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Biologics

ConvaTec Extends Protection for Surgical Wounds with Launch of AQUACEL® Ag SURGICAL SP Dressing

September 19, 2016 OrthoSpineNews

LUXEMBOURG, Sept. 19, 2016 /PRNewswire/ — ConvaTec, a leading global medical technology company, today announced the U.S. launch of AQUACEL® Ag SURGICAL SP dressing, extending the company’s range of AQUACEL® Ag SURGICAL cover dressings developed to help reduce surgical site infections.*

AQUACEL® Ag SURGICAL SP dressing has a thin adhesive layer, to aid conformability for specific types of surgical wounds such as cesarean section and lumbar spine surgery. The new slim profile dressing is also designed to provide the same antimicrobial protection benefits** as AQUACEL® Ag SURGICAL cover dressings.

Surgical site infections (SSIs) can be devastating to a patient’s health and costly for health care providers. In addition to the burdens of further treatment, under the Affordable Care Act, hospitals in the U.S. with high rates of patient readmissions 30 days post-surgery are subject to reduced reimbursement from Medicare.

“Postoperative wound infection is a leading cause of patient readmission following surgery, and a significant issue for both patients and health care providers,” said Bryan D. Springer, MD, Fellowship Director at OrthoCarolina Hip & Knee Center. “Reducing the risk of SSI is a major focus for our facility. Our experience with AQUACEL® Ag SURGICAL dressings is that these advanced dressings offer compelling value in terms of patient satisfaction, clinical outcomes and cost.”

“Patients undergoing back, abdominal and other types of surgeries have unique needs to support their post-operative healing and daily activities such as bathing, changing clothes and sleeping,” said Fiona Adam, Vice President and General Manager of Advanced Wound Care. “ConvaTec developed AQUACEL® Ag SURGICAL SP dressing in response to these specific needs as well as to address the risk of SSIs across a broad range of surgical wounds – in keeping with our commitment to the community of wound care specialists and patients whom we serve and whose lives we touch, every day.”

Published Studies Support Value of AQUACEL® Ag SURGICAL Dressings

In previous studies, AQUACEL® Ag SURGICAL cover dressings significantly demonstrated the ability to reduce the incidence of post-operative infection and other complications, such as skin blistering, and improve patient satisfaction.

In a retrospective clinical study of 1,778 patients undergoing hip and knee replacement surgery (total joint arthroplasty or “TJA”), published in The Journal of Arthroplasty, the use of AQUACEL® Ag Surgical cover dressing vs. standard gauze surgical dressing reduced periprosthetic joint infection (“PJI”) by 76 percent (0.4% vs. 1.7%, p=0.005).

Further results of a randomized controlled trial of 262 TJA patients, published in the American Journal of Orthopedics, found the use of AQUACEL® Ag SURGICAL cover dressing vs. standard surgical dressing reduced skin blistering by 88 percent (0.7% vs. 6%, p=0.026).  The study also found overall patient satisfaction improved 14 percent (mean satisfaction score of 92 vs. 81 out of 100, p=<.0001).

Like AQUACEL® Ag SURGICAL cover dressing, the new AQUACEL® Ag SURGICAL SP dressing features Hydrofiber® Technology, ConvaTec’s proprietary technology designed to help create a beneficial moist wound environment that supports healing. The antimicrobial silver dressing is highly conformable and provides a waterproof viral and bacterial barrier*** that supports patient comfort and hygiene, such as the ability to shower, after surgery.

AQUACEL® Ag SURGICAL SP received 510(k) clearance from the U.S. Food and Drug Administration earlier this year and is available in a range of sizes to cover a variety of surgical site incisions.

For more information about the AQUACEL® family of advanced wound dressings and Hydrofiber® Technology, visitwww.convatec.com or call ConvaTec customer service at 1-800-422-8811.

About ConvaTec
ConvaTec is a global medical products and technologies company focused on therapies for the management of chronic conditions with leading market positions in advanced wound care, ostomy care, continence and critical care, and infusion devices. ConvaTec’s products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. The company is owned by Nordic Capital and Avista Capital Partners.

