Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017

Matrixx_System.jpg

October 4, 2017 OrthoSpineNews

October 04, 2017

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the NEXXT MATRIXX™ System.

The NEXXT MATRIXX™ System of 3D printed porous titanium leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

Several studies have shown that textured titanium alloy surfaces elicit a positive bone response including an increase in osteoblast differentiation and surface osteointegration as compared to classically smooth surfaces. With these studies in mind, Nexxt Spine has coupled their proprietary, residue-free, surface technology with an open, varied porosity, titanium architecture whereby the NEXXT MATRIXX™ implants exhibit up to 4X more surface area for bone apposition and up to 2X more open pore volume than conventional spinal implants.

Andy Elsbury, President of Nexxt Spine, stated, “The NEXXT MATRIXX™ System applies breakthrough technology to our company’s product portfolio and surgeon response has been overwhelmingly positive. We will continue to expand our NEXXT MATRIXX™ offering throughout 2017 and into 2018 to ensure this differentiated technology is available for all spinal fusion surgical approaches.”

The first products to feature the NEXXT MATRIXX™ technology are available in both interbody and VBR options in an assortment of height, length, width and lordotic angulation combinations to accommodate the unique anatomic and clinical circumstances of each patient.

For more information about NEXXT MATRIXX, visit www.nexxtspine.com.

Nexxt Spine, LLC is a privately held medical device manufacturer dedicated to increasing procedural efficiency and patient outcomes through development of innovative products, manufactured on the most technologically advanced platforms, and utilizing irreproachable quality standards to treat painful and debilitating spinal pathologies.

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

Contacts

Nexxt Spine, LLC
Sarah Koch
Info@NexxtSpine.com


cropped-drkendall.png

October 4, 2017 OrthoSpineNews

WASHINGTONOct. 3, 2017 /PRNewswire/ — National Spine & Pain Centers (NSPC) (https://treatingpain.com/) is pleased to announce one of its physicians, Dr. Dan Kendall, recently treated a vertebral compression fracture (VCF) using the AVAflex Balloon System from Stryker. This technology is less invasive than traditional VCF treatments, with potential for less risk and patient trauma. National Spine & Pain Centers is committed to pioneering solutions to chronic pain, and this first application of the AVAflex Balloon System in the D.C. Metro area is only the latest example.

“In using Stryker’s AVAflex technology during a balloon kyphoplasty procedure,” says Dr. Kendall, “I was able to treat the patient using only one trocar while still achieving the results I look for with using two trocars. Using one trocar provides less patient trauma and further minimizes risk for infection.”

Balloon kyphoplasty is a minimally invasive treatment for vertebral compression fractures. In a standard balloon kyphoplasty, two trocars are inserted into the fractured vertebrae.  Balloon catheters are then inserted through the trocar needles and inflated to create a void.  The hardened bone cement creates an internal cast in the fractured vertebrae stabilizing the fracture and alleviating pain. Stryker’s AVAflex Balloon System represents a crucial step forward for balloon kyphoplasty, offering a less invasive approach.

Dr. Kendall performs balloon kyphoplasty’s in his office in McLean, Virginia.  With the advancement of technology in treating VCF’s, patients no longer have to go to the hospital and can receive the treatment without receiving general anesthesia.  Dr. Kendall now is able to treat his patients with painful compression fractures with a short 20-minute procedure and mild sedation. This allows the patient to be treated as out-patient enabling them to walk out of the office when released.

“I am always looking for the best and most effective way to treat my patients,” adds Dr. Kendall. “Typically, my patients with VCFs are elderly and in severe pain. Stryker’s AVAflex balloon technology allows me to perform a balloon kyphoplasty procedure efficiently while still delivering great results.”

In addition to treatments for VCFs, National Spine & Pain Centers also provides solutions for people experiencing arthritis, migraine headaches, spinal stenosis and diabetic neuropathy, among many other conditions. Innovative treatment modalities include discography, epidural nerve block, platelet rich plasma (PRP) therapy, stem cell therapy and spinal cord stimulation.

