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Current Issues in Spine

February 2-4, 2017
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Spine

Paradigm Spine Announces Company Activities Highlighting coflex® Interlaminar Stabilization® At NASS Annual Meeting 2018

September 24, 2018 OrthoSpineNews

NEW YORK, Sept. 24, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced its Company activities and scientific podium presentation on coflex® Interlaminar Stabilization® at the upcoming the 2018 North American Spine Society (NASS) Annual Meeting, being held September 26-29 in Los Angeles, Calif. coflex® is the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe spinal stenosis.

“The annual NASS meeting provides an optimal opportunity to directly engage with our U.S. spine surgeon audience and we look forward to demonstrating – on the podium and through our surgeon reception – the substantial results adding up from both our newly published ESCADA study and long-term findings from the U.S. FDA IDE trial supporting coflex® against decompression alone and against fusion, respectively,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine.

Details of Paradigm Spine’s activities below:

Oral Presentation: Interlaminar Stabilization versus PLF in the ≤ 65 Year-Old Patient: Five-Year Follow-Up
Abstract:  # 91 
Session: Preserving Spinal Motion; Session moderated by Richard D. Guyer, MD
Date, Time: Wednesday, September 26th at 4:41-4:47 p.m. PDT
Location: Room 403A 
Presenting Author: Antonio T. Brecevich, MD
Institutions: Hospital for Special Surgery (HSS), New York, NY
Product: Coflex (Approved for this indication)

Paradigm Spine Sponsored Surgeon Reception  
Date, Time: Thursday, September 27th at 5:30-8:00 p.m. PDT
Location: GRAMMY Museum at L.A. Live 
800 W. Olympic Boulevard, Los Angeles, CA 90015 
(a 3-minute walk from the Convention Center)

To learn more about coflex® Interlaminar Stabilization® and the newly-published ESCADA results, please visit Paradigm Spine at Booth # 1429 in the Exhibit Hall.

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion.  Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

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Recon

Ethicon’s Novel Skin Closure System Leads To Higher Patient And Surgeon Satisfaction After Total Knee Replacement

September 24, 2018 OrthoSpineNews

SOMERVILLE, N.J., Sept. 24, 2018 /PRNewswire/ — Total knee replacement patients and their surgeons were more satisfied with the cosmetic results and less worried about after care and possible infections when the DERMABOND PRINEO Skin Closure System was used to close the knee’s surgical incision rather than traditional skin staples, according to a new quantitative research study conducted by Ethicon,* part of the Johnson & Johnson Medical Devices Companies,** the manufacturer of the novel skin closure device that combines a topical skin adhesive with a self-adhering patch.1

As a replacement for sutures or staples, the DERMABOND PRINEO System provides minimally invasive closure — no holes in the skin; no sutures or staples to remove, and no dressing changes, which may potentially reduce follow-up visits and support good cosmetic results for patients.2 The DERMABOND PRINEO System has been used to close the surgical incisions of more than 1 million patients.

The double-blinded quantitative study (90% CI) of 88 total knee replacement patients and 83 orthopaedic surgeons, found more patients had overall greater satisfaction with the proven DERMABOND PRINEO System (88.2% vs. 81.8%) and were happier with the appearance of their skin incision (80% vs. 71%). Fewer patients were worried about post-operative care (55% vs. 63%) or concerned about complications (56% vs. 60%) when the DERMABOND PRINEO System was used.

Orthopaedic surgeons were more satisfied with the DERMABOND PRINEO System too, but by even wider margins than their patients. Overall surgeon satisfaction was 83.7 percent compared to 56.1 percent for skin staples. Surgeons felt the System led to greater overall patient satisfaction (84% vs. 45%), better cosmetic results (88% vs. 40%) and better overall healing of the knee incision (82% vs. 52%). Surgeons were also less worried about surgical site infections (77% vs. 52%).