AQUACEL and Hydrofiber are trademarks of ConvaTec Inc.
© 2016 ConvaTec Inc.
AP-016879-US

*Indicated for wounds healing by primary intent.  Refer to product Instructions for Use for more information.
**As demonstrated in vitro
**Provided the dressing remains intact and there is no leakage.  The use of this dressings neither guarantees nor warranties against AIDS or Hepatitis virus transmission.

– References available on request –

Contact:

Punnie Donohue
ConvaTec
punnie.donohue@convatec.com

SOURCE ConvaTec

Related Links

http://www.convatec.com

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Regulatory

NuVasive Receives FDA 510(k) Clearance Reinforcing Comprehensive Portfolio Supporting Pediatric, Adolescent and Adult Spinal Deformity Patients

September 19, 2016 OrthoSpineNews

September 19, 2016

 

SAN DIEGO, CA–(Marketwired – September 19, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it has received FDA 510(k) clearance for the Company’s market-leading MAGEC® system to be surgically implanted using its Reline® posterior fixation system for treating patients with severe spinal deformity conditions.

The Company’s MAGEC system is the only magnetically controlled growing-rod system cleared by the FDA for pediatric spinal deformity. MAGEC helps surgeons reduce the number of planned surgeries required to effectively treat patients with Early Onset Scoliosis (EOS). Supported by the versatility of the Reline system, NuVasive now offers surgeons a comprehensive solution for treating the most difficult spinal deformities.

“The FDA 510(k) clearance is a key milestone for NuVasive as we continue to deliver new innovation to the spine market, and now more specifically, the pediatric deformity market. More importantly, it reflects an increased ability to better treat children with EOS. Combining the game-changing innovation of MAGEC and the versatility of Reline, we help transform the experience for these young patients. NuVasive is committed to partnering with surgeons to revolutionize deformity surgery for patients in need around the globe,” said Jason Hannon, NuVasive’s president and chief operating officer.

Sonia Garcia, a six-year-old patient suffering from EOS and severe kyphosis, was identified by Shriners International to need urgent spinal deformity correction surgery. Dr. Robert H. Cho, chief of staff and a leading pediatric orthopedic surgeon at Shriners Hospitals for Children — Los Angeles, accepted the case.

“When I first met Sonia, she had a poor chance of surviving past her late teens. Because of her severe scoliosis, her quality of life was declining secondary to her lungs becoming collapsed and constricted by her progressive spinal curvature. Leveraging the versatility and reliability of Reline with the innovative MAGEC rod, we have significantly impacted Sonia’s life and minimized the number of surgeries she will require in the future. Immediately following her surgery, Sonia’s lung capacity increased by more than 30 percent, she reclaimed 10cm of height and her future is bright. This is why I do what I do, to help improve and change lives,” said Dr. Cho.

Sonia’s mother, Sonia Rafaela Garcia Navarro, shared, “I was willing to do whatever it took to find help for my daughter. As a single mother in a remote village in Mexico, we had exhausted our options, and were without hope. However, thanks to Dr. Cho and his clinical staff, Shriners Hospital and NuVasive, I’m speechless. Sonia’s best days are ahead.”

NuVasive’s minimally invasive, procedurally-integrated solutions feature a full portfolio of market-leading spinal deformity technologies, supporting pediatric, adolescent and adult deformities. NuVasive has a rich history of revolutionizing the treatment of adult deformity with the Reline system, Integrated Global Alignment platform (iGA™), Anterior Lumber Interbody Fusion (ALIF) and eXtreme Lateral Interbody Fusion (XLIF®) Anterior Column Realignment™ (ACR) systems. Details of the two technologies from the Company’s comprehensive deformity portfolio that Dr. Cho leveraged to successfully treat Sonia include:

  • MAGEC is comprised of a single-use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet controlled by an external remote controller. Periodic lengthening of the rod is performed in an office setting where the surgeon externally controls the implant, eliminating the need for a series of distraction surgeries used in the traditional surgical treatment for young patients.
  • The Reline portfolio reflects an evolution of posterior fixation technology, and is integrated with the iGA platform to treat patients through traditional open or minimally-invasive procedures. Whether preserving or restoring spinal alignment, Reline’s single system addresses the spectrum of spinal pathologies from adult degenerative and deformity to specialized pediatric deformity.

