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Medovex Corporation Presents Initial Data on the DenerveX® System During NSpine 2nd Platinum Course in Arosa, Switzerland

Posted On February 14, 2018 By OrthoSpineNews In Spine /  

ATLANTA, Feb. 13, 2018 (GLOBE NEWSWIRE) — Medovex Corp. (OTCQB:MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced that the Company participated at the NSpine Platinum Small Group Educational Event in Arosa, Switzerland, held January 29th through February 3rd, 2018.

Medovex medical advisory board member Vik Kapoor MD, from Manchester, U.K. presented on two separate days at the N-Spine Platinum Small Group Educational Event. Dr. Kapoor presented initial data on his first 20 cases using the DenerveX System, which he considers very positive. The presentation was well received by approximately 50 European neuro, spinal, and orthopedic surgeons. Attending surgeons were granted 30 European CME credits (6 ECMEC® per day) by the European Accreditation Council for Continuing Medical Education (EACCME).

A third day marketing presentation focused on the DenerveX System including discussion related to reimbursement opportunities specific to individual countries, leading to expressed interest from many attendees to start performing DenerveX cases in their respective countries.

In an effort to enhance the value of the meeting, the third day of the event consisted of novel technologies identified by NSpine as improving the field of spine care. The Medovex team was pleased to have been selected.

The value of the Arosa meeting lies in its educational content – to gain a greater understanding of current trends and decision making in spinal surgery – and in the networking with senior decision makers in the world of spinal surgery.

Manfred Sablowski, Medovex Senior Vice President of Global Sales & Marketing stated, “We are pleased to have been selected for participation at The NSpine Platinum Small Group Educational Event. The professional networks built through these events are as valuable as the educational content itself. During this master’s course, Medovex had the privilege of meeting many of the world’s preeminent surgeons who we continue to draw on for advice in managing unusually complex cases.”

Sablowski continued, “Events like these are important milestones for Medovex, as well as a key inflection point gaining us leverage for our Company’s growth strategy focused in Europe, South America, and Australia. Importantly, it provides potential future customers the opportunity to experience firsthand the intuitive DenerveX System.”

Please also follow us on Facebook at https://www.facebook.com/medovex/.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement                                                     

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact Information

 

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Centric Medical™ Announces New Release of Sterile-Packed Rogue+™ Hammertoe Correction System Implants

Posted On February 13, 2018 By OrthoSpineNews In Extremities /  

February 13, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the release of the ROGUE+ Hammertoe Correction System. This sterile-packed innovative system adds to the original implant design also available, while providing internal fixation via a dual threaded construct which is inserted between the proximal and middle phalanges so that the opposing threads fixate within the phalangeal canals of the toe to compress the proximal interphalangeal (PIP) joint.

“Centric Medical’s Rogue+ Hammertoe Correction System implant is a well-designed, patient focused, surgeon friendly device that allows for safe and predictable treatment of patients’ forefoot problems,” said Gregory G. Caronis, M.D. of Advocate Condell Medical Center in Libertyville, Illinois.

The sterile-packed ROGUE+ Hammertoe Correction implant is designed to have less implant extruding into the PIP Joint when reducing the joint, which allows for easier reduction of the joint and less bone removal, maintaining more of the original toe length. It offers benefits of strength, compression, internal bone fixation and simplicity. With streamlined instrumentation to reduce OR time, along with an improved technique, the implant can be consistently placed across the PIP Joint to optimize bone purchase in the proximal and middle phalanx.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

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

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Exactech Shareholders Approve Merger Agreement with TPG Capital

Posted On February 13, 2018 By OrthoSpineNews In Financial /  

February 13, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech (Nasdaq: EXAC), a leading developer and producer of orthopaedic implant devices and surgical instrumentation for extremities and large joints, today announced that at a Special Meeting of Shareholders held earlier today, Exactech’s shareholders approved the previously announced merger agreement with TPG Capital and certain of its affiliates, and approved the other two proposals described in Exactech’s proxy statement relating to today’s meeting.

Approximately 94.5% of voting Exactech shareholders cast their votes in favor of the merger, representing approximately 73.7% of Exactech’s outstanding common stock as of the record date for the special shareholder meeting. The final results will be available on a Current Report on Form 8-K, to be filed later this week by the company.

