Aurora Spine Corporation Trent Northcutt President and Chief Executive Officer (760) 424-2004 Laszlo Garamszegi Chief Technology Officer (760) 424-2004 www.aurora-spine.com
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, Surg.io LLC Surg.io 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. Surg.io saves time and money. It's like having an extra person on the team. /Surg.io /https://surg.ioRead More
ATTUNE® Knee System Four-Year Revision Rate is Lower Than Total Knee Class, According to New & Independent Joint Registry Data
May 31, 2017
ContactsGeneral enquiries Orthocell Limited Paul Anderson, +61 8 9360 2888 Managing Director email@example.com or Investor and Media enquiries WE Buchan Ben Walsh, +61 411 520 012 firstname.lastname@example.org
May 31, 2017
ContactsInvestor contacts: Exactech Jody Phillips, 352-377-1140 Executive Vice President of Finance & Chief Financial Officer or Hawk Associates Julie Marshall or Frank Hawkins, 305-451-1888 EXAC@hawkassociates.com or Media contact: Exactech Priscilla Bennett, 352-377-1140 Vice President, Corporate & Marketing Communication
May 26, 2017
ContactsGlodow Nead Communications Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500 StimwavePR@GlodowNead.com
Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs
- 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 UseThe 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 RecallZimmer 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. READ THE REST HERE Read More
Bone Therapeutics strengthens Board with the appointments of Steve Swinson and Damian Marron as Non-Executive Directors
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: www.bonetherapeutics.com.
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 email@example.com
For Belgium and International Media Enquiries: Consilium Strategic Communications Amber Fennell, Jessica Hodgson and Hendrik Thys Tel: +44 (0) 20 3709 5701 firstname.lastname@example.org
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 email@example.comRead More
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: http://www.paragon28.com/products/jones-fracture-screw-system/ Contact: Jim Edson, Director of Product Management and Marketing, firstname.lastname@example.org SOURCE Paragon 28
Related Linkshttp://www.paragon28.com Read More
May 29, 2017
“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, 20172About 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 www.vexim.com 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. Nom : VEXIM 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 www.truffle.fr and www.fcpi.fr. 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.