K2M to Highlight Balance ACS™ Platform & Three-Dimensional Total Body Balance™ at EPOSNA 2017

LEESBURG, Va., May 03, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced that it will showcase the Balance ACS (or BACS™) platform at the 2017 combined meeting of The European Paediatric Orthopaedic Society and The Pediatric Orthopaedic Society of North America (EPOSNA) from May 3–6 in Barcelona, Spain, at Stand #13. The Company will also host a clinical symposium in 3D spinal solutions on May 4 in Sala H3.

“K2M is excited to participate in this year’s EPOSNA, a keynote meeting encompassing the latest science, education, and advocacy to improve surgical care in children across Europe and North America with spinal deformities,” said K2M President and CEO, Eric Major. “We look forward to further introducing Balance ACS—a comprehensive platform of products, services, and research—to surgeons across Europe and North America. With BACS, our goal is to help surgeons holistically manage the entire patient experience over the full episodic care continuum, and ultimately, achieve Total Body Balance for spine patients.”

Balance ACS provides solutions to balance the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. During the meeting, K2M will demo the BACS System services offering—which includes BACS Preauthorization, BACS Surgical Planner, BACS Anatomical Models, and BACS Data Management—and the BACS app, a convenient portal for surgeons to access the BACS System.

K2M will also host an interactive clinical symposium entitled: “Techniques to Optimize Spinal Balance” facilitated by Dennis P. Devito, MD, an orthopaedic surgeon and director of the Spine Program at Children’s Healthcare of Atlanta. The session will begin at 12:45 p.m. on May 4 in Sala H3.

For more information about Balance ACS and K2M, visit www.BACS.com and www.K2M.com.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in our 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 in our main facility or information technology systems;  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; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; 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 www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

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

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

NuVasive Announces Sponsorship Of EPOSNA 2017 And Launches New Monthly Pediatric Spinal Deformity Podcast

SAN DIEGO, May 2, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company is a leading sponsor of EPOSNA 2017, the combined meeting of the EPOS (European Paediatric Orthopaedic Society) and POSNA (Pediatric Orthopaedic Society of North America) annual meetings, held this week in Barcelona, Spain. NuVasive also announced the launch of a monthly podcast, MAGEC Matters, featuring interviews with the leading surgeons in pediatric deformity and sharing clinical insights on the treatment of early-onset scoliosis.

“At NuVasive, we are not only passionate about the world-class innovation we are bringing to market to help improve pediatric spinal deformity, but we’re also passionate about the education and research that is necessary to provide surgeons with the information they need to advance the care options available to pediatric patients,” said Jason Hannon, NuVasive’s president and chief operating officer. “We’ve made tremendous investments in building a comprehensive pediatric deformity portfolio, with our MAGEC® system, RELINE®posterior fixation platform and PRECICE® limb lengthening system. By supporting events such as EPOSNA, we are able to connect surgeons from around the world and help improve the lives of children.”

EPOSNA is the world’s largest pediatric orthopaedic scientific meeting with over 1,300 abstracts submitted. The Company’s sponsorship of the event includes exhibit floor presence featuring pediatric spine and orthopedic solutions and the following workshops:

  • “MAGEC Masters Roundtable: Key Principles for Challenging Applications”; Wednesday, May 3, 2017 from 12:45 – 13:35 p.m. (CEST); Featuring Michael Vitale, M.D., Peter Sturm, M.D., Burt Yaszay, M.D. and Jeff Sawyer, M.D.
  • “So You’re Not Sure You Can Do Limb Lengthening”; Thursday, May 4, 2017 from 12:45 – 13:35 p.m. (CEST); Featuring Christof Radler, M.D. and Frank Schiedel, M.D.

As a key education initiative for the pediatric spinal deformity community, NuVasive also announced the launch of a monthly podcast series, MAGEC Matters, featuring interviews with leading surgeons in pediatric deformity discussing tips for the treatment of early-onset scoliosis, which is now available on iTunes, SoundCloud and other leading podcast platforms.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Implanet’s new JAZZ™ Standalone implant receives European marketing clearance (CE)

May 03, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces its new JAZZ™ Standalone implant has been granted approval by the European authorities and obtained the CE Mark.

