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May 31, 2017 OrthoSpineNews

CARLSBAD, CALIFORNIA–(Marketwired – May 31, 2017) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that the company has selected its proprietary implant locking technology covered by United States Patent No.: 9,603,637 entitled “POLYAXIAL INTERSPINOUS FUSION IMPLANT AND BONE GROWTH STIMULATION SYSTEM” for out-licensing opportunities for medical and industrial applications.

“Aurora Spine is now offering its new Polyaxial ZIP® Interspinous device patent for out-licensing or private label opportunities. The combination of the proven ONE-STEP™ locking mechanism, with no setscrew, and the polyaxial feature could be a unique opportunity in new product development for orthopedic and other medical and industrial manufacturers,” said co-inventor, Trent Northcutt, President and CEO of Aurora Spine.

“Aurora’s patented features offer new design directions for hardware connections that do not rely on conventional threads and screws thus preventing hardware loosening related problems,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine.

For more information on out-licensing or private label opportunities using the Polyaxial ZIP ISP platform, contact Laszlo Garamszegi at 760-424-2004 or

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.



  • Aurora Spine Corporation
    Trent Northcutt
    President and Chief Executive Officer
    (760) 424-2004

    Laszlo Garamszegi
    Chief Technology Officer
    (760) 424-2004


May 31, 2017 OrthoSpineNews

Published on

The orthopedic industry is changing faster than ever before. Whether you’re a surgeon, sales rep or orthopedic patient, much of the impact is less than positive. It seems that the industry is piling on the sales rep in an effort to marginalize and some might say eliminate the rep altogether. I recently read a headline about HCA’s record quarterly profits topping $980 MILLION. Keep in mind that this was Q4, 2016 at a time when hospitals are crying poor while fighting orthopedic companies on pricing like never before. Gone are the days where it was customary to assess a 3% price increase tied to the Consumer Price Index (CPI) each year. Now as a rule, hospitals and GPO’s are forcing prices to new lows year over year and even seem willing to sacrifice the presence of the rep in the operating room. It is impossible to argue the point that the orthopedic sales rep is being marginalized. In recent years, they have been told by various constituents that they are a “non-essential” part of the healthcare continuum. In an effort to increase profits, not only are these hospitals and GPO’s fighting to bring down prices, but they also seem to be fighting over the remaining piece of the pie belonging to the sales rep by way of confiscating their commissions. But are sales reps expendable? Do they only add cost to the continuum as some suggest?

If reps are eliminated from the picture, who will step in to bear the burden of support that surgeons are accustomed to receiving from their sales reps? Are surgeons going to be expected to hire P.A.’s to fill in the void of what the reps currently do? Does anyone really grasp the full picture of what the orthopedic rep does and value they bring to the healthcare system? Let me try to give you a former sales rep’s perspective on the value of the orthopedic sales rep.

A historical perspective

When I started as a sales rep for Zimmer in the orthopedic industry 30 years ago, it was evident to me that being a rep afforded me the privilege of being an integral part of the surgical team to ensure the most optimal surgical outcomes for the orthopedic patient. There was a level of trust, camaraderie and appreciation that made the role extremely rewarding. Reps like myself felt appreciated because it was evident that surgical teams wanted us in the room during cases because of the unique value we brought to the case. Ours was a special role of supporting both the surgeons as well as the hospital’s support staff. Whether we were an extra set of hands to hold the patient’s leg during prep or opening that sterile peel pack when someone dropped a disposable suction tip when the circulator was preoccupied, we stepped in to do whatever we could to keep the case progressing without a delay. Having a rep in the room was an obvious value to all because we possessed a unique perspective and skill set. We were the ones with experience in those unfortunate scenarios when things did not go just like they are supposed to in the technical video. On the infrequent occasion of a surgical complication, the reps are typically leaned on for their expertise. They help the surgeon troubleshoot during the procedure to bring about an optimal successful outcome. In many cases, the rep is the person with the most diverse experience with the products and procedure even if only by observation. Countless times, I was leaned on by the surgeon to solve a complex challenge that arose either out of some unexpected pathology or a complication. I was the one who witnessed thousands of procedures encountering far more complications and variables than the scrub tech, assistant or the surgeon. I was the one with the broadest experience to walk them through how to resolve it in such a way as to bring about the best result. In extreme cases, observers said that watching a good sales rep in surgery was often like seeing the sales rep “conduct surgery through remote control.” I was accustomed to it and considered it a privilege to ensure my surgeon’s patient had the best possible result. This kind of support is an everyday routine for many sales reps in O.R.s around the world. Before my time, I heard stories from reps that actually scrubbed in and held retractors, and in some cases doing far more of the procedure than anyone would expect until finally someone got into deep trouble. There was a book written about it called, “Salesman Surgeon” that recounts a situation where the surgeon was not even in the room when some cases were being done.

