Lima Corporate Celebrates 15 years of SMR System by Launching Two New Additions to the Shoulder Portfolio

Posted On May 17, 2017 By OrthoSpineNews In Extremities, Top Stories /

San Daniele del Friuli, Udine, Italy – 15th May 2017 – Lima Corporate is celebrating the 15th anniversary of the SMR shoulder modular system, by launching the SMR Bone Graft Instruments and Lima Personalized Surgical Instruments (LPSI). This anniversary positions Lima as the pioneer in modularity applied to shoulder replacement. The SMR is the first shoulder platform with 15 years of clinical follow up, demonstrated by the several different studies. The innovation and the versatility of the system are now complemented by the SMR Bone Graft Instruments and LPSI Shoulder guides combined with the preoperative planning software.

The SMR Modular Shoulder System is on the market since 2002 and has been developed with the support of several shoulder surgeons, led by Prof. Mario Randelli, from Humanitas Clinical Institute in Milan (Italy). The aim of the SMR system is to provide to surgeons a complete platform, where the modularity of the system allows intraoperative versatility and a simple conversion from anatomic to reverse, without removing the humeral stem and the Metal Back glenoid.

The SMR Bone Graft Instruments are used in combination with the SMR TT Metal Back. These innovative instruments combined with Lima Corporate’s proprietary Trabecular Titanium of the TT Metal Back, allow surgeons to address a great variety of clinical cases.

“I decided to start using the Lima SMR due to the advantages provided by the modularity of the system. I appreciate the innovative solutions developed by the Company to assist us on our daily practice, such as the Trabecular Titanium”, said Dr. Kevin Setter from SUNY Upstate Medical University Syracuse (US).

The LPSI Shoulder guides and its preoperative planning software assist in planning the intraoperative positioning of the LPSI guide, finding the best position for the glenoid implants of the SMR Anatomic and Reverse shoulder system.

“Since many years Lima is focusing on innovation with the idea to be a pioneer on orthopedic applications. We are very proud to celebrate the 15 years of clinical history of our SMR System: the first shoulder modular platform and the only one with a so long follow up. Lima is continuing growing in the extremities market and developing solutions to support our customers on their always more challenging practice”, said Mr. Luigi Ferrari, Lima Corporate CEO.

SMR System is performing extremely well in different Countries around Europe, Asia Pacific and Americas, and with over 90.000 implants to date.

“The SMR System is like a friend who supports you on dealing the shoulder surgery with calm on standard situation and sort out brilliantly the complex situations”, said Dr. Alessandro Castagna from Humanitas Clinical Institute in Milan (Italy).

About Lima Corporate

Lima Corporate is a global medical device company providing reconstructive orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, Lima Corporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. Lima Corporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

For additional information on the Company, please visit www.limacorporate.com

Limacorporate spa Via Nazionale, 52 33038 Villanova di San Daniele Udine – Italy t: +39 0432 945511 e.: info@limacorporate.com www.limacorporate.com

Orthonika accelerates development of total meniscus replacement and secures additional funding

Posted On May 17, 2017 By OrthoSpineNews In Financial, Sports Medicine, Top Stories /

London, UK, 15th May 2017 / Orthonika Limited, a spin-out from Imperial College London, is pleased to announce success in securing funding for development of its novel synthetic total knee meniscus replacement. The company has closed a second round of investment of £675,000 from a group of angel investors alongside a Biomedical Catalyst award and an Industrial Challenge award. The funding is being used to accelerate progress on biomechanical testing and carry out a pre-clinical pilot trial.

Dr Mario Alberto Accardi, Co-Founder and Chief Executive Officer, commented “We are delighted to have raised the funds to bring this revolutionary treatment for meniscus injury into a pre-clinical pilot trial. We are very grateful to our angel investors and Innovate UK for their support.”

Dominique Kleyn, Co-Founder and Chief Operating Officer, added “This investment demonstrates a strong endorsement of our progress in developing a novel solution for meniscus injury and allows us to cement our network of collaborators and suppliers.”

