BONESUPPORT™ appoints Michael Diefenbeck as Chief Medical Officer

Lund, Sweden, 11th April, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the appointment of Michael Diefenbeck MD PhD as Chief Medical Officer.

Dr Diefenbeck founded Scientific Consulting in Orthopaedic Surgery in 2014 and has worked for BONESUPPORT on a range of clinical projects related to CERAMENT™ as an independent clinical advisor.

He is currently honorary consultant at Nuffield Orthopaedic Centre, Oxford University Hospitals. Dr. Diefenbeck studied medicine at Munich and was trained as an orthopaedic surgeon, specializing in trauma care and bone infections. He has 14 years’ clinical experience at different German hospitals (BG Unfallklinik Murnau, BG Kliniken Bergmannstrost Halle/Saale, University Hospital Jena and Schön Klinik Hamburg Eilbek). At University Hospital Jena he finished his PhD in 2011 and has since been involved in surgical education and training programs for students. He is author of 24 Pub-med listed research articles.

Dr Diefenbeck said: “I am excited to be joining BONESUPPORT at a particularly exciting time for the Company. I look forward to working with the BONESUPPORT team, to help shape the future development of the Company as it continues to develop and reinforce the clinical benefits that its CERAMENT based products deliver.”

Richard Davies, CEO of BONESUPPORT, said: “We are pleased to welcome Michael to the BONESUPPORT team. I have no doubt that his extensive medical experience in the orthopaedics field and his knowledge of our CERAMENT platform that he will be a real asset to BONESUPPORT as we look to grow our business and deliver value to all of our stakeholders.”

Dr Diefenbeck began his new role in April 2017 and reports to the CEO.

 

Contact Information

Citigate Dewe Rogerson

David Dible, Mark Swallow, Pip Batty

+44 (0)20 7282 2949/2948/1022

bonesupport@citigatedr.co.uk

 

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

 

Pip Batty

Account Manager

Tel: +44 (0)20 7282 1022

Mob: +44 (0)7808 642 922

Email: Pip.Batty@citigatedr.co.uk

 

Citigate Dewe Rogerson

3 London Wall Buildings

London Wall

London EC2M 5SY

 

Web: www.citigatedewerogerson.co.uk

Twitter: @CDRLifeSciences

LinkedIn: CitigateDeweRogerson / PipBatty

K2M Group Holdings, Inc. & LifeHealthcare Group Limited Announce New Distribution Agreement for Australia & New Zealand

LEESBURG, Va., April 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (“K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, and LifeHealthcare Group Limited (ASX:LHC) (“LifeHealthcare”), a leading independent provider of medical devices and healthcare solutions in Australia and New Zealand (ANZ), today announced that the two companies entered into a new supply agreement for the distribution of K2M’s innovative spinal technologies.

The K2M/LifeHealthcare distribution partnership, which dates back to 2010, has yielded strong growth and a significant spine market position in ANZ. Looking to build on this success, K2M and LifeHealthcare have entered into a new five-year agreement with the shared goal of establishing a number one spine market position in ANZ.

Matt Muscio, LifeHealthcare’s CEO, stated, “I am very pleased to announce our new five-year contract with K2M through 2021. K2M is a globally recognized innovator in complex spine, having led the way in deformity and now minimally invasive and 3D-printed spine solutions. Through our partnership, we have delivered highly successful product initiatives, such as the EVEREST® MI XT and MESA® platforms, and market leading education forums, such as Deformity Down Under, to address the needs of Australian and New Zealand clinicians and their patients. We look forward to working with Eric Major and the K2M team over the coming years to reach our shared aspiration of the number one market share position in the Australian and New Zealand spine market.”

Eric Major, K2M’s President and CEO, stated, “LifeHealthcare has been an important strategic partner of ours for many years and their established distribution presence and strong surgeon relationships have been instrumental in K2M’s strong market share growth in Australia and New Zealand. We are happy to announce our new agreement and look forward to offering innovative spinal technologies, such as our EVEREST MI XT Spinal System, our industry-leading 3D-printed CASCADIA™ Lateral Interbody System, and our comprehensive Balance ACS platform focused on achieving three-dimensional spinal balance, to surgeons in this important international spine market.”

