OrthoPediatrics Could Win By Tapping A Massive, Underserved Market, Says Stifel

Posted On November 6, 2017 By OrthoSpineNews In Financial, Top Stories /

Shanthi Rexaline , Benzinga Staff Writer /November 6, 2017

Orthopediatrics Corp KIDS 4.9% is poised to achieve strong top-line growth due to its exclusive focus on the sizeable and largely underserved $2.5 billion pediatric orthopedic market, according to Stifel.

Stifel initiated coverage of Orthopediatrics with a Buy rating and a $23 price target for the shares. The valuation represents a 5.5 times enterprise value to revenue multiple, applied to Stifel’s 2019 revenue estimate for Orthopediatrics of $63.6 billion and discounted 10 percent to the end of 2018.

The pediatric orthopedic market, including trauma and deformity, complex spine and sports medicine, offers the most comprehensive and still-expanding portfolio of pediatric orthopedic implants and instruments to treat a wide array of orthopedic conditions, said analyst Rick Wise.

Capitalizing on this opportunity, Wise said the firm can deliver top-line CAGR in the solid high teens, suggesting revenues that would icrease from an estimated $45 million this year to $98.5 million in 2022. This would put Orthopediatrics above the average revenue growth among its peers.

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Hologic to retain CEO MacMillan | Personnel Moves – November 3, 2017

Posted On November 6, 2017 By OrthoSpineNews In Financial, Top Stories /

NOVEMBER 3, 2017/ BY FINK DENSFORD

Hologic (NSDQ:HOLX) said this week its current prez and CEO Stephen MacMillan will stay on with the company, resolving rumors that he may depart it to take up the corner office at Zimmer Biomet (NYSE:ZBH).

In an SEC filing, the Marlborough, Mass.-based company’s board said it approved a special “performance-based retention equity grant” to MacMillan after he had begun to receive interest from other medical device firms.

“Mr. MacMillan has led a dramatic turnaround of Hologic since joining in December 2013. The company’s performance has increased significantly under his leadership and he personally has recruited a large number of leaders to the company. In light of his long track record of success, other larger medical device companies have expressed interest over time in retaining him to serve as chief executive officer. Mr. MacMillan recently received such an offer from a large medical device company. The independent members of the company’s board of directors considered the potential for disruption to Hologic and its business should Mr. MacMillan leave, and determined that it was in the best interests of Hologic and its stockholders to retain him as chairman, president and chief executive officer. Accordingly, the independent members of the board, after careful consideration and discussions with Mr. MacMillan and the compensation committee’s compensation consultant, awarded him a special retention equity grant, all of which is performance-based. He has formally declined the other more substantial offer, reaffirmed his full commitment to Hologic, and will remain as chairman, president and chief executive officer of Hologic,” the company wrote in an SEC filing.

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Osiris Therapeutics, Inc. Announces Resolution of SEC Investigation

Posted On November 3, 2017 By OrthoSpineNews In Financial, Top Stories /

COLUMBIA, Md., Nov. 02, 2017 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (OTC Pink:OSIR) (the “Company”), a leading regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, today announced the resolution of the previously disclosed investigation by the Securities and Exchange Commission (the “SEC”) into the Company’s historical accounting practices.

The Company has agreed to settle with the SEC, without admitting or denying the allegations of the SEC, by consenting to the entry of a final judgment, subject to court approval, that permanently restrains and enjoins the Company from violating certain provisions of the federal securities laws. As part of the resolution, the Company also has agreed to pay a civil penalty in the amount of $1,500,000. This resolution, if approved by the Court, will resolve, as to the Company, the matters alleged by the SEC in the complaint.

The Company cooperated fully with the SEC during its investigation. Since the SEC’s investigation began, the Company has made numerous important changes to its internal control over financial reporting and disclosure practices, hired a new chief executive officer, chief financial officer and general counsel, and enhanced staff in its accounting and finance departments.

“We are very pleased to have reached the resolution announced today, which relates to activities that occurred during the tenure of the Company’s former management team,” said Peter Friedli, Chairman of the Board of the Company. “We have instituted broad remedial measures designed to detect and prevent the issues that led to the matter being resolved, and this resolution allows us to continue moving forward with the Company’s critical mission of making advances in the area of cellular and regenerative medicine.”

