Spinal-Cord-300x178-1.png

North America Will Remain Dominant in the Global Spinal Cord Stimulators Market: Future Market Insights

Posted On July 17, 2017 By OrthoSpineNews In Financial, Neuro /  

VALLEY COTTAGE, New York, July 17, 2017 /PRNewswire/ —

Introduction of affordable devices would pave huge opportunities for the global spinal cord stimulators market across developing economies. Customized spinal cord stimulators as per the requirements of an individual is expected to offer higher growth potential for leading market players. Specialists in healthcare settings are more likely to prescribe devices that are smaller in size, owing to their easy implantation and less painful surgical procedure.

     (Logo: http://photos.prnewswire.com/prnh/20161020/430874LOGO )

In terms of value, an impressive 6.4% CAGR is estimated for the global spinal cord stimulators market by a report of Future Market Insights (FMI). In 2017, the market will account for nearly US$ 2,000 Mn in revenues; by 2027 this number is estimated to reach US$ 3,568.2 Mn. Growth of the market is primarily attributed to under penetration of potential market.

Request a Sample Report with Table of Contents and Figures: http://www.futuremarketinsights.com/reports/sample/rep-gb-2030

Spinal Cord Stimulators‘ Ability of Reducing Opioid Analgesics Addiction to Drive the Market Growth

Majority of patients with chronic pain are increasingly depending upon opioid analgesics; however spinal cord stimulators is capable of reducing this addiction to a great extent. Entry of additional competitors in the market is expected to increase awareness about effectiveness of spinal cord stimulators. Spinal cord stimulators are comparatively more cost-effective than conventional medical management (CMM). Leading companies in the market are taking initiatives in improving technology for spinal cord stimulators. The aforementioned factors are estimated to drive growth of the global spinal cord stimulators market.

However, spinal cord stimulators have little access to evidence-based data in order to confirm effectiveness of these devices for management of chronic pain. Clinical validation of spinal cord stimulation is based on observational data, instead of verified data. This had led several private insurance companies to refuse reimbursement of costs, which in turn is impeding the market growth. In addition, complications associated with spinal cord stimulators, such as paresthesia- characterised by burning sensation, is further expected to restrain growth of the global spinal cord stimulators market.

Preview Analysis on Global Spinal Cord Stimulators Market Segmentation End User – Hospitals, Ambulatory Surgical Units, Clinics; Application – Failed Back Surgery Syndrome, Complex Regional Pain Syndrome, Ischemic Limb Pain, Others; Product Type – Rechargeable, Non-Rechargeable: http://www.futuremarketinsights.com/reports/spinal-cord-stimulator-market

Rechargeable Spinal Cord Stimulators will Remain Sought-After Product in the Market

In terms of value, rechargeable spinal cord stimulators are expected to remain sought-after product in the market. Revenues amassed from sales of rechargeable spinal cord stimulators are expected to reach US$ 2,530.4 Mn by 2027-end. In addition, sales of non-rechargeable spinal cord stimulators are anticipated to expand at 4.6% CAGR through 2027. Factors such as low battery life, and requirement of surgery for replacement of battery are restricting adoption of non-rechargeable spinal cord stimulators across the globe.

Application of spinal cord stimulators will remain highest in failed back surgery syndrome (FBSS), with sales estimated to surpass US$ 1,000 Mn in 2017. In addition, complex regional pain syndrome (CRPS) is projected to be the second-fastest growing application of spinal cord stimulators in the market. In terms of value, sales of spinal cord stimulators in CRPS are estimated to register 5.8% CAGR through 2027.

Adoption of Spinal Cord Stimulators to Witness Fastest Growth in Ambulatory Surgical Centres

Although hospitals will continue to be largest end-users of spinal cord stimulators, adoption will witness fastest growth in ambulatory surgical centres. Sales of spinal cord stimulators in hospitals are estimated to account for revenues worth US$ 627.9 Mn in 2017. Demand for spinal cord stimulators in ambulatory surgical centres is projected to exhibit 6.8% CAGR through 2027. In contrast, demand for spinal cord stimulators in clinics will remain sluggish in the market.