For more information about K2M, visit www.K2M.com. For more information about LifeHealthcare, visit www.lifehealthcare.com.au.

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.

About LifeHealthcare

LifeHealthcare Group Limited is a leading independent provider of healthcare solutions in Australia and New Zealand across clinically specialized therapeutic channels bringing Australian and New Zealand healthcare professionals innovative medical devices by partnering with world class companies who share the vision of innovation and making a real difference to people’s lives.

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; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

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

LifeHealthcare Contact:
Kristine James				              
General Manager Corporate Development		  
+61 2 8114 1534					 
kristine.james@lifehealthcare.com.au

OMNIlife science™, Inc. And Global Orthopaedic Technology Enter into Licensing Agreement for APEX™ Knee System

RAYNHAM, Mass. and SYDNEY, April 7, 2017 /PRNewswire/ — OMNIlife science™, Inc. (“OMNI™”) and Global Orthopaedic Technology Pty Ltd. today announced an exclusive licensing agreement for OMNI’s ‘s APEX™ Knee Implants for Australia, New Zealand and South Africa.

Under the terms of the agreement, Global Orthopaedic Technology will acquire exclusive rights to manufacture, market and distribute the APEX™ Knee Implants in the three countries listed above. Global will continue to market OMNI’s OMNIBotics® robotic-assisted total knee and computer-assisted total hip replacement technology in the agreed markets under a separate distribution agreement. In addition, OMNI will continue to market Global’s Paragon Hip Implants in the United States also under a separate distribution agreement.

“The clinical performance of the APEX™ Knee in Australia, aided by OMNIBotics and other advanced implant delivery systems, continues to drive APEX™ knee growth in Australia,” said Rick Randall, OMNI CEO. “Licensing the knee implants to Global ensures the APEX™ Knee will continue to expand in the evidence-based Australian healthcare market and provide OMNI non-dilutive capital to support the demand for robotic-assisted total joint replacement products in the large U.S. orthopedics market.”

“Following six years of successful distribution of the APEX™ knee in Australia we believe the time is right for Global to secure the license and long term tenure for the product,” commented Andrew Fox-Smith, Global CEO. “The proven clinical success of the APEX™ Knee in conjunction with emerging technologies out of Australia, will provide Global with solid foundations for future development and growth.”

About OMNI
OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

About Global
Global Orthopaedic Technology Is the largest Australian-owned orthopaedic implant designer and manufacturer.  Through strong engagement with some of Australia’s leading surgeons, universities and researchers, Global endeavours to lead the way in the distribution and development of new and innovative products   to meet the needs of both the surgeons and their patients. Global provides an extensive range of orthopaedic implant solutions from early intervention through to complex end stage surgery for both knee and hip replacement surgery. The hip and knee portfolio is also complimented by a suite of enabling technologies including robotics, patient specific instrumentation and planning tools, designed to improve efficiencies and optimise patient outcomes throughout the continuum of care. For more information about Global, please visit www.globalortho.com.au.

Forward-Looking Statements
Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including statements using the terms “plans,” “believes” or similar expressions are “forward- looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI,  increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release

Contact
Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com

Alphatec Spine Launches Battalion™ Lateral System with Squadron™ Retractor to support Minimally Invasive Lateral Access Procedures

CARLSBAD, Calif., April 07, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC) and a provider of spinal fusion technologies, announced today that the Company has launched its new Battalion Lateral System with the Alphatec Squadron Lateral Retractor, and successfully completed initial patient surgeries including degenerative, multilevel and L4/L5 spinal segment cases.  With the launch of the Battalion Lateral System, the Company is well positioned to begin to compete in the $500M U.S. Lateral market.

“The launch of Battalion Lateral represents a significant milestone for Alphatec, opening up new commercial opportunities for us.  With this launch, we are now able to compete in the MIS Lateral market—one of the fastest growing markets in spine,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “The Battalion Lateral System includes our proprietary Squadron Retractor that is designed to enhance the surgeon’s experience and improve clinical outcomes.  Early feedback from surgeon customers has been very positive regarding the system performance, differentiated feature set and ability to successfully treat even the most complex patient cases with a minimally invasive approach.  The launch of Battalion Lateral also enables Alphatec to access new distributors with strong surgeon relationships in the Lateral space. We look forward to expanding into this new market and increasing surgeon adoption.”

