Invibio and Carbofix Partnering With UK Olympic Sprinter James Ellington on New “Passion For Progress” Initiative

Posted On July 21, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

THORNTON CLEVELEYS, England, July 13, 2017 /PRNewswire/ —

UK Olympic sprinter James Ellington has joined forces with the UK´s Invibio Biomaterial Solutions and CarboFix Orthopedics on his road to recovery and his overall ambition to return to the world stage of athletic competition after a devastating motorcycle accident in Tenerife earlier this year.

(Photo: http://mma.prnewswire.com/media/535235/Invibio_Biomaterial_Solutions.jpg )

The two companies and the athlete share a passion for progress and pushing boundaries; for James Ellington, mentally and physically first in sport and now in recovery, and for CarboFix and Invibio with innovative biomaterials and devices that have the potential to change the treatment of trauma fractures. For patients recovering from traumatic injuries this could serve as an inspiration not to lose track of their goals and passion.

Changes in destiny couldn´t be more pronounced for an athlete like James Ellington, who suddenly turned from being a world-class, elite sprinter training for his next competition to a patient in recovery facing an unknown future. However, even the life-changing experience of a severe head-on collision of his motorbike with a car hasn’t stopped James Ellington from fighting for his goals, despite having his legs and pelvis completely smashed.

“In extreme situations, it’s important not to lose faith and to consider all (therapeutic) options available,” explains Ellington. “I had a severe tibia fracture, and was offered two choices to fix it: a traditional Titanium nail or a Carbofix nail using a relatively new, but promising carbon fibre, composite technology. For me, it’s all about giving myself the best chance of achieving my goal and returning to competitive athletics. I chose the Carbofix nail because it’s lighter weight and for its faster healing potential.” Continues Ellington, “The rod is made from a new composite polymer. It’s strong, in a way that’s similar to metal implants, but not as stiff, which means it has the capability to stress the bone more and provide some micro-motion, so it works more like natural bone. The idea is that this will help support a quicker recovery – which is what convinced me this was the right path for me.” The sprinter nevertheless considers himself lucky: because he survived, is not paralyzed, is walking again and is so far on a good recovery path that may also include running in the future.

With trauma implants made from Invibio’s PEEK-OPTIMA™ Ultra-Reinforced, a composite polymer, CarboFix Orthopedics is hoping to support James and other patients in a similar position. Ron Szekely, the company´s Vice President of Sales and Marketing, says: “The aim itself to get back on track is fantastic, whether that’s the athletic track or returning to other individual recovery goals. This can be an important driver for rehabilitation. In addition to dedication and enthusiasm, patients need to have access to innovative medical devices that can support this. At CarboFix we believe in the potential of changing trauma treatment to improve the quality of life for many patients.”

Coming back (on track): high quality of life is an important aspect for recovery

“James Ellington´s passion for progress is the common denominator and connecting link between himself and Invibio,” explains Medical Business Unit Director, John Devine of Invibio Biomaterial Solutions. “Metals have been used to treat trauma fractures for decades, but patient demands for a quicker recovery with fewer device breakages coupled with the global increase in patient risk factors such as obesity and diabetes mean we need to be open to progress. That includes being open to the possibility that new innovative carbon fibre reinforced devices made from less stiff materials could really change how successful surgery and patient recovery is. The medical (device) industry itself very often and for good reasons, has to make small albeit important steps, to overcome challenges and achieve substantial progress towards the ultimate objective of improving patient outcomes and quality of life. James knows exactly how that feels and his positive attitude and firm belief in capabilities and future performance is another point we have in common.”

Inspiring people to achieve new records

This “passion for progress” after a traumatic injury or challenging operation is a theme supported by the two companies and centering on James Ellington´s hope to become an active athlete again. Together, Ellington, CarboFix and Invibio are pleased that James has already achieved so much in the months since the accident. The progress and hope shown by James Ellington could also help and inspire patients and trauma surgeons alike – whether Ellington is a pioneer by being an Olympic athlete sprinter again, or simply back and participating in the race of life.

About CarboFix

CarboFix Orthopedics, is the world-wide leader in developing, manufacturing and marketing orthopedic implants made of continuous Carbon-Fiber reinforced polymers.

The products company currently markets around the world its Piccolo Trauma and Carboclear spine lines.

