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SANUWAVE Announces AMBIENSYS SRL as Distributor for dermaPACE® in Romania

Posted On May 9, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, May 09, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that it has appointed AMBIENSYS SRL as the distributor for the dermaPACE® System in Romania.  The expected revenue from this agreement will be north of $400,000 over the next three years.

Globally, AMBIENSYS SRL is known as a service provider in the areas of consulting, training in European funding, project management and implementation. AMBIENSYS SRL strives to provide clients with comprehensive information and services on funding opportunities, funding preparation, training and technical assistance during project implementation. AMBIENSYS SRL’s intent is to contribute to commercialization strength locally and regionally to sustainable innovations like the dermaPACE® System. After successful training, the cognitive and clinical knowledge will be transferred by Certified Trainers at AMBIENSYS SRL to hospitals throughout Romania to ensure the safe and effective use of dermaPACE® consistent with approved labeling, EU requirements and a focus on best practices of patient care and comfort during treatments.

Kevin A. Richardson II, Chairman of the Board of SANUWAVE, stated, “The decision to engage AMBIENSYS SRL was made to introduce the dermaPACE® system throughout the wound care market in Romania, which is the largest country in Southeastern Europe. It is paramount that we partner with global distributors that have complementary contacts and a positive impact within the local Romanian market.  It is well known that diabetes and related concerns need to be addressed within Romania and having access to outstanding technology such as SANUWAVE’s within the country is a remediable step towards a healthier tomorrow.”

Shipment of the first devices and training will occur in the second quarter of 2018 to AMBIENSYS SRL.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www.sanuwave.com.

About AMBIENSYS SRL

AMBIENSYS SRL is registered as a consultancy and business development company with the Romanian Health Ministry and Romanian Agency for Medication and Medical Devices.  The company is authorized for the import and distribution of medical devices on the Romanian market.  AMBIENSYS SRL has the approval for the importation of dermaPACE® Systems from SANUWAVE.  AMBIENSYS SRL is located in Ramnicu Valcea, Strada General Magheru, Nr. 25, SOCOM Building, Suite 67, Judetul Valcea.

Contacts:

AMBIENSYS SRL

CEO/General Manager

Ing. Daniel Ioan Badescu

Executive Manager

Ing. Dan Crisu Turcitu

Phone: (40) 0350 419 770

Email: ambiensys.office@gmail.com

About SANUWAVE Health, Inc. 

SANUWAVE Health, Inc. (OTCQB:SNWV) (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 CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE® is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. 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

312-724-7845

cwynne@mparkcm.com


SANUWAVE Health, Inc.

Kevin Richardson II

Chairman of the Board

978-922-2447

investorrelations@sanuwave.com
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Clinical Evidence Presented at SAWC on Application of AMNIOX Medical Products

Posted On May 8, 2018 By OrthoSpineNews In Biologics /  

May 08, 2018

MIAMI–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, highlighted four clinical posters demonstrating the effectiveness of NEOX® Wound Allograft at the Symposium on Advanced Wound Care (SAWC) in April.

The presentations illustrate applications of NEOX Wound Allograft in combination with other therapies, and among a range of severe wounds that are resistant to current standard of care or are under served.

“The clinical effectiveness and value of NEOX continues to be reinforced in these studies, as well as opportunities to combine different approaches to advanced wound care,” said Adrian Roji, Chief Commercial Officer of TissueTech. “The authors found that patients who received NEOX experienced closure of hard-to-heal wounds, further highlighting the unique properties of cryo-preserved umbilical cord tissue.”

The studies presented at SAWC included:

  • Treatment of Post-Operative Left Temporal Wound with Umbilical Cord Based Particulate and Negative Pressure Wound Therapy, Timothy Plackett, DO
  • Use of Hydrated Shelf Stable Umbilical Cord Allograft for the Treatment of Chronic Wounds, Allen Raphael, DPM
  • Treatment of Close-Range Gun Shot Wound with Umbilical Cord Based Particulate (pUC) and Negative Pressure Wound Therapy Timothy Plackett, DO
  • Treatment of Invasive Carcinoma Wound with Hyperbaric Oxygen and Cryopreserved Umbilical Cord, Luis Fernandez, MD

AMNIOX parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote healing. AMNIOX utilizes its proprietary CryoTek® process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 300,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.