Attendees of the 51st Annual Scoliosis Research Society annual meeting in Prague, Czech Republic will have the opportunity to learn more about the MAGEC system, as guest speakers David Marks and Dr. Sulken Shah discuss best practices on September 22 at 4:30 p.m. in the Corinthia Hotel Prague.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

About Shriners Hospitals for Children

Shriners Hospitals for Children is changing lives every day through innovative pediatric specialty care, world-class research and outstanding medical education. Our 22 locations in the United States, Canada and Mexico provide advanced care for children with orthopedic conditions, burns, spinal cord injuries, and cleft lip and palate. Generally, care is provided until age 18, although, in some cases, it may be extended to age 21. All services are provided in a compassionate family-centered environment. For more information, please visit www.shrinershospitalsforchildren.org/losangeles.

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 Information

Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
Email contact


Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
Email contact
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NeuroSpine

Don’t Forget the Pulses! Aortoiliac Peripheral Artery Disease Masquerading as Lumbar Radiculopathy—A Report of 3 Cases

September 19, 2016 OrthoSpineNews

Am J Orthop. 2016 July

Lumbar radiculopathy is a common problem encountered by orthopedic surgeons, and typically presents with lower back or buttock pain radiating down the leg.1 While the most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis, the differential diagnosis for lower extremity pain is broad and can be musculoskeletal, vascular, neurologic, or inflammatory in nature.1,2Differentiating between orthopedic, neurologic, and vascular causes of leg pain, such as peripheral artery disease (PAD), can sometimes be challenging. This is especially true in aortoiliac PAD, which can present with hip, buttock, and thigh pain. Dorsalis pedis pulses can be palpable due to collateral circulation. A careful history and physical examination is crucial to the correct diagnosis. The history should clearly document the nature of the pain, details of walking impairment, and the alleviating effects of standing still or positional changes. A complete neurovascular examination should include observations regarding the skin, hair, and nails, examination of dorsal pedis, popliteal, and femoral pulses in comparison to the contralateral side, and documentation of dural tension signs. Misdiagnoses can send the patient down a path of unnecessary tests, unindicated procedures, and ultimately, a delay in definitive diagnosis and treatment.1

To our knowledge, this is the first report on a series of patients with thigh pain initially diagnosed as radiculopathy who underwent unproductive diagnostic tests and procedures, and ultimately were given delayed diagnoses of aortoiliac PAD. The patients provided written informed consent for print and electronic publication of these case reports.

Case 1

An 81-year-old woman with a medical history notable for hypertension, hyperlipidemia, and stroke initially presented to an outside orthopedic institution with complaints of several months of lower back and right hip, thigh, and leg pain when walking. She did not report any history of night pain, weakness, or numbness. Examination at the time was notable for painful back extension, 4/5 hip flexion strength on the right compared to 5/5 on the left, but symmetric reflexes and negative dural tension signs. X-rays showed multilevel degenerative disc disease of the lumbar spine, and magnetic resonance imaging (MRI) showed a small L3/4 disc protrusion causing impingement of the L4 nerve root.

A transforaminal epidural steroid injection at the L4 level was performed with minimal resolution of symptoms. Several months later, right-sided intra-articular facet injections were performed at the L4/5 and L5/S1 levels, again with minimal relief of symptoms. At this point, the patient was sent for further physical therapy.

Over a year after symptom onset, the patient presented to our institution and was evaluated by a vascular surgeon. Physical examination was notable for 1+ femoral artery and dorsal pedis pulses on the right side, compared to 2+ on the left. An aortoiliac duplex ultrasound showed severe significant stenosis of the right common iliac artery (>75%).

 

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Biologics

New Amniotic “Stem Cell” Review Paper: Misinformed or Misleading?

September 19, 2016 OrthoSpineNews

By

One of the things that’s often hard for patients to understand is that when it comes to using stem cells for orthopedic conditions, the universities are way behind private-practice physicians. The good news is that we’re seeing some universities, like Stanford, Emory, and the Mayo Clinic, begin to embrace simple cell therapies. The bad news is that other universities are still way behind the average private-practice doctor in using these therapies. An example of that issue is a recently published amniotic stem cell review paper by physicians at Rush University in Chicago. These guys are likely well meaning, but they clearly have little knowledge of what’s not in commercially available amniotic tissues being sold on the market today.

