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February 2-4, 2017
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RegulatorySpine

NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures

October 16, 2017 OrthoSpineNews

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the Company’s TLX interbody system, used in the leading spinal fusion surgery. New clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine.

The TLX interbody system is a market-leading solution that is inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach. NuVasive developed a minimally invasive approach for the TLIF procedure, the MAS® TLIF or Maximum Access Surgery (MAS) TLIF. Designed to be used with a minimally invasive spine surgery approach, TLX implants can be placed seamlessly into the disc space due to their low profile, bulleted design. A proprietary inserter allows the surgeon to insert, expand and rapidly post pack the implant through the same instrument, optimizing surgical efficiency. The TLX interbody system provides restoration of sagittal alignment with customizable degrees of lordosis and was designed to induce lordosis in an anatomical fashion, unique to what is currently on the market.

Prior to the expanded 510(k) clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft. The recent clearance includes a 20 degree expandable interbody, and additional indications for use with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The new indications also include use in the thoracic spine and at the thoracolumbar junction for treatment of disc degeneration disease or degenerative spondylolisthesis at one or two adjacent levels. Use of the TLX interbody system as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis was also cleared. The TLX system’s size offerings provide multiple options for varying patient size and anatomic considerations.

“With the additional clearance for our latest TLX system, we now provide the leading tools for TLIF procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” said Matt Link, executive vice president of strategy, technology and corporate development of NuVasive. “This clearance highlights our persistant investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”

The TLX interbody system, coupled with the Company’s Integrated Global Alignment® (iGA) suite of software that allows surgeons to calculate, correct and confirm a patient’s pathology, has the ability to improve TLIF procedures overall. The software can calculate alignment parameters with the preoperative planning tools NuvaLine® and NuvaMap® and can intraoperatively correct using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.

“The procedurally-integrated TLIF platform from NuVasive has allowed me to become much more efficient in my TLIF procedures,” said William Hunter, MD, neurosurgeon at The Spine Clinic at Neuroscience and Spine Center of the Carolinas. “The platform also allows me to confirm restoration of my patients’ lordosis intra-operatively using NuvaMap O.R. These tools have made my procedures more predictable, providing optimal treatment for my patients.”

NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new TLX interbody system in NuVasive Booth #713 at the North American Spine Society Annual Meeting held October 25-28, 2017 in Orlando, Fla.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. 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

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Spine

Cervical Posterior: Smart Solutions for Complex Surgeries

October 16, 2017 OrthoSpineNews

With an estimated market value of $350M, posterior cervical fusion is still an attractive growing market. Common indications for Posterior cervical fixation are pain caused by excessive motion, sagittal balance correction and instability from a traumatic event. Cervical posterior systems are often described as smaller lumbar versions, grossly discounting the often unpredictable challenges of the cervical anatomy.

A comprehensive implant range is your best bet to overcome unforeseen intraoperative struggles. For example, the C7 vertebra is often skipped due to its location, yet a very low profile screw head with extreme angulation can overcome the challenge. Crosslinks fixed to screw heads help avoid spinal cord compression while transition rods and a wide variety of domino connectors allow effortless constructs.

When the Perla® system was designed, focus was placed on creating an extensive implant range, combined with a single compact instrument set. Dr Vittorio Morreale, Henry Ford Hospital (MI), has described Perla® as ‘truly efficient and complete’. In conjunction with surgical power for screw insertion, Perla® has become his system of choice for posterior cervical fixation. “I prefer inserting the screws with the aid of a power tool. I have observed over the years increasing reproducibility, control and precision that I couldn’t quite achieve with manual placing.”

For additional information on Perla, click here.

Discover the advantages of partnering with Spineart

 

Spineart will be at NASS, booth #316.

