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August 30, 2016 OrthoSpineNews

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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

In the event of publication please kindly send us a voucher copy.

For further information please do not hesitate to contact us.

With best regards

Nadja Schatz
Consulting

m:werk GmbH & Co. KG
Healthcare Communication
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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


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August 29, 2016 OrthoSpineNews

MARIETTA, Ga., Aug. 29, 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 an update to  its intellectual property portfolio.

Since the last update of the MiMedx patent portfolio in the Company’s November 19, 2015 press release, the U.S. Patent and Trademark Office has issued six new patents to MiMedx. Of these six, five were issued for the Company’s amniotic membrane allograft product lines and one was issued for the Company’s CollaFix technology platform:

U.S. Patent Number Title Patent Issue Date
9,216,077 “MEDICAL CONSTRUCTS OF TWISTED LENGTHS OF COLLAGEN FIBERS AND METHODS OF MAKING SAME” 22-Dec-2015
9,265,800 “PLACENTAL TISSUE GRAFTS” 23-Feb -2016
9,265,801 “PLACENTAL TISSUE GRAFTS” 23-Feb -2016
9,272,005 “PLACENTAL TISSUE GRAFTS” 01-Mar -2016
9,272,003 “PLACENTAL TISSUE GRAFTS” 01-Mar-2016
9,415,074 “PLACENTAL TISSUE GRAFTS” 16-Aug-2016

The ‘077 patent expands the portfolio of MiMedx patents related to the Company’s proprietary methodology for the linear organization of natural collagen fibers to form the mechanical construct for optimal stiffness and strength to treat orthopedic and other conditions such as tendon repair. The ‘800; ‘801; ‘005; ‘003; and ‘074 patents further add to the portfolio of patents issued to the Company for its proprietary methodology of preparing placental membrane tissue grafts for medical use.

Parker H. “Pete” Petit, Chairman and CEO, said, “We are continually creating and developing new intellectual property as well as adding to our portfolio of patents that protect our existing  intellectual property. At present, the Company’s robust patent portfolio consists of 33 amniotic and placental patents issued and allowed, and nearly 100 amniotic patent applications pending with the U.S Patent and Trademark Office. Counting all of the MiMedx technologies, we currently have over 200 patents issued or pending.”

Bill Taylor, President and COO, added, “We are strongly resolute in enforcing our rights when our patents are infringed upon. Often, this includes complex and costly litigation; however, this is essential if we want to protect our intellectual property to the fullest extent.”

MiMedx also announced today that a finding has been rendered from the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office regarding MiMedx’s United States Patent No. 8,372,437. As with the PTAB’s recent ruling on the ‘687 embossment patent, the PTAB ruled that the ‘437 patent was invalid based on alleged prior art rendering it obvious. This ‘437 patent is not primary to MiMedx’s proprietary processing of amniotic tissues, which processing preserves the cytokines, growth factors, proteins and other critical factors that enhance the clinical performance of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts.

Petit stated, “The ancillary ‘437 patent is simply one among our robust patent portfolio, and this decision has zero impact on any of our other issued patents and pending applications. Most importantly, the PTAB finding on the ‘437 patent has no bearing on our cornerstone EpiFix® and AmnioFix® patents, the 8,709,494 and 8,323,701 patents, respectively. The validity of these patents was recently upheld by the PTAB. In addition, it should be noted that the PTAB’s decision utilized a far broader standard for construing claims than what is utilized in federal courts. We believe that standard undoubtedly led to the flawed outcome.  And, while the ‘437 patent is by no means one of our primary patents, we believe the decision is fundamentally incorrect and we plan to appeal.”

“We have other claims more relevant to product effectiveness and efficacy that are embedded in our other patents covering the topics included in the broad ‘437 patent. The PTAB ruling does not affect our active district court litigations on the cornerstone EpiFix® and AmnioFix® patents, in which Musculoskeletal Transplant Foundation, Inc. (“MTF”), Liventa Bioscience, Inc. and Medline Industries, Inc. are defendants in the one case, and Transplant Technology, Inc. d/b/a Bone Bank Allografts and Texas Human Biologics, Ltd., are defendants in the other case. Those lawsuits remain pending with upcoming trials. As mentioned in our August 11, 2016 press release, the strength of our patent portfolio and the upheld validity of our cornerstone patents contribute to our high confidence for the successful outcome of our pending lawsuits,” noted Taylor.

Petit added, “We are working diligently to bring our patent litigation to closure and look forward to reporting to shareholders positive results from these first trials.  Some of these litigation issues can be quite complex so we will continue to inform shareholders of relevant actions.  The key issue is that if we are successful in these trials, we will have access to injunctive relief in terms of stopping other competitors from selling products that infringe our patents.  We will then be able to proceed against other violators of our patents and seek injunctive relief to stop their distribution of these infringing products.”

“Businesses ultimately succeed or fail through competition in the marketplace.  We have proven our ability to compete and win in the marketplace with our products over the last five years.  However, as a patent holder, we also believe it is worth investing time and expense on the legal front as well to protect the extensive effort that we have put into the development of our patents,” concluded Petit.