CarboFix is working worldwide through its distributor network and through its subsidiaries in the US, China and Israel.
https://www.carbo-fix.com/

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in around nine million implanted devices worldwide.

About Victrex plc

Victrex, headquartered in the UK, is an innovative world leader in high performance polymer solutions focused on the Aerospace, Automotive, Electronics, Energy and Medical markets. Every day, millions of people rely on products or applications which contain our polymers, from smartphones, aeroplanes and cars to oil & gas operations and medical devices. With over 35 years’ experience, we are delivering leading edge solutions to shape future performance for our customers and our markets, and to drive value for our shareholders. Find out more at http://www.victrexplc.com

SOURCE Invibio Biomaterial Solutions

Smith & Nephew joins forces with Imperial’s Biomechanics Group

Posted On July 21, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

19 July 2017/by Naomi Black

The medical device giant Smith & Nephew have signed a 3-year partnership with a research group in the Department of Mechanical Engineering to find new ways to support one of our most important joints.

With an increasing participation in sport, and a trend to keep active later in life, the treatment of sports injuries of the knee has been identified by Smith & Nephew as one offering high growth opportunities.

The USD $1m research study is led by Professor Andrew Amis, Professor of Orthopaedic Biomechanics and leader of The Biomechanics Group, who already has a long-standing working relationship with the company. His expertise with artificial ligaments and total and partial knee prostheses as well as field experience working directly with surgeons has set the groundwork for this latest agreement.

READ THE REST HERE

SANUWAVE Appoints Alat Medika Indonesia as Distributor for dermaPACE and Liaison to Clinical Trials Participation for Company’s Wound Care Product(s) in Indonesia

Posted On July 20, 2017 By OrthoSpineNews In Biologics, Top Stories /

SUWANEE, GA–(Marketwired – Jul 20, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the Company has appointed Alat Medika Indonesia as distributor for dermaPACE^® and liaison for clinical trials participation for Company’s wound care product in Indonesia. The expected revenue from this agreement will be north of $1 million over the next three years.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage Alat Medika Indonesia was made to increase our focus and visibility within Indonesia for the wound care market. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Indonesian market. It is well known that diabetes and related concerns need to be addressed within Indonesia and having access to outstanding technology such as SANUWAVE’s within the country is a positive step. We will need speedy access to potential clinical trials to ensure we add value with our product offering as well as clinical proven outcome. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOLs),” concluded André Mouton.

Christian Hainsch, Chief Product Officer of Alat Medika International Group, declared, “Setting the ‘PACE^®‘ in wound healing in Indonesia! A technical milestone in professional wound healing is coming to Indonesia. With dermaPACE, SANUWAVE developed an innovative medical device for patients suffering from diabetic wounds, ulcer or burn injuries. One of the major indications for the use of dermaPACE, and most important for Indonesia, is the treatment of diabetic ulcers. With dermaPACE the regeneration process of tissue from chronic wounds is increased and can be an alternative to amputation or medication based treatment. Diabetes and other patients benefit from a simple, painless and side-effect free treatment for faster healing and quicker recovery to improve quality of life,” concluded Mr. Hainsch.

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

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

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE^®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron^® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron^® and orthoPACE^® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About Alat Medika Indonesia
Being a reliable partner for hospitals, doctors and health care facilities, Alat Medika Group Indonesia brings the best medical devices to Indonesia. Serving the health care market with dedication, passion and highest quality technology standards the expert team of Alat Medika provides local medical practitioners, clinics and hospitals with a full range of medical devices ranging from laboratory equipment to radiology, sonography, laser technology for diagnostics, therapy and health care. Our team of technical and medical experts helps customers all over Indonesia to identify their needs, supply best in class medical devices and maintain and service the health care infrastructure.

Contact:
PT. Alat Medika Indonesia
Graha Mustika Ratu Bldg. 10^th Floor
Jl. Jend. Gatot Subroto Kav. 74-75
Jakarta 12870 – Indonesia
sales@almed-indonesia.com
Phone: +62 21 83708874

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

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

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

Medovex Announces First Human Cases Using Its DenerveX Device and First Revenue Events

Posted On July 19, 2017 By OrthoSpineNews In Spine, Top Stories /

ATLANTA, GA–(Marketwired – Jul 19, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), a developer of medical technology products, today announced the first human cases performed using its recently launched DenerveX™ System and first revenue events.