We are a long way away from that, and that is a very good thing. However, there are very real benefits as a result of having reps participate in the O.R. I am convinced that there are profound benefits to the hospital, surgeon, staff and patient.

1. Better Patient Outcomes

2. Time Savings

3. Cost Savings

These merely represent the value of the rep in the room. However, there is great value to healthcare beyond having an orthopedic sales rep present during surgery. In fact, it is what leads up to the surgical theater that is often overlooked and without a talented rep, a void will be created that must be filled by someone. It was always gratifying to me the appreciation that I received from nurses and administrators. However, I remember showing up to sell in my new territory at an O.R. in Lancaster, CA to introduce myself as the new Zimmer rep back in 1989. I entered the O.R., while staying behind the line, and asked the gal at the desk if I could speak with the O.R. Supervisor. She gave me a long up and down look then proceeded to speak into the microphone to the overhead intercom to announce my arrival. “Jennifer, there’s a gentleman with tassels on his shoes at the desk waiting to see you.” That is how some people see reps. Just well dressed people who waltz in and expect to have the red carpet to sell people stuff. In reality, reps spend a ton of time meeting with surgeons to help them with preoperative planning, reviewing x-rays to ensure that they are ready for anything when the patient is under anesthesia. It is the job of a rep to be 100% certain that you have everything you need for the case which may require flying equipment in from cross country, but not having it is never an option.

It seems overlooked that sales reps, especially those who cover trauma, are on the clock 24/7 in support of their surgeon and hospital clients. It might seem like no big deal to those who don’t understand the implications, but imagine for a moment that you are a sales rep and you have 20 surgeons you support, each with their own individual schedule and demands. It is a balancing act like no other to support the needs of these surgeons and their patients. Not showing up or having the equipment ready for a case is never an option, and certainly would result in risking losing business and tarnishing your reputation. There are always competitors standing in lurch waiting for someone to mess up. I always said that for every surgeon who uses a product, there is a rep “on deck” waiting for their chance to save the day when you screw up.

Another reality for many reps is never taking a family vacation that wasn’t somehow tied to a business event. In my day, not only did I have to pay my own way but also those of some of my surgeon customers and their families. It wasn’t so much about getting new business as it was about protecting your business. The expectation was that since they used my products and I benefitted from it, I would cover the major expenses of their trip to get CME credits. The risk was that if I did not, one of my competitors would entice them to go to one of their meetings and they may come home and switch.

The industry has changed in some positive ways as well. When I was the Zimmer rep, I covered everything from Recon to Trauma. This meant that I could easily be in surgery all day on Monday, get a trauma case in the evening requiring me to be there all night, and not make it home before my 7:30AM case the next morning. When I was on call, I could be at dinner or a movie with my wife and suddenly have to run her home to run sets and cover a case. Sunday mornings looked like driving to church in separate cars in case the pager went off and I had to leave on the spur of the moment.

The point I’m making is that in a very real sense, many sales reps have the insane schedule of a surgeon with many similar time demands, and yet without some of the upside. It is also the rep that enables surgeons to make quick decisions about treatment of a patient and they know their rep will take care of getting everything they need to fix the patient. It may be as simple as calling the office and having it delivered or more complex as having to drive across town to borrow it from another hospital or distributor, or even times when you have to contact someone out of state and have equipment flown cargo on a commercial airline to get there in time. The reality is that most of the stressful things that happen never see the light of day and no one in the hospital is aware of the extreme measures taken in order to see to it that the patient got the very best treatment.

