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October 4, 2017 OrthoSpineNews

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

 


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October 4, 2017 OrthoSpineNews

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.


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October 4, 2017 OrthoSpineNews

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

Related Links

http://www.4webmedical.com


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October 4, 2017 OrthoSpineNews
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.

 

READ THE REST HERE


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October 4, 2017 OrthoSpineNews

WATERLOO, ONOct. 4, 2017 /PRNewswire/ – Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the approval of the CE Mark (Conformité Européenne) for its intellijoint HIP® System in Europe. A 3D Mini-Optical Navigation System, intellijoint HIP® provides surgeons with precise measurements for cup position, leg length and offset for Total Hip Arthroplasty (THA). Requiring no pre-operative or intra-operative imaging, the system can be used with any implant manufacturer.

intellijoint HIP, the flagship product by Intellijoint Surgical is available for both an anterior approach as well as lateral and posterior approaches, regardless of incision size. The 3D Mini-Optical tracking by Intellijoint is the only one of its kind and serves as the core technology for THA’s and other orthopedic surgical applications in development.

“The CE mark supports our mission of making the intellijoint HIP technology accessible to every surgeon and every patient,” explained Intellijoint CEO Armen Bakirtzian. “Intellijoint Surgical has developed a global strategy for its product portfolio and our rapid expansion in the US market paired with our versatile business model has prepared us for global scale.”

Intellijoint Surgical plans to enter the European market in 2018 and expects approval for intellijoint HIP from the Australian Therapeutic Goods Administration (TGA) by November 2017. Intellijoint Surgical will be demonstrating the capabilities of the intellijoint HIP System at several orthopedic conferences this year including the American Association of Hip and Knee Surgeons (AAHKS) annual meeting in Dallas, Texas this fall.

About Intellijoint Surgical:

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

SOURCE Intellijoint Surgical Inc.

Related Links

https://www.intellijointsurgical.com/


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October 4, 2017 OrthoSpineNews

October 04, 2017

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the NEXXT MATRIXX™ System.

The NEXXT MATRIXX™ System of 3D printed porous titanium leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

Several studies have shown that textured titanium alloy surfaces elicit a positive bone response including an increase in osteoblast differentiation and surface osteointegration as compared to classically smooth surfaces. With these studies in mind, Nexxt Spine has coupled their proprietary, residue-free, surface technology with an open, varied porosity, titanium architecture whereby the NEXXT MATRIXX™ implants exhibit up to 4X more surface area for bone apposition and up to 2X more open pore volume than conventional spinal implants.

Andy Elsbury, President of Nexxt Spine, stated, “The NEXXT MATRIXX™ System applies breakthrough technology to our company’s product portfolio and surgeon response has been overwhelmingly positive. We will continue to expand our NEXXT MATRIXX™ offering throughout 2017 and into 2018 to ensure this differentiated technology is available for all spinal fusion surgical approaches.”

The first products to feature the NEXXT MATRIXX™ technology are available in both interbody and VBR options in an assortment of height, length, width and lordotic angulation combinations to accommodate the unique anatomic and clinical circumstances of each patient.

For more information about NEXXT MATRIXX, visit www.nexxtspine.com.

Nexxt Spine, LLC is a privately held medical device manufacturer dedicated to increasing procedural efficiency and patient outcomes through development of innovative products, manufactured on the most technologically advanced platforms, and utilizing irreproachable quality standards to treat painful and debilitating spinal pathologies.

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

Contacts

Nexxt Spine, LLC
Sarah Koch
Info@NexxtSpine.com


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October 4, 2017 OrthoSpineNews

OrthAlign, Inc., a privately held U.S.-based medical device and technology company, received CE Mark Approval to market its advanced precision technologies for Direct Anterior Approach Total Hip (DAA HipAlign®) and Unicompartmental Knee Arthroplasty (UniAlign®) surgeries, in Europe and other countries.

“As OrthAlign has focused on expanding customer reach and its application pipeline in 2017, we are pleased that surgeons outside of the United States and Japan can now have access to our newest precision technologies DAA HipAlign and UniAlign,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We will continue providing orthopedic surgeons and healthcare facilities throughout the world our clinically beneficial portfolio of products, staying true to our core design principles of ease of use, precision, and cost effectiveness.”

