Zimmer Biomet Spine Announces Mobi-C® Cervical Disc Seven-Year Follow-Up Data Published in International Journal of Spine Surgery

WARSAW, Ind.March 28, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the full seven-year follow-up data from a study evaluating the Company’s Mobi-C® Cervical Disc for total disc replacement has been published in the peer-reviewed International Journal of Spine Surgery, the official scientific journal of the International Society for the Advancement of Spine Surgery (ISASS). The Mobi-C Cervical Disc is a leading option for cervical total disc replacement (cTDR) that is designed to maintain patient range of motion post-surgery. The paper can be accessed online at the following web address: http://ijssurgery.com/10.14444/4031. Complete disclosure of surgeon affiliations and potential conflicts of interest can be found in the article.

The article, titled “Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C® Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up,” reports on the continuation of a prospective, randomized clinical trial of cTDR with Mobi-C compared to the previous standard of care, anterior cervical discectomy and fusion (ACDF), and follows the nearly 600 patients through seven years. Researchers found that cTDR with Mobi-C was associated with lower pain scores, maintained range of motion, less adjacent level degeneration and adjacent level subsequent surgery, as well as a lower rate of secondary surgery compared to ACDF.

“This study further validates the strengths of Mobi-C as a solution for cervical total disc replacement. The positive clinical outcomes remain consistent with previous findings, mainly that Mobi-C continues to deliver positive patient outcomes including efficacy, safety, patient satisfaction and fewer follow-up surgeries,” said Joe Ross, General Manager of Zimmer Biomet’s Spine division. “It is particularly important that the clinical effectiveness of cTDR versus ACDF becomes more apparent when treatment increases from one to two levels, indicating a significant benefit for Mobi-C in two-level procedures, which affects an estimated one in three cervical disc patients.”

The published article discusses the Investigational Device Exemption/Post-Approval Study that evaluated 599 patients, including 164 treated with one-level cTDR, 225 treated with two-level cTDR, 81 treated with one-level ACDF and 105 treated with two-level ACDF. At seven years, follow-up rates ranged from 73.5 percent to 84.4 percent (overall 80.2 percent). Overall success rates for two-level patients were 60.8 percent for cTDR and 34.6 percent for ACDF. Overall success rates for one-level patients were 55.2 percent for cTDR and 50.0 percent for ACDF. Researchers concluded that the composite success analysis demonstrated clinical superiority of two-level cTDR over ACDF and non-inferiority of one-level cTDR versus ACDF. For two-level procedures, the Neck Disability Index (NDI) success rate was significantly greater in the cTDR group (79.0 percent) compared to ACDF (58.0 percent), marking significant patient-reported improvements with cTDR. In addition, overall, more than 86.0 percent of patients who received cTDR (two-level) and 73.9 percent of patients who underwent ACDF (two-level) reported they were “very satisfied” after seven years. Finally, the rate of subsequent surgery at the index level was significantly lower in the two-level cTDR group compared to the ACDF group (cTDR: 4.4 percent vs. ACDF:16.2 percent; p=0.001); and similarly, the rate of adjacent level secondary surgery was significantly lower in the two-level cTDR (4.4 percent) patients compared to the ACDF (11.4 percent; p=0.03) patients.  The clinical data for the seven-year results and associated product labeling updates are currently under review with the U.S. Food and Drug Administration (FDA).



575 patients included in the 7-year analysis:







Overall Success Rate:




Clinical Superiority of
Mobi-C versus ACDF





Non-inferiority of
Mobi-C versus ACDF


Two-level Neck Disability Index (NDI) success rate









Patients (from both groups) reporting “very satisfied” with the procedure









Rate of secondary surgery at the index level









Rate of secondary surgery at an adjacent level









Mobi-C Cervical Disc
Mobi-C is the first cervical disc prosthesis approved by the FDA for reconstruction of a cervical disc at both one and two levels (C3-C7). Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels.  The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.



SOURCE Zimmer Biomet Holdings, Inc.

Related Links


Data Showcasing Strength of RTI’s SImmetry® System in Sacroiliac Joint Fusion Published in The Spine Journal

March 28, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced data on the SImmetry® Sacroiliac Joint Fusion System have been published in The Spine Journal, the official journal of the North American Spine Society. The study results demonstrate the SImmetry System produces effective joint fixation, markedly reducing range of motion (ROM) in the SI joint. The SImmetry System is the only minimally-invasive surgical procedure that uses proprietary decortication technology to help facilitate bone fusion, providing opportunity for long-term relief.

