Tangible Solutions Inc., Achieves ISO 13485:2016 and 9001:2015 Certification

September 29, 2017

Fairborn, Oh – September, 2017, Tangible Solutions, Inc., Contract Manufacturer of 3D Printed Implants operates a quality management system and has received full certification in compliance with ISO 13485:2016 and 9001:2015. Tangible Solutions was independently audited and verified by Eagle Certification Group to conform to the specific requirements necessary to achieve this distinction.

A quality management system (QMS) is a set of integrated policies, processes and procedures that ensure an organization’s services are reliable and meet their customer’s expectations. ISO 13485: 2016 and 9001:2015 are examples of Quality Management Systems and a standard that outlines the requirements an organization must have in order to maintain their QMS certification.

Tangible Solutions’ ISO 13485: 2016 and 9001:2015 registration adds yet another level of credibility, expertise, and distinction.

Tangible Solutions is pioneering the field of additive manufacturing to provide large-scale, cutting-edge contract manufacturing solutions within the medical field. End-to-end lifecycle management of product lines provides solutions and support from prototype through production and sustainment.

 

About Tangible Solutions

Tangible Solutions specializes in innovative trabecular and complex lattice features that allow integrated device structures to mimic the human body and potentially provide better results for the patient. Tangible Solutions manages the entire lifecycle of your orthopedic products from the micro to the macro. From build plate orientation through supply chain management, we are here to help.

www.tangiblesolutions3d.com | aclark@tangiblesolutions3d.com | 937-912-4603

Sports Medicine Market to Grow 7.4% CAGR by 2022

PUNE, IndiaOctober 6, 2017 /PRNewswire/ —

The global sports medicine market will reach $8.24 billion by 2022 from $5.78 billion in 2017 at a CAGR of 7.4% during (2017-2022) driven by increasing incidences of sports injuries, continuous influx of new products and treatment modalities, and development in the field of regenerative medicine, while in 2017, North America accounted largest share of the said market followed by Europe, APAC and RoW according to RnRMarketResearch.

Browse 103 Market Data Tables and 32 Figures spread through 169 Pages and in-depth TOC on “Sports Medicine Market by Product (Implants, Arthroscopy, Prosthetic, Orthobiologics, Braces, Compression Clothing, Physiotherapy (Thermal, Ultrasound), Bandages & Tapes), Application (Knee, Shoulder, Elbow) – Global Forecast to 2022 http://www.rnrmarketresearch.com/sports-medicine-devices-market-by-products-application-2012-2017-bone-cartilage-ligament-tendon-reconstruction-repair-braces-hot-cold-therapy-topical-pain-relief-compression-clothing-market-report.html .

The key players in the global sports medicine market are Arthrex, (US), Smith & Nephew (UK), DePuy Synthes (US), Stryker (US), CONMED (US), Zimmer Biomet (US), Breg (US), DJO Global (US), Mueller Sports (US), Wright Medical Group (US), Medtronic (Ireland), RTI Surgical (US), and Performance Health International (US).

Based on application, the sports medicine market is segmented into shoulder injuries, foot and ankle injuries, elbow and wrist injuries, back and spine injuries, hip and groin injuries, knee injuries, and other injuries (head, face, and finger injuries). The elbow and wrist injuries segment is expected grow at the highest CAGR during the forecast period. This growth can be attributed to the increasing number of injuries in sports like rowing, racquet sports, and golf, where there is a repetitive overuse of elbow and wrists.

Make an Inquiry on Sports Medicine Market – Global Forecast to 2022 research report at http://www.rnrmarketresearch.com/contacts/inquire-before-buying?rname=80170 .

On the basis of product, the sports medicine market is segmented into body reconstruction products, body support & recovery products and accessories. In 2017, the body reconstruction products segment is expected to account for the largest share of the market. The large share of this segment can primarily be attributed to the wide usage of implants and arthroscopy devices by sports medicine surgeons and orthopedic surgeons for sports-related injuries. The body reconstruction products segment is further segmented into implants, fracture & ligament repair devices, arthroscopy devices, prosthetics, and orthobiologics.