What Are Amniotic Tissues?

While I’ve blogged on this topic many times, amniotic tissues are derived from the waste products of the delivery of a child—namely, the amniotic fluid that surrounds the baby as well as the birth sac and placenta. Given that these tissues are cheap and plentiful, they’ve been sold for many years for use in wound healing, neurosurgery, and ophthalmology. These same amniotic products have been more recently used in orthopedic injuries, despite a lack of data showing that they could help these problems. More concerning is that many physicians have been convinced by sales reps that commercially available amniotic tissues contain stem cells, but they, in fact, contain no live cells. Even more concerning is that many physicians extend this ruse to their patients, convincing them to spend big bucks on amniotic “stem cell” injections that, in fact, contain no stem cells.

Conflicts?

Before I read many papers, I always do a little snooping on the authors, just to see who they are, who they work for, and whether there may be bias in what they write. In this paper, they list 14 different companies that have funded research, paid royalties or speaking or consulting fees, or provided stock or stock options. While this isn’t automatically a significant conflict, three of the companies (NuTech, Arthrex, and Zimmer) make or vend amniotic tissues. Hence, the authors have conflicts of interest on this topic. Having said that, I run a large, international, medical-group practice that has chosen not to use amniotic stem cells, so some would say that I have the opposite bias.

The Familiar Amniotic Stem Cell Shuffle Is Alive and Well 

Here’s my big concern with this paper. While I expect the usual rank-and-file uneducated physician to make the mistake that commercial amniotic products contain living stem cells, I don’t expect university physicians to make that same mistake.

 

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Regulatory

RTI Surgical® Receives Regulatory Clearances, Expands Distribution of nanOss® Bioactive in Australia, Europe

September 19, 2016 OrthoSpineNews

September 19, 2016

ALACHUA, Fla. (DATE) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, announced it has recently received regulatory clearance from the Australian Therapeutic Goods Administration (TGA) for nanOss® Bioactive bone void filler in Australia. The company also announced it has received CE Mark from BSI for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe.

NanOss Bioactive bone void filler is an advanced bone graft substitute composed of nano-structured hydroxyapatite granules and an open structured engineered collagen carrier. It is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. NanOss Bioactive is among few synthetic-based grafts* with peer-reviewed evidence of posterolateral fusion. NanOss Bioactive bone void filler will be distributed for RTI Surgical in Australia by LifeHealthcare Group Limited (ASX: LHC), one of Australia’s leading independent medical device distributors.

NanOss Bioactive Loaded bone void filler is a closed system with a pre-filled mixing syringe for consistency, sterility, compression and easy delivery of NanOss Bioactive bone void filler. NanOss Bioactive 3D bone void filler is an advanced bone graft composed of nano-structured hydroxyapatite granules suspended in a porous gelatin-based foam matrix. NanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler will be distributed by RTI Surgical and its independent distributors in Europe.

“We are pleased to have received regulatory clearance to launch nanOss Bioactive bone void filler in Australia, as well regulatory approval for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe,” said Carrie Hartill, executive vice president and chief scientific officer. “These clearances expand our broad portfolio of surgical implants offered across the globe and give surgeons worldwide more options to help their patients improve their quality of life.”

*A product that is manufactured from synthetic material but may also include carrier materials derived from non-human materials.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website atwww.rtix.com or the SEC’s website at www.sec.gov.

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Financial

Developing New Orthopaedic Business Models: 2020 and Beyond

September 19, 2016 OrthoSpineNews

Posted in Health Reform Watch | Sept., 2016 – Carolyn LaWell is ORTHOWORLD’s Chief Content Officer

To thrive in the healthcare environment of tomorrow, orthopaedic device companies will need to operate within a greater portion of the supply chain, assisting upstream and downstream customers in finding operational value. This will require companies to forge stronger relationships, focus on internal efficiencies and launch services, not just devices. Ultimately, the business models of orthopaedic device companies must radically change if they want to maintain profitability, margins and independence in coming years. This was the message from OMTEC® 2016 keynote speaker Bill Tribe, Ph.D., Partner at A.T. Kearney’s Health Practice.