Upon completion of the transaction, Exactech shareholders will receive an amount in cash equal to $49.25 per share of Exactech common stock. The transaction remains subject to customary closing conditions and is expected to close on or around February 14, 2018, at which time Exactech will become a private company and its common stock will no longer trade on the NASDAQ. In addition, the company’s common stock will cease to be registered under Section 12 of the Securities Exchange Act of 1934, as amended.

Advisors

Greenberg Traurig, P.A. (Miami) and Greenberg Traurig, LLP (NYC) are acting as Exactech’s legal advisor. J.P. Morgan Securities LLC is acting as financial advisor to Exactech. Ropes & Gray LLP is acting as legal advisor to TPG Capital.

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.

About TPG

TPG is a leading global alternative asset firm founded in 1992 with more than $73 billion of assets under management and offices in Austin, Beijing, Boston, Dallas, Fort Worth, Hong Kong, Houston, London, Luxembourg, Melbourne, Moscow, Mumbai, New York, San Francisco, Seoul, and Singapore. TPG’s investment platforms are across a wide range of asset classes, including private equity, growth venture, real estate, credit, and public equity. TPG aims to build dynamic products and options for its investors while also instituting discipline and operational excellence across the investment strategy and performance of its portfolio. For more information, visit www.tpg.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements regarding Exactech’s proposed business combination transaction with TPG Capital, all statements regarding Exactech’s expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budgets, capital expenditures, competitive positions, growth opportunities, plans and objectives of management, and statements containing the words such as “anticipate,” “approximate,” “believe,” “plan,” “estimate,” “expect,” “project,” “could,” “would,” “should,” “will,” “intend,” “may,” “potential,” “upside,” and other similar expressions. All Statements in this press release that are not historical facts, are forward-looking statements that reflect the best judgment of Exactech based upon currently available information.

Such forward-looking statements are inherently uncertain, and shareholders and other potential investors must recognize that actual results may differ materially from Exactech’s expectations as a result of a variety of factors, including, without limitation, those discussed below. Such forward-looking statements are based upon management’s current expectations and include known and unknown risks, uncertainties and other factors, many of which Exactech is unable to predict or control, that may cause its actual results, performance or plans to differ materially from any future results, performance or plans expressed or implied by such forward-looking statements. These statements involve risks, uncertainties and other factors discussed below and detailed from time to time in Exactech’s filings with the Securities and Exchange Commission (the “SEC”).

Risks and uncertainties related to the proposed merger include, but are not limited to, the potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger, uncertainties as to the timing of the merger, adverse effects on Exactech’s stock price resulting from the announcement of the merger or the failure of the merger to be completed, competitive responses to the announcement of the merger, the risk that regulatory, licensure or other approvals required for the consummation of the merger are not obtained or are obtained subject to terms and conditions that are not anticipated, litigation relating to the merger, the inability to retain key personnel, and any changes in general economic and/or industry-specific conditions.

In addition to the factors set forth above, other factors that may affect Exactech’s plans, results or stock price are set forth in its most recent Annual Report on Form 10-K and in its subsequently filed reports on Forms 10-Q and 8-K.

Many of these factors are beyond Exactech’s control. Exactech cautions investors that any forward-looking statements made by it are not guarantees of future performance. Exactech disclaims any obligation to update any such factors or to announce publicly the results of any revisions to any of the forward-looking statements to reflect future events or developments.

Contacts

TPG
Luke Barrett, 415-743-1550
media@tpg.com
or
Priscilla Bennett, 352-377-1140
media@exac.com

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Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2018

Posted On February 13, 2018 By OrthoSpineNews In Financial /  

DUBLIN – February 13, 2018 – Medtronic plc (NYSE: MDT) announced today that it will report financial results for the third quarter of fiscal year 2018 on Tuesday, February 20, 2018. A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at http://newsroom.medtronic.com. The news release will include summary financial information for the company’s third quarter of fiscal year 2018, which ended on Friday, January 26, 2018.

Medtronic will host a webcast at 7:00 a.m. CST to discuss financial results for its third quarter of fiscal year 2018. The webcast can be accessed at http://investorrelations.medtronic.com on February 20, 2018.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at http://investorrelations.medtronic.com.

