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Current Issues in Spine

February 2-4, 2017
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ExtremitiesSports Medicine

Knee surgery: Have we been doing it wrong?

August 7, 2017 OrthoSpineNews

August 7, 2017, MDLinx/University at Buffalo Health and Medicine News

Cleaning up loose cartilage is not always beneficial, according to a new University at Buffalo study that could impact athletes and seniors, reduce health care costs.
A team of University at Buffalo medical doctors has published a study that challenges a surgical practice used for decades during arthroscopic knee surgery.

When treating meniscal tears surgeons also have clipped and smoothed any dislodged cartilage they found in the belief it was helping patients. But the new study finds that practice does not benefit the patient. Patients who did not have dislodged cartilage removed, recovered faster, with less pain, and ended up a year later with identical results.

“Those with less surgery got better faster in comparison with the people we did more surgery on,” said Leslie J. Bisson, MD, professor and chair in the Department of Orthopaedics at the Jacobs School of Medicine and Biomedical Sciences at UB and lead author of the study.

The finding was so surprising that an editor at The Journal of Bone & Joint Surgery, which published the study, also published a commentary that said, “The conclusion that unstable cartilage lesions do not need debridement could have a dramatic impact on practice management, save health–care dollars, and improve early patient outcomes.”

The American Academy of Orthopaedic Surgeons also distributed the study on its weekly collection of papers of note.

 

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Financial

SeaSpine Reports Second Quarter 2017 Financial Results

August 7, 2017 OrthoSpineNews

CARLSBAD, Calif., Aug. 03, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the second quarter ended June 30, 2017.

Second Quarter 2017 Financial Highlights and Recent Accomplishments

  • Revenue of $34.2 million, an increase of 3.0% year-over-year
  • U.S. revenue of $30.4 million, an increase of 1.1% year-over-year
    — U.S. orthobiologics revenue of $16.0 million
    — U.S. spinal instrumentation revenue of $14.4 million
  • International revenue of $3.8 million, an increase of 20.5% year-over-year
  • Full commercial launch of the Mariner® Posterior Fixation System, a modular pedicle screw system that provides surgeons with multiple intra-operative options to facilitate posterior lumbar fixation
  • Limited commercial launch of the Skipjack™ Expandable Interbody System, an expandable interbody system that provides in-situ expansion in either height or lordosis for an improved anatomical fit

“We are pleased with our second quarter results, which reflect our ongoing commitment to develop innovative and cost effective solutions to treat spinal disorders and expand our distributor footprint,” said Keith Valentine, President and Chief Executive Officer. “We remain focused on our mission to drive improved procedural solutions that combine efficient spinal instrumentation systems with industry leading orthobiologics to deliver clinical value to surgeons, hospitals, and patients.”

Second Quarter 2017 Financial Results
Revenue for the second quarter of 2017 totaled $34.2 million, a 3.0% increase compared to the same period of the prior year. Total revenue in the U.S. was $30.4 million, a 1.1% increase compared to the same period of the prior year due primarily to the improved performance of orthobiologics distributors during the current year period.

Orthobiologics revenue totaled $17.6 million, a 4.8% increase compared to the second quarter of 2016. The growth in orthobiologics revenue was driven by an increase in U.S. sales. Spinal instrumentation revenue totaled $16.6 million, a 1.1% increase compared to the second quarter of 2016 that was driven by stocking orders from a recently added distributor in Latin America.

Gross margin for the second quarter of 2017 was 59.1%, compared to 58.0% for the same period in 2016.  The increase in gross margin was mainly driven by lower manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility.  This was partially offset by a $0.2 million increase in non-cash amortization of technology intangible assets acquired in September 2016 from N.L.T. Spine Ltd and by lower gross margins associated with international sales, which were slightly higher as a percentage of total revenue in the second quarter of 2017 compared to the same period of the prior year.

Operating expenses for the second quarter of 2017 totaled $28.4 million, compared to $31.5 million for the same period of the prior year.  The $3.1 million decrease in operating expenses was driven by lower selling, general and administrative and intangible amortization expenses.