The DenerveX System which has recently received CE Mark approval and clearance for commercialization in the European countries, is a new and novel device designed for enduring relief of Facet Joint Syndrome related to lower back pain.

Jarrett Gorlin, Medovex CEO stated, “Our first human use cases for the DenerveX System which took place in Manchester, England recently with very encouraging initial procedural success. We anticipate performing up to as many as 30 plus additional procedures by the end of August. This is the beginning of delivering on our goal of ‘proof of principle’ in the adoption of the technology in this very sizable market.” Gorlin concluded, “We are also pleased to have also reached our first revenue events in the EU with others soon to expected to follow.”

The DenerveX System offers a fast and simple way to perform a safe Facet Joint Syndrome treatment.

Patrick Kullmann, Medovex President and COO., added, “With the DenerveX™ System, we can offer surgeons and pain management specialists the ability to attain precise treatment of the Facet Joint pain. The DenerveX treatment uses ‘Rotacapsulation™,’ a combination of high heat and rotational capsular tissue shaving, in a minimally invasive posterior procedure for the treatment of Facet Joint Syndrome. The DenerveX System offers an alternative to existing treatments only providing temporary relief.”

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

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 device, 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 patent 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

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

PathPartner Technology Contributes to Arthromeda’s Successful Preclinical Study of Arthrosight-PS™ Hip Alignment Navigation System

Posted On July 19, 2017 By OrthoSpineNews In Recon, Top Stories /

FREMONT, CA–(Marketwired – July 19, 2017) – PathPartner Technology Inc., a technology enabler in developing intelligent systems, announces a successful cadaveric study of Arthromeda’s (www.arthromeda.com) innovative patient-specific hip alignment navigation product, Arthrosight-PS™.

In a recent press release, Arthromeda Inc., a developer of intelligent orthopedic navigation systems, announced the successful completion of cadaveric studies demonstrating the efficient performance of Arthrosight-PS™ at the Cincinnati Children’s Hospital and Medical Center (CCHMC, Cincinnati, OH). These cadaveric studies confirmed that the patient-specific Arthrosight-PS™ Hip Alignment System is an intuitive, all-in-one system for accurate implant positioning and providing real-time position angles (inclination and anteversion), leg-length and femoral offset difference measurements.

With an increase in the number of hip procedures, and 80% of them being represented by Total Hip Arthroplasty¹; technology serves as a panacea to improve surgical methodologies and also as an enabler towards enhanced outcomes of surgeries. Accurate hip implant positioning is an extremely important criterion for patients, physicians, regulators and device companies. A device that enables the surgeons to perform accurate hip arthroplasty procedures with minimal interference in their work-flow is the need of the hour and this is being ably addressed by Arthrosight-PS™.

This was the result of an intense and ingenious design process, fabricated from Arthromeda’s intellectual property combined with their design input specifications and our talented team spanning the entire electronics engineering space that included hardware design, algorithms, firmware and application developments. PathPartner, with its vast experience in delivering state-of-the-art technologies from ideation to complete system solutions, provided critical support to build the platform that included MEMS sensors, laser sensors, photodiodes, wireless connectivity, Android applications and cloud solutions to provide an easy-to-use device in the operation-room offering accurate angular positioning (inclination and anteversion) and leg-length/femoral offset difference measurements.

“PathPartner has been a valuable partner to Arthromeda,” commented PJ Anand, Executive Chairman and Co-Founder of Arthromeda. “We fully intend to leverage this relationship with the PathPartner team to expand the platform into knee and shoulder procedures.”

“The joint positioning system that offers four key measurements (with an accuracy of 2 degrees for inclination/anteversion and 2 millimeters for leg-length/femoral offset difference), without the need for costly capital equipment, is a game changer in helping surgeons and patients in hip arthroplasty procedures,” commented PathPartner Technology Senior Vice President Raman Narayan.

1: Source: Third Annual report of AJRR (American Joint Replacement Registry)

About PathPartner Technology

PathPartner offers design, development and integration services in advanced embedded technology. Based out of Fremont, Calif., PathPartner Technology Inc is an affiliate of PathPartner Technology Pvt. Ltd., Bangalore, India.

