies, including as Vice President, Global Medical Affairs at UCB, and various senior positions at the European Medicines Agency, Bristol-Myers Squibb, Abbott, and Wellcome Laboratories (now part of GSK).

Dr. Forte graduated in Medicine from the University of Lisbon, specializing in infectious diseases. He obtained a PhD in Immunology at the University of Birmingham and received post-graduate training in Health Economics of Pharmaceutical and Medical Technology at Stockholm School of Economics. Dr. Forte is currently Associate Professor in Health Sciences and Pharmacy at the University of Aveiro and the University of Lisbon. Dr. Forte succeeds Prof. Dr. Valerie Gangji, who will focus on her role as Head of the Rheumatology and Physical Medicine Unit at the Erasme University Hospital. Dr. Gangji will remain available to the Company during a transistion period to provide advice and support on ongoing clinical programmes.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “We are delighted to strengthen our clinical development team with the appointment of Dr. Forte. His vast expertise in cell therapy will be a strong asset to our company and will further drive the progress of Bone Therapeutics’ innovative pipeline. In addition to his specific experience with cell therapy products, Dr. Forte has extensive experience in interacting with regulatory bodies and establishing strong relationships with investigators and key opinion leaders. We would like to thank Valérie Gangji for her contribution to our company. She pioneered the use of differentiated bone forming cells and her work forms part of the foundation of Bone Therapeutics’ bone cell therapy products.”

Commenting on his appointment, Dr. Miguel Forte said: “I am very excited to be joining Bone Therapeutics, a leading biotechnology company in bone cell therapy products. The Company has an advanced clinical pipeline with promising products in clinical development and I am impressed with its progress to date. I look forward to working with the Bone Therapeutics team to realise the potential of its ground breaking products for the benefits of patients.”

About Bone Therapeutics

Bone Therapeutics is a leading biotechnology company specializing in the development of cell therapy products intended for orthopaedics and bone diseases. The current standard of care in this field involves major surgeries and long recovery periods. To overcome these problems, Bone Therapeutics is developing a range of innovative regenerative products containing osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.

PREOB®, Bone Therapeutics’ autologous bone cell product, is currently in pivotal Phase IIB/III clinical studies for two indications: osteonecrosis and non-union fractures. ALLOB®, its allogeneic “off-the-shelf” bone cell product, is in Phase II for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. The Company also runs preclinical research programs for the development of novel product candidates.

Founded in 2006, Bone Therapeutics is headquartered in Gosselies (South of Brussels, Belgium). Bone Therapeutics’ regenerative products are manufactured to the highest GMP standards and are protected by a rich IP estate covering 9 patent families. Further information is available at: www.bonetherapeutics.com.

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Wim Goemaere, Chief Financial Officer
+32 (0)2 529 59 90
investorrelations@bonetherapeutics.com
or
For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
+44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com
or
For French Media and Investor Enquiries:
NewCap Investor Relations
& Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
+ 33 (0)1 44 71 94 94
bone@newcap.eu

Pacira Pharmaceuticals Announces Proposed Offering of $300 Million Aggregate Principal Amount of Convertible Senior Notes

PARSIPPANY, N.J., March 06, 2017 (GLOBE NEWSWIRE) — Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX) today announced that it intends to offer, subject to market and other conditions, $300 million aggregate principal amount of convertible senior notes due 2022 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).  Pacira also intends to grant the initial purchasers of the notes a 30-day option to purchase up to an additional $45 million aggregate principal amount of notes.

The terms of the notes, including the interest rate, initial conversion rate and other terms, will be determined by negotiations between Pacira and the initial purchasers of the notes.

Pacira intends to use a portion of the net proceeds to enter into privately negotiated agreements with certain holders of its 3.25% convertible senior notes due 2019 (the “2019 Notes”) to exchange their 2019 Notes for a combination of cash and shares of Pacira common stock. The remaining net proceeds will be used for general corporate purposes, including working capital, research and development expenditures and the license or acquisition of complementary products and/or technologies.

This offering is being made to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and the shares of Pacira common stock, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or any state securities laws, and, unless so registered, the notes and such shares may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall it constitute an offer, or the solicitation of any sale, of any securities in any jurisdiction in which such offer, solicitation or sale is unlawful.

About Pacira

Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time.