Orthonika brings design and development expertise to exploit a novel approach for the replacement of a damaged meniscus, restoring knee biomechanics and allowing patients to return to an active lifestyle. The goal is to advance the meniscus replacement into a product and obtain regulatory approval for its clinical application.

Ends

For further information, contact:

Orthonika

Dr Mario Alberto Accardi
CEO and Co-Founder
E: ma.accardi@orthonika.com

Dominique Kleyn
COO and Co-Founder
E: d.kleyn@orthonika.com

Media Relations, Sciad Communications

Deborah Cockerill
Managing Partner
E: deborah@sciad.com
T: +44 (0)20 7470 8801

Notes to Editors

About Orthonika Limited:
Orthonika is a spin-out from Imperial College London founded in 2015, developing an anatomical total meniscus replacement for the knee joint. Orthonika’s revolutionary meniscus implant accurately mimics the natural structure of meniscal tissue replicating its ‘structure-function’ relationship. It is designed to restore knee biomechanics and allow patients to return to an active lifestyle, an option currently not available to patients with severe meniscus injury hence fulfilling a gap of high unmet clinical need. For further information visit www.orthonika.com.

About Innovate UK:
Innovate UK is the UK’s innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk.

About meniscus injury:
Meniscus injury is the most frequent orthopaedic surgical intervention with meniscus-related operations accounting for up to 50% of all knee surgeries with an average of 1.7m total surgeries performed each year in the EU and U.S. Despite this prevalence, today’s standard of care for a severely damaged meniscus is partial or total meniscectomy (removal) with no total meniscus replacement currently available on the market. Removal of the meniscus is well understood to be a major risk factor for osteoarthritis (OA) a chronic and debilitating condition, with an estimated 50% of partial meniscectomy patients being diagnosed with OA as a result.

Category:

Press Release

Episurf Medical continues its communication with the US FDA for market acceptance in the U.S.

Posted On May 16, 2017 By OrthoSpineNews In Regulatory, Top Stories /

Press Release – 15.05.2017

In July 2016, Episurf Medical participated in a pre-submission meeting with the FDA in Washington. Following this meeting, Episurf Medical submitted a 513(g) Request for Information for obtaining FDA’s views about the classification and the regulatory requirements that may be applicable to the Episealer device.

Episurf Medical has now received feedback from the FDA regarding the 513(g) request. The feedback is not decisive and opens up various alternatives for Episurf Medical to assess; further interaction with the FDA has been initiated. There are several factors to consider when deciding what regulatory pathway to select and what kind of application to submit to the FDA. Episurf Medical has started an internal process to decide on a regulatory pathway for application for US market acceptance. The Company expects to complete its review and reach a decision by the third quarter of 2017.

“With our European launch of the Episealer technology now well underway, we are eager to move on with the strategic development and regulatory process for the important North American market. We are happy to now have feedback on our 513(g) application, and we look forward to continuing our constructive interaction with FDA in determining our best route forward.” comments Pål Ryfors, Acting CEO and CFO, Episurf Medical.

For more information, please contact:

Pål Ryfors, acting CEO, Episurf Medical

Tel: +46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 14.45 CET on 15 May 2017.

Life Spine Announces Full Commercial Launch of PROLIFT® Lordotic Expandable Interbody Solution

Posted On May 16, 2017 By OrthoSpineNews In Spine, Top Stories /

May 16, 2017

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 full commercial launch of PROLIFT Lordotic expandable interbody solution with OSSEO-LOC™ technology.

PROLIFT Lordotic allows for in-situ disc height restoration, for minimally invasive PLIF, TLIF and oblique approaches. PROLIFT Lordotic, 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 expandable technologies at Life Spine.

OSSEO-LOC, Life Spine’s proprietary surface treatment, creates a geometric surface architecture which offers the clinical advantage of providing an osteoclastic environment, documented for the recruitment of bone building cells (osteoblasts) on titanium implants to assist with healing and solid fusions.