Battalion Lateral System Overview

The Battalion Lateral System with the Alphatec Squadron Lateral Retractor provides surgeons with a next-generation Lateral system with innovative, unique functionality designed to improve clinical outcomes by reducing tissue creep, minimizing psoas retraction time, and achieving alignment and fusion objectives.  The Battalion Lateral System includes numerous proprietary features, including the Squadron Lateral Retractor.  The system is designed to allow surgeons to customize the access to match the patient’s unique anatomy through independent retraction of the cranial/caudal blades, DepthControl™ technology that provides in-situ height adjustment for the low-profile blades, and LevelToe™ mechanics to ensure that the blades maintain a parallel plane when toed up to 15°.  The Squadron Retractor is also fully compatible with most neuromonitoring platforms enabling access safely through the psoas. The Battalion Lateral Spacer is available in 0° and 15° lordosis with a variety of width and height options for lumbar and thoracic approaches as well as angled and offset instrumentation to provide access to the L4/L5 segment.

“Alphatec’s Battalion Lateral System provides great options for accessing and preparing the space via the retractor, but the retractor itself completes the procedure,” said Dr. Frank K. Kuwamura, a board-certified orthopedic spine surgeon, in San Antonio, Texas.  “The ability to independently raise and lower blades to accommodate the anatomy really separates this retractor from other retractors available on the market.  It saves time in the psoas and that supports better patient outcomes.”  Dr. Kuwamura was one of the first surgeons to use the system and completed the case with Alphatec’s Illico® percutaneous pedicle screws.  The patient had a previous fusion and had developed adjacent disc disease.

Michael E. Russell, II, M.D., a board-certified orthopedic surgeon in Tyler, Texas, was also one of the first surgeons to use the Battalion Lateral System in a clinical setting.  He used the system to perform a Lateral procedure at L3/L4 and instrumented posteriorly using Alphatec’s Arsenal™ Spinal Fixation System. The Squadron Lateral Retractor allowed Dr. Russell to access the disc space from an offset trajectory.

Dr. Russell commented, “The Squadron Retractor enabled me to attach to multiple attachment points giving me the flexibility to use my preferred Lateral technique.  The combination of the level toeing and the ability to lower the low-profile blades individually allowed me to successfully navigate osteophytes without the need for blade extenders.”

Battalion Lateral to be Featured at Upcoming Surgeon Conferences

The Battalion Lateral System and Squadron Retractor will be featured at the International Society for the Advancement of Spine Surgery, ISASS, April 12th through April 14th in Boca Raton, Florida and at the Annual Meeting of the American Association of Neurological Surgeons, AANS, April 24th through April 26th in Los Angeles, California for surgeon review.

About Battalion Lateral System and Squadron Retractor Lateral Access System

The Battalion Lateral System features a full array of access and disc preparation instrumentation in straight, angled, and offset orientations.  The system is recommended for use with the Arsenal Spinal Fixation System or the Illico MIS Posterior Fixation System. The Battalion Lateral implant is also cleared for use with both autograft and allograft biologic materials.
For more information, please visit:   http://alphatecspine.com/Battalion-Lateral.

About Alphatec Spine

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

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

Forward Looking Statements  

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors.  Forward-looking statements include the Company’s ability to compete and expand its presence within the U.S. MIS Lateral market and the size of such market; the Company accessing new distributors with strong surgeon relationships in the Lateral space and increasing surgeon adoption; and the ability of Battalion™ Lateral System to enhance the surgeon’s experience and improve clinical outcomes.  The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the uncertainty of success in developing and launching new products, including without limitation the products discussed in this press release; the Company’s ability to compete directly with the market leaders in the U.S. MIS Lateral market; the Company’s ability to gain market share in the U.S. MIS Lateral market and to benefit a vast number patients in such market; and the acceptance of the Company’s products by the surgeon community and the success of procedures by spine surgeons, including without limitation the products and procedures discussed in this press release.  Please refer to the risks detailed from time to time in Alphatec Holdings’ SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations 
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Paragon 28 announces launch of 12 unique titanium wedges to address flatfoot deformities-TITAN 3-D™ Wedge System

ENGLEWOOD, Colo., April 6, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help streamline medical procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The TITAN 3-D™ Wedge System builds on Paragon 28’s portfolio of osteotomy wedges and uses the same patented shapes as the PRESERVE™ Evans and Cotton Wedges.  These porous titanium wedges offer surgeons an alternative to autograft and allograft bone.