In view of the opioid crisis, Interventional Pain Management (IPM) groups such as National Spine & Pain Centers are playing a pivotal role in delivering outcome-driven treatment solutions that provide comprehensive, effective care for patients suffering from chronic pain.

Dr. Dan Kendall joined NSPC in 2004 after completing an interventional pain management fellowship at Johns Hopkins Hospital. He has published numerous articles and lectured nationally on interventional pain topics, and has earned not only the esteem of his peers but also the admiration of his patients.

About National Spine & Pain Centers

National Spine & Pain Centers (NSPC) is the nation’s leading network of pain management practices with over 65 pain physicians on staff at more than 60 locations in ConnecticutMarylandNew JerseyNew YorkNorth CarolinaVirginiaWashington DC and West Virginia. Many NSPC physicians are among the most respected pain practitioners in the world.

Contact:

Manju Regmi
P: 301-881-7246 ext: 10163
11921 Rockville Pike #505
Rockville, MD 20852
http://www.treatingpain.com/
177514@email4pr.com

SOURCE National Spine & Pain Centers


descarga-7.jpg

October 3, 2017 OrthoSpineNews

October 02, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today the results of a new White Paper titled Patient-Specific Rods show a reduction in rod breakage incidence. The paper shows that, relative to manually bent rods, patient-specific rods generated using Medicrea’s UNiD ASI technology significantly reduce the incidence of postoperative rod breakage in adult complex spine surgical cases.

The study, authored by an international group of 9 complex spine surgeons from the U.S. and France, reviews a cohort of more than 450 Adult Spinal Deformity (ASD) patients with at least 1 year from the surgical implantation of patient-specific UNiD™ Rods, generated by Medicrea’s UNiD ASI™ systems-based technology for personalized spinal care. This cohort includes more than 120 patients who additionally had pedicle subtraction osteotomy (PSO) performed.

The White Paper demonstrates the rate of rod fracture is considerably less in ASD patients implanted with UNiD™ Rods, when compared to current literature, especially in those having undergone PSO. With a UNiD™ Rod, breakage was detected in 2.2% of all ASD patients and in 4.7% of cases with a PSO performed. These rates decrease further when you remove patient-specific rods that were adjusted during the operation. In the current literature involving non-personalized spinal implants, overall rod breakage incidence is reported as high as 14.9% of patients following ASD surgery [3-5]. When a PSO is performed, the rod fracture rate increases up to 22% and in these cases, 90% of failure is found to occur at, or adjacent to, the PSO level [3-4]. Furthermore, the time to failure is most often seen to occur within 10 months after surgery.

Rod Fracture Incidence

ASD Patients

ASD Patients
with PSO

ASD Patients
with no manual
rod bending

ASD Patients
with PSO and
no manual rod
bending

Standard Rod 14.9% 22.0%
Patient-Specific UNiD™ Rod 2.2% 4.7% 1.8% 3.1%
Fracture Reduction with UNiD™ Rod -85% -79% -88% -86%

Adult Spinal Deformity surgery is increasingly prevalent in an aging population and poses particular challenges with high complication rates that can lead to revision surgery in a reported 16.5% of cases [1] at a substantial cost to the healthcare system found to total around $80,000 per surgery [2]. Thus, avoiding revision surgery can provide a significant savings to the health care system.

Dr. Themistocles Protopsaltis, of NYU Langone Medical Center and co-author of the White Paper, stated, “This review demonstrates that utilizing digitally planned, patient specific UNiD™ Rods which avoids manual rod contouring has a major impact on rod fracture incidence in the treatment of Adult Spinal Deformity. This is important because rod breakage leads to revision surgery at significant cost to the patient, hospital and payer.” Dr. Protopsaltis continued, “Adopting an iterative, data-based approach that is shown to make spinal surgery more efficient can change a surgeon’s practice, making UNiD ASI™ a true advance in our standard of care.”

