NuVasive Announces First Quarter 2017 Financial Results

Posted On April 25, 2017 By OrthoSpineNews In Financial /

SAN DIEGO, April 25, 2017 /PRNewswire/ — NuVasive, Inc. (Nasdaq: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today financial results for the quarter ended March 31, 2017.

First Quarter 2017 Highlights

Revenue increased 16.2% to $250 million, or 16.0% on a constant currency basis;
GAAP operating profit margin of 9.3%; Non-GAAP operating profit margin of 14.1%;
GAAP diluted earnings per share of $0.22; Non-GAAP diluted earnings per share increase of 11.8% to $0.38; and
Expanded existing revolving line of credit from $150 million up to $500 million.

“NuVasive is off to a solid start to the year, with our International business exceeding our expectations, and we saw momentum building in our U.S. business as we exited the quarter,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “We are on track to deliver non–GAAP operating profit margin expansion of at least 100 basis points in 2017, reflecting our continued focus on operational efficiencies and the ramp up of our in-house manufacturing facility. Coupled with several innovative product and systems launches planned for 2017, including LessRay designed for radiation reduction, RELINE Trauma system, expandable cages and UNYTE system for complex fractures, we anticipate strong revenue acceleration for the balance of the year.”

The Company also announced it amended its existing revolving line of credit to expand the facility from $150 million up to $500 million. The credit facility amendment demonstrates the Company’s opportunistic approach to its capital structure, and provides for a five-year term at reasonable borrowing rates. The Company expects the expanded facility to allow greater flexibility in planning for the maturity of its convertible notes due July 2017, and support future investment in organic and inorganic growth initiatives.

A full reconciliation of GAAP to non-GAAP measures can be found in the tables of this news release.

First Quarter 2017 Results

NuVasive reported first quarter 2017 total revenue of $249.9 million, a 16.2% increase compared to $215.1 million for the first quarter 2016. On a constant currency basis, first quarter 2017 total revenue increased 16.0% compared to the same period last year.

For the first quarter 2017, both GAAP and non-GAAP gross profit was $188.3 million, and both GAAP and non-GAAP gross margin was 75.3%. These results compared to GAAP and non-GAAP gross profit of $160.9 million and $165.8 million, respectively, and GAAP and non-GAAP gross margin of 74.8% and 77.1% respectively, for the first quarter 2016. The lower gross margin profile year-over-year is primarily driven by the expense profile of the Biotronic NeuroNetwork business acquired in July 2016. Total GAAP and non-GAAP operating expenses were $165.0 million and $152.9 million, respectively, for the first quarter of 2017. These results compared to GAAP and non-GAAP operating expenses of $148.6 million and $135.5 million, respectively, for the first quarter 2016.

The Company reported a GAAP net income of $12.8 million, or $0.22 per share, for the first quarter 2017 compared to a GAAP net loss of ($3.4) million, or ($0.07) per share, for the first quarter 2016. On a non-GAAP basis, the Company reported net income of $20.0 million, or $0.38 per share, for the first quarter 2017 compared to net income of $17.2 million, or $0.34 per share, for the first quarter 2016.

Cash, cash equivalents and short and long-term marketable securities were approximately $134 million at March 31, 2017.

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Orthopedic practice among the first to pursue bundled payments with private payers

Posted On April 25, 2017 By OrthoSpineNews In Financial, Top Stories /

By Joanne Finnegan – April 20, 2017

The largest orthopedic private practice group in the country hopes to be among the first to negotiate bundled payments for seven surgical procedures.

The Centers for Advanced Orthopaedics, which is centered in Virginia, the District of Columbia and Maryland, is currently working to develop seven initial bundles for various orthopedic surgeries, Louis Levitt, M.D., the centers’ vice president, said in an interview with FierceHealthcare.

It will be among the first orthopedic private practice groups to participate in a bundled payment program, which Levitt said is expected to decrease patient costs and improve clinical outcomes by putting doctors in control of the patient’s entire episode of care.

Levitt, an orthopedic surgeon, has taken the lead in building the group’s bundled payment offerings which will initially include total hip, total knee, partial knee, knee scope, cervical spine fusion, anterior cruciate ligament and rotator cuff procedures.

“This is the value-based medicine,” Levitt said. “You’ve got to get the best value for the amount of effort and dollars you spend now on healthcare. Engaging the doctors in a risk-sharing environment is the only way to make it happen.”

