NuVasive Appoints Skip Kiil As Executive Vice President, International

SAN DIEGO, June 1, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced Skip Kiil is joining the Company as executive vice president, International. In this role, Mr. Kiil will oversee the Company’s international operations, reporting to NuVasive’s chairman and chief executive officer, Gregory T. Lucier, and serving on the Company’s executive leadership team.

Mr. Kiil brings to NuVasive more than 15 years of experience as a global medical technologies and life sciences business leader. He joins NuVasive from Alcon, a division of Novartis Corporation, where he most recently served as surgical head, Europe, Middle East, Africa and Russia.

“I am excited to welcome Skip as a member of the NuVasive executive leadership team,” said Mr. Lucier. “Skip has led complex, global commercial enterprises in Europe, the Middle East, Africa, Japan, Asia Pacific and the United States within the healthcare and spine technology industries. He brings significant strategic and operational expertise in market entry and development and proficiency in maintaining P&L responsibility, both of which are key elements as we scale and expand our high-growth international channels. We are pleased to have a global leader of Skip’s caliber join NuVasive’s world-class leadership team at this time as we accelerate past $1 billion in revenue, enhance our international operations and continue to change patients’ lives around the world.”

Mr. Kiil’s career includes extensive corporate experience in global markets. Prior to joining Alcon, Mr. Kill spent more than 12 years with Stryker Corporation, most recently as vice president and general manager, Medical Surgical Group, based in London and Rome. In that capacity, he was responsible for commercial operations for six strategic business units, including Neuro Spine/ENT, Surgical Instruments, Endoscopy, Sports Medicine and General Surgery/Visualization. Previously, as a senior leader at Stryker, Mr. Kill was general manager, MedSurg Japan, based in Tokyo. Prior to that, he had increasing corporate development, sales and marketing roles for Stryker in the United States. Mr. Kiil received a Bachelor of Science in Kinesiology from California State University, Fullerton and a Masters of Business Administration from University of Michigan.

NuVasive is the third largest global spine technology company with significant momentum to drive global growth and expansion as the Company seeks to double its international market share in the coming years. NuVasive is targeting international revenue growth at 20 percent or higher annually and scaling international operations to support the Company’s profitability expansion goals. The Company’s share-taking strategy and innovative product introductions drove growth across all of its international geographies including Europe, the Middle East, Asia Pacific and Latin America in the first quarter of 2017, leading to a 34% year-over-year increase on a reported basis in international revenues, excluding the impact of currency.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Orthopaedic Pediatric Market Draws New Companies, Products

Carolyn LaWell – May 2017

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.

 

READ THE REST HERE

CollPlant Provides Operational Update for Q1 2017

NESS ZIONA, Israel, May 31, 2017 /PRNewswire/ —

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 of CollPlant, 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

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1. U.S. Department of Health & Human Services; https://optn.transplant.hrsa.gov/

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.

For more information about CollPlant, visit http://www.collplant.com

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2. Grand View Research; “3D Bioprinting Market Size To Be Worth $1.82 Billion By 2022,” April 2016

Contact at CollPlant:
Eran Rotem
Chief Financial Officer
Tel: +972-73-2325600/612
Email: eran@collplant.com

Contact at Rx Communications Group, LLC: Paula Schwartz (for US Investors)
Managing Director
Tel: +1-917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

Paxeon Reconstruction Appoints Kyle Sineath President and Announces His Role in Becker’s 15th Annual Conference

May 31, 2017

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.

______

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.

 

Aurora Spine Offers Its Patented Polyaxial ZIP® ISP Technology for Out-Licensing Opportunities

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

    Laszlo Garamszegi
    Chief Technology Officer
    (760) 424-2004
    www.aurora-spine.com

The Unsung Hero of the Ortho Industry – the Rep

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.io

 

Ortho-ACI® Included on the Australian Register of Therapeutic Goods

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 www.orthocell.com.au or follow us on Twitter @Orthocellltd and Linkedin www.linkedin.com/company/orthocell-ltd

Contacts

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

Exactech Announces Successful First Surgeries with Truliant® Knee System

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 http://www.exac.com.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

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

Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs

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.

 

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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.

Contacts

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

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

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
bone@newcap.eu