Denys Sournac, President and CEO of Medicrea, stated, “These results highlight how our proprietary UNiD system can improve both clinical and economic outcomes in spine surgery. We will continue to follow these cases and add to our growing database of more than 1,700 cases. The advanced data science built into our recently FDA-cleared UNiD HUB™ software allows Medicrea to perform advanced surgical simulations as we further harness the power of big data to plan the optimal surgical strategy and design implants adapted to the specific requirements of each patient and surgeon.”

White Paper Authors: A. Vaccaro, V. Fiere, S. Fuentes, T. Raabe, P. Passias, T. Protopsaltis, A. Faure, P. Tropiano, B. Blondel

To receive a pdf of Patient-Specific Rods show a reduction in rod breakage incidence please contact clinicalstudy@medicrea.com.

References

1 – Passias, P.G., et al., Predictors of Revision Surgical Procedure Excluding Wound Complications in Adult Spinal Deformity and Impact on Patient-Reported Outcomes and Satisfaction. J Bone Joint Surg Am, 2016;98:536-543.
2 – McCarthy IM, Hostin RA, Ames CP, et al. Total hospital costs of surgical treatment for adult spinal deformity: an extended follow-up study. Spine J. 2014.
3- Smith, J.S., et al., Prospective multicenter assessment of risk factors for rod fracture following surgery for adult spinal deformity. J Neurosurg Spine, 2014;21:994-1003.
4 – Barton, C., et al., Risk factors for rod fracture after posterior correction of adult spinal deformity with osteotomy: a retrospective case-series. Scoliosis, 2015:10-30.
5 – Hamilton, D.K., et al., The Fate of Adult Spinal Deformity (ASD) Patients Incurring Rod Fracture After Thoracolumbar Fusion. World Neurosurgery, 2017. In press.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:

FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com


Elitewithfibers311.jpg

October 3, 2017 OrthoSpineNews

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in Anatomy-Conserving Surgery™, is pleased to announce the full market release of the Elite Expandable Interbody Fusion System. More than 300 cases have been completed using Elite, and system utilization continues to accelerate as the full market release of Elite is initiated.

“Following the successful completion of the Elite Expandable Interbody Fusion System limited release and the receipt earlier this year of the expanded FDA clearance, which included the addition of a narrower 10mm footprint and allograft bone labeling, we have now initiated the full market release of Elite,” said John Booth, CEO of Spineology. “The Elite’s robust design, broad size offering, and allograft bone labeling which allows the surgeon to pair Elite with Incite™ Cortical Fibers, have all been received extremely well by our customers. We are excited to continue to accelerate the growth of Elite in the expandable cage market.”

The Elite Expandable Interbody Fusion System implant is inserted into the lumbar disc space at a contracted minimum height and, once in position, is expanded to restore anatomic disc height, provide anterior column support, and potentially indirectly decompress. Elite offers the surgeon the ability to control device expansion and lock the device at any position in the expansion range. The Elite implant is constructed of titanium alloy and has a large graft window to enable bone through-growth, maximizing fusion potential.

Incite Cortical Fibers are a unique and versatile bone grafting solution. The fibers offer an osteoconductive and inductive matrix, excellent handling properties, in-situ expansion, and placement options via a variety of delivery methods.

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com


1502736943678-1-1.png

October 3, 2017 OrthoSpineNews

WARSAW, Ind.Oct. 2, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it is officially launching in the United States the Avenue® T TLIF Cage. Avenue T advances posterior lumbar cage technology by incorporating VerteBRIDGE® plating, which facilitates simplified cage insertion and zero-profile, intradiscal fixation through a direct, minimally invasive surgical (MIS) approach. Avenue T is the first and only posteriorly implanted cage with integrated, anti-migration fixation, solidifying Zimmer Biomet as the first company to offer a suite of lumbar cages with integrated fixation for every fusion approach. Avenue T joins a family of cages with VerteBRIDGE plating, including ROI-C® Cervical Cage, Avenue® L Lateral Lumbar Cage and ROI-A® ALIF Cage.

