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Exactech Comments on Impact of Hurricanes Irma and Harvey; Adjusts Q3 Earnings Guidance and Announces Q3 Earnings Call

Posted On October 12, 2017 By OrthoSpineNews In Financial /  

October 12, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, said today it is adjusting guidance for the third quarter of 2017 as a result of the impact of Hurricanes Irma and Harvey.

CEO and President David Petty said the estimated US revenue impact of the two hurricanes was approximately $1.2M to sales in Q3 across Florida, Texas, Georgia and the Carolinas.

“We were fortunate that our facilities were undamaged during the hurricanes. However, the storms caused our surgeon customers in the affected states to postpone scheduled surgeries, directly affecting our Q3 revenue stream. In addition, due to hurricane preparation procedures at our Gainesville and Sarasota locations, our manufacturing and shipping operations lost two days of operating capacity. As a result, domestic revenues were near the bottom of our expectations. We now expect to report approximately $61.4MM in worldwide revenue for the third quarter. We also are adjusting our EPS guidance for the quarter to $0.19-$0.21 per share, a reduction of approximately $0.04 per share from our previously issued guidance of $0.23-$0.25 per share due to the net income impact of these lower revenues as well as the impact of the operations interruption,” Petty said.

The company will release its third quarter 2017 financial results on Monday, October 30, 2017. A copy of the earnings release will be available at http://www.hawkassociates.com.

The company will host a conference call with CEO David Petty and key members of the management team on Tuesday, October 31 at 10:00 a.m. Eastern Time. The call will cover Exactech’s third quarter 2017 results. Mr. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 1-800-334-0872 any time after 9:50 a.m. Eastern on October 31. International and local callers should dial 1-719-325-4845. A live webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm or http://public.viavid.com/index.php?id=126701. This call will be archived for approximately 90 days.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech, Inc. can be found at http://www.exac.com. Copies of Exactech’s press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.exac.com and http://www.hawkassociates.com.

An investment profile on Exactech may be found at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech, Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Media contact
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

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Oska Wellness Wins TechCo’s 2017 Startup of the Year Competition

Posted On October 12, 2017 By OrthoSpineNews In Extremities, Sports Medicine, Top Stories /  

October 11, 2017/Adam Rowe

Oska Wellness, a health-tech, wearable pain relief device startup based out of Carlsbad, CA, is the 2017 Startup of the Year winner.

The announcement, made at the Innovate Celebrate conference held by TechCo in partnership with CTA, came following a three-day event attended by 100 startup semifinalists, and eventually narrowed down to five finalist startups today. Of all contestants at the wide-sweeping startup competition, Oska Wellness has officially risen to the top.

As the first-place winner, Oska Wellness will receive a prize package worth potentially $150,000 and from a list of companies including Start Co., 500 Startups, Techstars, Dreamit Ventures, Business Blocks, American Airlines, and Moo.

Oska Wellness Is the 2017 Startup of the Year

Oska Wellness designs a technology that can help areas of the body prone to injury and degeneration. You can listen to their final competition pitch below, and can watch the other four startup of the year finalists pitch here.

 

READ THE REST HERE

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NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology

Posted On October 12, 2017 By OrthoSpineNews In Regulatory /  

SAN DIEGO, Oct. 12, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s PRECICE® system from NuVasive Specialized Orthopedics™ (NSO) with expanded indications that now include open and closed fracture fixation, pseudoarthrosis, malunions, nonunions, and bone transport.

The PRECICE system is an innovative, market-leading solution to treat patients with limb length discrepancy, limb deformities and chronic nonunions. The platform consists of an intramedullary device that once implanted utilizes an external remote controller to non-invasively compress and distract long bones. The key to the PRECICE platform is the magnetic interaction between the PRECICE intramedullary nail and external remote control. The proprietary technology includes a complex internal gear system remotely activated and controlled by permanent magnets. This advancement in limb reconstruction allows for a precision controlled distraction phase with the ability to non-invasively customize treatment.