Our advisory services are aimed at helping you with specific, customised insights that are relevant to your specific challenges. Let us know about your challenges and our trusted advisors will connect with you: http://www.futuremarketinsights.com/askus/rep-gb-2030

North America will continue to remain dominant in the global spinal cord stimulators market, with sales estimated to reach nearly US$ 3,000 Mn in revenues by 2027-end. Western Europe will remain the second-largest market for spinal cord stimulators, expanding at 6.1% CAGR through 2027. In addition, markets in Eastern Europe and Japan are estimated to exhibit parallel expansion at 6% CAGR through 2027.

Key market players identified in FMI’s report include Boston Scientific Corp., Medtronic Private Limited Company, St Jude Medical LLC, Nevro Corp, Nuvectra Corporation, Stimwave, Saluda Medical PTY Limited.

More from FMI‘s Cutting-edge Intelligence:

  • Paediatric Vaccine Market Segmentation By Technology – Live Or Attenuated Vaccine, Inactivated Or Killed Vaccine, Toxoid Vaccine, Conjugate Vaccine and Subunit Vaccine; By Indication – Pneumococcal Conjugate Vaccine, DTP Vaccine, Influenza, Meningococcal Vaccine, Polio Vaccine, Rotavirus Vaccine, MMR Vaccine and Varicella Virus Vaccine; By End User – Hospital Pharmacies, Retail Pharmacies and Institutional Health Centres; By Vaccine Type – Monovalent Vaccines and Multivalent Vaccines: http://www.futuremarketinsights.com/reports/pediatric-vaccines-market
  • Microfluidics Market Segmentation By Material Type – Polymer (Polyvinyl chloride (PVC), Non-polyvinyl chloride), Glass, Silicon, Metal, Ceramics; By Application Type – Point of care testing, Clinical Diagnostics, Drug Delivery, Analytical Testing (Genomics, Proteomics, Cell Based Analysis); By Industry – Pharmaceuticals, In-vitro Diagnostics, Environmental Research, Life Science Research, Clinical Diagnostics: http://www.futuremarketinsights.com/reports/microfluidics-market
  • Teleradiology Services Market Segmentation By Process Type – Certified Reporting Services Process and Preliminary Reporting, By Service Type – Emergency Nighthawk, Day Time Coverage, Subspecialty Reading, Second Opinion and Clinical Trails, By Modality – X-Ray Scans, Computerised Tomograph (CT) Scans, MRI Scans, Ultrasound Scans and Nuclear Scans, By End User – Hospital Pharmacies, Clinics, Ambulatory Surgical Centres and Radiology Centres: http://www.futuremarketinsights.com/reports/teleradiology-services-market

About Us

Future Market Insights (FMI) is a leading market intelligence and consulting firm. We deliver syndicated research reports, custom research reports and consulting services which are personalized in nature. FMI delivers a complete packaged solution, which combines current market intelligence, statistical anecdotes, technology inputs, valuable growth insights and an aerial view of the competitive framework and future market trends.

Browse More Healthcare, Pharmaceuticals and Medical devices Market Insights

Contact Us
616 Corporate Way, Suite 2-9018,
Valley Cottage, NY 10989,
United States
T: +1-347-918-3531
F: +1-845-579-5705
T (UK): +44-(0)-20-7692-8790
Sales: sales@futuremarketinsights.com
Press Office: Press@futuremrketinsights.com

Find Market Research: http://www.findmarketresearch.org/

Read More
EXOGEN_Photo.jpg

Bioventus Expands EXOGEN® Performance Program in Canada to Include All Fracture Types

Posted On July 17, 2017 By OrthoSpineNews In Biologics /  

July 17, 2017

MISSISSAUGA, Ontario–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced it has expanded the Performance Program* for its EXOGEN Ultrasound Bone Healing System to include delayed union and acute fractures. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.1

Since 2014, the Performance Program has been in place to refund patients their out-of-pocket payment for EXOGEN if progression of fracture healing for nonunion was not shown. The company is now expanding this program in Canada to include delayed union and acute (fresh) fractures, excluding the skull and vertebrae.

