First Surgery Completed Utilizing the Gramercy Extremity Orthopedic™ Systems

Posted On May 25, 2017 By OrthoSpineNews In Extremities, Top Stories /

DALLAS, TEXAS, USA, May 24, 2017 /EINPresswire.com/ — Gramercy Extremity Orthopedics (GEO) is pleased to announce the first surgery using the GEO™ Bone Screw and GEO CART™ systems. The first surgery was performed by Dr. Peter A. Blume, D.P.M., F.A.C.F.A.S. at Shoreline Surgery Center LLC, Guilford, CT, with outstanding results. As the first offering in the company’s product line, this marks a major milestone for Gramercy Extremity Orthopedics™.

Dr. Blume remarked on the advantages of the GEO™ Bone Screw and GEO CART™ Systems, “I was extremely impressed and pleased with the outcome when utilizing the GEO™ Bone Screw and GEO CART™ systems. The ease in which the system operated was noted by the entire Surgical Center staff and felt that the systems created many efficiencies that are lacking in today’s operating environment. The surgical back table was free of clutter and the implant and instruments were truly best of class. The GEO CART™ finally addresses all the pitfalls when operating with orthopedic hardware, whether it be at the Surgery Center or in the hospital setting.”

The GEO CART™ proprietary point-of-sale system reduces delays in surgery, decreases sterility risks to the patient, eliminates billing mistakes and hand written forms, automatically generates the Implant Usage Form and reduces facility operating expenses.

The GEO CART™ is a computerized mobile implant and instrumentation inventory system based on RFID technology. No bigger than the average medical cart, the GEO CART™ system can hold over 2,000+ items.

The GEO™ Bone Screw System offers a comprehensive array of low profile titanium screw lengths, diameters, thread lengths and fully threaded options. All GEO™ Bone Screws are double sterile packaged, self-drilling, self-tapping, reverse-cutting with variable length short and long threads and a hexalobe head to provide additional stability and torque transfer with less potential for head stripping. All instruments within the GEO™ Bone Screw system are also double sterile packaged in single use kits to ensure a new and sterilized instrument is used every surgery.

“We are all very pleased with the results from today’s surgery. Not only did the implant and instruments all work superbly, the case was performed without issue and in an efficient manner,” says Michael P. Simpson, President and CEO of Gramercy Extremity Orthopedics™. “As for the GEO CART™, in my 16 years in orthopedic medical devices, I have never had the ability to see the transactions remotely from a case within minutes of the surgery happening. This is a significant breakthrough in our industry. I want to thank the GEO™ team for all of their hard work in getting this system to the marketplace”

GEO™ will be exhibiting at the AOFAS Scientific Conference, Seattle, July 12-14, 2017. Booth #610.

About Gramercy Extremity Orthopedics™:

GEO™ was formed from the idea that there could exist a more cost-effective, user-friendly way to supply Orthopedic Medical Implants in today’s healthcare environment. This is accomplished through the use of RFID technology, a groundbreaking Point-of-Sale delivery system, and GEO™ designed best in class sterilized single-use orthopedic implants and instruments. GEO™ is the only solution that provides a significant opportunity to lower real operating costs by creating efficiencies and controls throughout the delivery and consumption of orthopedic implants.

Michael Nugent
Gramercy Extremity Orthopedics™
855-436-2278 ext 103
email us here

DERMABOND® PRINEO® Skin Closure System May Improve Outcomes and Lower Hospital Costs

Posted On May 24, 2017 By OrthoSpineNews In Financial, Recon, Top Stories /

SOMERVILLE, N.J., May 24, 2017 /PRNewswire/ — Ethicon^* announced the results of two economic analyses demonstrating that the DERMABOND^®PRINEO^® Skin Closure system, a product that combines a topical skin adhesive with a self-adhering patch, is associated with improved patient outcomes and lower healthcare costs for hospitals. Both studies are being presented at the International Society for Pharmacoeconomics and Outcomes Research’s 22nd Annual International Meeting this week.