JAZZ™ Standalone is an implant that further strengthens the Implanet’s freestanding, rod less fixation line, launched in 2016 with the JAZZ™ Lock implant. It is used in the treatment of adult degenerative bone disorders, the largest spine surgery market segment, representing $246 M1 in Europe.

The JAZZ™ Standalone offers fast and simple freestanding posterior fixation to replace traditional fixation systems. Degenerative spine surgery is experiencing strong growth in Europe and the United States, driven by an aging demographic that demands functional restoration in a less invasive manner.

The JAZZ™ Standalone will be incorporated in the JAZZ product range without new investments in equipment or training for surgical teams.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “The result of our work with thought leading surgeons, the JAZZ™ Standalone is a new variant of our JAZZ technology devoted to treating degenerative pathologies. This implant utilizes the JAZZ™ Band platform and enables vertebral segments to be stabilized without the need for pedicle screws and rods. This is a fast, simple and safe surgical procedure that only requires limited surgical accessibility.

Ludovic Lastennet, Implanet CEO, adds: “We are continuing to rigorously pursue our execution plan by regularly marketing new products and line extensions. The marketing approval of a major new component of the JAZZ™ Band platform in Europe is another key breakthrough in terms of expanding the range. Indeed, the JAZZ™ Standalone meets a major and persistent demand from surgeons regarding their need to continually simplify surgical procedures. It should rapidly be adopted by our partners, whether they be pediatric surgeons or surgeons specializing in adult degenerative disorders.”

IMPLANET will participate this week in two major Congresses:

Global Spine Congress (degenerative surgery), Milano, Italy, 3 to 6 May 2017

• E-POSNA Congress (pediatric surgery), Barcelona, Spain, 3 to 6 May 2017

Next financial press release: Q2 2017 revenue, on July 18, 2017

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

1 Source : Company

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

K2M Group Holdings, Inc. Reports First Quarter 2017 Financial Results and Announces Key Product Approvals in Japan

LEESBURG, Va., May 02, 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 its first fiscal quarter ended March 31, 2017.

First Quarter 2017 Financial Summary:

  • Total Q1 revenue of $61.9 million, up 9.9% year-over-year. Total Q1 revenue increased 10.7% year-over-year on a constant currency basis.
  • Domestic Q1 revenue of $46.2 million, up 9.5% year-over-year, comprised of:
    – U.S. Complex Spine growth of 7.6% year-over-year
    – U.S. Minimally Invasive Surgery (MIS) growth of 14.4% year-over-year
    – U.S. Degenerative growth of 9.4% year-over-year.
  • International Q1 revenue of $15.7 million, up 11.1% year-over-year, or 14.4% on a constant currency basis.
  • Net loss of $10.9 million for the three months ended March 31, 2017, compared to a net loss of $10.2 million in the comparable period last year.
  • Adjusted EBITDA loss of $0.3 million for the three months ended March 31, 2017, compared to Adjusted EBITDA loss of $1.1 million in the comparable period last year.

Year-to-Date 2017 Highlights:

  • On February 15, 2017, the Company introduced Balance ACSTM (or BACSTM), a comprehensive platform featuring products and services that apply three-dimensional solutions across the full continuum of care with the goal of facilitating 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 an important component to surgical success.
  • On April 6, 2017, K2M and LifeHealthcare Group Limited announced a new distribution agreement for K2M’s innovative spinal technologies in Australia and New Zealand (ANZ). The K2M/LifeHealthcare distribution partnership dates back to 2010 and has yielded strong growth and a significant spine market position in ANZ. Looking to build on this success, K2M and LifeHealthcare entered into a new five-year agreement with the shared goal of establishing a number one spine market position in ANZ.
  • On April 21, 2017, K2M received key product registrations in Japan from the PMDA, which are now under its control, including the MESA® and EVEREST® product lines.