About AMNIOX Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, AMNIOX Medical is dedicated to developing and marketing products processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. AMNIOX Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.AMNIOXmedical.com.

About TissueTech, Inc.

TissueTech, Inc., the parent company of AMNIOX Medical, Inc. and BioTissue, Inc., pioneered the development and clinical application of amniotic tissue-based products. AMNIOX Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 300,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing.

Contacts

for AMNIOX Medical, Inc.
Chris Gale
(646) 695-2883
cgale@greentarget.com

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Amedica Corporation Provides Update on its Clinical Studies

Posted On May 8, 2018 By OrthoSpineNews In Spine /  

SALT LAKE CITY, May 08, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided an update on its clinical study activities.

Single Center Retrospective Comparative Study

A clinical study comparing silicon nitride spinal implants to allograft spacers in cervical fusion showed faster and more effective outcomes with silicon nitride.  “While silicon nitride might have been expected to perform better in light of its properties, the surprising finding in our study was how good the outcomes with silicon nitride proved to be.  Significantly earlier and more effective bone fusion was observed with silicon nitride than allograft spacers at 3- 6-, and 12-month time points after surgery, all the way to 24 months” said Dr. Micah Smith, orthopaedic surgeon in Fort Wayne, Indiana, who is the principal investigator. Study findings have been submitted to for release at the December 2018 Cervical Spine Research Society meeting.

Multi-Center Retrospective Study

Amedica reported completion of an exhaustive retrospective survey of over 2,000 silicon nitride spinal implants implanted in more than 1,000 patients over the last eight years.  The study was designed to understand clinical outcomes from silicon nitride implants in spine fusion from four different clinics in the US.  “Preliminary data analysis toward publication of this study is very encouraging in this large cohort of patients derived from our long-term surgeon users.  Not only are the data consistent with our other clinical studies, but the outcomes corroborate our basic science understanding of the surface chemistry of the material, the key strength of silicon nitride,” said Dr. Sonny Bal, President of Amedica.

Silicon Nitride Against PEEK (SNAP)

SNAP, a 24-month double-blinded multicenter randomized controlled human trial for lumbar fusion comparing intervertebral cages from either silicon nitride or polyetheretherketone (PEEK), has been completed. The purpose of the study was to show that fusion using silicon nitride cages was at least non-inferior to PEEK devices. Preliminary data at 3, 6, and 12-months on the Roland Morris Disability Questionnaire and VAS back and leg pain scores, as well as quantitative radiographic data at 24 months appear to confirm the study’s hypothesis of silicon nitride’s non-inferiority. Additional detailed analyses are currently being conducted in anticipation of publishing the overall results in a prominent scientific journal later this year.

Goat Study

 An interbody fusion study using a goat model comparing silicon nitride to PEEK was just accepted for publication in the Journal of Biomedical Materials Research, Part B – Applied Biomaterials. The results of the study showed improved fusion and greater bone volume using silicon nitride implants versus PEEK at the study’s six-month end-point. These results also suggest that silicon nitride is not inferior to PEEK and that silicon nitride implants may be more effective in promoting arthrodesis.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, silicon nitride and our products may not have the impact we expect, the outcomes of our ongoing studies may not be positive, and the results of our studies may not come in the anticipated timeframes.   Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC.  Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Amedica IR
801-839-3502
IR@amedica.com

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Anika to Showcase Commercial and Pipeline Portfolio at 18th Bi-Annual European Society for Sports Traumatology, Knee Surgery and Arthroscopy Congress

Posted On May 8, 2018 By OrthoSpineNews In Extremities /  

May 08, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced plans to showcase its innovative commercial and pipeline portfolio at the 18th bi-annual European Society for Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA) Congress, being held in Glasgow, Scotland on May 9-12, 2018.

