Axolotl Biologix Launches AxoBioMembrane™ to Expand Amnion-Derived Allograft Products for Wound Care

Posted On May 2, 2017 By OrthoSpineNews In Biologics /

Phoenix – May 2, 2017 — Axolotl Biologix, an innovator in regenerative medicine technologies that improve patient outcomes with less pain and lower costs, today announced that it has begun shipping its second amniotic allograft product, AxoBioMembrane™, to meet a wide range of wound care needs.

AxoBioMembrane is a dehydrated human amniotic membrane allograft that helps accelerate and improve soft tissue repair, while helping inhibit bacteria and infection, inflammation, and scar tissue formation. Containing extracellular matrix components and providing a natural biological wound barrier, AxoBioMembrane offers many clinical applications in wound care for surgical, orthopedic, podiatric, ophthalmic, maxillofacial and other applications.

AxoBioMembrane is available for order immediately in three standard sizes 1×2 cm, 2×3 cm, and 4×4 cm, as well as custom sizes which may be ordered.

“Launching our second new amnion-derived product so far this year, we are excited to be rapidly building a portfolio of regenerative treatment products that provide significant improvement in patient outcomes, while delivering high value for clinicians,” noted Bob Maguire, founder and CEO of Axolotl Biologix.

About Axolotl Biologix, Inc.

Axolotl Biologix, Inc., is expanding the human body’s ability to regenerate by developing and manufacturing regenerative human cell and tissue medical technologies that are disrupting traditional, more invasive, painful, and expensive treatment protocols. The Phoenix-based company is rapidly building a portfolio of unique, patented regenerative treatment products to improve patient outcomes with less pain and lower costs. For more information, please visit the company’s website at www.axobio.com.

Media:

bsamson@axobio.com

714-955-3951

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Twenty-one Physicians Charged in Kickback Scheme

Posted On May 2, 2017 By OrthoSpineNews In Regulatory, Top Stories /

Robert Lowes – April 27, 2017

A southern California practice management company called Monarch Medical Group used to advertise that it could provide physicians with new revenue streams from transdermal pain creams, oral medication dispensing, and urine drug-screening tests.

Those revenue streams could lead to prison for 21 physicians charged in a California state court last week with fraudulently billing workers’ compensation insurers for these ancillary services and accepting kickbacks for patient referrals. It was all part of a scheme allegedly masterminded by Tanya King and her husband, Christopher King, owners of Monarch Medical Group and related companies, according to state prosecutors and the California Department of Insurance (CDI).

The Kings also were charged in the case, as were two pharmacists who owned a pharmacy and a physician assistant.

“The Kings and their co-conspirators played with patients’ lives, buying and selling them for profit without regard to patient safety,” said CDI Commissioner Dave Jones in a news release.

From 2011 to 2015, the operation fraudulently billed insurers for $40 million and collected more than $23 million for services rendered to some 13,000 patients. The 21 physicians netted almost $2.2 million in kickbacks, which were labelled as marketing expenses to make them look legitimate, prosecutors said. The average age of the physicians was 57.

Buy for $40, Bill for $700

The scams alleged by prosecutors were based on the three ancillary services that Monarch Medical Group advertised on its website.

READ THE REST HERE

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Surgeons Perform World’s First-Ever Dual Robotic Surgery at Jerusalem’s Hadassah Hospital

Posted On May 2, 2017 By OrthoSpineNews In Robotics, Top Stories /

NEW YORK, April 28, 2017 /PRNewswire-USNewswire/ — The world’s first-of-its-kind dual robotic surgery was performed on April 23 at Hadassah Hospital Ein Kerem in Jerusalem, announced National President Ellen Hershkin of Hadassah, the Women’s Zionist Organization of America, Inc. (HWZOA).

The revolutionary dual robotic surgery assisted in the repair of a severe spinal fracture suffered by Aharon Schwartz, 42, a factory worker in Jerusalem who was injured when a steel object pinned him to the ground, fracturing his leg in two places and breaking six of his spinal vertebrae. The 3-hour surgery took place in the state-of-the-art $30M underground hybrid operating theater at Hadassah’s Sarah Wetsman Davidson Hospital Tower.