With an unparalleled experience in transforming innovative ideas into full-fledged products, PathPartner provides its clients the advantage of top-of-the-line technologies, superior performance and faster time-to-market options. Having the expertise in BSP & device drivers, multimedia codecs, algorithms, imaging and hardware design, PathPartner is geared for technology driven execution and quality delivery for corporations across industries including automotive, semiconductor, healthcare, cameras and surveillance.

More information is available at www.pathpartnertech.com.

CONTACT INFORMATION

Contact:
Raman Narayan
Phone: 408-242-7411
Email: raman.narayan@pathpartnertech.com
Website: www.pathpartnertech.com

CMS proposes Medicare coverage for outpatient joint replacements, changes to SNF 3-day stay rule

Posted On July 19, 2017 By OrthoSpineNews In Recon, Regulatory, Top Stories /

Emily Mongan, Staff Writer/July 17, 2017

The Centers for Medicare & Medicaid Services released two proposals last week that may change where beneficiaries receive joint replacements, and how accountable care organizations deal with the agency’s three-day stay rule waiver.

The first proposal, contained within a proposed rule concerning hospital outpatient prospective payments, would allow Medicare to cover knee replacement surgeries in outpatient facilities.

Research on conducting the procedures in outpatient settings has shown outpatients did not experience higher complication or readmission rates than inpatients, CMS said. If the rule were to be enacted, beneficiaries would still be able to undergo the procedures in an inpatient setting “based on the beneficiary’s individual clinical needs and preferences,” the agency said.

CMS also is soliciting public comment on possibly doing the same with hip replacements.

READ THE REST HERE

OrthAlign, Inc. Announces First KneeAlign Cases for Total Knee Arthroplasty in Hong Kong

Posted On July 19, 2017 By OrthoSpineNews In Recon, Top Stories /

HONG KONG (PRWEB) JULY 19, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the first KneeAlign® cases completed for total knee arthroplasty (TKA) in Hong Kong. These cases were completed by Hong Kong-based orthopaedic surgeon Professor Kevin K.W. Ho at Prince of Wales Hospital, one of the country’s leading public hospitals, in collaboration with OrthAlign’s local distribution partner Smith & Nephew Hong Kong.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits in recovery for the patient.

Professor Ho stated, “KneeAlign is large console navigation in a small, handheld box. The technology is so easy to use and gives me accurate information that I need, all within the sterile field, without all of the hassles and extra costs that large console computer assisted surgery systems require. I was pleased with my first set of cases and will continue using it because I believe it is valuable for my practice in providing the best possible outcomes for my patients.”

“Navigation plays a very important role in Hong Kong’s joint arthroplasty market,” said Priscilla Chan, General Manager of Smith & Nephew Hong Kong & Taiwan. “Surgeons and hospital facilities believe in navigation, but cost and operational inefficiencies have been key barriers in adoption optimization. I believe OrthAlign provides a revolutionary technology that addresses those barriers and will finally give Hong Kong a product that can be accessible by every hospital and surgeon. We look forward to growing the business through our partnership with OrthAlign.”

In a published TKA clinical study by Denis Nam, M.D. (Rush University Medical Center, Chicago, IL), significant differences favoring the use of KneeAlign vs. conventional Computer Assisted Surgery were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mean mechanical alignment of the limb, with 92.5% of patients within 3° of neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.

In another study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively).

“Hong Kong’s orthopaedic market may be one of the most fascinating in the world,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “There are so many dynamics in the marketplace, such as public vs. private hospitals, long queues for patients who are on 3-year waiting lists for their total knee arthroplasties, and a strong desire for technology by surgeons. Without question, hospitals and surgeons value navigation technology, and OrthAlign will be the best option for them, not only from a price point, but also in terms of accuracy and operational workflow. As OrthAlign continues to focus on its mission in expanding customer reach, we welcome Hong Kong to the growing OrthAlign family and look forward to working with Smith & Nephew Hong Kong in providing local hospitals, surgeons, and patients our technology.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Simplify Medical Closes $21 Million Series B Financing to Support Innovative Cervical Artificial Disc

Posted On July 19, 2017 By OrthoSpineNews In Financial, Spine, Top Stories /

July 19, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced the closing of a Series B financing of $21 million. LSP (Life Sciences Partners) led the round, with additional investment from Sectoral Asset Management and returning investor M.H. Carnegie. The new funds will be used to complete two ongoing U.S. pivotal clinical trials of the Simplify Disc studying its use in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease.

