Hospitals’ can’t afford not to’ provide value-based care

By Tara Bannow  | July 2, 2018

LAS VEGAS—The calls for health systems to ditch fee-for-service payment in favor of value-based models were downright urgent at this year’s Healthcare Financial Management Association conference in Las Vegas.

“We can’t afford not to make the change,” David Hammer, a principal in Healthcare Performance Management Consultants’ revenue cycle and managed-care practice in Fort Lauderdale, Fla., told attendees on the conference’s opening day.

It’s been a topic of discussion at the annual conference for years. But this year, conversations seemed to indicate a breaking point. Healthcare costs are unsustainable, and anyone not on the capitation train—or at least without a ticket in their hand—is part of the problem, presenters echoed.

Speakers also acknowledged the real fear C-suite leaders have about taking that leap. When margins are already squeezed, they offered, it can be hard to agree to a change that could decrease revenue further. Indeed, individual discussions with health system leaders revealed more caution than was present in thought leaders’ presentations.

“Honestly, there is too much fear,” said Christer Johnson, health analytics advisory leader with Ernst & Young. “They’re not clear on how they’re going to make money. And that’s why the bundled-payment programs are voluntary today.”

Nonetheless, the resounding theme of this year’s HFMA conference: It’s time to bite the bullet.

In his keynote speech June 25, HFMA President Joseph Fifer urged a packed audience to forge ahead into the value-based unknown, despite a recent study by the HFMA, Leavitt Partners and McManis Consulting that found such models didn’t lower the total cost of care. He attributed the finding to a lack of incentive in those programs to lower the cost of care and too little downside risk and upside opportunity.

The chief financial officers of the future have a different mindset, he said. They’re willing to implement payment models that truly share the risk and use metrics to assess the return on investment.

“If you invest, you’re part of the solution, even if your fee-for-service revenue goes down,” Fifer said. “But if you don’t invest, someone else will. And the revenue could still go down.”

A forward-thinking CFO will also formulate a value-based payment arrangement that fits within his or her specific health system and market, he said. Perhaps that’s why discussions about such programs can begin to sound nebulous, like when you’ve seen one, you’ve seen one.

Health systems at different levels of adoption

Only a very small proportion of the hip and knee replacements performed on commercially insured patients at Providence St. Joseph Health’s hospitals are paid for in bundles, or lump sums regardless of whether the total cost exceeds that amount. On the Medicare side, the Renton, Wash.-based system has seen its costs decrease significantly since it started participating in the CMS’ Comprehensive Care for Joint Replacement bundles, said Kevin Fleming, Providence St. Joseph’s vice president of orthopedics and sports medicine. Twenty of the system’s 50 hospitals are enrolled in the joint replacement program.

“Working with those government bundles really caused us to re-examine what we were doing and take a whole new approach—not being so laser-focused on what’s going on within the four walls of our own hospital and looking at what we’re doing for patients before they come to the hospital and then after discharge,” he said.

Even the system’s markets that aren’t enrolled in the CMS program have adopted some of those hospitals’ value-based strategies, such as using case managers to make sure patients get the right care once they leave the hospital, Fleming said.

Globus Medical Adds Two Innovative Solutions to Growing Trauma Portfolio

AUDUBON, Pa., July 03, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today the expansion of its orthopedic trauma product portfolio with two new product offerings, the ANTHEM® Ankle Fracture System and the ANTHEM® Proximal Humerus Fracture System, marking the Trauma division’s fourth and fifth comprehensive product launches over the last 10 months.

“This is an exciting time for Globus Trauma as we continue to execute our product launch strategy and build a comprehensive Trauma product portfolio,” said Barclay Davis, Vice President, Orthopedic Trauma. “With each new product introduction, our goal is to design systems that help streamline the procedure, increase versatility, reduce operative time, and improve patient care.”