Asia Pacific is expected to witness the highest sports medicine market growth during 2017 to 2022. The influx of international players, government initiatives to promote sports medicine, and collaborations for sports medicine research are the key factors responsible for the growth of this market in the APAC region.

Inquire for Discount on Sports Medicine Market – Global Forecast to 2022 research report at http://www.rnrmarketresearch.com/contacts/discount?rname=80170 .

The report analyzes the sports medicine market and aims at estimating market size and future growth potential of this market based on various segments such as product, application, and region. In 2017, the fracture & ligament repair devices segment is expected to account for the largest share of the market. The high incidence of fractures and ligament tears in sports is expected to drive the market for fracture and ligament repair devices. The orthobiologics segment is expected to register the highest CAGR during the forecast period. The recent developments in regenerative medicine, allografts, and stem cell therapy to treat broken bones are expected to drive the growth of the orthobiologics market.

Break of primary participants was as mentioned below:

  • By Company Type: Tier 1-55%, Tier 2-25% and Tier 3-20%
  • By Designation: C-level-43%, Director Level-32%, Others-25%
  • By Region: North America-38%, Europe-23%, Asia Pacific-29%, RoW-10%

Another research titled Orthobiologics Market Global Forecast to 2022 says, the global orthobiologics market is projected to reach $6.06 billion by 2022 from $4.66 billion in 2017, at a CAGR of 5.4%. The PRP segment is expected to grow at the highest rate during the forecast period. The spinal fusion segment is expected to grow at the highest CAGR. Hospitals, orthopedic clinics, and ambulatory care centres are expected to be the fastest-growing segment. Asia Pacificis expected to register the highest growth rate in the orthobiologics market. Companies such as DePuy Synthes, Medtronic, Stryker, Zimmer Biomet, Harvest Technologies, Globus Medical have been profiled in this 159 pages research report available athttp://www.rnrmarketresearch.com/orthobiologics-market-by-product-viscosupplementation-synthetic-orthobiologics-dbm-bmp-prp-bmac-allograft-application-fracture-recovery-osteoarthritis-spinal-fusion-soft-tissue-end-user-hospitals-as-st-to-2022-market-report.html .

Explore more reports on Medical Devices Market athttp://www.rnrmarketresearch.com/reports/life-sciences/medical-devices .

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Zimmer Biomet, Wright Medical Lead US Market for Elbow Repair Devices Fueled by Cases of Arthritis and Use of New Anatomic Plates

Vancouver, BC — (ReleaseWire) — 10/05/2017 –According to a new series of reports on the U.S. market for orthopedic small bone and joint devices by iData Research (www.idataresearch.com), elbow open reduction internal fixation (ORIF) is growing due to the use of anatomic plates which are low profile designed specifically for the olecranon, coronoid and distal humerus. The fastest growing procedure of the elbow is complete replacement which is prescribed in cases of arthritis, fractures which cannot be managed using other techniques and for revision of the elbow. The elbow repair market is segmented by primary elbow and radial head implants with a combined market value in the U.S. of just under $50 million in 2016.

“Radial head implants are primarily used for traumatic fixation, as degeneration of radial head articulation is not a frequent occurrence,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “Fractures of the radial head typically result from falls on outstretched hands; therefore, the demand for these products increases as the population ages.”

The primary elbow implant market is sub-segmented into semi-constrained and unconstrained devices. The majority of unit sales are semi-constrained due to greater durability and the higher complication rate of unconstrained devices. Only Wright Medical’s Latitude™ EV Total Elbow Prosthesis can be installed unconstrained and, of those devices, just under half are done this way. The radial head market meanwhile, is the fastest growing segment with both units sold and ASP expected to grow over the next several years.

