Amedica Announces Positive Scientific Data and Re-files FDA Submission

Posted On December 19, 2016 By OrthoSpineNews In Regulatory, Spine /

SALT LAKE CITY, UT — (Marketwired) — 12/19/16 — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company’s porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation. “We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future. The porous silicon nitride sample used in this study is the cancellous-structured ceramic (CsC) used in the center of our composite cervical implants that were the subject of recent FDA communications,” said Dr. B. Sonny Bal, CEO and President of Amedica Corporation.

Amedica has re-filed an application with the FDA, with a modified CsC-based cervical implant that is comparable to Amedica’s own commercially-available Valeo^®C cervical implants. “With this submission, the goal is to introduce our proprietary CsC technology platform into the U.S. market without further delay,” said Dr. Bal.

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label 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. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can 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 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

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

Source: Amedica Corporation

Released December 19, 2016

Safe Orthopaedics Receives CE Mark for a New Implant to Treat Vertebral Fractures

Posted On December 19, 2016 By OrthoSpineNews In Regulatory, Spine /

December 16, 2016

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments, today announces that it has received CE Mark for a new version of its patented Oak screw used to treat thoracic vertebral fractures.

Previously, 7.5 mm, 6.5 mm and 5.5 mm diameter versions of the screw were available for lumbar (lower back) vertebral fractures. With its smaller diameter, the new 4.5 mm version caters more widely for thoracic (middle-back) vertebral fractures.

Oak is the only pedicle screw in the world to offer simultaneous correction and fixation of trauma-related vertebral fractures. It combines the advantages of a multi-axial screw, which eases insertion of the rod, with the benefits of a mono-axial screw in reducing the fracture without any additional instruments.

This Safe Orthopaedics-patented innovation is ideal for minimally invasive surgeries and is also compatible with conventional open approaches. SteriSpine modular kits can be used with either of these approaches, making it possible to switch from one to the other in mid-surgery should the need arise.

Combined with their sterile single-use instruments, Oak screws are also constantly ready for use, and so surgery can go ahead without any delay—a major advantage in trauma cases. Vertebral fractures, which are usually the result of accidents, require rapid emergency surgery.

Dr. Van Gaalen, orthopedic surgeon at the Utrecht Hospital, Netherland, commented: “The Oak screw is a major breakthrough for trauma surgery because it facilitates and enhances the treatment of vertebral fractures. The CE Mark of this latest 4.5 mm diameter version of the product, which previously catered largely to lumbar vertebral fractures, opens up new possibilities for the treatment of thoracic vertebral fractures. This means we can now offer the benefits of this technology to a larger number of patients.”

Dr. Vouaillat, orthopedic surgeon, Cedar Clinic, Echirolles, France, and co-inventor of the system added: “This unique system offers new possibilities in the management of trauma surgeries and also opens up new solutions for degenerative surgeries.”

Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics, concluded: “The CE Mark of this new version of the Oak screw further strengthens our position in the key trauma market. Our ground-breaking innovations are ideally suited for trauma treatment because surgical procedures become easier and can go ahead more rapidly. They also open the way for minimally-invasive approaches—still used all too rarely in emergency surgeries.”

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, with the aim of facilitating safer, optimized and lower-cost spinal surgery. By avoiding the reuse of surgical instruments, Safe Orthopaedics reduces the risk of infection, avoids the cumbersome and unreliable logistics of instrument sterilization, and limits hospital costs. Protected by 17 patent families, the SteriSpine™ Kits are CE-marked and FDA cleared. The company is based at Eragny-sur-Oise (France), and has 34 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
Thierry Lambert
CFO
Tél. : +33 (0)1 34 21 50 00
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
Tél. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

Predictive Technology Group, Inc. (PRED) Announces Notice of US Patent Allowance for Method for Treating Patients with Genetic Spinal Deformities and Syndromes

Posted On December 19, 2016 By OrthoSpineNews In Regulatory, Spine /

SALT LAKE CITY, UT–(Marketwired – December 16, 2016) – Predictive Technology Group, Inc. (OTC PINK: PRED), a life sciences technology holding company, announced today that the United States Patent and Trademark Office (USPTO) has allowed a fundamental patent application — US20160296671 -that covers the practice of administering “ANY” spine deformation therapeutics to a patient having a spine deformation altered risk associated biomarker.

“We are pleased to see this latest allowance that supports PRED’s novel approach to diagnosing spinal disorders and syndromes, “said Mike Schramm, PRED’s Director of Intellectual Property. “This allowed US patent application supports the commercial use of both our diagnostic and next-generation companion treatment products.”

The claims of the ‘671 application build on previously issued US patents 8,123,787, 8,641,738, and 9,370,431 to which ‘671 claims priority and further bolster Predictive Technology Group’s Intellectually Property position.