“I like DERMABOND PRINEO because I think it creates a water tight skin closure of the arthrotomy, which is important for addressing some of the risk factors for surgical site infections and is also nice for the patient,” said Dr. Ryan Nunley,***Associate Professor of Orthopaedic Surgery at Washington University, St. Louis MO, and orthopaedic surgeon at Barnes Jewish Hospital. “With PRINEO, the patient may start showering soon after the procedure and feel like a normal person again, and mentally I think this helps them achieve a faster recovery period.  We don’t see the train track appearance of staples and don’t need to have home nurses come to the house to remove staples or do wound management, so there is the convenience factor as well, and this is also a cost savings by eliminating the home nursing visits or additional office visits as we enter into the world of bundled payments for total joint,” said Dr. Nunley.

The new research adds to a growing body of evidence showing the value of the DERMABOND PRINEO System in orthopaedic surgery. Recently, two economic analyses demonstrated that its use may be associated with improved patient outcomes and lower healthcare costs for hospitals.3,4 Both studies were presented at the International Society for Pharmacoeconomics and Outcomes Research’s 22nd Annual International Meeting in 2017.

Building on a legacy of 20 years in topical skin adhesives, Ethicon offers a comprehensive portfolio of skin closure systems for a wide variety of incision lengths and closure strength needs, including DERMABOND PRINEO Skin Closure system (42cm) – a new configuration for longer incisions to address growing customer needs in hip, knee and spine surgery. The DERMABOND family of products are the only skin closure devices backed by an extensive body of evidence, including 5,718 patients across 51 Randomized Controlled Trials (RCTs).****

For complete indications, contraindications, warnings, precautions, and adverse reactions associated with the DERMABOND PRINEO System, reference the full package insert.

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies** have been working to make surgery better for more than a century. With substantial breadth and depth in surgical and orthopaedic technologies and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

About Ethicon

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues, and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon and LinkedIn.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon, LLC is the legal manufacturer of DERMABOND® PRINEO® and STRATAFIX™ Knotless Tissue Control Devices. All other trademarks are the property of their respective owners.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, interventional and specialty solutions businesses within Johnson & Johnson’s Medical Devices segment. 
***Dr. Ryan Nunley is a paid consultant for Ethicon.
****Based on published literature in PubMed and SCOPUS, using only RCTs that evaluated the use of the product in a manner consistent with intended indication.

©2018 Ethicon, Inc.

1 Double-blinded quantitative research study comparing surgeon experience with DERMABOND PRINEO System (22 cm) and skin staples in total knee arthroplasty. N=83 Orthopaedic surgeons. 90% CI. Fielded June/July 2017.
2 Ethicon Inc. DERMABOND PRINEO Skin Closure System (22cm) Instructions for Use. LAB100114233v2. 5/15
3Johnston S, Sutton N. Comparison of Economic and Clinical Outcomes between the Dermabond® Prineo® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
4 Sadik, K, Flener J, Gargiulo J, Graves M, Nunley, R Post, Z, Wurzelbacher, Sutton, N, Hogan, Hollman, S, Ferko, N.  A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.

087415-180205

SOURCE Ethicon

Related Links

http://www.ethicon.com

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Biologics

NuVasive Expands Biologics Portfolio To Meet Clinical And Economic Needs

September 24, 2018 OrthoSpineNews

SAN DIEGO, Sept. 24, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ :NUVA ), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the U.S. commercial launch of three new biologics offerings to include traditional bone allograft, amniotic membrane DS and additional form factors to the current PropelTM DBM product line. This portfolio expansion demonstrates the Company’s strategic efforts to deliver the most differentiated biologics portfolio in the spine industry.

