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August 30, 2016 OrthoSpineNews

August 29, 2016

MIAMI–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, has achieved long-term success for hundreds of pain patients during the early adaptor rollout of the world’s first miniature wireless pain relief system. Embraced by pain specialists seeking non-opioid treatments, the drug-free, breakthrough remedy offers new hope to the more than 400 million people worldwide who suffer from chronic pain.

“Every day in the U.S. an average of 120 people die as a result of drug overdose, more than from motor vehicle crashes, and another 6,700-plus are treated in emergency departments for the misuse or abuse of prescription pain medication,” said Stimwave Chairman and CEO Laura Tyler Perryman. “We believe that Stimwave’s Wireless Pain Relief® technology is not only a viable option to help millions of people who suffer from chronic pain, but a potential life-saver as the U.S. faces an epidemic of opioid addiction that in many cases is an unavoidable side effect of long-term use of addictive pain medication.”

Stimwave’s Wireless Pain Relief devices are 95 percent smaller than any other neuromodulation device on the market, so small, with a diameter of less than 1.5 millimeters, that they are simply implanted through a standard needle during an outpatient procedure and a minimally invasive receiver placement technique. Because they are wireless, with the power source discreetly worn outside the body, there is no need for the invasive “open surgery” required of earlier neuromodulation devices, reducing the risk of infection, pain at the site of a large battery, and other long-term complications of battery units and connectors that account for 85 percent of adverse events, according to registries. Further, this miniature wireless device is powered by a wearable antenna, easily integrated into clothing and requiring no sticky gels that could irritate the skin, and there are no “wires” protruding from the body.

“This is great news for pain specialists and chronic pain patients who previously did not have a minimally-invasive implant option available for pain,” said Dr. Sanjay Gupta, president of the American Pain Association and principal clinician at Atlantic Pain and Wellness Institute. “Our country is facing a horrible epidemic of drug overdose deaths. These wireless products provide an alternative to opioids, which is much needed in the armamentarium for effective pain control.”

Stimwave launched it’s FDA-cleared devices for the relief of chronic back and leg pain to a limited number of patients throughout 2015, and in March 2016 was granted FDA 510(k) for the relief of peripheral nervous system (PNS) pain, becoming the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

“The major issue with peripheral nerve stimulators in the past has always been the bulk and length of cables, connectors and pulse generators,” said Dr. Richard North, consultant and retired Professor of Neurosurgery at John Hopkins University School of Medicine. “A miniature wireless peripheral nerve stimulator will minimize the need for surgery in patients who already are suffering from pain. It has long been needed and now is finally a reality.”

Stimwave’s wireless device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. The Stimwave device contains no internal batteries or other toxic materials. The device is fixed in place by an anchor, so it stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.

The Stimwave portfolio also includes the only neuromodulation system approved for “full body” MRI examinations, meaning the device does not have to be removed for 3-Tesla MRI exams. This is a significant diagnostic breakthrough as it allows patients with pain to benefit from neuromodulation without restricting their access to MRI-assisted diagnoses, for current or future medical issues.

“Stimwave saved my life. Without this amazing product, I would still be in terrible pain, on medication, and having my health fail,” said Anthony Torres, a cargo crane operator severely injured in an industrial accident. [Please see accompanying Patient Profiles.] “The external wireless batteries are small, effective, and simple-to-use.

“The best thing about Stimwave is that it gave me relief from the pain and allowed me to get off the pain medications. I wanted to get off all the pain medications.”

Please visit www.stimwave.com for more information.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management.

Contacts

Glodow Nead Communications
Casey Shaughnessy, Sonia Sparks and Evan Nicholson, 415-394-6500
stimwavepr@glodownead.com


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August 30, 2016 OrthoSpineNews

MARIETTA, Ga., Aug. 30, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that it will attend the Morgan Stanley Global Healthcare Conference in New York, NY.  Parker H. “Pete” Petit, Chairman and CEO, William C. Taylor, President and COO, and Michael J. Senken, Chief Financial Officer, are scheduled to participate in one-on-one and small group meetings on Wednesday, September 14, 2016, at the Grand Hyatt New York.

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone.  “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ brand; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix,  EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft;  EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and  CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.