Zimmer Biomet is the leading competitor in the U.S. elbow repair market. They have experienced strong growth in the past few years and offer a full range of products for the orthopedic elbow surgeon. Zimmer Biomet’s Coonrad-Morrey total elbow product has a long history in the market with over 25 years of clinical use, set the standard for primary elbow replacement. The Coonrad-Morrey is the most popular primary elbow joint replacement in the world and is designated for rheumatoid arthritis, osteoarthritis and fractures.

 

READ THE REST HERE

OMNIlife science™, Inc. Surpasses 17,000 Procedures Milestone for OMNIBotics® Robotic-Assisted Total Knee Replacements

RAYNHAM, Mass.Oct. 5, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), an established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that surgeons have completed more than 17,000 total knee replacements worldwide using the OMNIBotics robotic-assisted total knee replacement technology platform. The OMNIBotics system enables optimized implant placement using robotics driven by OMNI’s proprietary ART™ software. Surgeons can efficiently plan a procedure that is specific to each patient using a patented intra-operative 3-D modeling technique that eliminates the need for preoperative CT scans or x-rays. This results in a more precise alignment of the knee implant that many surgeons believe can lead to more rapid recovery and a more natural feeling knee replacement.

In addition to the clinical benefits, the OMNIBotics system provides proven savings per episode of care through a reduced learning curve for the surgeon and O.R. staff as well as a fast case-to-case turnaround and a compact physical footprint which improves efficiency. There is no capital investment cost for the hospital and no annual maintenance or software upgrade fees. This makes the OMNIBotics system a more cost-effective way for healthcare providers to offer robotic-assisted total knee replacement surgery to their patients.

“As one of the first surgeons to adopt OMNIBotics and having performed more than 1500 procedures, this significant milestone validates my experience with the technology,” said Ronald LaButti, DO, FAOAO, orthopedic surgeon with Advanced Orthopedics of Oklahoma and Oklahoma Surgical Hospital in Tulsa, OK. “I am committed to providing orthopedic care that is second to none and find that the precision of the OMNIBotics patient-specific procedure enables my patients to recover more quickly and results in excellent clinical outcomes as well as very satisfied patients.”

Market research estimates that in the next 5 years, more than 20% of total knee replacement procedures will be performed using robotic-assistance. OMNI has anticipated this demand and is focused on designing breakthrough complementary technologies like their recently FDA cleared Active Spacer which, for the first time, provides the surgeon with a quantitative tool to actively manage the tension on ligaments and pressures in the knee joint itself  with dynamic real-time feedback.

“OMNI has been at the forefront of robotic-assisted total knee replacement technology since the initial introduction of our first robotic total knee systems in 2010 and passing this 17,000 robotic- assisted TKA procedure milestone shows that we are still going strong,” stated Carl Knobloch, OMNI’s Vice President of Marketing.  “We continue to see increased interest in our latest OMNIBotics technology from surgeons, patients and hospitals.  With the pending addition to the OMNIBotics platform of our recently FDA cleared Active Spacer robotic soft tissue balancing technology, we expect the rate of adoption and case volumes to increase significantly in the coming year.

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.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as 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 
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com

Renew Spinal Care Announces Strategic Alliance Agreement with SpineMark

HOUSTONOct. 5, 2017 /PRNewswire/ — Renew Spinal Care, Inc. announces a strategic alliance agreement with SpineMark Corporation, adding a key component to its rapidly expanding structure. The agreement with SpineMark will allow the two dynamic companies to complement one another through mutually aligned strategies that will enhance patient diagnosing, integrate operational minimally invasive spine surgery protocol and merge state-of-the-art medical technology.

Renew consists of a national network of board-certified spine surgeons who specialize in minimally invasive spine surgery (MISS). Physicians utilize innovative techniques to repair multiple levels of the spine, bilaterally, in the lumbar, cervical and even the thoracic region in one anesthetic experience. Through MISS procedures, spinal nerve impingements are released through the least invasive approaches available. In most cases, patients do not require an overnight hospital stay; rather, they leave the surgical facility on the same day with just a bandage and no stitches.