The first study, Comparison of Economic and Clinical Outcomes between the DERMABOND® PRINEO® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice,¹ found that the DERMABOND PRINEO System is associated with improved outcomes for patients receiving total knee arthroplasty (TKA) when compared to skin staples. The findings are based on a retrospective analysis of 1,942 TKA procedures using the Premier Perspective^®Hospital Database. Specifically, the DERMABOND PRINEO System was associated with a statistically significant reduction in readmission rates at 30, 60 & 90 days, a reduction in length of hospital stay and a lower probability of being discharged to a skilled nursing facility (SNF). The analysis showed that the 30-day readmission rate for the DERMABOND PRINEO System group was 1.8%, compared to 4.4% for the skin staple group. The costs of 30 day readmissions for TKA have been estimated to be $12,839.² The DERMABOND PRINEO System was also associated with a 12% reduction in length of hospital stay and a 31% reduction in discharge to a SNF or other non-home setting, which could lead to savings in the acute and post-acute setting.

The second study, A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty, estimates the 90-day cost impact of the DERMABOND PRINEO System compared to other wound closure methods for hip and knee arthroplasty from a U.S. provider perspective.³ The analysis showed that the use of the DERMABOND PRINEO System DERMABOND PRINEO System in hip and knee arthroplasty may achieve cost savings that could translate into an annual hospital budgetary savings ranging from $28,349 to $39,809 when assuming 500 arthroplasties.³ The predicted cost savings was driven by reductions in dressing materials and post-operative healthcare visits when the DERMABOND PRINEO System is utilized.

“Ethicon is committed to bringing to market innovative products that are designed to provide improved outcomes for patients and enable our customers to provide the best care for their patients,” says Nefertiti Greene, Vice President, Global Wound Closure and Repair Platform Leader at Ethicon. “The DERMABOND PRINEO System has been shown by this research to be an excellent approach to wound closure.”

Reducing the length of a patient’s hospital stay can lead to reduced costs and may also lower the chances of contracting an infection.⁴In addition, reducing readmissions can prevent hospitals from being penalized for readmission rates above the national average for TKA.⁵ The reductions in health care resource utilization demonstrated in these studies are important for hospital systems and health care professionals particularly those who are part of or are considering episode-based payments where both acute and post-acute costs are combined into one payment.

Several benefits associated with the DERMABOND PRINEO System may explain the findings. The product provides significantly greater skin holding strength than skin staples and subcuticular suture,⁶⁺ and acts as a barrier to microbial penetration against organisms commonly associated with surgical site infection.⁷ The DERMABOND PRINEO System requires no postsurgical dressings which may mean easier self-care and greater self-confidence for patients.⁷ Also, if directed by their healthcare professional, patients can shower immediately after surgery⁷ which could lead to a higher level of patient satisfaction.

About Ethicon

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

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates Ethicon, Inc. is the legal manufacturer of the DERMABOND^®PRINEO^® Skin Closure system. All other trademarks are the property of their respective owners.

+In an ex vivo study, more load in N was required to create a 3-mm gap between skin edges approximated with DERMABOND PRINEO System (22 cm) than with subcuticular 4-0 MONOCRYL® (poliglecaprone 25) Suture or PROXIMATE® Ethicon Endo-Surgery skin staples (P<.001).

073076-170517

¹Johnston S, Sutton N. Comparison of Economic and Clinical Outcomes between the Dermabond® Prineo® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
² HCUP Statistical Briefs website. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sbtopic.jsp. Accessed May 17, 2017
³ Sadik, K, Flener J, Gargiulo J, Graves M, Nunley, R Post, Z, Wurzelbacher, Sutton, N, Hogan, Hollman, S, Ferko, N. A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
⁴ Hassan M, Tuckman HP, Patrick RH, Kountz DS, Kohn JL. Hospital length of stay and probability of acquiring infection. International Journal of Pharmaceutical and Healthcare Marketing. 2010;4(4):324-338.
⁵ Centers for Medicare & Medicaid Services Readmissions Reduction Program (HRRP) https://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/readmissions-reduction-program.html. Accessed May 17, 2017.
⁶ Data on file, Ethicon, Inc.: Kumar A. AST-2012- 0290. Completion Report: Study to compare the tissue holding strength of PRINEO Skin Closure System with conventional wound closure techniques. 2012.
⁷ Data on file. Ethicon, Inc. Dermabond Prineo System Master Claims Matrix.