We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com


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August 30, 2016 OrthoSpineNews

Published on

Last year, I wrote an article called The Distributor Dilemma. Fortunately, the article received very positive feedback so I thought I’d write something else to further elaborate on a few key points. If you didn’t want to take the time to read (or re-read) my previous post, here is a quick recap:

As a manufacturer, you have to differentiate yourself from the competition to prevail at the end of the day. There are obviously a few ways to do that but they generally fall into one of two categories. The first is manipulation. That isn’t as sinister as it sounds. You can differentiate by using manipulation via price cuts, increased commissions, sales inducements, etc. These can be effective but are generally not sustainable and transition the relationship with your distributor from relational to transactional.

The second way you can differentiate is through inspiration. At first, that sounds fairly altruistic, but here is my explanation. You can inspire a business partner through uncommon customer service that makes their job easier, unparalleled support in helping them develop their business to achieve their own personal goals and/or a true alignment in goals and objectives.

UNCOMMON CUSTOMER SERVICE

Every single company does their best to service their customer. I am a firm believer that no one in the professional world would wake up each morning with the intention of alienating the very customers that help them grow. If that is true, why do so many distributors have such legitimate gripes with the manufacturers they currently represent? It is my analysis from working with many companies, some with great reputations of working with their distributors and others that can’t say the same thing, that the fundamental issue here is knowing who the real customer is.

A spine company with an independent sales force has to view its primary customer as the distributor because they are the one with the key relationship. They are the ones that you want to approach a surgeon with their head held high and excited to have the honor of representing you. Without that level of enthusiasm, the sales process if often reduced to “Hey Doc, what do you think of this widget?” and that isn’t compelling at all.

Here are a few quick questions you can ask yourself to determine if your customer service is a positive for your sales story or if its holding you back?

  1. Do we have a good game plan to ensure that we can support any surgery with implants, instruments and technical guidance if necessary?
  2. Do we equip our field sales agents/reps with well-made demo kits to help turn a lecture into a show and tell?
  3. Does our company have a cohesive and easily understood marketing strategy?
  4. Once we have signed up a distributor, what is the specific process we use to help ensure they have everything they need?
  5. Once they have obtained interest from a surgeon, how do you support them throughout the hospital approval process?
  6. What kind of communication do you expect from (and offer to) your distributor customer?

If you are unsure how your process works compared to others in the industry, feel free to reach out for a quick conversation. I have a strong passion to help companies succeed in this space and have been granted the gift of perspective to help you potentially avoid trouble that is in your blind spot.

UNPARRALLED SUPPORT IN HELPING THEM DEVELOP

Anyone that has seen the changes in how manufacturers engage with distributors for the past 10 years can see an almost seismic shift. Companies used to want to find a distributor organization that could support a large geographic territory. These distributors took on the risks of hiring sales reps to develop the geographic territory on your behalf. This type of distributor might still be present for the larger, full line companies but if you are a smaller manufacturer with a niche line or gaps, they aren’t interested in you. So now what?

What you have the ability to capitalize on is that many of these distributors trained reps that later figured out that they can make more than 7-10% on an ever shrinking territory by signing up with a manufacturer directly. By doing so, they could almost quadruple their income and reduce their workload by 50%. We call this type of “distributor” a rep principal. What most manufacturers would say about this type of distributor is that they follow the path of least resistance in selling new products and services. What I think is that they are incredibly hard working individuals that are so focused on protecting the relationship with their surgeons that they are very careful to put that at risk for a company that might not be here next month. (Example: see LDR Spine distributors)

To be able to properly entice and support a distributor, you must first understand who they are and who they want to be. That may sound overly simplistic and I agree that it probably is. However, it is just the starting point. Understand where they want to be and offer help to get them there. Here is a short list of the most frustrating things distributors have to deal with:

  1. Manufacturers want them to do all the heavy lifting to get products approved in their hospitals without any longer term commitment or up-front investment.
  2. Sometimes products aren’t available when they need them and the person that bears all the political responsibility for such a failure is the distributor.
  3. Due to the cost of sets, there is usually a shortage so companies want the distributors to be a team player and ship them to other locations without any real incentive to do so outside of goodwill.