Dr. Meir Liebergall, Chairman of the Hadassah Medical Organization’s (HMO) Orthopedic Department and head of HMO’s Musculo-Skeletal Medicine Division, explained the pioneering surgery. “Two robots, Siemens’ Artis Zeego and the Mazor Robotics’ Renaissance^® Guidance System, were involved in the surgery. Artis Zeego, overseen by Dr. Amal Khouri, Director of HMO’s Orthopedic Hospitalization Center, provided real-time 3-dimensional imaging during the surgical procedure, which eliminated the need for pre-surgery CT scans and post-surgery X-rays. Renaissance^® Guidance System, a screw placement system which allows spinal implant placement with maximum safety and accuracy, was controlled by HMO Sr. Orthopedic Surgeon Dr. Josh Schroeder. Renaissance communicated with Artis Zeego during the minimally-invasive surgery while Dr. Schroeder led the Hadassah orthopedic team in the insertion of eleven pedicle screws into the patient’s spine with clinical exactitude.”

Dr. Liebergall predicted that patient Schwartz will completely recover from the surgery and will be walking again very shortly.

Hershkin states, “Once again, HMO achieves another world-first – a dual robot-assisted spinal surgery, solidifying its reputation for world class medical innovation and treatment. Our congratulations go to Dr. Liebergall and his brilliant surgical team for continuing Hadassah’s mission of bringing ground-breaking medical care to the people of Israel.”

The Mazor Robotics Renaissance^® Guidance System transforms spine surgery from freehand procedures to highly-accurate, state-of-the-art procedures that may reduce fluoroscopy—even for minimally-invasive surgery (MIS), scoliosis, and other complex spinal deformity cases.

The Siemens Artis Zeego^® Robotic Technology enables smoother, swifter and trouble-free patient positioning and execution procedures.

Hadassah, the Women’s Zionist Organization of America, Inc. (HWZOA) is the largest Jewish women’s organization in the United States. With 330,000 members, associates and supporters Hadassah brings Jewish women together to effect change and advocate on critical issues such as medical care and research and women’s empowerment. Through the Hadassah Medical Organization’s two hospitals, the world-renowned trauma center and the leading research facility in Jerusalem, Hadassah supports the delivery of exemplary patient care to over a million people every year. HMO serves without regard to race, religion or nationality and earned a Nobel Peace Prize Nomination in 2005 for building “bridges to peace” through equality in medical treatment. For more information, visit www.hadassah.org.

SOURCE Hadassah, The Women’s Zionist Organization of America, Inc. (HWZOA)

Cleveland Clinic CEO Toby Cosgrove to step down

Posted On May 2, 2017 By OrthoSpineNews In Financial /

By Maria Castellucci | May 1, 2017

Dr. Toby Cosgrove, the longtime CEO of the Cleveland Clinic, announced on Monday he will be stepping down by the end of this year.

A succession process for his replacement has now begun and Cosgrove will stay on at the clinic in an advisory role, according to a news release. The clinic also said his successor will be a practicing physician, keeping up with the system’s long history as a physician-led institution.

“It is an honor and a privilege to be a part of an extraordinary and forward-thinking organization that puts patients at the center of everything we do,” Cosgrove said in statement.

During his nearly 13 years at the helm, Cosgrove led the prestigious institution through widespread expansion. But his tenure has also been marred with controversy, especially recently due to his ties with the Trump administration.

Under his leadership, revenue at the clinic grew from $3.7 billion in 2004 to $8.5 billion in 2016. He oversaw growth by establishing multiple new locations nationwide and internationally, including setting up services in Canada and Abu Dhabi.

The number of physician-scientists nearly doubled under his leadership from 1,800 to 3,400. And total visits to the clinic increased from 2.8 million to 7.1 million.

READ THE REST HERE

Life Spine® Achieves Considerable Sales Growth of ProLift® Expandable Spacer System, Doubling Sales Quarter over Quarter

Posted On May 2, 2017 By OrthoSpineNews In Spine, Top Stories /

May 02, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today continued growth of their micro invasive expandable interbody, ProLift. “With the introduction of ProLift to the market in Q2 of 2016, we have since consistently doubled our sales growth quarter over quarter,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We are excited about the adoption of ProLift, and will continue to focus on technological advancements that strive to improve surgical efficiencies and outcomes through procedural based and micro invasive expandable solutions. Products such as ProLift are the core competencies which we will continue to drive for our procedural based product portfolios.”

ProLift, a titanium expandable posterior interbody solution allows for in-situ expansion for restoration of normal anatomic disc height and decompression of neural elements. ProLift, used in conjunction with CALYPSO^™Retractor and CENTERLINE^®Cortical Bone Screws, provides the surgeon minimal tissue disruption while achieving surgical goals.