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SpineTop Stories

Spine Surgeons in Texas and Indiana Advance Patient Care with Structurally Encoded Devices

October 13, 2017 OrthoSpineNews

SAN ANTONIO, TEXAS (PRWEB) OCTOBER 13, 2017

Zeshan Hyder, DO, of Bone & Joint Specialists in Merrillville, Ind.; Frank K. Kuwamura, III, MD, of Innovative Spine in San Antonio, Texas; and Larry M. Kjeldgaard, DO, of Cervical Spine Specialist in Fort Worth, Texas are the first surgeons to implant medical devices from Nvision Biomedical Technologies with Structural Encoding® technology. The Structural Encoding technology advances patient care by providing permanent marking embedded within the device that is accessible through an x-ray image.

“We are always looking for the best technologies available to improve the results for our patients and get them back to their productive and pain-free activity as quickly as possible. Having a clear knowledge of their history helps us create the best plan of care. Structural encoding provides transparency for surgeons and patients that creates a new level of knowledge from patient research to implant integrity, all of which equals better patient care,” said Dr. Hyder.

Dr. Kuwamura agrees, “As surgeons, we take care to understand our patients’ lifestyles and activity level. The more knowledge we have, the better decisions we can make for their care. Patients move, physicians retire, and when we see patients that have had previous procedures with other surgeons, it can be almost impossible to get their records. We spend significant time trying to track that information down, but sometimes we don’t know what has previously been implanted until we are in surgery. Structural Encoding changes all of that. We now have a way to know everything about a device and previous surgeries simply by taking an x-ray.”

Structural Encoding, a patented technology platform developed by Watershed Idea Foundry, is the industry’s most innovative solution for medical device identification with permanent direct part marking. Manufacturers can license the technology for use in their medical devices to meet the U.S. Food and Drug Administration’s (FDA) regulation around permanent marking of the device itself, called Unique Device Identification (UDI). Nvision Biomedical Technologies, a San Antonio-based medical device and biologics manufacturer, is the first company to launch devices with the Structural Encoding technology.

“We work with our patients to determine the best outcomes for getting them back to their quality of life and sometimes that means surgery,” said Dr. Kjeldgaard. “If we do determine surgery is the best course of action, the knowledge we have and the more information we can provide our patients, the better. Structural Encoding gives us an advantage in patient care and gives the patient peace of mind for a lifetime.”

Nvision initially launched three devices in the nv line with Structural Encoding. nv(c)® is an anterior cervical interbody fusion system; nv(p)® is a posterior lumbar interbody fusion system; and nv(a)® is an anterior lumbar interbody fusion system. The initial surgeries were anterior cervical discectomy with fusion at one and two levels, with a structurally encoded nv(c) PEEK interbody implant.

“The entire medical device industry is looking to provide UDI compliant devices, but none are as seamless or as user-friendly as those with Structural Encoding,” said Dr. Hyder. “Structural Encoding is self-contained and doesn’t cause any extra steps or paperwork for the surgeon or the hospital, and that alone is good for our patients.”

About Nvision Biomedical Technologies 
Nvision is a San Antonio-based medical device and biologics manufacturing company focused on providing surgeons implants that are paired with instrumentation and biologics to simplify and improve surgery procedures that help patients get back to their quality of life.

Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep the patients, surgeons, healthcare providers and distribution partners in mind. Nvision is aligned with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the most innovative concepts.

About Dr. Zeshan Hyder 
Dr. Zeshan Hyder is partner with Bone & Joint Specialists in Merrillville, Ind. He is a board-certified orthopedic surgeon, who has been voted Best of the Region for Spine Care by The Times for three straight years.

He graduated Cum Laude from the University of Illinois and throughout his medical education has published articles on various subjects related to arthroplasty and spinal surgery. During his fellowship and residency programs he gained valuable expertise in sports medicine, orthopedics and trauma as well as conservative and surgical management of all orthopedic spinal disorders.

About Dr. Frank Kuwamura 
Dr. Frank K. Kuwamura, the founder and chief surgeon at Innovative Spine in San Antonio, Texas, is a board-certified orthopedic surgeon who specializes in emerging technology for spinal care.