“We have made significant progress during the first four months of 2017, driving toward our fiscal year growth objectives and achieving multiple operational milestones, which together will enhance our ability to increase our share of the global spine market over time. We reported constant currency revenue growth of 10.7% year-over-year in the first quarter, driven by 10% growth in the U.S. and 14.4% constant currency growth in our international markets,” said President and Chief Executive Officer, Eric Major. “We delivered strong revenue growth in the U.S. in the first quarter, which represents solid performance in light of the 20% U.S. growth we reported in the same period last year, and we continue to believe in our ability to grow U.S. revenue in the mid-teens in 2017. Outside the U.S., we continue to see progress in both Australia and Japan that is in line with our goal of creating a solid foundation for future growth in each of these markets. In April, we announced a new supply agreement with our Australian partner, LifeHealthcare. Later in April, we received product registrations in Japan, that we now control, for key products including our MESA and EVEREST systems. With these registrations, K2M will have an opportunity to implement a new distribution strategy in the entire spine surgery market in Japan.”

First Quarter 2017 Financial Results

  Three Months Ended March 31, Increase/Decrease
($, thousands) 2017 2016 $ Change % Change
% Change
  (as reported)
(constant currency)
United States $46,207 $42,193 $4,014 9.5 % 9.5 %
International 15,678 14,113 1,565 11.1 % 14.4 %
Total Revenue $61,885 $56,306 $5,579 9.9 % 10.7 %

Total revenue for the first quarter 2017 increased $5.6 million, or 9.9%, to $61.9 million, compared to $56.3 million for the first quarter of 2016. Total revenue increased 10.7% 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 partially by lower sales in certain international distributor markets as compared to last year.

Revenue in the United States increased $4.0 million, or 9.5% year-over-year, to $46.2 million, and international revenue increased $1.6 million, or 11.1% year-over-year, to $15.7 million. First quarter 2017 international revenue increased 14.4% year-over-year on a constant currency basis. Foreign currency exchange impacted first quarter international revenue by approximately $0.4 million, representing approximately 329 basis points of international growth year-over-year.

The following table represents domestic revenue by procedure category.

  Three Months Ended March 31, Increase/Decrease
($, thousands) 2017 2016 $ Change % Change
Complex Spine $17,136 $15,930 $1,206 7.6 %
Minimally Invasive 7,872 6,881 991 14.4 %
Degenerative 21,199 19,382 1,817 9.4 %
U.S. Revenue $46,207 $42,193 $4,014 9.5 %

By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 37.1%, 17.0% and 45.9% of U.S. revenue, respectively, for the three months ended March 31, 2017.

Gross profit for the first quarter of 2017 increased 10.1% to $40.4 million, compared to $36.7 million for the first quarter 2016.  Gross margin was 65.3% for the first quarter of 2017, compared to 65.2% last year. Gross profit includes amortization expense on investments in surgical instruments of $3.5 million, or 5.6% of sales, for the three months ended March 31, 2017, compared to $3.3 million, or 5.8% of sales, for the comparable period last year.

Operating expenses for the first quarter 2017 increased $2.9 million, or 6.1%, to $49.5 million, compared to $46.6 million for the first quarter 2016. The increase in operating expenses was driven primarily by a $2.7 million increase in sales and marketing expenses compared to the comparable period last year.

Loss from operations for the first quarter of 2017 improved  $0.8 million, to $9.1 million, compared to a loss from operations of $9.9 million for the comparable period last year. Loss from operations included intangible amortization of $2.4 million and $2.6 million for each of the first quarters of 2017 and 2016, respectively.

Total other expenses for the first quarter of 2017 increased $1.6 million to $1.8 million, compared to $0.2 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, to a lesser extent, an increase of $0.4 million year-over-year 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 first quarter of 2017 was $10.9 million, or $(0.26) per diluted share, compared to a loss of $10.2 million, or $(0.25) per diluted share, for the first quarter of 2016.

As of March 31, 2017, we had cash and cash equivalents of $38.6 million as compared to $45.5 million as of December 31, 2016. We had working capital of $110.4 million as of March 31, 2017 as compared to $115.9 million as of December 31, 2016.

At March 31, 2017, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $37.4 million and the capital lease obligation of $34.7 million. The Company had no borrowings outstanding on the revolving credit facility as of March 31, 2017.