Net loss for the second quarter of 2017 was $8.0 million, compared to a net loss of $12.0 million for the second quarter of 2016.

Cash and cash equivalents at June 30, 2017 were $12.3 million and the Company had $4.0 million of outstanding borrowings against its $30.0 million credit facility. The Company realized $4.6 million in net proceeds in the second quarter of 2017 through the sale of approximately 477,000 shares of its common stock under its “at the market” equity offering program.

2017 Financial Outlook
SeaSpine expects full-year 2017 revenue to be in the range of $130.0 million to $133.0 million, reflecting growth of 1% to 3% over full-year 2016 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 49156714. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

About SeaSpine
SeaSpine 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 instrumentation 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 instrumentation 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 instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete 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: revenue expectations for full-year 2017.  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, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the Company’s ability to attract and retain new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; unexpected expense, including as a result of developing and supporting the launch of new products; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; 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.

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended June 30, Six Months Ended June 30,
2017 2016 2017 2016
Total revenue, net $ 34,196 $ 33,201 $ 66,090 $ 64,600
Cost of goods sold 13,994 13,930 27,166 28,213
Gross profit 20,202 19,271 38,924 36,387
Operating expenses:
Selling, general and administrative 24,249 26,989 48,219 52,363
Research and development 3,344 3,181 6,394 5,934
Intangible amortization 792 1,281 1,584 2,562
Total operating expenses 28,385 31,451 56,197 60,859
Operating loss (8,183 ) (12,180 ) (17,273 ) (24,472 )
Other income (expense), net 185 (232 ) 172 26
Loss before income taxes (7,998 ) (12,412 ) (17,101 ) (24,446 )
Provision (benefit) for income taxes 45 (429 ) 45 (456 )
Net loss $ (8,043 ) $ (11,983 ) $ (17,146 ) $ (23,990 )
Net loss per share, basic and diluted $ (0.68 ) $ (1.07 ) $ (1.46 ) $ (2.15 )
Weighted average shares used to compute basic and diluted net loss per share 11,888 11,179 11,705 11,173
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
June 30, 2017 December 31, 2016
Cash and cash equivalents $ 12,287 $ 14,566
Trade accounts receivable, net of allowances of $522 and $483 21,689 20,982
Inventories 42,515 45,299
Short-term debt — 445
  Total current liabilities 25,617 24,418
Long-term borrowings under credit facility 3,994 3,835
Total stockholders’ equity 105,466 110,977

 

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

OrthoPediatrics Corp. Launches New Pediatric Specific Clavicle Plates

August 7, 2017 OrthoSpineNews

WARSAW, INDIANA (PRWEB) AUGUST 04, 2017

OrthoPediatrics Corp. is pleased to announce the launch of the PediFrag™ Pediatric Specific Clavicle Plate. This innovative new plate is specifically designed for treating mid-shaft clavicle fractures in young patients. The OP Clavicle Plates are unique due to their pre-contoured shape. This curvature was derived from studying 36 pediatric clavicle skeletons from OrthoPediatrics’ exclusive access to the Hamann-Todd skeletal collection in Cleveland, Ohio.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma and Deformity Correction, is excited to bring another device to the Pediatric Orthopedic market – saying, “We are successfully implementing our strategy of surrounding pediatric surgeons with all the surgical systems they need. The breadth and depth of our Trauma and Deformity Correction portfolio is unmatched and we are continuing to develop new products.”

President and Chief Executive Officer, Mark Throdahl echoed this excitement, adding “The launch of our clavicle plates is one more example of our continued growth. OrthoPediatrics is committed to improving the lives of children with orthopedic conditions through the development of new products and supporting clinical education for pediatric orthopedic surgeons.”

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 20 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics also has the only global sales organization focused exclusively on pediatric orthopedics and distributes its products to 32 countries outside the United States.