“We look forward to showcasing our pioneering orthopedic and regenerative medicine solutions, including CINGAL and HYALOFAST, at the 18th ESSKA Congress,” said Joseph Darling, President and CEO, Anika Therapeutics. “Our participation represents an important opportunity to highlight real-world evidence from CINGAL and HYALOFAST to the 4,000 medical experts in the field of sports traumatology, knee surgery and arthroscopy participating from all over the world.”

Company-Sponsored Physician Education
Location: Anika Booth #51, Hall no.4, Scottish Event Campus

Wednesday, May 9, 2018

  • 10:00 – 11:00 Dr. Mikolaj Wrobel, OrtopediKa Clinic in Warsaw, Poland, will be available at the booth for guided training sessions with the HYALOFAST Virtual Surgical Simulator.

Thursday, May 10, 2018

  • 15:30 – 16:30 Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy, will be available at the booth for guided training sessions with the HYALOFAST Virtual Surgical Simulator.

Company-Sponsored Lunch Symposium
Location: Room Boisdale 1/2, Scottish Event Campus

Friday, May 11, 2018

  • 12:30 – 13:30 Boisdale 1/2 Room, Lunch Symposium: HYALOFAST One-step Procedure: Best Practice and New Evidence in Cartilage Repair
    Moderator: Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy

Speakers and Topics:

  • Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy: HYALOFAST Long-Term Clinical Outcomes in the Treatment of Full-Thickness Cartilage Lesions of the Knee
  • Dr. Bogusław Sadlik, St. Luke Clinic, Bielsko Biala – Poland: HYALOFAST Arthroscopic Implantation in the Knee: Pitfalls, Pearls and MRI Based Rehab Protocol
  • Prof. Stephan Nehrer, Danube University, Krems – Austria: HYALOFAST in the Treatment of Cartilage Defects in the Ankle: Surgical Technique and Clinical Results

About ESSKA Congress

The 18th ESSKA (European Society for Sports Traumatology, Knee Surgery and Arthroscopy) Congress is expected to include 4,000 medical experts in the field of sports traumatology, knee surgery and arthroscopy from all over the world. It offers many opportunities to interact with orthopedic surgeons, physio therapists and other medical professionals.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Contacts

Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer

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NuVasive Unveils Newest Additions To Early Onset Scoliosis Portfolio At POSNA Annual Meeting

Posted On May 8, 2018 By OrthoSpineNews In Spine, Top Stories /  

SAN DIEGO, May 8, 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 Company will officially unveil MAGEC X, the newest offering in its Early Onset Scoliosis (EOS) procedural solutions portfolio at the POSNA Annual Meeting in Austin, Texas. NuVasive is a Double Diamond Sponsor of the conference, reflecting its continued support of advancing pediatric care.

The launch of MAGEC X is the culmination of over a decade of research and innovation. The new and improved MAGEC X features a strong, smart and sleek design with a new 5.0mm rod option that offers 68 percent improved fatigue-strength performance over the previous 4.5mm optioni. The internal rod mechanism of the previous product generation has been redesigned with a robust actuator seal, a reinforced locking pin and anti-jam protection. Aesthetic improvements to the new design enhance ease-of-use by providing visual indicators for cutting and implanting the rod.

At its core, the MAGEC system features magnetically-controlled growing rods designed to eliminate planned distraction surgeries from the treatment for EOS. This innovative system simplifies care for EOS by helping to reduce the anxiety and complication risks associated with repetitive growing-rod surgeriesii.

“The MAGEC system continues to be the gold standard for the minimally-invasive treatment of Early Onset Scoliosis,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “With MAGEC X, we have found a way to take an exceptional solution to another level through internal rod mechanism advancements to boost performance and by providing surgeons with expanded size options. With MAGEC X clinicians can treat a greater variety of EOS cases—giving them a less invasive and traumatic experience as they work to achieve a straighter spine and a higher quality of life.”