SOURCE Ethicon

MemorialCare Joint Replacement Center At Long Beach Memorial Now Offering Newest Technology In Total Knee Replacement

Posted On May 24, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

LONG BEACH, Calif., May 24, 2017 /PRNewswire-USNewswire/ — The MemorialCare Joint Replacement Center at Long Beach Memorial is the first hospital in Long Beach and North Orange County to offer Stryker’s robotic-arm assisted total knee application for use with its Mako System – and now has successfully performed its first total knee replacement case in that region using this new technology. This latest advancement in joint replacement surgery transforms the way total knee replacements are performed.

Total knee replacements in the United States are expected to increase 673 percent by 2030,¹ yet studies have shown that approximately 30 percent of patients are dissatisfied after conventional surgery.² Mako Total Knee combines Stryker’s advanced robotic technology with its clinically proven GetAroundKnee (Triathlon Total Knee System), which enabled surgeons to have a more predictable surgical experience with increased accuracy during laboratory testing.³

“Mako is changing the way joint replacement surgeries are performed by providing each patient with a personalized surgical experience based on their specific diagnosis and anatomy,” said Andrew Wassef, M.D., medical director, MemorialCare Joint Replacement Center, Long Beach Memorial. “Using a virtual 3D model, the Mako System allows surgeons to create each patient’s surgical plan pre-operatively before entering the operating room. During surgery, the surgeon can validate that plan and make any necessary adjustments while guiding the robotic-arm to execute that plan. It’s exciting to be able to offer this transformative technology across the joint replacement service line to perform total knee, total hip and partial knee replacements.”

The Mako Total Knee application is a knee replacement treatment option designed to relieve the pain caused by joint degeneration due to osteoarthritis. Through CT-based 3D modeling of bone anatomy, surgeons can use the Mako System to create a personalized surgical plan and identify the implant size, orientation and alignment based on each patient’s unique anatomy. The Mako System also enables surgeons to virtually modify the surgical plan intra-operatively and assists the surgeon in executing bone resections.

“We are proud to be the first hospital to offer this highly advanced robotic technology in our area,” said Tamra Kaplan, PharmD, chief operating officer, Long Beach Memorial. “This addition to our orthopaedic service line further demonstrates our commitment to provide the community with outstanding healthcare.”

About the MemorialCare Joint Replacement Center at Long Beach Memorial:

Long Beach Memorial is lauded for superior clinical quality outcomes and has been listed on U.S. News & World Report’s America’s Best Hospitals since the annual rankings began. In this year’s results, Long Beach Memorial received “high performance” rankings in nine clinical specialty areas, including Hip Replacement, Knee Replacement and Orthopedics. It also is among a small percentage of U.S. hospitals consistently recognized for outstanding dedication to patient safety by maintaining a top “A” grade in eight of nine Leapfrog Group Hospital Safety Score evaluations for its ability to prevent errors, injuries, accidents and infections.

JRC specializes in a rapid rehabilitation program – where patients walk the same day of surgery – resulting in a shorter hospital stay – average hospital stay is zero to two days. The JRC features a dedicated unit for joint replacement patients with 15 private rooms, a joint care coordinator to help patients navigate through the program, patient education before and after surgery and “rehab coaches” to provide support as patients take their first steps toward an active lifestyle.

1. Kurtz AAOS. Total knee and hip replacement projections 2030. www.prnewswire.com/news-releases/total-knee and-hip-replacement-surgery projections-show-meteoric-rise-by-2030-55519727.html. Accessed July 4, 2016. 2. Christiaan Keurentjes J, Fiocco M, So-Osman C, et al. Patients with severe radiographic osteoarthritis have better prognosis in physical functioning after hip and knee replacement: a cohort-study. PLOS One. 2013; 8(4): 1-8. 3. Hampp EL, Scholl LY, Prieto M, Chang T, Abbasi AZ, Bhowmik-Stoker M, Otto JK, Jacofsky DJ, Mont MA. “Accuracy Assessment of Robotic and Manual TKA in a Cadaveric Model.” Robotic-arm assisted total knee arthroplasty demonstrated greater accuracy to plan compared to manual technique. ORS 2017 Annual Meeting. San Diego. Poster No.2412.