“We are gratified by the confidence investors are showing in our Simplify Disc, which is designed to be clearly viewed on MRI without the artifact that can result from metal used in typical spine implants. By avoiding the radiation that would otherwise accompany a computed tomography (CT) scan, we intend to minimize patient exposure to unnecessary radiation risk,” said Simplify Medical Chief Executive Officer David Hovda. “The new funds will enable us to develop the rigorous evidence that gets us one step closer to availability for U.S. patients in need.”

“We are very impressed with the intelligence of the Simplify Disc technology,” said LSP General Partner Dr. Fouad Azzam. “With hospitals being held to higher standards relative to complications and post-operative costs, it is important that innovations minimize patient risk. Not only does the Simplify Disc avoid substantial radiation exposure, it also avoids metal wear that has been problematic for other orthopedic devices. In addition, it offers the lowest-profile device available, opening up a broader patient population for the technology.”

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Two Simplify Disc U.S. pivotal trials are currently enrolling. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 15 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The other pivotal trial is studying one-level cervical implantation of the device between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. For information about eligibility or enrollment in either pivotal trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and has been used to treat more than 700 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 949-545-6654
michelle@chronic-comm.com

Anika Announces $5 Million Milestone Payment from U.S. Commercial Sales of MONOVISC

Posted On July 18, 2017 By OrthoSpineNews In Financial, Top Stories /

July 17, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that it will receive a $5 million milestone payment under the terms of the Company’s license agreement with its U.S. commercial partner. The milestone payment was triggered by MONOVISC^® achieving $100 million in U.S. end-user sales within a consecutive 12-month period at the end of June 2017. The Company will recognize this milestone payment as revenue in the second quarter of 2017.

“This significant commercial milestone reflects a strong 12 months of growth in U.S. end-user demand for MONOVISC, especially in the second quarter of 2017,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer of Anika Therapeutics. “We are proud of MONOVISC’s growth and success in the U.S., and we remain focused on the global expansion of MONOVISC to drive future growth.”

The Company also announced preliminary revenue for the second quarter of 2017. Anika expects total revenue growth for the second quarter of 2017 to be in the range of 23% to 26% year-over-year, including licensing, milestone and contract revenue of approximately $5 million as a result of the milestone payment announced today. The company will provide a complete update on its second quarter 2017 financial results on July 26, 2017.

About MONOVISC

MONOVISC is Anika’s second-generation hyaluronic acid-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit www.monovisc.com.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST^®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the third paragraph of this press release, which are not statements of historical fact, are 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 statements include, but are not limited to, those relating to the Company’s expectations regarding its financial results for the second quarter of 2017, which preliminary results were announced herein. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, Chief Financial Officer
781-457-9000
or
For Media Inquiries:
Pure Communications, Inc.
Sonal Vasudev
917-523-1418
sonal@purecommunicationsinc.com

EIT Emerging Implant Technologies Announces 510(k) Approval from the FDA for Full 3D Printed Cage Portfolio and Begins Commercialization in the U.S.

Posted On July 18, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

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 full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.

EIT Cellular Titanium^® is a porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize bone ingrowth. Due to the availability of metal 3D printing Selective Laser Melting (SLM) technology and proprietary post-processing methods, it has been possible to create a highly porous, osteo-influential titanium scaffold for osseointegration. This EIT Cellular Titanium^® structure has been applied in the complete ALIF, TLIF, PLIF and Cervical implant line, and clinical case studies and retrieval analysis demonstrate extensive bone ingrowth throughout the total implants in the cervical and lumbar spine in a short time frame.

EIT Cellular Titanium^®Interbody cages target for Smart Spinal Fusion™ in combining an osteo influential scaffold with designs to address spinal alignment. The implants have been used in over 10,000 cases in over 15 countries including Germany, France, Australia, Korea and the Netherlands. With the milestone of this 510(k) approval, EIT is moving towards full commercialization effective immediately.

Guntmar Eisen, Co-Founder and CEO for EIT says “This is a major milestone for EIT. We look forward to bringing our unique technologies to the United States and partnering with top tier surgeons and institutions to bring the best results to patients that are in need of these devices.”

About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen.

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 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 10.000 EIT cases have been performed in over 15 markets globally.