Starting in summer 2018, NuVasive will kick-off the Journey Together Program featuring a limited warranty on MAGEC X rods when used with cleared NuVasive procedural solutions. Through this unique partnership with patients, families, surgeons and hospitals, NuVasive hopes to provide a healthcare solution that maximizes the value of EOS treatment.

During POSNA 2018, NuVasive is also showcasing RELINE Small Stature and LessRay within its pediatric spine solutions portfolio.

RELINE Small Stature is the first pediatric deformity fixation solution to accept both 4.5mm and 5.0mm rods in a low-profile tulip—eliminating the need to sacrifice strength for size in EOS patients. The instrumentation helps surgeons gain heightened anatomical awareness to optimize implant placement, and when paired with the new MAGEC X 5.0mm rod, the procedural solution may minimize the occurrence of revision surgeries.

In addition, as part of the Company’s Surgical Intelligence™ platform, LessRay offers the surgeon and hospital system the opportunity to use significantly reduced radiation imaging in the operating room. Following a recent procedure using LessRay, Dr. Amer Samdani, Chief of Surgery at Shriners Hospital for Children — Philadelphia, remarked, “I was amazed that the NuVasive LessRay technology allowed us to take less shots and reduce the radiation emission with every shot, which has significant impact for staff and patients of all ages.”

Attendees at the POSNA Annual Meeting are encouraged to stop by NuVasive booth # 25-26 to learn more about MAGEC X, RELINE Small Stature, LessRay and the Company’s comprehensive, industry-leading solutions for creating better clinical outcomes for pediatric spine procedures.

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.

i Data on File
ii Yoon WW, Sedra F, Shah S, et al. Improvement of pulmonary function in children with early-onset scoliosis using magnetic growth rods. Spine. 2014;39 (15):1196-1202.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Orthopedic Trauma Devices Market Expected to Account for US$ 14 Bn by 2028

Posted On May 8, 2018 By OrthoSpineNews In Extremities, Top Stories /  

VALLEY COTTAGE, New York, May 8, 2018 /PRNewswire/ —

Primarily driven by increasing instances of fractures due to road accidents and sports related injuries, the global market for orthopedic trauma devices is anticipated to expand at a promising CAGR of 6.8% over the next decade. By the end of 2028, the orthopedic trauma devices market is estimated to attain the global revenues beyond US$ 14 Bn. As per the research presented in a recently published report by Future Market Insights, titled “Orthopedic Trauma Devices Market: Global Industry Analysis 2013 – 2017 and Opportunity Assessment, 2018 – 2028,” the market will also continue to be driven by impactful presence of some of the local players within respective regional markets.

“While the advent of 3D printing technology is likely to present the market a heap of new growth opportunities in 3D printed orthopedic implants, another significant opportunities lies in the popularly trending reverse shoulder arthroplasty. The rise of digital orthopedics will continue to fuel market growth through to 2028,” states a research analyst at Future Market Insights.

(Logo: https://mma.prnewswire.com/media/677274/Future_Market_Insights_Logo.jpg )

Request a Sample Report with Table of Contents and Figures: https://www.futuremarketinsights.com/reports/sample/rep-gb-2840

Based on the regional analysis, the global orthopedic trauma devices market will continue to witness dominance of North America, which currently accounts for a major portion of the total revenues. With around 48% value share observed in 2017, North America’s orthopedic trauma devices market is estimated to attain a value in excess of US$ 6 Bnby the end of 2028. Western Europe is also identified to be a key market, holding the second largest position in terms of value. Manufacturers will however discover attractive opportunities in developing economies, including Asia Pacific, Latin America, and Middle East and Africa. Among the emerging regional markets, Asia Pacific excluding China and Japan (APECJ) is likely to emerge at a relatively higher pace, followed by MEA. China is expected to be the most lucrative market owing to the highest estimated CAGR value over 2018-2028. Strong presence of key companies will reportedly uplift the markets in North America and China.