SOURCE Long Beach Memorial

Boston Scientific is the 2nd biggest dealmaker in medtech since 2012

Posted On May 24, 2017 By OrthoSpineNews In Financial, Top Stories /

Max Stendahl, Biotech Reporter / Boston Business Journal – May 4, 2017

The last five years have seen a flurry of dealmaking in the medical device industry. And according to a new report, Marlborough-based Boston Scientific is responsible for more acquisitions than any other company since 2012 except one.

With 27,000 employees worldwide and around 2,500 here in Massachusetts, Boston Scientific (NYSE: BSX) is the largest medical device firm based in the state by headcount. It’s pulled off eight acquisitions since the beginning of 2012, according to the report by market research firm CB Insights. (The actual number appears to be 10; the report appears to omit one recent deal for an endoscopy firm and another in 2014 for a manufacturer.)

The only medical device company that was more active during this period was Boston Scientific’s rival, Ireland-based Medtronic (NYSE: MDT), which acquired a whopping 15 device firms.

For Boston Scientific, the string of acquisitions has coincided with the tenure of Mike Mahoney, who joined as president in October 2011 and was named CEO a year later. Boston Scientific has seen its stock price increase steadily with the 52-year-old Mahoney at the helm. He remains one of the highest-paid executives among public companies in the state, earning $35.7 million in total compensation plus value realized from past stock awards in 2016.

READ THE REST HERE

Doctor who faced retaliation for raising concerns about double-booked surgeries wins lawsuit

Posted On May 24, 2017 By OrthoSpineNews In Regulatory, Top Stories /

By Jonathan Saltzman – GLOBE STAFF MAY 24, 2017

A prominent Boston neurosurgeon was illegally forced out of his previous job at a New York hospital for strongly objecting to a policy that allowed another surgeon to perform complex spine surgeries on two patients simultaneously, a judge ruled.

Double-booking, as the practice is sometimes called, triggered a fierce dispute among doctors at Massachusetts General Hospital in recent years, leading to the 2015 dismissal of an orthopedic surgeon who opposed it. But Dr. James Holsapple may be the first doctor to win a lawsuit alleging he faced retaliation for challenging the practice.

New York Supreme Court Justice James P. Murphy ruled after a bench trial that University Hospital in Syracuse retaliated against Holsapple after he spoke out about the surgeon running two operating rooms at once.

“Dr. Holsapple vehemently objected and opposed the procedures for valid public health and safety reasons,” Murphy ruled in a 13-page decision received by the neurosurgeon Monday.

Holsapple, now chief of neurosurgery at Boston Medical Center, was awarded $88,277 in lost wages under the New York State whistle-blower statute. His lawyer estimated that the award could top $150,000 because Holsapple is entitled to interest on lost wages.

Holsapple, who resigned under pressure from University Hospital in 2009 and moved to Boston, said he felt vindicated.

“I did what I thought was right, and I’m grateful that the judge who heard the case saw it the same way,” said Holsapple, who heads the neurosurgery department at the Boston University School of Medicine.

The New York attorney general’s office, which defended University Hospital as part of the State University of New York, referred all questions to the hospital. Darryl Geddes, a hospital spokesman, said he could not comment because the attorney general’s office is considering an appeal.

READ THE REST HERE

Agency for Healthcare Research and Quality Accepts ReedGroup’s MDGuidelines

Posted On May 24, 2017 By OrthoSpineNews In Spine /

May 23, 2017

WESTMINSTER, Colo.–(BUSINESS WIRE)–ReedGroup®, a leading international provider of health and productivity solutions, is today announcing the National Guideline Clearinghouse (NGC)—a program of the federal Agency for Healthcare Research and Quality (AHRQ)—has accepted ReedGroup’s MDGuidelines® for Low Back Disorders and Cervical and Thoracic Spine Disorders.

The NGC uses exacting criteria to objectively review guidelines, and publishes only guidelines that meet the Institute of Medicine’s (IOM) criteria for transparent, reproducible, high-quality guidelines. In 2014, the NGC revised its guideline inclusion criteria to align with advances in Clinical Practice Guidelines We Can Trust (CPG) development, and the revised inclusion criteria reflect the IOM’s more rigorous standards.