Recent global statistics have shown that the direct anterior approach for total hip arthroplasty is growing, as it arguably leads to quicker recovery, less pain, and more normal function for patients after hip replacement. DAA HipAlign does not require any pre-operative imaging or intraoperative fluoroscopy, while providing more clinically relevant positioning for cup placement and leg length measurement. Early clinical data from the United States demonstrates that surgeons can expect to reduce fluoroscopy exposure time by about 45%. Early clinical data from Japan shows cup placement (for both inclination and anteversion) accuracy of ±10°, with at least 95.9% confidence.

Unicompartmental knee arthroplasty procedures are also growing in popularity, worldwide. UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The system has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth. This accuracy has been validated with at least 90% confidence.

“As international expansion has been one of OrthAlign’s priorities, receiving CE Mark approvals for use of our technology in two rapidly growing segments is great news,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “Our international distributor network has been waiting for these approvals, as many of their local surgeons have been asking for the technology.”

DAA HipAlign and UniAlign will be included in OrthAlign Plus® handheld navigation devices, along with OrthAlign’s award-winning KneeAlign® technology. To date, OrthAlign technology has successfully been used in over 65,000 cases, in over 25 countries, with more than 15 published international clinical studies demonstrating its accuracy.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

 


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October 4, 2017 OrthoSpineNews

WASHINGTONOct. 3, 2017 /PRNewswire/ — National Spine & Pain Centers (NSPC) (https://treatingpain.com/) is pleased to announce one of its physicians, Dr. Dan Kendall, recently treated a vertebral compression fracture (VCF) using the AVAflex Balloon System from Stryker. This technology is less invasive than traditional VCF treatments, with potential for less risk and patient trauma. National Spine & Pain Centers is committed to pioneering solutions to chronic pain, and this first application of the AVAflex Balloon System in the D.C. Metro area is only the latest example.

“In using Stryker’s AVAflex technology during a balloon kyphoplasty procedure,” says Dr. Kendall, “I was able to treat the patient using only one trocar while still achieving the results I look for with using two trocars. Using one trocar provides less patient trauma and further minimizes risk for infection.”

Balloon kyphoplasty is a minimally invasive treatment for vertebral compression fractures. In a standard balloon kyphoplasty, two trocars are inserted into the fractured vertebrae.  Balloon catheters are then inserted through the trocar needles and inflated to create a void.  The hardened bone cement creates an internal cast in the fractured vertebrae stabilizing the fracture and alleviating pain. Stryker’s AVAflex Balloon System represents a crucial step forward for balloon kyphoplasty, offering a less invasive approach.

Dr. Kendall performs balloon kyphoplasty’s in his office in McLean, Virginia.  With the advancement of technology in treating VCF’s, patients no longer have to go to the hospital and can receive the treatment without receiving general anesthesia.  Dr. Kendall now is able to treat his patients with painful compression fractures with a short 20-minute procedure and mild sedation. This allows the patient to be treated as out-patient enabling them to walk out of the office when released.

“I am always looking for the best and most effective way to treat my patients,” adds Dr. Kendall. “Typically, my patients with VCFs are elderly and in severe pain. Stryker’s AVAflex balloon technology allows me to perform a balloon kyphoplasty procedure efficiently while still delivering great results.”

In addition to treatments for VCFs, National Spine & Pain Centers also provides solutions for people experiencing arthritis, migraine headaches, spinal stenosis and diabetic neuropathy, among many other conditions. Innovative treatment modalities include discography, epidural nerve block, platelet rich plasma (PRP) therapy, stem cell therapy and spinal cord stimulation.

In view of the opioid crisis, Interventional Pain Management (IPM) groups such as National Spine & Pain Centers are playing a pivotal role in delivering outcome-driven treatment solutions that provide comprehensive, effective care for patients suffering from chronic pain.

Dr. Dan Kendall joined NSPC in 2004 after completing an interventional pain management fellowship at Johns Hopkins Hospital. He has published numerous articles and lectured nationally on interventional pain topics, and has earned not only the esteem of his peers but also the admiration of his patients.