Looking ahead, Medtronic plans to report its fiscal 2018 fourth quarter financial results on Thursday, May 24, 2018, and for fiscal year 2019, the company plans to report its fiscal first and second quarter financial results on Tuesday, August 21, 2018, and Tuesday, November 20, 2018, respectively. Medtronic also plans on hosting its biennial Institutional Investor & Analyst Day on June 5, 2018. Confirmation and additional details will be provided closer to the specific event.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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Orthofix Announces Initiation of Enrollment in Rotator Cuff Repair Study

Posted On February 13, 2018 By OrthoSpineNews In Extremities /  

February 13, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced that enrollment has begun in a study that will evaluate the use of pulsed electromagnetic field (PEMF) technology for rotator cuff repair. This study will assess the efficacy and safety of the Company’s RCStim™ device as an adjunctive treatment to surgical repair of full thickness rotator cuff tears.

The study will evaluate if PEMF technology that is currently used to promote bone growth can reduce the rate of repaired tendons being subsequently torn again and improve overall patient outcomes. The study will also gather data to see if there is a correlation between patients treated with PEMF and improvements in muscle strength and range of motion and a decrease in pain scores.

“Arthroscopic repair of rotator cuff tears can improve pain and functional use of the shoulder but a continuing challenge is the high retear rates after repair,” said Dr. Andrew Kuntz, an orthopedic shoulder surgeon at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia and an investigator in the clinical study. “If PEMF therapy can prove effective in improving the patient’s ability to heal after repair surgery, this could provide us with a way to lower the number of revision surgeries and improve overall outcomes.”

The PEMF study for rotator cuff repair is a prospective, randomized, double-blind, placebo-controlled trial that will enroll approximately 538 patients who are between 21 and 80 years of age at up to 30 sites in the U.S. Study participants will be randomized in a two-to-one ratio to either an active or placebo control (inactive) device and followed for 24 months after initiation of treatment.

“PEMF technology has been used for many years to promote bone growth and the healing of nonunion fractures,” said James Ryaby, Ph.D., Chief Scientific Officer for Orthofix. “The rotator cuff clinical trial is based on our compelling pre-clinical research and it is our second ongoing study evaluating PEMF therapy for a soft tissue application. As we previously announced, we also have a study for Osteoarthritis of the Knee for providing symptomatic relief of OA pain, reducing cartilage breakdown and stimulating new cartilage formation. Ultimately, if results of these studies are positive, it could open the door to important new applications of this technology.”

The Orthofix RCStim device is an investigational device and use in the study is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). More information about the study is available at ClinicalTrials.gov.

Orthofix PEMF technology devices are currently approved by the FDA for the treatment of nonunion fractures that have not healed or have difficulty healing and as an adjunct to cervical and lumbar spinal fusions. To learn more please visit bonegrowththerapy.com.

About Rotator Cuff Tears

According to the American Academy of Orthopaedic Surgeons, rotator cuff tears send as many as two million Americans to their physicians’ offices every year, many with a full-thickness or complete tear. A full-thickness tear means the tendon has separated from the bone. This common musculoskeletal injury often requires surgical intervention. An estimated 250,000 patients get rotator cuff surgery in the U.S. annually.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. 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 described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, 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

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SANUWAVE Signs $1 Million Equipment Financing Line With NFS Leasing

Posted On February 13, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, Feb. 12, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the Company has signed a one million dollar equipment financing lease agreement with NFS Leasing, Inc.  This agreement will enable SANUWAVE to begin placing the dermaPACE® System in the hands of clinicians and wound care centers in the United States to utilize in the treatment of diabetic foot ulcers, a billion dollar market.

NFS Leasing, Inc. has an extensive background in medical equipment financing and will be a valuable partner to SANUWAVE in our initial commercialization of dermaPACE in the United States after receiving FDA clearance in December 2017.  The line will be called as we order equipment, which will allow us to distribute the dermaPACE System domestically without dilution to the current shareholders.