2017 Outlook

The Company is reaffirming 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.
  • Total revenue on a constant currency basis is expected to increase 12% to 15% year-over-year in 2017.
  • The Company continues to expect 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 May 2nd to discuss the results of the first quarter, and to host a question and answer session. Those who would like to participate may dial 877-741-4244 (719-325-4870 for international callers) and provide access code 9971371 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 9971371. 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.  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; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in our 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 in our main facility or information technology systems;  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; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; 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 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
(Unaudited)
 (In Thousands, Except Share and Per Share Data)
March 31, December 31,
2017 2016
ASSETS
Current assets:
Cash and cash equivalents $ 38,580 $ 45,511
Accounts receivable, net 46,155 46,430
Inventory, net 63,667 61,897
Prepaid expenses and other current assets 7,563 6,147
Total current assets 155,965 159,985
Property, plant and equipment, net 51,614 50,714
Goodwill 121,814 121,814
Intangible assets, net 20,412 22,758
Other assets, net 29,239 28,254
Total assets $ 379,044 $ 383,525
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current maturities under capital lease obligation $ 1,009 $ 973
Accounts payable 20,502 15,367
Accrued expenses 14,619 15,673
Accrued payroll liabilities 9,388 12,068
Total current liabilities 45,518 44,081
Convertible senior notes 37,444 36,894
Capital lease obligation, net of current maturities 34,675 34,933
Deferred income taxes, net 5,017 5,017
Other liabilities 1,047 1,032
Total liabilities 123,701 121,957
Stockholders’ equity:
Common stock, $0.001 par value, 750,000,000 shares authorized; 42,565,112 and 42,282,741 shares issued and 42,556,501 and 42,274,130 shares outstanding, respectively 43 42
Additional paid-in capital 478,796 474,512
Accumulated deficit (221,954 ) (211,081 )
Accumulated other comprehensive loss (1,408 ) (1,771 )
Treasury stock, at cost, 8,611 and 8,611 shares, respectively (134 ) (134 )
Total stockholders’ equity 255,343 261,568
Total liabilities and stockholders’ equity $ 379,044 $ 383,525
K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 (In Thousands, Except Share and Per Share Data)
Three Months Ended March 31,
2017
2016
Revenue $ 61,885 $ 56,306
Cost of revenue 21,479 19,604
Gross profit 40,406 36,702
Operating expenses:
Research and development 5,250 5,028
Sales and marketing 30,474 27,755
General and administrative 13,754 13,848
Total operating expenses 49,478 46,631
Loss from operations (9,072 ) (9,929 )
Other expense, net:
Foreign currency transaction (loss) gain (27 ) 420
Interest expense (1,732 ) (651 )
Total other expense, net (1,759 ) (231 )
Loss before income taxes (10,831 ) (10,160 )
Income tax expense 42 25
Net loss $ (10,873 ) $ (10,185 )
Basic and diluted $ (0.26 ) $ (0.25 )
Weighted average shares outstanding:
Basic and diluted 42,224,734 41,353,123
K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
 (In Thousands)
Three Months Ended
March 31,
2017 2016
Net loss $ (10,873 ) $ (10,185 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 7,195 6,743
Provision for inventory reserves 1,146 1,013
Provision for allowance for doubtful accounts (57 )
Stock-based compensation expense 1,541 2,106
Accretion of discounts and amortization of issuance costs of convertible senior notes 32
Changes in operating assets and liabilities:
Accounts receivable 438 (2,862 )
Inventory (1,263 ) (2,139 )
Prepaid expenses and other assets (4,032 ) (2,705 )
Accounts payable, accrued expenses, and accrued payroll liabilities 969 (3,351 )
Net cash used in operating activities (4,847 ) (11,437 )
Investing activities
Purchase of surgical instruments (3,157 ) (3,339 )
Purchase of property, plant and equipment (1,553 ) (6,141 )
Changes in cash restricted for leasehold improvements 61 3,333
Purchase of intangible assets (23 ) (1,282 )
Net cash used in investing activities (4,672 ) (7,429 )
Financing activities
Borrowings on bank line of credit 5,000
Principal payments under capital lease (223 )
Issuances and exercise of stock-based compensation benefit plans, net of income tax 2,744 365
Net cash provided by financing activities 2,521 5,365
Effect of exchange rate changes on cash and cash equivalents 67 32
Net increase in cash and cash equivalents (6,931 ) (13,469 )
Cash and cash equivalents at beginning of period 45,511 34,646
Cash and cash equivalents at end of period $ 38,580 $ 21,177
Significant non-cash investing activities
Leasehold improvements under capital lease $ $ 8,562
Additions to property, plant and equipment $ 750 $ 1,234
Significant non-cash financing activities
Accretion of discount on convertible senior notes $ 550 $
Cash paid for:
Income taxes $ 64 $ 109
Interest $ 1,090 $ 623