About National Spine & Pain Centers

National Spine & Pain Centers (NSPC) is the nation’s leading network of pain management practices with over 65 pain physicians on staff at more than 60 locations in ConnecticutMarylandNew JerseyNew YorkNorth CarolinaVirginiaWashington DC and West Virginia. Many NSPC physicians are among the most respected pain practitioners in the world.

Contact:

Manju Regmi
P: 301-881-7246 ext: 10163
11921 Rockville Pike #505
Rockville, MD 20852
http://www.treatingpain.com/
177514@email4pr.com

SOURCE National Spine & Pain Centers


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October 4, 2017 OrthoSpineNews

MARIETTA, Ga.Oct. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that Dr. Gloria Matthews has joined the Company as its Senior Vice President, Research and Development.  Dr. Matthews will lead the Company’s overall research function as well as the development of new products.

Parker H. “Pete” Petit, Chairman and CEO, stated, “Dr. Matthews brings over 20 years of experience encompassing programs from discovery into Phase 3 clinical development for devices, orthobiologics, combination products, and new chemical entities for osteoarthritis, cartilage repair, and regenerative medicine.  She is an accomplished scientific leader with broad ranging expertise in orthopedic and rheumatologic diseases, among other therapeutic areas, and she has significant functional experience in cellular and gene therapy, biomaterials and growth factors.”

Bill Taylor, President and COO, commented, “The addition of Dr. Matthews to our staff is an important step in our continued expansion into biopharmaceuticals. We will continue to expand our clinical and scientific talent and resources to further drive our growth in this area. We are very excited to welcome Dr. Matthews to our organization.”

Immediately prior to joining MiMedx, Dr. Matthews served as Chief Medical Officer at Histogenics Corporation, where she oversaw all clinical and medical affairs activities with strategic oversight of various United States and global development programs across biologics, drugs and devices.

Prior to Histogenics, Dr. Matthews spent 12 years at Genzyme Corporation and Sanofi Genzyme.  During her tenure at Genzyme, Dr. Matthews held progressively more responsible leadership positions and was involved in clinical and preclinical development and/or post-market support of cell, gene, growth factor, small molecule and biomaterial based products in the orthopedic and rheumatologic space. Dr. Matthews last served with Sanofi Genzyme in the role of Senior Director and Global Head of Bone and Joint Disease Research and Development.

Dr. Matthews earned her DVM and Ph.D. from Cornell University.  Dr. Matthew’s Ph.D. concentration was in cell and molecular biology of osteoarthritis.

The Company also reaffirmed its previously communicated revenue expectations for the third quarter of 2017. “In our press releases of September 5 and September 13, 2017, we communicated that we expected to exceed the $80 millionupper end of our forecasted third quarter revenue range in spite of the disruption from Hurricane Harvey and Hurricane Irma. Our preliminary revenue estimates clearly show that our forecasting was correct. We are experiencing robust revenue growth, and we look forward to reporting our actual third quarter revenue on or about the 13th of October,” added Petit.

About MiMedx
MiMedx® is 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. 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 1,000,000 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 revenue expectations for the 2017 third quarter; and expectations for sales performance, despite the effects of Hurricane Harvey and Hurricane Irma.  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 the Company’s revenue for the 2017 third quarter may not materialize as expected; and that the Company’s sales performance, may be more negatively impacted than anticipated due to  Hurricane Harvey and Hurricane Irma.  For more detailed information on the risks and uncertainties, 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


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October 3, 2017 OrthoSpineNews

October 02, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today the results of a new White Paper titled Patient-Specific Rods show a reduction in rod breakage incidence. The paper shows that, relative to manually bent rods, patient-specific rods generated using Medicrea’s UNiD ASI technology significantly reduce the incidence of postoperative rod breakage in adult complex spine surgical cases.