“Physicians and patients have enjoyed positive outcomes from EXOGEN and the expansion of the Performance Program to include all fracture types underscores our belief in the device,” said Tony Bihl, CEO, Bioventus. “If progression of healing is not shown, we will take the device back and refund the patient associated out-of-pocket costs for it.”

Absence of healing (progression to bony union) is determined by the prescribing physician by comparing the patient’s X-rays taken prior to using EXOGEN to one taken at 120 days or later. Patients must treat their fracture with EXOGEN per product instructions, for a minimum of 120 days and achieve maximum adherence of 90%. The device contains an internal patient usage monitor that records the date, time and duration of each treatment session.

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.

*Certain restrictions apply, visit our website for full details.

1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001; 16(4):671-680.

Summary of Indications for Use: In Canada, the EU, Australia and New Zealand

EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:

• Treatment of delayed union and non-unions†

• Accelerating the time to heal of fresh fractures

• Treatment of stress fractures

• Accelerating repair following osteotomy

• Accelerating repair in bone transport procedures

• Accelerating repair in distraction osteogenesis procedures

• Treatment of joint fusion

† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have 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.

Contacts

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

Read More
djo-usl-1080-1-1.png

DJO Global Named Official Sports Brace of U.S. LaCrosse

Posted On July 17, 2017 By OrthoSpineNews In Sports Medicine /  
Paul Ohanian / June 26, 2017

US Lacrosse announced today that DJO Global has been named as the Official Sports Brace of US Lacrosse and Supporting Partner of Team USA.

DJO Global, Inc. is a medical device company that produces a variety of orthopedic products for rehabilitation, pain management and physical therapy, and provides advanced protective and preventive technologies to the world’s most elite athletes.

As part of the partnership, Team USA players will wear DJO Global brand bracing and durable goods products exclusively, and receive medical treatments through the use of state-of-the art equipment.

Collaboration on injury prevention research will also be among the priorities of the partnership.

“This is a great opportunity for our Center for Sport Science to work with a world leader in sports medicine while also providing a valuable benefit to all of our members,” said Dr. Bruce Griffin, director of the Center for Sport Science at US Lacrosse.

 

READ THE REST HERE

 

Read More
Seaspine_010-L-1.jpg

SeaSpine Announces Limited Commercial Launch of Skipjack™ Expandable Interbody System

Posted On July 14, 2017 By OrthoSpineNews In Spine /  

CARLSBAD, Calif., July 13, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch of and completion of initial cases for its Skipjack Expandable Interbody System.

Skipjack is an expandable interbody system based on patented technology acquired as part of the NLT transaction announced in August 2016.  Skipjack is designed to provide continuous in-situ expansion in either height or lordosis for a tailored anatomical fit.  Skipjack adds to SeaSpine’s portfolio of differentiated solutions within the interbody device market, which is estimated to be one of the fastest growing segments of the U.S. spinal instrumentation market.  Notably, Skipjack implants provide up to 20 degrees of lordotic correction from a posterior approach and are accompanied by integrated graft delivery instrumentation to post-pack the implant and surrounding disc space.

“The alpha launch of Skipjack reflects the culmination of our ability to identify and acquire novel technologies and combine it with our surgeon-focused development and marketing expertise to rapidly bring innovative new products to market,” said Keith Valentine, President and Chief Executive Officer of SeaSpine.  “In surgeon-responsive and rapid fashion, SeaSpine has translated NLT’s intellectual property into what we believe will be high clinical-value products that contribute to improving patient lives.”

Skipjack provides surgeons the ability to place smaller implants that expand within the interbody space, potentially enabling smaller incisions and more limited nerve retraction without sacrificing the advantages of larger, but more disruptive, implants.  This in-situ expansion is intended to reduce tissue disruption, minimize endplate damage and, thereby, improve patient outcomes.

“The parallel and lordotic options that Skipjack offers allow me to expand in-situ for a more patient-specific fit.  The initial stability is excellent and being able to backfill the cage with the same set of instruments helps simplify the procedure,” stated Dr. James Brennan, Sentara Virginia Beach Hospital.