SpineMark Destination Centers are a unique, comprehensive delivery system, starting with accurate diagnosis of the origin of the pain. SpineMark advocates for holistic modalities and minimally invasive procedures and surgeries to restore patients’ abilities to live a productive life. SpineMark leads with a “first-do-no-harm” minimally invasive spine approach, with more complex surgeries, such as fusions, always considered a last resort.

SpineMark’s mission is to create a universal standard based on early intervention for the treatment of patients suffering from spinal pain with the help of physicians, industry payors and governmental agencies. SpineMark’s protocol and Renew’s network of board-certified surgeons are combining to offer Spine Centers of Excellence in an unparalleled partnership in the history of the development of MISS.

In addition to focusing on spine, the agreement integrates minimally invasive foot and ankle surgery. Both companies are in the forefront of assisting leading nationally recognized surgeons specializing in ambulatory foot and ankle surgery avoiding plates, pins and screws.

Pairing of Leading Minds on Spine Care

Sam Bailey, CEO of Renew, and Marcy Rogers, President of SpineMark, bring more than 45 years combined business experience and leadership in the development of spinal modalities. The agreement between Renew and SpineMark unites their formidable experience and relationships, forming an alliance that offers a platform for physicians to maximize their practice and healthcare consumers to benefit from the latest developments in spine surgery.

Bailey said, “I am honored and humbled to work together with Marcy and the SpineMark team. Her tireless pursuit of excellence in uniting the greatest minds in MISS is inspirational to all who know her and have had the privilege of working alongside her.”

Concerning the agreement, Rogers said, “The time is right for the mutual synergies of Renew and SpineMark to unite. Both companies are privileged to work with the greatest physician leaders in the industry. Sam and I have known each other since the early days of MISS. We believe this agreement will help change the course of medical history.”

Neurosurgeon Dr. Adam Lewis, National Medical Director for SpineMark, welcomes the opportunity to work closely with Renew. “In just five years, Renew has established its reputation as a true leader in the MISS space. As a long-time advocate of MISS, I am excited for SpineMark to help Sam and his team bring their innovative techniques to even more communities.”

Dr. Michael Keogh, National Director of Marketing for SpineMark, says the agreement between Renew and SpineMark will improve the quality of life for people nationwide. “The biggest beneficiaries of this agreement are patients,” he says. “They will gain access to the most advanced care that delivers exceptional outcomes at low costs — the type of services our healthcare system desperately needs more of.”

For Press Inquiries, contact:
Ashley@RenewSpinalCare.com
917.478.4533

SOURCE Renew Spinal Care, Inc.

Related Links

http://www.renewspinalcare.com

Recent Studies Show Backpacks Affect the Spine in Adolescents

DALLAS, TX, October 05, 2017 /24-7PressRelease/ — According to Spine Journal, over 60% of adolescents aged 6 to 19 have reported that their daily backpack use caused back pain. The majority of American children carry backpacks to school every day, making it imperative that students are taught how to carry their backpacks in the correct way to result in the 60% statistic dropping. The Spine Journal puts an emphasis on the 60% percent statistic, claiming that the frequency of carrying the backpack and its position on the body is directly related to the lower back pain. Now that the school year is in full swing and the homework is piling up, it is important to help young students adopt proper carry habits to keep their spine healthy and pain free.

A separate study from SPINE (Volume 35, pp 83-88) found that the weight of backpacks significantly affected the rate of back pain in children. According to the study, carrying a loaded backpack with books, folders, and other supplies frequently caused a compression of spinal discs in the lower spine. When additional weight was added to these backpacks, children had to continually adjust their posture to carry the weight as comfortably as they could. Unfortunately, these altered positions resulted in disc pressure, causing low back pain. SPINE’s study concluded that a large portion of low back pain sufferers presented changes in their lumbar spine by MRI scan. They were carrying anywhere from 10 to 20 percent of their bodyweight.