The TITAN 3-D™ Wedges have an open geometry with a three-dimensional scaffold that allows for blood entry, bone through growth, and the incorporation of biologics if used. Each wedge has a central opening which allows for passage of a 3.5 or 4.0mm screw across the osteotomy to help increase stability of the construct.  In order to ensure accurate and consistent placement of this crossing screw, both wedge families leverage the patented PRECISION GUIDE™ System. Unlike many competitive implants, Titan 3-D™ Wedges do not require the use of an ancillary surface plate. To increase the coefficient of friction and minimize the chance of implant expulsion, the TITAN 3-D™ wedges are built with spikes which interface with bony surfaces.  To facilitate accurate implantation, the system includes product specific inserters which thread onto the back of each wedge and have a strike plate to aid in final seating. The system also includes resection guides which limit excessive bone removal if explanation is required.

Paragon 28 is grateful for the significant contributions Dr. Thomas Chang, DPM Sutter Health, Santa Rosa, CA, made as surgeon designer of this system.

About Paragon 28 Inc.

Paragon 28, Inc was established in 2010 to address the unmet and under-served needs of the foot and ankle community. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

www.paragon28.com

 

SOURCE Paragon 28, Inc.

Related Links

http://www.paragon28.com

Exclusive: Cardinal Health nears $6 billion deal for Medtronic unit – sources

By Carl O’Donnell – Wed Apr 5, 2017

U.S. drug distributor Cardinal Health Inc (CAH.N) is nearing a deal to acquire medical device maker Medtronic Plc’s (MDT.N) medical supplies business for close to $6 billion, people familiar with the matter said on Wednesday.

The sale would streamline Medtronic’s portfolio after its $42.9 billion acquisition of Covidien Plc in 2014. In that deal, it inherited most of the company’s medical supplies business, which sells everything from syringes to surgical instruments.

Medtronic and Cardinal Health have entered into exclusive talks over the sale of the business, and a deal could be announced later this month, the sources said, cautioning that there was always a chance that the negotiations could end unsuccessfully.

The sources asked not to be identified because the negotiations are confidential. Medtronic and Cardinal Health declined to comment.

For Cardinal Health, the deal would boost efforts to build out its medical products business, which it has highlighted as a priority for dealmaking.

 

READ THE REST HERE

Alphatec Spine Adds Experienced Spine Executives to Sales Leadership Team

CARLSBAD, Calif., April 05, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC), and a provider of spinal fusion technologies, announced today the addition of two new sales executives with proven track records in the spine industry, naming James (Jim) Duffy as Area Vice President, U.S. Sales, South, and Greg Rhinehart as Area Vice President, U.S. Sales, East.  Drawing on their deep commercial spine experience, Messrs. Duffy and Rhinehart will be responsible for expanding the Company’s presence in the Southern and Eastern United States, respectively, including continuing to build dedicated sales agent relationships, targeting new customer and market opportunities, and providing service and support for existing surgeon customers.

“I’m excited to welcome Jim and Greg to the Alphatec family as we continue to build out a strong sales leadership team that is focused on driving sustainable growth and improving patient outcomes,” said Terry Rich, Alphatec Spine’s Chief Executive Officer. “Jim and Greg bring tremendous track records to Alphatec and they will be instrumental in recruiting and developing top distributors and sales talent to deepen our engagement with surgeons and build greater awareness and adoption of our differentiated products.  I look forward to working with both leaders as we accelerate our sales strategy and aggressively work to become the fastest growing company in spine.”