Dr. Craig Chebuhar, a board-certified orthopaedic spine surgeon in Atlanta, Georgia, who implanted one of the first Avenue T cages in the U.S., commented, “I regularly use Zimmer Biomet’s ROI-C Cervical Cage featuring VerteBRIDGE plating in my practice.  Transforaminal lumbar surgery is another attractive application for integrated plating.  For my TLIF patients, I appreciate the additional fixation VerteBRIDGE provides to the construct, all via a minimally invasive approach.”

The Avenue T Cage is a prime example of Zimmer Biomet’s commitment to the advancement of MIS surgery. The Avenue T Cage and self-guided, curved VerteBRIDGE plating are delivered in the plane of the disc through a simplified technique. The VerteBRIDGE plates are sterile packaged and pre-assembled on a PEEK cartridge. The cartridge simplifies the technique, enabling the cage and plates to be loaded simultaneously on the Inserter. Once the cage is implanted, the Impactor advances both plates at the same time, reducing implantation steps. The unique anterior column fixation provided by the plating may permit the surgeon to select from a greater array of options for supplemental fixation.

Indications: The Avenue T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.


TakingMIS_LEAD_DrHyderMISTLIF_WEB-1.jpg

October 2, 2017 OrthoSpineNews

Tracey Romero/9-29-2017

Photo: PROLIFT® and Dr. Zeshan Hyder/Courtesy of Life Spine

In an arena of rapid technological advancement, it takes an innovation powerhouse to design products that have the ability to disrupt the spine industry. Life Spine, a manufacturer of spinal implants that launched 27 products in 2016, has revolutionized the TLIF taking it from a 90+ minute minimally invasive procedure to a micro-invasive procedure that has been completed in as little as 25 minutes.

Surgeons like Zeshan Hyder, D.O. of the Bone and Joint Specialists of Northwest Indiana are executing up to six of these procedures in one day. The potential benefits of a drastic reduction in procedural time are directly realized by surgeons and their patients. The system is designed to offer the benefits of: less time in the hospital and OR, reduced incision size, a safer surgery and a more reproducible procedure that caters to an ambulatory surgery center (ASC) setting.

The main benefit of the micro-invasive TLIF is less time in the operating room which typically correlates to a faster recovery.

Traditional TLIF procedures can take up to six hours. Six hours of muscle retraction, anesthesia, blood loss and fatigue to the hospital staff. Additionally, the longer the operating time, the fewer the patients a surgeon can operate on and the higher the cost of surgery.

 

READ THE REST HERE

 


5818-Building_CRW_4599-509x400-1.jpg

October 2, 2017 OrthoSpineNews

CARLSBAD, Calif., Oct. 02, 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, announced that Patrick Miles has been appointed as Executive Chairman and Quentin Blackford as a member of the Board, effective today.  Miles will lead the organization, and Terry Rich, Alphatec‘s Chief Executive Officer, will continue in his role, reporting to Miles. In conjunction with these appointments, Miles and Blackford are personally investing in Alphatec common stock in an aggregate amount in excess of $3.5 million.

“Today’s announcement marks continued execution of our vision to reposition Alphatec as the most respected, fastest-growing company in U.S. spine,” said Mr. Rich. “Pat and Quentin have decades of industry experience and well-deserved reputations that speak for themselves. Their personal financial commitments are a powerful testament to their personal commitments to increase shareholder value; a conviction that has been expressed by our entire leadership team.”

Rich continued, “Pat is a globally recognized spine visionary and a proven driver of market-share expansion.  His passionate belief that our most important business is in the operating room aligns absolutely with the Alphatec value system, and positions him extraordinarily well to lead the organization. I have great confidence that Pat’s influence on daily operations, product development decisions, and surgeon engagement will accelerate the business transformation that we are driving. I look forward to partnering with him to advance Alphatec’s growth trajectory by executing our mission to improve patient lives.”