The message is bold, yet not surprising. One needs to look no further than the product—not device, but product—launches of the largest industry players in recent years. Observe a number of examples: DePuy Synthes’ focus on bundled payment services,Stryker’s purchase and subsequent launch of the Mako robot, Smith & Nephew’s development of Syncera. Additional players and offerings, like Cardinal Health’s expansion into the commercialization of orthopaedic implants and Millstone Medical Outsourcing’s direct-to-patient and hospital distribution model, are reaching new portions of the supply chain.

Tribe referred to these as pilot programs. While it can be assumed that a large amount of research and resources, both personnel and capital, went into the creation of these technologies and services to gain meaningful return on their investments, most on this list are too early in their lifecycles to deem successful long-term.

What these companies attempt to do with these models, though, is to solve a different problem for their customers while generating a new revenue stream for themselves. They move beyond legacy devices and distribution to target new price points and customers, and even create new audiences. Tribe argued that all orthopaedic companies, regardless of size or position in the supply chain, should introduce alternative business models that match the shifts in healthcare and their own company needs.

Here is why.

The Economic Case

Margins across the medical device sector have been falling for more than a decade, and will continue to erode by about 5% if unaddressed, according to Tribe’s research. Compounding that is the continued negative impact of price pressure, at nearly 3% per year. An average orthopaedic company would need to reduce its cost of goods by 12% or its Selling, General and Administrative expenses by 8%, or some combination of the two, to offset that 3% in price pressure, he says. That pressure is consistent; therefore, companies must get leaner each year.

On a positive note, orthopaedics is a $46 billion industry growing in the low-single-digits year over year, according to ORTHOWORLD’s THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. Healthy procedural volumes due to a growing and aging population, and untapped and underserved markets, mean that the industry remains attractive.

 

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Regulatory

FDA Clears Omega3-Rich Fish Skin for Surgical Applications

September 19, 2016 OrthoSpineNews
SEPTEMBER 16, 2016
McClean, VA – (Marketwired – Sept 13, 2016) – Kerecis, the company using Omega3-rich fish skin for tissue healing, has received clearance from the Food and Drug Administration (FDA)
to market the proprietary Kerecis technology as a surgical buttress in the United States. The Kerecis Omega3 Secure Mesh can be used in lung, bariatric, gastric, colorectal and other surgeries.
Kerecis Omega3 is intact fish skin rich in naturally occurring Omega3 polyunsaturated fatty acids. The material, which is used to regenerate damaged human tissue, has the potential to accelerate healing, and was developed in collaboration with the U.S. Office of Naval Research.
Surgical staplers are commonly used during laparoscopic operations to simultaneously cut organs and staple the resulting organ wound closed. The Kerecis Omega3 fish-skin product can strengthen the staple line and reduce the possibility of leakage. The Kerecis Omega3 material recruits the body’s cells from the tissue surrounding the organ cut. These cells are incorporated into the fish skin, which is ultimately converted into functional, living tissue. Studies have shown that cells and stem cells proliferate faster in this structure than in mammalian-sourced materials such as pericardium tissue.

“With diabetes and obesity so common today, improved surgical technologies are needed to cope with more stress and tissue mass,” said Fertram Sigurjonsson, CEO, president and chairman of Kerecis Limited. “Our technology can help improve outcomes by reducing the possibility of leakage from surgical wounds. The FDA approval represents an important milestone for us, as we now have two approved products in the world’s largest market for surgical products.”

About Kerecis

Kerecis develops regenerative technologies based on fish skin and Omega3 polyunsaturated fatty acids.

The Kerecis technology is patented in the U.S. and multiple other countries. The initial Kerecis product, Kerecis Omega3 Wound, has been approved by the FDA and European regulatory authorities for wound healing. The product has a Medicare “Q” code (Q4158), allowing it to be easily identified and processed by Medicare and private insurance companies. The FDA has also cleared Kerecis Omega3 SecureMesh for surgical use in the United States.

Kerecis Omega3 is produced in Iceland from fish locally harvested in the North Atlantic waters. For more information, visit www.kerecis.com. Distributor and licensing inquiries are welcome.