Forward-Looking Statements

Certain of the statements made in this press release, such as those, among others, relating to our expectations regarding the completion of the proposed offering, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements.  Actual results or developments may differ materially from those projected or implied in these forward-looking statements.  Factors that may cause such a difference include, without limitation, risks and uncertainties related to whether or not we will be able to raise capital through the proposed offering, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed offering and the impact of general economic, industry or political conditions in the United States or internationally.  There can be no assurance that we will be able to complete the proposed offering on the anticipated terms, or at all. Additional risks and uncertainties relating to the proposed offering, Pacira and our business are discussed in the “Risk Factors” section of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in other filings that we periodically make with the SEC.  In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and, as such, we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor Contact:
Susan Mesco
(973) 451-4030
susan.mesco@pacira.com

K2M Group Holdings, Inc. Reports Fourth Quarter and Full Year 2016 Financial Results

LEESBURG, Va., March 06, 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 BalanceTM, today reported financial results for the fourth quarter and fiscal year ended December 31, 2016.

Fourth Quarter 2016 Financial Summary:

  • Total Q4 revenue of $61.8 million, up 14.0% year-over-year. Total Q4 revenue increased 14.9% year-over-year on a constant currency basis.
  • Domestic Q4 revenue of $47.7 million, up 21.5% year-over-year, comprised of:
    – U.S. Complex Spine growth of 18.0% year-over-year
    – U.S. Minimally Invasive Surgery (MIS) growth of 37.3% year-over-year
    – U.S. Degenerative growth of 19.3% year-over-year
  • International Q4 revenue of $14.1 million, down approximately 5.8% year-over-year, or 2.8% on a constant currency basis.
  • Net loss of $12.5 million for the three months ended December 31, 2016, compared to a net loss of $8.5 million in the comparable period last year.
  • Adjusted EBITDA loss of $0.8 million for the three months ended December 31, 2016, compared to Adjusted EBITDA of $1.3 million in the comparable period last year.

Fourth Quarter 2016 Highlights:

  • On October 6, 2016, the Company announced it had received 510(k) clearance from the FDA to expand its CASCADIA™ Lateral Interbody System featuring Lamellar 3D Titanium Technology™, the Company’s innovative technology that uses 3D printing with the goal of allowing for bony integration throughout the implant. The CASCADIA Lateral Interbody System line extension clearance strengthens K2M’s MIS portfolio and the Company’s leadership in the 3D printing of spinal devices, as evidenced by its having the most comprehensive 3D-printed spinal portfolio available on the market among leading spine companies.
  • On October 26, 2016, the Company announced the U.S. launch of its award-winning CASCADIA Interbody Systems, featuring Lamellar 3D Titanium Technology, during the 31st North American Spine Society (NASS) Annual Meeting. K2M presented clinical background on its 3D-printed spinal devices and showcased the Company’s comprehensive CASCADIA product portfolio, which was recognized by Orthopedics This Week with a 2016 Spine Technology Award as one of the best new spine technologies of 2016.

Highlights Subsequent to Quarter-End:

  • On February 15, 2017, the Company introduced Balance ACSTM (or BACSTM), a comprehensive platform that applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes for patients undergoing spinal surgery. BACS provides 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 a critical component to surgical success.

“We reported constant currency revenue growth of 14.9% year-over-year in the fourth quarter, driven by U.S. constant currency revenue growth of 21.5% year-over-year,” said President and Chief Executive Officer, Eric Major. “We delivered approximately 17% growth in the U.S. in calendar year 2016 and we believe this strong performance reflects the Company’s success in executing our strategic plan to introduce differentiated spine technologies and expand our global distribution network. Our U.S. growth reflects the clearest indication yet of the increasing adoption of our innovative products by the spine surgeon community. Outside the U.S., we successfully navigated challenging market disruptions with our distributors in Australia and Japan earlier in 2016, and look forward to building on our improving results during 2017 without the expectation of these headwinds.  We continue to anticipate our ability to grow our U.S. revenue in the mid-teens in 2017 with improved profitability.”