It is unclear to me who will be there to step into the gap and support the orthopedic surgeon if the rep is tossed to the side. I think we always expected that over time the market would force out the more skilled and experienced orthopedic reps in favor of cheap labor, similar to a pharma rep. Our saving grace was always that they didn’t like to work that hard. Perhaps the time has come that the market will shift the reps support responsibilities on to the surgeons who will undoubtedly need to hire someone to support them. Maybe the market simply needs to see what it looks like to force the best and brightest out and see the impact on the surgical teams. One thing is for sure, the market seems to behave like they see reps as unnecessary. Time will tell.

Drue De Angelis

CEO, LLC is the total orthopedic distributor/rep solution to go from working “in” your business, to working “on” it. A simple software solution that adapts to your workflow enabling greater communication, accuracy and efficiency. saves time and money. It’s like having an extra person on the team. /





May 31, 2017 OrthoSpineNews

VIENNA, May 31, 2017 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Family of Companies, today announced new ATTUNE® Knee implant survivorship data based on an independent analysis of 10,605 ATTUNE Knee implantations, showing that the cumulative revision rate for the ATTUNE Knee is 1.3% at four years (98.7% implant survivorship at four years), comparing favorably to the 1.9% cumulative revision rate (98.1% implant survivorship at four years) for the overall class of total knee replacement.1

Of the 10,605 ATTUNE Knees included in the analysis from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR), 46 required revision. Based on a separate analysis, the report concluded that 63 ATTUNE Knee revisions would be expected at four years – a difference that was statistically significant (p<0.05).1 The expected number of ATTUNE Knee revisions was calculated by the NJR based on duration of implantation, age group, gender and indications.

DePuy Synthes announced the four-year data in Vienna, coinciding with the 18th European Federation of the National Associations of Orthopaedics and Traumatology (EFORT) Congress. The full analysis, including a breakdown of the reasons for revision, is available on and can be accessed here.

“This most recent analysis adds to the body of evidence on the positive performance of the ATTUNE Knee,” said Joshua Bridgens, DePuy Synthes Franchise Medical Director. “The information and data in this analysis, such as reasons for revision and preliminary findings on patient-reported outcomes, continue to validate the design principles and our expectations for the clinical performance of the ATTUNE Knee.”

NJR publishes an annual report including 1, 3 and 5-year outcome data; however, additional survivorship data is now also available more frequently to manufacturers who subscribe to the NJR’s Implant Summary Report service.

DePuy Synthes is committed to the continued evaluation of outcomes through its comprehensive ATTUNE Knee Evidence Generation Program that, in addition to national joint registries, gathers information from investigator-initiated studies, independent studies and company initiated studies. ATTUNE Knee clinical evidence to date is available on

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

DSUS/JRC/0517/2149 May 2017


1National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Summary Report for DePuy ATTUNE CR and ATTUNE PS. NJR Database extract April 7, 2017, pages 1-17. Licensed for use until April 19, 2018. Available at

Data Source

The data used for this analysis was obtained from the NJR Supplier Feedback System. The Healthcare Quality Improvement Partnership (“HQIP”) and/or the National Joint Registry (“NJR”) take no responsibility for the accuracy, currency, reliability and correctness of any data used or referred to in this report, nor for the accuracy, currency, reliability and correctness of links or references to other information sources, and disclaims all warranties in relation to such data, links and references to the maximum extent permitted by legislation.


SOURCE DePuy Synthes


May 31, 2017 OrthoSpineNews

May 31, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (“Orthocell or Company”) is pleased to announce it has received confirmation from the Therapeutic Goods Administration (TGA) that Ortho-ACI® has been included on the Australian Register of Therapeutic Goods (ARTG).

Orthocell’s Autologous Chondrocyte Implantation (Ortho-ACI®) for cartilage repair and regeneration has previously been approved for sale in Australia pursuant to a TGA issued manufacturing license, but in order to maintain regulatory approval in Australia for the commercial sale of Ortho-ACI® pursuant to the relevant transitional provisions, Orthocell had lodged an application for approval and inclusion on the ARTG.

Inclusion on the ARTG marks a significant milestone for the Company enabling the commencement of the process for reimbursement and also the wider sale and distribution of Ortho-ACI® for cartilage repair and regeneration within Australia and the treatment of patients in other countries such as Hong Kong, Singapore and New Zealand. This milestone also represents the first cell therapy for cartilage repair to be included on the ARTG.