NuVasive’s newest biologic product lines help promote enhanced clinical outcomes for patients, improved economic outcomes for hospital systems, as well as meet the variety of handling preferences of spine surgeons:

  • Traditional Bone Allograft includes cancellous chips, demineralized cancellous chips, cortical cancellous chips and cancellous crushed, which all function as economical bone graft options. Traditional Bone Allograft has osteoconductive properties that provide a scaffold for bone growth, and can be packed into bony voids or gaps in a patient’s skeletal system. This product is available in a variety of grind sizes and volumes.
  • Amniotic Membrane DS is a double-sided layer of human amniotic membrane intended to be a biologic barrier that may help prevent adhesions and reduce scar tissue formation near adjacent muscle, nerve and fascia layer tissue. The strong, pliable properties of this biologic help it adapt to the surrounding anatomy making it easy to handle and position into place. Amniotic Membrane DS is naturally rich in growth factors and has been shown to control inflammation and reduce bacterial and viral activity at the surgical site, supporting the patient’s overall healing process.
  • Propel DBM product line, launched in 2017, now introduces gel, gel plus and putty plus as additional form factors with enhanced handling properties to address surgeon preferences. The gel form factor is packaged in a syringe for convenient graft delivery, while Propel DBM putty plus and gel plus contain cancellous chips for additional osteoconductive properties helping promote bone growth. With a variety of DBM form factors available, surgeons can tailor the graft selection to the clinical needs of the patient.

“The addition of these three new product lines strengthens our comprehensive spine portfolio and further positions NuVasive as a full-service provider of biologics,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “NuVasive is committed to investing in innovative offerings to meet the clinical and economic needs of our patients, surgeons and hospital partners.”

About NuVasive
NuVasive, Inc. (NASDAQ :NUVA ) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Biologics

SpinalCyte to Feature Fibroblast-Based Cell Therapy Results at the 2018 North American Spine Society Annual Meeting

September 24, 2018 OrthoSpineNews

HOUSTON, Sept. 24, 2018 /PRNewswire/ — SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of spinal discs using Human Dermal Fibroblasts, today announced it will be showcasing its fibroblast-based cell therapy product CybroCell at the North American Spine Society (NASS) 2018 Annual Meeting Sept. 26 – 29 in Los Angeles.

The company recently published data in The Spine Journal that suggest fibroblast cell therapies can prevent the degeneration and promote the regeneration of spinal discs. This publication is available at https://www.thespinejournalonline.com/article/S1529-9430(18)31093-3/. The transplantation of dermal fibroblasts was found to significantly increase the markers of disc regeneration and supported the hypothesis that the intervertebral disc is immune privileged.

“The data we’re sharing at NASS demonstrate that CybroCell has the potential to fundamentally change the way back pain is treated,” said Pete O’Heeron, SpinalCyte Chief Executive Officer. “With our strong intellectual property position and ongoing Phase 1/Phase 2 trials, SpinalCyte has the potential to relieve pain and improve function for millions who currently have no viable treatment options.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell

CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated preliminary six-month data whereby 83% of patients had an increase or no change in disc height.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal replacement using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contact: 
David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SOURCE SpinalCyte, LLC

Related Links

http://www.spinalcyte.com

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Financial

TransEnterix Acquires Assets, Intellectual Property and Retains R&D Team from MST Medical Surgery Technologies

September 24, 2018 OrthoSpineNews

September 23, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it has acquired substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israel medical technology company, in a cash and stock transaction with a total consideration, further described below. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

“Adding innovative, novel technological capabilities to Senhance is a critical part of our long-term strategy as we work towards digitizing the interface between the surgeon and the patient,” said Todd M. Pope, President and CEO of TransEnterix. “The addition of the MST technology to our Senhance platform will increase the effectiveness of surgeons, making procedures quicker and less error-prone, leading to better outcomes for the patient.”

“We are very excited to be partnering with TransEnterix, one of the leaders in surgical robotics who is pioneering the industry with their Senhance platform,” said Motti Frimer, CEO of MST. “The Senhance is a fantastic product with incredible potential, and we have a shared vision with TransEnterix of providing digital laparoscopy to better equip surgeons with innovative technologies that enhance their abilities, providing better quality, more consistent outcomes.”