A graduate of Boston University Medical School, Kuwamura completed his internship in general surgery and residency in orthopedic surgery at the National Naval Medical Center in Bethesda, Maryland where he earned the rank of Commander in the 3rd Marine Division. He is a member of the American Academy of Orthopedic Surgeons and the Bexar County Medical Society. He has held the title of Diplomat of the National Board of Medical Examiners and served on the American Board of Orthopedic Surgeons, Board Certification.

About Dr. Larry Kjeldgaard
Dr. Larry M. Kjeldgaard, founder and owner of Cervical Spine Center in Fort Worth and Hurst, Texas is a board-certified orthopedic surgeon who specializes in the treatment of the spine, neck and back.

A graduate from the Philadelphia College of Osteopathic Medicine, Dr. Kjeldgaard completed his residency at the Community General Osteopathic Hospital in Harrisburg, PA, and his orthopedic surgery residency training in Pontiac, Michigan. He’s a member of American Osteopathic Board of Orthopedic Surgeons, American Medical Association, the American Osteopathic Academy of Orthopedics and Texas Osteopathic Medical Association.

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SpineTop Stories

DePuy Synthes EMEA Showcases Minimally Invasive Spine System Designed To Improve Intraoperative Efficiencies

October 13, 2017 OrthoSpineNews

Dublin, Ireland – 11 October 2017 –Today, DePuy Synthes, part of the Johnson & Johnson Family of Companies, unveiled the VIPER PRIME™ System, an innovative Minimally Invasive Surgery (MIS) pedicle screw designed to simplify MIS spinal fusion surgery. VIPER PRIME reduces the number of instruments needed, the number of instrument passes and the number of steps required to insert a percutaneous screw utilizing a minimally invasive technique. The product was shown for the first time during this week’s EUROSPINE 2017 congress taking place in Dublin, Ireland.

Minimally invasive spinal fusion surgery is gaining popularity thanks to evidence that it may help improve outcomes when performing surgery through a smaller skin incision, which leads to less trauma to surrounding soft tissue, reduced blood loss during operation, and potentially a faster recovery for patients(3,4). However, as MIS fusion becomes more common, there is a need to simplify these procedures and overcome clinical challenges associated with the current technology.

By combining all the pedicle preparation instruments into one single tool, the VIPER PRIME System eliminates the need for guidewires, Jamshidi needles and additional pedicle preparation instruments. In one bench study, the VIPER PRIME System demonstrated a 33 percent reduction in the time required to insert a pedicle screw compared to traditional MIS techniques(2).

“I find the VIPER PRIME System easy and straightforward and I look forward to using it again for my future spinal fusion cases,” said Dr Kavakebi, an early user of the system from University Hospital Innsbruck, Austria.

Dr. Bordon from Hospital Manises, Valencia, Spain, who conducted the first surgery with the system in Europe concludes, “My OR team were very positive about the ease of assembly and the low footprint of the new system, that led to a more organized operating room.”

The VIPER PRIME System requires only two instrument trays, which may result in a more organized back table with fewer instruments, enhancing surgical workflow. The streamlined instrument set means a smaller procedural footprint that can also help reduce waste and processing costs.

“As a leader in pedicle screw technology, we have a responsibility to continue to innovate ways to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine.

“The VIPER® System has more than ten years of clinical heritage and this introduction of VIPER PRIME is our latest example of how we are providing differentiated technologies that simplify spine surgery, making it more reproducible for every surgeon while improving patient outcomes,” concluded Jordy Winters, DePuy Synthes Spine EMEA Lead.

About DePuy Synthes Companies
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, 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 .

Notes to editors
The VIPER PRIME System is currently being introduced to health care professionals in the Europe, Middle East and Africa (EMEA) region during educational and industry events. Full EMEA commercial availability of this tool is expected in early 2018.

The third-party trademarks used herein are the trademarks of their respective owners.

©Johnson & Johnson Medical Limited. 2017. All rights reserved.