Preview Orthopedic Trauma Devices Market Segmentation by Product Type – Internal Fixators, Screws, Plates, Intramedullary Nails, Others, External Fixators, Unilateral Fixators, Circular Fixators, Hybrid Fixators; by end user – Hospitals, Orthopedic and Trauma Centers, Ambulatory Surgical Centers: https://www.futuremarketinsights.com/reports/orthopedic-trauma-devices-market

A majority of the key companies operating in the global orthopedic trauma market are opting for strategic mergers and acquisitions, in addition to new product launches. According to the report, most of the revenue is contributed by the tier 1 companies, followed by the tier 3 players. The tier 1 includes DePuy Synthes Inc., Stryker Corporation, Zimmer Biomet Holdings Inc., and Smith & Nephew Plc., which collectively represent nearly 70% share of the total market revenues. Among these, DePuy and Stryker will continue to remain the top players worldwide over the next decade. Tier 3 accounts for a relatively decent revenue share and includes brands such as Arthrex, Inc., RTISurgical, Medartis, Integra LifeSciences Corporation, Japan MDM, S. H. Pitkar Orthotools Pvt Ltd, Weigao Group Co Ltd, and Invibio Ltd.

Others operating in the global orthopedic trauma devices market include Johnson & Johnson Services, Inc., Wright Medical Group NV, B. Braun Melsungen AG, Orthofix International, and OsteoMed. Growing outpatient surgical procedure demand and boosting funds for delivery of the top-notch trauma care are foreseen to collectively create a lucrative pool of opportunities for the leading bunch of companies in the global marketplace. The market is also witnessing the development of novel and effective products for use in trauma care, which stands to be another important opportunity.

Our advisory services are aimed at helping you with specific, customized insights that are relevant to your specific challenges. Let us know about your challenges and our trusted advisors will connect with you: https://www.futuremarketinsights.com/askus/rep-gb-2840

More from FMI‘s Healthcare, Pharmaceuticals & Medical Devices:

  • Bone Growth Stimulators Market Segmentation By Product – Invasive Bone Growth Stimulators, Non-Invasive Bone Growth Stimulators and Ultrasound Bone Growth Stimulators; By End User – Hospital, Ambulatory Surgical Centers, Orthopedic Clinics, and Home Care; By Application – Trauma Injury and Fractures, Spinal Fusion, and Osteogenesis; Others – Market Size, Growth, Forecast, Sales, Pricing Forecast, Share, Export Value, Export Volume, Trade: https://www.futuremarketinsights.com/reports/bone-growth-stimulators-market
  • Platelet Rich Plasma (PRP) Market Segmentation By Types – Pure Platelet-Rich Plasma, Leukocyte Rich Platelet Rich Plasma; By Origin – Autologus PRP, Allogenic PRP, Homologus PRP; By Applications – Orthopedic Surgery, Cosmetic Surgery, General Surgery, Neurosurgery: https://www.futuremarketinsights.com/reports/platelet-rich-plasma-market
  • Ambulatory Surgical Centres Market Segmentation centre type – Single Speciality Centres, Multispecialty Centres; modality type – Hospital-based Ambulatory Surgical Centre, Freestanding Ambulatory Surgical Centre; service type – Diagnostic Services, Surgical Services; speciality area – Gastroenterology, Ophthalmology, Orthopedics, Pain/Neurology, Urology, Dermatology, Others: https://www.futuremarketinsights.com/reports/ambulatory-surgical-centre-market-092017

About Us

Future Market Insights (FMI) is a leading market intelligence and consulting firm. We deliver syndicated research reports, custom research reports and consulting services which are personalized in nature. FMI delivers a complete packaged solution, which combines current market intelligence, statistical anecdotes, technology inputs, valuable growth insights and an aerial view of the competitive framework and future market trends.