Fourth Quarter 2016 Financial Results

Three Months
Ended December 31,
  Increase / Decrease
($,thousands) 2016 2015   $ Change % Change % Change
(as reported)  (constant currency)
United States $47,669 $39,236 $8,433 21.5% 21.5%
International $14,122 $14,984 $(862) (5.8%) (2.8%)
Total Revenue: $61,791 $54,220   $7,571 14.0% 14.9%

Total revenue for fourth quarter 2016 increased $7.6 million, or 14.0%, to $61.8 million, compared to $54.2 million in the fourth quarter of 2015. Total revenue increased 14.9% year-over-year on a constant currency basis. The increase in revenue was primarily driven by greater sales volume from primarily domestic new surgeon users and newer product offerings, offset by decreases in both international direct and distributor revenue compared to last year.

Revenue in the United States increased $8.4 million, or 21.5% year-over-year, to $47.7 million, and international revenue decreased $0.9 million, or 5.8% year-over-year, to $14.1 million. Fourth quarter 2016 international revenue decreased 2.8% year-over-year on a constant currency basis. Foreign currency exchange impacted fourth quarter international revenue by approximately $0.5 million, representing approximately 302 basis points of international growth year-over-year.

The following table represents domestic revenue by procedure category.

Three Months
Ended December 31,
  Increase / Decrease
($,thousands) 2016 2015   $ Change % Change
Complex Spine $17,934 $15,194 $2,740 18.0%
Minimally Invasive 8,058 5,867 2,191 37.3%
Degenerative 21,677 18,175 3,502 19.3%
U.S Revenue: $47,669 $39,236   $8,433 21.5%

By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 37.6%, 16.9% and 45.5% of U.S. revenue, respectively, for the three months ended December 31, 2016.

Gross profit for fourth quarter of 2016 increased 6.7% to $38.4 million, compared to $35.9 million for fourth quarter 2015.  Gross margin was 62.1% for the fourth quarter of 2016, compared to 66.3% last year.  After adjusting for a medical device tax recovery of $0.7 million in 2015, Gross margin was 62.1% for the fourth quarter of 2016 as compared to 65.0% in the comparable period last year.  Gross profit includes amortization expense on investments in surgical instruments of $3.6 million, or 5.8% of sales, for the three months ended December 31, 2016, compared to $3.2 million, or 5.9% of sales, for the comparable period last year.

Operating expenses for fourth quarter 2016 increased $4.2 million, or 9.7%, to $47.7 million, compared to $43.5 million for fourth quarter 2015. The increase in operating expenses was driven primarily by a $2.5 million increase in general and administrative expenses, a $1.2 million increase in sales and marketing expenses and, to a lesser extent, a $0.5 million increase in research and development expenses compared to the comparable period last year.

Loss from operations for the fourth quarter of 2016 was $9.4 million, compared to a loss from operations of $7.6 million for the comparable period last year. Loss from operations included intangible amortization of $2.6 million for each of the fourth quarters of 2016 and 2015.

Total other expenses for the fourth quarter of 2016 increased $2.3 million to $3.1 million, compared to $0.8 million last year. The increase in other expense, net, was primarily attributable to interest expense incurred on the capital lease obligation related to our headquarters and operations facilities as well as the Convertible Senior Notes issued in August 2016, and an increase of $1.1 million in unrealized losses from foreign currency re-measurement on intercompany payable balances.  Foreign currency losses impacted operating results compared to last year due to changes in the average exchange rates of the U.S. Dollar, Pound Sterling and Euro applied to intercompany balances in both periods.

Net loss for the fourth quarter of 2016 was $12.5 million, or $(0.30) per diluted share, compared to a loss of $8.5 million, or $(0.21) per diluted share, for the fourth quarter of 2015.

Twelve-Months 2016 Financial Results

Twelve Months
Ended December 31,
  Increase / Decrease
($,thousands)  2016  2015   $ Change % Change % Change
(as reported)  (constant currency)
United States $181,078 $155,291 $25,787 16.6% 16.6%
International $55,556 $60,716 (5,160) (8.5%) (6.6%)
Total Revenue: $236,634 $216,007   $20,627 9.5%  10.2%

For the twelve months ended December 31, 2016, total revenue increased $20.6 million, or 9.5%, to $236.6 million, compared to $216.0 million for the twelve months ended December 31, 2015. Total revenue increased 10.2% year-over-year on a constant currency basis. U.S. revenue increased $25.8 million, or 16.6%, to $181.1 million in fiscal year 2016, compared to $155.3 million last year. International revenue decreased $5.1 million, or 8.5%, to $55.6 million in fiscal year 2016, compared to $60.7 million last year. International revenue decreased 6.6% year-over-year on a constant currency basis.