Strategic Rationale

The addition of MST’s technology, IP portfolio, and R&D team supports and accelerates TransEnterix’s vision to leverage its Senhance Surgical System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability.

  • Innovative Surgical Technology Portfolio: MST’s technology and software engine will help accelerate Senhance platform innovation to meaningfully advance the benefits of digital laparoscopy to patients, surgeons and operating rooms globally. Key components of MST’s technology include advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.
  • Established R&D Center: Provides immediate access to an established R&D center in Israel, with a core team of experienced engineers. In addition, the R&D center allows the Company to tap into talent from one of the world’s top technology hubs.

Transaction Structure

TransEnterix acquired from MST substantially all of its assets, which includes technology and intellectual property, and will transfer MST’s Israeli-based R&D team to a newly formed subsidiary, TransEnterix Israel, Ltd.

The transaction will be financed with a combination of cash and stock, delivered in two separate tranches. At the closing of the transaction, MST will receive approximately $5.8 million in cash and 3,150,000 shares of TransEnterix common stock. The second tranche of $6.6 million, payable in cash or stock, is to be paid within one year of closing. The timing and form of payment of the second tranche is at TransEnterix’s sole discretion.

Conference Call

TransEnterix, Inc. will host a conference call tomorrow, Monday, September 24, 2018 at 8:00 AM ET to discuss this acquisition. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers, and reference the “Acquisition of Medical Surgical Technologies Ltd” conference call, approximately ten minutes prior to the start time. To access the live audio webcast with presentation slides or archived recording, use the following link http://ir.transenterix.com/events.cfm. The presentation materials for the conference call will be available for download at 7:00 AM ET at http://ir.transenterix.com/events.cfm. The replay will be available on TransEnterix’s website for approximately 90 days after the conference call.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the acquisition of the assets and R&D team of MST and the anticipated uses of such assets by TransEnterix in the future, including related to the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the reported transaction with MST is successfully consummated, our ability to use the acquired assets as intended, and our commercial success related to such assets. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investors:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

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Biologics

MiMedx Provides Update on Previously Announced Senior Executive Separations

September 24, 2018 OrthoSpineNews

MARIETTA, Ga., Sept. 20, 2018 /PRNewswire/ — The Board of Directors (the “Board”) of MiMedx Group, Inc. (Nasdaq :MDXG ), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it has determined that the previously announced separations of four senior MiMedx executives – Parker H. Petit, William C. Taylor, Michael J. Senken, and John E. Cranston (collectively, the “Separated Employees”) – be treated as terminations “for cause”. The Compensation Committee separately reached this determination as well.  These determinations are based on information identified as part of the Audit Committee’s ongoing independent investigation.

Mr. Petit is the Company’s former Chairman and Chief Executive Officer; Mr. Taylor is the Company’s former President and Chief Operating Officer and a former member of the Board; Mr. Senken is the Company’s former Chief Financial Officer and principal accounting officer; and Mr. Cranston is the Company’s former Vice President, Corporate Controller and Treasurer. Messrs. Petit and Taylor resigned as officers of the Company effective June 30, 2018, and Messrs. Senken and Cranston stepped down from their positions on June 6, 2018.  Mr. Taylor resigned from the Board effective June 30, 2018.

As a result of findings related to the conduct of the Separated Employees, the Board and the Compensation Committee, as the administrators of the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan (the “2006 Plan”) and the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (together with the 2006 Plan, the “Plans”), have taken all required action to cause all equity and incentive awards outstanding under the Plans held by the Separated Employees to be forfeited.  The Board and Compensation Committee action was based on findings that the Separated Employees engaged in, among other things, conduct detrimental to the business or reputation of the Company.

In addition, the Board and the Compensation Committee have determined that action shall be taken to recover compensation previously paid to the Separated Employees pursuant to the Plans and the Company’s Compensation Recoupment Policy, based upon the final results of the Company’s restatement of its previously issued consolidated financial statements and financial information.