“These results reinforce the effectiveness of the SImmetry System in aiding patients who suffer from chronic low back pain caused by SI joint dysfunction,” said Camille Farhat, President and CEO, RTI Surgical. “The SImmetry System is the only minimally-invasive surgical procedure that promotes SI joint fusion through decortication, reducing the range of motion in all directions with only two implants.”

RTI Surgical recently acquired the SImmetry System as it continues to invest in advanced spinal surgery innovations supported by clinical data, including minimally-invasive technologies that ease the surgical experience and may help patient outcomes.

About The Study: “Biomechanical Evaluation of Sacroiliac Joint Fixation with Decortication”

The manuscript describes the results of a human cadaveric biomechanical study in which two minimally-invasive techniques for placing primary (12.5mm) and secondary (8.5mm) threaded implants were compared for their effectiveness in stabilizing the SI joint. The study also evaluated the link between fixation and bone mineral density, as well as the impact of removing the secondary implant on construct rigidity. Fourteen human cadaveric SI joints were prepared, grafted and then fixated using threaded SImmetry implants. Mechanical testing on the rigidity of the construct and ROM calculation was completed at the study initiation with the joint intact, after destabilization, after implantation, and after removal of the secondary implant.

This biomechanics study found that the SImmetry implants provided a significant, 65-71 percent reduction in joint motion using multiple configurations of the implants. This benefit was maintained after repeated loading, and was greater than that seen in previous studies using triangular SI joint implants. The results provided evidence of immediate fixation, which is intended to relieve pain and provide an environment suited to bone growth across the joint, which is the ultimate goal in long-term relief of SI joint pain.

Growing Body of Evidence on SImmetry System

These study results support the growing body of evidence on the effectiveness of the SImmetry System. The ongoing EVoluSIon Clinical Study is evaluating the impact of SImmetry on SI joint fusion and pain reduction in up to 250 patients at up to 40 sites. More than 180 patients have been enrolled to date. An early analysis of the first 50 patients published in December 2017 showed a 54 percent reduction in SI joint pain at six months as well as a 55 percent reduction in opioid use.1 A separate CT fusion study on the SImmetry System demonstrated a 73 percent reduction in average pain over 24 months.2 Additional data from the EVoluSIon Clinical Study will be presented at the upcoming International Society for the Advancement of Spine Surgery (ISASS) 2018 Annual Meeting taking place April 11-13 in Toronto, Canada.

Approximately 20 percent of all chronic low back pain derives from the SI joint,3 which links the base of the spine to the pelvic bone. When nonsurgical therapy is ineffective in managing SI joint pain, surgical fusion is a viable long-term option. Traditional open fixation is a complex and invasive procedure associated with considerable morbidity and risk of injury.4

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

1 Araghi A et al. Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Open Orthop J. 2017;11:1440-1448.
2 Cross W et al. Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System. Open Orthop J. 2018 Jan 17;12:7-16.
3 Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116.
4 Snyder LA et al. The technological development of minimally invasive spine surgery. Biomed Res Int. 2014:293582.


RTI Surgical, Inc.
Media Contacts

Annie Claggett+1-312-995-2856
Molly Poarch, +1-224-287-2661
Investor Contact
Nathan Elwell, +1-847-530-0249

MiMedx Enrolls First Patient In Its Phase 2B Clinical Trial Of RMAT Designated AmnioFix® Injectable For The Treatment Of Osteoarthritis Of The Knee

MARIETTA, Ga.March 28, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that the first patient has been enrolled in the Company’s Phase 2B Investigational New Drug (IND) clinical trial to assess the safety and efficacy of AmnioFix® Injectable as a treatment for pain associated with Osteoarthritis (OA) of the knee.

OA of the knee is a degenerative and irreversible condition that is associated with pain, restricted mobility, and ultimately joint instability.  For many, the disease significantly limits day-to-day function and can only be treated with joint replacement surgery. According to the National Institutes of Health’s US National Library of Medicine, OA is the most common joint disorder in the United States and its prevalence increases with age. Approximately 20% of the U.S. population, or more than 60 million adults, is over the age of 60, and symptomatic knee OA occurs in 10% of men and 13% of women in that age group.