ANTHEM® Ankle Fracture Plating and other lower extremity systems will be exhibited at the annual American Orthopedic Foot and Ankle Society Meeting in Boston, Massachusetts July 11th-14th.  Globus Medical invites meeting attendees to Booth 206 to experience its recent product innovations and discuss trauma advancements with the company’s product development experts.

  • The ANTHEM® Ankle Fracture System is an extensive range of 7 unique plating options for treatment of virtually any ankle fracture. Over 25% thinner than the market leader’s plate, ANTHEM®’s low profile ankle fracture plates are designed to minimize soft tissue irritation from implant prominence. Anatomically contoured plates, extensive screw options and instruments specifically designed for ankle anatomy are rolled into one efficient and comprehensive system for treating ankle fractures.
  • The ANTHEM® Proximal Humerus Fracture System is designed to treat a wide variety of shoulder fractures and streamline procedural flow. The unique polyaxial screw technology allows for more accurate targeting of dense calcar bone to enhance fixation, independent of plate position. Large suture holes simplify suture attachment for soft tissue or rotator cuff repair. This comprehensive stand-alone system includes small fragment instruments and innovative retractors to help streamline the surgical procedure, aid in visibility of the fracture site, and optimize surgical time.

Indications

The ANTHEM™ Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint.

Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults.  Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.

To learn more about the complete line of Globus Medical Trauma products visit www.globusmedical.com/trauma.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com

University Hospital Center of Grenoble Alpes (CHUGA) Becomes the 20th University Hospital Equipped with the EOS® System in France

July 03, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the installation of its EOS® system at the University Hospital Center of Grenoble Alps (CHUGA), a state-of-the-art hospital facility for osteoarticular surgery in children and adults. CHUGA is the 20th university hospital center to acquire an EOS® system, and the new system will be dedicated to the center’s clinic as well as to clinical research activities.

With more than 2,100 beds, CHUGA employs nearly 8,000 professionals, including 1,700 doctors. It has an advanced technical platform and provides highly specialized care. The center’s teams are recognized for their excellence in orthopedic surgery, particularly in the field of advanced surgical techniques assisted by navigation or robotics.

The new EOS system will be located in the pediatric radiology department within the pediatric section of the hospital. It will be used in the care of both pediatric and adult patients through a collaboration with two adult orthopedic services located in the North and South Poles of CHUGA.

“The EOS system will allow us to further develop the clinical care of our pediatric patients through imaging at low radiation dose. It will also significantly accelerate our collaborative research programs with EOS on the orthopedic treatment of scoliosis with braces,” commented Professor Aurélien Courvoisier, Pediatric Orthopedic Surgeon.

“We are very pleased to serve the Grenoble Hospital Center for clinical and research applications,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “The patient has always been our main concern as we work to spread low-dose, 2D/3D imaging capabilities. EOS has changed the care of osteo-articular pathologies and has become a standard thanks to lower radiation, higher accuracy, and 3D imaging of the full body, all of them valuable in choosing the most effective treatments, preparing surgical intervention, as well as in post-operative follow-up. On the research side, we hope to open new perspectives on the treatment of spinal deformities with braces, and will also pursue collaborative programs on the integration of the EOS examination data in the operating room.”

About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Marie Meynadier, Ph: +33 (0)1 55 25 60 60
CEO
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman, Ph: 646-536-7006
The Ruth Group
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
Ph: 646-536-7008 / 7024
The Ruth Group
EOS-imagingIR@theruthgroup.com

Woven Orthopedics raises $5m

 By 

Woven Orthopedic Technologies has raised $5.4 million in a new round of equity and options financing, according to an SEC filing posted this week.

Manchester, Conn.-based Woven Orthopedics is developing orthopedic products which aim to improve fixation, specifically for procedures using screws, according to the company’s website.

The company produces the OGmend implant system which uses biotextiles to enhance fixation. The first generation version of the device is designed from a biopolymer intended to increase surface area contact between bone and screw to distribute load transfer and aid in bone healing and remodeling, according to the company’s website.

A total of 64 unnamed investors have joined in the round so far, with the first sale date noted last August 9. The round has a minimum investment of $50,000, according to the filing.