Browse More: Healthcare, Pharmaceuticals & Medical Devices Market

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SOURCE Future Market Insights

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NN, Inc. Completes Acquisition Of Paragon Medical

Posted On May 7, 2018 By OrthoSpineNews In Financial /  

JOHNSON CITY, Tenn., May 7, 2018 /PRNewswire/ — NN, Inc., (Nasdaq: NNBR) a diversified industrial company, today announced that it successfully completed its acquisition of Paragon Medical, Inc. Paragon Medical is a medical device manufacturer which focuses on the orthopedic, case and tray, implant and instrument markets.

Richard Holder, President and CEO, commented, “We are thrilled to welcome the Paragon team to the NN family. Paragon Medical enhances our technical proficiencies, diversifies our product and finished device offerings, and adds key employees that will make impactful contributions throughout the organization. This acquisition continues our strategic focus to expand our Life Sciences portfolio as well as create a balanced business.”

NN, Inc., a diversified industrial company combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Johnson City, Tennessee, NN has 51 facilities in North America, Western Europe, Eastern Europe, South America and China.

Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These, and similar statements, are forward-looking statements concerning matters that involve risks, uncertainties and other factors which may cause the actual performance of NN, Inc. (the “Company”) and its subsidiaries to differ materially from those expressed or implied by this discussion. All forward-looking information is provided by the Company pursuant to the safe harbor established under the Private Securities Litigation Reform Act of 1995 and should be evaluated in the context of these factors. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “assumptions”, “target”, “guidance”, “outlook”, “plans”, “projection”, “may”, “will”, “would”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “potential” or “continue” (or the negative or other derivatives of each of these terms) or similar terminology. Factors which could materially affect actual results include, but are not limited to: general economic conditions and economic conditions in the industrial sector, inventory levels, regulatory compliance costs and the Company’s ability to manage these costs, start-up costs for new operations, debt reduction, competitive influences, risks that current customers will commence or increase captive production, risks of capacity underutilization, quality issues, availability and price of raw materials, currency and other risks associated with international trade, the Company’s dependence on certain major customers, and the successful implementation of the global growth plan including development of new products. Similarly, statements made herein and elsewhere regarding pending and completed transactions are also forward-looking statements, including statements relating to the future performance and prospects of an acquired business, the expected benefits of an acquisition on the Company’s future business and operations and the ability of the Company to successfully integrate recently acquired businesses or the possibility that the Company will be unable to execute on the intended redeployment of proceeds from a divestiture, whether due to a lack of favorable investment opportunities or otherwise.

For additional information concerning such risk factors and cautionary statements, please see the section titled “Risk Factors” in the Company’s periodic reports filed with the Securities and Exchange Commission, including, but not limited to, the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements make in this press release, whether as a result of new information, future events or otherwise.

 

SOURCE NN, Inc.

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EY Announces OrthoPediatrics as Entrepreneur of The Year® 2018 Award Finalist in the Midwest

Posted On May 7, 2018 By OrthoSpineNews In Extremities /  

WARSAW, Ind., May 04, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce that Ernst & Young (EY) has named President & CEO, Mark Throdahl, a finalist for the Entrepreneur of The Year® 2018 Award in the Midwest Region. The awards program recognizes entrepreneurs excelling in areas such as innovation, financial performance and personal commitment to their businesses and communities. OrthoPediatrics was selected as a finalist by a panel of independent judges. Award winners will be announced at a gala on June 13 at Navy Pier Grand Ballroom in Chicago.

“We are thrilled to receive this prestigious recognition,” said Mr. Throdahl.  “It validates our belief that entrepreneurship is much more than having a new idea.  It’s about continuously reassessing our strategy and implementing the operating, quality, and financial systems that drive performance.  It’s about consistent growth that attracts blue chip investors.  And, most importantly, it’s about building an entrepreneurial culture that engages everybody in the Company.  Truly, every OrthoPediatrics associate deserves credit for this recognition.”