Prior to the expanded FDA clearance, the PRECICE system was indicated for limb lengthening of the femur and tibia. The system is now indicated for bone transport of long bones in addition to limb lengthening. Bone transport is a technique that allows for regeneration of bony tissue and is typically used to fill segmental bone loss due to trauma or infection, i.e. infected nonunions, segmental defect, and chronic bone infections. The expanded indications for use allows the Company to continue to build a platform for further growth in the limb reconstruction and trauma markets.

“This FDA 510(k) clearance of PRECICE for expanded indications, including bone transport, demonstrates the evolving innovative capabilities of our technology to transform and expand the limb reconstruction and trauma markets,” said Massimo Calafiore, president of NSO. “NSO remains committed to providing trauma surgeons with proper solutions to treat unmet clinical needs and challenging fractures. This allows us to treat more patients suffering from debilitating segmental bone defects through the use of PRECICE in bone transport procedures.”

The Company has also created a patient and family online resource dedicated to providing information on limb length discrepancy with Reach Your Height. The digital resource center provides education on treatment options and shares patient success stories. To learn more, visit reachyourheight.com.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. 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

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New System Designed to Enhance Implant Fixation for Hip Fracture Patients with Poor Bone Quality Launches in the U.S.

Posted On October 12, 2017 By OrthoSpineNews In Recon, Top Stories /  

WEST CHESTER, Pa., Oct. 12, 2017 /PRNewswire/ — Today DePuy Synthes* announced the U.S. launch of the new TFNA Augmentation System, the first and only polymethylmethacrylate (PMMA) cement with specific trauma device indications, offered exclusively for use with the TFNA System. The TFNA Augmentation System is used to address the needs of patients with hip fractures and who have poor bone quality.

The TFNA Augmentation System can be used to provide enhanced implant fixation in cases where the potential risk of cut-out is significant. Cut-out is a loss of implant anchorage or stability in the bone, frequently occurring in those with poor bone quality. It causes the femoral neck-shaft angle to collapse, and is a leading clinical complication during hip fracture surgery. Cut-out can also lead to reoperation, which increases risks to the patient and increases costs to the healthcare system. Each year, more than 300,000 hip fractures occur in the U.S.1 These fractures are common in the elderly, especially those with osteoporotic bone. Fractures are expected to increase as the population ages.2 When used together with the TFNA System, the TFNA Augmentation System is designed to help reduce the risk of cut-out and provide enhanced implant fixation.3,4

“The TFNA Augmentation System addresses an important clinical need for patients who undergo hip fracture surgery, especially those who suffer from poor bone quality,” said Charisse Y. Sparks, MD, Franchise Medical Leader Trauma, DePuy Synthes Trauma. “This new system complements the TFNA System and has the potential to improve patient outcomes, reduce costs, and increase patient satisfaction.”

About DePuy Synthes 
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies**, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of the TFNA Augmentation System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.

**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

DSUS/TRM/0817/1555

1 Agency for Healthcare Research and Quality. National and regional estimates on hospital use for all patients from the HCUP Nationwide Inpatient Sample (NIS). 2013.http://www.ahrq.gov/research/index.html. Accessed 12 October 2015.

2 Cummings SR. Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs and potential effect of postmenopausal estrogen. Clin Orthop Relat Res. 1990;252:163-166

3 DePuy Synthes test data on file, Windchill 0000268245. 

4 Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann M, Windolf M, Gueorguiev B. Biomechanical effect of bone cement augmentation on the fixation strength of TFNA blades and screws. Presented at 22nd Congress of the European Society of Biomechanics. 10-13 July 106. Lyon, France.