Mariusz Knap, Vice President of Marketing noted, “We are excited to offer PROLIFT Lordotic with the OSSEO-LOC subtractive process, as it deepens Life Spine’s commitment to providing surgeons access to our highly differentiated, minimally invasive spinal solutions. Addressing a variety of pathologies, Life Spine’s procedural based solutions increase the value of care by delivering both the ability to correct spinal alignment, an improved patient experiences. Life Spine continues to develop technologies that centers on achieving restoration of spinal alignment, which has been proven to be a significant driver to successful, long-term surgical outcomes. This will be a driving force as we continue to expand the Life Spine armamentarium of surgical solutions, and partner with surgeons to help them deliver superior surgical outcomes.”

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.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

EOS Announces NYU Langone’s 3rd System Installation

Posted On May 16, 2017 By OrthoSpineNews In Spine, Top Stories /

May 15, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced the EOS System is now available for patients at The Scoliosis Center, a division of Advocare The Orthopedic Center, which is the third site within the world-class NYU Langone Medical Center Healthcare System to offer the EOS System to patients. The first two units within the organization were dedicated to adult patients at the Center for Musculoskeletal Care and the Hospital for Joint Diseases.

The EOS solution including the low-dose, 2D/3D EOS imaging equipment, the 3D modeling workstation and the spineEOS software for 3D surgical planning will allow physicians to plan and manage treatment for scoliosis and other orthopedic conditions in 3D while avoiding high levels of radiation exposure. Advocare The Orthopedic Center provides pediatric and adolescent patients with the highest quality care for these pathologies.

Dr. Mark A. Rieger, MD, FAAOS, pediatric orthopedist, founding partner, and senior physician at Advocare The Orthopedic Center, commented, “The Scoliosis Center, established in 1994, is the first center within our network exclusively dedicated to the treatment of patients with scoliosis, which is a complex condition affecting the curvature of the spine. The addition of the EOS System is an important step as we create a world-class scoliosis center right here in New Jersey, thanks to our affiliation with NYU Healthcare System, offering high-end quality treatment management options leading to better outcomes for our patients.”

Researchers from NYU Langone Medical Center presented a study at the last American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting on the ‘Concepts in Radiation Exposure and Dosage’ that included a comparison of the radiation exposure with EOS imaging to traditional x-rays for pediatric patients. The study reported that a full 2D/3D EOS spine exam uses 60% less radiation than traditional x-rays. The importance of reducing radiation exposure from imaging exams was supported by new data on radiation-induced fatal cancer and genetic defects for female scoliosis patients associated with the significant number of imaging exams required to diagnose and follow the progression of their disease and treatment.

Marie Meynadier, CEO of EOS imaging, said, “The installation of a third EOS system within the NYU Langone network provides further validation of our technology and its potential to become a standard of care for orthopedic patients. The placement at The Scoliosis Center will facilitate access to the EOS technology to patients in the suburban communities served by NYU, a first class healthcare system adopting the latest technologies to provide optimal care to its patients.”

The Scoliosis Center, a division of Advocare The Orthopedic Center, is located at 218 Ridgedale Avenue in Cedar Knolls, New Jersey 07927. Interested patients and their families can call the office at (973)-538-7700.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteo-articular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Jamie Milas, +33-7-7695-2955
Vice President of Marketing
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot
+33 (0)1-4471-9496
eosimaging@newcap.eu
or
Media Relations
Annie-Florence Loyer
+33 (0)1-4471-0012 / 6-8820-3559
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

Exactech Receives 510(k) Clearance for Computer-Assisted Shoulder Arthroplasty Technology

Posted On May 15, 2017 By OrthoSpineNews In Regulatory, Top Stories /

GAINESVILLE, Fla.–(BUSINESS WIRE)– May 15, 2017

Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS® Shoulder Application. Combining preoperative planning with computer-assisted surgery, the industry-leading technology allows for greater intraoperative visibility in both standard and challenging shoulder arthroplasty.