Twelve Months
Ended December 31,
  Increase / Decrease
($,thousands) 2016 2015   $ Change % Change
Complex Spine $71,915 $63,398 $8,517 13.4%
Minimally Invasive 28,711 23,633 5,078 21.5%
Degenerative 80,452 68,260 12,192 17.9%
U.S Revenue: $181,078 $155,291   $25,787 16.6%

Sales in our complex spine, MIS and degenerative categories represented 39.7%, 15.9% and 44.4% of U.S. revenue, respectively, for the twelve months ended December 31, 2016.

As of December 31, 2016, we had cash and cash equivalents of $45.5 million as compared to $34.6 million as of December 31, 2015. We had working capital of $115.9 million as of December 31, 2016 as compared to $107.4 million as of December 31, 2015. At December 31, 2016, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $36.9 million and the capital lease obligation of $34.9 million. In addition, we had no borrowings outstanding under our credit facility.

2017 Outlook

The Company is introducing its fiscal year 2017 guidance expectations. The Company expects:

  • Total revenue on an as reported basis in the range of $263.0 million to $270.0 million, representing growth of 11% to 14% year-over-year, compared to total revenue of $236.6 million in fiscal year 2016.  The Company expects mid-teens growth in its U.S. business in 2017.
  • Total net loss of approximately $34.0 million to $31.0 million, compared to a total net loss of $41.7 million in fiscal year 2016.
  • Adjusted EBITDA in a range of $6.0 million to $10.0 million, compared to Adjusted EBITDA of $0.6 million in fiscal year 2016.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on March 6th to discuss the results of the quarter, and to host a question and answer session. Those who would like to participate may dial 888-208-1814 (719-457-2552 for international callers) and provide access code 4389380 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 4389380. The webcast will be archived on the investor relations section of the Company’s website.

About K2M Group Holdings, Inc.

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

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. 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.

K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share and Per Share Data)
December 31,
2016 2015
ASSETS
Current assets:
Cash and cash equivalents $ 45,511 $ 34,646
Accounts receivable, net 46,430 38,773
Inventory, net 61,897 62,002
Prepaid expenses and other current assets 6,147 19,820
Total current assets 159,985 155,241
Property, plant and equipment, net 50,714 38,318
Goodwill 121,814 121,814
Intangible assets, net 22,758 33,123
Other assets, net 28,254 26,016
Total assets $ 383,525 $ 374,512
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current maturities under capital lease obligation $ 973 $ 284
Accounts payable 15,367 22,483
Accrued expenses 15,673 13,559
Accrued payroll liabilities 12,068 11,507
Total current liabilities 44,081 47,833
Convertible senior notes 36,894
Capital lease obligation, net of current maturities 34,933 34,140
Deferred income taxes, net 5,017 5,042
Other liabilities 1,032 835
Total liabilities 121,957 87,850
Stockholders’ equity:
Common stock, $0.001 par value, 750,000,000 shares authorized; 42,282,741 and 41,337,692 shares issued and 42,274,130 and 41,337,692 shares outstanding, respectively 42 41
Additional paid-in capital 474,512 454,153
Accumulated deficit (211,081 ) (169,421 )
Accumulated other comprehensive (loss) income (1,771 ) 1,889
Treasury stock, at cost, 8,611 and 0 shares, respectively (134 )
Total stockholders’ equity 261,568 286,662
Total liabilities and stockholders’ equity $ 383,525 $ 374,512
K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Data)
Three Months Ended
December 31,
Year Ended
December 31,
2016
2015
2016
2015
Revenue $ 61,791 $ 54,220 $ 236,634 $ 216,007
Cost of revenue 23,431 18,284 82,178 71,791
Gross profit 38,360 35,936 154,456 144,216
Operating expenses:
Research and development 5,558 5,060 21,547 19,868
Sales and marketing 27,244 26,047 111,376 105,635
General and administrative 14,921 12,408 56,264 54,983
Total operating expenses 47,723 43,515 189,187 180,486
Loss from operations (9,363 ) (7,579 ) (34,731 ) (36,270 )
Other expense, net:
Foreign currency transaction loss (1,331 ) (261 ) (2,430 ) (1,813 )
Interest expense (1,720 ) (587 ) (4,425 ) (941 )
Total other expense, net (3,051 ) (848 ) (6,855 ) (2,754 )
Loss before income taxes (12,414 ) (8,427 ) (41,586 ) (39,024 )
Income tax expense 53 67 74 192
Net loss $ (12,467 ) $ (8,494 ) $ (41,660 ) $ (39,216 )
Net loss per share attributable to common stockholders:
Basic and diluted $ (0.30 ) $ (0.21 ) $ (1.00 ) $ (0.97 )
Weighted average shares outstanding:
Basic and diluted 41,995,284 41,263,912 41,729,013 40,237,848