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NeuroRegulatory

Mainstay Medical’s ReActiv8-B Clinical Trial Passes Mid-point

August 7, 2017 OrthoSpineNews

August 03, 2017

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that over half the required number of implants in the ReActiv8-B Clinical Trial have been performed.

The trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US. Information about the trial can be found at https://clinicaltrials.gov/show/NCT02577354.

69 subjects have been implanted with ReActiv8 in the trial. The trial design requires 128 subjects in the pivotal cohort to reach the 120-day endpoint before data are made available. An “interim look” for sample size re-estimation is planned when half the implanted subjects have data from the 120-day visit. The enrolment rate has been accelerating as the number of active sites has increased during 2017.

ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.Mainstay has begun commercialization in Europe, focusing initially on Germany, where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. More recently, commercialization has begun in Ireland, Mainstay’s home market.

Peter Crosby, CEO of Mainstay, commented: “The ReActiv8-B Clinical Trial is advancing well, and, based on our experience to date, we anticipate completing enrolment around the end of this year, with results available in 2018. The ReActiv8-B trial is a key step towards commercialization in the US, our most significant target market, and we are pleased with the progress.

“Our initial commercialization of ReActiv8 in Europe is well underway. Our strategy is to work with key reference centers in Germany, and then build on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.”

ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE). The statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit. Total number of subjects implanted will also include some enrolled and implanted as part of the surgical roll-in phase, in addition to subjects in the pivotal cohort. The Trial is designed with an “interim look” for sample size re-estimation when primary outcome data are available from half the subjects in the pivotal cohort, and if necessary the number of subjects in the pivotal cohort may be increased to achieve the targeted statistical significance. The interim analysis will be performed by a third-party independent statistician under the direction of the Data Monitoring Committee (DMC), and the interim results, other than a DMC recommendation regarding the findings, will remain blinded to the Company, study subjects, investigators and Clinical Trial sites.

The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide what is referred to as Level 1A Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
or
FTI Consulting (for Ireland)
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
or
NewCap (for France)
Louis-Victor Delouvrier
Tel: +: +33 1 44 71 98 53
Email: lvdelouvrier@newcap.fr
or
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com
or
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com
or
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialisation of ReActiv8®, the progress and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Short Name: Mainstay Medical
Category Code: STR
Sequence Number: 600858
Time of Receipt (offset from UTC): 20170802T174402+0100

Contacts

Mainstay Medical

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Spine

SpineSource Awarded Department of Defense Distribution and Pricing Agreement

August 7, 2017 OrthoSpineNews

August 02, 2017

CHESTERFIELD, Mo.–(EON: Enhanced Online News)–SpineSource, Inc. today announced it has been awarded a national contract from the U.S. Department of Defense for its L-Varlock® Expandable Lumbar Cage. Under the contract, SpineSource will supply L-Varlock® through a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency which offers U.S. military medical treatment facilities access to a full spectrum of medical products for active U.S. military personnel and veterans.

“The L-Varlock® continues to impress,” said Tom Mitchell, Founder/CEO of SpineSource. “The fundamental nature of spinal bone healing, sagittal balance and disc height restoration are all found within this implant.”

The L-Varlock® is the only lordotic expandable device in the United States that can be expanded from any range of zero to 24.5° of angle, and from zero to 7.1 mm of expansion within the disc space. Made of titanium alloy, it provides a preferred material for bony osteointegration and a wide open framework for bony in-growth.

 

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Biologics

SurGenTec’s GRAFTGUN Receives Core Patent for Post Filling Cages Using Their Graft Delivery Technology

August 4, 2017 OrthoSpineNews

August 03, 2017

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec® has been issued device and method patent No. 9,668,881 from the United States Patent and Trademark Office for its graft loading technology to post-fill implant cages. The Graftgun® is a universal graft delivery system that allows surgeons to use the bone graft of their choice. The device permits minimally invasive delivery of bone graft material into bone voids, disc spaces, cages, and implants. Once the implant has been positioned and the inserter is removed, the device can be connected to post-fill a variety of implants. The Graftgun kit will include a universal loading device which enables surgeons to load allograft, autograft, or synthetic biologics into the gun’s delivery tube and dispense it to an orthopedic site.