Those are the most commonly complained about issues and I have to say, I totally get it. Take your time to understand their market and realistic possibility. Unfortunately for the manufacturer, the burden falls upon you and if you don’t support the distributor customer, someone else will be happy to. Also, consider looking into Ortho Sales Partners (www.orthosalespartners.com) to see the offerings they can provide on a consulting basis to help you and your distributor customer navigate the approval process in a win/win fashion.

ALIGN GOALS AND OBJECTIVES

Ok, so this one is the biggest no brainier, right? If you both have the attitude of selling as much product as possible, that sounds like alignment but you might be worlds apart. How do you sell? How do you communicate? How do you support?

Transparency is a very important part of goal alignment. Companies often believe that they deserve to know every detail of a distributors business, which is a fact that most distributors will reject emphatically. Often times there is way too much scare tissue from previous experiences. Again, let’s look at the recent acquisition of LDR Spine. It’s my understanding that LDR had somewhere around 100 distributors in the field. All of them had tremendous success in helping the company grow to a $1 BILLION acquisition by Zimmer Biomet. What was their thank-you you ask? One day they received a call from a ZB AVP letting them know they are excited to work together and that they need all the historical data of their users and current inventory on hand. It’s obvious to everyone why they wanted that information. ZB has large scale geographic distributors. The LDR guy is not going to win that battle so they are beginning the transition process. So if you are that distributor, you can either comply and hand over your hard earned customers or you can quit on the spot and begin the hunt for another product line to replace that revenue. Neither of those options sound particularly enticing to me… you?

As a company, you must be sensitive to those situations and the stress that adds to the distributors business. If you invest in their business and give them tools that they can use to immediately succeed on your behalf, but also makes them a better distributor in the years after a potential take-out, you are all better off because of that relationship. A few things you could offer outside of standard points that will provide the distributor with long-term tangible value:

  1. Sales skills development training. Most companies offer clinical training for their products, but what about a training program that helps develop the person and makes them a more effective sales agent.
  2. A software infrastructure that will help them more efficiently run their business and eliminate mistakes. (Check out Surg.io)
  3. If the distributor is on the right track, offer an incentive to help them afford hiring an associate/cover rep. The distributor is the rainmaker and needs to spend some time in the OR, but if he’s in the OR every single day, he’s limited in his ability to find new opportunities.

WRAP UP

I am completely aware that when you read articles like this, things can come across simplistic and elementary. My intention in writing these things is to make you take 10-15 minutes to think about how you view and treat your distributor customers. If you are experiencing great success, keep doing what you are doing! If you find yourself at times frustrated that it seems like you are spinning your wheels, then re-evaluate. You might need to change the way you are doing things.

I don’t think the answer is always “more points”. It is my conviction from the years I have spent in the business that if you can out-service, out-support and align your goals, you will see dramatic improvement in the relationships you already have and that will quickly lead to new business opportunities. If you’d like to speak with me, please reach out via private message or email me at js@orthospineco.com. I am always interested in helping work through these complex challenges and provide any support that I can.

 


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August 30, 2016 OrthoSpineNews

By Bob Herman  | August 29, 2016

The CMS proposed rules Monday afternoon that would make several changes to the Affordable Care Act marketplaces and refine the law’s risk adjustment, heeding calls from the health insurance industry.

The proposed rules (PDF), which normally are released in November, come after weeks of intense scrutiny and uncertainty about the viability of the new ACA insurance exchanges. Aetna, Humana and UnitedHealth Group, which have bigger footprints in the employer and Medicare Advantage markets, all have announced major retrenchments for the 2017 season, which begins Nov. 1.

One of the biggest changes involves the ACA’s permanent risk-adjustment program. Lawmakers created risk adjustment to compensate plans for taking on sicker enrollees who have higher healthcare costs, thereby attempting to eliminate the incentive to cherry-pick healthier people.

Starting in 2018, risk adjustment would factor in prescription drug data in addition to all the normal conditions and illnesses that are factored into someone’s risk score. Health insurers have argued their members look healthier than they actually are because the program doesn’t account for the medicines people are taking. But some risk-adjustment experts believe using drug data could create perverse incentives for doctors to write unnecessary prescriptions.

The CMS said the change was worth pursuing while considering those concerns. “We sought to strike a reasonable balance between increasing predictive accuracy and reducing incentives for overprescription,” the agency said. “One way we sought to do so was by focusing on drugs for which guidelines on when they should be prescribed are clear.”