 

K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
Year Ended
December 31,
Operating Activities 2016 2015
Net loss $ (41,660 ) $ (39,216 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 29,212 24,940
Provision for inventory reserve 5,572 1,680
Provision for allowance for doubtful accounts 68 319
Stock-based compensation 6,956 11,188
Accretion of discounts and amortization of issuance costs of convertible senior notes 1,604
Deferred income taxes (33 )
Changes in operating assets and liabilities:
Accounts receivable (9,381 ) (5,082 )
Inventory (3,439 ) (8,766 )
Prepaid expenses and other assets (10,256 ) (9,738 )
Accounts payable, accrued expenses, and accrued payroll liabilities 8,059 6,365
Net cash used in operating activities (13,298 ) (18,310 )
Investing activities
Purchase of surgical instruments (12,275 ) (10,905 )
Purchase of property, plant and equipment (17,439 ) (2,787 )
Changes in cash restricted for leasehold improvements 6,608
Purchase of intangible assets (1,307 ) (588 )
Net cash used in investing activities (24,413 ) (14,280 )
Financing activities
Borrowings on bank line of credit 19,500 25,000
Payments on bank line of credit (19,500 ) (25,000 )
Proceeds from issuance of convertible senior notes, net issuance of costs 47,108
Proceeds from issuances of common stock, net of issuance costs 54,209
Principal payments under capital lease (219 )
Issuances and exercise of stock-based compensation benefit plans, net of income tax 2,244 2,017
Net cash provided by financing activities 49,133 56,226
Effect of exchange rate changes on cash and cash equivalents (557 ) (401 )
Net increase in cash and cash equivalents 10,865 23,235
Cash and cash equivalents at beginning of period 34,646 11,411
Cash and cash equivalents at end of period $ 45,511 $ 34,646
Significant non-cash investing activities
Buildings under capital lease $ $ 26,469
Leasehold improvements, including property under capital lease $ 171 $ 6,884
Significant non-cash financing activities
Capital lease obligation $ 1,708 $ 33,938
Accretion of convertible senior notes 807
Common stock offering costs 52
Cash paid for:
Income taxes $ 159 $ 126
Interest $ 382 $ 428


K2M GROUP HOLDINGS, INC.

Reconciliation of GAAP to Non-GAAP Measures
(Unaudited)
(In Thousands)

Use of Non-GAAP Financial Measures

This press release includes the non-GAAP financial measures of revenue in constant currency, Adjusted Gross Profit, and Adjusted EBITDA.

The Company presents these non-GAAP measures because it believes these measures are useful indicators of the Company’s operating performance.  Management uses these non-GAAP measures principally as a measure of the Company’s operating performance and believes that these measures are useful to investors because they are frequently used by analysts, investors and other interested parties to evaluate companies in the Company’s industry.  The Company also believes that these measures are useful to its management and investors as a measure of comparative operating performance from period to period.

Constant currency information compares results between periods as if exchange rates had remained constant period-to-period.  We calculate constant currency by converting the prior-year results using current-year foreign currency exchange rates.

Adjusted Gross Profit represents Gross Profit less amortization expense of surgical instruments and medical device excise tax expense (recovery).  The Company presented Adjusted Gross Profit because it believes it is a useful measure of the Company’s gross profit and operating performance because the measure is not burdened by the timing impact of instrument purchases and related amortization as well as the medical device tax.

Adjusted EBITDA represents net loss plus interest expense, income tax (benefit) expense, depreciation and amortization, stock-based compensation expense, foreign currency transaction loss and a deduction for cash payments made for rent on the capital lease of the Company’s new headquarters and operations facilities, which commenced in October 2016.