About SeaSpine

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal instrumentation solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal instrumentation portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements

SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design and other potential benefits of the Skipjack Expandable Interbody System, including its providing a tailored anatomical fit, its differentiation and ability to compete in the interbody device market, its ability to enable smaller incisions, limit nerve retraction, reduce tissue disruption and minimize endplate damage, and its clinical value and ability to improve patient lives.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that the Skipjack Expandable Interbody System has not been validated clinically, may not address adequately surgeon requirements, and may require substantial additional development activities, which could introduce unexpected expense and delay, including potentially requiring resubmission of one or more products to FDA for clearance, which clearance cannot be certain, whether on a timely basis or at all; surgeons’ willingness to use the Skipjack Expandable Interbody System; the risk that the Skipjack Expandable Interbody System may not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support a full commercial launch; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact 
Lynn Pieper 
(415) 937-5402
ir@seaspine.com
Read More
MSW-ortho-1-1.jpg

Mount Sinai Opens World-Class Orthopaedic Center on Manhattan’s West Side

Posted On July 14, 2017 By OrthoSpineNews In Extremities, Recon /  

(New York, NY – July 14, 2017) – Mount Sinai has announced the opening of the Orthopaedic Center at Mount Sinai West. The new facility, located at 425 West 59th Street, is the first of its kind on Manhattan’s West Side, with state-of-the-art equipment and exam rooms to enhance patient experience and care.

The Orthopaedic Center at Mount Sinai West will be the Health System’s location for all orthopedic patient appointments on the West Side. The new facility offers a larger space to accommodate more patients and physicians specializing in all areas of orthopedics. Four new surgeons have joined the center’s 12 existing physicians to expand care and services in the areas of total joint replacement, sports medicine, spine, foot and ankle, shoulder, elbow and hand injuries. This facility gives patients new and direct on-site access to radiologists, rheumatologists, and pain management physicians for  coordinated care.

Michael Bronson, MD, Chair, Department of Orthopaedics, Mount Sinai West; Chief, Joint Replacement Surgery, Mount Sinai West; and Associate Professor, Icahn School of Medicine at Mount Sinai, will direct the Orthopaedic Center at Mount Sinai West.

“We are extremely excited about the opening of our new facility, which will provide patients throughout the city and especially on the west side of Manhattan with state-of-the-art care, and give them access to orthopedic physicians in all sub-specialties,” said Dr. Bronson. “The Center will also provide immediate access to patients with acute orthopedic problems so these can be addressed in a timely manner. A larger facility means patients won’t have to wait weeks or months to see a world-renowned specialist.”

Additionally, the Orthopaedic Center at Mount Sinai West will serve as a major teaching site for medical students, residents, and fellows in all areas of orthopedics. This will add an extra level of expertise on the West Side, leading to increased medical research and breakthroughs in treatments to advance patient care.

“The Orthopaedic Center at Mount Sinai West represents Mount Sinai’s commitment to growth of the Department of Orthopaedics and signifies integration of care and dedication to patients on the West Side,” said Leesa Galatz, MD, System Chair, Orthopaedics, Mount Sinai Health System, and Mount Sinai Professor, Leni and Peter W. May Department of Orthopaedic Surgery, Icahn School of Medicine at Mount Sinai. “This is a center for excellence in orthopedics and patients will know that when they come here they will get exemplary care.”

About the Mount Sinai Health System
The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.

The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is in the “Honor Roll” of best hospitals in America, ranked No. 15 nationally in the 2016-2017 “Best Hospitals” issue of U.S. News & World Report.  The Mount Sinai Hospital is also ranked as one of the nation’s top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke’s, and Mount Sinai West are ranked regionally. Mount Sinai’s Kravis Children’s Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report in “Best Children’s Hospitals.”

For more information, visit http://www.mountsinai.org/, or find Mount Sinai on Facebook, Twitter and YouTube.

Read More
jeff-sessions-1.jpg

Hundreds ensnared in Justice Department health-care fraud crackdown on $1.3 billion in false billings

Posted On July 14, 2017 By OrthoSpineNews In Regulatory, Top Stories /  

By   and   / July 13, 2017

A fake drug rehab in Palm Beach recruited addicts with gift cards, strip-club visits and even drugs, federal officials said Thursday, July 13, enabling the company to bill for more than $58 million in false treatments and tests.