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.  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.

Adjusted EBITDA represents net loss plus interest expense, income tax expense, depreciation and amortization, stock-based compensation expense and foreign currency transaction loss (gain).

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.

Three Months Ended March 31,
2017 2016
Reconciliation from Gross Profit to Adjusted Gross Profit
Gross profit $ 40,406 $ 36,702
Surgical instrument amortization 3,464 3,272
Adjusted gross profit (a Non-GAAP Measure) $ 43,870 $ 39,974
Three Months Ended March 31,
2017 2016
Reconciliations from Net Loss to Adjusted EBITDA
Net loss $ (10,873 ) $ (10,185 )
Interest expense 1,732 651
Income tax expense 42 25
Depreciation and amortization 7,195 6,743
Stock-based compensation expense 1,541 2,106
Foreign currency transaction loss (gain) 27 (420 )
Adjusted EBITDA (a Non-GAAP measure) $ (336 ) $ (1,080 )

The following table presents a reconciliation of net loss to Adjusted EBITDA for our 2017 guidance:

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

Expanding Orthopedics Inc (EOI)-Announces Record Q1 Growth & Revenue

OR AKIVA, Israel, May 2, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced a significant increase in new surgeon users in Q1 has led to record revenues in the sales of their FLXfit™ 3D Expanding TLIF Cage, achieving its largest revenue quarter to date.

Dale Binke, Vice President of US Sales, commented, “Our record breaking quarter was highlighted by strong clinical acceptance which accelerated our growth in both MIS and open surgical approaches.” He explained that “As we build the sales organization, we have been able to recruit and retain best in class distributors and sales agents. They recognize that FLXfit™ offers features that no other cage on the market can rival, which provides tremendous value with surgeon satisfaction and surgeon retention.”

Ofer Bokobza, CEO of Expanding Orthopedics, commented, “Our growth and rapid expansion is fueled by surgeons’ pursuit to provide the best care to their patients”.  Ofer explained “FLXfit™ provides clear differentiation over competitive expandable cages. The large footprint design coupled with a unique expansion mechanism helping to restore and retain lordosis leading to sagittal alignment”. He concluded “Additional product releases this year will continue our strong growth for 2017.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is a medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is backed by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: +1(347)3219683

SOURCE Expanding Orthopedics Inc. (EOI)

Life Spine® Achieves Considerable Sales Growth of ProLift® Expandable Spacer System, Doubling Sales Quarter over Quarter

May 02, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today continued growth of their micro invasive expandable interbody, ProLift. “With the introduction of ProLift to the market in Q2 of 2016, we have since consistently doubled our sales growth quarter over quarter,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We are excited about the adoption of ProLift, and will continue to focus on technological advancements that strive to improve surgical efficiencies and outcomes through procedural based and micro invasive expandable solutions. Products such as ProLift are the core competencies which we will continue to drive for our procedural based product portfolios.”

ProLift, a titanium expandable posterior interbody solution allows for in-situ expansion for restoration of normal anatomic disc height and decompression of neural elements. ProLift, used in conjunction with CALYPSORetractor and CENTERLINE® Cortical Bone Screws, provides the surgeon minimal tissue disruption while achieving surgical goals.

Zeshan Hyder, D.O., of Bone and Joint Specialists of Northwest Indiana notes,“The continued evolution of MIS surgery to reduce tissue morbidity and restore anatomical alignment, especially in severe degenerative and collapsed disc, is being achieved in my practice with the expandable technologies such as ProLift, and the lateral system LONGBOW®. Both of these systems reduce the requirements for multiple instrument passes by important neural structures while maintaining my surgical goals and positive patient outcomes.”