In addition to meeting NGC’s guideline inclusion criteria, ReedGroup’s MDGuidelines were held up against the IOM’s Systematic Review (SR), which comprehensively evaluates evidence and takes into account search strategies, study descriptions, syntheses and summaries of evidence, systematic review bases, and more. MDGuidelines also were evaluated to ensure they maintained documentation demonstrating each guideline’s recommendations considered the assessment of benefits and harms of recommended care and alternative care options.

MDGuidelines incorporates the gold standard ACOEM Practice Guidelines that provide evidence-based recommendations for diagnostic and treatment practices and are based upon a systematic review of evidence, and its recommendations optimize patient care and assist health care providers and patients in making decisions about appropriate health care. The ACOEM Practice Guidelines adhere to the highest standards set forth by the IOM, AGREE II, AMSTAR, and GRADE.

“In our view, the NGC is doing great work to ensure that U.S. healthcare providers are given the best evidence-based guidelines, and MDGuidelines is honored to be a part of that,” said Joe Guerriero, senior vice president of MDGuidelines at ReedGroup. “The requirements of value-based care continue to heighten so healthcare organizations, employers and all industry stakeholders need a clear and proven treatment roadmap for their patients and employees. This means the guidelines used must truly be evidence-based, otherwise, the safety of U.S. workers is at stake.”

Learn more about MDGuidelines.

About ReedGroup

ReedGroup, a wholly owned subsidiary of The Guardian Life Insurance Company of America®, is a leading health and productivity organization providing services to over half of the Fortune 100 companies. With more than 2000 employees, ReedGroup has operations across the United States, Canada, and India. ReedGroup’s flagship product, MDGuidelines, is the industry’s leading solution for total health management and workplace productivity. MDGuidelines features the world’s most trusted disability duration estimates and evidence-based Practice Guidelines from ACOEM. MDGuidelines is a proven approach to managing and measuring the impact of evidence-based care across entire populations.

Contacts

ReedGroup
Tracy Dunagan, 303-246-3308
tracy.dunagan@reedgroup.com

Integra LifeSciences Announces Agreement with aap to Distribute LOQTEQ® Distal Radius System

Posted On May 24, 2017 By OrthoSpineNews In Extremities /

PLAINSBORO, N.J. and BERLIN, May 23, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, announced today that it has signed an agreement with aap Implantate AG (“aap”) to distribute the LOQTEQ® Distal Radius System within the United States. Berlin-based aap is a globally operating medical device company developing, manufacturing and marking trauma products for orthopedics.

“Integra is a leader in the hand and wrist arthroplasty market,” said Bob Davis, corporate vice president and president, Orthopedics and Tissue Technologies. “Adding a wrist plating system to our portfolio elevates Integra into a one-stop solution for our customers’ wrist needs- from fracture plating to fusion and arthroplasty.”

The LOQTEQ® distal radius system features state-of-the-art designs with multiple plate options to accommodate a variety of fracture patterns and anatomies, as well as instrumentation designed for intra-operative efficiency.

Bruke Seyoum Alemu, CEO of aap, said, “We are looking forward to expanding our footprint in the US with a proven force in the upper extremity field. The alliance between aap and Integra is a natural fit for both companies and will additionally drive our dynamic development in North America.”

Integra’s industry-leading products in the upper extremity market include the Freedom Wrist Arthroplasty System and the PyroCarbon MCP prosthesis.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, and orthopedics and tissue technologies. For more information, please visit www.integralife.com.

About aap
aap’s aspiration is to make trauma treatment better and cost-effective through innovations dedicated to create a sustainable value for patients, surgeons and hospitals. The company provides a comprehensive plates and screws portfolio for mainstream trauma and has a pipeline with new innovative products. aap’s IP-protected core platform technologies are the LOQTEQ® locking compression technology, its antimicrobial silver coating technology and its resorbable coated magnesium implants technology. For more information, please visit www.aap.de.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2016 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: 
Integra LifeSciences Holdings Company

Investors
Nora Brennan                                    
609-936-2488                           
nora.brennan@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984 
laurene.isip@integralife.com

aap Implantate AG

Fabian Franke 
+49 (0)30 / 750 19 134
f.franke@aap.de

SANUWAVE Health Announces Shock Wave Scientific Program in Milan, Italy Conducted by Medical Advanced Technologies, 26 May, 2017

