joimax® shows major presence at NASS 2016 with a User Meeting and Workshop at Harvard Medical School, a NASS CME Lab and an Expert Panel Forum at the exhibition booth

Posted On October 24, 2016 By OrthoSpineNews In Spine /

Irvine, CA and Karlsruhe, Germany – October 25, 2016 – joimax^®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally-invasive spinal surgery, will again exhibit at the annual meeting of the North American Spine Society (NASS) 2016, taking place from October 26 – 29 in Boston, USA. Prior to the convention, on Monday, October 24, joimax^® will hold a User Meeting followed by a workshop at the Harvard Medical School Conference Center. On Tuesday, October 25, the NASS CME-Lab with a joimax^® station will take place. During the exhibition a group of internationally respected spine experts will also give presentations in a forum at the joimax^® booth.

Key topics of the joimax^® User Meeting will be centered around the endoscopic treatment of degenerative spinal diseases on the basis of the joimax^® portfolio products with TESSYS^®, CESSYS^®, iLESSYS^® Delta systems as well as EndoLIF^® and Percusys^®. A group of spine experts will share their expertise and extensive knowledge on the treatment of spinal diseases. The meeting will be completed with a cadaver lab with 3-4 stations at the Conference Center of the Harvard Medical School to train attendees on the whole range of endoscopic minimally-invasive spine surgery applications based on the joimax^® techniques.

Tuesday’s NASS CME-Lab will be chaired by Professor Michael Y. Wang, M.D. FACS, University of Miami Miller School of Medicine, Miami, Florida, another pioneering spine surgeon and joimax^® faculty member, who recently published a special edition in theJournal of Neurosurgery called Neurosurgical Focus, focused on Endoscopic Spine Surgery.

Additionally, joimax^® will host a “Meet the Expert Forum” with presentations at its booth given by Dr. Ralf Wagner and Dr. Erik Traupe, both from Germany, and also Dr. Menno Iprenburg from the Netherlands. Topics discussed will include the benefits of spinal endoscopic transforminal and interlaminar decompression methods over traditional ones. joimaxs’^® novel treatment options for advanced indications enjoy a fast growing adoption rate of its endoscopic technologies worldwide will also be discussed.

“In the context of the annual NASS meetings’ we aim to share the latest information, innovative techniques and best practices with renowned spine care professionals from around the world. These joimax^® activities will satisfy the requirements of spine specialists to take advantage of the latest innovations and technologies in endoscopic minimally-invasive spine surgery,” says Wolfgang Ries, CEO and founder of joimax^®.

“With our existing product range as well as with our newly launched products – the MultiZYTE^® SI endoscopic sacroiliac joint therapy set, MultiZYTE^® RT for endoscopic minimally-invasive treatment of the facet joint and the new Intracs^® Intraoperative Navigation Tracking & Control System, joimax^® uniquely enhances its endoscopic minimally-invasive product portfolio to fully meet users’ needs,” he continues.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS^® (transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, MultiZYTE^® RT (e.g. for rhizotomy) and with MultiZYTE^® SI for SI-Joint therapy or with EndoLIF^® and Percusys^® for endoscopic minimally-invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Press Contact Germany

joimax^® GmbH
Sabine Jarosch
sabine.jarosch@joimax.com
Phone +49 721 25514 0

Press Contact USA

joimax^® Inc.
Melissa Brumley
Melissa.brumley@joimaxusa.com
001 949 859 3472

DeGen Medical Launches Latitude-C™ Porous Ti Cervical Interbody Spacer

Posted On October 24, 2016 By OrthoSpineNews In Spine /

FLORENCE, SC–(Marketwired – October 24, 2016) – DeGen Medical introduces Latitude-C™ Porous Ti Cervical Interbody Spacer, an extension of our popular and effective Latitude-C™ product line, is designed to consider the uncinate process of the cervical vertebra. The lateral angled shape is a shift from traditional rectangular shape and mimics patient anatomy. The variety of profiles and angles provided allows a perfect fit at every fusion level and match individual patient anatomy. The Latitude-C™ Porous Ti Spacers with porous titanium coated surfaces are designed to provide an effective surface for bone implant contact.