 

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

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In Start to Unwinding the Health Law, Trump to Ease Insurance Rules

Posted On October 12, 2017 By OrthoSpineNews In Regulatory /  

October 12, 2017/APhA

President Trump is expected to sign on Thursday an executive order that would initiate the unwinding of the Affordable Care Act (ACA). With the order, the president will direct federal agencies to take actions aimed at providing less expensive options and fostering competition in the individual insurance markets. According to two senior White House officials, the specific steps in the order will represent just the first moves in his White House’s effort to strike parts of the ACA. By increasing alternative insurance arrangements that would be exempt from some key ACA rules, the change would provide more choices for consumers. Health insurance experts note, however, that it could increase costs for sicker individuals by drawing together healthier, younger consumers to the alternative plans, which could be cheaper and provider fewer benefits. The executive order will seek to increase access to plans that allow small businesses and possibly individuals band together to purchase insurance. In addition, it will life limits on the sale of short-term insurance and will expand the ways in which workers use employer-funded accounts to purchase their own insurance policies. White House officials also noted Wednesday that the order would call on agencies to study and issue a report on federal and state policies that could contribute to increasing health costs, including, potentially, the effect of health care provider consolidation.

Wall Street Journal (10/11/17) By: Radnofsky, Louise; Armour, Stephanie; Mathews, Anna Wilde

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Alphatec Denounces “Baseless” NuVasive Complaint

Posted On October 11, 2017 By OrthoSpineNews In Spine, Top Stories /  

CARLSBAD, Calif., Oct. 11, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, released a statement in response to a recent complaint filed by NuVasive, Inc. (Nasdaq:NUVA) against Patrick S. Miles, Alphatec’s recently appointed Executive Chairman.

On October 10, NuVasive, without prior inquiry or notice, filed a baseless lawsuit against Mr. Miles. NuVasive then issued a press release to broadcast the complaint, not to “protect corporate assets” as stated, but in an attempt to inflict maximum damage to the public reputations of both Mr. Miles and Alphatec. The complaint is fictional, and includes disclosures by NuVasive that breach its contractual confidentiality obligations owed to Alphatec.  It was filed by a law firm in violation of its own ethical obligations, as the firm is currently actively representing Alphatec in related matters.

“I was fortunate to be a part of NuVasive’s growth from zero dollars in sales to close to a billion dollars in revenue,” said Mr. Miles.  “I am exceptionally proud of my contribution, and I have lifelong friends who remain affiliated with the organization.  I did not leave NuVasive to damage the company; in fact, I remain a significant shareholder.  I chose to pursue a new opportunity at Alphatec because I want to align my talents and influence with a Company that is focused on serving spine surgeons and their patients.  The allegations made by NuVasive against me are clearly false, and typical of a management team reacting to mass departures of key, spine-experienced executives.  I intend, ultimately, to clear my name. In the meantime, I will not be distracted by baseless claims, and will drive Alphatec’s pursuit of improved surgical outcomes.”

Terry Rich, Alphatec’s Chief Executive Officer, continued, “I have known Pat since I joined him in building NuVasive twelve years ago. He is well known to the spine industry worldwide and is highly respected for his integrity.  The complaint against him is full of false claims, and is nothing more than a PR stunt by NuVasive.  It has been orchestrated to detract from a decaying, toxic culture that has contributed to the resignations of three C-Suite officers since July 2017, and caused dozens of NuVasive employees and countless surgeon customers to reach out to Alphatec, seeking more attractive opportunities. The current issues at NuVasive have nothing to do with Pat. We look forward to continuing to move our business forward under his leadership.”

Mr. Miles plans to file a timely response to the complaint. Alphatec will vigorously support him in this matter.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:

Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com

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K2M’s Lamellar 3D Titanium Technology™, BACS™ Surgical Planner, & RAVINE® Lateral Access System to Be Presented at EUROSPINE 2017

Posted On October 11, 2017 By OrthoSpineNews In Spine /  

LEESBURG, Va., Oct. 10, 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 clinical data related to K2M spinal solutions will be presented at EUROSPINE 2017, occurring October 11–13, 2017, in Dublin. The Company will also showcase its comprehensive product portfolio, 3D-printed spinal solutions, and Balance ACS™ (BACS™) platform at Booth F20.

“Taking a comprehensive approach to spine surgery allows me to address my patients’ individual treatment needs more precisely,” said Robert Lee, FRSC, TR & Orth, a spine surgeon at Royal National Orthopaedic Hospital NHS Trust in Stanmore, UK, and author of five studies on K2M products to be presented this week. “Our research supported favorable findings on surgical planning software, minimally invasive surgical techniques, and 3D porous CASCADIA™ interbody cages that utilize Lamellar 3D Titanium Technology™.”