Posted On May 24, 2017 By OrthoSpineNews In Biologics /

SUWANEE, GA–(Marketwired – May 23, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company’s exclusive distributor in Italy, Medical Advanced Technologies S.R.L. (MATEK) is sponsoring a one day scientific program to be conducted in Milan, Italy on May 26, 2017. This program, Workshop@Rooftop, will be held at the exclusive Hotel The Square in Milan. MATEK has been one of SANUWAVE’s most active partners in promoting both dermaPACE® and orthoPACE® in Europe. Their innovative and proactive approach towards promoting dermaPACE and orthoPACE is reflected in this program which will assemble some of the most accomplished medical researchers and medical practitioners in Italy. The program will discuss the newest clinical information related to the mechanism of action for SANUWAVE’s product line and to discuss clinical case-studies and on-going research in the field of extracorporeal shock wave technology (ESWT) and in particular the use of dermaPACE for wound indications and orthoPACE for orthopedic indications. Specific topics include:

Update on mechanism of action: from mechanobiology to the clinical practice, M.C., D’Agostino
Shock Wave Therapy for Myofascial Syndrome “Trigger Point”, A. Previtera
Update about international guidelines and new therapeutic frontiers, E. Tibalt

MATEK, with headquarters in Milan, Italy, has long been SANUWAVE’s partner in Italy. With their strength, experience and knowledge of the orthopedics and the wound care market, they are well positioned to help expand SANUWAVE’s market penetration via increased clinical presence and to continue to promote the company’s core products, dermaPACE and orthoPACE. “MATEK, once again, is setting the stage for creativity in furthering the field of ESWT. They are a model, not just in Italy, but in all of Europe, for how to create excitement and discussion among clinical researchers and practitioners alike.” stated Mr. Richardson, Chief Executive Officer of SANUWAVE. “We are extremely fortunate to have MATEK as a key team member in promoting our products abroad.”

For information related to MATEK’s Scientific Program, contact Ms. Annalisa Ali by email at commerciale@mateksrl.com or by telephone at +39 02 87264725.

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.

About MATEK

Operating since 2010 in the field of medical instruments, MATEK s.r.l. is the exclusive distributor in Italy of the products manufactured by SANUWAVE Inc., an emerging US-based regenerative medicine company. With the support of its specialized technical experts and qualified professionals, MATEK s.r.l. supplies its customers with electrohydraulic focused shock wave generators. This technique has been proven to have a high success rate in the treatment of soft tissue and bone diseases. MATEK’s mission is to provide users of medical devices, and in particular of focused shock wave generators, all-inclusive support to ensure consistently high quality levels even with intensive use. We offer training courses, assistance in promoting the presence and use of the medical device, medical/scientific support and technical/administrative information in relationships with the competent health authorities.

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.

CONTACT INFORMATION

Contact:
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

General Meeting of Kuros Biosciences approves all resolutions

Posted On May 23, 2017 By OrthoSpineNews In Biologics, Financial /

23 May 17

Kuros Biosciences announced that yesterday’s General Meeting approved all resolutions proposed by the Board of Directors with a vast majority. In particular, shareholders resolved on an increase of the conditional and authorized capital. Prof. Dr. Clemens van Blitterswijk, Frank-Jan van der Velden, Giacomo Di Nepi and Dr. Ivan Cohen-Tanugi were elected as new members of the Board of Directors. A total of 36.1 % of shares were represented at the General Meeting.

The General Meeting approved the Annual Report, the Annual Financial Statements, and Consolidated Financial Statements for the year 2016 and took note of the Reports of the Auditors. Shareholders also voted in favor of the proposed appropriation of the Annual Results, discharged the members of the Board and the Executive Comittee and approved their compensation.

Dr. Christian Itin was re-elected as Chairman as were Leanna Caron, Didier Cowling, Dr. Gerhard Ries and Harry Welten as members of the Board. Shareholders also elected Prof. Dr. Clemens van Blitterswijk, Frank-Jan van der Velden, Giacomo Di Nepi und Dr. Ivan Cohen-Tanugi as new Board members. Dr. Ries and Leanna Caron were elected as members of the Compensation Committee. Finally, the current Independent Proxy as well as the Auditors were confirmed for another term.