Zeshan Hyder, D.O., of Bone and Joint Specialists of Northwest Indiana notes,“The continued evolution of MIS surgery to reduce tissue morbidity and restore anatomical alignment, especially in severe degenerative and collapsed disc, is being achieved in my practice with the expandable technologies such as ProLift, and the lateral system LONGBOW^®. Both of these systems reduce the requirements for multiple instrument passes by important neural structures while maintaining my surgical goals and positive patient outcomes.”

ProLift continues Life Spine’s commitment of offering innovative micro invasive procedural solutions to better improve patients’ lives. In addition, Life Spine launched its new website highlighting their complete core and micro invasive procedural solutions. The website is a staple to the new look of Life Spine, and helps surgeons access information about advancements in surgical innovations.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

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

MiMedx Receives Innovative Technology Supplier of the Year Award from Vizient, Inc.

Posted On May 1, 2017 By OrthoSpineNews In Biologics /

MARIETTA, Ga., May 1, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today it has received the Innovative Technology Supplier of the Year Award from Vizient, Inc., the nation’s largest member-driven health care improvement company in the country. The award recognizes MiMedx for its positive impact on patient care provided through Vizient members in 2016. The award was presented earlier this month at the 2017 Vizient Supplier Summit.

The award honors MiMedx for the high level of member adoption of the EpiFix® dehydrated Human Amnion/Chorion Membrane (dHACM) allograft, which received an Innovative Technology contract in May 2015. The contract was based on recommendations from experts at Vizient member hospitals that the MiMedx allograft offers unique and incremental benefit over other products available on the market today.

Chris Cashman, MiMedx Executive Vice President and Chief Commercialization Officer, said, “To be chosen as one of three finalists and then be selected as the top supplier in this category is something for which we are very proud. MiMedx received this recognition for a number of reasons. There has been a very wide adoption of our technology by Vizient members, and utilization within our contract with Vizient has grown by over 500% since its inception in 2015. We have seen the utilization of our allografts produce many extremely positive outcomes and improvements in patient care.”

Vizient’s diverse membership base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers, and represents more than $100 billion in annual aggregate purchasing volume.

“We are pleased to recognize MiMedx Group, Inc. with the Innovative Technology award for 2016. This achievement reflects their commitment to bringing innovative products to the market and to our members that offer improvements to patient care,” said Pete Allen, Executive Vice President, Sourcing Operations for Vizient. “MiMedx has backed their innovative products with clinical support and service excellence that has helped them to be widely adopted as a part of delivering exceptional care for patients by organizations within our membership.”

Bill Taylor, MiMedx President and COO, noted, “We have built a strong relationship with Vizient since contract inception as demonstrated by the significant utilization growth. We are pleased to work with Vizient, and share a common goal with them to improve patient outcomes while controlling costs. Vizient brings clinical and cost effective resources to hospitals, health systems, physician practices and other entities they serve. Our allografts have been recognized for improving patient outcomes, reducing costs and eliminating waste. We believe our mutual focus to this cause has contributed to our rapid growth and success with Vizient.”

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative and therapeutic biopharmaceutical products processed from donated placental tissues. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 800,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the the positive outcomes and improvements in patient care produced by MiMedx products, the Company’s belief that the focus on clinical and cost effectiveness by both the Company and Vizient has contributed to the Company’s rapid growth and success with Vizient. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the results achieved utilizing MiMedx products may vary, the focus on clinical and cost effectiveness by MiMedx may not have contributed to the Company’s rapid growth and success with Vizient or may not continue to result in growth and success with Vizient, MiMedx allografts may not continue to be cost effective, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Orthofix Introduces New Brand Identity for Extremity Fixation Pediatric Products

Posted On May 1, 2017 By OrthoSpineNews In Extremities /

May 01, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced the launch of JuniOrtho^™, a new pediatric brand focused on solutions for children and young adults with orthopedic and congenital deformities. The Company will unveil “JuniOrtho, paediatrics powered by Orthofix” at the EPOSNA annual meeting in Barcelona on May 3, 2017.

Designed to be the link between surgeons, parents and children, Orthofix is bringing products and resources together under the JuniOrtho brand to give medical professionals and families alike the best in pediatric orthopedic solutions.

“With a long history of developing innovative and cutting edge extremity fixation technologies, Orthofix has now brought all of our pediatric expertise and products together under the JuniOrtho banner,” said Davide Bianchi, President of the Extremity Fixation strategic business unit. “This launch represents much more than our products; it’s also a commitment to be a resource for surgeons and the parents and caregivers of pediatric patients before, during and after surgery.”