Data from five clinical studies on K2M’s CASCADIA Interbody Systems featuring Lamellar 3D Titanium Technology, BACS Surgical Planner, and RAVINE® Lateral Access System will be presented:

  • 3D Porous Lamellar Titanium Lateral Interbody Cages: Subsidence Rates Compared to PEEK and Early Clinical Outcomes, Lee R (Poster 26)
  • Clinical and Radiographic Results Following the Use of Lateral Interbody Cages to Restore Lumbar Lordosis in Revision Fusion Surgery, Lee R (Poster 27)
  • 3D Porous Lamellar Titanium versus PEEK and Solid Titanium Interbody TLIF Cages: A Prospective Clinical and Radiographic Comparison, Lee R, Wilson L (Poster 28)
  • Minimally Invasive Anterior Column Reconstruction in Primary Adult Degenerative Scoliosis Correction Surgery, Lee R (Poster 84)
  • Reliability of Pre-Operative Surgical Planning Software in Predicting Postoperative Alignment in Patients Undergoing Minimally Invasive Multilevel Anterior Column Reconstruction for Positive Sagittal Balance Deformity, Lee R (Poster 85)

K2M Chairman, President, and CEO Eric Major said, “We are pleased by the amount of research on K2M products being presented at this year’s EUROSPINE meeting. K2M is leading the way in 3D spinal innovation—as evidenced by our market-leading 3D-printed product portfolio and comprehensive Balance ACS platform—to help surgeons treat many different spinal pathologies both in European countries and across the globe.”

At the meeting, K2M will showcase its comprehensive portfolio of complex spine, minimally invasive, and degenerative solutions, including the CASCADIA Interbody Systems featuring Lamellar 3D Titanium Technology, the EVEREST® Minimally Invasive XT Spinal System, the EVEREST Deformity Spinal System, the RAVINE Lateral Access System, the MESA® Deformity Spinal System, the RHINE™ Cervical Disc System*, and more.

K2M will also feature its Balance ACS platform, which provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. The Company will demo the BACS Surgical Planner, a surgical image measuring technology that assists in planning and preoperative implant selection.

For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

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

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; 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 the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions 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; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

Media Contact:

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

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

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Anika to Issue Third-Quarter 2017 Financial Results and Business Highlights on Wednesday, October 25

Posted On October 11, 2017 By OrthoSpineNews In Financial /  

October 11, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK) today announced that the Company plans to issue its third-quarter 2017 financial results after the close of the market on Wednesday, October 25, 2017 and to hold a conference call the next day, Thursday, October 26, 2017, at 9:00 a.m. ET to discuss its financial results, business highlights, and outlook.

The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation also can be accessed via the Anika Therapeutics website. The call will be archived and accessible on the same website shortly after its conclusion.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®,which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®,a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, Chief Financial Officer
Tel: 781.457.9000
or
For Media Inquiries:
Pure Communications
Sonal Vasudev
Tel: 917.523.1418

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ORHub, Inc. Welcomes Internationally Recognized Spine Surgeon to its Advisory Board

Posted On October 11, 2017 By OrthoSpineNews In Spine, Top Stories /  

NEWPORT BEACH, CA–(Marketwired – Oct 6, 2017) – ORHub, Inc. (OTC: ORHB), an advanced medical software provider focused on real-time digital delivery of case-based data analytics, today announces the appointment of Dr. Choll Kim, an industry-leading physician and instructor in the technological automation of surgical procedures, to its advisory board.

As an internationally renowned expert in the field of computer-assisted, minimally invasive spine surgery, Dr. Kim has considerable insight into the intricate evolution of technology in the surgical sector, an invaluable resource that will strengthen ORHub’s grasp in the marketplace.