The first anterior cervical fusion surgery using DeGen Medical’s Porous Ti technology was performed by Dr. Bauerle. “The right roughness developed by DeGen Medical allows better bone apposition increasing fusion rates,” exclaims Dr. Bauerle, “The remarkable increase in graft volume benefit early union and wide surface area support is very beneficial to decrease micro-motion between vertebral bodies and subsidence.”

The Latitude-C™ Porous Ti Cervical Interbody Spacer comes in a variety of shapes and sizes:

Five different footprints from 12x12mm to 20x15mm, with each footprint having 13 different heights ranging from 5mm to 14mm
Three different shape options to choose from — Anatomic, Lordotic and Parallel

The Latitude-C PEEK Interbody Spacer has been available since February 2016.

Come see us at NASS 2016, Booth #1159!

About DeGen Medical, Inc.

DeGen Medical, Inc. is a medical-device development company dedicated to providing surgeons with innovative products designed to improve quality of life for patients with complex spinal disorders. World-class implants, coupled with intuitively-designed instrumentation, provide a complete package to promote superior surgical outcomes. Our passion to advance spine-care solutions is driven by clinical insights, sound research, and science-based design. DeGen Medical maintains the highest quality standards to provide reliable products and safeguard patient health.

Image Available:http://www.marketwire.com/library/MwGo/2016/10/24/11G119230/Images/Coated_PEEK-8840b4993c1e9de2afbc9fe43e0d3b30.jpg

CONTACT INFORMATION

For more information, please contact:
Jessica Clark
DeGen Medical, Inc.
Phone: 877-240-7838
www.DeGenmedical.com

Spinal Elements® Announces Initial Procedures with Katana™ MIS Lateral System

Posted On October 24, 2016 By OrthoSpineNews In Spine /

October 24, 2016

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that the first procedures with its minimally invasive (MIS) Katana Lateral System were successfully completed.

The Katana Lateral System is a muscle-splitting system that is designed to overcome some of the inherent challenges in MIS lateral surgery. Traditionally, spine surgery has been performed from the back (posterior) or the front (anterior). Recent MIS advancements allow for accessing the spine from the side (lateral). Currently-marketed systems can intrap tissue as the access is created. Furthermore, the nature of how these systems create the surgical corridor can compress neural structures near the spine.

The Katana System was designed to address both of these challenges. Surgical access with Katana is gently created in the plane of the muscle, preventing the muscle intrapment that can plague earlier technology based system. The posterior-forward design philosophy of the Katana system further helps prevent the nerve compression problems that other systems can create. Both of these design enhancements are proprietary to Spinal Elements’ next generation system.

The implants used with the Katana Lateral System take advanatage of Spinal Elements’ Ti-Bond® titanium surface technology. The application of Ti-Bond allows the spinal implants to maintain their radioulucent properties that permit intraoperative montoring of implant position while allowing postoperative assessment of fusion progress. These implants also maintain their load-sharing strength profile that has been clinically proven important to the bone healing process. These properties are further enhanced by the additional stability of Ti-Bond’s roughened surface and longer-term benefits of its hydrophilic titanium structure.

Burak Ozgur, MD, a leading MIS spine surgeon based in Newport Beach, California, had this to say about his experience with the Katana System: “The system far exceeded my expectations. The Katana System’s design allows for efficient access to the spine without the drawbacks of the other systems available. The lack of muscle intrapment and encroachment into my surgical corridor allows for a more fluid procedure. I believe this could be a game changing technology that surgeons could easily adopt into their practice.”

Spinal Elements will be exhibiting (Exhibit 1341) October 26^th through the 28^th at the North American Spine Society meeting in Boston. The company has seen over 20% growth this year in its core technologies, fueled by demand for its advanced technologies including Ti-Bond coated implants.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

Contacts

For Spinal Elements
Laura Charlton (formerly Johnson)
760-450-7749
laurajohnsonpr@yahoo.com

Spine Wave Announces the Commercial Launch of the Velocity® P Expandable Interbody Device

Posted On October 24, 2016 By OrthoSpineNews In Spine /

October 24, 2016

SHELTON, CT–(Marketwired – October 24, 2016) – Spine Wave, Inc. is committed to the commercialization of high-quality, innovative medical devices for the treatment of spinal disorders. Spine Wave is pleased to announce that it will be fully launching the Velocity^® P Expandable Interbody Device system in mid-November with the arrival of commercial-scale inventory quantities. The company has been a pioneer in the field of expandable spacers since 2008, and surgeons have subsequently implanted over 50,000 Spine Wave expandable devices.