The resolution announced today relates only to the SEC. As previously disclosed, there is an ongoing criminal investigation being conducted by the U.S. Attorney’s Office for the Southern District of New York relating to matters that were also investigated by the SEC, and the Company is cooperating fully with the investigation by the U.S. Attorney’s Office.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the Company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine — including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in wound care, orthopedics, and sports medicine, including Grafix^®, Stravix^®, BIO^4® (available exclusively through Stryker), and Cartiform^® (available exclusively through Arthrex). Osiris, Grafix, Stravix and Cartiform are registered trademarks of Osiris Therapeutics, Inc., and BIO⁴ is a registered trademark of Howmedica Osteonics Corp. Osiris makes no claims concerning functional activities of Grafix or Stravix. Although well characterized in scientific literature and studies, preservation of tissue integrity including cells may not be indicative of clinical outcome. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about the Company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements include, without limitation, statements regarding the Company’s ability to move forward with its business activities, the effectiveness of the Company’s remediation measures, including the effectiveness of completed and planned improvements in its internal control over financial reporting. Forward-looking statements are subject to known and unknown risks and uncertainties and could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Several factors could cause actual results to differ materially from those expressed in or contemplated by the forward-looking statements. Such factors include, but are not limited to, the identification of additional errors in the restatement process for the 2015 quarterly and interim periods, changes or additional errors uncovered by the Company or its independent registered accounting firm, changes in the scope or focus of the accounting adjustments, the risk that additional information may arise prior to the expected filing with the SEC of the Company’s audited financial statements for 2015, 2016 and 2017 or subsequent events that would require us to make adjustments. In addition, the Company’s independent registered accounting firm may determine that other adjustments or errors exist in previously reported 2015 interim periods or other prior periods. Other risk factors affecting the Company are discussed in detail in the Company’s filings with the SEC, including its Form 10-K/A for 2014. Accordingly, you should not unduly rely on these forward-looking statements. The Company undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

For additional information, please contact:

Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

Medacta Announces FDA Clearance and First Surgeries Utilizing 3DMetalTM Tibial Cones for Knee Revision

Posted On November 3, 2017 By OrthoSpineNews In Recon, Top Stories /

November 03, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Family-owned orthopedics leader Medacta International today announced the first surgeries utilizing its recently FDA-cleared 3DMetal^TM Tibial Cones for knee revision surgery. The 3DMetal Tibial Cones can be used for structural support in areas of bone deficiencies that may compromise revision implant fixation, and are indicated for use with Medacta’s GMK Revision and GMK Hinge Knee systems, as well as the GMK tibial extension stems and offset. The first surgeries utilizing this technology were performed by Kevin Hardt, M.D., and David Manning, M.D., of the Northwestern University Feinberg School of Medicine in Chicago, Illinois and Dragan Jeremic, M.D., of St. Vincenz Krankenhaus Brakel in Brakel, Germany.

“Medacta’s 3DMetal Tibial Cones recreate a proximal structural foundation for the intended revision implant by achieving proximal fixation and force transmission in the remaining host bone,” said Dr. Manning, a revision knee specialist and designer of the 3DMetal Tibial Cones. Dr. Hardt added: “The instrumentation was straightforward to use and complementary to my typical revision workflow. I was impressed with the surgical press fit of the implant.”

A Medacta innovation, 3DMetal is a three-dimensional advanced biomaterial based on 3D printing technology that enables direct structural and functional connection with the bone through an interconnecting pore structure similar to the cancellous bone structure. With this new solution, the Medacta knee portfolio allows surgeons to address multiple revision scenarios, including even the most challenging of cases.

Dr. Jeremic, also an expert in primary and revision total knee replacement, commented: “I am very satisfied with this new implant and the result. From now on, this will be an excellent option for my patients.”

“It is Medacta’s mission to be a partner for our surgeons, even in the most challenging scenarios,” said Francesco Siccardi, Executive Vice President of Medacta International. “With our innovative 3DMetal technology, we have extended the range of advanced solutions for our surgeons and we will continue to do so in the future.”

Medacta will launch the 3DMetal Tibial Cones for the U.S. market at the American Academy of Orthopaedic Surgeons Annual Meeting, which will be held in New Orleans in March 2018. The Medacta Shoulder System, announced earlier this month, will also be introduced at the meeting. For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter.