Source: FDA Clears Omega3-Rich Fish Skin for Surgical Applications

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Spine

UNYQ Showcases 3D Printed Scoliosis Brace with Embedded Wearable Technology at White House Event Celebrating Inclusive Design, Assistive Technology & Prosthetics

September 19, 2016 OrthoSpineNews

September 15, 2016

WASHINGTON–(BUSINESS WIRE)–

UNYQ, the San Francisco- and Seville-based pioneer in personalized prosthetics and orthotics, today showcased their new state-of-the-art scoliosis brace, UNYQ Align™, and their personalized prosthetic cover, UNYQ Performance™, at a White House event hosted by the White House Office of Public Engagement and Office of Science and Technology Policy. UNYQ Align™ combines 3D-printing and digital design, powered by the Intel® Curie™ module, into a stylish, customized, and lightweight medical device that assists scoliosis sufferers.

This Smart News Release features multimedia. View the full release here:http://www.businesswire.com/news/home/20160915006398/en/

For this special White House event, UNYQ teamed up with Studio Bitonti, led by famed designer, Francis Bitonti, to imagine a brand new type of UNYQ Align™ brace. The result is not only fashionable, but, through innovative topology optimization technology, Studio Bitonti and UNYQ were able to reduce the material significantly to create their most breathable and lightweight scoliosis brace yet.

“It was a privilege to collaborate with UNYQ on this solution. These are the kinds of projects designers need to be paying very close attention to,” said Francis Bitonti, CEO of Studio Bitonti. “UNYQ Align™ demonstrates how innovative technologies, designers, and technologists can combine to revolutionize treatment of medical conditions and dramatically improve the lives of the people who rely on assistive devices.”

Around 7 million US citizens suffer from scoliosis, a curvature of the spine that afflicts both young and old. Bracing is the most common treatment for children and teens, with prescribed usage of up to 16-18 hours a day. Traditional braces make it difficult for patients to reach the minimum recommended bracing period per day because they are constricting, bulky and perceived as unattractive.

UNYQ Align™ uses sensors to detect how long a user wears the device, and monitors pressure points to ensure fit and function. A mobile app collects the data for use by clinicians to make adjustments based on empirical data. At 3.5mm thick, the new brace is lightweight and slim enough to wear under a shirt, and comes in a wide variety of colors and patterns. These innovations dramatically improve the patient’s experience and impact their willingness to wear the brace.

“We are thrilled to have been invited to feature 2 of our products, UNYQ Performance™ and UNYQ Align™ at the White House Event Celebrating Inclusive Design, Assistive Technology & Prosthetics,” said Eythor Bender, UNYQ CEO and Co-Founder. “I’m continually inspired by people who have overcome personal barriers, and am proud we have developed products that allow them more opportunities to do so.”

The White House event included remarks from administration officials, industry experts, and designers, and featured a fashion show highlighting inclusive creations.

Included in the fashion show:

  • The UNYQ Align™ concept scoliosis brace designed by Studio Bitonti for UNYQ, was modeled by Grace Mosier, a 15-year-old with scoliosis. Grace demonstrated how the tiny, yet powerful embedded Intel Curie™ Module is helping her reach her treatment goals, while its stylish, customized, and lightweight design gives her more confidence and increases her willingness to wear the brace.
  • An example of UNYQ Performance™, personalized prosthetic covers, that empower amputees to celebrate their authenticity in a fashionable way was worn by retired US Marine Corps Sergeant, Kyle Garcia, whose left leg was amputated after suffering a blast injury from an IED during his third deployment in Afghanistan.

UNYQ Align™ will be launched to a limited number of the top clinics in the U.S. in October. The UNYQ Align™ App will be available in the spring of 2017. Sign up for updates at www.unyq.com.

About UNYQ
UNYQ delivers personalized non-invasive orthopedic devices that improve quality of life and celebrate user’s authenticity fashionably. The company employs digitization and 3D printing and cognitive systems to enhance device functionality and democratize access to everyone affordably. To learn more about UNYQ, its Hub Network and complete product lines, visit unyq.com.