The Velocity^® P Expandable Interbody Device is the latest iteration in a long line of expandable devices from Spine Wave and will be prominently featured at NASS. The implant’s low profile allows for a less invasive surgical approach that may result in less nerve root retraction and bone resection. The load-bearing core is made from PEEK, a material well known for its favorable modulus. A unique titanium shell encompasses the implant and enhances its strength, while a plasma-sprayed titanium coating provides the surface texture and endplate interface many surgeons prefer. The controlled incremental expansion with an integrated trial feature is designed to allow surgeons to restore disc height and optimize the implant-to-patient fit. The device has a spacious graft chamber that can be easily filled post expansion utilizing the company’s proprietary guided funnel system. Post-expansion grafting allows for both maximum graft volume and graft-to-endplate contact within the device.

“The Velocity^® P Device is the most complex and challenging development project we have ever undertaken, and, based on surgeon feedback received during the limited market release, we could not be more pleased with the results. The Velocity^® P Device, when combined with the original StaXx^® platform and the more recently launched Leva^® Interbody Device, provides us with a market-leading portfolio of expandable implants in what we believe is one of the fastest growing and most strategically important segments of spine,” said Mark LoGuidice, Spine Wave’s Chief Executive Officer.

“I have been a vocal proponent of expandable implants since 2008 and have had an opportunity to use many of the more popular devices available,” said Domagoj Coric, M.D., Chief of Neurosurgery at Carolinas Medical Center. “The Velocity^® P device encompasses all the key features surgeons are looking for in an expandable implant. This powerful device has ideal material properties, and it is easy and intuitive to use. When using an expandable device, surgeons understand the importance of being able to pack additional graft material post expansion, and the guided grafting system on the Velocity^® is easily the best I have seen.”

About Spine Wave

In addition to the products mentioned above, Spine Wave’s product portfolio features many highly differentiated technologies including the StaXx^® family of products, which has a seven year proven track record in posterior surgery. The Leva^® Interbody Device is an expandable titanium implant that is optimized for ease of insertion and for maximum post expansion bone graft capability. The True Position^® Pivoting Spacer System is a pivoting “crescent-style” interbody fusion device that is implanted with the widely used TLIF technique and features Center Pivot Point Technology. The Velocity^® L Expandable Interbody Device, which is the Velocity^® Expandable Interbody Device designed for lateral interbody fusion procedures, was launched earlier this year alongside Spine Wave’s enhanced lateral system. The Sniper^® Spine System has developed a reputation as a leading MIS screw system and is now complemented with its Sniper^® Spine System XT extended tab screws and the the Annex^® Adjacent Level System. Spine Wave provides the simple yet versatile CapSure^® PS3 Spine System, which is proving to be a high quality, user friendly, traditional screw system. Spine Wave is dedicated to continuously delivering a robust and highly differentiated product pipeline, with a strong emphasis on minimally invasive solutions that will meet and exceed the expectations of our spine surgeon customers.

The Company is growing rapidly and continues to recruit new sales managers and independent distributors to fuel the growth. For further information on all of the Spine Wave products please visit the Company’s website at www.SpineWave.com.

CONTACT INFORMATION

Contact:
Terry Brennan
Chief Financial Officer
Email contact

203-712-1810

SIGNUS Medizintechnik receives 510(k) clearance for posterior pedicle screw system DIPLOMAT®

Posted On October 24, 2016 By OrthoSpineNews In Spine /

Alzenau, October 24, 2016.

In august SIGNUS announced the 510(k) clearance from the United States Food and Drug Administration (FDA) for their new DIPLOMAT pedicle screw system.

The DIPLOMAT has been developed in cooperation with international spine experts. As a posterior fixation system it provides user-friendly and reliable instrumentation for all spine treatments.

“The main focus of DIPLOMAT is the optimized balance between clinical perfor- mance and user-friendliness,” says SIGNUS Managing Director, Uwe Siedler. The system combines maximal clinical efficiency with all the important properties required for optimal patient treatment.