Parker H. “Pete” Petit, Chairman and Chief Executive Officer, said, “The enrollment of our first patient in this Phase 2Bclinical study is another important milestone for MiMedx. This comes on the heels of the Regenerative Medicine Advanced Therapy (RMAT) designation, which highlights the need to advance promising therapies in areas of considerable unmet medical need, and reaffirms the significant potential for AmnioFix Injectable.”

By granting the RMAT designation to AmnioFix Injectable for use in the treatment of OA of the knee, the FDA commits to taking specific actions to facilitate the development of the product.  These actions may also include an accelerated and priority review.

“Given the lack of  treatment options for patients with knee OA, and the high risks associated with using opioids to manage pain, AmnioFix Injectable has the opportunity to address a significant unmet clinical need by providing physicians and their patients with a new, safe, effective and durable front-line therapy for treating OA knee pain,” added Bill Taylor, President and COO. “In addition, we believe AmnioFix Injectable has the potential to become a blockbuster therapeutic biologic, with long-term peak revenue potentially reaching $4 billion for musculoskeletal pain management within the more than $12 billion U.S. joint pain injection market.”

Clinical Study Design

This Phase 2B, prospective, double blinded, randomized controlled trial will enroll approximately 318 patients at 20 centers.  Patients will be randomized 1:1 into two treatment groups; a single injection of saline (placebo control) or a single injection of 40mg of AmnioFix® Injectable.  The co-primary efficacy endpoints are the change in Visual Analog Scale (VAS) score and the change in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index between baseline and day 90 expressed as the difference in means between each group.  The primary safety endpoint is the incidence of adverse events, serious adverse events, and unanticipated adverse events during the first 12 months post injection in the AmnioFix Injectable group versus the placebo-controlled group.

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 give 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 produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 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 that may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s 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 from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s 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 the Company assumes no obligation to update any forward-looking statement.


SOURCE MiMedx Group, Inc.

Related Links


SANUWAVE Will Have Four Podium Presentations as New Clinical Research at EWMA in Poland in May 2018

SUWANEE, GA, March 27, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that during its participation at the European Wound Management Association (EWMA) Conference in Krakow, Poland on May 9 – 11, 2018, the Company will present new pre-clinical and clinical research associated with the dermaPACE® System, SANUWAVE’s flagship medical care device.  The dermaPACE System is currently CE Marked within Europe for the treatment of various acute and chronic conditions of the skin.  In December 2017, SANUWAVE received US FDA clearance for the treatment of Diabetic Foot Ulcers (DFUs), which makes the dermaPACE System the only approved focused shockwave system in the US market for such indication.  SANUWAVE will exhibit at expo booth D508 in Dunaj Hall together with Matek and Ortho Medico, the Company’s Italian and BeNeLux distribution partners.

For the 2018 EWMA conference the following four (4) abstracts, sponsored by SANUWAVE, were accepted that support the use of the dermaPACE System for various wound management conditions:

– “Pulsed Acoustic Cellular Expression as a Protective Therapy against Ischemia-Reperfusion Injury in a Cremaster Muscle Flap Model”, by Siemionow M., Krokowicz L., Klimczak A., Cwykiel J., Mielniczuk M. – this animal study tested PACE® conditioning mechanism of action on microcirculatory hemodynamics in ischemia-reperfusion injury model.  The results showed that pre- and post-ischemic PACE conditioning improved functional capillary density and stimulated angiogenesis as confirmed by up-regulated VEGF expression. Furthermore, post-ischemic PACE conditioning correlated with decreased expression of early proinflammatory factors (iNOS, CCL2, CXCL5).  Both types of PACE conditioning ameliorated deleterious effect of ischemia-reperfusion injury on microcirculatory hemodynamics of muscle flaps.  The importance of this study is that it lays the basic foundation for using PACE technology for improving outcomes after grafting.  The presenter of the study will be Dr. Maria Siemionow, a Polish transplant surgeon and scientist, who performed the world’s first near-total facial transplant successfully at Cleveland Clinic, U.S.A.  Dr. Siemionow was twice honored with the James Barrett Brown Award for best publication in a plastic surgery journal in 2004 and 2007 and received the Folkert Belzeer Award in 2001.  She is the recipient of the Commander’s Cross Polonia Restituta award given by the President of Poland in 2009, and in 2014, she received the Great Immigrants Award from the Carnegie Foundation of New York.  Dr. Siemionow is now affiliated with University of Illinois at Chicago College of Medicine, as a professor of orthopedic surgery and Director of Microsurgery Research.