About Studio Bitonti
Studio Bitonti creates tools that push ideas into the world. It designs manufacturing processes, products, and software to enable clients to use emerging technologies on a variety of projects with a variety of materials. The studio’s goal is to help clients produce their ideas with the most innovative tools available. Studio Bitonti is based in Brooklyn, NY. More information can be found at studiobitonti.com

About Intel
Intel (INTC) expands the boundaries of technology to make the most amazing experiences possible. Information about Intel can be found at newsroom.intel.com and intel.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160915006398/en/

MULTIMEDIA AVAILABLE:http://www.businesswire.com/news/home/20160915006398/en/

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Biologics

Bioventus Launches EXOGEN® Ultrasound Bone Healing System in the Kingdom of Saudi Arabia

September 19, 2016 OrthoSpineNews

September 19, 2016

HOOFDDORP, The Netherlands–(BUSINESS WIRE)–Bioventus, a leader in orthobiologic solutions, today announced the launch of itsEXOGEN Ultrasound Bone Healing System in the Kingdom of Saudi Arabia. EXOGEN uses safe, effective low-intensity pulsed ultrasound to help stimulate the body’s natural healing process.1 It also has an 86% heal rate for fractures not healing on their own2 and provides 38% faster healing of fresh fractures.3,4 In addition, 89% of patients with high-energy fractures reported healing when treated with EXOGEN.5

“This announcement marks another milestone as Bioventus continues expanding to international markets and growing its global footprint in orthobiologics,” said Tony Bihl, CEO Bioventus. “ZIMMO, which has more than 40 years of experience serving the healthcare sector in the region, is working with us to distribute EXOGEN.”

“Earlier this spring a team from Bioventus that included representatives from sales and marketing and medical science experts and consultant, visited Riyadh and Jeddah and, trained more than 30 surgeons and key opinion leaders on how to use EXOGEN with patients for both fresh fractures and non-unions,” said Andrew Hosmer, Managing Director International, for Europe, Middle East and Africa, Bioventus. “In addition, this move further grows our relationship with ZIMMO as the company also distributes DUROLANE®, our single injection hyaluronic acid osteoarthritis product.”

EXOGEN is available in the Kingdom of Saudi Arabia now and more information can be found at www.exogen.com.

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. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. 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. DUROLANE is a registered trademark of Galderma.

EXOGEN – Indications for use in the Middle East.

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

• Treatment of delayed unions 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 to the use of EXOGEN.

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.

2. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH Low-intensity pulsed ultrasound in the treatment of non-unions.J Trauma. 2001; 51(4):693−703.

3. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF Acceleration of tibial fracture-healing by non-invasive, low intensity pulsed ultrasound. J Bone Joint Surge [Am].

1994; 76(1):26−34.

4. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo controlled study. J Bone Joint Surg [Am]. 1997; 79(7):961−973.

5. Lerner A, Stein H, Soudry M. Compound high-energy limb fractures with delayed union: our experience with adjuvant ultrasound stimulation (EXOGEN). Ultrasonics. 2004; 42(1):915-917.

Contacts

Bioventus
Media Contacts:
Thomas Hill
+1 919-474-6715
thomas.hill@bioventusglobal.com
or
Berdine Vonk
+31 (0)23 554 88 14
berdine.vonk@bioventusglobal.com

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Financial

Troubled hospital giant CHS looking to sell its business

September 19, 2016 OrthoSpineNews

By Dave Barkholz  | September 16, 2016

Troubled Community Health Systems is considering selling its entire business, according to various reports Friday.

Quoting anonymous sources “with knowledge of the matter,” Bloomberg said hospital giant CHS had enlisted advisers to consider options. Deliberations are in the early stages and there is no certainty of a deal, according to reports.

CHS’s battered stock price surged on the rumors, closing up 16% Friday to $12.27 per share.

CHS spokeswoman Tomi Galen said CHS does not comment on rumors.

Earlier this month, Modern Healthcare reported that CHS plans to sell more than the 12 hospitals it has for sale, quoting CFO Larry Cash speaking at the Wells Fargo Securities Healthcare Conference in Boston.

Cash said they are getting interest in additional hospitals. And after examining its portfolio of 159 hospitals, it likely will see “other transactions” before the end of the year, he said.

 

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