“The agreement with NFS is a crucial announcement for the Company as we execute our plan for a successful rollout in the massive US diabetic foot ulcer (DFU) market.  This allows us to access capital to place devices which in turn will drive procedures and ultimately revenue,” stated Kevin A. Richardson II, Chief Executive Officer of SANUWAVE.  “We have a well developed plan in place to roll out dermaPACE methodically throughout 2018.  We are very excited to have this line in place which allows us to launch our rapid revenue growth,” concluded Mr. Richardson.

The Company has had overwhelming inbound information calls and support from the wound care community since the announcement of our FDA clearance.  We anticipate the first draw on this line later in February with our initial delivery shortly thereafter.

“We have been following SANUWAVE’s progress for a while and began discussions about doing business together prior to their good news from the FDA.  We are glad to be providing capital for a business model that will help heal a massive medical problem involving diabetic foot ulcers.  The Company has developed a great go to market strategy and we are looking forward to a successful strategic relationship,” stated David DePamphilis, Chief Operating Officer of NFS Leasing, Inc.

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 US FDA cleared for the treatment of Diabetic Foot Ulcers.  The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. 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 NFS Leasing, Inc.

NFS Leasing Inc. (www.nfsleasing.com) is an independent equipment leasing company, serving growth-oriented companies in a variety of fields.  NFS specializes in leasing technology equipment, scientific and medical equipment, as well as robotic, manufacturing and construction equipment.  Having helped a wide array of businesses grow for more than a decade, NFS is approaching a billion dollars in lease originations.  NFS’ management team averages over 25 years of technology and finance experience.  NFS has developed a broad base of extensive affiliations throughout the IT, medical, scientific, construction and manufacturing marketplace that can be leveraged to bring their customers unique incremental value.

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:

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

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
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EIT Emerging Implant Technologies Announces CE Mark and First Cases for the World’s First Fully 3D Printed Adjustable Cage.

Posted On February 13, 2018 By OrthoSpineNews In Spine /  

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received CE mark and performed the first surgeries in Germany with the first fully 3D printed adjustable interbody fusion cage worldwide.

The adjustable EIT PLIF cage is printed as one piece with no assembly needed in the production process. This reduces cost significantly compared to regular expandable cages that are manufactured with traditional machining processes.

The adjustable PLIF allows for restoration of lordosis angles up to 18° and supports minimally invasive insertion techniques. The goal is to reduce intraoperative trauma, optimize size adaptation and improve restoration of sagittal balance to improve fusion rates, reduce subsidence and adjacent segment disease (ASD) related to insufficient sagittal balance restoration. The bone contact areas consist of EIT Cellular Titanium® porous structure to enhance primary stability and bony integration.

“Adjustable cage technology has the potential to change the interbody fusion cage market as it can be offered at reasonable pricing that copes with existing pressures and reimbursement systems all over the globe. Additive manufacturing allows us to bring down cost tremendously. We are thrilled to be the first that have accomplished this platform technology and can now offer this technology to the European spine community” says Guntmar Eisen, founder and CEO of EIT.

Nancy Lamerigts, MD, PhD and VP of Marketing and Research says “with the new devices we now start the launch of our 2nd generation product line combining EIT Cellular Titanium® technology with functionality. So now we can really combine faster fusion and better alignment, respecting the economic environment that has prevented the breakthrough of expandable cage technology for years.”

Dr. Marcus Eif, head of neurosurgery at the Klinikum Görlitz in Germany, who has performed the first case with the new system, experienced that the EIT adjustable PLIF implant allowed for a minimal invasive approach while still being able to restore the required lordosis. “The intuitive instrumentation and the functionality of the implant enabled a straightforward procedure and an excellent postoperative result”.

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of EIT Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT received various FDA approvals and began introducing products in the US in Q4 of 2017.

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K2M Group Holdings, Inc. to Participate in the 2018 RBC Capital Markets Global Healthcare Conference

Posted On February 12, 2018 By OrthoSpineNews In Spine /  

LEESBURG, Va., Feb. 12, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced its participation in the 2018 RBC Capital Markets Global Healthcare Conference at the Lotte New York Palace Hotel in New York, New York. Management will participate in a fireside chat on Thursday, February 22 at 2:05 p.m. Eastern Time.

A live audio webcast of the presentation will be provided under the ‘Events & Presentations’ section of the Company’s investor relations website at http://Investors.K2M.com/. It is recommended that listeners log on 15 minutes early in order to register and download any necessary software. An archive of the webcast will be available for replay following the conference.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS®, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on November 1, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.