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.

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 approach to new patent filings and applications and enforcing its rights when its patents are infringed upon are essential elements of protecting its intellectual property; the Company’s belief that the PTAB’s finding that the ‘437 patent is invalid was wrongly decided; the Company’s belief that the standard employed by the PTAB led to the flawed ruling; the belief that the ‘437 patent is a novel concept; the Company’s beliefs that claims more relevant to product effectiveness and efficacy are embedded in its other patents covering the topics included in the broad ‘437 patent; the Company’s belief that it has proven its ability to compete and win in the marketplace with its products over the last five years; and the fact that both the ‘494 and ‘701 patents were upheld in IPR challenges gives the Company confidence that it will fully prevail at the conclusion of the two noted lawsuits at trial. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include  the patents that have been developed and the Company’s approach to filing and enforcement of its rights may not provide sufficient protection of the Company’s intellectual property assets; that the Company’s development of patentable technology may not continue at the same pace; the fact that the ‘494 and ‘701 patents were upheld in IPR challenges does not require that the patents be upheld at trial; if appealed, the PTAB decision on the ‘437 patent may still be upheld, despite the Company’s belief that the case was wrongly decided and that the patent is a novel concept; the Company’s ability to successfully compete in the marketplace may change in the future; the normal risks and uncertainties of litigation; 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, 2015 and its most recent 10Q. 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


Ferring-Pharmaceuticals-Logo-eps-vector-image.png

August 29, 2016 OrthoSpineNews

August 29, 2016 03:13 AM Eastern Daylight Time

SAINT PREX, Switzerland–(BUSINESS WIRE)–Ferring Pharmaceuticals announced today that it has signed an agreement with Seikagaku Corporation granting Ferring the exclusive worldwide rights (excluding Japan) to SI-6603 (condoliase), a chemonucleolytic product in Phase III development for the treatment of radicular leg pain (e.g. sciatica) due to lumbar disc herniation.

Seikagaku has been developing condoliase for the U.S. and Japan and has two on-going Phase III clinical trials (a pivotal double-blind study and an open-label safety study). Seikagaku is responsible for completing development and obtaining U.S. regulatory approval. Following approval from the Food and Drug Administration, Ferring will commercialize the product in the United States and has received further rights to develop, register and commercialize condoliase worldwide, excluding Japan. In consideration, Ferring will pay Seikagaku an upfront licensing fee, development and regulatory milestones and royalties.

“We believe condoliase may answer a substantial unmet need among those patients suffering from radicular leg pain due to lumbar disc herniation,” said Michel Pettigrew, President of the Ferring Executive Board and COO. “This is a significant opportunity to expand our global Orthopaedics franchise with a new innovative drug therapy.”

“Condoliase is an exciting product being developed with the potential to return a proven mechanism, chemonucleolysis, as a treatment alternative for radicular leg pain associated with lumbar disc herniation,” said Gunnar Andersson, MD, Professor and Chairman Emeritus of the Department of Orthopaedic Surgery at Rush University Medical Center in Chicago, U.S.A.

“Condoliase could offer a non-surgical alternative to patients for whom conservative therapy and/or corticosteroid injections have failed to provide durable relief, while maintaining the option for surgery should it later become medically necessary,” said Ray Baker, MD, past president, North American Spine Society.

About radicular leg pain and Condoliase (SI-6603)

Lumbar disc herniation (LDH) is the result of a progressive and degenerative process within the intravertebral disc (IVD) that affects between 1.6% of the general population to 43% of individuals in selected working groups worldwide, with the majority of incidents occurring in the fourth and fifth decades of life1,2. In the US, 3 to 5% of the population is symptomatic (i.e. sciatica)3. The IVD is made up of the nucleus pulposus and annulus fibrosis that together cushion and allow flexibility within the spine. The disc herniation may increase pressure on a surrounding root nerve resulting in lower back pain and radicular leg pain (e.g. sciatica).

Condoliase is being developed for use as a chemonucleolysis treatment to break down selected components of the IVD, primarily within the nucleus pulposus. This reduces its water content and volume, thereby relieving disc pressure and compression on the spinal nerve root. A Japanese Phase III study (163 patients) met its primary endpoint of significantly reducing worst leg pain at 13 weeks (vs. a saline placebo injection) with sustained relief at 52 weeks4.

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

FERRING is a trademark of Ferring B.V.

1 Konstantinou, K., Dunn, K.M. Spine (Phila Pa 1976) 2008, 33, 2464-2472

2 Ropper, A.H., Zafonte, R.D. New Engl J Med 2015, 372, 1240-1248

3 Tarulli, A, W et al. Neurol Clin 2007, 25, 387-405

4 Seikagaku (Study 6603/1031) Data on File)

Contacts

US
Patrick Gorman
+1-862-286-5035
patrick.gorman@ferring.com
or
Global
Lindsey Rodger
+41-58-451-40-23
lindsey.rodger@ferring.com