– “Healing Venous Leg Ulcers with Pulsed Acoustic Cellular Expression (PACE) Therapy” by Miller C., Kapp S., Green J., McGuiness W., Woodward M. – this is a case series for venous leg ulcers (VLUs) with six (6) participants with a mean age of 78.67 (SD=9.97) and wound duration of 34.80 weeks (SD=23.02) who were treated with the dermaPACE System.  Positive wound healing trends were observed for all patients. A reduction in wound size was observed for five patients and although one patient developed an increased wound size, the tissue quality was improved. The treatment was easy to implement for clinicians and client acceptability was very good; some pain was recorded during 2 treatments (of 17 treatments) and occurred when the patient was reporting pain at the dressing change in general.  The importance of this study is that it shows that the dermaPACE System has promising effects when used to treat venous leg ulcers.  The presenter at this study will be Dr. William McGuiness, who is an Associate Professor at La Trobe University, Victoria, Australia and the Director of the La Trobe Alfred Clinical School of Nursing and Midwifery.  Dr. McGuiness has been involved in wound management since 2000, as both an educator and a clinician.  He was the President of the Australian Wound Management Association (AWMA).

– The New Life” of a Stuck Wound: The Real ESWT Mission”, by Cassino R. – in this study the dermaPACE System was used for twelve (12) patients with chronic skin lesions of known etiology (pressure ulcers, venous leg ulcers, diabetic foot lesions), older than 6 months, not responding to ongoing treatments for at least 4 weeks or in a worsening status. The dermaPACE System treatment sessions were performed once a week for 4 weeks.  The follow up was performed after the 4 applications, and then again after 5 and 10 weeks from the first assessment, by evaluating the Healing Rate (HR) and Wound Area Reduction (WAR).  All wounds improved after the PACE treatment with a mean HR of 0.139 cm/week (ratio of A/P, where A = area in square centimeters and P = perimeter in centimeters) and a mean WAR/week of 28.6%.  This trend of improvement continued for 10 other weeks.  Also, at the end of the follow-up the mean total WAR was about 74%.  The presenter at this study will be Dr. Roberto Cassino, who is affiliated with the Interdepartmental Center Team of Diabetic Foot from Istituto Clinico Città Studi – Milano, Italy.  Dr. Cassino is an expert in geriatrics, gerontology, and general surgery.

– “Extracorporeal Shock Wave Therapy Improves Healing of Chronic Ulcers and Patients’ Quality of Life”, by Leemans G., Gutermuth J., Janmohamed S. – this study used ten (10) patients with chronic, therapy-resistant ulcers.  The results demonstrated improvement in 10 out of 10 investigated ulcers in all measured parameters after Extracorporeal Shock Wave Therapy (ESWT).  A mean decrease in wound surface and wound depth of 71% and 60% respectively, were observed six weeks after the first treatment session.  Chronic ulcers and pain had a significant impact on patients’ Quality of Life (QoL), and to assess QoL, patients were asked to complete a Dermatology Life Quality Index (DLQI) questionnaire and pain was evaluated with a Visual Analogue Scale (VAS).  A mean decrease in DLQI scores (i.e. an increase in QoL) of 60% was observed and a significant mean decrease of 62% in VAS scores (i.e. a decrease in the amount of pain) after ESWT could be seen.  In comparison with other additional treatment options such as negative-pressure wound therapy and hyperbaric oxygen, ESWT is a non-time-consuming method and does not have systemic side effects.  The importance of this study is that it shows that the dermaPACE System has significant success in treating chronic ulcers that were very difficult to heal using other technologies.  The presenter of this study will be Dr. Gaëlle Leemans, who has medical studies at Vrije Universiteit Brussel (Free University Brussel) with the specialization in wound healing and dermatopathology.  Dr Leemans is now affiliated with the Department of Dermatology, from the Universitair Ziekenhuis Brussel (University Hospital Brussels), Brussels, Belgium.