For more than 30 years, the Entrepreneur of the Year program has expanded to recognize business leaders in more than 145 cities and more than 60 countries throughout the world. Regional award winners are eligible for consideration for the Entrepreneur of The Year National competition. Award winners in several national categories, as well as the Entrepreneur of The Year National Overall Award winner, will be announced at the Entrepreneur of The Year National Awards gala in Palm Springs, California, on November 17, 2018. The awards are the culminating event of the Strategic Growth Forum®, the nation’s most prestigious gathering of high-growth, market-leading companies.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 37 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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SRMC doctor preps patients for knee surgery with unique nerve numbing procedure

Posted On May 7, 2018 By OrthoSpineNews In Recon /  

MAY 7, 2018 – Staff Writer MARY ANN GREIER, Salem News

SALEM–More mobility, less pain, little to no narcotics — that’s what Dr. Dominic Peters is now offering his knee replacement patients at Salem Regional Medical Center.

“I don’t like prescribing narcotics and I don’t like patients in pain,” Peters said during a recent interview about the iovera treatment.

Iovera is basically a nerve-freezing procedure done seven to 14 days before surgery that temporarily numbs the nerve at the area where the surgical incision will be made.

Peters, an orthopaedic surgeon with Salem Orthopaedic Surgery, described what happens like a subway train not completing its trip through a tunnel along its route. The wheels come off the train so it can’t go up or down the tunnel. The lack of wheels prevents the train from reaching its destination.

In this case, the iovera handheld device uses three prongs on a smart tip to convert a small amount of nitrous oxide into an ice ball and injects it into the patient’s skin on the front of the knee.

“It doesn’t kill the nerve, it just shocks the nerve,” he said.

The effect is a temporary paralysis of the skin nerve to the knee, blocking the nerve from sending pain signals to the brain. The numbness lasts three or four months and gradually goes away as the nerve regenerates and starts feeling again.

 

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(Salem News photo by Mary Ann Greier)

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Misonix Reports Record Third Quarter Revenue

Posted On May 7, 2018 By OrthoSpineNews In Financial /  

FARMINGDALE, N.Y., May 07, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today reported financial results for the third quarter of fiscal year 2018 ended March 31, 2018 as summarized below:

($ in millions) Three Months Ended Nine Months Ended
March 31, March 31,
2018 2017 2018 2017
Revenue $   12.4 $   7.2 $   28.0 $   19.4
Gross Profit $   9.8 $   5.1 $   20.8 $   13.5
GP Percentage – product revenue 68.8 % 70.6 % 69.7 % 69.9 %
Operating income (loss) $   2.2 $   (1.5 ) $   (1.1 ) $   (4.6 )
Net income (loss) $   2.2 $   (0.1 ) $   (5.8 ) $   (1.3 )
EBITDA (1) $   2.6 $   (0.0 ) $   0.4 $   (0.8 )
Adjusted EBITDA (1) $   4.0 $   0.5 $   4.4 $   (0.2 )
March 31, June 30,
 2018  2017
Long Term Debt $   – $   –
Cash $   12.3 $   11.6
(1) Definitions and disclosures regarding non-GAAP financial information including reconciliations are included on page 6 of this press release

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, stated, “Misonix delivered solid financial results in the 2018 fiscal third quarter, including our second consecutive quarter of record revenue. The successful ongoing execution of our strategies to aggressively grow our leading ultrasonic medical device platform is providing Misonix with a solid foundation to continue expanding market share domestically as well as abroad. Importantly, our strong performance reflects our ability to achieve top line growth, while preserving healthy margins and maintaining a strong balance sheet and liquidity position, which allows us to continue making return-focused growth investments, including the development of our next generation of products.

“Our record third quarter revenue of $12.4 million includes $4 million of license revenue related to an agreement with a Chinese partner. In addition to the license revenue, we generated continued revenue growth across domestic and international markets, both on a quarterly and on a nine-month basis, as well as ongoing growth in both consumables and sales of our core products. Misonix’s strong revenue growth reflects growing market demand for our products, resulting in a 17% growth in product revenue for the quarter and a 24% increase year to date. We are also very pleased to see our consumables business continue its double-digit revenue growth trajectory, something the team has been laser focused on given the high margins and added predictability of this revenue stream. Excluding license revenue, consumables accounted for 70% of total sales for the quarter, including 88% of domestic sales.