 

READ THE REST HERE


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August 30, 2016 OrthoSpineNews

By Brittney Klingl – August 29, 2016

It makes sense that an accomplished inventor, entrepreneur and med tech executive would help mold the next generation of medical device leaders.

But for Dr. Dan Mooradian, director of graduate studies for the Master of Science in Medical Device Innovation(MDI) degree program, it goes beyond simply training engineers to be well-rounded professionals; it’s about improving the industry as a whole.

“We always focus on what is going to help our students meet the needs of their employers. I’ve been an executive, so I know what they’re looking for when they’re hiring and promoting.”

Dr. Mooradian is originally from Michigan, but it was in Minnesota – home to half of the world’s medical device companies – where he began his successful career.

“My career as a research scientist at the University of Minnesota, and my experience as a member of the teaching faculty in the biomedical engineering program helps me understand the research and discovery side of the industry. Having then spent 15 years applying that research to innovation, I have a unique perspective on what we can do for our students to prepare them to make a difference in the medical device industry. I came to the University of Minnesota to do my postdoctoral fellowship in laboratory medicine and pathology, and I ended up staying.”

Since then, Dr. Mooradian has worked at companies like Synovis Life Technologies, Baxter International and Boston Scientific, in positions ranging from an individual inventor and researcher to vice president. In 2013, he joined the Technological Leadership Institute to help launch its third and newest Master of Science degree program: Medical Device Innovation. Dr. Mooradian’s background and experience made him the perfect fit for the director of graduate studies role.

“My career as a research scientist at the University of Minnesota, and my experience as a member of the teaching faculty in the biomedical engineering program helps me understand the research and discovery side of the industry,” he says. “Having then spent 15 years applying that research to innovation, I have a unique perspective on what we can do for our students to prepare them to make a difference in the medical device industry.”

 

READ THE REST HERE


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August 30, 2016 OrthoSpineNews

ORLANDO, Fla., Aug. 30, 2016 — Mazor Robotics Ltd. (TASE:MZOR) (NASDAQGM:MZOR), a developer of innovative guidance systems and complementary products, installed a Renaissance® Guidance System at Grand Strand Medical Center in Myrtle Beach, SC on July 6, 2016 and has since completed an initial case series. Grand Strand is the second in the state of South Carolina and the ninth HCA-affiliated facility to purchase a Renaissance system. See how Renaissance works.

“One of our main goals is to help improve outcomes for our patients,” said Mark Sims, Chief Executive Officer for Grand Strand Medical Center. “Adding the Renaissance technology to our spine surgery program will elevate the level of quality care available to our community.”

Grand Strand Medical Center is a 301-bed acute care hospital serving residents of Horry and surrounding counties. The hospital offers the only cardiac surgery program, neurosurgery program and pediatric intensive care unit (PICU) in Horry and Georgetown counties and is a designated Level II Trauma Center by DHEC and the American College of Surgeons.

“Now, thanks to Grand Strand Medical Center, spine surgeons and their patients in the Myrtle Beach area have access to our technology” said Mazor Robotics Inc. CEO Christopher Prentice. “We believe in healing through innovation and we look forward to Grand Strand Medical Center redefining the standard of quality care.”

About Mazor
Mazor Robotics (TASE:MZOR) (NASDAQGM:MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a precise manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the benefits of the Renaissance technology, and other statements containing the words believes, anticipates, plans, expects, will and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

CONTACT:Stephani Shipman

Marketing Communications Manager

Mazor Robotics

s.shipman@mazorrobotics-us.com

(407) 591-3461

 


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August 30, 2016 OrthoSpineNews

August 30, 2016

LEXINGTON, Ky.–(BUSINESS WIRE)–With the continuation of extremely positive clinical results at the 1-month juncture, Intralink-Spine, Inc. (ILS) explains why the early reduction of low back pain in each of its four safety study patients was expected, given the almost immediate device formation associated with the Réjuve System.

Initially conceived by Tom Hedman, Ph.D. while an Associate Professor at the University of Southern California, the Réjuve device provides almost immediate mechanical support and stabilization to the spinal joint by the addition of numerous molecular bonds, which act as cross-ties in the tissue matrix. This immediate effect, according to ILS, is now being demonstrated in the clinical trial stage of its development.