The Company presents Adjusted EBITDA because it believes it is a useful indicator of the Company’s operating performance.  Management uses Adjusted EBITDA principally as a measure of the Company’s operating performance and for planning purposes, including the preparation of the Company’s annual operating budget and financial projections.

Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to net loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP and it should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items.  In addition, Adjusted EBITDA is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as tax payments, debt service requirements, capital expenditures and certain other cash costs that may recur in the future.  Adjusted EBITDA contains certain other limitations, including the failure to reflect the Company’s cash expenditures, cash requirements for working capital needs and cash costs to replace assets being depreciated and amortized.  In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same as or similar to some of the adjustments in this presentation.  The Company’s presentation of Adjusted EBITDA should not be construed to imply that the Company’s future results will be unaffected by any such adjustments.  Management compensates for these limitations by primarily relying on its GAAP results in addition to using Adjusted EBITDA supplementally.  The Company’s definition of Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.

The following table presents reconciliations of gross profit to adjusted gross profit and net loss to Adjusted EBITDA for the periods presented.

$ in thousands Three Months Ended December 31,  Year Ended December 31,
2016 2015 2016 2015
Reconciliation from Gross Profit to Adjusted Gross Profit
Gross Profit $ 38,360 $ 35,936 $ 154,456 $ 144,216
Surgical instrument amortization 3,575 3,188 13,725 12,334
Medical device excise tax 12 (694 ) (854 ) 514
Adjusted Gross Profit (a Non-GAAP Measure) $ 41,947 $ 38,430 $ 167,327 $ 157,064
$ in thousands Three Months Ended December 31, Year Ended December 31,
2016 2015 2016 2015
Reconciliation from Net Loss to Adjusted EBITDA
Net loss $ (12,467 ) $ (8,494 ) $ (41,660 ) $ (39,216 )
Interest expense 1,720 587 4,425 941
Income tax expense 53 67 74 192
Depreciation and amortization 7,760 6,544 29,212 24,940
Stock-based compensation expense 1,575 2,325 6,956 11,188
Foreign currency transaction loss 1,331 261 2,430 1,813
Cash-based rent payments (801 ) (801 )
Adjusted EBITDA (a Non-GAAP Measure) $ (829 ) $ 1,290 $ 636 $ (142 )

The following table presents a reconciliation of net loss to Adjusted EBITDA for our 2017 guidance ($ in thousands):

Year Ended
December 31,
2017
Net loss $ (32,450 )
Interest expense 6,700
Income tax expense 100
Depreciation and amortization 27,500
Stock-based compensation expense 6,150
Foreign currency transaction loss
Adjusted EBITDA $ 8,000

The reconciliation assumes the mid-point of the Adjusted EBITDA range and the midpoint of each component of the reconciliation, corresponding to guidance of $6.0 million to $10.0 million for 2017.

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

Global Vertebral Compression Fractures Devices Market Expected to Reach $1,109 Million by 2022

Press release from: Allied Market Research – March 06,2017

Vertebral Compression Fracture Devices Market Report, published by Allied Market Research, forecasts that the global market was valued at $748 million in 2015, and is expected to reach $1,109 million by 2022, supported by a CAGR of 5.7% during the forecast period 2014 – 2022.

Access Full Summary at: www.alliedmarketresearch.com/vertebral-compression-fractu…
Vertebral compression fracture (VCF) generally occurs when the block-like part of a single bone of the spine (vertebra) is compressed due to trauma. The surgical approach for VCF treatment involves injecting cementing material in the fractured vertebra to provide immediate relief from pain and stability to the patient.

The vertebral compression fractures devices market is driven by factors such as advent of minimally invasive spine surgery techniques and rise in incidence of osteoporosis and arthritis. In addition, rise in geriatric population, short recovery period, low risk of infection, and shorter hospital stay are anticipated to boost the demand for VCF devices, globally. However, risk of post-surgical complications and stringent regulatory approval process hamper the market growth.

Balloon kyphoplasty devices segment is projected to maintain its leading trend in the global market, owing to the benefits offered by these procedures such as reduction of back pain and restoration of vertebral body height. Furthermore, vertebroplasty segment is anticipated to grow rapidly during the forecast period.

The global VCF devices market is segmented on the type of surgery into open spine surgery and minimally invasive spine surgery. The open spine surgery segment contributed the highest revenue in the global market in 2015. However, the MISS market is estimated to grow at the highest CAGR during the study period.