	

		

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Bioventus to Continue Distributing SUPARTZ FX™ Through 2028

			


	Posted On February 12, 2018

	By OrthoSpineNews

	In Biologics

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February 12, 2018




DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into an extension of its agreement with Seikagaku Corporation to continue distributing SUPARTZ FX™, a five-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). Under terms of this new agreement, Bioventus will be the exclusive distributor of SUPARTZ FX in the US through May 2028.


“We are pleased SUPARTZ FX will remain in the Bioventus portfolio, along with three-injection HA GELSYN-3™ and DUROLANE®, our single-injection HA, for many years to come,” said Tony Bihl, CEO of Bioventus. “Joint fluid treatments safely manage knee osteoarthritis pain allowing people to resume active lives and we believe our complement of HA offerings is unmatched in meeting the varied needs of patients, physicians and payers in the US. This is consistent with our strategy to be a market leading biologics company in treatments for OA.”


About Bioventus


Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.


Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.


Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3 is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku.


SUPARTZ FX – Summary of Indications for Use:


SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.


You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.






Contacts


Bioventus

Thomas Hill, 919-474-6715

thomas.hill@bioventusglobal.com




	

		

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Camber Spine Technologies Announces First Implantations Of SPIRA™-C Open Matrix Cervical Interbody

			


	Posted On February 12, 2018

	By OrthoSpineNews

	In Spine, Top Stories

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WAYNE, Pa., Feb. 12, 2018 /PRNewswire/ — Camber Spine, a leading innovator in spine and medical technologies, today announced the first surgeries using the company’s proprietary SPIRA™-C Open Matrix Cervical Interbody device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology. The first cases were performed successfully this past week with several surgeons across the country performing multilevel ACDF procedures.


Dr. Michael Dorsi, M.D. of Ventura Neurosurgery was one of the first surgeon design team members to perform a multilevel procedure using SPIRA™-C this past week. According to Dr. Dorsi: “I really appreciate the design of this implant. Upon insertion, I feel as though the cage has immediate stability because of the roughened surface which provides significant friction. The arched design has large openings which allows for significant graft packing and creates a snowshoe-like effect of distributed load sharing which should decrease the risk of subsidence. The open matrix architecture eliminates the need for the central lumen in traditional cervical cages, potentially speeding up the mechanical fusion process, optimizing clinical and fusion outcomes.”


Dr. Michael Dorsi, M.D., is a board-certified, fellowship trained neurosurgeon who has been providing state-of-the-art care to the greater Ventura County area since 2012. Dr. Dorsi attended The Johns Hopkins University, graduated Phi Beta Kappa with Highest Honors and a degree in Neuroscience and subsequently completed his residency training in neurosurgery. He was awarded the Cloward Award from the American Association of Neurological Surgeons for Fellowship Training in Minimally and Invasive Spine Surgery at UCLA.


SPIRA™-C was designed to address surgeon frustrations associated with traditional cervical interbody devices such as the need for immediate stability. SPIRA™-C was developed for Camber Spine under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company. With an extensive faculty of dedicated physicians, IMSE leverages the collaborative balance between engineering and surgeon ingenuity to create next-level medical devices. The SPIRA™-C design team included several John Hopkins trained Neurosurgeons, all with extensive backgrounds treating complicated cervical pathologies.


“Surgeon design team members are a key component to our success. The insight they provide helps us create smarter solutions, maximizing technological advances and ultimately driving innovation in minimally invasive spine surgery. We are fortunate to have an esteemed surgeon such as Dr. Dorsi on our team helping us turn surgeon frustrations into innovations. There is a lot of excitement around the SPIRA™ technology platform and we expect products like SPIRA™-C and SPIRA™ALIF to fuel our continued sales growth.”


– Seth Anderson, Founding Partner and Vice President, Surgeon Relations


SPIRA™-C is the second in the SPIRA™ family to employ a novel arched design as well as Surface by Design™ technology specifically designed to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.


About Camber Spine


Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber Spine, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.


All of Camber Spine’s products are proudly MADE IN THE USA.


SOURCE Camber Spine Technologies


Related Links


http://cambermedtech.com


	

		

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