EPOSNA 2017, the combined annual meeting of the European Paediatric Orthopaedic Society and Pediatric Orthopaedic Society of North America, served as an unveiling for new products, brands and companies as a focus on this niche market is drawing in device companies.
Two dozen device, bracing and pharmaceutical companies exhibited at EPOSNA in early May. The way Nick A. Deeter tells it, a decade ago there were three at the North American meeting: OrthoPediatrics (the company that Deeter founded in 2006), Biomet and Smith & Nephew. Attending EPOSNA with WishBone Medical, the pediatric company he founded earlier this year, Deeter said that he believes the pediatric segment is ripe for growth. For one, there is demand. WishBone estimates the market at $1.4 billion, growing at 10% per year. Two, it is one of the few areas in orthopaedics that has yet to gain attention from device companies—though our tracking of announcements in the space suggests that could be changing.
Here’s what’s happened just since 4Q16:
Implanet received global regulatory clearance for Jazz Frame connectors for use with the JAZZ Band in the treatment of adult and pediatric spinal deformity.
Materialise gained FDA clearance for Surgicase Orthopaedics to assist in pre-op planning for pediatric patients undergoing radius and ulna osteotomies.
Medicrea received FDA clearance of specialized posterior fixation and band connector components.
Mighty Oak Medical obtained FDA clearance for 3D-printed FIREFLY Pedicle Screw Navigation Guides, reported to be the only patient-specific pedicle screw guide indicated for use in pediatric patients.
NuVasive announced that it’s building up a salesforce for exclusive focus on pediatrics to promote its MAGEC rod for early onset scoliosis and PRECICE technology for limb lengthening.
Onkos Surgical, focused on the adult and pediatric surgical oncology market, received its first FDA 510(k) for the Eleos Limb Salvage System.
Orthofix launched JuniOrtho, a new brand to house services (apps, games, education tools) and products that treat pediatric orthopaedic and congenital deformities, including the TL HEX TrueLok Hexapod system and Guided Growth plates.
OrthoPediatrics, a solely-focused pediatric ortho company, launched a new distal femoral osteotomy system.
WishBone Medical formed and announced planned launch of single use, disposable implants and instruments for foot and ankle, trauma, spine and sports medicine indications.
SAN DIEGO, CA – May 22, 2017 – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company’s increased investment and support of adult and pediatric deformity research, education, and awareness initiatives throughout 2017.
NuVasive increased its focus on the $2.5 billion deformity market in May 2015 with the launch of its Integrated Global Alignment® (iGA®) platform and RELINE® posterior fixation system. In February 2016, NuVasive expanded its footprint into the early onset scoliosis market with the addition of its industryleading MAGEC® system, which utilizes innovative magnetic technology within adjustable growing rods. Today, NuVasive has the fastest growing spinal deformity portfolio and is expanding its support of key programs to drive improved clinical and economic outcomes. NuVasive recently launched the ‘Embracing the Journey Together’ program, which includes pediatric spinal deformity research, education and spinal deformity event support, supporting leading surgeons as they educate surgeons around the world.
“At NuVasive, we remain laser-focused on transforming the lives of patients through disruptive innovation and support of clinical education and research,” said Greg Lucier, NuVasive chairman and chief executive officer. “We’ve made tremendous gains in adult and pediatric spinal deformity innovation, with the versatile RELINE portfolio and MAGEC system. With the upcoming launch of the RELINE Small Stature system available this summer, I’m confident in our ability to outpace the market. We’re proud NuVasive has taken the lead in supporting key global initiatives designed to help improve the lives of patients around the world.”
SmarTech Publishing, the leading provider of in-depth industry analysis services to the additive manufacturing industry, has published its first ever true industry opportunity deep dive market research report on the burgeoning ‘additive orthopedics’ industry, revealing an area of well-defined opportunity for additive manufacturing that is being faced with sizeable change over the next several years.
Additive manufacturing technologies have been employed by orthopedic device manufacturers for the production of approved medical implants for almost a decade, however the use of such technology is at a critical tipping point today. SmarTech’s proprietary market models have been adapted to this growing serial manufacturing opportunity as part of its ongoing analysis plan in biomedical 3D printing/additive manufacturing, and reveal that the additive orthopedic market generated nearly $500M in total opportunities in 2016.
Use of additive manufacturing (AM) technologies for the production of approved orthopedic devices has been a driving force in the growth of metal AM technology to address true serial manufacturing applications. Today, the industry is rapidly expanding these efforts to include not only titanium implants in new orthopedic care segments, but also the use of polymer and bioactive materials and 3D printing technologies to revolutionize the future of orthopedic care using implantable devices.
CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human “rhCollagen”) technology for tissue repair products, provided an operational update for the first quarter ended March 31 2017.
During the period, the company continued to focus on product commercialization while pursuing its activities, including potential joint ventures with international companies, to develop biological ink (bioInk) for 3D printing of organs and tissues. Additionally, CollPlant has substantially reduced its operating costs, chiefly as a result of last year’s successful completion of clinical trials, and the transition to commercialization of its first products. Subsequent to the end of the first quarter, the company expanded its footprint in Europe with the signing of a distribution agreement in Turkey for its wound healing product, VergenixFG®, and is working towards the signing of additional distribution agreements in these territories.
The biological ink sector – Collagen protein is a fundamental and significant component of connective tissues in the human body, and is therefore an ideal building block for the synthesis of bioInk, which is used in the production of 3D scaffolds, together with human cells and/or therapeutic proteins. Management views this sector as a major growth opportunity and is, therefore, pleased to report during the period, that it has been actively pursing key collaborations with international companies in the field of 3D printing of organs and tissues utilizing CollPlant’s rhCollagen technology. Specifically, the Company is examining bioInk applications in the areas of orthopedics, dermatology, ophthalmology and cardiology, and others.
Yehiel Tal,Chief Executive Officer ofCollPlant, stated, “CollPlant’s proprietary rhCollagen represents a potential key component of biological ink, due to a number of unique and important attributes, including its excellent biological functionality, which is reflected in its rapid cell proliferation. Our rhCollagen also has a high level of homogeneity at the molecular level, which enables the production of bioInk with controlled and supervised physical attributes such as viscosity, strength and transparency. Additionally, CollPlant’s rhCollagen has proven to be safe to use and does not cause allergic responses or lead to the transmission of diseases.”
According to the U.S. Department of Health and Human Services[1], the number of people in the United States waiting for a transplant of a critical, life-saving organ such as a kidney, liver or pancreas, is approximately 118,000, and the organ transplant waiting list grows every year. BioInk is a significant component of the burgeoning 3D bioprinting market, which is expected to grow to approximately
USD 1.8 billion by 2022[2], and to increase substantially as the printing technology, and all its components, continue to mature.
About CollPlant
CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.
Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces the promotion of Kyle Sineath to President. Prior to this appointment, Mr. Sineath served as Vice President of Global Sales for Paxeon. Mr. Sineath joined Paxeon after 10 years in the medical technology and orthopaedics industry, where he held a number of senior level leadership roles at Amedica and most recently, Vice President of Sales for NuTech Medical. Mr. Sineath holds a duel Bachelor of Science from the University of Pikeville.
“The orthopedics market has changed dramatically over the past 10 years and I am thrilled to be in a position to bring new products and creative ideas that further assist our surgeons deliver the best possible outcomes for patients around the world.” Said Mr. Sineath.
In addition to this appointment, Mr. Sineath has been asked to participate as a panelist at the upcoming Becker’s 15th Annual Spine, Orthopedic and Pain Management-Driven ASC Conference + The Future of Spine on June 22-24, 2017 in Chicago, IL.
With keynote speakers Andrew Hayek (Chief Executive Officer of Optum Health and Surgical Care Affiliates), Michael Kasper (Chief Executive Officer of DuPage Medical), Lou Dobbs (Fox News) and Marcus Allen (Former NFL Running Back and Member of the NFL Hall of Fame), this conference includes more than 1,100 Attendees at this World-class ASC Event Focused on Orthopedics, Spine and Pain.
In the session titled “Investing in Early Stage Spine and Device Companies – Smart? Dumb? and Practical Advice”, Mr. Sineath will be joined by President and CEO of AngelMD, Tobin Arthur, as well as President and CEO of Life Spine, Michael Butler. The session will be moderated by John Harig, JD.
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About Paxeon Reconstruction
Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.
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 info@auroraspine.us.
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.
CONTACT INFORMATION
Aurora Spine Corporation
Trent Northcutt
President and Chief Executive Officer
(760) 424-2004
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
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 ATTUNEevidence.com 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 ATTUNEevidence.com.
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 www.depuysynthes.com.
*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
DSUS/JRC/0517/2149 May 2017
References
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 www.attuneevidence.com.
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.
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.
General enquiries Orthocell Limited Paul Anderson, +61 8 9360 2888 Managing Director paulanderson@orthocell.com.au
or Investor and Media enquiries WE Buchan Ben Walsh, +61 411 520 012 bwalsh@buchanwe.com.au
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 http://www.exac.com.
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.
Contacts
Investor 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