“We are gratified to see this latest application allowance, which covers the core technology underlying the Company’s molecular diagnostic test” said Bradley Robinson, President and Chief Executive Officer of Predictive Technology Group, Inc. “Furthermore, this fundamental patent covers not only spinal applications of our technology, but establishes a precedent for the other patent applications that have been submitted on the Company’s portfolio of next-generation diagnostic and companion treatment products.”

The allowance of this new application is a significant milestone for Predictive Technology Group. The patent establishes the foundation of key intellectual property (IP) covering ANY treatment options (drug, surgery, bracing, etc.) for patients having a specific spine deformity biomarker. This newly allowed application is additive to previously announced patents. Furthermore, the Company has additional US and International patent applications pending and will pursue such applications with the objective of receiving additional issued patents in additional disease states.

About Predictive Technology Group, Inc.

Predictive Technology Group, Inc. (PRED), through its wholly owned subsidiaries, revolutionizes the treatment of serious and debilitating diseases through the commercialization of novel therapeutics leveraged by proprietary gene-based companion diagnostics. The Company develops and/or acquires proprietary technologies that open windows into the origin of human disease and the role that genes and their related proteins play in diseases’ onsets and progressions. PRED’s subsidiaries use gene-based information as cornerstones in the development of new diagnostics that assess a person’s risk of disease and therapeutic products designed to effectively prevent and/or treat diseases, www.predictivetechnologygroup.com

For more information about PRED, contact Mr. Richard Kaiser, Investor Relations, YES INTERNATIONAL, 757-306-6090 and yes@yesinternational.com

Forward-Looking Statements

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new vaccines and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment and other risks the Company may identify from time to time in the future.

Image Available: http://www.marketwire.com/library/MwGo/2016/12/16/11G125445/Images/predlogo-872a3d3903e49728b49b4214eae8dea8.jpg

Vericel Corporation Prices $17 Million Public Offering of Common Stock

Posted On December 19, 2016 By OrthoSpineNews In Financial /

CAMBRIDGE, Mass., Dec. 16, 2016 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced the pricing of its previously announced underwritten public offering of 6,200,000 shares of its common stock, offered at a price to the public of $2.75 per share. The gross proceeds to Vericel from this offering are expected to be approximately $17 million, before deducting the underwriting discount and other estimated offering expenses payable by Vericel. Vericel has granted the underwriter a 30-day option to purchase at the public offering price up to an aggregate of 930,000 additional shares of its common stock to cover over-allotments, if any. The offering is expected to close on or about December 21, 2016, subject to customary closing conditions. Vericel anticipates using the proceeds from the offering to support the commercialization of MACI, expand promotional efforts for Epicel, expand and optimize manufacturing and for other general corporate purposes.

Piper Jaffray & Co. is acting as the sole manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities Exchange Commission (SEC) on June 29, 2015 and declared effective by the SEC on July 15, 2015. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement has been filed with the SEC and a final prospectus supplement for the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924 or by email: prospectus@pjc.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

About Vericel Corporation
Vericel develops, manufactures, and markets expanded autologous cell therapies for the treatment of patients with serious diseases and conditions. The company currently markets two cell therapy products in the United States. Carticel^® (autologous cultured chondrocytes) is an autologous chondrocyte implant for the treatment of cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Epicel^® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also plans to market MACI^® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults, which was recently approved by the FDA. Vericel is also developing ixmyelocel‑T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy.

Cautionary Statement on Forward-Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the proposed public offering of Vericel’s common stock. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ, including, the satisfaction of customary closing conditions related to the proposed public offering, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vericel’s Annual Report on Form 10-K for the year ended December 31, 2015 and Vericel’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Vericel’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Vericel’s results. There can be no assurance that the actual results or developments anticipated by Vericel will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on Vericel. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

CONTACT:
Chad Rubin
The Trout Group crubin@troutgroup.com 
(646) 378-2947
or
Lee Stern
The Trout Group lstern@troutgroup.com
(646) 378-2922

New Medical Device Registration Requirements Issued in South Africa

Posted On December 16, 2016 By OrthoSpineNews In Regulatory /

December 14, 2016 by Stewart Eisenhart

EMERGO SUMMARY OF KEY POINTS:

New South African registration requirements for medical devices and IVDs appear to have taken immediate effect from December 9, 2016.
Registration will initially be required only for devices participating in South Africa’s public tender system.
The Medicines Control Council (MCC) will continue requiring licensing of local manufacturers, distributors and importers in order to import devices into South Africa.

The South African Department of Health has issued new regulatory requirements covering both medical devices and in vitro diagnostic (IVD) devices, according to Emergo consultants in Cape Town.