The practice is currently negotiating with payers in the region and expects that by the end of 2017 it will have an agreement in place with the largest, Blue Cross, to begin the bundled payments, he said.

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Amendia Partnership with Global Spine Outreach Strengthens

Posted On April 25, 2017 By OrthoSpineNews In Spine, Top Stories /

Marietta, GA (PRWEB) April 25, 2017

Amendia, Inc., designer, developer, and manufacturer of spinal implant and instrument solutions, announces the continuation of its strategic partnership with and platinum sponsorship of Global Spine Outreach (“GSO”), a charitable organization dedicated to training surgeons in developing nations in the safe and effective management of complex spine deformity cases, particularly in children.

GSO’s focus is to provide hands-on surgical education and training to in-country surgeons. Through graduated, long-term educational models, GSO empowers local surgeons to safely treat the most severe spine conditions in their own communities. Over time, the organization helps to create sustainable spine centers that serve local communities year-round.

As a strategic supporter of GSO’s designated surgical mission sites, Amendia enables on-going interaction between the U.S. team and local surgeons. The bi-annual missions allow surgeons to perform multiple surgeries on children with complex spine deformities.

“The physician education and training GSO provides is invaluable to the spine industry’s success and advancement in first-rate treatment of the most severe spinal deformities,” said Chris Fair, Amendia’s CEO. “Through our partnership, we empower young U.S. surgeons to participate in mission trips with established surgeons, and then bring that experience back to their hospitals and patients.”

“Amendia’s support streamlines GSO’s mission to provide children around the world access to life-transforming surgical care,” said Dr. Anthony S. Rinella, orthopaedic spine surgeon, GSO Board President, and founder of the Illinois Spine and Scoliosis Center. “Together, we advocate for the nearly 200 million people afflicted with scoliosis and educate those who can make a difference in their lives.”

The continued sponsorship supports the annual Spinal Deformity Symposium for surgeons, to be held October 29, 2017 in Mexico City, which unites industry experts, U.S. faculty, and over 100 Mexican surgeons in a combination of case presentations and workshops designed to improve and expand care to spine deformity patients. In addition, the support provides for a robust databasing program that results in the continued improvementof spinal deformity management.

About Global Spine Outreach

Global Spine Outreach is a 501(c)(3) nonprofit organization providing medical treatment to children suffering from the effects of spinal deformities worldwide without charge to the patient or their families. GSO physicians are 100% volunteers, and all donations go directly to providing and improving the care of children with spinal deformities. To learn more about Global Spine Outreach, please visit http://www.globalspineoutreach.org.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, Georgia, Amendia is a leading designer, developer, and manufacturer of medical devices used in spinal surgical procedures. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes with innovative implant solutions. For more information, please visit http://www.amendia.com.

HOSPITAL WITH LOWEST READMISSION RATE SHARES MORE DATA

Posted On April 25, 2017 By OrthoSpineNews In Recon, Top Stories /

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, April 20th, 2017

Orange County California’s Hoag Orthopedic Institute (HOI), just released its 2017 Outcomes Report. In it, readers can find information regarding HOI’s previous year’s surgical volumes, care quality metrics, infection and readmission rates, and patient satisfaction scores.

HOI has performed the most joint replacements in California for five consecutive years. It has also had the lowest readmission rate in the nation for hip and knee replacements from 2012 through 2015.

In addition to the data on infection rates and volume, the report also highlights quality improvement initiatives, distinctions and innovations, details on HOI’s education and research program, compelling patient testimonials, and much more.

“Our quest to provide greater value and optimize outcomes in musculoskeletal care unfolds in this issue of our annual outcomes report,” said Sopida Andronaco, R.N., director of Performance Improvement and Clinical Outcomes for HOI. “The entire HOI staff works tirelessly to continually reach this exemplary level of excellence and we are proud to showcase their dedication and commitment to delivering quality care to our patients.”

READ THE REST HERE

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Medicare advisers consider tighter rules on doctor-owned medical distributors

Posted On April 25, 2017 By OrthoSpineNews In Regulatory /

By Christine Ayala, The Hill Extra – 04/18/17

Regulators are mulling tightened oversight over physician-owned distributors of medical products, on fears that conflicts of interest could lead to fraud.

Some hospitals have set up barriers to avoid anti-kickback entanglements with device distributors, and the Medicare Payment Advisory Commission (MedPAC) is looking at more specific requirements in congressional recommendations. Some commissioners argue these types of physician-owned distributors of medical products should be outlawed.