ProLift continues Life Spine’s commitment of offering innovative micro invasive procedural solutions to better improve patients’ lives. In addition, Life Spine launched its new website highlighting their complete core and micro invasive procedural solutions. The website is a staple to the new look of Life Spine, and helps surgeons access information about advancements in surgical innovations.

About Life Spine

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

Contacts

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

SI-BONE – SI Joint Fusion Study Showed Patients Were 11X Less Likely to be Taking Opioids at Last Follow-Up Using the iFuse Implant™

SAN JOSE, Calif., May 1, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced results from two recently published comparative studies showed patients treated with the iFuse ImplantTM were significantly less likely to be taking opioid medications than patients treated with non-surgical care.  The most recently published paper titled Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study,1 published in the journal Neurosurgery, showed that patients treated with iFuse were 11X less likely to be taking opioids at last follow-up than those who were denied coverage for iFuse and treated with either conservative care or radiofrequency ablation (>80% vs, 7%) (Figure 1, below).

“Given the catastrophic opioid addiction epidemic we are currently dealing with in this country today, any procedure, device or technology that demonstrates the ability to significantly reduce opioid use should be made available to anyone who can benefit,” said Frank Guinta, former New Hampshire congressman and co-founder of the Congressional Bipartisan Committee on opioid and heroin addiction. “Given the overwhelming amount of high quality level 1 clinical evidence associated with the iFuse Implant, it seems prudent and obvious to me that anyone properly diagnosed as an appropriate surgical candidate should have access to the procedure.”

A second publication of two-year results from INSITE,2 a randomized controlled trial of MIS SI joint fusion with the iFuse Implant compared to non-surgical management, showed a 30% decrease from baseline in the number of subjects taking opioids at two years compared to patients treated non-surgically (Figure 2, below).

“It’s rather remarkable that in both studies the number of patients taking opioids in the iFuse Implant group was significantly lower than the number of patients taking opioids in the non-surgical care group in spite of a lack of a structured program focused on opioid use dependence,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE.  “It’s clear from the evidence in these two studies that treatment with the iFuse Implant was associated with a reduction in opioid use in patients with chronic SI joint pain who were taking opioids and who no longer responded to non-surgical care.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone on-growth and ingrowth*, facilitating long-term fusion of the joint.  iFuse is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are more than 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  iFuse Implant is the only SI joint fusion device with a FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

* MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9875.050117

1

Vanaclocha V, Herrera JM, Sáiz-Sapena N, Rivera-Paz M, Verdú-López F. Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study. Neurosurgery. 2017 April 20. [Epub ahead of print]. doi: 10.1093/neuros/nyx185.

2

Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10.Article 28. doi:10.14444/3028.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

Innovasis receives 510k for first Stand-Alone ALIF System made from PEEK-OPTIMA™© HA Enhanced polymer

Salt Lake City, UT, April 28th, 2017 – Innovasis, Inc. is the first company to receive US FDA 510(k) clearance for a Stand-Alone ALIF* System made from PEEK-OPTIMA™© HA Enhanced polymer from Invibio©.  Designed for use in spinal-fusion procedures, the implantable Ax™ Stand-Alone ALIF System implants contain osteoconductive hydroxyapatite (HA) fully integrated into the matrix of the polymer and exposed on all surfaces of the body of the implant, including within the inner walls of the graft chamber.

This is the second PEEK-OPTIMA HA Enhanced device marketed by the company.  At the end of Q416 the company launched a PxHA a PLIF device made from the same material.

The Innovasis Ax Stand-Alone ALIF System is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and is inserted using an anterior lumbar interbody fusion (ALIF) procedure.

The Ax Stand-Alone ALIF implant also features a tapered leading edge, which aids in implant insertion within limited anatomical space. It also features a slightly convex profile to match the anatomy of the spine and provide a stable anti-migration surface during the fusion process. The large graft cavity provides increased volume for autograft loading. 