It’s a scenario often repeated in Southern California, which was part of a massive crackdown on health-care fraud that netted hundreds of arrests across the nation Thursday, including charges against 115 doctors, nurses and licensed medical professionals, according to the U.S. Department of Justice.

Officials said it was the largest-ever health care fraud enforcement action by a Medicare Fraud Strike Force and involved the arrests of more than 400 people for alleged false billings totaling some $1.3 billion.

More than 120 of them were charged for prescribing and distributing opioids and other dangerous narcotics.

The names of all those arrested weren’t immediately available, and it did not appear that California was a primary focus of the action, despite recurring reports of fraudulent practices in Southern California’s large addiction-treatment industry.

In California, 17 people were charged with scheming to defraud Medicare of $147 million; and two of them were indicted for alleged involvement in a $41.5 million scheme targeting Medicare and a private insurer, the DOJ said.

The scheme involved submitting fraudulent claims – and receiving payments for prescription drugs – that were never filled by pharmacies or given to patients.

 

READ THE REST HERE

Read More
pete-petit-chairman-ceo-mimedx-group.jpg

MiMedx Announces That Its Second Quarter Revenue Exceeds The Guidance Range

Posted On July 14, 2017 By OrthoSpineNews In Financial /  

MARIETTA, Ga., July 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 its revenue results for the second quarter of 2017.

Second Quarter 2017 Revenue Highlights 

  • Q2 2017 Revenue of $76.4 Million exceeds MiMedx guidance range of $73.5 to $75.0 Million
  • Q2 2017 Revenue grew 33% over Q2 2016 revenue
  • First Six Months of 2017 Revenue grew 35% over First Six Months of 2016

The Company recorded record revenue for the 2017 second quarter of $76.4 million, a $19.1 million or 33% increase over 2016 second quarter revenue of $57.3 million. Revenue for the six months ended June 30, 2017 was $149 million, a $38.3 million or 35% increase over revenue for the six months ended June 30, 2016 of $110.7 million.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are very pleased with our second quarter revenue performance. It is always gratifying when we exceed the top end of our guidance and outperform our forecasts. Our revenue performance for the second quarter marks 26 consecutive quarters of sequential revenue growth and 25 of the last 26 quarters of meeting or exceeding our revenue guidance. As with our first quarter results, the second quarter is also expected to demonstrate very strong year-over-year operating cash flow performance compared to the second quarter of last year.  We were very confident that our new sales management system would be a key asset and facilitator of strong revenue growth, and we are pleased with its positive impact on our sales productivity since its implementation in early 2016. The corresponding informatics and organizational structure investments made at that time are delivering results as planned.  We are optimistic about the continuation of our robust revenue growth.”

Bill Taylor, President and COO, said, “Our second quarter revenue performance was especially gratifying in light of the tedious and time-consuming tasks that our sales force undertook to ensure the wind-down of our contract with AvKARE was seamless for our federal accounts and their patients. We are in a very good position in terms of year-to-date revenue performance as we move into the third quarter, which is typically one of our strongest quarters of the year. We had very solid revenue performance during the second quarter, and we are building momentum for a strong showing in the second half of the year and the delivery of a robust year overall. In addition to the fact that the AvKARE conversion is now behind us, there are several other catalysts expected in the second half of this year, such as the publication  of our Venous Leg Ulcer (VLU) and Diabetic Foot Ulcer (DFU) studies and the Plantar Fasciitis Phase IIb study interim data results. These catalysts should provide further fuel to our rising momentum.”

Dates for Release of Second Quarter 2017 Results and Live Broadcast of Conference Call

The Company also announced today that it plans to release its full results for the second quarter ended June 30, 2017, before the opening of the market on Thursday, July 27, 2017. The Company also announced that it will provide revenue guidance for the third quarter of 2017 in that quarterly earnings release.

MiMedx will host a live broadcast of its first quarter conference call on Thursday, July 27, 2017 at 10:30 a.m. eastern time.  A listen-only simulcast of the MiMedx conference call will be available online at the Company’s website at www.mimedx.com.  A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast.  The replay can also be found on the Company’s website at www.mimedx.com.