Ortho-ACI® is the gold standard intervention for symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle. Damage to articular cartilage can occur through injury or normal wear and tear. When articular cartilage is damaged, it does not repair itself effectively like other tissues and cartilage defects lead to increasing joint pain and impaired mobility, which affects activities of daily living and exercise. These defects present a difficult clinical problem and if left untreated can lead to osteoarthritis.

Ortho-ACI® provides the opportunity for the body to regenerate its own cartilage and provide a functional and durable outcome. Orthocell has treated patients in Australia, Hong Kong and Singapore. Ortho-ACI® is indicated as a pre-arthritis cell therapy that is designed to treat the localized defects in the knee, patella and ankle that can lead to osteoarthritis and cartilage degeneration

Orthocell Managing Director Paul Anderson said “the inclusion by the TGA of Ortho-ACI® on the ARTG is a significant milestone for the Company and enables the continued pathway towards reimbursement.”

About Orthocell Limited

Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-licensed cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is Celgro®, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.

For more information on Orthocell, please visit or follow us on Twitter @Orthocellltd and Linkedin


General enquiries
Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
Investor and Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012


May 31, 2017 OrthoSpineNews

May 31, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, is pleased to announce that the first surgeries using the new Truliant® Knee System were performed yesterday. Truliant, which recently received 510(k) clearance from the U.S. Food and Drug Administration, offers a comprehensive portfolio of implants and instrumentation designed to help surgeons address the remaining clinical challenges of total knee replacement.

Craig Morrison, MD, of the Southern Joint Replacement Institute in Nashville, Tenn., and Michael Dayton, MD, from the University of Colorado in Denver, Colo. were the first surgeons to use the new knee system. According to Dr. Dayton, “The Truliant system has the advantage of being very user-friendly from the standpoint of ergonomic instrumentation. It should allow me to more accurately size, balance and efficiently perform the surgeries.”

“The Truliant system is intuitive,” Dr. Morrison said. “What I saw today is that you put the instrument in a surgeon’s hand, and they know what to do with it right away. I think the competitive advantage of this system is going to be how easily Truliant accommodates a surgeon’s preferred workflow.”

Designed with the ultimate surgical experience in mind, the Truliant Knee System is a high-performance, comprehensive platform that addresses the clinical challenges in primary and revision total knee replacement. Leveraging Exactech’s core principles, Truliant applies advanced design philosophies and surgical technologies to help surgeons deliver clinical outcomes reproducibly case after case.

According to Exactech’s Vice President of Knee Marketing Joseph Pizzurro, “With the number of knee arthroplasty surgeries on the rise, there is a market and clinical need for a system that offers enhanced efficiency and overall reproducibility. Based on input from a wide array of surgeons, Exactech’s design team of engineers and surgeon consultants converged to develop a modern, fully comprehensive knee system that offers a broad range of implants, intuitive instrumentation and computer-assisted technology to accommodate a variety of surgical approaches and philosophies. We are thrilled to introduce Truliant to the marketplace.”

Surgeons cite Exactech’s collaborative culture as a key to the new knee system’s intuitive design. “The people at Exactech are always leaning forward and engaging the surgeons,” said Ronald Hillock, MD, an orthopaedic surgeon in Las Vegas, Nev. “They have been very receptive to feedback, and I’ve always been impressed with the depth of their interest, from the top down. Everybody is in tune with designing a product that will give the best outcomes. It is engrained in their culture and it definitely comes through the products. Truliant is a prime example.”

Truliant is in pilot launch with a group of U.S. surgeons. Full market availability is expected in the United States during 2018.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at

A current investment profile on Exactech (Nasdaq: EXAC) is available online at To receive future releases in e-mail alerts, sign up at

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.


Investor contacts:
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
Media contact:
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication


May 31, 2017 OrthoSpineNews

May 26, 2017

BREDA, Netherlands–(BUSINESS WIRE)–Freedom Neuro BV, a medical device distributor for Stimwave Technologies Incorporated, today announced CE Mark approval for the world’s first Percutaneous Injectable Anchor System. The injectable anchor is utilized in conjunction with the company’s wireless neurostimulator devices to provide true innovation in fixating Stimwave’s Wireless Pain Relief®technology through a minimally-invasive outpatient procedure for those who suffer from chronic pain.