Dr. Maria Siemionow, Dr. William McGuiness, Dr. Roberto Cassino, and Dr. Gaëlle Leemans will be available to answer questions at SANUWAVE’s booth on May 10th, between 2 and 4 pm.  Please contact Dr. Iulian Cioanta via e-mail at iulian.cioanta@sanuwave.com; in case that you want to meet individually with any the authors of the above studies.

“We are excited to exhibit at EWMA in Krakow, Poland, and to have our distinguished guests presenting scientific studies that show additional evidence regarding our PACE technology effectiveness in treating various types of hard-to-heal wounds and also its mechanism of action.  Our FDA clearance for the dermaPACE System is built on solid clinical scientific evidence provided by two US-based randomized-controlled clinical trials enrolling 336 subjects, which showed that SANUWAVE’s technology is safe and effective in the treatment of Diabetic Foot Ulcers.  Within a few weeks of initial treatment, wounds treated with the dermaPACE System showed a reduction in area at superior rates compared to control subjects.  The support and interest coming from the wound care community has been overwhelmingly positive, both domestically and internationally.  The scientific presentations for the EWMA 2018 conference validate our continuous commitment and strong belief in clinically based research in order to find new avenues for our technology and provide improved treatment options for patients, healthcare professionals, and clinicians,” stated Kevin A. Richardson, CEO and Chairman of the Board.

If you are interested in distribution opportunities for SANUWAVE in Europe or in scheduling a meeting with the SANUWAVE team during the conference, please contact Dr. Iulian Cioanta via e-mail at iulian.cioanta@sanuwave.com; otherwise, please stop by our booth D508 in Dunaj Hall at the conference in May.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is US FDA cleared for the treatment of Diabetic Foot Ulcers.  The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

Millennium Park Capital LLC
Christopher Wynne

SANUWAVE Health, Inc.
Iulian Cioanta, Ph.D.
Vice President of Research and Development
678-578-0106 (Office)

Life Spine Announces Key Clinical Advancements around Procedural Solutions with PROLIFT® Expandable Spacer System and CENTERLINE™ Cortical Screw System

March 27, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders today announced the launch of the minimally disruptive procedural solution with CENTERLINE Cortical Screw System and the PROLIFT Expandable Spacer System.

PROLIFT allows for in-situ disc height restoration, for Micro-Invasive PLIF, TLIF and oblique approaches. PROLIFT, which incorporates the proprietary surface technology OSSEO-LOC™, provides the surgeon the ability to restore normal spinal pelvic parameters with the multiple lordotic options, while continuing to build upon the patented Micro-Invasive expandable technologies at Life Spine.

CENTERLINE is a 4.75mm diameter rod system developed for cortical or pedicular fixation. In conjunction with the CALYPSO™ Retractor System, CENTERLINE is designed to minimize the lateral retraction requirements to reduce the risk of denervation of the neurovascular attachments of the multifidus so as to retain paraspinal muscle integrity.

Bryan B. Barnes, MD of the Georgia Neurological Surgery & Georgia Comprehensive Spine in Athens, Georgia notes, “Micro-Invasive, or minimally disruptive surgery, is a highly studied and tenured approach for most spine surgeons. As with most technologies, spine surgery is an ever-evolving practice, facilitated by advancements in medical implant design and access options. As static interbody devices are being supplanted in my practice by expandable options such as the PROLIFT device from Life Spine, so are tried and true posterior fixation options. CENTERLINE and its cobalt chrome components, provide a lower profile and enhanced material option so as to reduce iatrogenic impact to the muscles and surround structures while maintaining the stability associated with earlier, larger systems. Expandable interbody cages like PROLIFT reduce the number of instrument passes by important neural structures, while allowing me to tailor the height and sagittal correction to the patient’s needs, even in severely collapsed disc spaces.” Dr. Barnes additionally notes, “Minimally disruptive approaches continue to be an important facet of my surgical procedures, including those performed at ambulatory centers. Providing positive patient outcomes has been the cornerstone of my research that has shown a significant decrease in complication rates over time when spine surgery is performed at an ASC.”

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.


