News – Page 151 – Selby Spine

image1_0_high_quality.png_full_jpegtran_q95-e1505410341929.jpg

QUEBEC CITY, Sept. 14, 2017 /PRNewswire/ — Bodycad has announced that the first personalized restoration procedures using its Unicompartmental Knee System in patients have been successfully performed.

Bodycad’s revolutionary system is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy, resulting in a better fit and the potential for improved clinical results and patient satisfaction.

“The personalized restoration enabled me to perform the procedure in an exact manner with minimal bone resection,” said Dr. Brian Hamlin, Co-Director of the Bone and Joint Center of Magee-Womens Hospital of University of PittsburghMedical Center, one of two orthopaedic surgeons to perform the procedure. “The reconstruction resulted in a well balanced knee with optimized tracking while avoiding overcorrection.”

Bodycad uses proprietary imaging algorithms to produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient, rapid, and highly automated process is the only one of itskind in the world that is impeccably integrated between software and modern manufacturing such as 3D printing.

“I was involved throughout the production of the personalized restoration,” said Prof. Werner Siebert of Vitos Orthopedic Clinic Kassel and incoming President of the German Orthopaedic Society, who also performed the procedure. “I provided patient imaging, consulted with a Bodycad PREP Tech on the resulting rendering, and then reviewed and approved the final design. The result was an exceptional fit for the patient.”

“Everyone’s anatomy is unique and that’s why standardized implants have limitations,” says Jean Robichaud, President and Founder of Bodycad. “These recent procedures reinforce a growing body of evidence that demonstrates the benefit of personalized restorations.”

Earlier this year, the company received US and European clearance for its Unicompartmental Knee System and is working collaboratively with practitioners to offer this personalized approach to orthopaedics.

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedic restorations. They are the only company in the world to have a seamlessly integrated, purpose-built, CAD/CAM platform. Its proprietary approach offers patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Contact

Andy McLeod
2035 rue du Haut-Bord
Quebec, Quebec, Canada
G1N 4R7
(418) 527.1388
info@bodycad.com

SOURCE Bodycad

September 13, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced the first patients have been enrolled in its BONES (Bioventus Observational Non-interventional EXOGEN Studies) clinical development program. BONES includes three observational, non-interventional, direct-to-patient studies designed to collect real world data on the use of the EXOGEN Ultrasound Bone Healing System. EXOGEN uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural bone healing process.

The BONES studies will compare the incidence of fracture nonunions in patients utilizing EXOGEN with patients from a national health insurance claims database who received standard of care alone. The studies will include long and small bones of upper and lower extremities and the unique design of BONES was discussed with FDA during its development. Its primary endpoint is defined as the ability of EXOGEN to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors.

“We are excited to build on the vast clinical experience available on this established therapy and further develop our knowledge on the real world effectiveness of EXOGEN, by assessing its value in reducing nonunions, a highly disabling complication that also carries a significant societal burden,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “Accomplishing this ambitious goal requires an alternative methodology to randomized controlled trials and involves epidemiologically grounded research of large patient cohorts enrolled both prospectively, and within the big data available from US health insurance claims.”

About Bioventus

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

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

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

EXOGEN – Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

MARIETTA, Ga., Sept. 13, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company’s production operations in Georgia and placenta recovery functions are operating normally, and its previously published expectation for third quarter of 2017 revenue to exceed the $80 million mark is unaffected by Hurricane Irma.

Parker H. Petit, Chairman and CEO, stated, “In our press release of September 5, 2017, we announced that based on the strength of our July and August revenue performance, we expected to exceed $80 million in revenue for the third quarter of 2017 and surpass our guidance for the quarter. While that press release was issued prior to Hurricane Irma making landfall in Florida and continuing its path through other southern states, the Company continues to expect third quarter revenue to be above $80 million. As the medical communities in the area of the country affected by Irma get back to their normal levels of wound care and surgical procedures, we anticipate our performance in other parts of the country should more than compensate for this temporary impact due to our improved sales efficiencies, territory analytics and sales management system.”