The regulations are based heavily on guidance and principles of the International Medical Device Regulators Forum (IMDRF) and its predecessor organization, the Global Harmonization Task Force (GHTF); the new rules appear to take effect immediately, but Emergo offices in South Africa and the US are working to verify implementation and compliance details.

Based on an initial analysis of the new regulations, registration with the South African Medicines Control Council or MCC is for now required only for devices whose manufacturers and sponsors participate in the country’s public tender system. However, the MCC has the authority to impose registration requirements at its discretion for devices not participating in public tenders, as well.

READ THE REST HERE

Groundbreaking spinal surgery done at StoneCrest

Posted On December 16, 2016 By OrthoSpineNews In Spine /

Michelle Willard – mwillard@dnj.com – December 16, 2016

Back pain sufferers will try anything to relieve the constant pain from therapy to medications to injections before going under the knife.

That was no different for one patient at TriStar StoneCrest Medical Center in Smyrna.

Daniel Gamber had done everything short of surgery to relieve his nerve pain originating in the neck, said Dr. James Fish, an orthopedic spine surgeon affiliated with Hughston Clinic.

“Every patient that enters our doors is different, which is why TriStar StoneCrest Medical Center continues bringing alternative spine surgery options to our community,” Fish said. “We have to be able to provide the best treatment, surgical or non-surgical, for each patient based on their pathology.”

In the case of Gamber, the best option was a ground-breaking procedure, the first two level cervical disk replacement in Rutherford County.

Fish performed the disk replacement at StoneCrest. This procedure is less invasive that other surgical procedures and reduces the likelihood of additional surgical needs, especially in young patients.

“Continuing to bring alternative spinal surgery to our suburban-based hospital is exciting for TriStar StoneCrest Medical Center and Rutherford County,” Fish said about the surgery that aims to remove a damaged disc in the spine that is causing pain and replace it with an artificial disc.

READ THE REST HERE

Spinal Intervention: Markets for Surgical, Replacement & Neurostimulation Technologies – Research and Markets

Posted On December 16, 2016 By OrthoSpineNews In Financial, Neuro, Spine /

December 16, 2016

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Spinal Intervention: Markets for Surgical, Replacement and Neurostimulation Technologies” report to their offering.

The global market for spinal and neurostimulation intervention products is expected to reach $15.8 billion by 2021 from $12.6 billion in 2016, rising at a compound annual growth rate (CAGR) of 4.5% from 2016 through 2021.

The report provides an analysis of the markets for spinal and neurostimulation products, including trends and sales to 2021. It analyzes the market in terms of key product and technology areas, major manufacturers and factors influencing market growth.

Manufacturers of neurostimulation and spinal technologies are discussed and analyzed based on product types, market share and key corporate activities, including a mergers and acquisitions, strategic alliances, and research and development. In addition to neurostimulation products used for the treatment of spinal conditions, the report looks at the wider neurostimulation industry in order to provide a more comprehensive analysis of the overall market and growth opportunities for companies operating in this field.

The report also includes an in-depth analysis of new products and technologies in development, as well as the development of new products that can address a growing number of therapeutic indications.

Companies Mentioned:

Alphatec Holdings
B. Braun/Aesculap
Boston Scientific
CVRX
Depuy Synthes
Globus Medical
K2M
Livanova
Medtronic
Medtronic
Neuropace
NEVRO
Nuvasive
Orthofix International
St. Jude Medical
Stryker
Zimmer Biomet

Key Topics Covered:

1: Introduction

2: Summary – Complimentary

3: Market Overview

4: Current Market Environment

5: Spinal Implant Products And Technologies

6: Neurostimulation Products And Technologies

7: Product And Technology Pipeline

8: Industry Developments

9: Company Profiles

For more information about this report visit http://www.researchandmarkets.com/research/mwb9t2/spinal

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Orthopedic Devices, Neurology Devices

Health data breaches hit 2016 high in November

Posted On December 16, 2016 By OrthoSpineNews In Regulatory /

By NEIL VERSEL

Just when you think the cybersecurity problem couldn’t get any worse in healthcare, along comes a report saying that there were more health data breaches disclosed in November than in any other month in 2016.

In a report released Thursday, Protenus, a startup focused on tracking and preventing healthcare data breaches, said there were 57 such incidents last month. That is 60 percent higher than the 35 in October, based on statistics compiled by DataBreaches.net.

Surprisingly, 31 of the data breaches in October, or 54 percent, were inside jobs, according to the monthly Protenus Breach Barometer, while just nine were traced to hackers. The Ponemon Institute said in May 2015 that criminal activity had become the top source of health data breaches.