About Innovasis
Innovasis, Inc. is a rapidly growing company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery. Innovasis is fully committed to providing surgeons and distributors with training, support and excellent customer service, thus ensuring the establishment of a strong and long-term strategic partnership.

 

Ortho Sales Partners Announces the Addition of Amanda Tracy as Senior Vice President of Business Development

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is pleased to announce the addition of Amanda Tracy as Senior Vice President of Business Development, further filling out its team of orthopedic and spine industry veterans. Ms. Tracy is a talented and well respected industry leader that has spent her career helping companies find solutions to complex problems.

Ms. Tracy is the third high-profile hire for Ortho Sales Partners in recent months and comes at an opportune time as the business continues to grow by assisting companies approach commercialization while mitigating the risks associated with such a big task. In recent years, there has been a huge shift in the market that reveals a reduction of surgeon influence with the adoption of new technologies. Ortho Sales Partners works with orthopedic and spinal device manufacturers to leverage their significant relationships with surgeons, distributors and national buying groups to help their clients realize faster growth while taking advantage of the economies of scale that have been implemented.

Ms. Tracy joins Ortho Sales Partners with 20 plus years of professional expertise. Notable is her most recent 10 years spent as the Vice President of Global Market Development for Musculoskeletal Clinical Regulatory Advisors, LLC ( MCRA).  Ms. Tracy established the business development function after joining MCRA during its early growth stage. Over tenure, Ms. Tracy played an instrumental role in expanding the firm’s portfolio services beyond its initial regulatory affairs service offering. Prior to MCRA, Ms. Tracy held senior product roles that included work for : Cyberonics ( LivaNova), Janssen Pharmaceutica (Johnson and Johnson ) and Eli Lilly and Company.

“I am thrilled to be able to join Ortho Sales Partners executive team at a true industry inflection point, when we can actualize the potential of novel approaches to technology sales execution and commercialization support.” said Ms. Tracy. “As a team, we will work to disrupt a fast-growing industry by building and launching innovative service products that extend Ortho Sales Partners’ current platform and build efficiencies for the industry.”

Maintaining her current geographical location in Southern California, Ms. Tracy will focus on accelerating Ortho Sales Partners innovative line of service offerings to support manufacturers, surgeons, distributors and investors alike. Ms. Tracy will also be representing the brands The De Angelis Group, Surg.io, OrthoExpress and OrthoSpineDistributors.com.

“We are thrilled to bring someone aboard with the pedigree and expertise of Amanda Tracy. We have had the pleasure of knowing her for more than 10 years and have seen first-hand the incremental value she brings to her employers and clients” said Josh Sandberg President, Ortho Sales Partners.  “This hire is another example of our commitment to offering our clients the best possible strategies and outcomes.”

Providence Medical Technology Announces Issuance of Four Additional U.S. Patents

WALNUT CREEK, Calif., April 27, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing cervical spine technology, today announced the U.S. Patent Office’s issuance of four additional patents, Nos. 9,622,873; 9,622,791; 9,622,874; and 9,629,665, covering various aspects of its proprietary DTRAX® and CAVUX® posterior cervical spinal fixation technologies.

These patents cover, among other things, posterior placement of an implant in a facet joint using a chisel and guide tube; placement of an implant in a facet joint using a forked guide tube; placement of implants of various configurations in a cervical facet joint; and distraction of a facet joint after posterior placement of an implant in the facet joint.

These four recent issuances bring the number of issued patents in Providence’s growing patent portfolio to 35 total. Providence has already filed approximately 40 other applications in various stages of prosecution in the U.S. and overseas covering various aspects of its proprietary technologies.

“We have invested tremendous resources over the years in filing both broad and detailed disclosures covering the important aspects of our technology for tissue-sparing posterior cervical and spinal intervention,” commented Jeff Smith, Chief Executive Officer. “We are extremely pleased with the continued and accelerating growth of our patent portfolio as it provides the means to protect our innovations and rapidly expanding business.”

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits in the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com.

Related Links: www.providencemt.com; www.providencemt.com/intellectualproperty/

 

SOURCE Providence Medical Technology, Inc.

Related Links

http://www.providencemt.com