According to Hedman, who is now the Chief Scientific Officer for ILS and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, “Four chronic low back pain patients were treated by orthopedic surgeon Dr. Harwant Singh at Pantai Medical Center (Kuala Lumpur, Malaysia) in an NMRR registered clinical safety study. Each of the four patients are pleased with their treatment and continue to have positive results at the 1-month juncture.”

“Patients experienced an average Visual Analog Scale (VAS) pain score reduction of 92% and an average Oswestry Disability Index (ODI) disability reduction of 88% at the 1-month interval. These positive one-month data are great news, especially as we move forward to our larger pivotal clinical studies,” says Hedman.

“All four patients are already enjoying a better quality of life than prior to the Réjuve treatment. And, they didn’t have to wait weeks or months, because the effects of Réjuve are almost immediate,” says Lyle Hawkins, CEO of ILS.

“The patients received fluoroscopic image-guided injections of the Réjuve medical device in the lumbar intervertebral discs, with two posterolateral injections per treated level,” states Dr. Singh. According to Hedman, “It’s unrealistic to think that all of our patients will achieve these same results, but these early data make us very optimistic that a single set of injections of the Réjuve medical device are all that some patients will ever need to receive permanent low back pain relief.”

According to Hawkins, “The Réjuve treatment is going to be very disruptive to how patients are currently treated for low back pain. Réjuve has the procedural simplicity of an epidural steroid injection, but with potential long-term positive effects. And, Réjuve is not patient dependent, complex, and expensive like most stem cell procedures currently in development.”

Contacts

Intralink-Spine Inc.
Lyle Hawkins, 502-419-8099
LHawkins@IntralinkSpine.com


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August 30, 2016 OrthoSpineNews

Posterior systems with transpedicular screws as basic element for stabilizing the spinal column have become the gold standard in surgical treatment of spinal deformities and are used in the majority of cases where correction of scoliosis or segmental fixation is required. What is to be done though in cases of severe kyphotic or scoliotic spinal deformities, particularly in connection with developmental anomalies such as hyperplasia or aplasia of the pedicles, which render it more difficult to introduce a screw? Not only does this often lead to an increase in the total time required for surgery, but the X-ray exposure time is also often increased considerably, resulting in unnecessary additional exposure of the patient and OR staff. The question arises whether other fixation methods can be resorted to.

Infralaminar hooks (LSZ) from SIGNUS Medizintechnik provide a useful alternative to pedicle screws in specific sections of the spinal column. Their stability is comparable to that of pedicle screws, as has been proven by a recent biomechanical in-vitro study [1]. The interaction between the infralaminar hooks and the pedicle screws is optimized in the DIPLOMAT Deformity system from SIGNUS Medizintechnik. Enhanced anchorage in cases of hypoplastic pedicles on the concave side, force transmission in translation too, extension of the posterior column and decreased implant density are achieved as a result of the hybrid technique.

You can download the biomechanical study from the SIGNUS website or view it directly on: www.signus.com, free of charge or directly on: http://link.springer.com/article/10.1007/s00586-016-4679-x. Further information on the hybrid technique with the DIPLOMAT Deformity system is also provided on the SIGNUS website.

¹Wilke HJ, Kaiser D, Volkheimer D, Hackenbroch C, Püschel K, Rauschmann M. A pedicle screw system and a lamina hook system provide similar primary and long-term stability: a biomechanical in vitro study with quasi-static and dynamic loading conditions. EurSpine J, 2016 Jul 12. DOI 10.1007/s00586-016-4679-x.

©image rights: SIGNUS Medizintechnik

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For further information please do not hesitate to contact us.

With best regards

Nadja Schatz
Consulting

m:werk GmbH & Co. KG
Healthcare Communication
Humboldtstraße 11
65189 Wiesbaden

Phone: 0611 / 1 60 86-22
Fax: 0611 / 1 60 86-15

e-mail: schatz@m-werk.de
http://www.m-werk.de

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August 30, 2016 OrthoSpineNews
Bordeaux, Boston, August 30, 2016 – IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that the US Patent and Trademark Office (USPTO) has granted Implanet a patent for the JAZZ® technological platform in the United States.