“While insiders are always a major source of health data breaches and HIPAA violations in any given month, this month was particularly striking,” Protenus Cofounder and CEO Robert Lord said via email. “In November, there were insider breaches at a few business associates that resulted in a wide array of their clients submitting breach reports.”

At least three of the hacks involved ransomware; a fourth “mentioned ransom/extortion but not ransomware,” the Breach Barometer said.

READ THE REST HERE

BONESUPPORT confirms election of Dr. Håkan Björklund as Chairman of the Board

Posted On December 16, 2016 By OrthoSpineNews In Biologics, Financial /

Lund, Sweden, 16 December 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces, that Dr. Håkan Björklund has been confirmed as Chairman and that Ms. Tone Kvåle has been elected as a new Board Member. The appointments were made at an EGM held on 15 December 2016.

Dr. Björklund is Partner of Tellacq AB, a private investment firm. He joined the BONESUPPORT Board in September 2016 in conjunction with the Company’s $37 million (SEK 315 million) financing, which was led by Tellacq. Dr. Björklund has a long and successful track record in the healthcare industry, including as the former CEO of Nycomed, which he grew from a small Scandinavian company into a global business before its acquisition by Takeda in 2011. He is currently chairman of the board of Swedish Orphan Biovitrum AB and an Industry Executive at Avista Capital Partners.

Tone Kvåle joins as a Board Member and Head of the Audit Committee. She is currently Chief Financial Officer of Nordic Nanovector, an Oslo-listed biopharmaceutical company, and has more than 20 years’ biotech industry experience. Prior to joining Nordic Nanovector, she was CFO of NorDiag, Kavli Holding and Dynal Biotech, and has held senior management positions at Invitrogen, Life Technologies and ThermoFisher (US). Ms. Kvåle has a diploma in Finance & Administration from Harstad University College.

Richard Davies, CEO of BONESUPPORT, said: “I am extremely happy that Håkan has been elected Chairman and that Tone will be joining the Board. This is an exciting period for BONESUPPORT following our recent $37 million (SEK 315 million) financing. We are now focused on building further additional shareholder value by growing sales of our current CERAMENT products, generating further data highlighting the clinical and health economic benefits these products deliver and progressing our pipeline. I am confident that Håkan’s and Tone’s experience will be valuable in helping us achieve our strategic goals.”

Dr. Björklund said: “I look forward to working with the management team and the Board to deliver BONESUPPORT’s potential to become a global leader in the management and treatment of bone disease based on the unique properties of its CERAMENT platform.”

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 twelve 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 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.

CERAMENT G and V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at high 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

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

SANUWAVE Announces Cooperation with Ortho-Medico in Europe on a New 100 Subject Trial Treating Patients with Diabetic Foot Ulcers In-Home Care Using Dermapace

Posted On December 16, 2016 By OrthoSpineNews In Extremities /

SUWANEE, GA / ACCESSWIRE / December 15, 2016 / SANUWAVE Health, Inc. (OTC QB: SNWV) is pleased to announce that the Company, in partnership with Ortho-Medico, a member of B&Co, Herzele, Belgium, is sponsoring continuing clinical investigation on diabetic foot ulcers (DFU). This trial is expected to begin in January 2017, and will be conducted by the VUB (Free University of Brussels) and UZ Brussel (University Hospital). Earlier work in 2015 at this hospital found that DFU patients, treated in-home with dermaPACE system, responded positively to the treatment. This trial will take the home-care procedures, used in a limited basis, and extend them to a randomized, controlled trial of 100 subjects. The intent of this trial is to compare the effectiveness of in-home treatment of diabetic foot ulcers (DFUs) using dermaPACE as compared to in-home treatment of DFUs using standard of care only. This trial will help to provide evidence that dermaPACE can be used outside the clinical setting and in essence increase the potential for expanded sales in Europe.

Ortho-Medico has long been SANUWAVE’s partner in the European Union. With their strength, experience, and knowledge of the orthopedics and 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 systems.

Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board, said, “We are very excited about this opportunity to investigate the use of dermaPACE in the home environment. We are equally excited that this opportunity is the first of many that SANUWAVE will partner with Ortho-Medico to help expand the clinical evidence associated with the use of dermaPACE system on diabetic foot ulcers.” Added Jo Schops, General Manager of Ortho-Medico, “Our company has long been a proponent of dermaPACE and orthoPACE and this clinical trial will help to show the strong efficacy exhibited by the use of dermaPACE on DFU’s. We are pleased to be partnering with SANUWAVE and the combined strength of our two companies will only help to expand market penetration in the European Union.”

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is 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 Premarket Approval (PMA) 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 Ortho-Medico

Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico’s final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico’s success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions.

Month: December 2016

Contacts

Contacts