Jim Duffy Named AVP Sales, South Region

Mr. Duffy brings over 25 years of progressive spine and orthopedic sales leadership experience to Alphatec, including a proven history of building strong distributor relationships and dedicated distribution channels.  Mr. Duffy joins Alphatec from Zimmer Biomet Spine, where he was the Sales Vice President for the East region of the United States following Zimmer’s merger with Biomet, and was responsible for the strategic integration and management of the distribution channel.   Prior to Zimmer Biomet, Mr. Duffy served as the Area Vice President of Sales for Zimmer Spine.  Earlier in his career, Mr. Duffy served in a number of district and regional sales leadership roles, including at KARL STORZ Endoscopy-America, Medtronic Spinal and Biologics, and at Synthes Spine.

Mr. Duffy holds a Bachelor of Science in Business Management from Westfield State University.

Greg Rhinehart Named AVP Sales, East Region

With over two decades of spine and orthopedic sales leadership experience, Mr. Rhinehart brings significant expertise to Alphatec in developing high-performing sales organizations, and driving expansion and revenue growth.  Prior to joining Alphatec, Mr. Rhinehart was the Vice President of Sales at Medicrea.  Before that, Mr. Rhinehart held senior sales leadership roles at Globus Medical, Inc., where he most recently served as the Vice President of Sales for the Central U.S. region—a position he held for nine years.  Under his leadership at Globus, Mr. Rhinehart successfully built a new sales organization to continue Globus’ expansion in the Central U.S., significantly growing annual revenues.  Prior to joining Globus, Mr. Rhinehart held multiple sales leadership roles in spine and orthopedics at DePuy Spine, Medtronic, Sulzer-Spinetech and DePuy Orthotech.

Mr. Rhinehart holds a Bachelor of Science in Business Administration from Ohio State University.

Inducement Awards Granted

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec Holdings Inc.’s 2016 Employment Inducement Award Plan (the “Plan”), on March 30, 2017, the Compensation Committee of the Board of Directors of Alphatec Holdings, Inc. approved the following inducement awards:

  • Mr. Duffy: 25,000 restricted stock units (RSUs) and an option to purchase 25,000 shares of common stock.
  • Mr. Rhinehart: 25,000 restricted stock units (RSUs) and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan.  Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the first date of employment, which was March 31, 2017 for Mr. Rhinehart and April 4, 2017 for Mr. Duffy, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (the first date of employment). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Spine

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

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

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors.  Forward-looking statements include the Company’s ability to successfully expand in certain geographic regions, launch new products, deepen surgeon engagement, build brand awareness and accelerate growth. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in launching new products and developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; the Company’s ability to compete with other competing products and with emerging new technologies; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement.  Please refer to the risks detailed from time to time in Alphatec Holdings’ SEC reports, including its Annual Report Form 10-K, as well as its other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

KFx Medical, LLC Announces Another and Third License of its Knotless Double Row Patents

April 06, 2017

SAN DIEGO–(BUSINESS WIRE)–KFx Medical, LLC announced that it has entered into a license agreement with CONMED Corporation – CNMD (NASDAQ) relating to its patents used in knotless double row rotator cuff repair.

Under the agreement, CONMED and its affiliates will have the right to promote the use of products and techniques for knotless double row rotator cuff repair as claimed in US Patent number 7,585,311 and related patents and applications for the life of those patents. Approximately one-third of more than 400,000 rotator cuff repairs in the United States utilize the technique to achieve an anatomic reattachment of tendon.

Terms of the licensing agreement were not disclosed.

“We are proud to have our innovation recognized by CONMED. Previously we announced our licensing agreements with Smith & Nephew, Inc. and Mitek, a Johnson & Johnson Company for the same patents. I am pleased with the licensing arrangement with these three world leaders and knowing KFx’s valuable double row knotless rotator cuff technology will reach even more patients,” indicated Tate Scott, President and Chief Executive Officer.

About KFx Medical, LLC

KFx Medical LLC was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot, and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine. The company is privately held. Investors include Alloy Ventures, Charter Life Sciences, Arboretum Ventures, Montreux Equity Partners, and MB Venture Partners.