“The ExactechGPS Shoulder Application offers groundbreaking technology that is unique to the industry and should continue our selling momentum that delivered 21% growth in the first quarter,” said Darin Johnson, Vice President, Extremities Marketing. “Allowing surgeons to preoperatively plan the surgery and then execute it with a computer-assisted solution will help patients by ultimately improving outcomes. Importantly, it also reflects Exactech’s philosophy of keeping intraoperative decision making and control in the surgeon’s hands.”

An introduction to the new technology was the focal point at the recent 2017 Exactech Shoulder Masters Course, with live broadcasts of two surgeries performed by Pierre-Henri Flurin, MD, in Bordeaux, France.

“The live surgeries featuring the new ExactechGPS shoulder application for both anatomic and reverse total shoulder cases were incredible as it felt like we were in the operating room. It was exciting to witness the most advanced innovation in shoulder arthroplasty since reverse shoulders were first introduced,” said attendee Samuel Antuña, MD.

Setting a new standard in medical education, the Masters Course’s comprehensive scientific program featured 35 presentations by distinguished faculty who shared their experiences and philosophies with more than 150 surgeons from 17 countries around the world. Faculty member Joseph Zuckerman, MD, said, “This was one of the highest quality educational meetings I have participated in during my professional career. Between the scientific and technical presentations, debates, live surgeries and interactions between our surgeon peers, it was a truly unique and rewarding experience.”

The ExactechGPS Shoulder Application’s preoperative planning tool is designed to help surgeons understand their patient’s anatomy prior to surgery. Intraoperatively, ExactechGPS provides visibility into the glenoid vault in real time and allows for consistent, accurate glenoid placement.¹ A recent study showed that more accurate glenoid placement minimizes complications and theoretically increases implant survivability.²In addition, ExactechGPS provides a real-time view of retroversion and inclination, reaming and drilling depth, screw placement and the ability to adjust surgical plan intraoperatively, offering surgeons more flexibility.

The ExactechGPS Shoulder Application has been used successfully in the U.K., Spain, France and Australia. The initial launch in the U.S. is planned for this quarter. It is the latest addition to the Equinoxe® Shoulder System, which has been one of the fastest growing shoulder lines on the market since its introduction more than a decade ago. This year marks the 10^th anniversary of the first implantation of the Equinoxe reverse shoulder; Equinoxe products will be implanted in the 100,000^th patient before the end of this year.

Data on file at Exactech*
Walch G et al. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J. Shoulder and Elbow Surg. (2011) 20; 385-394.

* In vitro (bench) test results may not necessarily be indicative of clinical performance.

About ExactechGPS

ExactechGPS combines surgeon expertise with an advanced computer system to perform the patient’s surgery with a goal of improved accuracy and precision. Personalized for a patient’s unique bone structure and anatomy, ExactechGPS is designed to allow surgeons to decide where to remove bone and place the implant in the optimal position. Exactech first introduced ExactechGPS to surgeons in the United States for total knee arthroplasty, and has since broadened its reach by providing medical education and supporting surgeries in more than 11 countries. The technology has steadily gained market acceptance and worldwide reach.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Arthroscopic Surgery Doesn’t Help With Arthritis Knee Pain

Posted On May 12, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

Carmen Heredia Rodriguez, Kaiser Health News – May 11, 2017

An international panel of surgeons and patients has challenged the effectiveness of one of the most common orthopedic procedures and recommended strongly against the use of arthroscopic surgery for patients with degenerative knee problems.

The guidelines, published Wednesday in the journal BMJ, reviewed 13 studies involving nearly 1,700 patients and found the surgery did not provide lasting pain relief or improve function for most of them. Those studies compared the surgery with a variety of options, including physical therapy, exercise and even placebo surgery.

Fewer than 15 percent of patients felt an improvement in pain and function three months after the procedure, and that those effects disappeared after one year, the review found. In addition, the surgery exposed patients to “rare but important harms,” such as infection.