Registered Office: Johnson & Johnson Medical Limited, PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom. Incorporated and registered in Scotland under company number SC132162

References

  1. VIPER PRIMETM System Overview – DSEM/SPN/0617/0698
  2. Internal data on file: ADAPTIV test report 103327910. Note: Bench tests results may not necessarily be indicative of clinical performance.
  3. Jhala, Amit, et al. Minimally invasive transforaminal lumbar interbody fusion. Indian Journal of Orthopaedics 48(6) (2014 Nov-Dec); 562-567
  4. Peng, Chan Weam Benedict, et al. Clinical and Radiological Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion. SPINE Vol. 34, Number 13 (2009); 1385-1389.

DSEM/SPN/1017/0761

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ExtremitiesReconSpineTop Stories

The Big Squeeze – Reps are ditching Big Ortho bags to build their own. Why it’s happening, and how to be successful.

October 13, 2017 OrthoSpineNews

I have seen a lot of tenured ortho sales people leave the comfort of “Big Ortho” and take on the role of Distributor or rep for much smaller start-ups. I want to deconstruct the forces driving this change and the dynamics between all the players. Then, we will explore what drives the variability in results of this new model. Finally, I will leave you with some ideas on how you can become a high caliber distributor prepared to thrive in a new role.

Big Ortho vs The Rep

As pricing pressures continue to push profits down, manufacturers are looking for more ways to improve their bottom line. As referenced in my previous article The Unsung Hero of the Orthopedic Industry – The Rep, the distributors and reps bear the brunt of much of the pricing compression. It seems as though the easy target for the squeezing is the one furthest from the boardroom – the Sales Reps and Distributors.

We have seen large companies’ commission rates fall well below 20%. At the same time, ASP’s (Average Selling Prices) continue to fall with corporate negotiated hospital or GPO contracts. The result is an inverse relationship where reps have to do more cases to make the same amount of money as last year. Increasing business 20-30% is a more difficult challenge than ever before due to increased consolidation and competition in the marketplace.

We are left with a dynamic where Small Ortho can capitalize on the inverse relationship Big Ortho reps face. By offering significantly higher commission and the ability to be their own boss, small ortho is attracting experienced representation that can leverage established relationships and navigate familiar approval processes.

“The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.The Ortho Startup & The Rep”

The orthopedic start up market continues to attract venture and private equity funding as forecasts like, “OrthoBiologics market to reach $6.06B by 2022” present fertile ground. Additionally, as Big Ortho seems more comfortable investing in M&A rather than R&D, start-ups have a clear exit strategy.

As the device market matures and patents expire, new doors open for clever copycats. This phenomenon presents opportunity for smaller, more nimble competitors to gain a strategic advantage and capture business that was once securely owned by Big Ortho. Innovative technology or even just novel improvements to antiquated systems can lead to profitable acquisitions.

This is not to say it is an easy endeavor for start-ups to break into orthopedic implants. R&D, Regulatory affairs, and the rapidly evolving landscapes of hospitals and GPO requirements present evermore complex and time-consuming barriers for small companies. As with any new venture, more time translates into more money and that unknown timeline can be very detrimental to a small company. Finding representatives and distributors capable of steering through this “mine field” is a critical driver of their success.

The Challenge

The challenge for many smaller orthopedic companies is that the caliber of distributor that they are able to attract tend to be limited to a Sales Rep who decided to bail out of a larger company for the reasons described above. They require very little support or training and they can hit the ground running to achieve some success fairly quickly. But, for what these reps bring in strong relationships and technical know-how, they often lack in infrastructure and leadership experience. As a result, what the company ends up with is little more than what we call a “Super Rep” who’s sales plateau sooner than expected.

The reason most plateau quickly is that they don’t have any of the infrastructure that a seasoned distributor typically does. No one can blame them since they are essentially a rep who now enjoys the full distributor commission rather than a split. Rather than owning a business, they effectively only own a job and want to keep overhead low and profits high. This is a short-sighted solution and the distributors who are in this category are quite vulnerable. Without a team and support infrastructure, they are little more than the sum value of the surgeon relationships.