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 900,000 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 Company’s financial expectations for the year, preliminary revenues for the second quarter of 2017,  that the new sales management system and informatics and organizational structure investments are having a positive impact on sales productivity, that certain catalysts should provide fuel to the rising Company momentum, and that the second quarter financial results are expected to demonstrate strong year over year operating cash flow performance.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company’s actual second quarter of 2017 final revenue number may differ from the preliminary number; that the Company’s revenue may not grow as expected or may decline; even if revenue is achieved, the Company may not be able to achieve its projected earnings and profitability metrics; the Company may face challenges in quarters other than the second quarter that impact its performance; the sales management system and informatics and organizational structure investments may not continue to have a positive impact on sales productivity or may have a negative effect in the future; expected catalysts to momentum such as publication of certain clinical studies and interim results, and the elimination of the time-consuming tasks related to the AvKARE contract wind down may not have the expected impact; 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 and its most recent 10Q filing.  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.

Related Links

http://www.mimedx.com

Read More
step1.png

Vericel to Host Symposium on MACI Implant for Treating Articular Cartilage Defects in the Knee at AOSSM 2017 Annual Meeting

Posted On July 13, 2017 By OrthoSpineNews In Sports Medicine /  

CAMBRIDGE, Mass., July 13, 2017 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, announced today that the company is hosting a symposium on the  MACI® (autologous cultured chondrocytes on porcine collagen membrane) implant for treating articular cartilage defects in the knee at the American Orthopedic Society for Sports Medicine’s 2017 Annual Meeting.

Symposium topics will include a review of MACI published clinical studies, patient case profiles, and a discussion of the regulatory approval process for MACI.  Featured speakers include Daniël Saris, MD, PhD, Professor of Orthopedics at University Medical Center in Utrecht, Netherlands; Alison Toth, MD, Associate Professor of Orthopaedic Surgery at Duke University in Durham, North Carolina; Eric Strauss, MD, Assistant Professor of Orthopaedic Surgery at the NYU Hospital for Joint Diseases in New York; Seth Sherman, MD, Assistant Professor of Orthopaedic Surgery at the University of Missouri in Columbia; and David Recker, MD, Vericel’s chief medical officer.

The symposium, entitled  “The MACI Implant for Treating Articular Cartilage Defects in the Knee,” is being held on Thursday, July 20, 2017 from 12:30 – 2:00 pm at the Metro Toronto Convention Center, 700 Level, Room 205.

To register for the symposium and for more information, go to:  http://BIT.LY/AOSSM-MACI

Editor’s Note:
Vericel will have MACI information at Booth #619 at the AOSSM 2017 Annual Meeting.

About MACI
MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellular scaffold product that is indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane.  Autologous cultured chondrocytes are human-derived cells which are obtained from the patient’s own cartilage for the manufacture of MACI.

Important Safety Information

  • MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.  MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders.  MACI is also not indicated for use in patients who have undergone prior knee surgery in the past six months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.
  • MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program. The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown.  Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.
  • Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases.  A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue.  Universal precautions should be employed when handling the biopsy samples and the MACI product.

About Articular Cartilage Defects of the Knee
Articular cartilage is a highly organized avascular tissue composed of chondrocytes embedded within an extracellular matrix of collagens, proteoglycans and noncollagenous proteins.  Its primary function is to enable the smooth articulation of joint surfaces, and to cushion compressive, tensile and shearing forces.  Articular cartilage damage is caused by both acute and repetitive trauma resulting in knee pain, effusion or mechanical symptoms such as catching and locking, and swelling.  Since articular cartilage is avascular it has little capacity to repair itself or regenerate.  Articular cartilage lesions that are left untreated may progress to debilitating joint pain, dysfunction, and osteoarthritis.1  The prevalence rate for cartilage lesions in the knee has been reported to be 63% in patients undergoing investigational arthroscopies.2

About Vericel Corporation
Vericel develops, manufactures, and markets autologous expanded cell therapies for the treatment of patients with serious diseases and conditions. The company markets two cell therapy products in the United States. Vericel is marketing MACI® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant for the treatment of cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Vericel is also marketing Epicel® (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel is developing ixmyelocel-T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy. For more information, please visit the company’s website at www.vcel.com.