About Medacta International

Medacta^® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^®system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, (516) 729-2250
Jill@torchcomllc.com

SeaSpine Announces Limited Commercial Launch of OsteoStrand™ Demineralized Bone Fibers

Posted On November 2, 2017 By OrthoSpineNews In Biologics, Spine, Top Stories /

CARLSBAD, Calif., Nov. 01, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch and completion of initial surgeries for its OsteoStrand™ Demineralized Bone Fibers. The first implantations were completed by Dr. Khalid Abbed, Vice Chair of Neuro Surgery and Director of Minimally Invasive Spine Surgery at Yale School of Medicine and orthopedic spine surgeon Michael W. Cluck, M.D., PhD, at the Bay Area Spine Care in San Jose, CA.

OsteoStrand fibers are the latest innovation in SeaSpine’s demineralized bone matrix (DBM) product family, which facilitate and aid in fusion. OsteoStrand fibers provide 100% demineralized bone fibers to maximize the osteoinductive content while providing a vastly improved conductive matrix. These fibers were developed through a disciplined R&D process that evaluated a variety of fiber geometries to deliver intraoperative handling and controlled expansion, to facilitate surgical placement, to maintain surgical position and to allow the fibers to better fill the surgical defect with the overriding goal to improve fusion potential.

“The handling properties of OsteoStrand Demineralized Bone Fibers are excellent; it is easily compressible and expands to fill the surgical defect upon implantation,” said Dr. Cluck. “The handling and 100% demineralized bone composition give me a high level of confidence for my fusion procedures.”

Dr. Khalid Abbed added, “The handling properties of OsteoStrand Demineralized Bone Fibers are excellent, and improved compared to other 100% DBM products that I have used in my practice. I believe this tissue product could lead to significant cost savings for my hospital and I look forward to evaluating the OsteoStrand Plus with Accell Bone Matrix.”

“OsteoStrand fibers will serve as a development platform for continued innovation in our orthobiologics portfolio and will further strengthen our top-three position in the U.S. DBM market while also providing operational leverage through our Irvine manufacturing facility,” said Keith Valentine, Chief Executive Officer and President of SeaSpine. “We plan to launch the OsteoStrand Plus Demineralized Bone Fibers with our proprietary Accell™ Bone Matrix on a limited basis in early 2018. We believe these product offerings deliver clinical value as payors and hospitals seek more cost effective orthobiologic solutions.”

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implant portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the potential benefits of the OsteoStrand Demineralized Bone Fibers product, including to improve fusion; the ability of the OsteoStrand Demineralized Bone Fibers to strengthen SeaSpine’s top-three position in the U.S. DBM market and provide operational leverage; the timing of launch of the OsteoStrand Plus Demineralized Bone Fibers product in early 2018; and the potential for new product offerings to clinical value to payors and hospitals. Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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

Consensus Orthopedics launches TracPatch Australia at the Australian AOA meeting in partnership with CUER

Posted On November 2, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

SACRAMENTO, CALIF. (PRWEB) NOVEMBER 01, 2017

Consensus Orthopedics, developer of the latest wearable technology, TracPatch™, has partnered with Neil Thomas and Peter Mackie of CUER, who have come together to cofound TracPatch Australia to distribute this wearable technology throughout Australia and New Zealand. The Australian market is in need of a device that will allow healthcare providers the ability to plan and monitor their patients’ orthopedic recovery. TracPatch can also be applied in ethics studies related to total knee replacements and in conjunction with sports injury reconstruction surgery.

Michael T. Droege, Vice President of Global Business Development, says “Just the idea that both Peter Mackie and Neil Thomas have collaborated together to put all of their career experiences to create TracPatch Australia is an amazing opportunity. We are extremely fortunate to have them as part of our global TracPatch team.”

TracPatch™ is revolutionizing evidence-based surgical care management in orthopedics. The changing dynamics of healthcare has called for transforming patient care through connected health solutions. TracPatch is a cutting-edge remote monitoring device designed to make recovering at home easily accessible, connected, and more predictable. The development of TracPatch, with its availability worldwide, will revolutionize the way data-capturing is used in orthopedics. Surgeons and healthcare providers will be able to monitor their patients in real time during the post-acute care period following surgery. Through data collection, monitoring, and analysis, TracPatch™ ensures patients will receive effective care based on their individual needs.