Bill Taylor, President and COO, said, “In 2013, we moved into our current headquarters facility in Marietta, Georgia. That facility also houses our Quality Assurance, Processing, Shipping and Distribution functions. We continued to maintain our prior production facility in Kennesaw, Georgia to serve as our disaster recovery site with the above operating functions retained for redundancy as well as our site to preserve excess capacity for periods of heightened demand for product. We recover donated placentas through contracted arrangements in a large number of hospitals located across the country, and have the capability to increase the placenta recoveries in these hospitals to offset any reduction in C-section deliveries in hospitals impacted by a natural disaster.”

“We are thankful for the infrastructure we have developed that allows us to continue our growth trajectory despite recent natural disasters across parts of the country. We are also extremely proud of the resolve and determination exhibited by our employees to help in any way they can to support their fellow employees and communities in time of need. We have set up various means of financial support for our employees and their families who have been impacted by Hurricane Harvey and Hurricane Irma. We are also supporting charities that are serving the communities devastated by these storms,” added Petit.

“To reiterate what we also stated a week ago, we remain confident in our ability to meet or exceed the revenue projections we have previously set for full year 2017, which are in the range of $309 million to $311 million. Any changes in our annual expectations will be discussed with our third quarter press release,” concluded Petit.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “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 1,000,000 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.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding revenue expectations for the 2017 third quarter and full year; expectations for sales performance, production operations and placenta recovery despite the effects of Hurricane Harvey and Hurricane Irma; and the effect of the Company’s sales efficiencies, territory analytics, sales management system, and infrastructure on growth continuation despite natural disasters in parts of the country. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the Company’s revenue for the 2017 third quarter and full year may not materialize as expected; that the Company’s sales performance, production operations and placenta recovery may be more negatively impacted than anticipated due to Hurricane Harvey and Hurricane Irma; the Company’s performance in other areas of the country may not compensate for the impact from the hurricanes; and that the Company’s sales efficiencies, territory analytics, sales management system, and infrastructure may not continue to contribute to growth despite natural disasters in parts of the country. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

September 13, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME eligible), a medical device company specializing in the minimally invasive treatment of vertebral fractures, will announce its 3^rd quarter 2017 sales on Wednesday, 25 October, 2017.

The other dates announced on the original schedule remain unchanged:

Announcement		Date^*
2017 Half-Year Results		Thursday September 14^th, 2017 (before the market opening)
3^rd quarter 2017 Sales		Wednesday October 25^th, 2017 (after the market close)
		Financial year ended December 31

* Subject to modification.

Financial reporting schedule:
2017 Half-Year Results: September 14^th, 2017¹

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital² and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 67 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® ³, a revolutionary implant for treating Vertebral Fractures
The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

¹ Indicative date, subject to changes.
² Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
³ This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tél. : +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com

sen-graham-cassidy-johnson-heller-gty-jef-170913_12x5_992-1.jpg

Robert Lowe – September 13, 2017

A group of Senate Republicans today introduced yet another bill that would largely repeal and replace the Affordable Care Act (ACA), this time around by giving block grants to states to enact their own healthcare reforms.

The money for the block grants would come from what the federal government now spends on the ACA.

The legislation goes by the names of its four sponsors ― Sen. Bill Cassidy, MD, (R-LA); Sen. Lindsey Graham (R-SC); Sen. Dean Heller (R-NV), and Sen. Ron Johnson (R-WI).

“If you believe repealing and replacing Obamacare is a good idea, this is your best and only hope,” said Graham at a press conference today. “Everything else has failed except this approach.”

Graham warned that if Republicans fail to pass his bill, a single-payer system like the kind proposed by Sen. Bernie Sanders (I-VT) and Democratic allies was inevitable.

The block grants under the Graham-Cassidy-Heller-Johnson bill would replace current ACA expenditures on Medicaid expansion, premium subsidies for health plans bought on insurance exchanges, cost-sharing subsidies, and the so-called Basic Health Program for low-income individuals that some states have adopted. States could use the block grants to contract with insurers to encourage their participation in the exchanges, subsidize premiums and out-of-pocket costs for individuals, pay physicians and hospitals, support their Medicaid programs, and create high-risk and reinsurance pools.