Casey Quinlan, 64, who had the surgery in 2003 and was on the panel issuing the guidelines, said her orthopedist told her the procedure would not only help restore mobility in her knee after a nasty ski accident but also improve her arthritis.

Quinlan, of Richmond, Va., said the procedure did not deliver, since her arthritis remained unchanged. “It was not what I was told to expect,” she says.

In an arthroscopic knee surgery, physicians make several small incisions around the joint and insert a tiny camera that allows them to see inside the knee as well as insert small instruments to correct problems they identify. Often the surgery is performed to remove part of a damaged meniscus, a disc of cartilage that helps cushion the knee.

The panel said meniscal tears “are common, usually incidental findings, and unlikely to be the cause of knee pain, aching or stiffness.”

READ THE REST HERE

SANUWAVE Appoints LOK North America as Territory Sales Manager for Sourcing and Screening of Potential Distributors for Company’s Products in Canada

Posted On May 12, 2017 By OrthoSpineNews In Biologics, Top Stories /

SUWANEE, GA–(Marketwired – May 11, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed LOK North America to act as Territory Sales Manager for sourcing and screening of potential distributors for SANUWAVE’s products in Canada.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage LOK North America was made to increase visibility within the Canadian market and to maximize the exposure that SANUWAVE can get for their registered and approved product line in Canada. LOK North America will give us an extended reach and establish rigorous evaluation methods of the regional distribution options in Canada to ensure the development of a strong distribution network. All of these factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOL’s),” concluded André Mouton.

Eric Fillion, V.P. Sales and Marketing of LOK North America, stated, “LOK North America is an ideal partner for SANUWAVE by providing both regulatory and commercial support when introducing and expanding the Company’s medical device portfolio in Canada.”

“LOK North America will provide targeted assistance to SANUWAVE with a team of professionals that are dynamic individuals with diversified backgrounds and each having his/her own area of expertise,” continued Mr. Fillion. “Our multidisciplinary approach enables us to offer our services in an integrated and efficient way. Our commercial support expertise, with its in-depth knowledge of the Canadian medical landscape will allow SANUWAVE to have the maximum impact in the shortest time span.”

SANUWAVE is using this occasion to further educate on our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

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

About LOK North America
Based out of Laval, Québec, Canada, LOK North America is a member of the LOK Network, which currently maintains 12 offices worldwide and has the combined expertise of over 150 seasoned professionals around the world. The consortium presents global solutions for start-ups, mid-size and multinational companies to accelerate their market entry and the commercialization of their products worldwide. Lok North America is your partner for both regulatory and commercial support when introducing medical devices in Canada. LOK North America has a wealth of expertise and experience advising clients on a range of issues by providing medical devices manufacturers with solutions ranging from market entry strategy, regulatory for Health Canada and FDA, quality system, clinical requirements, distributor identification and selection, distributor agreement negotiations to sales management

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

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Andre Mouton
Vice President International Sales and Relations
+1-678-578-0117 (Office)
+1-615-823-9907 (Cell)
+1-678-569-0881(Fax)
Skype: andre.w.mouton
Andre.Mouton@sanuwave.com

Cook Medical Sells Vertebroplasty Product Family to IZI Medical Products

Posted On May 11, 2017 By OrthoSpineNews In Spine, Top Stories /

May 10, 2017

BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical is pleased to announce the sale of its comprehensive family of vertebroplasty products to IZI Medical Products, LLC. This sale includes the Duro-Ject^® Osteo-Site^®, Osteo-Force^® and Vertefix^® brands in addition to other needles, injectors and cements. Moving this product family from Cook Medical to IZI Medical Products is a positive decision for both companies and for the patients impacted by spinal fractures.

“In the US, there’s an estimated 700,000 vertebral fractures a year due to osteoporosis¹,” said Pete Yonkman, president of Cook Medical and Cook Group. “We were not giving this product family the resources it needed to continue to advance, so we’re pleased to have found it a new home with IZI Medical. The sale of our vertebroplasty product family allows us to concentrate on our primary product lines while allowing IZI Medical to focus on helping to treat patients suffering from spinal fractures.”