Of the funds raised so far, $469,000 will be used to pay the CEO and six directors of the company for its calendar year 2018. The company is looking to raise an additional $12.6 million in the round, according to the filing.

 

READ THE REST HERE

 

The bad news keeps coming for MiMedx and its new auditor EY

July 3, 2018  – By Francine McKenna, Reporter

MiMedx Group, Inc. played a version of, “Can you top that?” on Monday, when the troubled biopharmaceutical company installed an interim CEO and a new board chairman following the latest wave of executive departures.

The company’s stock MDXG, -8.37%  tumbled 38% on the news, sending it to its lowest level since September, 2013.

The company appointed Charles R. Evans, previously the company’s lead independent director, as chairman of the board, replacing Parker H. “Pete” Petit who resigned as board chairman and chief executive. It named David Coles to serve as interim CEO, according to a press release.

Chief operating officer William C. “Bill” Taylor also resigned his role and left the board.

The news follows the dramatic announcement on June 7 that the company’s CFO and its controller/treasurer would exit after MiMedx said it would restate more than five years of financial statements, for the period stretching from 2012 through 2016, and the first three quarters of 2017. All communications and financial information, it said at the time, with respect to the fourth quarter of 2017 and the first quarter of 2018 “should no longer be relied upon,” the company said. It withdrew all prior guidance for 2018.

That’s four times more periods reviewed than the average, signaling a substantial and long-standing problem, research firm Audit Analytics wrote in its analysis of the announcement.

“A financial restatement of this magnitude is a significant red flag in respect to a company’s accounting quality,” Audit Analytics wrote in early June.

Coles is taking the assignment on an interim basis, while continuing to act as a Managing Director with Alvarez & Marsal, a global professional services firm that advises and provides turnaround and restructuring services to companies, including providing interim management.

Coles served as the CFO, principal accounting officer, treasurer and controller at Lehman Brothers Holdings, Inc. from September 2008 to February 2009. He worked for Arthur Andersen & Co. in the U.K. and New York before joining Alvarez & Marsal in 1996.

In describing the actions already taken to “promote accountability and strengthen oversight” MiMedx said it had retained “a leading, operationally focused finance and accounting consultancy firm to provide interim leadership for the chief accounting officer, corporate controller and other financial roles.”

Coles’ appointment seems to be part of a larger engagement for Alvarez & Marsal to provide interim staffing to a company that is suddenly bereft of senior management.

 

READ THE REST HERE

 

Kuros Biosciences Reports First U.S. & UK sales of MagnetOs

SCHLIEREN (ZURICH), Switzerland, July 02, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX:KURN) announced today it recorded the first commercial use last week of MagnetOs in the U.S., and the company expects to ramp up its commercial activities in Europe and the U.S. in the second half of 2018.

Joshua M. Ammerman, M.D. of Washington Neurosurgical Associates in Washington DC, successfully performed minimally invasive spinal fusion using MagnetOs Putty, and was satisfied with the handling and performance of MagnetOs.  Dr. Ammerman is a nationally and internationally recognized expert in the application of minimally invasive surgical techniques to disorders of the brain and spine.

Prior to this, the first commercial European use of MagnetOs occurred in the UK. Mr. Stewart Tucker MBBS, FRCS (Eng), FRCS (Ortho), performed a scoliosis intervention using MagnetOs Granules at the Wellington Hospital in London.  Mr. Tucker is Consultant Spinal Surgeon at Great Ormond Street Hospital for Children, and his specialist interests include childhood and adult scoliosis/kyphosis, degenerative cervical and lumbar disease, spinal trauma and spinal tumors, and complex revision spinal surgery.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “After reporting successful case studies with MagnetOs at last week’s State of Spine Surgery Think Tank, we are delighted to now report the first commercial usage of MagnetOs in the U.S. and Europe.  We commend Dr. Ammerman and Mr. Tucker for pioneering the clinical use of MagnetOs and look forward to ramping up our commercial effort in the U.S. and selected geographies in Europe, as we continue to execute on our strategy to build a leading orthobiologics company.”