Miles brings a wealth of orthopedics and innovation expertise, with over 25 years of industry experience, and as a named inventor on close to 100 industry patents. In his capacity as Executive Chairman, he will be fully engaged, focusing primarily on further defining and implementing Alphatec’s strategic initiatives, expanding and fortifying the Company’s relationships with surgeon customers, and leading Alphatec’s new technology development.  Miles joins Alphatec following a 17-year tenure at NuVasive, Inc., where he was a central figure in the company’s expansion from a start-up business to a global spine corporation with close to $1 billion in revenues.  He most recently served as NuVasive’s Vice Chairman; prior to that, he was its President and Chief Operating Officer, and President of Global Products and Services.  Before joining NuVasive, Mr. Miles held sales and marketing roles with Medtronic Sofamor Danek and Smith & Nephew.

“I am thrilled to work closely with Terry once again to reposition Alphatec as the next great growth story in spine. Together, we share roughly 50 years of spine and orthopedics expertise – a level unrivaled in spine leadership – which will guide us in determining how best to serve this market.  I look forward to driving toward improved surgical outcomes and market share expansion,” said Miles. “Alphatec has a broad and impressive product portfolio, improving surgeon engagement, and great access to hospitals; all of which position the Company exceptionally well to take market share in today’s environment. This is a high-caliber team driving an important mission, and I feel incredibly lucky to be a part of it.”

Blackford joins the Alphatec Board of Directors with 17 years of experience in the medical device industry.  He is currently Executive Vice President and Chief Financial Officer of DexCom, Inc. Prior to joining Dexcom, Blackford was Executive Vice President, Chief Financial Officer, Head of Strategy and Corporate Integrity for NuVasive.  In that role, he led the Finance, Strategy and Corporate Development, Compliance and Regulatory functions. Before joining NuVasive in 2009, Mr. Blackford held various leadership roles with Zimmer Holdings, Inc., including Director of Finance and Controller for Zimmer Dental.

“Alphatec has assembled an exceptional team of spine industry leaders who are already transforming the business.  I am excited to help shape the Company’s strategic direction as Alphatec evolves into a leading spine player,” said Blackford.

In connection with these appointments, Mortimer Berkowitz III, Alphatec’s Chairman since December 2016, will transition into the role of Lead Director. In addition, Stephen O’Neil has resigned from his position as a member of the Company’s Board of Directors, effective immediately.  Mr. Rich will also remain a key member of the Alphatec Board.

Mr. Berkowitz, said, “I would like to thank Steve for his 12 years of dedicated service to Alphatec, and for being a trusted colleague and counselor. I also enthusiastically welcome Pat and Quentin to the Alphatec family, and thank Terry for his efforts in bringing them aboard. They share the optimism and the vision that we have for the future of this Company, and I look forward to serving with them in the Lead Director role.”

Inducement Award 
As an inducement to accepting employment with the Company, and in accordance with applicable NASDAQ listing requirements, the Board of Directors has also approved an award to Mr. Miles of 1,000,000 restricted stock units (RSUs).

The RSUs will be granted following registration of the common stock underlying the RSUs and will vest in equal annual installments on each of the first three anniversaries of Mr. Miles’ date of employment if he remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The Board approved an amendment to Alphatec’s 2016 Employment Inducement Award Plan to increase the shares reserved for issuance thereunder by 1 million shares, effective October 2, 2017.

Equity Investments in Alphatec Common Shares
Mr. Miles has agreed to purchase 1.3 million shares of common stock and Mr. Blackford has agreed to purchase at least 220,000 shares of common stock and up to 440,000 shares of common stock, all at a purchase price of $2.26 per share (the consolidated closing bid price of Alphatec common shares on September 29, 2017), for gross proceeds to the Company of between $3.5 million and $4 million. The share purchases are expected to close on or before January 1, 2018. In connection with his purchase of Alphatec common stock, at the closing, Mr. Miles will also receive a five-year warrant to purchase up to 1.3 million shares of common stock at a purchase price of $5.00 per share which, if exercised, will generate additional gross proceeds to the Company of $6.6 million.

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


Screen-Shot-2017-09-29-at-2.09.27-PM-1.png

October 2, 2017 OrthoSpineNews

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is excited to announce the addition of Kevin McGann as Senior Vice President and General Manager. Mr. McGann joins the Ortho Sales Partners leadership team after a successful tenure with Stryker Spine as its Vice President of North American Sales where he was responsible for all US and Canadian sales, market development, commercial operations and medical education for all spine and biologics products in the US and Canada. Under his leadership, Stryker Spine saw consistent positive growth in revenue and share gain.