At issue are distributors making money by selling devices ordered by their doctor owners for surgical use on their own patients. Physician-owned distributors, or PODs, operate as middlemen, buying a device from manufacturers and selling the device to a hospital at a higher price, although ownership of a distributorship is not always obvious.

The practice developed as a way for physicians to cluster buying power and potentially save on device costs.

Devices from these distributors are bought at the same price or higher than those available from manufacturers, a practice which lead some to call these entities “inherently suspect,” according to a recent Office of Inspector General report.

The medical device industry also sees a need for caution.

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Amedica Announces Regulatory Clearance to Market and Sell Valeo® Silicon Nitride Spinal Implants in Australia

Posted On April 25, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

SALT LAKE CITY, UT–(Marketwired – Apr 24, 2017) – Amedica Corporation (NASDAQ: AMDA), an innovative medical device company that develops and commercializes silicon nitride, is pleased to announce it has been granted marketing clearance for its Valeo interbody fusion devices in Australia.

The Valeo product line is made entirely of Amedica’s proprietary medical grade silicon nitride ceramic — an ideal material for fusion because of its nanostructured surface, osteoconductivity, osteoinductivity, anti-microbial properties, and ease of radiographic imaging.

“The Australian clearance is a tremendous opportunity for Amedica. Interestingly, during 1986-1988, Australian surgeons and engineers were the first to synthesize reaction-bonded silicon nitride, and implant the material in lumbar spine fusion patients. Favorable outcomes in terms of pain relief and successful fusion were reported at the 15-year follow-up time interval. Thus, the pioneering clinical use of silicon nitride in spine fusion originated in Australia, and we are excited to see the material return to its place of birth,” said Dr. Sonny Bal, CEO. “The successful outcomes from Australia are now validated by 45 scientific papers published by Amedica in top-tier peer journals, and clinical data that will be published throughout this year. We look forward to working with Australian surgeons, and providing them with improved options for spinal fusion surgery.”

About Amedica Corporation
Amedica is the only manufacturer of medical grade silicon nitride — an innovative biomaterial technology ideal for use in spinal fusion and across a variety of medical applications. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility located in Salt Lake City, Utah. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, but are not limited to, the Company’s opportunities for global expansion, and the Company’s future commercialization plans. Such statements are subject to risks and uncertainties such as whether the FDA approves the Company’s submission, the timing of such approval and the Company’s success in commercializing its products. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

CONTACT INFORMATION

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

Titan Spine Record Sales in Q1 2017 and Reaches 1,000 Implantations nanoLOCK® Endoskeleton® Interbody Fusion Devices

Posted On April 25, 2017 By OrthoSpineNews In Spine /

April 24, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has achieved record sales revenue for the first quarter of 2017. Additionally, the company recently exceeded 1,000 implantations of its Endoskeleton^® titanium interbody fusion devices featuring nanoLOCK^® surface technology since its launch in the fourth quarter of 2016. nanoLOCK^® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.¹ Titan Spine will be showcasing nanoLOCK^® at booth #2249 during the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, taking place April 22-26 in Los Angeles.

The company reports the following:

Record quarterly sales for Q1 2017 that are significantly greater than prior year
nanoLOCK^® has been utilized to date by 74 surgeons in 52 hospitals across 26 states
nanoLOCK^® sales volume has increased by 270% since December 2016

Ted Bird, Chief Commercial Officer of Titan Spine, commented, “Achieving record sales growth in the first quarter this year speaks to the accelerating demand for our surface-enhanced titanium interbody devices and an increasing appreciation of the importance of our proprietary nano-architecture in its ability to drive rapid osteogenesis. The attainment of the 1,000-unit threshold of our nanoLOCK^®device in just six months of its commercial availability underscores the market demand for devices that benefit patients in the early post-op timeframe as spine surgeons are now under the microscope for improved early results more than ever before. Our rapid nanoLOCK^®adoption has certainly been aided by its sole access to the CMS new technology ICD-10 code for nanotextured interbody fusion devices, which has placed nanoLOCK^® in a category all its own and has resulted in a dramatic increase in the number of hospitals and surgeons that have access to it. We could not be more pleased with our sales results to date and the continued successful launch of nanoLOCK^®.”