TracPatch Australia will be the official Australia and New Zealand distributor. TracPatch Australia aims to develop business opportunities throughout the Oceania region. Together, Consensus Orthopedics and Tracpatch Australia presented TracPatch at the Australian Orthopedic Association Annual Scientific Meeting on 8-12 October 2017. TracPatch was well received to the international audience as an exceptional solution to post-surgical monitoring in orthopedics and as a market leader in Australia.

Neil Thomas, Business Development Manager at CUER, says “The need for not only remote monitoring of patients but of evidence based care management makes TracPatch a truly unique product. Australia is ready for an innovative way to create new care standards in orthopedics and TracPatch can help alleviate costs and unnecessary burdens to our healthcare system.”

Peter Mackie, Principle at CUER, states “TracPatch can dramatically shift how healthcare providers approach total joint surgeries in the future. Being able to monitor your patients and proactively get ahead of potential issues involved during a post-acute care period is a tremendous advantage. We are excited to be offering this new product to all Australian healthcare providers and we are looking forward to the future of orthopedics.”

For more Information on Tracpatch Australia please contact Neil Thomas at neil.thomas@cuer.com.au

About Consensus® Orthopedics, Inc.
Consensus Orthopedics was founded in 1992 as a medical device consulting company located in California. In 1996, Consensus Orthopedics acquired US Medical Products becoming a global manufacturer of reliable large joint orthopedic devices. Since 1996, Consensus Orthopedics has been providing the orthopedic industry with exceptional hip and knee joint replacement devices. Its signature knee system, the Consensus Knee System, has over 20 years of reliable and reproducible results. With a deep understanding of the orthopedic industry, Consensus launched its innovative TracPatch Technology division focusing on orthopedic wearable technology, which combines Consensus Orthopedics 25 years of orthopedic experience with innovative Big Data capabilities. TracPatch is a revolutionary new device empowering at-home patient recovery and remote monitoring for effective managed care. With a focus on evidence based medicine, Consensus Orthopedics is changing patient care and the future of orthopedics. Learn more at http://www.consensusortho.com.

About CUER Australia
CUER is a well connected and highly motivated company determined to be the market leaders in wearable technology in Australasia. CUER was founded with the purpose of developing business opportunities and sourcing new devices that are at the cutting edge of technology.

Intellijoint Surgical Inc. Receives FDA Clearance for Revision THA with intellijoint HIP®

Posted On November 1, 2017 By OrthoSpineNews In Recon, Regulatory, Top Stories /

WATERLOO, ON, Nov. 1, 2017 /PRNewswire/ – Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received FDA Clearance for revision Total Hip Arthroplasty (THA) with its intellijoint HIP® System. A 3D Mini-Optical Navigation System, intellijoint HIP® provides surgeons with precise measurements for cup position, leg length and offset for THA. Requiring no pre-operative or intra-operative imaging, intellijoint HIP can be used with any implant manufacturer, and for any primary or revision THA.

The revision indication provides surgeons with the ability to evaluate existing THA components to inform intra-operative decision making. The possibility to leave existing components in place can greatly reduce risk to the patient and can contain cost for the hospital. Other image based technologies are not suitable for revision THA as existing components create distortion to pre-operative images, making them unusable for critical patient registration.

“intellijoint HIP for revision gives me accurate positioning information about the existing cup. I can then determine which acetabular components need to be removed due to the component being malpositioned,” explained said Dr. Wayne Paprosky, Midwest Orthopaedics at Rush and a member of Intellijoint’s scientific medical advisory board. “I can document the position to defend why I removed or retained the component. When I am able to leave the cup in place, particularly in high risk patients, the risk of complication is greatly reduced and the procedure is significantly shortened.”

intellijoint HIP is available for Anterior, Posterior and Lateral approaches and can be used on primary and now revision THA. This milestone supports Intellijoint Surgical’s mission of making intellijoint HIP accessible to every surgeon and every patient.

“Our core technology is well suited for revision surgery as it provides accurate intra-operative information without relying on pre-operative x-rays or imaging of any kind,” added Intellijoint Surgical CEO Armen Bakirtzian. “Image-based robotics and navigation systems rely heavily on pre-operative imaging, which could result in significant inaccuracies due to image distortion by metal from the existing components”.

Visit Intellijoint Surgical at the upcoming American Association of Hip and Knee Surgeons (AAHKS) annual meeting (booth 100) in Dallas, Texas from November 3^rd to 4^th to learn about the cutting-edge technology behind intellijoint HIP.