Life Spine
Mr. Omar Faruqi
Chief Financial Officer

Intralink-Spine, Inc: Reaching to the “Five Corners” of the Earth for Clinical Trials

March 27, 2018

LEXINGTON, Ky.–(BUSINESS WIRE)–“We’re eager to expand our clinical studies into multiple sites and locations. Which is why we have finalized an agreement with Five Corners, a CRO focused on medical device clinical studies in Australia and New Zealand,” says Lyle Hawkins, CEO of Intralink-Spine, Inc.

“We’ve restructured for growth and to better position ourselves for a successful CE submission. Now with the involvement of Five Corners, 2018 is shaping up to be a great year for Intralink-Spine,” states Hawkins.

“We are very excited to be supporting Intralink-Spine in conducting their study to gain CE Mark for the Réjuve™ medical device. There remains an unmet need for micro-invasive solutions for the treatment of DDD and we look forward to assisting Intralink-Spine in their journey through to successful commercialization,” says Deborah Bell, Managing Director of Five Corners.

“Twelve-month data from our early safety and feasibility study demonstrated exceptional results with regard to reducing or eliminating low back pain and disability. And, these benefits began within days of the initial procedure. This was a great start, especially as we begin our larger pivotal clinical studies,” states Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky.

According to Hawkins, “We believe the Réjuve™ medical device, which structurally reinforces the native intervertebral disc itself, is going to be a better treatment option for many patients with low back pain. Réjuve has the procedural simplicity of an epidural steroid injection, but with potential long-term positive effects. For example, we continue to see excellent results from our initial patients as they approach the two-year junction. And, we expect these excellent results to continue for years to come.”

About Intralink-Spine, Inc.(ILS): formed to manufacture and exclusively sell the Réjuve™ injectable medical device to treat Degenerative Disc Disease (DDD), low back pain, and related spinal diseases such as scoliosis. ILS is currently conducting a Round C fundraising event for accredited investors.

About Five Corners Pty Ltd: Five Corners is a privately owned Australian CRO (Clinical Research Organization) based in Sydney. They provide contract services to manufacturers and distributors of medical devices wishing to perform clinical research in Australia and New Zealand.


Intralink-Spine Inc.
Lyle Hawkins, 502-419-8099

MiMedx Reports Positive Pain And Foot Function Results From Phase 2B Clinical Trial Of AmnioFix® Injectable In The Treatment Of Plantar Fasciitis

MARIETTA, Ga.March 26, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced positive pain and foot function results from its Phase 2Bclinical trial of AmnioFix® Injectable in the treatment of Plantar Fasciitis.

The Phase 2B IND clinical trial evaluating the use of AmnioFix Injectable for the treatment of Plantar Fasciitis demonstrated a clinically and statistically significant difference compared to patients in the Control Group in their reduction in the visual analog scale (VAS) score for pain (p<0.0001) and Foot Function Index-Revised (FFI-R) scores (p=0.0004) at 3 months compared to baseline. Additionally, the safety of the product was demonstrated by the absence of serious, unanticipated, product-related adverse events and the relative absence of an elicited immune response post-injection demonstrated by the Treatment Group.

Plantar Fasciitis is the most common cause of chronic heel pain in adults, comprising 11–15% of the foot symptoms requiring professional care among adults, according to studies published in the Journal of Research in Medical Sciences. It is estimated that 1 in 10 people will develop Plantar Fasciitis during their lifetime, with approximately one million people per year seeking medical treatment. The Company believes 60% of these patients could be potential candidates to receive AmnioFix Injectable, which MiMedx estimates represents a $450 million annual market opportunity for the Company.

“As we noted in January 2018 when we initiated our Phase 3 trial to treat Plantar Fasciitis, we believe AmnioFix Injectable can become a new first-line therapy for the treatment of musculoskeletal degeneration pain,” said Parker H. “Pete” Petit, Chairman and Chief Executive Officer. “We believe that our product will meet this need and quickly become a physician’s product of choice for patients.”

“These Phase 2B results clearly show that AmnioFix Injectable has the potential to provide safe, effective, and durable relief from pain associated with chronic Plantar Fasciitis,” added Bill Taylor, President and COO. “We expect our Phase 3 study initiated in January 2018 to confirm these results as we move toward filing a Biologics License Application (BLA) in the second half of 2020 based on our current projections.”