Steve Cichy, Executive Vice President of Sales of Titan Spine, added, “Our Q1 achievements reflect the growing demand from our current surgeon base plus new relationships we have made with surgeon adopters that are beginning to embrace the benefits of nanotechnology for their patients. As a result, we have significantly invested in our field sales management team by tripling the number of Area Vice Presidents and Regional Managers we employ in just under a year. We are uniquely positioned to continue to take market share throughout the rest of 2017 and beyond.”

Titan Spine offers a full line of Endoskeleton^® devices that feature Titan Spine’s proprietary nanoLOCK^® surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4 All Endoskeleton^® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton^® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

²Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

³Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

Company
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

Pascale Davis, an internationally renowned expert on the spine market, joins Safe Orthopaedics as Global Head of Marketing

Posted On April 24, 2017 By OrthoSpineNews In Spine, Top Stories /

April 24, 2017

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

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, is today announcing the appointment of Pascale Davis, an internationally renowned expert on the spine market, as Global Head of Marketing.

Pascale is a seasoned veteran with over 18 years’ experience in marketing and scientific affairs. She worked for industry leaders including Zimmer Biomet, Synthes and SpineArt, where she acquired both marketing and scientific knowledge in Europe and in the United States.

Before joining Safe Orthopaedics, Pascale was Marketing Director for Europe, Middle East and Africa (EMEA) at Zimmer Biomet Spine, since 2012 where initially her role was EMEA Scientific Affairs Director. Previously, she held various positions of responsibility at Synthes Spine and SpineArt in Switzerland and then in the United States. Concurrently, Pascale was also Director of Education and Marketing for the International Society for Advancement of Spinal Surgery (ISASS) from 2001 until 2006.

“It gives us great pleasure to welcome Pascale to Safe Orthopaedics. Her arrival illustrates the Company’s ability to attract well-known international talents and the growing interest in its technology, as was recently demonstrated by AP-HP’s decision to list our products,” commented Pierre Dumouchel, Co-Founder and Chief Executive Officer of Safe Orthopaedics. “Pascale’s arrival will provide a significant boost to our marketing capabilities and training programs that we provide to surgeons to foster the take-up of our products and to give them more information about the benefits of Safe Orthopaedics’ sterile single-use products for both minimally-invasive and trauma surgery.”

Pascale Davis, Safe Orthopaedics’ Head of Global Marketing, added: “I’m delighted to be joining Safe Orthopaedics. Their innovative technology is highly acclaimed and respected and gaining more and more traction in France and internationally. I will be applying my market knowledge together with the experience I gained in the scientific community to accelerate adoption of our products by surgeons and centers of excellence for spinal surgery — in France, Germany and also in other European and emerging markets.”

Next report: Full-year 2016 results on Friday, April 28, 2017

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpine^TM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

Contacts

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

SI-BONE, Inc. Announces Publication of 6-year Clinical Results Demonstrating Long-Term Positive Outcomes of iFuse Implant System®

Posted On April 24, 2017 By OrthoSpineNews In Spine /

SAN JOSE, Calif., April 24, 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 the publication of a 6-year study comparing the iFuse Implant^TM to both conservative management and radiofrequency denervation. The long-term study titled Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study, was published in the journal Neurosurgery.

The study evaluated 137 patients seen in an outpatient neurosurgery clinic who received either conservative management (63 patients), SI joint denervation (47) or SI joint fusion with the iFuse Implant (27) for SI joint pain due to either osteoarthritic degenerative sacroiliitis or SI joint disruption. Outcomes were based on SI joint pain ratings using a 0-10 visual analog scale (VAS), functional status using Oswestry Disability Index (ODI), pain medication use and work status. Patients treated with conservative management as well as those treated with radiofrequency denervation had no long-term improvement in pain or function, and in fact got worse, whereas the iFuse Implant group had markedly superior improvements in pain (See Figure 1) and function.

At last follow-up, 80% of the patients in both the conservative management and radiofrequency denervation groups were using opioids, compared to only 7% of the patients in the iFuse Implant group. At last follow-up, 70% of patients treated with the iFuse Implant had returned to work, compared to 34% of those treated with radiofrequency denervation and 19% of those treated with conservative management.

Figure 1 VAS SI joint pain score

Publication of results of this long-term study extends the duration of follow-up out to 6 years with the iFuse Implant. iFuse is specifically designed for SI joint fusion with a unique triangular shape that prevents rotational motion and a porous surface that promotes bony ongrowth and ingrowth¹. The iFuse Implant is the only SI joint fusion device with prospective peer-reviewed publications demonstrating safety, effectiveness and durable positive outcomes, and the only SI joint fusion device with a FDA-cleared claim that clinical studies demonstrate improvements in pain, patient function and quality of life.