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact: 
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

LifeSci Advisors
Hans Herklots
Media & Investors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG 
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

Medovex Corporation’s DenerveX System Demonstrates Clinical Benefits in Patients Suffering from Low Back Facet Joint Pain

ATLANTA, July 02, 2018 (GLOBE NEWSWIRE) — Medovex Corp. (OTCQB:MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced the release of patient data that demonstrates clinical benefits of its DenerveX System in patients suffering from low back facet joint pain at 6 months post-treatment.

Facet Joint Syndrome (FJS) is among the leading causes of low back pain and affects millions globally. Typically manifesting from spinal osteoarthritis (OA), FJS is a painful, chronic condition whose treatment options, often temporary in nature, have remained unchanged in the past four decades.

Medovex’s DenerveX is a novel, minimally invasive system developed to provide potential long-term relief via a combination of controlled thermal energy and rotational capsular tissue shaving of the bony structure to disrupt nociceptive signals and receptors. The Company hypothesized that use of this novel system would result in sustained pain relief and improved health metrics associated with mobility.

Methods

This prospective multicenter European cohort included patients with chronic intractable pain of the low back resulting from FJS who had failed conservative treatments for pain. Patients who were treated between July 2017 and February 2018 were evaluated for joint groupings treated, pain and quality of life as measured by the visual analog score (VAS), medication log, Oswestry Disability Index (ODI) and EQ-5D-5L. Follow-up was conducted at 1, 3, and 6 months post-treatment; data reported correspond to these time points.

Results

Results from 61 patients (60.7% females; average age 55.1±11.5 years) were evaluated. Prior to treatment, 47 patients regularly used one or more prescribed analgesics and had predominately undergone either physiotherapy (81.4%), spinal injections (86.4%), or both to help alleviate pain. A total of seven joint groupings were treated, with L3 – S1 (45.6%) and L4 – L5 (17.5%) being the most common. Baseline average VASback prior to treatment was 74.7±14.2mm, a 42.0±16.6 ODI score with a EQ-5D-5L score of 3 (out of 5). At 1, 3, and 6 months post-treatment, VASback decreased to 31.7±17.5mm (-57.5%), 25.5±22.9mm (-65.8%), and 17.7±18.3mm (-76.3%). Similarly, ODI 1, 3, and 6 months post-treatment decreased to 19.9±14.4 (-52.7%), 20.1±15.0 (-52.3%), and 14.1±9.9 (-66.4%). These decreases from baseline were consistently observed in more than half of the population. EQ-5D-5L scores post-treatment remained, on average 32% below baseline values.

Conclusions

Review of real world cases from five independent sites across Europe demonstrated reduction in pain scores and general improvement of health metrics up to 6 months following treatment as evidenced by VASBACK, ODI and EQ-5D-5L.

Jill Schweiger, Medovex Senior Vice President of Regulatory, Clinical and Quality stated, “We are pleased to present these initial results which affirm our belief that the DenerveX System provides significant quality of life improvement and relief from pain associated with facet joint syndrome. We look forward to releasing one-year data as soon as it is available.”

The Company also plans in upcoming months to attend EuroSpine 2018 in Barcelona, Spain, NASS 2018 In Los Angeles, California and the annual DWG Meeting in Wiesbaden, Germany to support further sales and marketing activities. It also presented its DenerveX in Adelaide, Australia during the SSA (Spine Society of Australia) with sizeable audience interest, followed by ten successful first cases.

After successful INVIMA product approval in Colombia, first DenerveX cases are scheduled for July 14, 2018 in Medellin followed by additional cases in Bogota and other areas throughout Colombia.

In April, the Company was issued two US patents and a trademark covering the EU for “Rotacapsulation”.