READ THE REST HERE

September 13, 2017

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving surgery™, is pleased to announce that Hermed Capital, a private equity fund located in Shanghai, China, has made a $5 million investment in the form of a convertible debenture. The proceeds from this financing are expected to fund additional commercialization, product development, and clinical research efforts for the company.

“We believe the Spineology investment is a very exciting opportunity,” stated Dr. Jerry Xiao, Managing Director of Hermed Capital. “Spineology possesses a very novel product portfolio in an otherwise very homogeneous market. We look forward to working with them as they grow in the U.S. and hope to be able to leverage our resources as they begin to explore global opportunities.”

“The Hermed investment comes at a very opportune time for Spineology,” said John Booth, CEO for Spineology. “With the recent approvals of Rampart One and Duo we are poised to dramatically expand our procedure base into additional market segments.”

The Duo System significantly reduces the surgical access required for lateral procedures while providing a large conforming device footprint.

The Rampart One System minimizes the exposure requirements associated with anterior spinal fusion procedures and is manufactured from Invibio® PEEK-OPTIMA® HA Enhanced material.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

About Hermed Capital Co. Ltd.
Hermed Capital Co., Ltd is a venture capital investment firm specializing in growth capital investments in the healthcare industry including biotech, pharma. medical device and diagnostics projects globally, which is based in Shanghai China. With its abundant China resources, Hermed capital adds in values to those portfolio companies by leveraging its expertise and networks.

Contacts

Spineology Inc.
Dan Walsh, 651-256-8500
dwalsh@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

WASHINGTON, Sept. 13, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it has been chosen to lead three separate training sessions with the FDA. These three training sessions will take place during the months of September and November of 2017 and will be focused on the areas of clinical trials, reimbursement, and innovation.

The Experiential Learning Program (ELP) is a program designed to help all levels of FDA within the Center for Devices and Radiological Health (CDRH) better understand real-world experience as it relates to the design, manufacture and use of medical devices. The ELP program aims to collaboratively explore device technology and obtain the necessary knowledge to enhance the review process and support communication between sponsors and the CDRH review staff.

MCRA’s experts will provide insights and case studies on key strategic considerations in the important areas of technology development as it relates to industry, and the related impact of timing and cost in creating both value and mitigating risk. Additionally, as reimbursement and healthcare economics is becoming increasingly more important, MCRA will address how procedure labeling affects reimbursement coding and how Health Technology Assessment Groups and payers determine the increasing clinical evidence requirements that FDA regulates, which increases the investment required for successful commercialization of both new and existing technology.

Speaking on the impact of programs like ELP, MCRA’s General Manager, David Lown said, “MCRA is proud to be selected by FDA to participate in its ELP program. It confirms the value of our experience and the expertise our consultants deliver to over 500 medical device clients globally. Our hope is that FDA benefits from our CRO’s shared knowledge in the areas of regulatory affairs, reimbursement, quality assurance and compliance”

For more information on MCRA, please visit www.mcra.com.

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and medical device industries. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves over 500 clients globally.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

New-Nuvasive-less-ray-image-nuv_p_lessray.12.15.16rtx018-1-e1505319519304.jpg

SAN DIEGO, Sept. 13, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the commercial launch of its LessRay® software technology system. The LessRay system, comprised of a propriety software algorithm and hardware components, is designed to help address over exposure to radiation in hospital operating rooms (O.R.), particularly in the case of minimally invasive spine surgery (MIS).

“The launch of LessRay is a significant milestone for NuVasive, as we begin to sell capital equipment and bring technology advancements into the hospital O.R.,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “With LessRay’s ability to dramatically reduce radiation exposure, as well as its enhanced imaging capability, we are now executing on our imaging and navigation strategy to improve spine surgery productivity and ultimately predictability. Given the healthy pipeline of interest from customers already, the strong demand demonstrates a critical need for a solution like LessRay to address a major safety issue related to radiation facing surgeons and hospital administrators.”