Dr. Christian Itin, Chairman of the Board, commented on the election of Prof. Dr. van Blitterswijk, Dr. Cohen-Tanugi and Messrs van der Velden and Di Nepi: „Kuros is in transition to become a commercial-stage orthobiologics company. Ahead of the market launches of our product lines MagnetOs^TM and Neuroseal, we strengthen the commercial and scientific expertise on the Board level.” He continued: „We thank Dr. Arnd Kaltofen and Dr. Jörg Neermann who did not stand for re-election. As long-time Board members, Arnd and Jörg sustainably contributed to Kuros’ development.“

Shareholders also resolved on an increase of the authorized (to 3,224,661 registered shares) and conditional share capital for Employee Benefits (to 1,208,389 registered shares) and corresponding changes to the Articles of Incorporation.

The General Meeting took place at the Company’s headquarters in Schlieren. It was attended by 36 shareholders. 2,326,113 shares or 36.1% of a total of 6,449,323 shares were represented.

Updated company presentation

An updated corporate presentation is available under the following link: www.kuros.ch/investors/reports-presentations.html.

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel: +41 79 750 15 64

harry.welten@kuros.ch

About Kuros Biosciences Ltd

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

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BONESUPPORT™ Announces First Patient Enrolled in FORTIFY Trial with CERAMENT®|G

Posted On May 23, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 22 May 2017– BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that the first patient has been enrolled by Dr Ravi Karia at the University of Texas Health Science Center at San Antonio into the company’s pivotal Investigational Device Exemption (IDE) trial: A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (the FORTIFY trial: ClinicalTrials.gov Identifier: NCT02820363).

CERAMENT G is an injectable antibiotic-eluting bone graft substitute that has proven remodeling capabilities and provides local sustained delivery of gentamicin. The data from the trial will support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G in the US.

In spite of modern day care of open tibial fractures, bone loss coupled with wound contamination and soft tissue damage continue to impair healing and recovery, particularly if infection develops. In addition, open tibial fractures result in a general infirmity, long-term disability and reduction in quality of life for patients, and a significant clinical challenge for orthopedic surgeons.

The FORTIFY trial will assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union. The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Dr. Douglas Dirschl, the trial’s Principal Investigator, said: “I am excited to take part in the FORTIFY clinical trial. The open tibial fracture remains the most common and one of the most troublesome open fractures managed by orthopedic surgeons. Even with modern treatment protocols, patients suffering this fracture continue to be at substantial risk of infection, fracture non-union, and prolonged disability. A product that could be inserted into the fracture site at the time of definitive treatment that could promote bone formation at the same time as reducing the risk of subsequent infection, would be a major advance in the treatment of these troublesome fractures and would have the potential to provide benefit to thousands of patients each year in the United States.”

Douglas R. Dirschl, MD is the Lowell T. Coggeshall Professor of Orthopedic Surgery and Chairman, Department of Orthopedic Surgery and Rehabilitation Medicine at The University of Chicago Medicine.

“The treatment of the first patient in the FORTIFY trial is another key corporate milestone for BONESUPPORT. This clinical trial in a complex trauma indication is designed to demonstrate proof-of-concept that CERAMENT G can be used to improve and protect the healing process in open bone fractures in combination with standard procedures, minimizing the risk of deep infections which would result in the need for additional remedial procedures,” added Richard Davies, CEO of BONESUPPORT. “We plan to use the clinical data to support our planned PMA filing for CERAMENT G in the US. We also intend to generate additional clinical data with CERAMENT G to gain a broad US label for this novel, injectable antibiotic-eluting bone graft substitute, which is rapidly being adopted in Europe.”

CERAMENT G combines the bone healing and bone remodeling properties of CERAMENT with the antibiotic, gentamicin. CERAMENT G drug-eluting properties enable it to provide an initial high concentration of gentamicin to the environment of the bone fracture and then a longer sustainable dose above the minimum inhibitory concentration of many of the bacteria that could cause a bone infection at the fracture site. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.

CERAMENT G received the European CE Mark in February 2013 and is now marketed in 19 countries outside the US.

Notes to Editor

About BONESUPPORT

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENTG and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

BONESUPPORT AB

Richard Davies

info@bonesupport.com

+46 (0)46 286 53 24

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

+44 (0)20 7638 9571

bonesupport@citigatedr.co.uk

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