For the manufacturer, this poses a problem of scalability. If these Super Reps don’t begin to take on the responsibilities of a true distributor or agent, they will struggle to capture more geography and build a valuable and sustainable business. While it may satisfy some, manufacturers don’t see these players as long-term partners. The success of Big Ortho came from having strong, long-term partnerships with distributors and agents who invested in their businesses and built sustainable enterprises that were able to scale.

Where many of these new distributors are failing is in building a foundation of scalability and making the necessary investments into their company’s future sustainability. Setting the right foundation for success early in the scaling process is paramount. It’s not necessary to make large capital investments, but setting up the right foundation is paramount to prolonged success.

“As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers.”

Data-driven Distribution

Where does one start? First, start with the basics: as a distributor, you need to have a legitimate company website if you want to be seen and prospected by companies looking for new distributors. You and I both know the surgeons and hospitals don’t give much thought to that. But, if you’re successful, M&A will eventually impact the lines you carry. Continually prospecting and being visible to companies with new technologies is a key part of remaining relevant and positioning yourself for success in your local market. Having a website enables you to project the image that you take your business seriously and are taking steps to be professional. Manufacturers want to see that you work ON your business and not merely in it.

Having a website also enables you to use an email address with your company’s name on it rather than a gmail, or worse: your AOL address. Nothing says “mom & pop” like a distributor using a internet service provider’s email address. The quality of your website is also important as it projects the image of your company. If it is too “1990’s,” people will draw the conclusion that you are still back in the dark ages and not availing yourself of the latest technologies. This can be an impediment to attracting some of the companies with newer innovations that are seeking representation. A website can be done very inexpensively and deliver the right message and image.

Another inexpensive way to differentiate your distributorship is by leveraging technology to manage your business. Using a whiteboard, Google Calendar and group text messages to manage inventory presents you as a risky proposition when it comes to companies allocating valuable assets to you. As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers. Technology should impact your business in several ways: coordinate your team’s schedules, quickly schedule cases, manage day to day sales activities, track your inventory from multiple manufacturers, consolidate your manufacturer’s invoices and open PO’s. In other words, run your business in the 21st century.

While I am biased in believing our platform, Surg.io, is the best solution for reps and distributors, any electronic system is better than none. Keep in mind that manufacturers entrust a great deal of money into your hands by way of implant and instrument inventories. Your existing and future partners want to see that your utilization brings about a healthy return on investment. Nothing is more compelling than efficient infrastructure and solid data to support your request for additional inventory or even, data to support keeping the inventory you currently have. Equally, nothing more undermines your partnership with a manufacturer than inefficient use and tracking of their inventory.

Implementing one of these platforms doesn’t need to be onerous. While there is always a bit of a learning curve when starting up, once you get through the on-boarding process and everyone is using it, it will be a lifesaver. In addition to better organization and inventory utilization, using Surg.io, or a similar platform, helps you create margin in your day for more selling by streamlining all your processes. It enables you to better communicate as well as ensure that everyone is singing from the same sheet of music. If all you’re using is Google Calendar, you’re missing a whole host of features and analytics that can take your business to the next level.

Looking Ahead

As challenges continue to mount and the odds continue to stack against orthopedic distributors, only those who embrace technology and figure out how to leverage it will be able to thrive through the next 10 years of the evolution of the industry. Doing more with less will continue to be the pressure and will require a strategic approach to supply chain management. Projecting a “no tech” business to manufacturers poses a profound risk to distributors and with how easy and inexpensive as it is, seems to be a very risky proposition. The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.

To learn more about Surg.io and how to leverage it for growth and scalability, visit www.Surg.io and request a demo.

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SpineTop Stories

Alphatec Denounces “Baseless” NuVasive Complaint

October 11, 2017 OrthoSpineNews

CARLSBAD, Calif., Oct. 11, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, released a statement in response to a recent complaint filed by NuVasive, Inc. (Nasdaq:NUVA) against Patrick S. Miles, Alphatec’s recently appointed Executive Chairman.