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.

SOURCE Intellijoint Surgical Inc.

MiMedx Agrees To Lawsuit Settlement With Halo Wound Solutions

Posted On November 1, 2017 By OrthoSpineNews In Biologics, Regulatory, Top Stories /

MARIETTA, Ga., Nov. 1, 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 the Company has agreed to a confidential settlement of the lawsuit the Company filed against BioResolutions LLC d/b/a Halo Wound Solutions (Halo) and one of the Halo executives.

MiMedx filed its lawsuit against Halo and its executive, Tracy Lucas, in January 2017. In its suit, MiMedx alleged that Lucas used MiMedx trade secrets and other confidential, proprietary business information to unlawfully solicit the sales of Halo’s medical products with the assistance of MiMedx employees, and tortiously interfered with MiMedx’s contracts with its employees. Mr. Lucas is a former employee of MiMedx. MiMedx alleged that during and after Mr. Lucas’ employment with MiMedx, Halo and Mr. Lucas engaged in wrongful conduct with MiMedx employees, knowing they were actively employed by MiMedx and knowing that MiMedx employees have contractual and legal obligations to the Company.

In addition to an undisclosed monetary settlement, other settlement terms were reached. Certain of these additional settlement terms include: for a period of two years Halo will not sell amniotic tissue products, human tissue/skin substitute products to MiMedx’ existing customers; and for a two-year period, Halo will not solicit MiMedx employees to work for Halo in any fashion or to leave MiMedx’s employment. Luke Esslinger, President and CEO of Halo, stated, “I apologize that this situation arose. To our knowledge, MiMedx was not aware that its employees were selling third party products or services, including Halo products. We realize now that MiMedx firmly disapproves of its employees selling our products and that such a situation had the potential to create a conflict with the rightful obligations these employees had with their employer, MiMedx.”

Parker H. “Pete” Petit, MiMedx Chairman and CEO, said, “We are pleased to have another one of these lawsuits behind us. We have reached an amicable and favorable settlement with Halo. I applaud Halo for dealing with this in a professional manner and treating it as a learning experience for their future business activities.”

“We have been very effective in continuing our growth trajectory and sustaining our operational excellence, in spite of these corporate distractions. Our constant focus has been on growing our business for the benefit of our customers and their patients, employees and shareholders. I could not be more proud and complementary of our organization for its continued concentration on our business while these distractions are being resolved,” added Bill Taylor, MiMedx President and COO.

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 potential outcomes of legal actions. 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 different or additional facts may be discovered that change conclusions, and the risks of litigation. 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.

ECA Medical Instruments Launches Cervical-One™ Sterile-Packed, Disposable Instrument Kit for One & Two-Level Fusions

Posted On November 1, 2017 By OrthoSpineNews In Spine, Top Stories /

November 1, 2017

Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting instruments and surgery-ready procedural kits for the medical industry and surgeons worldwide, has launched the Cervical-One™ single-procedure instrument set for use in one and two-level cervical spine implant procedures. The novel instrument set is available for tailoring and branding by spine implant OEMs for securing both plates and screws and interbodies commonly used to treat spine degeneration and deformity cases.

ECA markets and sells its single-use instruments and complete procedural kits to medical device OEMs for private labeling and branding, saving them significant R&D investment and accelerating time to market for new product introduction or legacy product refresh. Tailored to implant manufacturer specifications the Cervical-One™ kits can be branded in different colors, handle shapes and sizes. The instrument sets are ready for rapid adoption across the marketplace to reduce operating cost, eliminate instrument cleaning and re-sterilization, improve patient safety and provide perfect fixation of implants while reducing risk of surgical site infection.

“Cervical-One™ offers spine implant OEMs essentially an off-the-shelf and surgery ready solution that provides them differentiated instrumentation to both clinically and economically meet the growing demand for cervical spine degeneration repair,” said Lane Hale, president and CEO of ECA Medical Instruments. “The simplicity of design and modular instrument approach allows for easy branding and modification to meet surgeon needs for implant fixation, navigation, procedural stack up and OR efficiency gains,” he said.

ECA is marketing the fully disposable instrument kits in three configurations: 1) instrument set for anterior cervical plate and screw fixation, 2) interbody implant fixation kit, and 3) a combined anterior cervical discectomy fusion (ACDF) kit combining instrumentation.