The pedicle screws are a modular two-piece implant: depending on the indication and surgical application, the pedicle screws can be assembled as required with the appropriate tulips. If necessary, the tulips can be removed and replaced in situ during surgery. A very low tulip profile of only 14.9 millimeters guarantees optimal anatomical alignment and prevents any protrusion of the tulip even in slim or young patients. The patented ELASTOLOK^® locking mechanism ensures the highest strength for the screw/tulip connection. The DIPLOMAT system provides optimal flexibility and efficiency thanks to these features.

DIPLOMAT impresses users not only with its high level of safety but also with its ease of handling during surgery. All the pedicle screws are cannulated, as well as being fenestrated from a diameter of 5.5 millimeters. The comfortable screw-cannula diameter of 1.9 millimeters also allows the use of stronger guide wires, which noticeably stabilizes the insertion of the pedicle screw during MIS procedures. The DIPLOMAT pedicle screws have a self-tapping double thread that provides the best possible fixation and perfect anchoring in the bone. The high thread pitch enables faster insertion which considerably shortens surgery time.

More information about DIPLOMAT

Download press release as PDF

Vertera Spine Reports Successful Early Outcomes with the Porous PEEK COHERE Fusion Device

Posted On October 24, 2016 By OrthoSpineNews In Spine /

SOURCE Vertera Spine

ATLANTA, Oct. 24, 2016 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the first early successful outcomes using the COHERE® Cervical Interbody Fusion Device. COHERE is Vertera Spine’s first device featuring the company’s patented porous PEEK (polyetherether ketone) Scoria® biomaterial technology. Scoria’s porous architecture seamlessly integrates with the bulk PEEK implant providing an environment for bony tissue ingrowth while retaining the mechanical and imaging properties of traditional PEEK implants. Vertera Spine will be showcasing COHERE and its Scoria technology at the upcoming NASS meeting October 26-28^th in Boston, MA.

Since its initial soft launch in May 2016, over 400 COHERE devices have been implanted in anterior cervical fusion surgeries by a select number of surgeons across the United States. Dr. Robert McGuire, Past Chairman of AO Spine North America and from the University of Mississippi Medical Center in Jackson, Miss., was one of the first surgeons to use the COHERE implant.

“I have been very pleased with the early outcomes I am seeing with the COHERE device,” said Dr. McGuire. “There has been a clinical need for a porous PEEK fusion device that addresses the limited integration capabilities of traditional PEEK devices. I am excited to adopt COHERE into my practice.”

Studies have demonstrated that porous implants are able to generate a stronger osteogenic cellular response and better osseointegrate over implants with micro- and nano-roughness.^1,2While porous metal or porous metal-coated PEEK implants have found their way into spinal fusion applications, COHERE is the first device in clinical use to be manufactured entirely out of PEEK and contain porosity. Because there is no metal, COHERE also provides the additional advantage of not producing any medical imaging artifacts, allowing accurate visualization of the fusion site.

Dr. Clint Hill (The Orthopaedic Institute in Paducah, Kentucky), another soft launch COHERE user, has several several patients at 5 months post-surgery.

“COHERE with its porous PEEK architecture is the first of its kind to offer an osteoconductive environment without the use of metal. With all my patients who have received a COHERE device, I am observing early signs of fusion with significant bony bridging,” said Dr. Hill.

Likewise, Dr. Brandon Strenge, also from the Orthopaedic Institute in Kentucky, has implanted several COHERE devices and is observing similar outcomes at almost 5-months post-surgery.

“The hydrophilic nature and ingrowth capability of COHERE’s porous architecture gives me the confidence that fusion can be achieved even in more challenging multi-level cases,” said Dr. Strenge. “Porous PEEK Scoria is a game-changing technology that will make all other PEEK devices obsolete and could lend itself to many future applications.”

Vertera Spine’s porous PEEK Scoria technology is backed by extensive academic research at Duke University and the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology. Professor Ken Gall, Chair of the Department of Mechanical Engineering and Materials Science at Duke, will be sharing some of the latest research in a presentation entitled, “Biomechanical Performance of a Novel Porous PEEK for Interbody Fusion Devices” at the NASS meeting on Wednesday October 26^th.