Texas Back Institute recommends that a child’s backpack should, at maximum, weigh no more than 10-15% of their body weight before risking back pain. Likewise, it is crucial the backpack has an even distribution of weight by utilizing both straps over their shoulders. Slinging a backpack over one shoulder will force the child to lean to the side for extended periods of time under the weight of the pack. This will cause the spine to curve and increase the force on the lumbar discs, creating low back pain and discomfort.

The position and condition of the backpack is just as important. For example, backpacks should be replaced when the thick padding of the straps has worn down. The bottom of the pack should rest comfortably in the lower back’s curve and never hang too far past the waist. Helping parents and their children become aware of these crucial details will assist children in alleviating their back pain and lower the chronic low back pain statistic in adults.

About Texas Back Institute: Texas Back Institute and its team of spine surgeons, specializing in conditions from Scoliosis to Degenerative Disc Disease and Myelopathy, use experience, talent, state-of-the-art equipment, and technology to provide superior and innovative care for patients who suffer from back and neck pain, which has kept patients flying out of town to receive care from Texas Back spine surgeon in Dallas.

From its beginning in 1977, the goal to perform as a center of excellence while integrating the best of science and education with the best business practices has served Texas Back Institute well and continues to be the backbone of TBI’s success. Over 40 years later, Texas Back Institute is one of the largest freestanding multidisciplinary academic spine centers in the world. Utilizing the latest technological advancements and medical breakthroughs, leading and participating in numerous FDA trials, developing surgeons through its fellowship program and employing an expert medical team and compassionate support staff, Texas Back Institute remains dedicated to helping patients get back to life.

 

K2M Group Holdings, Inc. President & Chief Executive Officer Eric Major Elected Chairman of the Board of Directors

LEESBURG, Va., Oct. 04, 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 President and Chief Executive Officer Eric Major has been elected Chairman of the Company’s Board of Directors, effective immediately. Major succeeds Dan Pelak, who will assume the role of Independent Lead Director after serving as Chairman since 2010.

“On behalf of our Board, I am pleased that Eric Major will serve as our next Chairman at a time when K2M is defining itself as a preeminent spinal device company of the future,” said Pelak. “Eric’s leadership experience, industry expertise and vision of excellence in spinal innovation make him the ideal person to lead our Board of Directors, and I look forward to supporting him in his new role.”

Major, a co-founder of the Company, has served as K2M’s President, Chief Executive Officer, and a Director since January 2004.

“It is truly an honor to succeed Dan Pelak, whose tenure as Chairman is marked by significant achievement and success at K2M,” said Major. “I have also had the great opportunity to work with our founding Chairman and present Chief Medical Officer, Dr. John Kostuik, who helped to inspire a surgeon- and patient-focused culture. I look forward to continued cross-collaboration between our executive team and our Board. Innovation remains at the core of our Company as we strive to create value for our shareholders by helping surgeons to care for patients around the world who suffer from debilitating spinal pathologies.”

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

 

ChoiceSpine™ Granted FDA Clearance for 3D Printed Vertebral Body Replacement Device

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market HAWKEYE Ti, a 3D Printed Titanium Vertebral Body Replacement (VBR) device.

“Additive manufacturing techniques create intricate three-dimensional implants, layer by layer, allowing a freedom in design and surface unattainable through conventional machining,” explained Stephen Ainsworth, PhD, Vice President of Research & Development, ChoiceSpine. “It revolutionizes our approach to design and the benefits we can now offer to our spine surgeon customers and their patients.”

HAWKEYE Ti offers the same complete implant portfolio as the original PEEK HAWKEYE device with the added advantage of a 3D printed, open titanium structure optimized for bone in-growth. HAWKEYE Ti is the first of many 3D printed devices being developed and commercialized by ChoiceSpine.