Epicel®, Carticel®, and MACI® are registered trademarks of Vericel Corporation. © 2017 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of Vericel products, intended product development, clinical activity timing, regulatory process, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “can continue,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements, estimating the commercial potential of our products and product candidates, market demand for our products, product performance, ability of ICT to obtain approval to transfer funds to the U.S., and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2017, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

References

1Bedi A, Feeley BT, Williams RJ. Management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010;92(4):994‑1009.

2Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG. Cartilage injuries: a review of 31,516 knee arthroscopies. Arthroscopy. 1997;13(4):456-60.

Global Media Contacts:
David Schull
Russo Partners LLC
+1 212-845-4271 (office)
+1 858-717-2310 (mobile)
David.schull@russopartnersllc.com

Karen Chase
Russo Partners LLC
+1 646-942-5627 (office)
+1 917-547-0434 (mobile)
Karen.chase@russopartnersllc.com

Investor Contacts: 
Chad Rubin
The Trout Group
crubin@troutgroup.com
+1 (646) 378-2947

Lee Stern
The Trout Group
lstern@troutgroup.com
+1 (646) 378-2922
Read More
PuraPly-Box-and-Product_update.png

PuraPly™ Antimicrobial Named One of Top 10 Innovations in Podiatry

Posted On July 13, 2017 By OrthoSpineNews In Biologics, Extremities /  

CANTON, Mass., July 13, 2017 /PRNewswire/ — PuraPlyTM Antimicrobial (PuraPlyTM AM), an FDA 510(k)-cleared wound management product from Organogenesis Inc., has been named one of the “Top 10 Innovations in Podiatry” by Podiatry Today, an award-winning publication that covers the latest developments in podiatric medicine.

PuraPly AM was selected as a top innovation for 2017 for its impact on reducing bioburden in wounds.

It is estimated that the majority of wounds possess biofilm, which can negatively impact tissue repair and delay healing if not addressed. With PuraPly AM, clinicians have a product solution to specifically address this challenge.

“A lot of times, debridement alone isn’t enough to prevent the reformation of biofilm,” said Ryan Fitzgerald, DPM, FACFAS, Associate Professor of Surgery at the University of South Carolina School of Medicine, in the article from Podiatry Today. “As part of a comprehensive biofilm-based wound management approach including sharp debridement, PuraPly AM provides a barrier that helps prevent biofilm re-formation and supports healing.”

PuraPly AM is an FDA 510(k)-cleared Class II medical device that is intended for management of a variety of acute and chronic wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers. PuraPly AM is unique in that it combines purified native collagen with PHMB, which provides broad antimicrobial coverage and protects against a wide range of bacteria that colonize wounds and can progress to biofilm formation and infection.

“Developing and manufacturing innovative products that serve our customers’ needs is at the heart of what we do, so it’s an honor for PuraPly AM to receive this distinction,” said Gary S. Gillheeney, Sr., President & CEO of Organogenesis Inc. “We’re pleased about the extremely positive reception this product has received since its 2015 launch and look forward to helping more wound care clinicians utilize PuraPly AM in the fight against bioburden and infection.”

For more information on PuraPly AM, click here.

About Organogenesis Inc.
Headquartered in Canton, Massachusetts, Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’ versatile portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

Media Contact:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com/

Read More
Business-18-1.jpg

Jana granted regulatory clearance for Zimmer Biomet stake

Posted On July 13, 2017 By OrthoSpineNews In Financial, Regulatory /  

Michael Flaherty – July 13, 2017

(Reuters) – Jana Partners was granted regulatory clearance on Thursday for its purchase of shares in medical device maker Zimmer Biomet Holdings Inc, in a sign that the hedge fund is set to build its stake and press for changes at the company.

Jana on Thursday was granted early termination under the antitrust Hart-Scott-Rodino Act, a public filing required by the U.S. Federal Trade Commission’s when an investor buys shares in a company above a certain threshold.

The actual size of Jana’s stake in the company is not yet clear, nor are the hedge fund’s plans. Jana and Zimmer Biomet declined to comment.

READ THE REST HERE

Read More