Prior to his role with Stryker Spine, Mr. McGann served as President, Americas Region for Lumenis Incorporated where he was responsible for all North and South American sales, marketing and operations overseeing $110M in revenue as well as a $40M annual operating budget. Lumenis Incorporated’s products serve the Urology, ENT, GYN, Ophthalmic and Aesthetic verticals. One of his more notable contributions was his involvement in taking the company public (NASDAQ) in the first quarter of 2014.

Mr. McGann started his Orthopedic career with US Surgical for over 15 years. He was later recruited to Kyphon which was acquired by Medtronic Spine and Biologics in 2008 for $4.2 Billion. After the integration, he was promoted to Area Vice President of Sales for the Eastern Division and he spent the last 3 years of his tenure with Medtronic as the Vice President of Sales, US Spine, Biologics and Operations where he had responsibility for an organization with over $1.5 Billion in annual revenue.

In his new role, Mr. McGann will be focused on utilizing his experience in creating and managing high caliber sales teams with a focus on scalability for the benefit of Ortho Sales Partners clients. In addition, Mr. McGann will bring insights in the areas of mergers and acquisitions, licensing, field operations, marketing and product messaging.

“I am very proud to be joining Ortho Sales Partners and the team of dedicated healthcare professionals and executives” said McGann. “The business model and access to experts in all areas of commercializing medical device platforms and products is unique and a key differentiator of Ortho Sales Partners. I look forward to helping the business continue to grow.”

“I am excited for what today’s announcement means for our clients” said Josh Sandberg President, Ortho Sales Partners. “Kevin McGann and his experience checks all the boxes we could hope for in adding a key executive to our management team. Our team offers unparalleled access and insights to the orthopedic, spine and orthobiologic industries. This addition allows us to further advance and assist companies avoid the impact of stalled growth.”

About Ortho Sales Partners

About Ortho Sales Partners – Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations such as:

  • A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
  • OUS companies looking to establish or enhance their presence in the United States.
  • Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
  • Established companies looking for marketing horsepower to properly launch a new product.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis rather than surgery volumes from over 4 years ago.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US (http://www.orthosalespartners.com).


YUKON_ProductImage_01_FullConstruct.png

September 29, 2017 OrthoSpineNews

LEESBURG, Va., Sept. 29, 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 it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its YUKON OCT Spinal System. YUKON OCT offers surgeons an advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.

The YUKON OCT Spinal System features newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation. YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws facilitate screw introduction and minimize the potential for cross-threading, while an updated occipital plate features integrated lateral holes with the goal of enhancing occiput fixation.

“The YUKON OCT System expands on K2M’s current offering while accounting for the challenging posterior cervical cases surgeons often treat,” said Chambliss Harrod, MD, a spine and orthopedic surgeon at the Bone & Joint Clinic of Baton Rouge. “Unlike systems that feature only highly favored angulation screw designs, YUKON OCT is a comprehensive system that offers surgeons the ability to treat a variety of spinal conditions—including routine degenerative cases, revisions, and complex cervical deformities.”

YUKON OCT’s advanced, streamlined reduction instrumentation allows for intraoperative flexibility and ease of use. The pistol grip style Rod Reducer provides 20 mm of reduction, while the Sequential Reducers deliver 20 mm of controlled reduction and correction.

“We are pleased to announce FDA clearance of the YUKON OCT Spinal System and the successful completion of its first surgical cases,” said K2M President and CEO Eric Major. “K2M is a global leader in spinal innovation and YUKON OCT is our new solution that deepens our expanding portfolio of spinal devices for the occipito-cervico-thoracic region of the spine. Accompanied by our comprehensive Balance ACS platform, YUKON OCT offers a competitive surgical solution with the goal of achieving Total Body Balance for patients.”

Balance ACS (BACS) 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.