On October 10, NuVasive, without prior inquiry or notice, filed a baseless lawsuit against Mr. Miles. NuVasive then issued a press release to broadcast the complaint, not to “protect corporate assets” as stated, but in an attempt to inflict maximum damage to the public reputations of both Mr. Miles and Alphatec. The complaint is fictional, and includes disclosures by NuVasive that breach its contractual confidentiality obligations owed to Alphatec.  It was filed by a law firm in violation of its own ethical obligations, as the firm is currently actively representing Alphatec in related matters.

“I was fortunate to be a part of NuVasive’s growth from zero dollars in sales to close to a billion dollars in revenue,” said Mr. Miles.  “I am exceptionally proud of my contribution, and I have lifelong friends who remain affiliated with the organization.  I did not leave NuVasive to damage the company; in fact, I remain a significant shareholder.  I chose to pursue a new opportunity at Alphatec because I want to align my talents and influence with a Company that is focused on serving spine surgeons and their patients.  The allegations made by NuVasive against me are clearly false, and typical of a management team reacting to mass departures of key, spine-experienced executives.  I intend, ultimately, to clear my name. In the meantime, I will not be distracted by baseless claims, and will drive Alphatec’s pursuit of improved surgical outcomes.”

Terry Rich, Alphatec’s Chief Executive Officer, continued, “I have known Pat since I joined him in building NuVasive twelve years ago. He is well known to the spine industry worldwide and is highly respected for his integrity.  The complaint against him is full of false claims, and is nothing more than a PR stunt by NuVasive.  It has been orchestrated to detract from a decaying, toxic culture that has contributed to the resignations of three C-Suite officers since July 2017, and caused dozens of NuVasive employees and countless surgeon customers to reach out to Alphatec, seeking more attractive opportunities. The current issues at NuVasive have nothing to do with Pat. We look forward to continuing to move our business forward under his leadership.”

Mr. Miles plans to file a timely response to the complaint. Alphatec will vigorously support him in this matter.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:

Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com

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Spine

K2M’s Lamellar 3D Titanium Technology™, BACS™ Surgical Planner, & RAVINE® Lateral Access System to Be Presented at EUROSPINE 2017

October 11, 2017 OrthoSpineNews

LEESBURG, Va., Oct. 10, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that clinical data related to K2M spinal solutions will be presented at EUROSPINE 2017, occurring October 11–13, 2017, in Dublin. The Company will also showcase its comprehensive product portfolio, 3D-printed spinal solutions, and Balance ACS™ (BACS™) platform at Booth F20.

“Taking a comprehensive approach to spine surgery allows me to address my patients’ individual treatment needs more precisely,” said Robert Lee, FRSC, TR & Orth, a spine surgeon at Royal National Orthopaedic Hospital NHS Trust in Stanmore, UK, and author of five studies on K2M products to be presented this week. “Our research supported favorable findings on surgical planning software, minimally invasive surgical techniques, and 3D porous CASCADIA™ interbody cages that utilize Lamellar 3D Titanium Technology™.”

Data from five clinical studies on K2M’s CASCADIA Interbody Systems featuring Lamellar 3D Titanium Technology, BACS Surgical Planner, and RAVINE® Lateral Access System will be presented:

  • 3D Porous Lamellar Titanium Lateral Interbody Cages: Subsidence Rates Compared to PEEK and Early Clinical Outcomes, Lee R (Poster 26)
  • Clinical and Radiographic Results Following the Use of Lateral Interbody Cages to Restore Lumbar Lordosis in Revision Fusion Surgery, Lee R (Poster 27)
  • 3D Porous Lamellar Titanium versus PEEK and Solid Titanium Interbody TLIF Cages: A Prospective Clinical and Radiographic Comparison, Lee R, Wilson L (Poster 28)
  • Minimally Invasive Anterior Column Reconstruction in Primary Adult Degenerative Scoliosis Correction Surgery, Lee R (Poster 84)
  • Reliability of Pre-Operative Surgical Planning Software in Predicting Postoperative Alignment in Patients Undergoing Minimally Invasive Multilevel Anterior Column Reconstruction for Positive Sagittal Balance Deformity, Lee R (Poster 85)

K2M Chairman, President, and CEO Eric Major said, “We are pleased by the amount of research on K2M products being presented at this year’s EUROSPINE meeting. K2M is leading the way in 3D spinal innovation—as evidenced by our market-leading 3D-printed product portfolio and comprehensive Balance ACS platform—to help surgeons treat many different spinal pathologies both in European countries and across the globe.”