“An interesting observation from our study was that over one-third of patients seen in our clinic and initially treated with conservative management failed to achieve adequate pain relief and required additional treatments. Of the treatments available, only SI joint fusion with the iFuse Implant provided sustained, long term pain relief,” said Vicente Vanaclocha-Vanaclocha MD, PhD, primary author of the study. “Furthermore, the fact that the treatment option provided was often decided by external factors enhanced the comparability of groups. This study offers solid evidence that the iFuse Implant is an effective long-term treatment for those patients with chronic pain resulting from certain types of SI joint pathologies who fail to respond to initial conservative management.”

Jeffrey Dunn, President and CEO of SI-BONE commented: “This study is remarkable in that it highlights the profound positive impact on patients with SI joint pain who have access to SI joint fusion. The opioid epidemic is a challenging public health problem in the U.S. and coverage policies that provide access to technologies like the iFuse Implant can have a meaningful impact on reducing dependence on opioids.”

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 ongrowth and ingrowth¹, facilitating long-term fusion of the joint. The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant 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 benefits of the iFuse Implant (www.si-bone.com/results).

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]

SOURCE SI-BONE, Inc.

MiMedx to Present at the European Wound Management Association Annual Conference

Posted On April 24, 2017 By OrthoSpineNews In Biologics /

MARIETTA, Ga., April 24, 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 Company’s participation in the European Wound Management Association (“EWMA”) 2017 Conference to be held in Amsterdam, The Netherlands from May 3 through May 5, 2017.

The 2017 EWMA Conference is EWMA’s 27^th annual conference offering high-level scientific presentations, knowledge and best practices exchange, and presentation of the most recent advances in wound management research and treatment. With up to 5,000 attendees, the EWMA is one of the largest and most prestigious wound management conferences in the world.

MiMedx will sponsor a Symposium entitled, “The Dynamic Impact of EpiFix® Dehydrated Human Amnion/Chorion Membrane Allograft – Defining the New Standard for Bioactive Healing” on May 4, 2017 from 16:00 to 17:00. Severin Läuchli, MD, will chair the symposium and Matthew Garoufalis, DPM, FASPS, FACFAOM, CWS, will be a symposium speaker. This symposium will detail published peer-reviewed clinical data, clinical case examples, and intriguing scientific evidence supporting the use of EpiFix for the treatment for acute and chronic wounds.

Symposium Chair Dr. Läuchli is the Chief of Dermatologic Surgery/Mohs Surgery and Wound Care and Assistant Professor, Department of Dermatology at the University Hospital, Zurich, Switzerland, and the President of the EWMA. Dr. Läuchli will present “The Swiss Experience with EpiFix.” Physician and study author, Dr. Garoufalis is also the President of the International Federation of Podiatrists. Dr. Garoufalis will present “Application Techniques and Therapeutic Approached Using EpiFix Amniotic Allografts for Wound Healing and Surgical Procedures.”

Parker H. “Pete” Petit, CEO, said, “We are honored to be associated with the EWMA and participate in their outstanding conference. The EWMA is focused on investigating the barriers to and possibilities of advanced therapies in the next generation of wound management. They also have a key focus on the prevention and management of surgical site infections. Their focus is well aligned with our strategies and priorities, and we are proud to be associated with the EWMA. Our significant participation at this year’s EWMA Conference is part of our ongoing strategy to expand our presence in the international wound care markets and globally market our dHACM allografts.”

Bill Taylor, President and COO, commented, “The EWMA conducts its activities in coordination with various national and international organizations aimed at goals such as increased data collection and quality of evidence, implementation of knowledge, and development of education within wound management. We share these goals in our pursuit of advances in the treatment and healing of acute and chronic wounds. We are excited to work with the EWMA in improving the delivery and availability of advance wound care therapies internationally.”

MiMedx will provide in-booth education during the following times:

May 3 from 10:30 to 18:00;
May 4 from 9:00 to 16:30; and
May 5 from 9:00 to 14:30.

Throughout the conference, MiMedx will be located at Booth #3 C 06.

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.

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 are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include 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.

Our Blog

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, April 20th, 2017

CONTACT INFORMATION

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