The HAWKEYE Vertebral Body Replacement System was designed to stabilize and fuse the vertebral column with elegantly simple implants in a variety of shapes and sizes. The portfolio contains small and large footprints that range in size from 10 to 50 mm in height with either 0° or 6° lordosis. “The breadth of this portfolio married with the new 3D printed implants provides a wide variety of options to match varying patient anatomies and surgical needs,” said KC Gilbert, Vice President of Marketing & Professional Education, ChoiceSpine.

“The clearance of our first additively manufactured device is a great achievement for the ChoiceSpine R&D team and the company,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “HAWKEYE Ti allows us to meet the clinical demands of spine surgery in order to stay competitive in a dynamic market.”

About ChoiceSpine 
ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

4WEB Medical Announces Launch of Next Generation Anterior Spine Truss System

DALLASOct. 4, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, has announced the launch of its next generation interbody fusion product line for anterior lumbar spine procedures.  The new release of the Anterior Spine Truss System recently received FDA clearance for several impactful line extensions along with some key new indications for use and design enhancements.

“As the first ever FDA cleared additive manufactured spine implant, the original Anterior Spine Truss System paved the way for a new paradigm in implant technology,” said Jim Bruty, Sr. Vice President of Sales and Marketing at 4WEB Medical.  “The latest edition of the Anterior Spine Truss System builds upon 6 years of successful clinical use with a variety of upgrades that position it as the most advanced anterior interbody solution on the market today.”

The Anterior Spine Truss System features an array of new hyperlordotic options in 16, 20, and 25 degree angles and offset insertion functionality has been added for optimal oblique positioning of the device.  4WEB’s new clearance also includes an indication for allogenic bone graft in addition to autograft.  The key differentiator for the product remains the proprietary truss design that provides a more stimulative and stable environment for fusion than competitive annular designs across the industry.

“The hyperlordotic anterior lumbar offering demonstrates 4WEB’s commitment to further expand their market leading truss technology platform,” said Bobby Kalantar, M.D., orthopedic surgeon at Medstar Georgetown. “The new hyperlordotic footprints allow for greater anterior sagittal balance restoration while keeping the signature bi-convex truss design which has shown to increase bone interface and dramatically reduce the risk of expulsion.”

4WEB expects that the Anterior Spine Truss System will provide a considerable growth opportunity for the business as it takes the product to market in the fourth quarter.  The company’s spine business has just completed its eighth straight quarter of consecutive growth and is poised for its biggest quarter ever in Q4 with the most comprehensive portfolio of 3D printed interbody implants and the early success of its also recently released lateral product line.

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

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‘Lifelike’ 3D printed spine to help train spinal surgeons

Medicalxpress, October 4, 2017 – Credit: Nottingham Trent University

Researchers are 3-D printing replica human vertebrae which act and feel like real bone tissue to help train spinal surgeons before they go into live operations.

A project led by Nottingham Trent University aims to give trainee surgeons the “tactic knowledge” of how it feels to partly remove or drill into vertebrae before undertaking procedures on patients.

The models – which are created using powder printing technology to help achieve a lifelike porosity of real bone – feature hard outer layers and a softer centre.

“Consultants undertaking delicate and precise procedures like need as much knowledge and experience as possible as part of their surgical training before going into live operations,” said Professor Philip Breedon, of the university’s Design for Health and Wellbeing Group.

“One error can lead to catastrophic, life-changing consequences for a patient, so it’s imperative that surgeons can prepare themselves thoroughly.

“This research will enable clinicians to experience how performing spinal surgery feels both physically and mentally, but in a safe training environment.”

The project is in collaboration with consultant spinal surgeon Professor Bronek Boszczyk, of Nottingham University Hospitals Trust, who is a visiting professor at Nottingham Trent University.

 

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