As part of the JuniOrtho brand launch, the company has developed new resources to help educate families and enable them to make informed decisions regarding their child’s surgery. These include:

JuniOrtho website – www.juniortho.club featuring tools and resources for families and medical professionals
www.limbhealing.com – educational website dedicated to providing information about deformity correction featuring patient stories and useful resources
Age appropriate apps, games, coloring sheets, comic books and literature to help young patients understand and be comfortable with their orthopedic procedures

“For parents, the decision to have surgery for a child is a big one. Typically, they come to the surgery consultation after doing some online research regarding their child’s condition and of course they have a lot of questions,” said Christopher Iobst, Director, Center for Limb Lengthening and Reconstruction, Nationwide Children’s Hospital and Clinical Associate Professor of Orthopedic Surgery at The Ohio State University College of Medicine. “Having patient resources such as websites, activity sheets and games is a great way to provide children and their parents with additional insight.”

The JuniOrtho team at Orthofix boasts an unrivalled level of in-house expertise in the field of pediatric orthopedics that began in the late 1970s in Verona, Italy with orthopedic researcher Giovanni De Bastiani. He established the concept of “dynamization,” based on the natural ability of the bone to repair itself. De Bastiani developed a modular system of external axial frame devices that could be fitted to a bone, allowing micromovement at the fracture site to stimulate bone healing. Along with a few colleagues, De Bastiani founded Orthofix in 1980 in order to continue the development of these devices.

The first product commercialized by the Company was the Limb Lengthener, a pediatric extremity fixation product to correct bone deformities (lengthening). Since launching the first pediatric products in the early ’80s, Orthofix has brought to market more than 35 devices to help adults and children suffering from deformities and trauma to bones of the extremities.

Today, Orthofix’s JuniOrtho solutions consist of a wide-range of products designed for children and young adults. Flagship products in this family include the TL HEX^™ TrueLok Hexapod system and the Guided Growth^™ plating systems that are available in more than 70 countries around the world.

Orthofix invites those attending the EPOSNA Annual Meeting to visit Booth #17 to learn more about JuniOrtho products and resources.

About Orthofix

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

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks 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, Inc.
Investor Relations:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

SI-BONE – SI Joint Fusion Study Showed Patients Were 11X Less Likely to be Taking Opioids at Last Follow-Up Using the iFuse Implant™

Posted On May 1, 2017 By OrthoSpineNews In Spine, Top Stories /

SAN JOSE, Calif., May 1, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced results from two recently published comparative studies showed patients treated with the iFuse Implant^TM were significantly less likely to be taking opioid medications than patients treated with non-surgical care. The most recently published paper titled Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study,¹ published in the journal Neurosurgery, showed that patients treated with iFuse were 11X less likely to be taking opioids at last follow-up than those who were denied coverage for iFuse and treated with either conservative care or radiofrequency ablation (>80% vs, 7%) (Figure 1, below).

“Given the catastrophic opioid addiction epidemic we are currently dealing with in this country today, any procedure, device or technology that demonstrates the ability to significantly reduce opioid use should be made available to anyone who can benefit,” said Frank Guinta, former New Hampshire congressman and co-founder of the Congressional Bipartisan Committee on opioid and heroin addiction. “Given the overwhelming amount of high quality level 1 clinical evidence associated with the iFuse Implant, it seems prudent and obvious to me that anyone properly diagnosed as an appropriate surgical candidate should have access to the procedure.”

A second publication of two-year results from INSITE,² a randomized controlled trial of MIS SI joint fusion with the iFuse Implant compared to non-surgical management, showed a 30% decrease from baseline in the number of subjects taking opioids at two years compared to patients treated non-surgically (Figure 2, below).

“It’s rather remarkable that in both studies the number of patients taking opioids in the iFuse Implant group was significantly lower than the number of patients taking opioids in the non-surgical care group in spite of a lack of a structured program focused on opioid use dependence,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE. “It’s clear from the evidence in these two studies that treatment with the iFuse Implant was associated with a reduction in opioid use in patients with chronic SI joint pain who were taking opioids and who no longer responded to non-surgical care.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide an ideal environment for bone on-growth and ingrowth*, facilitating long-term fusion of the joint. iFuse is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are more than 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results). iFuse Implant is the only SI joint fusion device with a FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

* MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

1	Vanaclocha V, Herrera JM, Sáiz-Sapena N, Rivera-Paz M, Verdú-López F. Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study. Neurosurgery. 2017 April 20. [Epub ahead of print]. doi: 10.1093/neuros/nyx185.
2	Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10.Article 28. doi:10.14444/3028.