The vertebroplasty product family is used in the growing market for treating vertebral compression fractures through a minimally invasive procedure. IZI has planned a significant investment in a dedicated sales force, international distributor network, select product enhancements and new product development.

This product family is manufactured in Cook Medical’s Bloomington, Indiana, facility where many other products are built. This change will not impact that facility or its employees.

IZI Medical is the interventional products platform of Shore Capital Partners.

About Cook Medical

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at www.cookmedical.com, and for the latest news, follow us on Twitter,Facebook and LinkedIn.

¹ Ensrud KE, Schousboe JT. Clinical practice. Vertebral fractures. N Engl J Med. 2011;364(17):1634–1642.

Contacts

Cook Medical
Marsha Lovejoy, Global Manager, External Corporate Communications
812-320-6903 (mobile)
812-339-2235, ext. 10-2750 (office)
marsha.lovejoy@cookmedical.com

ZipLine® Medical Receives India Regulatory Approval for Non-Invasive Zip® Skin Closure System

Posted On May 10, 2017 By OrthoSpineNews In Regulatory, Top Stories /

May 09, 2017

CAMPBELL, Calif.–(BUSINESS WIRE)–ZipLine® Medical, Inc., an innovator in skin closure, today announced Central Drugs Standard Control Organization (CDSCO) approval of its Zip® Surgical Skin Closure device in India. This clearance will give the company access to the $3.5 billion medical device market in India, including growing specialties where the Zip has shown significant clinical and economic benefits, such as total joint replacement in orthopedics, and Cesarean-section and hysterectomy in obstetrics and gynecology.

The Zip is a non-invasive and easy to use skin closure device that replaces sutures, staples and glue for surgical incisions and lacerations. Clinical studies have demonstrated significant time savings and less procedure variability that can decrease hospital costs and improve efficiencies. Studies have also demonstrated fewer wound complications, and the comfortable and simple removal can reduce post-discharge home health and clinic visits that affect overall healthcare cost in a bundled care environment.

A patented force distribution design results in secure wound closure, excellent scar quality and high patient satisfaction. The Zip’s micro-adjustability and reversibility provide surgeons with precise control during closure, and care teams with security that they can adjust closure post-surgery, if needed. Unlike staples or sutures, there are no skin punctures with the Zip that can create pathways for bacteria. The Zip’s benefits have been demonstrated in clinical studies in orthopedic total-joint arthroplasty, foot and ankle surgery, pediatric cardiothoracic surgery, electrophysiology and dermatology.

In addition, clinical study results from the University of Florida demonstrated an 18 percentage point higher tissue perfusion rate versus baseline with the Zip compared to staples (p<0.001) after closure for total ankle replacement procedures. The results were presented in a poster at the American College of Foot and Ankle Surgeons (ACFAS) conference in Las Vegas in March.

Jason Piraino, DPM, MS, FACFAS, who presented the results, commented, “Maintaining adequate perfusion is one of the most important factors in ensuring wound healing. High perfusion correlates to fewer complications, such as dehiscence and infection. The Zip demonstrated a significant perfusion advantage over staples in our study.”

ABOUT ZIPLINE MEDICAL

ZipLine Medical is an innovator in cost-effective, non-invasive surgical skin closure devices that deliver high patient satisfaction and surgeon efficiency. Zip Surgical Skin Closure devices have been used in more than 100,000 cases, and in over 30 countries. worldwide. ZipLine Medical was founded by Amir Belson, M.D. and is headquartered in Campbell, CA. For more information, visit www.ziplinemedical.com.

Zip® Surgical Skin Closure devices are classified by the U.S. FDA as ‘Class I, 510(k) Exempt’ and have received the CE Mark and CFDA approval.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 310-902-1274
michelle@chronic-comm.com