“The strategic initiatives we have implemented through-out the company and the changes we have made are yielding positive results across our business and have positioned Misonix to pursue a range of near- and long-term profitable growth opportunities.

“Nexus, our next generation of products to be launched later this year, will present a compelling value proposition to both hospitals and physicians, while allowing Misonix to further penetrate operating rooms by expanding our addressable procedures. For the first nine months of fiscal 2018, over 45,000 surgical procedures have been performed with Misonix consumables, which positions us well to achieve our goal of 100,000 annual procedures world-wide within the next 3 years.

“Looking ahead, we are excited about the opportunities to enhance shareholder value by expanding our scale, growth and profitability. As we bring the next generation of products to market and complete our transformation to a direct commercialization platform, we remain confident in our ability to end fiscal 2018 with double-digit top-line growth and to continue that growth trend into fiscal 2019.”

Sales Performance Supplemental Data

For the three months ended
March 31, Net change
2018 2017 $ %
Total
Consumables $   5,898,937 $   5,281,454 $   617,483 11.7 %
Equipment   2,530,195   1,896,309   633,886 33.4 %
License   4,010,000   –   4,010,000 100.0 %
Total $   12,439,132 $   7,177,763 $   5,261,369 73.3 %
Domestic product:
Consumables $   4,340,759 $   3,736,960 $   603,799 16.2 %
Equipment   590,269   278,348   311,921 112.1 %
Total $   4,931,028 $   4,015,308 $   915,720 22.8 %
International product:
Consumables $   1,558,178 $   1,544,494 $   13,684 0.9 %
Equipment   1,939,926   1,617,961   321,965 19.9 %
Total $   3,498,104 $   3,162,455 $   335,649 10.6 %
License   4,010,000   –   4,010,000 100.0 %

Joe Dwyer, Chief Financial Officer, added, “Misonix generated record revenue and strong results across several key financial metrics in the 2018 fiscal third quarter, including net income, earnings per share, cash from operations and adjusted EBITDA, reflecting the ongoing success we are achieving in transforming our operations and cost structure to become more efficient, while implementing effective sales and marketing strategies focused on expanding our market footprint and creating added demand for our products.

“In the third quarter, we saw significant revenue contributions from our agreement with one of our Chinese partners, as we recognized $4 million in license revenue following the successful delivery of the SonaStar technology for future production in China. The license revenue was the main driver of the over 820 basis point gross margin improvement. Going forward, we expect gross margin to be in-line with recent results at around 70%.

“We also further strengthened our liquidity position, ending the fiscal third quarter with over $12.3 million in cash, while remaining debt free. We believe it is important to preserve our strong liquidity position while remaining as committed as ever to profitably growing the business through organic growth investments and select accretive acquisitions that will add complementary capabilities to our product portfolio and generate strong returns for our shareholders.

“With our focus on growth, disciplined expense management, efforts to drive operational efficiencies, emphasis on driving consumable sales and ongoing transition towards a direct sales force model, we are confident we are putting in place an operational structure that will appropriately position Misonix to achieve its potential and create significant value for shareholders.

“Given the strong performance in our fiscal third quarter and year-to-date results, we are increasing our total revenue guidance for the year ending June 30, 2018 to between $35 million and $36 million, which implies annual revenue growth of 28% to 32%.

Fiscal Third Quarter 2018 Conference Call
Misonix will host a conference call at 4:30 p.m. ET today, Monday, May 7, 2018.  Senior management will discuss the financial results and host a question and answer session.  The dial in number for the audio conference call is 800-263-0877 (domestic) or 323-794-2094 (international), conference ID 7937390. Participants may also listen to a live webcast of the call through the “Events and Presentations” section under “Investor Relations” on Misonix’s website at www.misonix.com.

A webcast replay will be available for 30 days following the live event at www.misonix.com.

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