LessRay Benefits
Studies show spine and orthopedic surgeons can receive their lifetime occupational radiation limit within the first 10 years of their career.¹ As a result, cancer rates and contraction of cataracts associated with radiation exposure are nearly double that of other surgery practices. LessRay’s proprietary image enhancement technology improves low-dose, low-radiation fluoroscopy (or x-ray) images to have similar diagnostic capabilities as conventional full-dose fluoroscopy images, thereby reducing radiation emission and exposure in the O.R while retaining the high resolution of a full radiation dose shot. Additionally, LessRay has other features to help reduce the number of fluoroscopic shots needed, thus decreasing the overall radiation even further. Results of a recent prospective study²conducted with patients randomized to which surgical intervals were performed with standard-dose fluoroscopy or fluoroscopy using LessRay, which measurement of radiation emission and exposure showed that radiation exposure of healthcare professionals in the O.R. was between 62 percent and 84 percent lower in the LessRay group compared to the conventional fluoroscopy group.

In addition, radiation exposure and limited imaging capabilities have been barriers to widespread spine MIS adoption, compared to general orthopedic MIS. By dramatically reducing these limitations, LessRay supports the increased adoption of MIS spine surgery and enables the well-documented patient benefits including less blood loss, lower risk of infection, faster recovery time and more. Additional hospital economic benefits include no disruption to current surgical workflow and no additional surgery time needed.

More about LessRay
NuVasive acquired the LessRay propriety software algorithm and technology system in September 2016, and has since improved upon its design. The Company completed robust alpha and beta testing in more than a dozen hospitals where spine surgery is performed, and incorporated trial feedback from surgeons and hospital staff. LessRay units will be sold as a capital sale or lease purchase, with a focus on selling into O.R.’s dedicated to spine surgery first and then proliferating the technology across additional areas of the hospital where this technology also solves a significant need.

Additional LessRay system benefits for spine surgeons and staff that help increase O.R. efficiency include:

C-arm tracking: Simplifies localization and target anatomy quickly, accurately and without the unnecessary fluoroscopy time and scouting images.
Image stitching: Minimizes surgical workflow interruption by quickly stitching together fluoroscopic images of any spine segment.
Angle finder: Minimizes O.R. steps required to obtain crisp endplate shots with fewer fluoroscopic images than traditional C-arm scouting.
Alternate view: Improves visualization by making metal instruments invisible or semi-transparent by fading out their obstruction.

“LessRay’s ability to reduce radiation usage is so compelling because it benefits not only the surgeon but also the patient and everyone in the operating room,” said Dr. Stephen Ryu, neurosurgeon at Palo Alto Medical Foundation in Palo Alto, Calif. “LessRay’s additional features that augment the capability of conventional fluoroscopy provide really useful tools for even the simplest surgeries. LessRay’s capability to assist accurate localization of spine levels alone is worth it.”

¹UI Haque M, Shufflebarger HL, O’Brien M, et al, Radiation exposure during pedicle screw placement in adolescent idiopathic scoliosis: is fluoroscopy safe? Spine 2006;31(21):2516-20.

²Wang TY, Farber SH, Perkins SS, et al. An internally randomized control trial of radiation exposure using ultra-low radiation imaging (ULRI) versus traditional C-arm fluoroscopy for patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion. Spine 2017;42(4);217-23.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com; OR Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com

This information is being sent to you by:
NuVasive, Inc.
7475 Lusk Boulevard, SAN DIEGO, CA, 92121, United States
http://www.nuvasive.com

MARIETTA, Ga., Sept. 12, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has been recognized by Fortune Magazine as the fifth ranked company in Fortune’s 2017 list of the top 100 fastest growing public companies.

The methodology utilized by Fortune Magazine for its ranking of the top 100 fastest growing public companies includes the company must be listed on a major U. S. stock exchange; have a minimum market capitalization of $250 million and a stock price of at least $5 on June 30, 2017; and have been trading continuously since June 30, 2014. These companies must have revenue and net income for the four quarters ended on or before April 30, 2017 of at least $50 million and $10 million, respectively; and have posted an annualized growth in revenue and earnings per share (EPS) of at least 15% annually over the three years ended on or before April 30, 2017.