 

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Summit Orthopedics’ Vadnais Heights Surgery Center Receives The Joint Commission’s Advanced Certification

WOODBURY, Minn., March 6, 2017 /PRNewswire/ — Summit Orthopedics is to pleased to announce that its Vadnais Heights Surgery Center has earned The Joint Commission’s Gold Seal of Approval® for Advanced Certification for Total Hip and Total Knee Replacement. The facility is one of just two ambulatory surgery centers nationwide to receive the certification.

“We are incredibly honored that our Vadnais Heights Surgery Center has been recognized for its work in the area of advanced total hip and total knee replacements,” said Adam Berry, Summit CEO. “And I, personally, am very proud of our physicians and staff who work tirelessly to ensure the best possible outcomes for our patients who undergo these advanced treatments.”

The advanced certification was developed in response to the growing number of patients undergoing a total hip or total knee replacement surgery in the U.S. Also, there has been an increased focus on clinical evidence-based patient care as it relates to pain management, quality of life issues, functional limitation in mobility, and the return to normal daily activities.

According to the American Academy of Orthopaedic Surgeons, between 1993 and 2009, the number of total knee replacement surgeries more than tripled and the number of total hip replacements doubled. The increase in the number of surgeries is attributed in great part to the rise in obesity rates as well as an active baby boomer generation. Berry noted that since opening in 2014, Summit’s Vadnais Heights facility has performed more than 1,800 total hip and total knee replacements. With the opening of Summit’s Eagan Surgery Center in March, he anticipates that Summit will perform nearly 800 such surgeries between the two surgery centers in 2017.

“There’s certainly a high demand for these advanced surgeries, but we’re finding that there’s also a demand for exceptional care, accelerated recovery times, and reduced costs,” he said. “Patients want the best care available at the best price. Through our Vadnais Heights Surgery Center—and very shortly our new Eagan Surgery Center, Summit provides this service. And now The Joint Commission, the leading healthcare accreditation organization in the country, has recognized Summit’s value.”

Summit’s value, according to Berry, is reflected in key data points critical to patients, insurers and The Joint Commission. For example, since opening in 2014, the average satisfaction level for patients undergoing total hip or knee replacements at Summit’s Vadnais Heights facility was 96.2 out of 100; the average infection rate was between just .1 – .5 percent; and the average time between surgery and ambulation was between 3 hours and 10 minutes and three hours and 23 minutes, with patients traveling an average of 95 to 98 feet.

Summit Orthopedics’ Vadnais Heights facility is a one-stop, state-of-the-art center offering patients comprehensive orthopedic treatment that includes physician consultations, advanced imaging, therapy, bracing, orthotics, and a seven-day-a-week walk-in clinic. The facility also offers surgical care and overnight recovery in specialized care suites adjacent to the surgical facility for those undergoing advanced spine procedures and total joint replacements. In a concept still new to Minnesota and launched at Summit’s Vadnais Heights facility, the care suites, which will open in Eagan in March, offer personalized services, such as catered meals from local restaurants and one-on-one education and physical therapy, as well as hotel-level amenities, including Wi-Fi, lounge seating, and concierge services. In addition, the suites boast Secure Tracks, a post-surgery accelerated walking system exclusive to Summit Orthopedics that gets patients up and walking within hours of surgery.

Summit’s new Eagan facility, which opens this week, mirrors the Vadnais facility in treatment offerings and amenities. The Eagan Surgery Center will pursue this same certification from The Joint Commission.

About The Joint Commission
Founded in 1951, The Joint Commission seeks to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. The Joint Commission accredits and certifies more than 21,000 health care organizations and programs in the United States. An independent, nonprofit organization, The Joint Commission is the nation’s oldest and largest standards-setting and accrediting body in health care. Learn more about The Joint Commission at www.jointcommission.org.

About Summit Orthopedics
Summit Orthopedics is privately owned and managed, with 50 highly trained orthopedic specialists teamed with 125 supporting providers such as physician assistants, therapists, and certified athletic trainers. For more than 30 years, Summit has provided a range of conservative and progressive care options for musculoskeletal conditions for patients across the Twin Cities, throughout Greater Minnesota and beyond. This includes prevention, surgical and non-surgical treatment, and rehabilitation. Summit employs about 850 people at 33 locations throughout Minnesota.