“We now have intellectual property that protects our ability to post-fill cages in situ,” said Travis Greenhalgh, CEO of SurGenTec. “One of the challenges when using expandable or monolithic cages is the ability to post-fill them once inserted into the disc space. The traditional way to post-fill a cage is to use a funnel or an elongated syringe. Most types of bone graft require significant force to extrude the material into the aperture of a cage. Our ratcheting technology provides users the force needed to extrude an array of bone graft materials, while maintaining superior control of the amount of graft that enters the cage and disc space. A concern with expandable cages is the ability to pack the implant with enough bone graft to provide maximum endplate contact. If there is a void between the bone graft and endplate there may be a higher risk of non-unions. The Graftgun ratcheting technology can help ensure the void is filled.”

SurGenTec has the capacity to customize the Graftgun so that it can be paired with nearly any cage on the market without requiring changes to their instruments. This will allow implant manufacturers seamless access to the Graftgun’s innovative technology, and the ability to offer an advantageous graft delivery solution to their end users. With the expandable cage market growing, this should be a viable option to optimize graft volume within a variety of implants.

SurGenTec looks forward to becoming the leader in bone graft delivery technologies, and has allocated a considerable amount of resources to ensure that they are on the forefront of this sector of orthopedic and spine surgery.

SurGenTec is a privately owned medical device company based out of Boca Raton, FL. They are focused on developing minimally invasive surgical technologies to help surgeons provide optimal care for their patients. SurGenTec anticipates the Graftgun to be released this summer.

Contacts

SurGenTec
Andrew Shoup, 561-990-7882

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ExtremitiesSpine

Orthofix to Present at Canaccord Genuity Annual Growth Conference

August 4, 2017 OrthoSpineNews

August 04, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that President and Chief Executive Officer Brad Mason will present at the Canaccord Genuity 37th Annual Growth Conference in Boston, MA on Thursday, August 10, 2017 at 1:30 p.m. ET.

A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

About Orthofix:

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Investor Contact:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Contact:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

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Financial

SANUWAVE Health Announces Extension of HealthTronics Promissory Notes

August 4, 2017 OrthoSpineNews

SUWANEE, GA–(Marketwired – Aug 3, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) today announced it has entered into a third amendment to certain provisions of the two promissory notes dated August 1, 2005 between the Company and HealthTronics, Inc. with an aggregate outstanding principal balance of $5,372,743.

The third amendment provides for the extension of the due date of the promissory notes to December 31, 2018. In connection with the second amendment, the Company issued to HealthTronics, Inc. an additional 2,000,000 Class K warrants to purchase shares of common stock, subject to anti-dilution protection. The exercise price of these additional Class K warrants issued is $0.11. The warrants vested upon issuance and expire after ten years.

“We are pleased we were able to successfully further extend the terms of our promissory notes with HealthTronics, from whom we acquired SANUWAVE’s extensive patent and technology platform in 2005. As a result, we now have financial flexibility to pursue several of our strategic initiatives and growth strategies slated for the second half of 2017 and beyond,” commented Kevin A. Richardson II, SANUWAVE’s Chairman of the board of directors. “We have a positive and strong relationship with HealthTronics and appreciate their continued support as we pursue our FDA approval,” concluded Mr. Richardson.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

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SpineTop Stories

K2M Acquires Exclusive License to Comprehensive Patent Portfolio of Expandable Spinal Implants to Increase 3D-Printed Offerings

August 3, 2017 OrthoSpineNews

LEESBURG, Va., Aug. 03, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has acquired the exclusive license to a robust portfolio of 17 issued and pending patents for expandable interbody technology. The license is another example of K2M’s focus on being a market-leading innovator and provider of expandable solutions for a diverse range of TLIF, Lateral, PLIF, and other procedures. The licensed IP is expected to provide K2M’s interbody portfolio with expansion capabilities that exceed many expandable devices currently on the market.