The study, authored by an international group of 9 complex spine surgeons from the U.S. and France, reviews a cohort of more than 450 Adult Spinal Deformity (ASD) patients with at least 1 year from the surgical implantation of patient-specific UNiD™ Rods, generated by Medicrea’s UNiD ASI™ systems-based technology for personalized spinal care. This cohort includes more than 120 patients who additionally had pedicle subtraction osteotomy (PSO) performed.

The White Paper demonstrates the rate of rod fracture is considerably less in ASD patients implanted with UNiD™ Rods, when compared to current literature, especially in those having undergone PSO. With a UNiD™ Rod, breakage was detected in 2.2% of all ASD patients and in 4.7% of cases with a PSO performed. These rates decrease further when you remove patient-specific rods that were adjusted during the operation. In the current literature involving non-personalized spinal implants, overall rod breakage incidence is reported as high as 14.9% of patients following ASD surgery [3-5]. When a PSO is performed, the rod fracture rate increases up to 22% and in these cases, 90% of failure is found to occur at, or adjacent to, the PSO level [3-4]. Furthermore, the time to failure is most often seen to occur within 10 months after surgery.

Rod Fracture Incidence

ASD Patients

ASD Patients
with PSO

ASD Patients
with no manual
rod bending

ASD Patients
with PSO and
no manual rod
bending

Standard Rod 14.9% 22.0%
Patient-Specific UNiD™ Rod 2.2% 4.7% 1.8% 3.1%
Fracture Reduction with UNiD™ Rod -85% -79% -88% -86%

Adult Spinal Deformity surgery is increasingly prevalent in an aging population and poses particular challenges with high complication rates that can lead to revision surgery in a reported 16.5% of cases [1] at a substantial cost to the healthcare system found to total around $80,000 per surgery [2]. Thus, avoiding revision surgery can provide a significant savings to the health care system.

Dr. Themistocles Protopsaltis, of NYU Langone Medical Center and co-author of the White Paper, stated, “This review demonstrates that utilizing digitally planned, patient specific UNiD™ Rods which avoids manual rod contouring has a major impact on rod fracture incidence in the treatment of Adult Spinal Deformity. This is important because rod breakage leads to revision surgery at significant cost to the patient, hospital and payer.” Dr. Protopsaltis continued, “Adopting an iterative, data-based approach that is shown to make spinal surgery more efficient can change a surgeon’s practice, making UNiD ASI™ a true advance in our standard of care.”

Denys Sournac, President and CEO of Medicrea, stated, “These results highlight how our proprietary UNiD system can improve both clinical and economic outcomes in spine surgery. We will continue to follow these cases and add to our growing database of more than 1,700 cases. The advanced data science built into our recently FDA-cleared UNiD HUB™ software allows Medicrea to perform advanced surgical simulations as we further harness the power of big data to plan the optimal surgical strategy and design implants adapted to the specific requirements of each patient and surgeon.”

White Paper Authors: A. Vaccaro, V. Fiere, S. Fuentes, T. Raabe, P. Passias, T. Protopsaltis, A. Faure, P. Tropiano, B. Blondel

To receive a pdf of Patient-Specific Rods show a reduction in rod breakage incidence please contact clinicalstudy@medicrea.com.

References

1 – Passias, P.G., et al., Predictors of Revision Surgical Procedure Excluding Wound Complications in Adult Spinal Deformity and Impact on Patient-Reported Outcomes and Satisfaction. J Bone Joint Surg Am, 2016;98:536-543.
2 – McCarthy IM, Hostin RA, Ames CP, et al. Total hospital costs of surgical treatment for adult spinal deformity: an extended follow-up study. Spine J. 2014.
3- Smith, J.S., et al., Prospective multicenter assessment of risk factors for rod fracture following surgery for adult spinal deformity. J Neurosurg Spine, 2014;21:994-1003.
4 – Barton, C., et al., Risk factors for rod fracture after posterior correction of adult spinal deformity with osteotomy: a retrospective case-series. Scoliosis, 2015:10-30.
5 – Hamilton, D.K., et al., The Fate of Adult Spinal Deformity (ASD) Patients Incurring Rod Fracture After Thoracolumbar Fusion. World Neurosurgery, 2017. In press.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

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Medicrea is listed on
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ISIN: FR 0004178572
Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com