The JAZZ technological platform’s intellectual protection now covers the braided implant and its tensioning system, the principal element of its instrumentation. Implanet now possesses intellectual property architecture covering the specificities of its JAZZ® platform in the countries defined as priority markets during the Company’s IPO, i.e. the United States, Europe, China, Japan, Australia and South Africa. Implanet is now the only spine surgery player, apart from Zimmer Spine, to have patents for a spinal fixation technical solution enabling the braid’s tension and the implant’s position on the rod to be locked with a single screw.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “Being granted this patent in the world’s most advanced medical market represents major recognition by the authorities of the pre-eminence and innovative nature of our spine implant technology. This patent is a guarantee of JAZZ’s future in the United States, where surgeons demand increasingly innovative medical technologies. Our band implant and its tensioning instrument are now protected in our priority markets, and we will continue to extend our field of protection to other innovations currently in late-stage development.”

Ludovic Lastennet, CEO of Implanet, adds: “Obtaining this patent is a major value-creation milestone for Implanet. This protection creates a solid barrier to potential competitors in an American market that places a strong emphasis on intellectual property rights. Thanks to this protection, we have total confidence in our continued acceleration in the United States.”

Contacts

Florent ALBA
NewCap

Investor Relations | Strategic Communication
21 Place de la Madeleine – 75008 Paris – France
Tel: +33 1 44 71 98 55

 

 


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August 30, 2016 OrthoSpineNews

Lund, Sweden, 30 August 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that presentations and posters covering research with its CERAMENT G and CERAMENT V will feature extensively at the upcoming 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) taking place September 1-3 in Oxford, UK – which is a key congress for physicians and surgeons managing patients with bone infections. CERAMENT G and CERAMENT V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.

The EBJIS annual meeting will feature 25 abstracts highlighting research and clinical findings with CERAMENT G and CERAMENT V. This is a significant increase in the number of presentations and posters that were made at the 34th Annual EBIJS meeting reflecting the impressive clinical performance reported, the launch of CERAMENT V in 2016 and the growing interest in the only injectable antibiotic eluting bone graft substitutes that are available in Europe. Both CERAMENT G and CERAMENT V are able to deliver an initial high concentration of antibiotic to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to promote and protect bone healing and remodeling.

Richard Davies, CEO of BONESUPPORT, said: “The broad range of research and clinical data on CERAMENT G and CERAMENT V being presented at this year’s EBJIS Annual meeting highlights the significant increase in interest in these novel injectable antibiotic eluting bone graft substitutes. The new data also underscores BONESUPPORT’s commitment to supporting high-quality research that will help improve the management of important bone diseases. We are confident that the growing body of clinical evidence in support of both CERAMENT G and CERAMENT V will allow them to be used increasingly in patients with problematic bone infections including osteomyelitis, as well as prophylactically in patients at risk for developing an infection.”

BONESUPPORT recently received approval from the US Food and Drug Administration (FDA) to begin the FORTIFY study, an IDE (Investigational Device Exemption) study, with CERAMENT G.  This study is a randomized multicenter controlled trial that will evaluate the safety and efficacy of CERAMENT G as part of surgical repair of open diaphyseal tibial fractures. The first patient is expected to be recruited into the FORTIFY study by the end of 2016. Data from the FORTIFY study will be an important component of BONESUPPORT’S planned PMA to gain US approval for CERAMENT G.

EBJIS is a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists. The aim of the Society is to promote the knowledge of all infections affecting the Musculoskeletal system (bone and joint infections) and to promote the prevention and treatment of these infections. The complete program of the EBJIS meeting is available at http://ebjis.org/

 Notes to Editor

About BONESUPPORT

BONESUPPORT has developed CERAMENT an innovative range of radiopaque injectable bone graft substitute products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (CERAMENT BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT BVF’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden with subsidiary locations in the U.S. and Germany. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

 

Contact Information

 

Citigate Dewe Rogerson

David Dible, Andrea Bici

+44 (0)20 7282 2949/1050

bonesupport@citigatedr.co.uk

 

BONESUPPORT AB 

Richard Davies, CEO

Phone +46 46 286 53 59

Richard.Davies@bonesupport.com