Additionally, the Board announced that Mr. Petit has resigned as a member of the MiMedx Board, effective immediately.

“The Board is taking the necessary steps to prepare MiMedx for its next chapter and a stronger future,” said Charles R. Evans, Chairman of the Board. “The Board is committed to taking the decisive actions necessary to develop enhanced systems and controls. Meanwhile, the Board and management team remain focused on executing the Company’s strategy to deliver operational and clinical successes to improve the lives of patients around the world and drive long-term business success and value creation.”

The Audit Committee is working with its advisors to complete the investigation expeditiously and has made significant progress. The investigation is ongoing, and there may be other actions taken based, at least in part, on information from the investigation. The Company is also working to prepare its financial statements for audit and regain compliance with its Securities and Exchange Commission reporting obligations as soon as practicable.

About MiMedx  
MiMedx® is a 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 the Company’s mission to provide physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million 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.

Safe Harbor Statement
This press release includes forward-looking statements including statements regarding the Audit Committee’s independent investigation and any actions that may arise in connection therewith.  Forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “would” and similar expressions and are based on current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors, including, without limitation, uncertainties relating to the outcome of the Audit Committee’s investigation.  For more detailed information on the risks and uncertainties that may apply to the Company’s business and the ownership of Company common stock, please review the Risk Factors section of the Company’s most recent annual report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release, and except as required by law, the Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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Spine

CoreLink Surgical Announces the launch of Articulating Expandable Posterior Lumbar System – FLXfit®15

September 24, 2018 OrthoSpineNews

September 21, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink Surgical today announces the expanded commercial launch for the FLXfit®15 articulating-expandable intervertebral body fusion device.

FLXfit15 is a posterior lumbar expandable interbody device that offers up to 15 degrees of controlled and continuous expansion and is one of the only expandable cages on the market that offers articulation, providing ease in precise anterior placement. FLXfit15’s open device architecture enables ample space for graft material and its bulleted-nose and single-instrument inserter/expander are designed to streamline insertion. FLXfit15 is offered in 2 lengths – 32mm and 40mm, and in heights from 8-13mm to accommodate diversity in anatomical need.

“The FLXfit15 Interbody device offers the surface area contact and lordosis often desired in an ALIF procedure but obtained with a less complicated posterior approach – this implant is inserted as a PL, deploys as a TL, and expands to gain lordosis of up to 15 degrees. It saves me time, is less invasive and offers optimal sagittal balance correction. In my opinion, it’s the best posterior interbody cage on the market,” said Grant Skidmore MD, Neurosurgeon, Norfolk, VA.

Jay Bartling, CEO, said, “The surgeon and distributor interest in FLXfit15 has far exceeded expectations in a very short period. CoreLink is committed to providing advanced technology with world class quality.”

“Last year, expandable devices grew to over 20% of the overall interbody market- expandable devices are clearly here to stay. CoreLink’s offering FLXfit15 is a great compliment to our growing product offering and positions us well to meet the increasing needs of surgeons and patients,” said Derek Kuyper, VP of Sales at CoreLink.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, booth #2038, where a full display of FLXfit15 and our family of Foundation 3D Products will be featured. Private appointments available.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

Photo: Business Wire

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808
www.corelinksurgical.com

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Regulatory

Surgeons call for ban on pedicle screw reuse and demand two-step asepsis process

September 24, 2018 OrthoSpineNews

14th September 2018

Contaminated pedicle screws cost hundreds of thousands of US dollars a year, and through an increase in surgical site infections result in additional and avoidable patient morbidity. Anand Agarwal (University of Toledo, Toledo, USA) and colleagues are calling for a change in the standard of care revolving around implant handling and delivery, cutting costs and improving patient safety.

Less widely recognised is the fact that contamination of pedicle screws still occurs in the sterile field, with intraoperative bacterial contamination needing an urgent solution.