“In today’s health care environment, excellent clinical care must be delivered in a cost-effective manner. ORHub recognizes this industry demand, and provides a much-needed point-of-service system that allows both surgeons and hospitals to monitor the time and cost of the entire episode of surgical care. By providing reliable data in a manner that is useful to both surgeons and hospitals, a real collaborative effort can be pursued to optimize patient care. I am excited to be part of ORHub and the important efforts that will arise from improved information gathering and analysis. With this advisory role, I finally feel like I can be a meaningful participant in the ongoing effort to optimize health care efficiency while providing the highest level of care to my patients,” states Dr. Kim.

A leader in his field, Dr. Kim is the founder and past-president of the Society for Minimally Invasive Spine Surgery (SMISS), the founder of Minimally Invasive Spine Centers of Excellence (MIS-COE), the chair of the MIS Committee for the International Society for the Advancement of Spine Surgery (ISASS), the director of the Advanced Spine & Joint Institute at Alvarado Hospital, and an associate clinical professor at the University of California, San Diego.

He utilizes a broad range of minimally invasive treatments to effectively treat all aspects of complex spinal disorders, including herniated disks, spinal stenosis, adult scoliosis, spondylolisthesis, traumatic injuries, tumors, and infections throughout the entire spine — from the neck to the low back. Dr. Kim is one of only a handful of surgeons in the world to master laser endoscopic spine surgery (LESS), a state-of-the-art minimally invasive procedure that effectively treats herniated disks, radiculopathy and sciatica.

Dr. Kim graduated cum laude from Harvard Medical School and completed his fellowship training in complex spine surgery at the Mayo Clinic. He is double-board certified by the American Board of Orthopedic Surgeons and the American Board of Spine Surgery.

“Dr. Kim is a phenomenal addition to our team, as he has gained international recognition in his field, and has trained a new generation of surgeons and operating room personnel in technologically advanced operating systems. As a substantial contributor to the evolving industry, he has trained innumerable specialists throughout the country on the safe and effective application of state-of-the-art techniques using image guidance and navigation technologies. We believe that he will be an invaluable source of knowledge as we grow in the industry,” states ORHub CEO Colt Melby.

About ORHub, Inc.

ORHub is a medical software company focused on delivering case-based data analytics at the speed of surgery. The Company’s suite of products serves the needs of the health care industry, hospital, patient, government and the medical device vendor. ORHub provides a cloud-based software solution that captures information before, during and after surgery, filling a void in the current surgical information infrastructure and providing the first process to capture and measure the surgical process — evolving Big Data into Intelligent Digital Data.

ORHub’s software applications allow hospitals and medical device vendors to utilize any web-enabled device to create an anatomical graphic depiction of exactly what occurs during surgery. The application automatically translates the resulting schematic into an intelligent, electronic operative report that links every detail of surgery, including implant location, surgical techniques, product usage, and all clinical parameters to create a dynamically new source of comparative information.

As a result, hospitals and surgeons can make real-time, data driven decisions to improve business profitability and the quality of patient care. This innovative technology results in hospitals understanding costs and identifying areas of cost reductions, as well as results in increased accountability, automatic creation of comprehensive anatomic implant registries, real-time analytics, improved efficiencies, and compliance with existing government regulations. ORHub has offices in Phoenix, Arizona; Newport Beach, California; and Bellevue, Washington.

For more information, visit www.ORHub.com

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although the Company believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, it can give no assurances that its expectations will be attained. Such statements are inherently uncertain, and actual results and activities may differ materially from those estimated or projected. Certain factors that can affect the Company’s ability to achieve its anticipated results include, among others, uncertainties inherent in the development of a new software product business.

CONTACT INFORMATION

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DePuy Synthes Launches The First 3D Simulation Assisted Orthopaedic External Circular Fixation Device

Posted On October 11, 2017 By OrthoSpineNews In Extremities, Top Stories /  

WEST CHESTER, Pa., Oct. 11, 2017 /PRNewswire/ — DePuy Synthes* is launching the MAXFRAME™ Multi-Axial Correction System, an external circular fixation device used to gradually correct bone or soft tissue deformities in the arm, leg, foot or ankle. The MAXFRAME System’s unique 3D planning software helps improve accuracy of the deformity correction plan, which may reduce overall treatment time while potentially improving procedural efficiency and reducing costs. The device represents DePuy Synthes’ commitment to improving patient satisfaction, procedure efficiency and clinical outcomes in deformity correction.