  • Patent No: US D810,290S Surgical Portal Driver
  • Patent No: US 9,883,882 Minimally Invasive Methods for Spinal Facet Therapy to alleviate pain and associated surgical tools, kits and instructional media

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement                                                     

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact Information

K2M Group Holdings, Inc. to Release Second Quarter of Fiscal Year 2018 Financial Results on August 1, 2018

LEESBURG, Va., July 02, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced that second quarter of fiscal year 2018 financial results will be released after the market close on August 1, 2018.

Management will host a conference call at 5:00 p.m. Eastern Time on August 1, 2018 to discuss the results of the second quarter, and to host a question and answer session. Those who would like to participate may dial 866-393-4306 (734-385-2616 for international callers) and provide access code 4666247 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 855-859-2056 (404-537-3406 for international callers); access code 4666247. The webcast will be archived on the investor relations section of the Company’s website.

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 in FacebookTwitterInstagramLinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. 

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use 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 payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; 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 associated with the exit of the United Kingdom from the European Union; 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 a fiscal 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; 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 price; our lack of current plans to pay cash dividends; 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.

SeaSpine Names Names Dennis L. Cirino Senior Vice President, Spinal Systems

CARLSBAD, Calif., July 02, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has appointed Dennis L. Cirino to the newly created position of Senior Vice President, Spinal Systems, effective immediately.

Mr. Cirino brings over 25 years of spine industry experience with numerous leadership roles in sales and marketing.  Prior to joining SeaSpine, Mr. Cirino spent eight years at NuVasive, Inc., where he served in roles of increasing seniority, most recently serving as vice president of market development for computer-assisted surgery. Prior to NuVasive, Mr. Cirino spent ten years at Medtronic, where he held senior marketing, development and marketing services positions focused on spinal systems, biologics, and pain stimulation. Mr. Cirino holds a Bachelor of Science in Business Administration from Duquesne University and a Master of Business Administration from the University of Notre Dame.

As Senior Vice President, Spinal Systems, Mr. Cirino will lead all aspects of the Company’s spinal implants activities and initiatives.  In this capacity, he will set direction for product innovation and development, marketing services, surgeon and sales education, and international strategy.

“Dennis’ deep experience building robust marketing programs, implementing international strategy, and driving surgeon education will serve us well as we leverage our recently launched and increasingly differentiated products, which are critical to accelerating our revenue growth,” said Keith Valentine, president and chief executive officer of SeaSpine. “His strong relationships in the spine industry further strengthen our surgeon-centric approach to product innovation and mission to deliver cost effective solutions to improve the quality of patient lives.”

“SeaSpine’s focus on innovation and clinical value coupled with its increasing investment in medical education and training has positioned the company as the spine company of choice among both surgeons and distributors,” said Mr. Cirino.  “I am thrilled to join this outstanding team and look forward to contributing to their powerful vision.”

Inducement Awards
As an inducement to accepting employment with the Company, on June 30, 2018, the Compensation Committee of the Company’s Board of Directors approved a restricted stock unit award to Mr. Cirino with respect to 39,619 shares of SeaSpine common stock, as well as restricted stock unit awards to seven new, non-executive employees with respect to an aggregate of 6,660 shares of SeaSpine common stock.  The awards are being granted under SeaSpine’s 2018 Employment Inducement Incentive Award Plan, which was adopted on June 29, 2018, and provides for the granting of equity awards to new employees of SeaSpine.  The awards will be granted effective on the date SeaSpine files a registration statement registering the common stock underlying the awards, which filing is expected to occur this month, and will vest in substantially equal installments on each of the first three anniversaries of the grant date.  The awards are intended to comply with Nasdaq Marketplace Rule 5635(c)(4).

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: Mr. Cirino’s ability to leverage the Company’s recently launched products to accelerate revenue growth and Mr. Cirino’s ability to strengthen the Company’s product innovation and ability to deliver cost effective solutions to improve the quality of patient lives.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients; the Company’s ability to attract new, high-quality distributors; pricing pressure; supply shortages; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com