So the issue of contamination is two-fold: outside of the operating room, concerning the reprocessing of pedicle screws, and inside the operating room, when pedicle screws are left exposed on trays and are infected with several common bacterial strains.

Reprocessed pedicle screws have been shown to still have residual microbial and non-microbial contaminants on them. In a study conducted by Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) and colleagues, published in the Global Spine Journal, traces of saccharides (including biofilm, endotoxins and fatty tissue), soap residue, and salt residue were identified on six pedicle screws randomly selected from four different trays of cleaned, wrapped and purportedly sterilised implants. In fact, there is evidence that the amount of carbohydrate residue increases following reprocessing. The investigators also found corrosion stains present on the outer surface of the implants.

The screws were retrieved using clean gloves, and immediately placed inside of clean zip-lock polybags before undergoing optical microscopy, scanning electron microscopy with energy dispersive spectroscopy, and Fourier transform infrared spectroscopy.

That reprocessed pedicle screws are not always fully sterile has already influenced policy decisions in some nations. Japan and Scotland have banned the reprocessing of spinal implants used for spinal surgery. The Scottish Health Department said in a statement that repeatedly reprocessing implants in the hospital “is a suboptimal procedure”, following a letter in 2006 from the then chief medical officer for Scotland, Harry Burns.

Burns wrote: “Most orthopaedic units in NHS Scotland use screws, small plates and other small orthopaedic implants which have been repeatedly reprocessed (cleaned and sterilised) by the local Central Decontamination Unit in racks or trays. Concerns have been raised that these implants cannot be properly cleaned, and we have photomicroscopic evidence that they retain or acquire organic and/or chemical residues during reprocessing. Legally, many of these devices are classified as ‘single use’, which means they must not be re-used following contact with a patient, but also that they should only be cleaned and sterilised once, prior to first use. We suspect many of these devices have been recirculating for many years, some perhaps for over two decades. Besides generic concerns over infection and CJD [Creutzfeldt-Jakob Disease] contamination, there is evidence to suggest that reprocessed steel implants can cause inflammatory reactions to a much greater degree than ‘pristine’ devices as delivered by the manufacturer, and there are also issues of corrosion and weakening caused by repeated processing. This has clear implications for reducing implant failures, and we have no option but to address the legal, regulatory and governance issues this practice raises.”

 

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SpineTop Stories

Biedermann Motech to launch iMAS 360™ procedure at NASS

September 24, 2018 OrthoSpineNews

Miami, FL – September 24, 2018 / Business Wire / – Biedermann Motech will launch the iMAS 360™ procedure at NASS 2018 in Los Angeles, September 26-28, 2018.

Biedermann Motech, the developer of the world’s first polyaxial pedicle screw (MOSS System) and pioneer in the spinal market for more than 30 years, announced today the launch of the iMAS 360™ procedure at the North American Spine Society (NASS) meeting in Los Angeles, September 26-28, 2018.

The iMAS 360 is a mini-open, microsurgical 360 fusion procedure for the lumbar spine developed by spinal surgeon Robert L. Masson, M.D., Orlando. It incorporates many of the traditional fusion techniques combined with advanced implants and instruments to create a less invasive muscle sparing procedural solution. The key takeaway of the iMAS 360 is the ability to treat any level of the lumbar spine between L2 and S1 with one small posterior midline skin incision.

“iMAS 360 is a lumbar fusion technique that is tissue sparing, has an optimized surgical field, allows for bilateral direct decompression and restoration of lordosis. The MOSS 100™ modular pedicle screw system and the TELIX K™ steerable interbody system have been specifically designed with the iMAS 360 procedure in mind,” says Ray Oktavec, Biedermann Motech’s Director of US Sales & Marketing, Spine.