Limb deformities can be congenital, developmental or acquired as the result of fracture, infection, arthritis or tumor. Left uncorrected, these deformities may lead to amputation and could have a potential cost burden of $500,000i per patient to the healthcare system. External circular fixation products currently on the market require precise X-rays and manual measurements by surgeons, and any inaccuracies can prolong treatment. Patients suffering from limb deformities may require an average of 37 outpatient visits over 12 months,ii iii and one in three patients will experience a residual deformity.iv

Unlike other computer-assisted external circular fixation systems, the MAXFRAME System’s 3D planning software creates accurate patient treatment plans using advanced algorithms, which eliminates the need for manual measurements and requires fewer inputs than any other system on the market. This can potentially lead to a reduction in the number of patient X-rays required, thus reducing procedural complexity, radiation exposure for both the patient and surgeon, and overall costs, while reducing treatment time for the patient.

Patients undergoing treatment with the MAXFRAME System are responsible for adjusting the struts on the device as per their custom treatment plan. These adjustments have been made easier with the system’s newly introduced ASSURE-STRUT™ Technology, wherein each time the patient adjusts the device, there is an audible click as the strut correctly locks into place.

“The MAXFRAME System incorporates three clinically important advantages that help provide great accuracy of correction for the patient and streamline the surgical phase of care,” said Dr. J. Spence Reid, MD, Professor and Chief of Trauma Division, Department of Orthopaedics and Rehabilitation. “The software eliminates significant sources of error inherent in earlier methods by removing the need to determine reference ring mounting parameters, as well as the requirement of ring orthogonality. The system also allows maximum flexibility in the location of strut attachment points on the ring which makes frame application easier, particularly in complex cases, and the ASSURE-STRUT™ Technology allows the patient to confidently make strut adjustments.”

MAXFRAME Patient Care Program
To support patients, DePuy Synthes has developed the MAXFRAME Patient Care Program, which includes a patient app featuring a character named “MAX,” and additional online content is available at www.maxframepatients.com. The program helps patients and their caregivers prepare for surgery, manage treatment and share their experiences through social media channels at the end of their treatment journey.

“There is a significant unmet need for treatment options that reduce both the burden to patients with limb deformities as well as surgical complexity,” said I.V. Hall, Worldwide Platform Leader, Trauma, CMF, Biomaterials and Veterinary Portfolios, DePuy Synthes. “With the launch of the MAXFRAME System, we are building on our long history of innovation, excellence in service and support for surgeons with unique 3D planning software and digital tools that help address these needs and enhance patient and surgeon satisfaction.”

Product Indications
The MAXFRAME System is indicated for the following treatments in adults and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed), pseudoarthrosis of long bones, limb lengthening (epiphyseal or metaphyseal distraction), joint arthrodesis, infected fractures or nonunions, correction of bony or soft tissue deformities, and correction of segmental defects.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies**, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com

i MacKenzie EJ, Jones AS, Bosse MJ, et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. The Journal of bone and joint surgery. American volume. Aug 2007;89(8):1685-1692.
ii Lerner J, Holy CE, Menzie A. Cost of post-operative care after implantation of multiplanar stereotactic-assisted external fixation systems. Poster presented at: 21st Annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Meeting, May 21-25, 2016; Washington, DC, USA.
iii Fenton P, Bose D. Patient-reported outcomes following treatment of tibial non-union with circular frames. Strat Traum Limb Recon. 2014;9(1):33-5.
iv Kucukkaya M, Karakoyun O, Armagan R, Kuzgun U. Calculating the mounting parameters for Taylor Spatial Frame correction using computed tomography. Journal of orthopaedic trauma. Jul 2011;25(7):449-452

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

DSUS/TRM/1017/1620

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

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