For more information on the YUKON OCT Spinal System and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

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 FacebookTwitterInstagramLinkedIn, 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


7290-1.jpg

September 29, 2017 OrthoSpineNews

09-29-2017/Persistence Market Research

Spinal stenosis is a condition which usually occurs in the elderly patients. Stenosis mean abnormal narrowing of a body channel. This mean spinal stenosis is narrowing of the spinal canal. The narrowing of spinal canal occurs due to degeneration of intervertebral disk and facet joint. This condition mainly affects people above 50 years but can also affect younger people who are born with abnormal spinal canal. If the narrowing is minimal symptoms will not occur but too much narrowing can lead to compression of nerves and can be problematic. Spinal stenosis symptoms include lower back pain, numbness in legs and balance problem. It can occur anywhere along the spine.

A sample of this report is available upon request @ www.persistencemarketresearch.com/samples/15376

Spinal Stenosis Implant Market: Drivers and Restraints

Increasing prevalence of spinal stenosis is one of the major factor driving the growth of spinal stenosis implant market. Other factors contributing to the growth of the market are increasing older population and rise in the obesity cases which can lead to spinal injury or stenosis. Increasing demand and adoption of the minimally invasive surgeries and better relief over the medication are also factors driving growth in this market.

Spinal Stenosis Implant Market: Segmentation

The global spinal stenosis implant market can be segmented on the basis of product type, material type, end user, and region.

On the basis of the product type global spinal stenosis implant market can be segmented into:

Spacing Devices
Fusion Devices
On the basis of the material type global spinal stenosis implant market can be segmented into:

Stainless Steel
Titanium
On the basis of end user global spinal stenosis implant market can be segmented as:

Hospitals
Clinics
Ambulatory Surgical Units
Spinal Stenosis Implant Market: Overview

Spinal stenosis implant market is expected to show significant growth over the forecast period. Increasing case of arthritis and ageing of the population is expected to be the factor facilitating the growth of spinal stenosis implant market. Spacing is devices are expected to be highest revenue generating and fastest growing product segment due to increasing demand for minimally invasive treatments as this procedure has lesser risks involved and also it allows easy movement in comparison to fusion or fixation devices which involves long surgical process and higher blood loss. Along with this spacing devices provide faster and lasting symptoms relief and has lesser hospital stay. Titanium spinal stenosis implants are expected to be fastest growing, and highest selling as titanium is strong and light in weight when compared to the stainless steel implants and it has better elasticity which allows easy movement. Ambulatory surgical units are expected to have the highest number of such surgeries as these units are being used for performing the minimally invasive surgeries and patients don’t need to stay overnight.

Spinal Stenosis Implant Market: Region Wise Outlook

Geographically, spinal stenosis implant market can be segmented as North America, Latin America, Europe, Asia-Pacific and Middle East & Africa. North America is the highest revenue generating market for the spinal stenosis implants due to reimbursement policies and better healthcare infrastructures followed by Europe. Higher adoption rate of non-medicated treatment options and focus of major players to aware people is driving growth in this region. Asia Pacific is also expected to show significant growth due to presence of large population pool, ageing population and increasing case of spinal injuries. Japan is expected to be biggest Asia Pacific market for spinal stenosis implants due to increasing geriatric population.

To view TOC of this report is available upon request @ www.persistencemarketresearch.com/toc/15376

Spinal Stenosis Implant Market: Key Players

Some of the market participants in the spinal stenosis implant market are Stryker, Paradigm Spine LLC, Vertiflex, Inc., Orthofix Holdings, Inc., Medtronic Public Limited Company, Kyphon, Inc., Abbott and Zimmer Spine. Focus of the companies is changing over the past few years from fixation devices to spacing devices.

The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to categories such as market segments, geographies, types, technology and applications.

About Us
Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.
To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Contact Us
Persistence Market Research
305 Broadway
7th Floor, New York City,
NY 10007, United States,
USA – Canada Toll Free: 800-961-0353
Email: sales@persistencemarketresearch.com
Web: www.persistencemarketresearch.com

This release was published on openPR.