K2M also announced its intent to integrate its 3D printing technology, Lamellar 3D Titanium Technology™, into new products developed with this intellectual property. This will further strengthen the Company’s leadership in the 3D printing of spinal devices. K2M was the first leading spine company to market a 3D-printed spinal implant and offers the most comprehensive portfolio of 3D-printed spinal devices on the market today. The Company’s 3D-printed portfolio currently extends across three product families and provides differentiated solutions to help achieve spinal balance in complex, minimally invasive, and degenerative spine procedures.

“We are excited to have obtained the exclusive rights to this intellectual property portfolio and look forward to integrating our 3D printing technology with new expandable spinal devices as part of our effort to build a comprehensive portfolio of industry-leading, 3D-printed solutions to address the full range of spinal pathologies,” said K2M President and CEO, Eric Major. “This strategic investment to enhance our intellectual property portfolio—coupled with our recent announcements around MOJAVE™ PL 3D Expandable, SAHARA® AL Expandable, and our Balance ACS™ platform—are key milestones to drive our strategy to be the technology and market leader in the next generation of 3D-printed expandables.”

K2M recently announced two additions to its expandable portfolio. K2M received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the MOJAVE PL 3D Expandable Interbody System, a first-to-market, 3D-printed, FDA-cleared expandable posterior-lumbar interbody system featuring K2M’s Lamellar 3D Titanium Technology.  The Company also introduced the SAHARA AL Expandable Stabilization System, the only lordotic expandable interbody device with integrated screw fixation on the market to help achieve spinal balance.

Balance ACS (BACS™) 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.

For more information on K2M, as well as its expandable and 3D-printed portfolios, visit www.K2M.com.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in 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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Biologics

Bone Biologics Announces Appointment of Bret Hankey to Company’s Board of Directors

August 3, 2017 OrthoSpineNews

August 03, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp. (OTCQB: BBLG) announced that Bret Hankey has joined the company’s board of directors. Mr. Hankey brings more than 15 years of operating and board director experience to the BBLG board.

Since 2000, Mr. Hankey, age 40, has served in various capacities within the Hankey Group where he currently serves as President and is a member of the board of directors on all major companies that comprise the Hankey Group.

Headquartered in Los Angeles, California, the Hankey Group is comprised of seven operating companies specializing primarily in the automotive, finance, technology, real estate and insurance industries. Since 2007, Mr. Hankey has also served in various capacities with Westlake Financial Services, a member of the Hankey Group, and is currently the Vice Chairman and Executive Vice President of Westlake Financial. Westlake Financial is the largest privately held automotive finance company in the United States. Mr. Hankey graduated from the University of Southern California in 2000 with a B.S. in Business Administration and Finance.

About Bone Biologics

Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work with the three founders and select strategic partners, building on unprecedented research on the Nell-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. Nell-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Bone Biologics trades on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies. OTCQB companies are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com.

About The Hankey Group

Headquartered in Los Angeles, California, the Hankey Group is comprised of seven operating companies specializing primarily in the automotive, finance, technology, real estate and insurance industries.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to trading in the Company’s common stock on the OTCQB; the next phase of the Company’s development and testing work; the Company’s expectation about moving its technology forward and setting the stage for future growth and enhanced shareholder value; and the future need for regenerative bone solutions. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of the Company and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: future revenues, expenditures, capital or other funding requirements, the adequacy of the Company’s current cash and working capital to fund present and planned operations and financing needs, expansion of and demand for product offerings, and the growth of the Company’s business and operations through acquisitions or otherwise, as well as future economic and other conditions both generally and in the Company’s specific geographic and product markets. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent current report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2017 and Form 10-Q, filed with the Securities and Exchange Commission on May 12, 2017. The Company anticipates that subsequent events and developments may cause their views and expectations to change. The Company assumes no obligation, and they specifically disclaim any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Compass Investor Relations
Mark Collinson, 714-222-5161
mcollinson@compass-ir.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com

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