OrthoPediatrics Corp. Launches New Pediatric Specific Clavicle Plates

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.

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

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

SpineSource Awarded Department of Defense Distribution and Pricing Agreement

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.

 

READ THE REST HERE

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

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

Orthofix to Present at Canaccord Genuity Annual Growth Conference

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

SANUWAVE Health Announces Extension of HealthTronics Promissory Notes

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

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

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 FacebookTwitterInstagramLinkedIn, and YouTube.

Forward-Looking Statements

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

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

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

TransEnterix Announces First Senhance U.S. Innovation Center at Florida Hospital Orlando

August 03, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that it has installed a Senhance Surgical Robot at the Institute for Surgical Advancement at Florida Hospital Orlando.

The Senhance Robot is placed under a collaboration agreement with Florida Hospital ISA. Nicholson Center Orlando will be used as a facility to perform pre-clinical training and procedural development in cooperation with surgical staff from Florida Hospital. Additionally, surgeons from around the world are participating in the robotic pre-clinical activities at the innovation center.

“The selection of a U.S. innovation center is a critical milestone in the global expansion of Senhance,” said Todd M. Pope, President and CEO at TransEnterix. “We are pleased to partner with a leading institution such as Florida Hospital Orlando and the clinicians at the Institute for Surgical Advancement. Together, we will continue to usher in an expansion in the use of robotics to advance minimally invasive surgery.”

“We have created a center for the interdisciplinary development of new surgical approaches utilizing the latest technology,” said Dr. Steve Eubanks, Surgeon and Executive Director for the Institute for Surgical Advancement. “Our team is excited to be the first U.S. center to explore the clinical and training pathway for this new surgical robotic platform, and to share these programs with surgeons from across the globe.”

About Florida Hospital Institute for Surgical Advancement

The Institute for Surgical Advancement was developed to facilitate the success of physicians who have the capabilities and desires to innovate academically and through procedural and instrumentation development. Through our various resources, we facilitate and assess the needs of our physicians to help develop advancements for patient care and innovate new surgical approaches. Combining physician experience with expertise in engineering improves the early phases of design and encourages the flow of ideas. We have various resources for this process, including the brainstorming room, our prototype lab, and Florida Hospital Nicholson Center, a world leader in surgical training. For more information, visit https://www.floridahospitalisa.com.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark, and is currently under FDA review for clearance in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

About Florida Hospital Nicholson Center

For over a decade, Florida Hospital Nicholson Center has trained more than 70,000 physicians from around the globe on leading-edge clinical and surgical techniques. Utilizing state-of-the-art surgical suites, and labs, plus advanced medical simulation robotics and learning centers, medical professionals can acquire and advance their skills in a highly collaborative surgical learning environment. For more information please visit NicholsonCenter.com.

Forward Looking Statements

This press release includes statements relating to the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “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, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the partnering between TransEnterix, Florida Hospital Orlando and the clinicians at the Institute for Surgical Advancement will continue to usher in an expansion in the use of robotics to advance miniminally invasive surgery . For a discussion of the risks and uncertainties associated with TransEnterix’ s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

MiMedx Initiates Phase 3 Plantar Fasciitis Clinical Trial

MARIETTA, Ga.Aug. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has initiated its Phase 3 Plantar Fasciitis clinical study.

The Company submitted a formal Investigational New Drug (IND) amendment to the Food and Drug Administration (FDA) requesting the initiation of the Phase 3 trial based on the interim results of its IND Phase 2B trial for the treatment of Plantar Fasciitis. To date, the Company has received no comments or changes to the amendment filing or the Phase 3 protocol, and the Company is moving forward with the Phase 3 trial. MiMedx anticipates enrolling the first Phase 3 patient within the next 30 to 60 days.

The Phase 3 clinical study is a prospective, double-blinded, randomized controlled trial of AmnioFix Injectable as compared to a saline placebo injection in the treatment of Plantar Fasciitis on subjects that have moderate or severe pain due to Plantar Fasciitis with failed treatment for at least one month. The comparison group will be treated with a 0.9% Sodium Chloride USP placebo injection. Approximately 164 patients will be enrolled in the study with an estimated enrollment period of 18 months. The primary efficacy endpoint will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group.

MiMedx also reported that the Company will be hosting a webcast on Monday, August 7, 2017 beginning at 2:00 p.m. Eastern Time to discuss this study as well as the progress of the Company’s numerous other clinical studies in support of its Biopharmaceutical strategy. MiMedx executives “Pete” Petit, Chairman and CEO; Bill Taylor, President and COO; Debbie Dean, Executive Vice President; Chris Cashman, EVP and Chief Commercialization Officer; and Mark Landy, Vice President Strategic Initiatives, will be presenting during the August 7th call. Also present will be Donald Fetterolf, M.D., Chief Medical Officer; Thomas Koob, PhD, Chief Scientific Officer; and other members of MiMedx senior management.

The Company expects the planned presentations to last approximately 45 minutes. After the planned presentations, the call will be open for questions and answers. The subject matter, topics and updates to be covered during the formal presentations include:

  • Update of Biopharma Transition Activities
  • Initiation Status of Plantar Fasciitis IND Phase 3 Study
  • Update on Plantar Fasciitis IND Phase 2B Study
  • Upcoming Filings for Additional IND Clinical Studies
  • Plantar Fasciitis and Pain Management Commercial Update

A listen-only simulcast of the MiMedx August 7, 2017 shareholder call will be available on-line at the Company’s website at www.mimedx.com beginning at 2:00 p.m. eastern timeAugust 7, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company’s website at www.mimedx.com.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com