At the meeting, K2M will showcase its comprehensive portfolio of complex spine, minimally invasive, and degenerative solutions, including the CASCADIA Interbody Systems featuring Lamellar 3D Titanium Technology, the EVEREST® Minimally Invasive XT Spinal System, the EVEREST Deformity Spinal System, the RAVINE Lateral Access System, the MESA® Deformity Spinal System, the RHINE™ Cervical Disc System*, and more.

K2M will also feature its Balance ACS platform, which provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. The Company will demo the BACS Surgical Planner, a surgical image measuring technology that assists in planning and preoperative implant selection.

For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

*This product is intended for export and is not sold or offered for sale in the United States.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

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SpineTop Stories

ORHub, Inc. Welcomes Internationally Recognized Spine Surgeon to its Advisory Board

October 11, 2017 OrthoSpineNews

NEWPORT BEACH, CA–(Marketwired – Oct 6, 2017) – ORHub, Inc. (OTC: ORHB), an advanced medical software provider focused on real-time digital delivery of case-based data analytics, today announces the appointment of Dr. Choll Kim, an industry-leading physician and instructor in the technological automation of surgical procedures, to its advisory board.

As an internationally renowned expert in the field of computer-assisted, minimally invasive spine surgery, Dr. Kim has considerable insight into the intricate evolution of technology in the surgical sector, an invaluable resource that will strengthen ORHub’s grasp in the marketplace.

“In today’s health care environment, excellent clinical care must be delivered in a cost-effective manner. ORHub recognizes this industry demand, and provides a much-needed point-of-service system that allows both surgeons and hospitals to monitor the time and cost of the entire episode of surgical care. By providing reliable data in a manner that is useful to both surgeons and hospitals, a real collaborative effort can be pursued to optimize patient care. I am excited to be part of ORHub and the important efforts that will arise from improved information gathering and analysis. With this advisory role, I finally feel like I can be a meaningful participant in the ongoing effort to optimize health care efficiency while providing the highest level of care to my patients,” states Dr. Kim.

A leader in his field, Dr. Kim is the founder and past-president of the Society for Minimally Invasive Spine Surgery (SMISS), the founder of Minimally Invasive Spine Centers of Excellence (MIS-COE), the chair of the MIS Committee for the International Society for the Advancement of Spine Surgery (ISASS), the director of the Advanced Spine & Joint Institute at Alvarado Hospital, and an associate clinical professor at the University of California, San Diego.

He utilizes a broad range of minimally invasive treatments to effectively treat all aspects of complex spinal disorders, including herniated disks, spinal stenosis, adult scoliosis, spondylolisthesis, traumatic injuries, tumors, and infections throughout the entire spine — from the neck to the low back. Dr. Kim is one of only a handful of surgeons in the world to master laser endoscopic spine surgery (LESS), a state-of-the-art minimally invasive procedure that effectively treats herniated disks, radiculopathy and sciatica.

Dr. Kim graduated cum laude from Harvard Medical School and completed his fellowship training in complex spine surgery at the Mayo Clinic. He is double-board certified by the American Board of Orthopedic Surgeons and the American Board of Spine Surgery.

“Dr. Kim is a phenomenal addition to our team, as he has gained international recognition in his field, and has trained a new generation of surgeons and operating room personnel in technologically advanced operating systems. As a substantial contributor to the evolving industry, he has trained innumerable specialists throughout the country on the safe and effective application of state-of-the-art techniques using image guidance and navigation technologies. We believe that he will be an invaluable source of knowledge as we grow in the industry,” states ORHub CEO Colt Melby.

About ORHub, Inc.