Robert L. Masson, M.D., said, “The iMAS 360 evolved over time to optimize accuracy, strategy, sequence and ultimately systems. It is an advanced procedural solution integrating technologically sophisticated equipment and techniques focusing on a specific 3D reconstructive plan…”

There will be presentations for surgeons discussing the clinical value of the iMAS 360 procedure at the Biedermann Motech booth # 2435 all three days during NASS with Robert L. Masson, M.D., Tim Keenen, M.D., Syed Aftab, FRCS, and PD Dr. med. Ali Reza Fathi.

More information is available at www.biedermann.com or call 866-622-6082.

Follow us on LinkedIn https://www.linkedin.com/company/biedermann-motech/

About Biedermann Motech

Biedermann Motech is a mid-sized, family owned group of companies with headquarters in Germany (Villingen-Schwenningen) and the USA (Miami). Since 1916 we have been working in synergy with world-class surgeons to solve significant clinical challenges through the development of next-generation technology. Our core competence is the development, production, and distribution of innovative implants and instruments for spinal and extremity surgery. We research, develop, manufacture and distribute high-quality implant systems in collaboration with healthcare professionals, technology partners, scientific institutions and specialized companies with the goal of achieving improved clinical outcomes.

Contact:  Serina Prado

305-722-5310 x132

sprado@biedermann.com

Biedermann Motech, Inc – USA

7620 NW 25th Street, Unit 3 & 4

Miami, FL 33122

Biedermann Motech GmbH & Co. KG
Bertha-von-Suttner-Str. 23
78054 Villingen-Schwenningen

Germany

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Biologics

Synergy Biomedical Announces Launch of BIOSPHERE MIS PUTTY

September 21, 2018 OrthoSpineNews

September 21, 2018

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance and is proceeding with a full commercial launch of BIOSPHERE® MIS PUTTY. BIOSPHERE® MIS PUTTY utilizes a pre-loaded bone graft cannula and trigger-based delivery system specifically designed for the unique challenges of minimally invasive surgery (MIS). The system permits controlled placement of Synergy’s proven, next-generation bone graft product (BIOSPHERE®PUTTY) in open, mini-open, and percutaneous minimally invasive settings.

“BIOSPHERE® MIS PUTTY was engineered to create a functionally ergonomic and easy to use bone graft delivery system,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “With the launch of BIOSPHERE® MIS, surgeons now have the means to precisely deliver BIOSPHERE®PUTTY to the surgical location.”

The BIOSPHERE® MIS PUTTY bone graft delivery system consists of a hand-held dispenser and cannula pre-loaded with BIOSPHERE® PUTTY. The system is easy-to-use and has a one-step assembly process that is achieved by attaching the cannula to the dispenser. As the trigger is engaged during delivery, a metered amount of BIOSPHERE® PUTTY is extruded from the cannula. By design, BIOSPHERE® MIS PUTTY can be extruded around implanted hardware or to remote anatomic locations in a targeted fashion. Delivery is controlled and stops as soon as the trigger is released. The dispenser and cannula were specifically engineered with a narrow sight line profile that maximize the surgeon’s view during graft placement. BIOSPHERE® MIS PUTTY is available in a kit (that includes a dispenser and putty-filled cannula), and also individual replacement cannulas to reload the delivery system, if additional bone graft is needed.

“The BIOSPHERE® MIS PUTTY delivery system improves the ability of a surgeon to place a bone graft material at a desired location. The system is significantly easier to use than standard graft funnels and allows for increased graft delivery due to the targeted placement,” stated Dr. Derek Thomas, MD. “The BIOSPHERE® MIS PUTTY delivery system is not only useful for MIS procedures, but also for open procedures with hard to reach graft areas.”

BIOSPHERE® MIS PUTTY utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a moldable bone graft material that has one of the highest bioactive glass contents on the market.

Synergy will be showcasing BIOSPHERE® MIS PUTTY and other products at Booth 2555 at the 2018 North American Spine Society Meeting in Los Angeles (September 26th – 28th).

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing and improving patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141
www.synergybiomedical.com
info@synergybiomedical.com

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