Contacts

KFx Medical
W. Tate Scott, 619-742-2010
Tate.Scott@KFxmed.com

Aesculap Launches Novel Spine Device Warranty on its Plasmapore®XP Surface

CENTER VALLEY, Pa., April 6, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC, a medical device company with long-standing expertise in applying biocompatible surface treatments to orthopaedic implants, announced today a new warranty program on its established portfolio of surface-enhanced interbodies for spinal fusion. This warranty announcement coincides with the launch of the TSpace®XP interbody system, treated with PlasmaporeXP surface enhancing technology. The warranty offers participating facilities a device replacement in the instance of a reoperation because of clinically-relevant delamination or the generation of impaction debris or a CT or MRI artifact caused by the device that impedes a physician’s ability to visualize adjacent anatomy. This is the first facility risk-share agreement on a titanium-enhanced PEEK interbody in the spine industry warranting against both delamination of a surface enhancement and the ability to visualize an implant without artifact.

This new Aesculap warranty on PlasmaporeXP devices differentiates the technology from other manufacturers who have less widely studied surface coated or otherwise enhanced spinal fusion interbodies. The current U.S. spine market favors PEEK, a medical grade plastic, for fusion. However, PEEK alone may lack the biocompatible characteristics necessary to stimulate a lasting fusion. For this reason, some spinal implant manufacturers are going back to all titanium implants; however, this structural material may create intraoperative and postoperative visualization issues which may jeopardize the safety profile for patients.

Aesculap began developing its expertise in surface enhancements with its BiContact™ Universal Hip System in 1986 and was first to the U.S. spine device market with surface-enhanced PEEK-OPTIMA®* interbodies for spinal fusion applications. Aesculap’s experience, with more than 20,000 PlasmaporeXP devices implanted to date plus results from over 20 clinical studies, provided the foundation to offer the device warranty.

According to Chuck DiNardo, President of Aesculap Implant Systems, LLC, “In the consumer market, if a product does not meet expectations, the purchaser expects a money-back type of guarantee. This has not been the norm in the device market. We created a program to demonstrate to healthcare providers that we believe in our product, our clinical data and our long-standing experience and ultimately share their goal of a lasting treatment for their patients’ chronic back issues.”

As a forerunner in surface enhancing technology, Aesculap’s proprietary process applies a pure titanium surface that is porous, osteoconductive and biocompatible to the core of each PlasmaporeXP implant on the top, bottom and lateral surfaces. Based on the global success of this surface enhancing technology, Aesculap has developed a full portfolio of PlasmaporeXP devices like the newest TSpace interbody to address a variety of degenerative spinal indications and approaches.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com/xp.

*PEEK-OPTIMA is a registered trademark of Invibio Limited.

SOURCE Aesculap Implant Systems, LLC

SI-BONE, Inc. Announces Published Guidance Recommendation for Minimally Invasive SI Joint Fusion from NICE

SAN JOSE, Calif., April 7, 2017 — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the U.K.’s National Institute for Health and Care Excellence (NICE) has published their Interventional Procedure Guidance document for minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain.1 The guidance recommends that MIS SI joint fusion be available to properly diagnosed patients in the U.K. National Health System (NHS).

NICE develops guidance and quality standards in health and social care and is a worldwide leader in technology evaluations. NICE’s role is to improve outcomes for people using the NHS and other public health services.2

The recommendation states that the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery, based primarily on the strong clinical evidence from the iFuse Implant, is adequate provided that standard arrangements are in place.  They also recommend that the procedure be performed by trained surgeons using a lateral transarticular approach, and that patients have been properly diagnosed with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

Use with standard arrangements is the most positive recommendation that NICE can make for an interventional procedure such as MIS SI joint fusion.  Standard arrangements means that there is enough high-quality clinical evidence to show that the procedure is effective and safe enough for doctors to consider as a treatment option for appropriate patients,” according to W. Carlton Reckling, MD, MBA, Chief Medical Officer and Vice President Medical Affairs at SI-BONE.

About SI-BONE, Inc.

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

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth3, facilitating long-term fusion of the joint.  The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

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

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9868.040617

  1. Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. NICE Interventional Procedures Guidance [IPG578]. April 2017. https://www.nice.org.uk/guidance/IPG578/chapter/1-recommendations

  2. https://www.nice.org.uk/Media/Default/About/Who-we-are/NICE_Charter.pdf

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