ORHub is a medical software company focused on delivering case-based data analytics at the speed of surgery. The Company’s suite of products serves the needs of the health care industry, hospital, patient, government and the medical device vendor. ORHub provides a cloud-based software solution that captures information before, during and after surgery, filling a void in the current surgical information infrastructure and providing the first process to capture and measure the surgical process — evolving Big Data into Intelligent Digital Data.

ORHub’s software applications allow hospitals and medical device vendors to utilize any web-enabled device to create an anatomical graphic depiction of exactly what occurs during surgery. The application automatically translates the resulting schematic into an intelligent, electronic operative report that links every detail of surgery, including implant location, surgical techniques, product usage, and all clinical parameters to create a dynamically new source of comparative information.

As a result, hospitals and surgeons can make real-time, data driven decisions to improve business profitability and the quality of patient care. This innovative technology results in hospitals understanding costs and identifying areas of cost reductions, as well as results in increased accountability, automatic creation of comprehensive anatomic implant registries, real-time analytics, improved efficiencies, and compliance with existing government regulations. ORHub has offices in Phoenix, Arizona; Newport Beach, California; and Bellevue, Washington.

For more information, visit www.ORHub.com

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although the Company believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, it can give no assurances that its expectations will be attained. Such statements are inherently uncertain, and actual results and activities may differ materially from those estimated or projected. Certain factors that can affect the Company’s ability to achieve its anticipated results include, among others, uncertainties inherent in the development of a new software product business.

CONTACT INFORMATION

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SpineTop Stories

French surgeons use robot & 3D printed model to fix 6-year-old’s spine in world-first surgery

October 11, 2017 OrthoSpineNews

Oct 10, 2017 | By Tess

A team of surgeons from the Amiens-Picardie University Hospital in France has successfully performed a complex spinal surgery on a six-year-old boy with the help of a robot and a patient-specific 3D printed model. The procedure was the first of its kind.

 

 

The patient in question is a six-year-old boy who was suffering from a combination of severe progressive scoliosis and infantile spinal amyotrophy, a condition that causes weak muscles. The scoliosis had become so severe that the young boy could not even sit. Obviously, something had to be done.

The complex surgery, which took place on September 28, was the result of over a year of planning on the part of Dr. François Deroussen, a pediatric orthopedic surgeon; Professor Richard Gouron, head of the child surgery department at the hospital; and Dr. Michel Lefranc, a neurosurgeon.

To prepare for the operation, the doctors took a scan of the child to get a detailed visualization of the position and state of his spine. With the 3D scan, the doctors were able to take their planning one step further by 3D printing an accurate replica model of the patient’s spine.

 

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RoboticsSpineTop Stories

Globus Medical Announces First Spine Surgeries Using ExcelsiusGPS™

October 10, 2017 OrthoSpineNews

AUDUBON, Pa., Oct. 10, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the first spine surgeries using ExcelsiusGPS™, a revolutionary robotic guidance and navigation system. Surgeries using ExcelsiusGPS™ were performed last week at The Johns Hopkins Hospital in Baltimore, Maryland and St. Mark’s Hospital in Salt Lake City, Utah.  The surgical team at Johns Hopkins was led by neurosurgeons Dr. Nick Theodore and Dr. Ali Bydon, while orthopedic spine surgeon Dr. Kade Huntsman performed the surgeries at St. Marks.

“ExcelsiusGPS™ is the only robotic system that combines surgical navigation and robotic guidance for spinal surgery, which offers significant advantages to spine surgeons,” said Dr. Huntsman, “The system has been designed to take into account the typical surgical workflow to facilitate procedural efficiency.”

“ExcelsiusGPS™ is the culmination of years of research and development efforts and demonstrates Globus Medical’s superior product development capabilities,” said Norbert Johnson, Vice President of Robotics, Imaging, & Navigation.  “We believe the ExcelsiusGPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.”

ExcelsiusGPS™ supports minimally invasive and open screw placement procedures. It seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

Globus Medical expects its first revenues from the sale of ExcelsiusGPS™ systems to occur in the fourth quarter 2017, in alignment with current company guidance.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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