SOURCE SI-BONE, Inc.

Posted On May 1, 2017 By OrthoSpineNews In Regulatory, Spine /

Salt Lake City, UT, April 28th, 2017 – Innovasis, Inc. is the first company to receive US FDA 510(k) clearance for a Stand-Alone ALIF* System made from PEEK-OPTIMA™© HA Enhanced polymer from Invibio©. Designed for use in spinal-fusion procedures, the implantable Ax™ Stand-Alone ALIF System implants contain osteoconductive hydroxyapatite (HA) fully integrated into the matrix of the polymer and exposed on all surfaces of the body of the implant, including within the inner walls of the graft chamber.

This is the second PEEK-OPTIMA HA Enhanced device marketed by the company. At the end of Q416 the company launched a PxHA a PLIF device made from the same material.

The Innovasis Ax Stand-Alone ALIF System is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and is inserted using an anterior lumbar interbody fusion (ALIF) procedure.

The Ax Stand-Alone ALIF implant also features a tapered leading edge, which aids in implant insertion within limited anatomical space. It also features a slightly convex profile to match the anatomy of the spine and provide a stable anti-migration surface during the fusion process. The large graft cavity provides increased volume for autograft loading.

About Innovasis
Innovasis, Inc. is a rapidly growing company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery. Innovasis is fully committed to providing surgeons and distributors with training, support and excellent customer service, thus ensuring the establishment of a strong and long-term strategic partnership.

OrthAlign, Inc. Announces New Leadership Appointments to Drive and Support Corporate Growth Initiatives

Posted On May 1, 2017 By OrthoSpineNews In Recon, Top Stories /

ALISO VIEJO, CA (PRWEB) MAY 01, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the executive appointment of Mike Bushlack as Chief Financial Officer and the promotion of James Young Kim as Vice President and General Manager of International.

Mike Bushlack comes to OrthAlign with over 15 years of financial leadership experience in the medical device industry, working with early growth stage and large multi-national companies. Prior to joining OrthAlign, Mike was Chief Financial Officer of Blue Belt Technologies, Inc. and held executive financial leadership and business development roles at ev3 Inc., Covidien, and Medtronic, garnering a proven track record of partnering with business teams to develop and implement strategic plans and financial processes and focus investments to drive growth and enhance entity value. Mike began his career at KPMG LLP in Minneapolis, where he was a Senior Manager.

James Kim has over 12 years of strategic marketing and sales experience in the medical and healthcare industry, responsible for strategic planning, product and brand management, product development, and multiple launch and global commercialization assignments. Since October 2013, James served as OrthAlign’s Vice President of Sales and Marketing, helping lead the organization through an important growth period, including expansion of OrthAlign technology into key international markets. Prior to joining OrthAlign, James served in key marketing roles with Allergan, CareFusion, and Johnson & Johnson, successfully managing the Natrelle®, Pyxis®, and OneTouch® brands, respectively. James received an MBA from the University of Southern California’s Marshall School of Business.

“The executive appointments of Mike and James are key elements in our continued efforts to successfully expand our customer reach, portfolio of products, and focus in providing world class customer service to our surgeons, hospitals, and surgery centers across the globe,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We are energized and excited about the growth opportunities before us and are heavily focused on our strategic initiatives as one of the leading technology companies in orthopaedics.”

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.”

Month: May 2017

Axolotl Biologix Launches AxoBioMembrane™ to Expand Amnion-Derived Allograft Products for Wound Care

Twenty-one Physicians Charged in Kickback Scheme

Buy for $40, Bill for $700

Surgeons Perform World’s First-Ever Dual Robotic Surgery at Jerusalem’s Hadassah Hospital

Related Links

Cleveland Clinic CEO Toby Cosgrove to step down

Life Spine® Achieves Considerable Sales Growth of ProLift® Expandable Spacer System, Doubling Sales Quarter over Quarter

Contacts

MiMedx Receives Innovative Technology Supplier of the Year Award from Vizient, Inc.

Related Links

Orthofix Introduces New Brand Identity for Extremity Fixation Pediatric Products

Contacts

SI-BONE – SI Joint Fusion Study Showed Patients Were 11X Less Likely to be Taking Opioids at Last Follow-Up Using the iFuse Implant™

Related Links

Innovasis receives 510k for first Stand-Alone ALIF System made from PEEK-OPTIMA™© HA Enhanced polymer

OrthAlign, Inc. Announces New Leadership Appointments to Drive and Support Corporate Growth Initiatives