Clinical Study Design

The Phase 2B prospective, single-blinded, randomized, controlled trial studied a single injection of 40 mg of AmnioFix Injectable (micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection) as compared to a single injection of saline (placebo control) in the treatment of Plantar Fasciitis. The trial enrolled and treated 145 patients at 14 study sites.

The primary efficacy endpoint was the change in VAS score for pain for subjects between baseline and 3 months expressed as the difference in the mean scores between the AmnioFix Injectable Treatment Group versus placebo-treated Control Group. The principal secondary efficacy endpoint was the change in FFI-R score for patients between baseline and 3 months expressed as the difference in mean scores between the AmnioFix Injectable Group versus the Control Group.

Summary of Top-line AmnioFix Injectable Phase 2B Results

The Phase 2B IND clinical trial evaluating the use of AmnioFix Injectable for the treatment of Plantar Fasciitis demonstrated a clinically and statistically significant difference compared to patients in the Control Group in their reduction in VAS score for pain and FFI-R scores at 3 months compared to baseline. Additionally, the safety of the product has been demonstrated by the absence of serious, unanticipated, product-related adverse events and the relative absence of an elicited immune response post-injection demonstrated by the Test Group.

At three months, the Treatment Group (n=73) experienced a mean reduction of 54.1 points in their VAS score for pain compared to baseline. The Control Group (n=72) experienced a mean reduction of 31.9 points in their VAS score for pain at three months compared to baseline, a difference of 22.2 points between the two treatment groups (p<0.0001).

At three months, the Treatment Group experienced a mean reduction of 36 points in FFI-R score compared to baseline. The Control Group experienced a mean reduction of 22 points in FFI-R at three months compared to baseline, a difference of 14 points between the two treatment groups (p=0.0004).

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 give 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 produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 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 that may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s 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 from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s 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 the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links


Ceterix Orthopaedics Receives New Patent for Transosteal Anchoring Methods for Meniscal Root Repair

March 26, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix Orthopaedics today announced the issuance of US Patent No. 9,913,638 relating to the company’s proprietary approach to knee meniscus and ACL repair, adding to an already expansive portfolio of innovative orthopaedic applications and issued patents.

Ceterix’s new patent further protects the company’s unique products and methods that allow surgeons to arthroscopically pass suture through soft tissue in very tight joint compartments. Specifically, the new patent describes the company’s method for securely fastening the knee’s meniscus during a meniscal root repair.

“We’re pleased that our approach, using the NovoStitch® Plus Meniscal Repair System, simplifies the procedure for surgeons and expands the tissue repair methods available to patients in need of meniscus repair,” stated John McCutcheon, president and CEO of Ceterix.

The meniscus is a crescent of soft cartilage that sits between the femur and tibia, cushioning the knee. The meniscus attaches to the tibia at its root but is subject to tearing at this attachment point. Historically, damage to the meniscal root was addressed with meniscectomy (complete or partial removal of the damaged tissue). However, meniscectomy has been shown to be associated with an increased risk of future complications. In a recent study, more than one-third of patients with a meniscal root tear who underwent meniscectomy required a total knee replacement within five years. In contrast, the same study revealed that patients who underwent meniscus root repair had no occurrences of knee replacement at the five-year mark1.

Current methods of meniscal root repair involve the surgical creation of a tunnel through the tibia bone to reach the meniscus, affixing a suture to the soft tissue, and extending this suture through the bone tunnel to an anchor resting just beneath the skin in the lower leg.

The potential issue with the standard procedure is that it results in too much space between the meniscal root and the anchor itself. This greater distance may cause the suture to lose tension or displace over time, thus negatively affecting the success of the repair.

Ceterix, well-known for innovations in arthroscopic surgery, has obtained patent protection for an alternate approach for surgeons to use when repairing a torn meniscal root. Using the NovoStitch Plus Meniscal Repair System, surgeons can affix sutures to the meniscus and secure those sutures with an anchor placed inside the bone tunnel, closer to the site of the root repair, thereby retaining the necessary tension for long-term repair viability. Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats the damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.

About Ceterix® Orthopaedics

Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix® Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue joint injuries such as meniscus tears. Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Plus meniscal repair system has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif. and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com.