“A wireless system that enables clinicians to actually have the full programming capabilities of IPGs, all in a device that can be injected, represents a paradigm shift in the field of options to provide the best in customization for patients to manage their pain profiles,” said Bart Billet, MD, from AZ Delta hospital group in Roeselare, Belgium.

Once the stimulator is injected, the SandShark is slid down over the device, progressing the un-deployed anchor into ligaments and strong connective tissues. Once the radiopaque anchor is in the desired location, the clinician pulls back on the handle, simultaneously deploying the wings of the anchor and pushing them laterally into the tissue. This injection process secures the anchor to the stimulator and secures the stimulator to the surrounding tissue to prevent migration throughout the life of the micro-implant. The injectable anchor stays in line with the body’s nerves, allowing for a freedom of movement generally not available in other neuromodulation devices.

“The SandShark Percutaneous Injectable Anchor System is a breakthrough for spinal cord stimulators, peripheral nerve stimulators, and all neurostimulation devices,” said Laura Tyler Perryman, founder and CEO of Stimwave. “It allows clinicians to inject a stimulator and its anchor through the same needle puncture port, opening the door for more clinicians to more easily provide patients with our highly efficient stimulators.”

Aiming to provide a non-opioid alternative in the treatment of chronic pain, Stimwave has pioneered the Stimwave Freedom Spinal Cord Stimulation (SCS) System and the StimQ Peripheral Nerve Stimulator (PNS) System. Stimwave’s devices use Wireless Pain Relief®technology, are 95 percent smaller than any other neuromodulation device on the market and are the only system to have full body 3T MRI Conditionality. Representing a life-changing technological breakthrough for the more than 400 million people who endure daily chronic pain, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the most versatile system available in the industry. The CE Marked Freedom-8A SCS System can provide European patients with up to 64 electrode contacts and offer traditional programming options, as well as other programming options, including frequencies up to 10,000 Hz or waveform customization. The Freedom-8A SCS System with eight electrodes continues to utilize the Apple iPad programmer, leveraging Bluetooth protocols for ease of use in programming the variety of options. The devices deliver small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief.

For more information, visit

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, 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.

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.


Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500


May 30, 2017 OrthoSpineNews

Recalled Product:

  • Product Description: The SpF® PLUS-Mini (60μA/W) & SpF® SpF XL IIB Implantable Spinal Fusion Stimulators
  • Serial Numbers:
    • SpF-XL IIB: 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667
    • SpF-PLUS: 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, 410171
  • Distribution Dates: March 28, 2017 to April 6, 2017
  • Manufacturing Dates: October 11, 2016 to January 18, 2017
  • Devices Recalled in the U.S.: 33

Device Use

The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine (backbone) together. The device is implanted into the patient’s back and provides constant electrical stimulation to the surgical site.

Reason for Recall

Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company’s routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.

The use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death.




May 30, 2017 OrthoSpineNews

Gosselies, Belgium, 29 May 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces the appointment of Steve Swinson and Damian Marron to its Board of Directors as Non-Executive Directors.

The appointments of Steve Swinson and Damian Marron, effective 26 May 2017, complement an already strong Board of Bone Therapeutics bringing in specific public company, orthopaedic and cell therapy understanding and expertise and will provide ongoing support to the leadership team. Steve Swinson and Damian Marron will replace Jacques Reymann and Jean-Jacques Verdickt.

Steve Swinson has served in a number of senior roles in orthopaedic medical technology and electronics companies, including general management, senior strategy, sales, marketing and commercial operation positions at Medtronic International, a global leader in medical technology. At Medtronic, he led the Spine and Biologics division for Canada and Western Europe, and was Vice President and General Manager for the international spine divison with substantial revenue responsibility. In a 30 year international business career covering Asia, US, Europe and Africa, he has also held senior positions at the diagnostic and medical departments of the blue chip engineering multinationals, General Electric and Hewlett Packard. Steve has a PhD in electrical engineering from the University of Manchester and a MBA from the University of Chicago.

Damian Marron is an experienced life sciences executive with a successful track record of value creation through public and venture capital financing, portfolio planning and turnaround, M&A, licensing agreements and research and marketing collaborations. He has particular competencies in cell therapy, immuno-oncology and orphan diseases. Damian served most recently as Chief Executive Officer of Agalimmune and has also served as Chief Executive Officer of TxCell, a France-based specialist in personalised T-cell immunotherapies, where he led the Company’s IPO on Euronext Paris. As Chief Executive Officer of Trophos, France, he helped raise EUR 34 million in financing and positioned the company for a subsequent acquisition by Roche for EUR 700 million. Damian also served as Executive Vice President, Corporate Development, for NiCox, where he supported the CEO in financing rounds raising over EUR 175 million.