Contact:

Patty Gibbs

Patty Gibbs & Company

651.653.7302

patty@pattygibbscompany.com

 

SOURCE Summit Orthopedics

Safe Orthopaedics expands into Germany and appoints Jochen Esser as Head of Sales Germany

Eragny-sur-Oise, France, March 6, 2017, 6pm (CET) – SAFE ORTHOPAEDICS (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, is today announcing that it is expanding into Germany and has appointed Jochen Esser as Head of Sales Germany.

Jochen has over 25 years’ sales development and sales force leadership experience in the spinal surgery sector, both in Germany and in international markets. Before joining Safe Orthopaedics, Jochen held various sales positions with Zimmer, and DePuy Synthes, the Johnson & Johnson group subsidiary specialized in medical devices, where he was awarded for his sales performance on several occasions. In 2010, he joined K2M, a leader in minimally invasive techniques for back surgery, as head of the Germany, Austria and Switzerland region where he built a team of seven sales representatives and more than tripled the sales base. Since 2015, Jochen has been head of sales Germany at Joimax, a specialist in endoscopic solutions for minimally invasive back surgeries. In this role, he also built up the company’s sales in Austria and Switzerland.

“We are delighted to welcome Jochen to Safe Orthopaedics. His knowledge of the German market and many years of experience in the spinal surgery sector will be invaluable to our development in Germany where we intend to replicate the success we have had in France with direct sales of our products”, said Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics. “2017 is shaping up to be a strategically important year for the Group, with the progressive strengthening of our sales force in regions experiencing the most rapid growth. Following on from the appointment of Dr. Franke, a highly renowned German surgeon, to our Scientific Advisory Board, the addition of Jochen as our Head of Sales represents another step forward establishing us in this very important market.”

The German market, Europe’s largest, is also growing most rapidly. Sales of spinal implants totaled €443 million in 2015, and a CAGR in sales of 4.7% has been forecast for the period to 2024. By comparison, sales in the French market totaled €64.7 million in the same year. Germany is also a very large market for traumatology, a segment estimated to be worth €50 million. It has around 600 centers specialized in trauma surgery, compared with around a hundred in France.

Jochen Esser, Safe Orthopaedics’ Head of Sales Germany, added: “I’m very excited to be joining Safe Orthopaedics’ team and to be contributing to its development, following on from its solid performance in 2016. With its steadily growing international footprint and its unrelenting commitment to innovation, Safe Orthopaedics is a breakthrough force in back surgery. Its single-use technology is particularly well-suited for minimally-invasive techniques and for trauma surgeries. With this in mind, I will initially focus on traumatology to establish our sales base in Germany in this key segment before building a larger sales team and catering to the degenerative condition segment.”

 

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally‑invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

 

CONTACTS

Safe Orthopaedics

Thierry Lambert
CFO

Tel. : +33 (0)1 34 21 50 00
investors@safeorthopaedics.com

NewCap

Julien Perez/Valentine Brouchot
Investor Relations

Nicolas Merigeau
Press Relations

Tel. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

Medical device makers stand to gain if Neil Gorsuch approved for Supreme Court

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Emergo Survey: Regulatory Issues Remain Biggest Challenge for Most Medical Device Companies

February 27, 2017 by

EMERGO SUMMARY OF KEY POINTS:

  • Regulatory issues continue to be the biggest business challenge for medical device companies of all sizes.
  • Managers at smaller firms report greater concern for funding and capital issues, while largest firms are more challenged by pricing and competition pressures.
  • Medium- and large-sized firms cite product development as a significant challenge, as well.
  • Changing regulatory environments continue to present the biggest business challenge for a majority of medical device company senior managers, according to an annual Emergo industry survey.

    Asked to identify the biggest business challenge they face as part of Emergo’s 2017 Global Medical Device Industry Outlook, nearly 70% of more than 500 senior managers of medical device companies surveyed cited changing regulatory environments as their top issue. But depending on respondents’ size, other challenges such as product development, profitability and funding were also identified.

  • Medical device regulatory challenges: still number one

    Regulatory issues perennially top the list of business challenges in Emergo’s industry surveys, and this year was no different. But while 66% of senior managers identified regulatory changes generally as their biggest challenge, managers of larger firms were more likely to cite regulatory changes as their top concern.

 

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