About Vertera Spine:

Vertera Spine is a privately-held medical device company that develops and commercializes multifunctional implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance, and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.com or call 678.705.9039.

COHERE and Scoria are registered trademarks of Vertera Spine. All other trademarks and trade names are the property of their respective holders.

¹Svehla M, Walsh MR et al. Morphometric and mechanical evaluation of titanium implant integration: Comparison of five surface structures. Journal of Biomedical Materials Research, 2000.

²Cheng A, Boyan BD, et al. Enhanced Osteoblast Response to Porosity and Resolution of Additively Manufactured Ti-6Al-4V Constructs with Trabeculae-Inspired Porosity. 3D Printing and Additive Manufacturing, 2016.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vertera-spine-reports-successful-early-outcomes-with-the-porous-peek-cohere-fusion-device-300349600.html

Orthofix Announces NASS Coverage Policy Recommendations for Electrical Bone Growth Stimulators

Posted On October 24, 2016 By OrthoSpineNews In Spine /

October 24, 2016

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, is pleased to announce the North American Spine Society (NASS) has issued first-of-its-kind coverage recommendations for electrical bone growth stimulators. These evidence-based coverage policy recommendations support the use of pulsed electromagnetic field (PEMF) stimulation devices as an adjunct to spinal fusion surgery.

Dr. Richard Guyer, orthopedic spine surgeon, co-founder and director at the Texas Back Institute in Dallas said, “Bone growth stimulation devices are an important option for patients with risk factors that might inhibit the success of their spinal fusion procedures. By stimulating bone growth, we can often avoid the need for revision surgery.”

The just-issued NASS coverage policy recommends the use of electrical stimulation for spinal fusion healing in all regions of the spine including cervical and lumbar regions. Orthofix is the only company with a bone growth (osteogenesis) stimulator approved by the U.S. Food and Drug Administration (FDA) as a noninvasive, adjunctive treatment option for cervical fusion.

“We are pleased that NASS has chosen to proactively examine the medical evidence and recommend electrical bone growth stimulation devices in order to assist payors, surgeons and patients by defining appropriate use and coverage positions,” said Brad Niemann, President of the Orthofix BioStim strategic business unit. “This policy is important as it further validates the use of bone growth stimulators like the Orthofix CervicalStim and SpinalStim systems, for improving spinal fusion outcomes in patients at risk of a failed fusion.”

The Orthofix CervicalStim^™ and SpinalStim^™ devices use a low-level pulsed electromagnetic field that helps activate and augment the body’s natural healing process. These devices provide patients with a safe, noninvasive treatment option for promoting spinal fusion.

Orthofix invites those attending NASS 2016 to visit Booth #615 to learn more about the Company’s BioStim devices and the coverage recommendations.

About NASS

The North American Spine Society (NASS) is comprised of more than 8,000 members from several disciplines, including orthopedic surgery, neurosurgery, physiatry, neurology, radiology, anesthesiology, research and physical therapy. As part of its mission to foster the highest quality, evidence-based and ethical spine care, NASS develops credible and reasonable coverage recommendations to assist payors, providers, and patients in defining appropriate and fair coverage decisions. NASS evidence-based coverage recommendations are developed to advocate for NASS’ positions on various clinical and practice issues to ensure continued provision of quality spine care.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, TX, the company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the company’s sales representatives, distributors and subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to: practices of health insurance companies and other third-party payors with respect to reimbursement for our PEMF devices; any future changes to the coverage determinations of NASS for electrical bone growth stimulators; and other risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix International N.V.
Investor Relations
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations
Denise Landry, 214-937-2529
deniselandry@orthofix.com

Exactech Schedules Third Quarter 2016 Earnings Release and Conference Call

Posted On October 24, 2016 By OrthoSpineNews In Financial /

October 24, 2016

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for extremities, hip, knee, and spine, will release its third quarter financial results after the market closes on Monday, October 31, 2016. A copy of the earnings release will be available at http://www.hawkassociates.com.

The company will hold a conference call with CEO David Petty and key members of the management team on Tuesday, November 1 at 9:00 a.m. Eastern Time. The call will cover Exactech’s third quarter results. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 1-877-440-5803 any time after 8:50 a.m. Eastern on November 1. International and local callers should dial 1-719-325-4765. A live and archived webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm orhttp://public.viavid.com/index.php?id=121574. This call will be archived for approximately 90 days.