Michel Helbig de Balzac, Chairman of Bone Therapeutics, commented: “We are delighted to welcome Steve and Damian to the Board of Bone Therapeutics. Their collective track record in leadership and value creation in the healthcare sector and their industry knowledge and expertise in orthopaedic medical technology and cell therapy respectively will be a major asset to the Company. They will be a valuable sounding board to the leadership team as it focuses on advancing our innovative allogeneic cell therapy platform towards commercialization. We would like to thank Jacques Reymann and Jean-Jacques Verdickt for their many years of dedication to Bone Therapeutics and wish them the best in their well-deserved retirement.”

Commenting on his appointment, Steve Swinson said: “Bone Therapeutics leads the field in regenerative approaches to orthopaedics and bone diseases, and its allogeneic cell therapy platform has the potential to transform medicine in these areas. I’m delighted to have the opportunity to use my deep experience in orthopaedic medical technology to help support this Company as it advances its technology towards commercialization.”

Damian Marron added: “I am very excited to be joining Bone Therapeutics. I look forward to bringing my experience in strategic development and my expertise in cell therapy to support the Company as it approaches key value inflection points with its innovative allogeneic cell therapy platform.”

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at:

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Wim Goemaere, Chief Financial Officer
Tel: +32 (0)2 529 59 90

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94


May 30, 2017 OrthoSpineNews

ENGLEWOOD, Colo., May 30, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The PRECISION™ Jones Fracture Screw System is the latest addition to Paragon 28®’s robust foot and ankle specific portfolio.  The system is comprised of 120 unique screw options spread across four screw families (4.0 mm, 4.5 mm, 5.5 mm, and 6.2 mm).  Solid and cannulated options of each screw length (34-60 mm; 65 mm) are available to address varying anatomies and fracture patterns. The screws are constructed from titanium alloy that is type II anodized for improved fatigue strength. All screws have a short thread and blunt tip to minimize disruption to the cortical bone and to ensure the intended trajectory through the intramedullary canal of the 5thmetatarsal is maintained during insertion. Additionally, the screws have a low profile head to minimize prominence and avoid impingement of the cuboid.

The PRECISION™ Jones Fracture Screw System also includes instrumentation designed to facilitate placement of a K-wire high and inside the proximal portion of the 5th metatarsal.  The patent pending PRECISION™ Jones Curved K-wire Guide has a tip which matches the base curvature of the 5th metatarsal and radius of curvature which aims the handle of the guide away from the lateral malleolus and cuboid.  This guide’s primary function is to aid in positioning a nitinol K-wire into the center of the intramedullary canal simplifying placement which may reduce intraoperative fluoroscopy time. Constructed from nitinol, the K-wire will flex and follow the curvature of the intramedullary canal while limiting the chance of broaching the surrounding cortex.

In addition to the Curved K-wire Guide, the system includes implant specific taps, countersinks, and standard and long drills to aid in implanting the screw through either a traditional or cannulated technique.

Product Page:

Contact: Jim Edson, Director of Product Management and Marketing,

SOURCE Paragon 28

Related Links


May 30, 2017 OrthoSpineNews

May 29, 2017

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

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces it has received the regulatory approval from ANVISA1, Brazil’s National Health Surveillance Agency, in order to commercialize the SpineJack® in Brazil.

The approval from ANVISA is a key achievement opening a new opportunity for VEXIM in this important international market with untapped potential. This clearance will provide us with new growth opportunities in this key Latin American market. VEXIM estimates that Brazil alone today represents a €15 million market in the vertebral compression fractures field.

This approval will enable us to have substantial growth in our international business. The Company is expecting to initiate export to Brazil in the coming months, after the conclusion of the product’s evaluation process and of distribution partnerships”, said Vincent Gardès, CEO of VEXIM.

Financial reporting schedule:
2nd quarter sales: July 11th, 20172

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital3, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit

SpineJack®4, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Code ISIN : FR0011072602
Code mnémonique : ALVXM

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


Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94