1 Chung et al. Arthroscopy. 2015; 31(10):1941-50.


for Ceterix Orthopaedics
Krysta Pellegrino, 650-255-6142

Paradigm Spine Expands Leadership Team With Four New Appointments

NEW YORKMarch 26, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that it has substantially expanded its leadership team with the appointments of Francis Magee, DVM as Chief Technology Officer, Charlie Gilbride as EVP, Sales & Marketing, Tim Hein as Vice President, Sales, and Lisa Denison as Vice President of Marketing. Dr. Magee will lead the product and technology development strategy and execution while Mr. Gilbride, Mr. Hein and Ms. Denison will lead the marketing and sales initiatives to drive increased U.S. adoption and use of lead product coflex® Interlaminar Stabilization®, 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.

“With published datasets of long-term Level 1 evidence from two prospective, randomized, controlled clinical studies, comparing coflex versus decompression plus fusion and more recently coflex versus decompression alone, we have entered a major inflection point for the company where we can conclusively show that coflex demonstrates composite clinical success for patients with spinal stenosis,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. “Based on this, and the recent NASS Coverage Recommendation for coflex for interlaminar stabilization, it becomes of paramount importance to strengthen both our technology development and sales and marketing teams to help educate surgeons, practices, patients, their families and the broader spine community on coflex as the motion-preserving lumbar option. We welcome these highly experienced members to our team and look forward to their results-driven strategies to increase awareness of coflex among our key audiences and enable market access for even more patients.”

Dr. Magee has 25 years of experience working exclusively to develop devices in orthopedics and spine. He has managed the successful commercialization of many Class 2 and Class 3 products in the U.S. and OUS, and was responsible for all functional areas, including design, development, regulatory, surgeon training and manufacturing. Previously, he served as the Chief Technology Officer for Orthologic, Spine Solutions and Synthes Spine, as well as the Head of Experimental Surgery at the Harrington Arthritis Research Center.

Mr. Gilbride has more than 20 years of experience in medical device sales, marketing and reimbursement, most recently as the Vice President of U.S. Product Marketing for LDR Spine (acquired by Zimmer Biomet Spine). Previously, he held positions in the spine industry in both venture capital funded start-ups and mid-sized public companies. Mr. Gilbride earned his B.S. in Biology from Boston College and his MBA from The Wharton School.

Mr. Hein has been in the medical device industry for 20 years, with leadership experience in creating high performing sales teams specialized in high growth with innovative product lines. Previously, he held positions at Zimmer Biomet Spine, LDR Spine, Medtronic, DePuy Spine, and Ethicon Endo-Surgery. Mr. Hein earned his B.S. in Engineering from the United States Military Academy at West Point and his MBA from Pacific Lutheran University.

Ms. Denison has worked in orthopedic and spine marketing and medical education for more than 20 years, including 14 years dedicated to implantable spinal devices. Prior experience includes positions at Sulzer Orthopedics, Abbott Spine, and LDR Spine, serving as the marketing lead on more than eight U.S. and four international medical device commercializations, four of which involved class III devices that underwent full IDE clinical trial and PMA processes. Ms. Denison earned her B.S. in Kinesiology/Biology from the University of North Texas and her MBA from Baylor University.

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 50 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


Titan Spine Announces New Memphis Distribution Center to Meet Growing Demand for nanoLOCK® Spinal Implants

March 26, 2018

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced it has opened a distribution facility in Memphis to meet the growing demand for the Company’s nanoLOCK® surface technology. nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.1

The new distribution facility increases Titan Spine’s capacity to more than 20,000 square feet and will be used to efficiently distribute nanoLOCK® as well as products from future launches. In addition, the facility is strategically located within close proximity to the FedEx world distribution hub, which allows Titan Spine to extend shipment hours when needed and enable agility in responding to customer needs.

Mark Berg, Executive Vice President Global Operations of Titan Spine, commented, “As the demand for our nanoLOCK® surface implants has continued to grow across the U.S., we recognized the need to strategically increase our distribution capacity to supply current and future demand. Our Memphis Distribution Center (MDC) offers an optimal solution that builds upon the efforts of our prior distribution partner. We are excited to further improve logistics for our surgeon and distributor customers who recognize the significance and uniqueness of nanoLOCK®’s very specific ability to promote a nano-fusion.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S., portions of Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

1 Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

4 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.


Titan Spine
Andrew Shepherd, 866-822-7800
The Ruth Group
Kirsten Thomas, 508-280-6592