The kits include the full complement of instruments needed by surgeons and OR teams including precision torque-limiters and drivers. All the instruments use state of the art medical grade polymers for strength and durability, are validated and packaged in sterile-pack fully recyclable trays.

An early adopter of the Cervical-One™ instrument kit is Zavation Medical, Jackson, MS. Zavation is collaborating with ECA to develop a family of kits for stand-alone and combined fixation of one and two-level plating and also interbody cages (artificial discs). Zavation expects to launch their new SteriCerv™ line of products in early 2018. Both Zavation and ECA demonstrated the new instrument kits to neurosurgeons and orthopaedic surgeons at the North American Spine Society (NASS) 2017 conference last week in Orlando.

“Single-use instrument kits coupled with sterile packed implants are clearly the way of the future for high volume and relatively low complexity spine surgeries in both the hospital and outpatient setting,” Hale said. “We’re excited to partner with both large and small/medium enterprise OEMs across the spine industry and bring these new instrument kits to market.”

Single-procedure instruments and procedural kits are providing surgeons and patients alike with a pristine set of ready for surgery instruments for securing a wide range of medical device implants. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection and reduction in hospital and ASC inventory management.

ECA is a one stop shop OEM instrument company providing implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments

ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA. ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 35 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2017 by LivaNova. www.ecamedical.com

Media Contact: James Schultz

Phone: +1 805-990-6177

Email: jschultz@ecamedical.com

Atlas Spine, Inc., Announces FDA 510(k) Clearance on Ortus Expandable Posterior Lumbar Interbody System

Posted On October 31, 2017 By OrthoSpineNews In Spine, Top Stories /

Jupiter, Florida., October 31, 2017 (PR NEWSWIRE) — Atlas Spine, Inc., a high technology, spinal implant and instrumentation company based in Jupiter, Florida, today announced that the Ortus™ Expandable Posterior Lumbar Interbody System has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). The device is designed to be delivered using either minimally invasive or open surgical approach. The Ortus™ PL is clearly differentiated from other expandable technology. For example it has one of the smallest starting heights (6.5mm) of any expandable device on the market, and relies on a unique, patented design that allows for implant expansion while restoring natural anatomic alignment in a single step. The device also features an open architecture that allows the surgeon to pack ample graft material after the device is deployed and expanded. This is the first implant in a comprehensive line of expandable interbody intellectual property that utilizes anterior, PLIF, oblique, and minimally invasive approaches and devices that the company plans on launching.

“Atlas has a deep pipeline of expandable technology and the Ortus™ 510(k) clearance presents a tremendous opportunity to establish our company as an expandable interbody technology market leader. The Ortus™ platform provides options and capabilities for surgeons focused on restoring spinal balance that is yet to be provided by other devices and companies. Paired with a minimally invasive surgical approach, Ortus™ PL is a powerful tool for spine surgeons seeking reliable fusions with minimal complexity and post-operative morbidity. Furthermore, the Ortus™ PL platform is well suited for anterior, posterior, lateral and oblique approaches, in addition to MIS,” notes Atlas Spine’s co-founder and CTO Matthew Baynham.

Atlas Spine’s CEO Douglass Watson adds, “We are thrilled to be in the expandable posterior lumbar interbody market. The response from key, opinion-leading surgeons is tremendous. We are preparing to launch the Ortus™ PL interbody device with our distributor network in the near future and look forward to numerous additional differentiated device clearances over the next several quarters.”

The U.S. FDA notified the company on the first day of the North Atlantic Spine Society (NASS) meeting. This is Atlas Spine, Inc’s 12^th product to receive 510(k) clearance by the U.S. FDA and allows the Company to access distribution channels and gain measurable market share. It also allows the company to focus on commercializing other significant projects in the pipeline.

About Atlas Spine, Inc.

Our mission is to create spinal implants and instrument systems that treat a variety of pathologies combining the highest level of performance with ease of use which translate to physician satisfaction and enhanced patient outcomes. The company has over 50 issued and pending patents and currently distributes a number of interbody and posterior stabilization systems and has also licensed technology to other companies in the spinal device market.

For more information about Atlas Spine, please visit atlasspine.com.

Contact: Matthew Miller, Atlas Spine Inc., (561) 741-1108 or mmiller@atlasspine.com. Atlas Spine Inc., 1555 Jupiter Park Drive, Suite 1; Jupiter, Florida 33458.

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