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.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Exactech Inc.
Media contact
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

aap: LOQTEQ® VA Distal Radius System has clinically proven and receives high level of market acceptance

Posted On October 21, 2016 By OrthoSpineNews In Extremities /

Press Release dated October 18, 2016

The evaluation following the market launch one year ago shows that the LOQTEQ® VA Distal Radius System 2.5 from aap Implantate AG (“aap”) has clinically proven and enjoys a high level of market acceptance. Both the implant and the related instruments meet with a positive response by users and customers. The LOQTEQ® VA Distal Radius System 2.5 is the first product in the LOQTEQ® VA (VA = Variable Angle) product family, which are polyaxial implants that facilitate inserting angle-stable screws at different angles. Polyaxial implants are required for treating areas such as the hand that in surgery require both angle stability and flexibility in the insertion of screws.

The LOQTEQ® VA Distal Radius System 2.5 was developed for the treatment of fractures of the distal radius (radius close to the wrist) and the distal ulna (ulna close to the wrist). Radius fractures account for about a quarter of all fractures. To meet patients’ growing demands, a fast, mobilization-stable treatment with a permanent retention of the repositioning result is required. The special combination of anatomically preformed and small, angle-stable plates in conjunction with freely selectable screw angles and user-friendly instruments fulfils all the requirements of modern fracture management.

After already granted FDA approval the polyaxial radius system has been in use in the USA since this year as well and receives an especially high acceptance there. A sterilizing and a sieve system were developed specially for the U.S. market. Overall the wide range of plates in a compact set and specially developed instruments such as the screwdriver, co-designed by users, meet with a positive response. As radius fractures belong to the most frequent fractures the system is a sales driver. aap will shortly be launching further polyaxial variants of different LOQTEQ® products for various anatomical areas in the market.

This release contains forward-looking statements based on current experience, estimates and projections of the management board and currently available information. They are not guarantees of future performance. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Many factors could cause the actual results, performance or achievements of aap to be materially different from those that may be expressed or implied by such statements. These factors include those discussed in aap‘s public reports. Forward-looking statements therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking statements contained in this release or to conform them to future events or developments

For further information, please contact:

aap Implantate AG
Lorenzweg 5
12099 Berlin

Fabian Franke
Manager Investor Relations
Tel.: +49 (0)30 / 750 19 134
Fax: +49 (0)30 / 750 19 290
Contact

SANUWAVE Announces Exhibition at MEDICA in Cooperation with Ortho-Medico in Europe

Posted On October 21, 2016 By OrthoSpineNews In Biologics /

SUWANEE, GA / ACCESSWIRE / October 21, 2016 / SANUWAVE Health, Inc. (SNWV) (www.sanuwave.com) SANUWAVE is pleased to announce that the company will exhibit, in conjunction with Ortho-Medico, a member of B&Co, at MEDICA in Dusseldorf, Germany on 14 -17 November, 2016. SANUWAVE and Ortho-Medico cordially invites you to our booth 17D61 in Hall 17. MEDICA is the world’s leading trade fair for the medical industry. SANUWAVE is using this occasion to announce SANUWAVE’s expanded cooperation with Ortho-Medico to strengthen and expand our business in Europe. In this partnership, Ortho-Medico will be the Company’s future contact for all EU distributors concerning sales and service. SANUWAVE sees this as a key initiative to improve our communication with, and responsiveness to all of our partners and customers in the European Community.

Ortho-Medico, with headquarters in Herzele, Belgium, has long been SANUWAVE’s partner in the Benelux region. 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. Mr. Kevin Richardson from SANUWAVE, and Mr. Jo Schops from Ortho-Medico will look forward to explaining new opportunities.

“We are very excited with our expanded partnership with Ortho-Medico. This arrangement will help us to coordinate and consolidate our activities in Europe,” stated Mr. Richardson, Chief Executive Officer of SANUWAVE. “Our exhibition, alongside Ortho-Medico at MEDICA will be the springboard to re-establish our market presence in the European Community.”

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (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 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.

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.

Month: October 2016

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