Companies that meet these criteria are ranked by revenue growth rate, EPS growth rate, and three-year annualized total return for the period ended June 30, 2017. Fortune determines the overall rank based on the sum of the three ranks. Once the 100 companies are identified, they are then re-ranked within the 100, using these three equally weighted variables.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are pleased to be among the top 100 companies in this prestigious group, and we are extremely honored to be ranked number 5. This recognition is a tribute to the outstanding employees who comprise the MiMedx team and the remarkable healing capabilities of the regenerative medicine products we offer. We are pleased that our dehydrated human amnion chorion membrane (dHACM) allografts are playing an expanding role in helping the healthcare community to improve clinical outcomes and reduce costs.”

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “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 1,000,000 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.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the remarkable healing capabilities of the regenerative medicine products the Company offers and the expanding role played by the Company in helping the healthcare community improve clinical outcomes and reduce costs. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the healing capabilities of the Company’s products may not continue to have the same results and the Company may not continue to play an expanding role in helping the healthcare community improve clinical outcomes and reduce costs. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

NEW YORK, Sept. 12, 2017 /PRNewswire-USNewswire/ — Todd J. Albert, M.D., surgeon-in-chief and medical director of Hospital for Special Surgery (HSS) was inducted as the 48^th president of the Scoliosis Research Society (SRS) at the 52^ndAnnual Meeting Course in Philadelphia, Pennsylvania on Saturday, September 9.

With over 1,000 members, SRS is an international society that was founded in 1966 with only 37 members. Current membership includes the world’s leading spine surgeons, researchers, physician assistants and orthotists who are involved in the research and treatment of spinal deformities.

Dr. Albert began his one-year term as president effective September 9. He has been a member of SRS since 1994 and has served in leadership positions including the chair of the Program Committee and the International Meeting of Advanced Spinal Techniques.

“I’m truly honored to lead this organization that has been a driving force in the field of spinal deformity,” said Dr. Albert. “As we continue to evolve into a global society, I hope to further advance the research, education and training that is necessary to bring high quality care to every patient with a spinal deformity.”

Dr. Albert joined HSS as surgeon-in-chief in 2014 and is also the Korein-Wilson Professor of Orthopaedic Surgery. Specializing in the field of orthopedic spine surgery, Dr. Albert focuses on disorders of the cervical spine. Additionally, he has an interest in minimally invasive surgical techniques and image guided technologies. He is the author of seven books and more than 40 book chapters and has published 300 peer-reviewed and non-peer-reviewed articles.

As president, Dr. Albert will travel both nationally and internationally to lecture and teach fellow spine surgeons. He will also oversee administration and the organization’s major meetings.

Outside of the OR, Dr. Albert loves biking, has a penchant for history and enjoys traveling. Dr. Albert lives in Manhattanwith his wife Barbara and has three adult children.

About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2017-2018), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. HSS has locations in New York, New Jersey and Connecticut.
www.hss.edu

SOURCE Hospital for Special Surgery

Newer Posts

Older Posts

Search

3 days / 6 sessions
Current Issues in Spine

Bodycad Announces First Use of Its Unicompartmental Knee System in Patients

Bioventus Announces First Patients Enrolled in BONES Study for EXOGEN®

Contacts

MiMedx Reiterates Its Third Quarter Revenue Expectation To Exceed $80 Million Despite Hurricane Irma

VEXIM: Amendment of the Financial Agenda for 2017

Contacts

New Senate Bill to Replace ACA Gives More Power to States

Spineology® Secures $5 Million Investment from Hermed Capital

Contacts

FDA Selects MCRA to Share Expertise as Part of the Experiential Learning Program (ELP)

NuVasive Announces Commercial Launch Of LessRay System Designed To Significantly Reduce Radiation Exposure

MiMedx Recognized as Number 5 on Fortune Magazine’s List of the 100 Fastest Growing Public Companies

Todd J. Albert, MD, Named President of Scoliosis Research Society

STAR Ankle Joint Replacements Last Long Term and Provide Relief for Patients

Medacta USA’s Spine Division Begins 2017 with Key Appointment, Significant Growth

Spinal Stabilization Technologies Announces Start of LOPAIN 2 Clinical Trial in South America for Lumbar Degenerative Disc Disease

$250K Pediatric Device Competition Now Accepting Proposals

First Single-Use Rigid Endoscope to be Demonstrated at AAOS